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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>WASHINGTON, D.C. 20549</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>FORM S-1</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>REGISTRATION STATEMENT</B> <B>UNDER</B>
<B>THE SECURITIES ACT OF 1933</B></P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><IMG SRC="s1_logo.jpg" ALT="">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><U>SYNTHETIC BIOLOGICS, INC.</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Exact Name of Registrant as Specified in
Its Charter)</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(State or Other Jurisdiction of Incorporation
or Organization)</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>2834</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in">(Primary Standard Industrial
Classification Code Number)</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>13-3808303</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(I.R.S. Employer Identification No.)</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>617 Detroit Street, Suite 100</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Ann Arbor, MI 48104</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(734)&nbsp;332-7800</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Address and telephone number of principal
executive offices)</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;<B>617 Detroit Street, Suite 100</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Ann Arbor, MI 48104</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(734)&nbsp;332-7800</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in">(Name, address and telephone
number of agent for service)</P>

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

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

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>405 Lexington Avenue, 26th Floor</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>New York, New York 10174<BR>
(212) 907-6457</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Approximate Date of Proposed Sale to the
Public: From time to time after the date this registration statement becomes effective.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">If
any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under
the Securities Act of 1933, check the following box. </FONT><FONT STYLE="font-family: Wingdings">x</FONT></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If this Form is filed to register additional
securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement for the same offering. <FONT STYLE="font-family: Wingdings">&#168;</FONT></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If this Form is a post-effective amendment
filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement
number of the earlier effective registration statement for the same offering. <FONT STYLE="font-family: Wingdings">&#168;</FONT></P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If this Form is a post-effective amendment
filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement
number of the earlier effective registration statement for the same offering. <FONT STYLE="font-family: Wingdings">&#168;</FONT></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Indicate by check mark whether the Registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.&nbsp;&nbsp;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 of 1934.</P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 42%; padding-right: 0.8pt">Large accelerated filer</TD>
    <TD STYLE="width: 10%; padding-right: 0.8pt"><FONT STYLE="font-family: Wingdings">&#168;</FONT></TD>
    <TD STYLE="width: 38%; padding-right: 0.8pt">Accelerated filer</TD>
    <TD STYLE="width: 10%; padding-right: 0.8pt"><FONT STYLE="font-family: Wingdings">&#168;</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">Non-accelerated filer</TD>
    <TD STYLE="padding-right: 0.8pt"><FONT STYLE="font-family: Wingdings">&#168;</FONT></TD>
    <TD STYLE="padding-right: 0.8pt">Smaller reporting company</TD>
    <TD STYLE="padding-right: 0.8pt"><FONT STYLE="font-family: Wingdings">&#120;</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.8pt 0pt 0">(Do not check if a smaller reporting company)</P></TD>
    <TD>&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24.5pt">&nbsp;<B> </B>&nbsp;</P>

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

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

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

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

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

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
<TR STYLE="vertical-align: bottom">
    <TD STYLE="font-size: 10pt; font-weight: bold; text-align: center">Title of Each Class of<BR> Securities to be Registered</TD><TD STYLE="font-size: 10pt; font-weight: bold">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; font-weight: bold; text-align: center">Amount to be<BR> Registered (1)(2)</TD><TD STYLE="font-size: 10pt; font-weight: bold">&nbsp;</TD>
    <TD COLSPAN="2" STYLE="font-size: 10pt; font-weight: bold; text-align: center">Proposed Maximum<BR> Offering<BR> Price per Security(3)</TD><TD STYLE="font-size: 10pt; font-weight: bold">&nbsp;</TD><TD STYLE="font-size: 10pt; font-weight: bold">&nbsp;</TD>
    <TD COLSPAN="2" STYLE="font-size: 10pt; font-weight: bold; text-align: center">Proposed Maximum<BR> Aggregate<BR> Offering Price</TD><TD STYLE="font-size: 10pt; font-weight: bold">&nbsp;</TD><TD STYLE="font-size: 10pt; font-weight: bold">&nbsp;</TD>
    <TD COLSPAN="2" STYLE="font-size: 10pt; font-weight: bold; text-align: center">Amount of<BR> Registration<BR> Fee</TD><TD STYLE="font-size: 10pt; font-weight: bold">&nbsp;</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: rgb(204,255,204)">
    <TD STYLE="width: 32%; font-size: 10pt">Common stock, par value $.001 per share</TD><TD STYLE="width: 2%; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="width: 15%; font-size: 10pt; text-align: center; padding-left: 10pt">4,260,855 shares</TD><TD STYLE="width: 2%; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="width: 1%; font-size: 10pt; text-align: left">$</TD><TD STYLE="width: 13%; font-size: 10pt; text-align: right">1.60</TD><TD STYLE="width: 1%; font-size: 10pt; text-align: left">&nbsp;</TD><TD STYLE="width: 2%; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="width: 1%; font-size: 10pt; text-align: left">$</TD><TD STYLE="width: 13%; font-size: 10pt; text-align: right">6,817,368</TD><TD STYLE="width: 1%; font-size: 10pt; text-align: left">&nbsp;</TD><TD STYLE="width: 2%; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="width: 1%; font-size: 10pt; text-align: left">$</TD><TD STYLE="width: 13%; font-size: 10pt; text-align: right">929.89</TD><TD STYLE="width: 1%; font-size: 10pt; text-align: left">&nbsp;</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: White">
    <TD STYLE="font-size: 10pt">&nbsp;</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: left">&nbsp;</TD><TD STYLE="font-size: 10pt; text-align: right">&nbsp;</TD><TD STYLE="font-size: 10pt; text-align: left">&nbsp;</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: left">&nbsp;</TD><TD STYLE="font-size: 10pt; text-align: right">&nbsp;</TD><TD STYLE="font-size: 10pt; text-align: left">&nbsp;</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: left">&nbsp;</TD><TD STYLE="font-size: 10pt; text-align: right">&nbsp;</TD><TD STYLE="font-size: 10pt; text-align: left">&nbsp;</TD></TR>
</TABLE>


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

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 5%">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0; text-align: right">(1)</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0; text-align: right">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0; text-align: right">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0; text-align: right"></P></TD>
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 94%">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0">Pursuant to Rule 416 under the Securities
Act of 1933, as amended (the &ldquo;Securities Act&rdquo;), the shares being registered hereunder include such indeterminate number
of shares of our Common Stock as may be issuable with respect to the shares being registered hereunder to prevent dilution by
reason of any stock dividend, stock split, recapitalization or other similar transaction.</P></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt; text-align: right">(2)</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">4,260,855 shares of common stock are to be offered by the Selling
        Stockholders named herein and were acquired in connection with a private placement consummated by the Registrant, of which 3,625,000
        shares of common stock are currently issued and outstanding and 635,855 are shares of common stock issuable upon exercise of warrants.</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt; text-align: right">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD></TR>
<TR>
    <TD STYLE="vertical-align: top; padding-right: 0.8pt; text-align: right">(3)</TD>
    <TD STYLE="vertical-align: top; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; padding-right: 0.8pt; text-align: justify">Estimated solely for the purpose of calculating
    the registration fee in accordance with Rule 457(c) of the Securities Act based upon a $1.60 per share average of high and
    low prices of the registrant&rsquo;s common stock on the NYSE MKT, LLC on December 11, 2012.</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Registrant hereby amends this
registration statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a
further amendment which specifically states that this registration statement shall thereafter become effective in accordance with
Section 8(a) of the Securities Act or until the registration statement shall become effective on such date as the Commission, acting
pursuant to said Section 8(a), may determine.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>THE INFORMATION CONTAINED IN THIS PROSPECTUS
IS NOT COMPLETE AND MAY BE CHANGED. THESE SECURITIES MAY NOT BE SOLD UNTIL THE REGISTRATION STATEMENT FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION IS DECLARED EFFECTIVE. THIS PROSPECTUS IS NOT AN OFFER TO SELL THESE SECURITIES AND IT IS NOT SOLICITING
AN OFFER TO BUY THESE SECURITIES IN ANY STATE WHERE THE OFFER OR SALE IS NOT PERMITTED.</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SUBJECT TO COMPLETION, DATED DECEMBER
13, 2012</B></P>

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

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>4,260,855</B> <B>Shares of Common Stock</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">This prospectus relates to the resale by
the investors listed in the section titled &ldquo;Selling Stockholders&rdquo;, and we refer to the investors as the Selling Stockholders
(the &ldquo;Selling Stockholders&rdquo;) of up to 4,260,855 shares of our common stock, par value $0.001 per share (the &ldquo;Shares&rdquo;),
of which 3,625,000 shares of common stock are currently outstanding and 635,855 shares of common stock are issuable upon exercise
of warrants (the &ldquo;Agent Warrants&rdquo;). The shares and warrants were acquired by the Selling Stockholders in connection
with a private placement offering we completed on October 30, 2012 (the &ldquo;October 2012 Private Placement&rdquo;). We are registering
the resale of the Shares as required by the Registration Rights Agreement we entered into with the Selling Stockholders in connection
with the October 2012 Private Placement (the &ldquo;Registration Rights Agreement&rdquo;).</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Selling Stockholders may offer and
sell or otherwise dispose of the Shares described in this prospectus from time to time through public or private transaction at
prevailing market prices, at prices related to such prevailing market prices, at varying prices determined at the time of sale,
at negotiated prices, or at fixed prices. See &ldquo;Plan of Distribution&rdquo; beginning on page 20 for more information.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We will not receive any of the proceeds
from the Shares sold by the Selling Stockholders.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our common stock became eligible for trading
on the NYSE MKT, LLC October 16, 2008. &nbsp;Our common stock is eligible for quotation on the NYSE MKT, LLC under the symbol &ldquo;SYN&rdquo;.
The closing price of our stock on December 11, 2012 was $1.60.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Investing in our securities involves a high degree of risk.
See &ldquo;<U>Risk Factors</U>&rdquo; beginning on page 7 of this prospectus for more information.</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Neither the Securities and Exchange Commission
nor any state securities commission has approved or disapproved of these securities or determined if this prospectus or the prospectus
to which it relates is truthful or complete. Any representation to the contrary is a criminal offense.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">The date of this prospectus is December
__, 2012.</P>

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

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

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

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

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 88%; padding-right: 1.8pt">&nbsp;</TD>
    <TD STYLE="width: 6%; padding-right: 1.8pt; font-weight: bold; text-align: center">Page</TD>
    </TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">&nbsp;</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: rgb(204,255,204)">
    <TD STYLE="padding-right: 0.8pt">ABOUT THIS PROSPECTUS</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">1</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">&nbsp;</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: rgb(204,255,204)">
    <TD STYLE="padding-right: 0.8pt">ABOUT FORWARD LOOKING STATEMENTS</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">1</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">&nbsp;</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: rgb(204,255,204)">
    <TD STYLE="padding-right: 0.8pt">PROSPECTUS SUMMARY</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">2</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">&nbsp;</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: rgb(204,255,204)">
    <TD STYLE="padding-right: 0.8pt">THE OFFERING</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">6</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">&nbsp;</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: rgb(204,255,204)">
    <TD STYLE="padding-right: 0.8pt">RISK FACTORS</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">7</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">&nbsp;</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: rgb(204,255,204)">
    <TD STYLE="padding-right: 0.8pt">USE OF PROCEEDS</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">18</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">&nbsp;</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: rgb(204,255,204)">
    <TD STYLE="padding-right: 0.8pt">SELLING STOCKHOLDERS</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">18</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">&nbsp;</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: rgb(204,255,204)">
    <TD STYLE="padding-right: 0.8pt">DETERMINATION OF OFFERING PRICE</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">20</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">&nbsp;</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: rgb(204,255,204)">
    <TD STYLE="padding-right: 0.8pt">PLAN OF DISTRIBUTION</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">20</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">&nbsp;</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: rgb(204,255,204)">
    <TD STYLE="padding-right: 0.8pt">DESCRIPTION OF SECURITIES</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">22</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">&nbsp;</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: rgb(204,255,204)">
    <TD STYLE="padding-right: 0.8pt">EXPERTS</TD>
    <TD STYLE="text-align: center">25</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">&nbsp;</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: rgb(204,255,204)">
    <TD STYLE="padding-right: 0.8pt">DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">25</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">&nbsp;</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: rgb(204,255,204)">
    <TD STYLE="padding-right: 0.8pt">LEGAL MATTERS</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">26</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">&nbsp;</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: rgb(204,255,204)">
    <TD STYLE="padding-right: 0.8pt">WHERE YOU CAN FIND MORE INFORMATION</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">27</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">&nbsp;</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: rgb(204,255,204)">
    <TD STYLE="padding-right: 0.8pt">INCORPORATION OF CERTAIN INFORMATION BY REFERENCE</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">27</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">&nbsp;</TD>
    </TR>
<TR STYLE="vertical-align: top; background-color: rgb(204,255,204)">
    <TD STYLE="padding-right: 0.8pt">PART II</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center">29</TD>
    </TR>
</TABLE>


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

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

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">You should rely only on the information
contained or incorporated by reference in this prospectus. Neither we nor the Selling Stockholders have authorized anyone to provide
you with information that is different from such information. If anyone provides you with different or inconsistent information,
you should not rely on it. The Selling Stockholders are offering to sell common stock only in jurisdictions where offers and sales
are permitted. You should not assume that the information we have included in this prospectus is accurate as of any date other
than the date of this prospectus or that any information we have incorporated by reference is accurate as of any date other than
the date of the document incorporated by reference. Our business, financial condition, results of operations and prospects may
have changed since that date.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The distribution of this prospectus and
the issuance of the common stock in certain jurisdictions may be restricted by law. Persons outside the United States who come
into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the issuance of the
common stock and the distribution of this prospectus outside the United States. This prospectus does not constitute, and may not
be used in connection with, an offer to sell, or a solicitation of an offer to buy, the common stock offered by this prospectus
by any person in any jurisdiction in which it is unlawful for such person to make such an offer or solicitation.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">It is important for you to read and consider
all of the information contained in this prospectus in making your investment decision. To understand the offering fully and for
a more complete description of the offering you should read this entire document carefully, including particularly the &ldquo;Risk
Factors&rdquo; section beginning on page 7. You also should read and consider the information in the documents to which we have
referred you in the sections entitled &ldquo;Where You Can Find Additional Information&rdquo; and &ldquo;Incorporation of Certain
Information by Reference&rdquo;.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As used in this prospectus, unless the
context requires otherwise, the terms &ldquo;we&rdquo;, &ldquo;us&rdquo;, &ldquo;our&rdquo;, or &ldquo;the Company&rdquo; refer
to Synthetic Biologics, Inc. and its subsidiaries on a consolidated basis. References to &ldquo;Selling Stockholders&rdquo; refer
to those stockholders listed herein under &ldquo;Selling Stockholders&rdquo; and their successors, assignees and permitted transferees.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">This prospectus contains forward-looking
statements within the meaning of Section 27A of the Securities Act, about the Company and its subsidiaries. These forward-looking
statements are intended to be covered by the safe harbor for forward-looking statements provided by the Private Securities Litigation
Reform Act of 1995. Forward-looking statements are not statements of historical fact, and can be identified by the use of forward-looking
terminology such as &ldquo;believes&rdquo;, &ldquo;expects&rdquo;, &ldquo;may&rdquo;, &ldquo;will&rdquo;, &ldquo;could&rdquo;,
&ldquo;should&rdquo;, &ldquo;projects&rdquo;, &ldquo;plans&rdquo;, &ldquo;goal&rdquo;, &ldquo;targets&rdquo;, &ldquo;potential&rdquo;,
&ldquo;estimates&rdquo;, &ldquo;pro forma&rdquo;, &ldquo;seeks&rdquo;, &ldquo;intends&rdquo;, or &ldquo;anticipates&rdquo; or the
negative thereof or comparable terminology. Forward-looking statements include discussions of strategy, financial projections,
guidance and estimates (including their underlying assumptions), statements regarding plans, objectives, expectations or consequences
of various transactions, and statements about the future performance, operations, products and services of the Company and its
subsidiaries. We caution our stockholders and other readers not to place undue reliance on such statements.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our businesses and operations are and will
be subject to a variety of risks, uncertainties and other factors. Consequently, actual results and experience may materially differ
from those contained in any forward-looking statements. Such risks, uncertainties and other factors that could cause actual results
and experience to differ from those projected include, but are not limited to, the risk factors set forth in the section entitled
&ldquo;Risk Factors&rdquo; beginning on page 7 of this prospectus and elsewhere in the documents incorporated by reference in
this prospectus, including our Annual Report on Form 10-K/A for the year ended December 31, 2011.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">All written or oral forward-looking statements
attributable to us or any person acting on our behalf made after the date of this prospectus are expressly qualified in their entirety
by the risk factors and cautionary statements contained in and incorporated by reference into this prospectus. Unless legally required,
we do not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances
after the date of this prospectus or to reflect the occurrence of unanticipated events.</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.05pt; text-align: justify"><I>This summary highlights information
contained elsewhere in this prospectus; it does not contain all of the information you should consider before investing in our
common stock. You should read the entire prospectus before making an investment decision.&nbsp;&nbsp;</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.05pt; text-align: justify">&nbsp;</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We are a biotechnology company focused
on the development of synthetic biologics and innovative medicines for serious infections and diseases. We are developing a biologic
for the prevention of <I>C. diff</I> infection, and a series of monoclonal antibodies (mAbs) for the treatment of serious infectious
diseases, including <I>Acinetobacter</I>. We are also developing a synthetic DNA-based therapy for the treatment of pulmonary arterial
hypertension (PAH). In addition, we are developing a drug candidate for the treatment of relapsing-remitting multiple sclerosis
(MS) and cognitive dysfunction in MS, and designing a clinical development pathway for the treatment of amyotrophic lateral sclerosis
(ALS), and, have partnered the development of a treatment for fibromyalgia. We are also evaluating additional in-licensing opportunities.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 27pt"><I>Product Pipeline:</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 27pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 27pt"><IMG SRC="s1_001.jpg" ALT="">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 27pt">&nbsp;&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 27pt"><I>Infectious Disease Programs:</I></P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 10%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 3%; padding-right: 0.8pt">&bull;</TD>
    <TD STYLE="width: 87%; text-align: justify">In November 2012, we acquired a series of beta-lactamase compounds (P1A, P2A and P3A) and related assets targeting the prevention of <I>Clostridium difficile </I>(<I>C. diff</I>)<I> </I>infection, the leading cause of hospital acquired infections (HAI), that may occur secondary to treatment with antibiotics. The assets include a pre-Investigational New Drug (IND) package, Phase I and Phase II clinical data, manufacturing process data and all issued and pending U.S. and international patents intended to support an IND and Biologic License Application (BLA) with the FDA. Utilizing the newly acquired biologic compounds, we intend to develop a proprietary oral beta-lactamase enzyme product candidate, SYN-004. When co-administered with certain beta-lactam antibiotics, it is expected that SYN-004 can degrade the antibiotic and preserve the balance of the patient's gastrointestinal (GI) microflora, thus preventing opportunistic <I>C. diff</I> infection (CDI). Beta-lactam antibiotics are a mainstay in hospital infection management and include both penicillins and cephalosporins. In 2011, an estimated 8.7 million Americans were administered intravenous beta-lactam antibiotics.</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 1.6pt; text-align: justify">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&bull;</TD>
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0; text-align: justify">In August 2012, we entered into
        a second worldwide exclusive channel collaboration with Intrexon Corporation (Intrexon) through which we intend to develop and
        commercialize a series of mAb therapies for the treatment of certain infectious diseases not adequately addressed by existing therapies.
        Utilizing Intrexon&rsquo;s comprehensive suite of proprietary technologies, including the mAbLogix&trade; and LEAP&trade; platforms,
        we intend to target three infectious disease indications as part of the Intrexon collaboration. In September 2012, we initiated
        efforts to develop our first mAb therapy for the treatment of acinetobacter infections. Many strains of <I>Acinetobacter</I> are
        multidrug-resistant and pose an increasing global threat to hospitalized patients, wounded military personnel and those affected
        by natural disasters. A treatment for acinetobacter infections represents a multi-billion dollar market opportunity.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0; text-align: justify">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.8pt 0pt 0; text-align: justify">(mAbLogix&trade; and LEAP&trade;
        are registered trademarks of Intrexon Corporation)</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0; text-align: justify">&nbsp;</P></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 27pt; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 27pt; text-align: justify"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 27pt; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 27pt; text-align: justify">&nbsp;<I>Synthetic Biologic Program:</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 27pt; text-align: justify">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 10%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 3%; padding-right: 0.8pt">&bull;</TD>
    <TD STYLE="width: 87%; padding-right: 0.8pt; text-align: justify">Our synthetic DNA-based product candidate is intended to treat PAH, a serious life-threatening lung disease. This product is designed to deliver DNA that encodes a therapeutic protein called prostacyclin synthase (PGIS) locally to the pulmonary arteries of PAH patients via a single procedure, and, via an oral daily pill, control the long-term local expression of such therapeutic protein. We are developing this initial product candidate pursuant a global exclusive channel collaboration that we entered into with Intrexon in November 2011. As part of this collaboration, we have access to Intrexon's UltraVector<SUP>&reg;</SUP> platform and RheoSwitch Therapeutic System<SUP>&reg;</SUP> for this product application. We anticipate that by continuously producing and delivering prostacyclin directly where it is needed, in the pulmonary arteries of PAH patients, this product candidate may overcome the dose limiting side effects of systemic prostacyclin treatments for PAH, a mainstay of PAH treatment. According to GlobalData, the global market for PAH treatments is estimated to exceed $3.6 billion by 2015.</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 76.5pt">(UltraVector<SUP>&reg;</SUP> and RheoSwitch Therapeutic
System<SUP>&reg;</SUP> are registered trademarks of Intrexon Corporation)</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 27pt"><I>Multiple Sclerosis Program:</I></P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 10%; padding-right: 9pt">&nbsp;</TD>
    <TD STYLE="width: 3%; padding-right: 9pt">&bull;</TD>
    <TD STYLE="width: 87%; padding-right: 9pt; text-align: justify">Trimesta<SUP>TM</SUP> (oral estriol) is being developed as an oral once-daily treatment for relapsing-remitting MS in women. Patient enrollment of 164 patients is complete in this randomized, double-blind, placebo-controlled Phase II clinical trial being conducted at 15 centers in the U.S. Patients are being dosed and monitored for two years. This clinical trial is supported by grants exceeding $8 million, which should be sufficient to fund the trial through completion. Current sales of injectable disease-modifying therapies for MS are estimated at $8.9 billion annually.&nbsp;According to various reports, sales of oral disease-modifying therapies for MS, of which Trimesta&trade;, if and when approved, would be in such class, are anticipated to grow from $500 million in 2010 to $5 billion annually by 2017.</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 9pt 0pt 1.5in; text-align: justify; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 10%; padding-right: 9pt">&nbsp;</TD>
    <TD STYLE="width: 3%; padding-right: 9pt">&bull;</TD>
    <TD STYLE="width: 87%; padding-right: 9pt; text-align: justify">Trimesta<SUP>TM</SUP> is also being developed for the treatment of cognitive dysfunction in female MS patients. In January 2012, patient enrollment began in a randomized, double-blind, placebo-controlled Phase II clinical trial being conducted at University of California, Los Angeles (UCLA). Patient recruitment and enrollment into this trial is ongoing. The majority of the costs of this trial are being funded by grants from foundations and charitable organizations and we have pledged approximately $500,000 to UCLA to partially fund this trial payable over three years. An estimated 50-65% of MS patients are expected to develop disabilities due to cognitive dysfunction and there is currently no approved treatment.</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1.5in; text-align: justify; text-indent: -0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 27pt; text-align: justify"><I>Other Programs:</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1.5in; text-align: justify; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 10%; padding-right: 9pt">&nbsp;</TD>
    <TD STYLE="width: 3%; padding-right: 9pt">&bull;</TD>
    <TD STYLE="width: 87%; padding-right: 9pt; text-align: justify">AEN-100 (gastroretentive zinc acetate) is a novel formulation of zinc acetate that may be used for the treatment of ALS, also known as Lou Gehrig&rsquo;s disease. Previous investigator studies have suggested that alterations in the handling and disposition of zinc ions in the brain may be important in the initiation and development of ALS. We are currently collaborating with the investigator and, based on feedback from the United States Food &amp; Drug Administration (FDA), intend to design a clinical development pathway for AEN-100 in the treatment of ALS. There is only one approved therapy for ALS, the efficacy of which is considered to be marginal. Based on an estimated annual price of $10,000 per ALS patient, we estimate that the total market potential in the U.S. is $300 million.</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 9pt 0pt 1.5in; text-align: justify; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 10%; padding-right: 9pt">&nbsp;</TD>
    <TD STYLE="width: 3%; padding-right: 9pt">&bull;</TD>
    <TD STYLE="width: 87%; padding-right: 9pt; text-align: justify">Effirma<SUP>TM</SUP> (flupirtine) is being developed for the treatment of fibromyalgia by Meda AB (Meda), a multi-billion dollar international pharmaceutical company. On May 6, 2010, we entered into a sublicense agreement with Meda covering all of our patents&rsquo; rights on the use of flupirtine for fibromyalgia in the U.S., Canada and Japan. According to Meda&rsquo;s 2011 Annual Report filed in May 2012, flupirtine for fibromyalgia is currently in Phase II development. The sublicense agreement provides that all ongoing and future development costs are to borne by Meda and we are entitled to receive certain payments if milestones are achieved and royalties on sales. Based on an estimated annual price of $1,200 per fibromyalgia patient, we estimate that the total market potential in the U.S. is $6 billion.</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On November 18, 2011, we entered
into a Channel Agreement with Intrexon (the &ldquo;Initial Channel Agreement&rdquo;) that governs an &ldquo;exclusive channel
collaboration&rdquo; arrangement in which we intend to use Intrexon&rsquo;s technology directed towards the production of
PGIS, through the use of <I>in vivo</I> conditionally regulated embedded controllable bioreactors for the treatment of PAH.
The Initial Channel Agreement establishes committees comprised of our and Intrexon representatives that will govern
activities related to the PAH program in the areas of project establishment, chemistry, manufacturing and controls, clinical
and regulatory matters, commercialization efforts and intellectual property. As partial consideration for execution of the
Initial Channel Agreement, we entered into a Stock Purchase Agreement with Intrexon (the Initial Stock Purchase
Agreement&rdquo;) pursuant to which we issued to Intrexon a number of shares of our common stock equal to 9.995% of the
number of shares of our common stock issued and outstanding following and giving effect to such issuance (the &ldquo;First
Tranche&rdquo;) at a purchase price equal to the $0.001 par value of such shares, which issuance was deemed paid in partial
consideration for the execution and delivery of the Initial Channel Agreement. We also agreed to issue additional shares of
our common stock to Intrexon upon dosing of the first patient in a Phase II clinical trial sponsored by us in the U.S., or
similar study as the parties may agree in a country other than the U.S.</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On December 21, 2011, we announced that
the Board of Directors had taken several actions to prioritize our focus on our entry into the emerging field of synthetic biology.
In connection with the change in business focus on March 8, 2012, we entered into a Membership Interest Purchase Agreement, and
certain related agreements, pursuant to which we sold all of our interest in the Adeona Clinical Laboratory (the &ldquo;Lab&rdquo;)
to Hartlab, LLC, an entity controlled by the Lab&rsquo;s former owner, in consideration for (i) the immediate assignment of the
Lab&rsquo;s outstanding accounts receivable up through the date of closing, plus (ii) Seven Hundred Thousand Dollars ($700,000)
payable pursuant to the terms of a two-year non-recourse promissory note secured by all of the assets of the Lab.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On February 15, 2012, upon stockholder
approval, we amended our Articles of Incorporation to change our name to Synthetic Biologics, Inc. Our common stock continues trade
on the NYSE MKT (formerly the NYSE Amex and American Stock Exchange), under the symbol &ldquo;SYN&rdquo;. Prior to this time and
since October 16, 2008, our name was Adeona Pharmaceuticals, Inc. and we traded on the NYSE MKT stock exchange under the symbol
&ldquo;AEN&rdquo;. We are incorporated in the State of Nevada. We continue to maintain our principal executive offices in Ann Arbor,
MI, and are currently located at 617 Detroit Street, Suite 100<B>,</B> Ann Arbor, MI 48104.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On August 6, 2012, we expanded our relationship
with Intrexon and entered into a Second Channel Agreement with Intrexon (the &ldquo;Second Channel Agreement&rdquo;) that governs
an &ldquo;exclusive channel collaboration&rdquo; arrangement in which we will use Intrexon&rsquo;s technology relating to the identification,
design and production of human antibodies and DNA vectors for the development and commercialization of a series of monoclonal antibody
therapies for the treatment of certain serious infectious diseases (the &ldquo;Program&rdquo;). The Second Channel Agreement establishes
committees comprised of our and Intrexon representatives that will govern activities related to the Program in the areas of project
establishment, chemistry, manufacturing and controls, clinical and regulatory matters, commercialization efforts and intellectual
property.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On October 16, 2012, a closing was held
for the transaction contemplated by the Second Channel Agreement. Pursuant to the terms of a Stock Issuance Agreement with Intrexon
(the &ldquo;Second Stock Purchase Agreement&rdquo;), we issued 3,552,210 shares of our common stock, $0.001 par value, which issuance
is also deemed paid in partial consideration for the execution and delivery of the Second Channel Agreement, dated August 6, 2012,
between ourselves and Intrexon. We also agreed to register the shares issued to Intrexon in accordance with the First Amendment
to Registration Rights Agreement.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On October 25, 2012, we entered into a
Stock Purchase Agreement (the &ldquo;Purchase Agreement&rdquo;) with certain accredited investors, which include the Selling Stockholders
(the &ldquo;Purchasers&rdquo;), pursuant to which we agreed to sell to the Purchasers in a private placement an aggregate of 6,750,000
shares of our common stock at a price per share of $1.60 (the &ldquo;Common Shares&rdquo;) for aggregate gross proceeds of $10.8
million and net proceeds of $10.1 million. On October 30, 2012, we completed the October 2012 Private Placement. We intend to use
the net proceeds from the October 2012 Private Placement to develop our monoclonal antibody and synthetic DNA programs through
our exclusive channel collaborations with Intrexon, and for general corporate purposes, including the execution of our business
plan and expansion of our pipeline.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In connection with the October 2012 Private
Placement, we also entered into a registration rights agreement with the Selling Stockholders (the &ldquo;Registration Rights Agreement&rdquo;).
The Registration Rights Agreement requires that we file a registration statement (the &ldquo;Initial Registration Statement&rdquo;)
with the Securities and Exchange Commission (the &ldquo;Commission&rdquo;) within forty-five (45) days of the closing date of the
October 2012 Private Placement (the &ldquo;Filing Date&rdquo;) for the resale by the Selling Stockholders of all of the Common
Shares owned by the Selling Stockholders and all shares of Common Stock issuable upon any stock split, dividend or other distribution,
recapitalization or similar event with respect thereto (the &ldquo;Registrable Securities&rdquo;). The Initial Registration Statement
must be declared effective by the Commission within ninety (90)&nbsp;days of the closing date of the October 2012 Private Placement
(the &ldquo;Effectiveness Date&rdquo;) subject to certain adjustments. Upon the occurrence of certain events (each an &ldquo;Event&rdquo;),
including, but not limited to, that the Initial Registration Statement is not filed prior to the Filing Date, we will be required
to pay to each of the Selling Stockholders liquidated damages of 1.5% of their aggregate purchase price upon the date of the Event
and then monthly thereafter until the&nbsp;Event is cured. In no event will the aggregate amount of liquidated damages payable
to the Selling Stockholders exceed in the aggregate 10% of the aggregate purchase price paid by such Selling Stockholder for the
Registrable Securities.</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In connection with the October 2012 Private
Placement, we also entered into an agreement with a certain Purchaser that is an affiliate of Intrexon (the &ldquo;Joinder Agreement&rdquo;)
pursuant to which such Purchaser agreed to be bound by the terms of and join Intrexon as a party to its registration rights agreement
with us entered into in connection with the Second Channel Agreement.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Griffin Securities, Inc. (&ldquo;Griffin&rdquo;)
served as the placement agent for the October 2012 Private Placement. In consideration for services rendered by Griffin in the
October 2012 Private Placement, we agreed to (i) pay to Griffin cash commissions equal to 6.0% of the gross proceeds received in
the October 2012 Private Placement, (ii) issue to Griffin, or its designee, the Agent Warrants, which are five-year warrants to
purchase 635,855 shares of our common stock with an exercise price of $1.60 per share; and (iii) reimburse Griffin for its reasonable
actual out-of-pocket expenses incurred in connection with the October 2012 Private Placement, including reasonable legal fees and
disbursements. The Agent Warrants also provide for the same registration rights and obligations, and are subject to certain limitations,
as set forth in the Registration Rights Agreement with respect to the Common Shares underlying such warrant.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On November 28, 2012, a closing was
held for the transaction contemplated by the Asset Purchase Agreement (the &ldquo;Prev Agreement&rdquo;) we entered into with
Prev ABR LLC (&ldquo;Prev&rdquo;), pursuant to which we acquired the <I>C. diff</I> program assets of Prev, including
pre-Investigational New Drug (IND) package, Phase I and Phase II clinical data, manufacturing process data and all issued and
pending U.S. and international patents.&nbsp; Pursuant to the Prev Agreement, we paid Prev an initial cash payment of
$100,000 upon execution of the Prev Agreement and at closing paid an additional cash payment of $135,000 and issued 625,000
unregistered shares of our common stock to Prev.&nbsp; In addition, upon the achievement of the milestones set forth below,
Prev may be entitled to receive additional consideration payable 50% in cash and 50% in our stock, subject to Prev&rsquo;s
option to receive the entire payment in shares of our stock, with the exception of the first milestone payments to be paid in
cash: (i) upon commencement of an IND; (ii) upon commencement of a Phase I clinical trial; (iii) upon commencement of a Phase
II clinical trial; (iv) upon commencement of a Phase III clinical trial; (v) upon Biologic License Application (BLA) filing
in the U.S. and for territories outside of the U.S. (as defined in the Prev Agreement); and (vi) upon BLA approval in the
U.S. and upon approval in territories outside the-U.S.&nbsp; The future stock issuances are subject to prior approval of the
NYSE MKT, LLC. No royalties are payable to Prev under the Prev Agreement. The Prev Agreement also provides that Prev has a
right to the return to it of all assets acquired by us under the Prev Agreement if on or prior to the date that is (i) thirty
(30) months after the execution of the Prev Agreement, we have not initiated toxicology studies in non-rodent models or (ii)
thirty six (36) months have not filed an IND under the program related to the assets and such failure is not due to action or
inaction of Prev or breach of its representations or warranties or covenants or if there is a change of control as defined in
the Prev Agreement and after such change of control the assets are not further developed; provided however that such thirty
(30) and thirty six (36) month periods can be extended by us for an additional twelve (12) months upon payment of a cash
milestone payment.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">To date, we have financed our operations
primarily through public and private sales of our common stock, and we expect to continue to seek to obtain the required capital
in a similar manner. We have incurred an accumulated deficit of $56.9 million through September 30, 2012. We cannot provide any
assurance that we will be able to achieve profitability on a sustained basis, if at all, obtain the required funding, obtain the
required regulatory approvals, or complete additional corporate partnering or acquisition transactions.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The description set forth above of the agreements is intended
to be a summary of the terms of the agreements that are material to a purchaser of our common stock. It does not purport to be
complete and is subject to and qualified in its entirety by reference to the complete text of each agreement filed as exhibits
to our Current Reports on Form 8-K.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our predecessor, Sheffield Pharmaceuticals,
Inc. was incorporated in 1986, and in 2006 engaged in a reverse merger with Pipex Therapeutics, Inc., a Delaware corporation formed
in 2001. After the merger, we changed our name to Pipex Pharmaceuticals, Inc., and in October 2008 we changed our name to Adeona
Pharmaceuticals, Inc. On October 15, 2009, we reincorporated in the State of Nevada. After reprioritizing our focus on the emerging
area of synthetic biologics and entering into a collaboration with Intrexon, on February 15, 2012, we amended our Articles of Incorporation
to change our name to Synthetic Biologics, Inc.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our executive offices are located at 617
Detroit Street, Suite 100, Ann Arbor, Michigan 48104, and our telephone number is (734) 332-7800. Our website address is www.syntheticbiologics.com.
The information on our website is not incorporated by reference into this prospectus, and you should not consider it part of this
prospectus.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For a complete description of our business,
financial condition, results of operations and other important information, we refer you to our filings with the Commission that
are incorporated by reference in this prospectus, including our Annual Report on Form 10-K/A for the year ended December 31, 2011.
For instructions on how to find copies of these documents, see &ldquo;Where You Can Find Additional Information.&rdquo;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #1F497D">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #1F497D">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 9.6pt; text-align: center"><B>THE OFFERING</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 9.6pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 9.6pt"></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 25%; padding: 0; font-weight: bold; text-indent: 0">Issuer</TD>
    <TD STYLE="width: 75%; padding: 0; text-indent: 0">Synthetic Biologics, Inc.</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding: 0; text-indent: 0">&nbsp;</TD>
    <TD STYLE="padding: 0; text-indent: 0">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding: 0; font-weight: bold; text-indent: 0">Securities offered</TD>
    <TD STYLE="padding: 0; text-indent: 0">This prospectus covers the sale of up to 4,260,855 shares of common stock, of which 3,625,000 shares of common stock are currently outstanding and 635,855 shares of common stock are issuable upon exercise of Agent Warrants.</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding: 0; text-indent: 0">&nbsp;</TD>
    <TD STYLE="padding: 0; text-indent: 0">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding: 0; font-weight: bold; text-indent: 0">Common stock to be  outstanding</TD>
    <TD STYLE="padding: 0; text-indent: 0">44,332,748 shares</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding: 0; font-weight: bold; text-indent: 0">&nbsp;</TD>
    <TD STYLE="padding: 0; text-indent: 0">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding: 0; font-weight: bold; text-indent: 0">Use of Proceeds</TD>
    <TD STYLE="padding: 0; text-indent: 0">We will not receive proceeds from the sale or other disposition of the shares of common stock covered by this prospectus.&nbsp; We will receive $1,017,368 if the Agent Warrants are exercised in full for cash; however, these warrants contain a cashless exercise feature. &nbsp;See &ldquo;Use of Proceeds&rdquo;.</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding: 0; font-weight: bold; text-indent: 0">&nbsp;</TD>
    <TD STYLE="padding: 0; text-indent: 0">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding: 0; text-indent: 0">&nbsp;<B>Risk Factors</B></TD>
    <TD STYLE="padding: 0; text-indent: 0">You should carefully read and consider the information set forth under &ldquo;Risk Factors,&rdquo; together with all of the other information set forth in this prospectus, before deciding to invest in shares of our common stock.</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding: 0; text-indent: 0">&nbsp;</TD>
    <TD STYLE="padding: 0; text-indent: 0">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding: 0; font-weight: bold; text-indent: 0">NYSE MKT symbol</TD>
    <TD STYLE="padding: 0; text-indent: 0">Our common stock is listed on the NYSE MKT, LLC under the symbol &ldquo;SYN&rdquo;.</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding: 0; text-indent: 0">&nbsp;</TD>
    <TD STYLE="padding: 0; text-indent: 0">&nbsp;</TD></TR>
</TABLE>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 9.6pt"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 9.6pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The number of shares of common stock outstanding after the offering
is based on 44,332,748 shares outstanding as of December 7, 2012 and excludes:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 9.6pt">&nbsp;&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR>
    <TD STYLE="width: 5%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="vertical-align: top; width: 2%; padding-right: 0.8pt">&bull;</TD>
    <TD STYLE="vertical-align: top; width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="vertical-align: top; width: 92%; padding-right: 0.8pt">1,632,501 shares of common stock issuable upon the exercise of warrants with a weighted average exercise price of $3.10 per share;</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 9.6pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR>
    <TD STYLE="width: 5%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="vertical-align: top; width: 2%; padding-right: 0.8pt">&bull;</TD>
    <TD STYLE="vertical-align: top; width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="vertical-align: top; width: 92%; padding-right: 0.8pt">4,383,746 shares of common stock issuable upon the exercise of options with a weighted average exercise price of $1.77 per share; and</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 9.6pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR>
    <TD STYLE="width: 5%; padding-right: 0.8pt"></TD>
    <TD STYLE="vertical-align: top; width: 2%; padding-right: 0.8pt">&bull;</TD>
    <TD STYLE="vertical-align: top; width: 1%; padding-right: 0.8pt"></TD>
    <TD STYLE="vertical-align: top; width: 92%">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.8pt 0pt 0">934,821 shares of common stock reserved for
future grants and awards under our equity incentive plans.</P></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><I>Investing in our common stock involves
a high degree of risk, and you should be able to bear the complete loss of your investment. You should carefully consider the risks
described below, the other information in this prospectus and the documents incorporated by reference herein when evaluating our
company and our business. If any of the following risks actually occur, our business could be harmed. In such case, the trading
price of our common stock could decline and investors could lose all or a part of the money paid to buy our common stock.</I></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>RISKS RELATING TO OUR BUSINESS</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>We will need to raise additional
capital to operate our business.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">With the exception of the three months
ended June 30, 2010, we have experienced significant losses since inception and have a significant accumulated deficit. We expect
to incur additional operating losses in the future and therefore our cumulative losses to increase. To date, other than the licensing
fee we received from Meda AB for the development and commercialization of Effirma (flupirtine) for fibromyalgia in the U.S., Canada
and Japan and limited laboratory revenues from Adeona Clinical Laboratory, which we have recently sold, we have generated very
minimal revenues. Inasmuch as our sole source of revenue (with the exception of the Meda licensing fee) has been our laboratory
revenue and our laboratory was sold recently, we do not expect to derive revenue from any source in the near future until we or
our partners successfully commercialize our products. As of September 30, 2012, our accumulated deficit totaled approximately $56.9
million on a consolidated basis. Until such time as we receive approval from the FDA and other regulatory authorities for our product
candidates, we will not be permitted to sell our products and therefore will not have product revenues from the sale of products.
For the foreseeable future we will have to fund all of our operations and capital expenditures from equity and debt offerings,
cash on hand, licensing fees and grants. If our current cash, cash equivalents and short-term investments are not sufficient to
sustain our operations, we will need to seek additional sources of financing and such additional financing may not be available
on favorable terms, if at all. Our recent loss of S-3 eligibility due to the failure of Berman &amp; Company, P.A. to follow proper
partner rotation procedures may also negatively affect our ability to raise capital. If we do not succeed in raising additional
funds on acceptable terms, we may be unable to complete planned preclinical and clinical trials or obtain approval of our product
candidates from the FDA and other regulatory authorities. In addition, we could be forced to delay, discontinue or curtail product
development, forego sales and marketing efforts, and forego licensing in attractive business opportunities. Any additional sources
of financing will likely involve the issuance of our equity or debt securities, which will have a dilutive effect on our stockholders.&nbsp;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>We have not been able to sustain
profitability.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Other than with respect to the three months
ended June 30, 2010, we have a history of losses and we have incurred&nbsp;and continue to incur substantial losses and negative
operating cash flow. Even if we succeed in developing and commercializing one or more of our product candidates, we may still incur
substantial losses for the foreseeable future and may not sustain profitability. We also expect to continue to incur significant
operating and capital expenditures and anticipate that our expenses will substantially increase in the foreseeable future as we
do the following:</P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 6%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 6%; padding-right: 0.8pt">&#9679;</TD>
    <TD STYLE="width: 88%; padding-right: 0.8pt; text-align: justify">continue to undertake preclinical development and clinical trials for our product candidates;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&#9679;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: justify">expand our research activities with Intrexon relating to monoclonal antibodies for infectious diseases;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&#9679;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: justify">seek regulatory approvals for our product candidates;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&#9679;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: justify">develop our product candidates for commercialization;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&#9679;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: justify">implement additional internal systems and infrastructure;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&#9679;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: justify">lease additional or alternative office facilities; and</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&#9679;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: justify">hire additional personnel, including members of our management team.</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We may experience negative cash flow for
the foreseeable future as we fund our technology development with capital expenditures. 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. Our failure to achieve or maintain profitability could negatively impact the value of our common stock and underlying
securities.</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>Our research and development efforts
may not succeed in developing commercially successful products and technologies, which may limit our ability to achieve profitability.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We must continue to explore opportunities
that may lead to new products and technologies. To accomplish this, we must commit substantial efforts, funds, and other resources
to research and development. A high rate of failure is inherent in the research and development of new products and technologies.
Any such expenditures that we make will be made without any assurance that our efforts will be successful. Failure can occur at
any point in the process, including after significant funds have been invested.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Regardless of whether our clinical trials
are deemed to be successful, promising new product candidates may fail to reach the market or may only have limited commercial
success because of efficacy or safety concerns, failure to achieve positive clinical outcomes, inability to obtain necessary regulatory
approvals or satisfy regulatory criteria, limited scope of approved uses, excessive costs to manufacture, the failure to establish
or maintain intellectual property rights, or infringement of the intellectual property rights of others. Even if we successfully
develop new products or enhancements, they may be quickly rendered obsolete by changing customer preferences, changing industry
standards, or competitors' innovations. Innovations may not be quickly accepted in the marketplace because of, among other things,
entrenched patterns of clinical practice or uncertainty over third-party reimbursement. We cannot state with certainty when or
whether any of our products under development will be launched, whether we will be able to develop, license, or otherwise acquire
drug candidates or products, or whether any products will be commercially successful. Failure to launch successful new products
or new indications for existing products may cause our products to become obsolete, which may limit our ability to achieve profitability.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>The technology on which our channel
partnering arrangements with Intrexon is based on early stage technology.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We have an exclusive channel collaboration
arrangement with Intrexon that contemplates the use of Intrexon&rsquo;s transgene engineering platform technology and regulatory
control technology for the <I>in vivo</I> cellular production of PGIS, a specific effector enzyme that regulates the production
of prostacyclin. Such technologies have a limited history of use in the design and development of human therapeutic product candidates
and may therefore involve unanticipated risks or delays.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On August 8, 2012, we announced an additional
exclusive channel collaboration with Intrexon relating to the design, production, testing and commercialization of monoclonal antibodies
for the treatment of certain infectious diseases. Although monoclonal antibody therapeutics are well established in the biotechnology
and pharmaceutical sectors, their use for the treatment of infectious disease is extremely limited. In order for monoclonal antibodies
to be effective for infectious diseases, they must not only properly target the organism of interest (or its toxins), but may also
need to overcome defenses and forms of resistance of such organisms. To accomplish this may require the use of more than one specific
monoclonal antibody, and mixtures of different monoclonal antibodies, which may create additional unforeseen complications, including
increased manufacturing complexity and expense. In order to be competitive, monoclonal antibodies will be required to be produced
at a low enough cost of goods in order to be profitably marketed. We have very limited development and manufacturing experience
in the field of monoclonal antibodies and infectious disease. We cannot assure that any monoclonal antibody candidates will provide
satisfactory in vitro and in vivo nonclinical results sufficient to warrant the expense of cGMP manufacture and clinical testing
in human clinical trials.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>DNA-based therapy has not yet been
proven to be successful.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The FDA has not yet approved any human
DNA-based therapy product for sale. The field of DNA-based therapy, also referred to as gene therapy or gene transfer, is experimental
and has not yet proven successful in many clinical trials. Clinical trials with DNA-based therapy have encountered a multitude
of significant technical problems in the past, including, unintended integration with host DNA, poor levels of protein expression,
transient protein expression, viral overload, immune reactions to either viral capsids utilized to deliver DNA, DNA itself, proteins
expressed or cells transfected with DNA. There can be no assurance that our preclinical animals studies or human clinical trials
will be successful or that we will receive the regulatory approvals necessary to initiate such studies. To the extent that we utilize
viral constructs or other systems to deliver our DNA-based therapies and the same or similar delivery systems demonstrate unanticipated
and/or unacceptable side effects in preclinical or clinical trials conducted by ourselves or others we may be forced to, or elect
to, discontinue development of such product candidates.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>We may not generate additional revenue
from our relationships with our corporate&nbsp;collaborators.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On May 6, 2010, we entered into a sublicense
agreement with Meda AB whereby we may receive milestone payments totaling $17.5 million (including an upfront payment of $2.5 million
that has already been received), plus royalties on our flupirtine program. There can be no assurance that Meda AB will successfully
develop flupirtine for fibromyalgia in the U.S., Canada or Japan that would allow us to receive such additional $15 million in
milestone payments and royalties on sales in connection with such agreement. The successful achievement of the various milestones
set forth in the sublicense agreement is not within our control and we will be dependent upon Meda AB for achievement of such milestones.
According to Meda&rsquo;s 2011 Annual Report filed in May 2012, flupirtine for fibromyalgia is in Phase II development.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>We have experienced several management
changes.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We have had significant changes in management
in the past few years. Jeffrey Riley was appointed Chief Executive Officer and President on February 3, 2012. Effective February
6, 2012, C. Evan Ballantyne was appointed Chief Financial Officer. James S. Kuo, M.D., served as Chief Executive Officer and President
from February 6, 2010 until February 3, 2012. Changes in our key positions, as well as additions of new personnel and departures
of existing personnel, can be disruptive, might lead to additional departures of existing personnel and could have a material adverse
effect on our business, operating results, financial results and internal controls over financial reporting.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>We may not be able to retain rights
licensed to us by others to commercialize key products and may not be able to establish or maintain the relationships we need to
develop, manufacture, and market our products.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In addition to our own patent applications,
we also currently rely on licensing agreements with third party patent holders/licensors for our products. We have an exclusive
license agreement with the McLean Hospital relating to the use of flupirtine to treat fibromyalgia which was sublicensed to Meda
AB and an exclusive license agreement with the Regents of the University of California relating to our Trimesta technology. Each
of these agreements requires us or our sublicensee to use our best efforts to commercialize each of the technologies as well as
meet certain diligence requirements and timelines in order to keep the license agreement in effect. In the event we or our sublicensee
are not able to meet our diligence requirements, we may not be able to retain the rights granted under our agreements or renegotiate
our arrangement with these institutions on reasonable terms, or at all. Furthermore, we currently have very limited product development
capabilities, and limited marketing or sales capabilities. For us to research, develop, and test our product candidates, we would
need to contract with outside researchers, in most cases those parties that did the original research and from whom we have licensed
the technologies. Our exclusive channel collaboration agreements with Intrexon provide that Intrexon may terminate such agreement
if we do not perform certain specified requirements, including developing therapies considered superior.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We can give no assurances that any of our
issued patents licensed to us or any of our other patent applications will provide us with significant proprietary protection or
be of commercial benefit to us. Furthermore, the issuance of a patent is not conclusive as to its validity or enforceability, nor
does the issuance of a patent provide the patent holder with freedom to operate without infringing the patent rights of others.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>We will incur additional expenses
in connection with our exclusive channel collaboration arrangements with Intrexon.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Pursuant to our exclusive channel collaborations
with Intrexon, we are responsible for future research and development expenses of product candidates developed under each such
collaboration, the effect of which has and will continue to increase the level of our overall research and development expenses
going forward. Although all manufacturing, preclinical studies and human clinical trials are expensive and difficult to design
and implement, costs associated with the manufacturing, research and development of biologic product candidates are generally greater
in comparison to small molecule product candidates. We have added additional personnel and expect to add additional personnel to
support our exclusive channel collaborations with Intrexon.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Because our collaborations with Intrexon
are relatively new, we have only recently assumed development responsibility and costs associated with such programs. In addition,
because development activities are determined pursuant to a joint steering committees comprised of Intrexon and ourselves and we
have limited experience, future development costs associated this program may be difficult to anticipate and exceed our expectations.
Our actual cash requirements may vary materially from our current expectations for a number of other factors that may include,
but are not limited to, unanticipated technical challenges, changes in the focus and direction of our development activities or
adjustments necessitated by changes in the competitive landscape in which we operate. If we are unable to continue to financially
support such collaborations due to our own working capital constraints, we may be forced to delay our activities. If we are unable
to obtain additional financing on terms acceptable to us or at all, we may be forced to seek licensing partners or discontinue
development.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>Developments by competitors may render
our products or technologies obsolete or non-competitive.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Companies that currently sell or are developing
both generic and proprietary products to treat serious diseases include: Actelion Pharmaceuticals, Bayer Health Care, Biogen Idec,
Eli Lilly &amp; Co., Genzyme, GlaxoSmithKline Pharmaceuticals, Merck &amp; Co., Pfizer, Novartis, Teva Pharmaceuticals and United
Therapeutics. Companies that currently sell or are developing both generic and proprietary products to treat infectious diseases
include: MedImmune, Pfizer, Cubist, Optimer Pharmaceuticals, Symphogen, Merus, GlaxoSmithKline Pharmaceuticals, Merck &amp; Co.
and Novartis. Many of our competitors have significant financial and human resources. The pulmonary arterial hypertension market
is highly competitive and several different product classes currently compete in this space, including prostacyclin-based therapies,
endothelin receptor antagonists and phosphodiesterase type 5 inhibitors. Prostacyclin-based therapies for PAH are available in
a number of delivery formats, including intravenous, subcutaneous and inhaled routes and an oral prostacyclin-based product candidate
is currently under NDA review in the U.S. The infectious disease market is highly competitive with many generic and proprietary
intravenous and oral formulations available to physicians and their patients. As monoclonal antibodies, we currently do not expect
to be able to deliver our infectious disease candidates via the oral route and may thus be limited to the in-patient and/or acute
treatment setting. In addition, academic research centers may develop technologies that compete with our Trimesta, sustained-release
zinc preparation - AEN-100, and flupirtine technologies. Should clinicians or regulatory authorities view these therapeutic regiments
as more effective than our products, this might delay or prevent us from obtaining regulatory approval for our products, or it
might prevent us from obtaining favorable reimbursement rates from payers, such as Medicare, Medicaid and private insurers.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>We operate in a highly competitive
environment</I>.</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The pharmaceutical and biotechnology industries,
including the monoclonal antibody industry, are characterized by rapidly evolving technology and intense competition. Our competitors
include major multi-national pharmaceutical companies and biotechnology companies developing both generic and proprietary therapies
to treat serious diseases. Many of these companies are well-established and possess technical, human, research and development,
financial, and sales and marketing resources significantly greater than ours. In addition, many of our potential competitors have
formed strategic collaborations, partnerships and other types of joint ventures with larger, well established industry competitors
that afford these companies potential research and development and commercialization advantages in the therapeutic areas we are
currently pursuing.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Academic research centers, governmental
agencies and other public and private research organizations are also conducting and financing research activities which may produce
products directly competitive to those being developed by us. In addition, many of these competitors may be able to obtain patent
protection, obtain FDA and other regulatory approvals and begin commercial sales of their products before us.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>Competitors could develop and/or
gain FDA approval of our products for a different indication.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Since we do not have composition of matter
patent claims for flupirtine, estriol or zinc acetate, others may obtain approvals for other uses of these products that are not
covered by our issued or pending patents. For example, the active ingredients in both Effirma (flurpirtine) and Trimesta (oral
estriol) have been approved for marketing in overseas countries for different uses and an oral immediate release form of zinc is
approved in the U.S. and Europe for the treatment of Wilson&rsquo;s disease. Other companies, including the original developers
or licensees or affiliates may seek to develop Effirma or Trimesta or their respective active ingredient(s) for other uses in the
U.S. or any country we are seeking approval for. We cannot provide any assurances that any other company may obtain FDA approval
for products that contain flupirtine, estriol or zinc in various formulations or delivery systems that might adversely affect our
ability or the ability of Meda to develop and market these products in the U.S. We are aware that other companies have intellectual
property protection using the active ingredients and have conducted clinical trials of flupirtine, estriol and zinc for different
applications than what we are developing. Many of these companies may have more resources than us. We cannot provide any assurances
that our products will be FDA-approved prior to our competitors.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If a product containing our active ingredients
is already marketed or if the FDA approves other products containing our active ingredients in the future to treat indications,
physicians may elect to prescribe and substitute a competitor&rsquo;s products to treat the diseases for which we are intending
to commercialize; this is commonly referred to as &ldquo;off-label&rdquo; use. While under FDA regulations a competitor is not
allowed to promote off-label uses of its product, the FDA does not regulate the practice of medicine and, as a result, cannot direct
physicians to select certain products for their patients. Consequently, we might be limited in our ability to prevent off-label
use of a competitor&rsquo;s product to treat the diseases we are intending to commercialize, even if we have issued method of use
patents for that indication. If we are not able to obtain and enforce our patents, if any, or otherwise receive orphan drug protection
in the case of ALS, a competitor could develop and commercialize similar products for the same indications that we are pursuing.
We cannot provide any assurances that a competitor will not obtain FDA approval for a product that contains the same active ingredients
as our products.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>We rely on method patents and patent
applications and various regulatory exclusivities to protect some of our product candidates and our ability to compete may be limited
or eliminated if we are not able to protect our products.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our competitiveness may be adversely affected
if we are unable to protect our proprietary technologies. We do not have composition of matter patents for Trimesta or Effirma,
or their respective active ingredients estriol and flupirtine. We rely on issued patent and pending patent applications for use
of Trimesta to treat MS (issued U.S. Patent No. 6,936,599) and various other therapeutic indications, which have been exclusively
licensed to us. We have exclusively licensed an issued patent for the treatment of fibromyalgia with flupirtine, which we have
sublicensed to Meda AB.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our AEN-100 drug candidate (gastroretentive
zinc acetate) is the subject of U.S. and international pending patent applications, such as published U.S. patent application Ser.
No. 11/621,962 and corresponding international applications that claim priority to January 10, 2006 as well as additional patent
applications. On October 26, 2011, we received a final rejection letter with regard to U.S. patent application Ser. No. 11/621,962.
On February 15, 2012, we filed a Request for Continued Examination.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The patent positions of pharmaceutical
companies are uncertain and may involve complex legal and factual questions. We may incur significant expense in protecting our
intellectual property and defending or assessing claims with respect to intellectual property owned by others. Any patent or other
infringement litigation by or against us could cause us to incur significant expense and divert the attention of our management.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Others may file patent applications or
obtain patents on similar technologies or compounds that compete with our products. We cannot predict how broad the claims in any
such patents or applications will be, and whether they will be allowed. Once claims have been issued, we cannot predict how they
will be construed or enforced. We may infringe intellectual property rights of others without being aware of it. If another party
claims we are infringing their technology, we could have to defend an expensive and time consuming lawsuit, pay a large sum if
we are found to be infringing, or be prohibited from selling or licensing our products unless we obtain a license or redesign our
product, which may not be possible.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We also rely on trade secrets and proprietary
know-how to develop and maintain our competitive position. Some of our current or former employees, consultants, scientific advisors,
current or prospective corporate collaborators, may unintentionally or willfully disclose our confidential information to competitors
or use our proprietary technology for their own benefit. Furthermore, enforcing a claim alleging the infringement of our trade
secrets would be expensive and difficult to prove, making the outcome uncertain. Our competitors may also independently develop
similar knowledge, methods, and know-how or gain access to our proprietary information through some other means.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>We may fail to retain or recruit
necessary personnel, and we may be unable to secure the services of consultants.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As of November 30, 2012, we had twelve
employees. We have also engaged clinical consultants to advise us on our clinical programs and regulatory consultants to advise
us on our dealings with the FDA and other foreign regulatory authorities. We have been and will be required to retain additional
consultants and employees in order to fulfill our obligations under our exclusive channel collaborations with Intrexon. Our future
performance will depend in part on our ability to successfully integrate newly hired officers into our management team and our
ability to develop an effective working relationship among senior management.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Certain of our directors,&nbsp;scientific
advisors, and consultants serve as officers, directors, scientific advisors, or consultants of other biopharmaceutical or biotechnology
companies that might be developing competitive products to ours. Other than corporate opportunities, none of our directors are
obligated under any agreement or understanding with us to make any additional products or technologies available to us. Similarly,
we can give no assurances, and we do not expect and stockholders should not expect, that any biomedical or pharmaceutical product
or technology identified by any of our directors or affiliates in the future would be made available to us other than corporate
opportunities. We can give no assurances that any such other companies will not have interests that are in conflict with our interests.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Losing key personnel or failing to recruit
necessary additional personnel would impede our ability to attain our development objectives. There is intense competition for
qualified personnel in the drug-development field, and we may not be able to attract and retain the qualified personnel we would
need to develop our business.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We rely on independent organizations, advisors,
and consultants to perform certain services for us, including handling substantially all aspects of regulatory approval, clinical
management, manufacturing, marketing, and sales. We expect that this will continue to be the case. Such services may not always
be available to us on a timely basis when we need them.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>If the parties we depend on for supplying
our drug substance raw materials and certain manufacturing-related services do not timely supply these products and services, it
may delay or impair our ability to develop, manufacture and market our products.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We rely on suppliers for our drug substance
raw materials and third parties for certain manufacturing-related services to produce material that meets appropriate content,
quality and stability standards and use in clinical trials of our products and, after approval, for commercial distribution. We
have not yet established a cGMP manufacturer for neither our DNA-based nor monoclonal antibody therapies. Our AEN-100 product candidate
has limited stability data to date and is the subject of ongoing stability studies. To succeed, clinical trials require adequate
supplies of drug substance and drug product, which may be difficult or uneconomical to procure or manufacture. We and our suppliers
and vendors may not be able to (i) produce our drug substance or drug product to appropriate standards for use in clinical studies,
(ii) perform under any definitive manufacturing, supply or service agreements with us, or (iii) remain in business for a sufficient
time to successfully produce and market our product candidates. If we do not maintain important manufacturing and service relationships,
we may fail to find a replacement supplier or required vendor or develop our own manufacturing capabilities which could delay or
impair our ability to obtain regulatory approval for our products and substantially increase our costs or deplete profit margins,
if any. If we do find replacement manufacturers and vendors, we may not be able to enter into agreements with them on terms and
conditions favorable to us and, there could be a substantial delay before a new facility could be qualified and registered with
the FDA and foreign regulatory authorities.</P>

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

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>If successful large-scale manufacturing
of DNA-based products is not possible, we or our collaborators may be unable to manufacture enough of our product candidates to
achieve regulatory approval or market our DNA-based products.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Few companies to date have demonstrated
successful large-scale manufacturing of DNA-based products, including those that have had significantly more resources than us
and it is anticipated that significant challenges will be faced in the scale-up of our manufacturing process for commercial production.
There are a limited number of contract manufacturers qualified to perform large-scale manufacturing of DNA-based products. We or
our collaborators may be unable to manufacture commercial-scale quantities of DNA-based products or receive appropriate government
approvals on a timely basis or at all. Failure to successfully manufacture or obtain appropriate government approvals on a timely
basis or at all would prevent us from achieving our business objectives.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>Clinical trials are very expensive,
time-consuming, and difficult to design and implement.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Human clinical trials are very expensive
and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The clinical trial
process is also time-consuming. We estimate that clinical trials of our product candidates would take at least several years to
complete. Furthermore, failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon or
repeat clinical trials. Commencement and completion of clinical trials may be delayed by several factors, including:</P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 3%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 3%; padding-right: 0.8pt">&#9679;</TD>
    <TD STYLE="width: 94%; padding-right: 0.8pt; text-align: justify">obtaining an IND application with the FDA to commence clinical trials;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&#9679;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: justify">identification of, and acceptable arrangements with, one or more clinical sites;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&#9679;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: justify">obtaining IRB approval to commence clinical trials;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&#9679;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: justify">unforeseen safety issues;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&#9679;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: justify">determination of dosing;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&#9679;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: justify">lack of effectiveness during clinical trials;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&#9679;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: justify">slower than expected rates of patient recruitment;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&#9679;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: justify">inability to monitor patients adequately during or after treatment;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&#9679;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: justify">inability or unwillingness of medical investigators to follow our clinical protocols; and</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&#9679;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: justify">unwillingness of the FDA or IRBs to permit the clinical trials to be initiated.</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">In addition, we, IRBs or the FDA may suspend our clinical trials
at any time if it appears that we are exposing participants to unacceptable health risks or if IRBs or the FDA finds deficiencies
in our submissions or conduct of our trials.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>The results of our clinical trials
may not support our product candidate claims and the results of preclinical studies and completed clinical trials are not necessarily
predictive of future results.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">To date, long-term safety and efficacy
have not yet been demonstrated in clinical trials for any of our diagnostic product candidates. Favorable results in our early
studies or trials may not be repeated in later studies or trials. Even if our clinical trials are initiated and completed as planned,
we cannot be certain that the results will support our product candidate claims. Success in preclinical testing and Phase II clinical
trials does not ensure that later Phase II or Phase III clinical trials will be successful. We cannot be sure that the results
of later clinical trials would replicate the results of prior clinical trials and preclinical testing. In particular, the limited
results that we have obtained for our diagnostic tests may not predict results from studies in larger numbers of subjects drawn
from more diverse populations over a longer period of time. Clinical trials may fail to demonstrate that our product candidates
are safe for humans and effective for indicated uses. Any such failure could cause us or our sublicensee to abandon a product candidate
and might delay development of other product candidates. Preclinical and clinical results are frequently susceptible to varying
interpretations that may delay, limit or prevent regulatory approvals or commercialization. Any delay in, or termination of, our
clinical trials would delay our obtaining FDA approval for the affected product candidate and, ultimately, our ability to commercialize
that product candidate.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>We depend on third parties, including
researchers and sublicensees, who are not under our control.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Since we have in-licensed some of our product
candidates, have sublicensed a product candidate and have collaboration agreements for the development of other product candidates,
we depend upon our sublicensee and independent investigators and scientific collaborators, such as universities and medical institutions
or private physician scientists, to conduct our preclinical and clinical trials under agreements with us. These collaborators are
not our employees and we cannot control the amount or timing of resources that they devote to our programs or the timing of their
procurement of clinical-trial data or their compliance with applicable regulatory guidelines. Should any of these scientific inventors/advisors
or those of our sublicensee become disabled or die unexpectedly, or should they fail to comply with applicable regulatory guidelines,
we or our sublicensee may be forced to scale back or terminate development of that program. They may not assign as great a priority
to our programs or pursue them as diligently as we would if we were undertaking those programs ourselves. Failing to devote sufficient
time and resources to our drug-development programs, or substandard performance and failure to comply with regulatory guidelines,
could result in delay of any FDA applications and our commercialization of the drug candidate involved.</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">These collaborators may also have relationships
with other commercial entities, some of which may compete with us. Our collaborators assisting our competitors at our expense could
harm our competitive position. For example, we are highly dependent on scientific collaborators for our Trimesta development program.
Specifically, all of the clinical trials have been conducted under physician-sponsored IND applications, not corporate-sponsored
INDs. Generally, we have experienced difficulty in collecting data generated from these physician-sponsored clinical trials for
our programs. We cannot provide any assurances that we will not experience any additional delays in the future.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We are also highly dependent on government
and private grants to fund certain of our clinical trials for our product candidates. For example, Trimesta (oral estriol) has
received grants totaling over $8 million,&nbsp;predominantly from the Southern California Chapter of the NMSS and the National
Institutes of Health which funds a majority of the ongoing clinical trial in relapsing-remitting MS for women. Although we believe
that the grant funding received to date is sufficient to complete the current clinical trial based upon current cost estimates,
if we experience any additional unanticipated costs or require further clinical trials, and our scientific collaborator is unable
to maintain or receive additional grants, we might be forced to scale back or terminate the development of this product candidate.
We will also need to cross reference our IND with the inventor/IND holder for this program should we elect to file our own corporate
IND for our Trimesta (oral estriol) program. The on-going and future development and commercialization of Effirma (flupirtine)
for fibromyalgia is the responsibility of Meda AB and no assurance can be given that Meda will gain the FDA&rsquo;s acceptance
of the NDA or obtain NDA approval from the FDA of flupirtine for fibromyalgia.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our AEN-100 program for ALS is reliant
on the investigator-initiated IND of PNA. The planned clinical trial that we intend to conduct with PNA is still the subject of
further protocol development. In addition, we may need to conduct additional clinical or non-clinical studies to support a New
Drug Application or to support further clinical trials. Any additional studies of AEN-100 may produce unanticipated and unacceptable
safety, tolerability or bioavailability results that may substantially delay further development work of the planned clinical trial.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">With respect to our synthetic biologic
product candidates, we are dependent upon Intrexon&rsquo;s synthetic biology facilities and capabilities as we have no such facilities
and capabilities of our own. We are also reliant on their vector engineering platform, gene expression switch technology, monoclonal
antibody discovery, production cell line development and know-how. If any of the foregoing were to become inaccessible or terminated,
it would be difficult for us to develop and commercialize our synthetic biologic product candidates.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>We may incur substantial costs as
a result of litigation or other proceedings relating to patent and other intellectual property rights, as well as costs associated
with lawsuits.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If any other person files patent applications,
or is issued patents, claiming technology also claimed by us in pending applications, we may be required to participate in interference
proceedings in the U.S. Patent and Trademark Office to determine priority of invention. We, or our licensors, may also need to
participate in interference proceedings involving our issued patents and pending applications of another entity.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The intellectual property environment in
the area of DNA-based therapeutics is particularly complex, constantly evolving and highly fragmented. Other companies and institutions
have issued patents and have filed or will file patent applications that may issue into patents that cover or attempt to cover
genes, vectors, cell lines, and methods of making and using DNA and DNA-based therapy products used in, or similar to our product
candidate, and technologies. The same is true of the monoclonal antibody field in terms of methods of producing monoclonal antibodies
for human use. We have not conducted freedom-to-use patent searches on all aspects of our product candidates or potential product
candidates, and we may be unaware of relevant patents and patent applications of third parties. In addition, the freedom-to-use
patent searches that have been conducted may not have identified all relevant issued patents or pending patents. We cannot provide
assurance that our proposed products in this area will not ultimately be held to infringe one or more valid claims owned by third
parties which may exist or come to exist in the future or that in such case we will be able to obtain a license from such parties
on acceptable terms.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We cannot guarantee that the practice of
our technologies will not conflict with the rights of others. In some foreign jurisdictions, we could become involved in opposition
proceedings, either by opposing the validity of another&rsquo;s foreign patent or by persons opposing the validity of our foreign
patents.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We may also face frivolous litigation or
lawsuits from various competitors or from litigious securities attorneys. The cost to us of any litigation or other proceeding
relating to these areas, even if deemed frivolous or resolved in our favor, could be substantial and could distract management
from our business. Uncertainties resulting from initiation and continuation of any litigation could have a material adverse effect
on our ability to continue our operations.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>If we infringe the rights of others
we could be prevented from selling products or forced to pay damages.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If our products, methods, processes, and
other technologies are found to infringe the proprietary rights of other parties, we could be required to pay damages, or we may
be required to cease using the technology or to license rights from the prevailing party. Any prevailing party may be unwilling
to offer us a license on commercially acceptable terms.</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>RISKS RELATING TO OUR STOCK</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>We will seek to raise additional
funds in the future, which may be dilutive to stockholders or impose operational restrictions.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We expect to seek to raise additional capital
in the future to help fund development of our proposed products. If we raise additional capital through the issuance of equity
or of debt securities, the percentage ownership of our current stockholders will be reduced. We may also enter into strategic transactions,
issue equity as part of license issue fees to our licensors, compensate consultants or settle outstanding payables using equity
that may be dilutive. Our stockholders may experience additional dilution in net book value per share and any additional equity
securities may have rights, preferences and privileges senior to those of the holders of our common stock.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>We are substantially controlled by
our current officers, directors, and principal stockholders.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Currently, our directors, executive officers,
and principal stockholders beneficially own a substantial number of shares of our common stock. As a result, they will be able
to exert substantial influence over the election of our Board of Directors and the vote on issues submitted to our stockholders.
Our executive officers and directors beneficially owned approximately 8.7 million shares of our common stock, including stock options
and warrants exercisable within 60 days of December 1, 2012. Our executive officers, directors and principal stockholders together
beneficially owned approximately 18.5 million shares of our common stock, including the stock options and warrants exercisable
within 60 days of December 1, 2012. Because our common stock has from time to time been &ldquo;thinly traded&rdquo;, the sale of
a substantial number of shares by our executive officers, directors and principal stockholders would have an adverse effect on
the market for our stock and our share price.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>Our shares of common stock are from
time to time thinly traded, so stockholders may be unable to sell at or near ask prices or at all if they need to sell shares to
raise money or otherwise desire to liquidate their shares.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our common stock has from time to time
been &ldquo;thinly-traded,&rdquo; meaning that the number of persons interested in purchasing our common stock at or near ask prices
at any given time may be relatively small or non-existent. This situation is attributable to a number of factors, including the
fact that we are a small company that is relatively unknown to stock analysts, stock brokers, institutional investors and others
in the investment community that generate or influence sales volume, and that even if we came to the attention of such persons,
they tend to be risk-averse and would be reluctant to follow an unproven company such as ours or purchase or recommend the purchase
of our shares until such time as we became more seasoned and viable. As a consequence, there may be periods of several days or
more when trading activity in our shares is minimal or non-existent, as compared to a seasoned issuer which has a large and steady
volume of trading activity that will generally support continuous sales without an adverse effect on share price. We cannot give
stockholders any assurance that a broader or more active public trading market for our common shares will develop or be sustained,
or that current trading levels will be sustained.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We cannot assure you that the common stock will be liquid
or that it will remain listed on the NYSE MKT.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We cannot assure you that we will be able
to maintain the continued listing standards of the NYSE MKT (formerly the NYSE Amex and the American Stock Exchange). The NYSE
MKT requires companies to meet certain continued listing criteria including certain minimum stockholders' equity&nbsp;and equity
prices per share&nbsp;as outlined in the NYSE MKT Exchange Company Guide. We may not be able to maintain such minimum stockholders'
equity or prices per share or may be required to effect a reverse stock split to maintain such minimum prices and/or issue additional
equity securities in exchange for cash or other assets, if available, to maintain certain minimum stockholders' equity required
by the NYSE MKT.&nbsp;If we are delisted from the NYSE MKT then our common stock will trade, if at all, only on the over-the-counter
market, such as the OTC Bulletin Board securities market, and then only if one or more registered broker-dealer market makers comply
with quotation requirements. In addition, delisting of our common stock could depress our stock price, substantially limit liquidity
of our common stock and materially adversely affect our ability to raise capital on terms acceptable to us, or at all. Delisting
from the NYSE MKT could also have other negative results, including the potential loss of confidence by suppliers and employees,
the loss of institutional investor interest and fewer business development opportunities. In order to remain listed on NYSE MKT,
we are required to maintain a minimum stockholders&rsquo; equity of $6 million. The net proceeds of $10.1 million from our recent
financing increased our stockholders&rsquo; equity well above the minimum requirement of $6 million. However, we could be subject
to certain additional regulatory requirements or additional inquiries from the NYSE MKT, because our stockholders&rsquo; equity
at September 30, 2012 was $5.4 million.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>There may be issuances of shares
of preferred stock in the future.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Although we currently do not have preferred
shares outstanding, the Board of Directors could authorize the issuance of a series of preferred stock that would grant holders
preferred rights to our assets upon liquidation, the right to receive dividends before dividends would be declared to common stockholders,
and the right to the redemption of such shares, possibly together with a premium, prior to the redemption of the common stock.
To the extent that we do issue preferred stock, the rights of holders of common stock could be impaired thereby, including without
limitation, with respect to liquidation.</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our failure to fulfill all of our registration requirements
may cause us to suffer liquidated damages, which may be very costly.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Registration Rights Agreement that
we entered into in connection with the October 2012 Private Placement requires that we file the Initial Registration Statement
with the Commission on or prior to the Filing Date and that the Initial Registration Statement is declared effective by the Commission
on or prior to the Effectiveness Date subject to certain adjustments. Upon the occurrence of an Event, including, but not limited
to, that the Initial Registration Statement is not filed prior to the Filing Date or declared effective prior to the Effectiveness
Date, the Company will be required to pay to each of the Purchasers liquidated damages of 1.5% of their aggregate purchase price
upon the date of the Event and then monthly thereafter until the Event is cured. In no event will the aggregate amount of liquidated
damages payable to each of the Purchasers exceed in the aggregate 10% of the aggregate purchase price paid by such Purchaser. In
addition, pursuant to the terms of the registration rights agreement that we entered into with Intrexon and an affiliated entity,
we are required to file a registration statement with respect to securities issued to them within a certain time period and maintain
the effectiveness of such registration statement. The failure to do so could result in the payment of damages by us. There can
be no assurance as to when the Initial Registration Statement will be declared effective or that we will be able to maintain the
effectiveness of any registration statement, and therefore there can be no assurance that we will not incur penalties or damages
with respect to such agreements.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>RISKS RELATED TO OUR INDUSTRY</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>We are subject to government regulation,
compliance with which can be costly and difficult.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In the U.S., the formulation, manufacturing,
packaging, storing, labeling, promotion, advertising, distribution and sale of our products are subject to regulation by various
governmental agencies, including (1) the FDA, (2) the Federal Trade Commission, or FTC, (3) the Consumer Product Safety Commission,
or CPSC, (4) the U.S. Department of Agriculture, or USDA. Our proposed activities may also be regulated by various agencies of
the states, localities and foreign countries in which our proposed products may be manufactured, distributed and sold. The FDA,
in particular, regulates the formulation, manufacture and labeling of over-the-counter, or OTC drugs, prescription drugs, conventional
foods, dietary supplements, and cosmetics such as those that we intend to distribute. FDA regulations require us and our suppliers
to meet relevant cGMP regulations for the preparation, packing, labeling, and storage of all drugs and foods.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Any products manufactured or distributed
by us pursuant to FDA approvals are subject to pervasive and continuing FDA regulation, including record-keeping requirements,
reporting of adverse experiences, submitting periodic reports, drug sampling and distribution requirements, manufacturing or labeling
changes, record-keeping requirements, and compliance with FDA promotion and advertising requirements. Drug manufacturers and their
subcontractors are required to register their facilities with the FDA and state agencies, and are subject to periodic unannounced
inspections for GMP compliance, imposing procedural and documentation requirements upon us and third-party manufacturers. Failure
to comply with these regulations could result, among other things, in suspension of regulatory approval, recalls, suspension of
production or injunctions, seizures, or civil or criminal sanctions. We cannot be certain that we or our present or future subcontractors
will be able to comply with these regulations.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The FDA regulates prescription drug labeling
and promotion activities. The FDA actively enforces regulations prohibiting the marketing of products for unapproved uses. The
FDA permits the promotion of drugs for unapproved uses in certain circumstances, subject to stringent requirements. We and our
product candidates are subject to a variety of state laws and regulations which may hinder our ability to market our products.
Whether or not FDA approval has been obtained, approval by foreign regulatory authorities must be obtained prior to commencing
clinical trials, and sales and marketing efforts in those countries. These approval procedures vary in complexity from country
to country, and the processes may be longer or shorter than that required for FDA approval. We may incur significant costs to comply
with these laws and regulations now or in the future.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We intend to develop our zinc candidate,
AEN-100, as a drug and intend to file an IND with the FDA in order to conduct necessary clinical trials to support new medical
claims and ultimately file one or more NDA with respect to such products which would subject us to time, expense and uncertainty
associated with achieving approval of such NDA by the FDA.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The FDA, comparable foreign regulators
and state and local pharmacy regulators impose substantial requirements upon clinical development, manufacture and marketing of
pharmaceutical products. These and other entities regulate research and development and the testing, manufacture, quality control,
safety, effectiveness, labeling, storage, record keeping, approval, advertising, and promotion of our products. The drug approval
process required by the FDA under the Food, Drug, and Cosmetic Act generally involves:</P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 3%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 3%; padding-right: 0.8pt">&#9679;</TD>
    <TD STYLE="width: 94%; padding-right: 0.8pt; text-align: justify">preclinical laboratory and animal tests;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&#9679;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: justify">submission of an IND, prior to commencing human clinical trials;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&#9679;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: justify">adequate and well-controlled human clinical trials to establish safety and efficacy for intended use;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&#9679;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: justify">submission to the FDA of an NDA or Biologics License Application (BLA); and</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&#9679;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: justify">FDA review and approval of an NDA or BLA.</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The testing and approval process requires
substantial time, effort, and financial resources, and we cannot be certain that any approval will be granted on a timely basis,
if at all.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Preclinical tests include laboratory evaluation
of the product candidate, its chemistry, formulation and stability, and animal studies to assess potential safety and efficacy.
Certain preclinical tests must be conducted in compliance with good laboratory practice regulations. Violations of these regulations
can, in some cases, lead to invalidation of the studies, requiring them to be replicated. In some cases, long-term preclinical
studies are conducted concurrently with clinical studies.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We will submit the preclinical test results,
together with manufacturing information and analytical data, to the FDA as part of an IND, which must become effective before we
begin human clinical trials. The IND automatically becomes effective 30 days after filing, unless the FDA raises questions about
conduct of the trials outlined in the IND and imposes a clinical hold, in which case, the IND sponsor and FDA must resolve the
matters before clinical trials can begin. It is possible that our submission may not result in FDA authorization to commence clinical
trials.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Clinical trials must be supervised by a
qualified investigator in accordance with good clinical practice (GCP) regulations, which include informed consent requirements.
An independent IRB at each medical center reviews and approves and monitors the study, and is periodically informed of the study&rsquo;s
progress, adverse events and changes in research. Progress reports are submitted annually to the FDA and more frequently if adverse
events occur.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Human clinical trials of drug candidates
typically have three sequential phases that may overlap:</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Phase I:&nbsp;The drug is initially tested
in healthy human subjects or patients for safety, dosage tolerance, absorption, metabolism, distribution, and excretion.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Phase II:&nbsp;The drug is studied in a
limited patient population to identify possible adverse effects and safety risks, determine efficacy for specific diseases and
establish dosage tolerance and optimal dosage.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Phase III:&nbsp;When Phase II evaluations
demonstrate that a dosage range is effective with an acceptable safety profile, Phase III&nbsp;trials to further evaluate dosage,
clinical efficacy and safety, are undertaken in an expanded patient population, often at geographically dispersed sites.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We cannot be certain that we will successfully
complete Phase I, Phase II, or Phase III testing of our product candidates within any specific time period, if at all. Furthermore,
the FDA, an IRB or the IND sponsor may suspend clinical trials at any time on various grounds, including a finding that subjects
or patients are exposed to unacceptable health risk. Concurrent with these trials and studies, we also develop chemistry and physical
characteristics data and finalize a manufacturing process in accordance with good manufacturing practice (GMP) requirements. The
manufacturing process must conform to consistency and quality standards, and we must develop methods for testing the quality, purity,
and potency of the final products. Appropriate packaging is selected and tested, and chemistry stability studies are conducted
to demonstrate that the product does not undergo unacceptable deterioration over its shelf-life. Results of the foregoing are submitted
to the FDA as part of a NDA (or BLA in case of biologic products) for marketing and commercial shipment approval. The FDA reviews
each NDA or BLA submitted and may request additional information.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Once the FDA accepts the NDA or BLA for
filing, it begins its in-depth review. The FDA has substantial discretion in the approval process and may disagree with our interpretation
of the data submitted. The process may be significantly extended by requests for additional information or clarification regarding
information already provided. As part of this review, the FDA may refer the application to an appropriate advisory committee, typically
a panel of clinicians. Manufacturing establishments often are inspected prior to NDA or BLA approval to assure compliance with
GMPs and with manufacturing commitments made in the application.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Submission of an NDA or BLA with clinical
data requires payment of a fee. In return, the FDA assigns a goal of ten months for issuing its &ldquo;complete response,&rdquo;
in which the FDA may approve or deny the NDA or BLA, or require additional clinical data. Even if these data are submitted, the
FDA may ultimately decide the NDA or BLA does not satisfy approval criteria. If the FDA approves the NDA or BLA, the product becomes
available for physicians prescription. Product approval may be withdrawn if regulatory compliance is not maintained or safety problems
occur. The FDA may require post-marketing studies, also known as phase IV studies, as a condition of approval, and requires surveillance
programs to monitor approved products that have been commercialized. The agency has the power to require changes in labeling or
prohibit further marketing based on the results of post-marketing surveillance.</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Satisfaction of these and other regulatory
requirements typically takes several years, and the actual time required may vary substantially based upon the type, complexity
and novelty of the product. Government regulation may delay or prevent marketing of potential products for a considerable period
of time and impose costly procedures on our activities. We cannot be certain that the FDA or other regulatory agencies will approve
any of our products on a timely basis, if at all. Success in preclinical or early-stage clinical trials does not assure success
in later-stage clinical trials. Data obtained from preclinical and clinical activities are not always conclusive and may be susceptible
to varying interpretations that could delay, limit or prevent regulatory approval. Even if a product receives regulatory approval,
the approval may be significantly limited to specific indications or uses.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Even after regulatory approval is obtained,
later discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal
of the product from the market. Delays in obtaining, or failures to obtain regulatory approvals would have a material adverse effect
on our business.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The FDA&rsquo;s policies may change, and
additional government regulations may be enacted which could prevent or delay regulatory approval of our potential products. Increased
attention to the containment of health care costs worldwide could result in new government regulations materially adverse to our
business. We cannot predict the likelihood, nature or extent of adverse governmental regulation that might arise from future legislative
or administrative action, either in the U.S. or abroad.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>We do not have a guarantee of patent
restoration and marketing exclusivity of the ingredients for our drugs even if we are granted FDA approval of our products.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The U.S. Drug Price Competition and Patent
Term Restoration Act of 1984 (Hatch-Waxman) permits the FDA to approve Abbreviated New Drug Applications (ANDAs) for generic versions
of innovator drugs, as well as NDAs with less original clinical data, and provides patent restoration and exclusivity protections
to innovator drug manufacturers. The ANDA process permits competitor companies to obtain marketing approval for drugs with the
same active ingredient and for the same uses as innovator drugs, but does not require the conduct and submission of clinical studies
demonstrating safety and efficacy. As a result, a competitor could copy any of our drugs and only need to submit data demonstrating
that the copy is bioequivalent to gain marketing approval from the FDA. Hatch-Waxman requires a competitor that submits an ANDA,
or otherwise relies on safety and efficacy data for one of our drugs, to notify us and/or our business partners of potential infringement
of our patent rights. We and/or our business partners may sue the company for patent infringement, which would result in a 30-month
stay of approval of the competitor&rsquo;s application. The discovery, trial and appeals process in such suits can take several
years. If the litigation is resolved in favor of the generic applicant or the challenged patent expires during the 30-month period,
the stay is lifted and the FDA may approve the application. Hatch-Waxman also allows competitors to market copies of innovator
products by submitting significantly less clinical data outside the ANDA context. Such applications, known as &ldquo;505(b)(2)
NDAs&rdquo; or &ldquo;paper NDAs,&rdquo; may rely on clinical investigations not conducted by or for the applicant and for which
the applicant has not obtained a right of reference or use and are subject to the ANDA notification procedures described above.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The law also permits restoration of a portion
of a product&rsquo;s patent term that is lost during clinical development and NDA review, and provides statutory protection, known
as exclusivity, against FDA approval or acceptance of certain competitor applications. Restoration can return up to five years
of patent term for a patent covering a new product or its use to compensate for time lost during product development and regulatory
review. The restoration period is generally one-half the time between the effective date of an IND and submission of an NDA, plus
the time between NDA submission and its approval (subject to the five-year limit), and no extension can extend total patent life
beyond 14 years after the drug approval date. Applications for patent term extension are subject to U.S. Patent and Trademark Office
(USPTO) approval, in conjunction with FDA. Approval of these applications takes at least nine months, and there can be no guarantee
that it will be given at all.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Hatch-Waxman also provides for differing
periods of statutory protection for new drugs approved under an NDA. Among the types of exclusivity are those for a &ldquo;new
molecular entity&rdquo; and those for a new formulation or indication for a previously-approved drug. If granted, marketing exclusivity
for the types of products that we are developing, which include only drugs with innovative changes to previously-approved products
using the same active ingredient, would prohibit the FDA from approving an ANDA or 505(b)(2) NDA relying on our safety and efficacy
data for three years. This three-year exclusivity, however, covers only the innovation associated with the original NDA. It does
not prohibit the FDA from approving applications for drugs with the same active ingredient but without our new innovative change.
These marketing exclusivity protections do not prohibit the FDA from approving a full NDA, even if it contains the innovative change.</P>

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

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

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">All of the shares of common stock covered
by this prospectus are being sold by the Selling Stockholders. See &ldquo;Selling Stockholders&rdquo; on page 18. We will not
receive any proceeds from these sales of shares of our common stock. A portion of the Shares covered by this prospectus are issuable
upon exercise of the Agent Warrants to purchase our common stock. Upon any exercise of the Agent Warrants for cash, such Selling
Stockholders would pay us the exercise price of the warrants. Cash received from exercise of Agent Warrants will be used for general
corporate purposes. Additionally, the Agent Warrants are exercisable on a cashless basis. If any Agent Warrants are exercised on
a cashless basis, we would not receive any cash payment from such Selling Stockholders upon any exercise of such Agent Warrants.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Selling Stockholders will pay any underwriting
discounts and commissions and expenses incurred by the Selling Stockholders for brokerage, accounting, tax, or legal services or
any other expenses incurred by the Selling Stockholders in disposing of the Shares. We will bear all other costs, fees, and expenses
incurred in effecting the registration of the Shares covered by this prospectus, including, without limitation, all registration
and filing fees, and fees and expenses of our counsel and our accountants.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We have prepared this prospectus to allow
the Selling Stockholders or their successors, assignees or other permitted transferees to sell or otherwise dispose of, from time
to time, up to 4,260,855 shares of our common stock. This prospectus covers the offer and disposition by the Selling Stockholders
identified below, or their transferee(s), of a total of 4,260,855 shares of our common stock. Of the shares of common stock being
offered under this prospectus 3,625,000 were acquired by the purchasers in our October 2012 Private Placement and 635,855 shares
are able to be acquired pursuant to the Agent Warrants we issued in connection with our October 2012 Private Placement, which Agent
Warrants are currently exercisable.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Shares sold to the Selling Stockholders
in the October 2012 Private Placement were sold pursuant to an exemption from registration provided by Rule 506 of Regulation D
under the Securities Act. In connection therewith, the investors made to us certain representations, warranties, covenants, and
conditions customary for private placement investments.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The table below presents information
regarding the Selling Stockholders and the Shares that they may sell or otherwise dispose of from time to time under this
prospectus. The table is based on information supplied to us by the Selling Stockholders and reflects holdings as of December
7, 2012. Percentages of beneficial ownership are based upon 44,332,748 shares of common stock outstanding as of
December  7, 2012. Beneficial ownership is determined under Section 13(d) of the Securities Exchange Act of 1934
(the &ldquo;Exchange Act of 1934&rdquo;) and generally includes voting or investment power with respect to securities and
including any securities that grant the Selling Stockholders the right to acquire common stock within 60 days of December 7,
2012. Unless otherwise noted, each person or group identified possesses sole voting and investment power with respect to the
Shares, subject to community property laws where applicable.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We do not know when or in what amounts
the Selling Stockholders may sell or otherwise dispose of the Shares covered hereby. We currently have no agreements, arrangements
or understandings with the Selling Stockholders regarding the sale of any of the Shares by them other than the registration rights
agreements described below. The Selling Stockholders might not sell any or all of the Shares covered by this prospectus or may
sell or dispose of some or all of the Shares other than pursuant to this prospectus. Because the Selling Stockholders may not sell
or otherwise dispose of some or all of the Shares covered by this prospectus and because there are currently no agreements, arrangements
or understandings with respect to the sale or other disposition of any of the Shares, we cannot estimate the number of the Shares
that will be held by the Selling Stockholders after completion of the offering.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Each Selling Stockholder has indicated
to us that neither it nor any of its affiliates has held any position or office or had any other material relationship with us
in the past three years except as described in the footnotes to the table.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Shares being offered under this prospectus
may be offered for sale from time to time during the period the registration statement of which this prospectus is a part remains
effective, by or for the accounts of the Selling Stockholders named below.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Selling Stockholders, or their partners,
pledgees, donees, transferees or other successors that receive the Shares and their corresponding registration in accordance with
the registration rights agreement to which the Selling Stockholder is party (each also a Selling Stockholder for purposes of this
prospectus), may sell up to all of the Shares shown in the table below under the heading &ldquo;Total Shares Offered By Selling
Stockholder in the Offering Covered by this Prospectus&rdquo; pursuant to this Prospectus in one or more transactions from time
to time as described below under &ldquo;Plan of Distribution.&rdquo; However, the Selling Stockholders are not obligated to sell
any of the Shares offered by this prospectus.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Information about the Selling Stockholders may change from time
to time. Any changed information with respect to which we are given notice will be included in prospectus supplements.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></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="font-size: 10pt; font-weight: bold; border-bottom: Black 1pt solid">Selling&nbsp;Stockholder</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1pt">&nbsp;</TD>
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center; border-bottom: Black 1pt solid">Shares <BR>Beneficially <BR>Owned&nbsp;Before <BR>the
    Sale of all Shares Covered by this Prospectus</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1pt">&nbsp;</TD>
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center; border-bottom: Black 1pt solid">Percentage&nbsp;of <BR>Beneficial <BR>Ownership <BR>Before <BR>the
    Sale of all Shares Covered by this Prospectus</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1pt">&nbsp;</TD>
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center; border-bottom: Black 1pt solid">Total&nbsp;Shares <BR>Offered&nbsp; <BR>By&nbsp;Selling <BR>Stockholder in the Offering Covered by this Prospectus</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1pt">&nbsp;</TD>
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center; border-bottom: Black 1pt solid">Shares <BR>Beneficially <BR>Owned&nbsp;After <BR>the
    Sale of all Shares Covered by this Prospectus</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1pt">&nbsp;</TD>
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center; border-bottom: Black 1pt solid">Percentage&nbsp;of <BR>Beneficial <BR>Ownership <BR>After <BR>the
    Sale of all Shares Covered by this Prospectus</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: rgb(204,255,204)">
    <TD STYLE="font-size: 10pt">&nbsp;</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: White">
    <TD STYLE="width: 35%; font-size: 10pt; text-align: left; text-indent: -9pt; padding-left: 9pt">Allen Adler</TD><TD STYLE="width: 1%; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="width: 12%; font-size: 10pt; text-align: center">193,750</TD><TD STYLE="width: 1%; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="width: 12%; font-size: 10pt; text-align: center">*</TD><TD STYLE="width: 1%; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="width: 12%; font-size: 10pt; text-align: center">93,750</TD><TD STYLE="width: 1%; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="width: 12%; font-size: 10pt; text-align: center">100,000</TD><TD STYLE="width: 1%; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="width: 12%; font-size: 10pt; text-align: center">*</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: rgb(204,255,204)">
    <TD STYLE="font-size: 10pt; text-align: left; text-indent: -9pt; padding-left: 9pt">Helen Hartnett, IRA Custodian</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">31,250</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">31,250</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">0</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: White">
    <TD STYLE="font-size: 10pt; text-align: left; text-indent: -9pt; padding-left: 9pt">Roger J. LaGratta, IRA Custodian</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">227,500</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">187,500</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">40,000</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: rgb(204,255,204)">
    <TD STYLE="font-size: 10pt; text-align: left; text-indent: -9pt; padding-left: 9pt">Eugene Mark Landry, IRA Custodian</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">31,250</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">31,250</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">0</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: White">
    <TD STYLE="font-size: 10pt; text-align: left; text-indent: -9pt; padding-left: 9pt">Barry Peters Roth IRA Custodian</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">31,250</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">31,250</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">0</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: rgb(204,255,204)">
    <TD STYLE="font-size: 10pt; text-align: left; text-indent: -9pt; padding-left: 9pt">Christopher Basta</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">31,250</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">31,250</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">0</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: White">
    <TD STYLE="font-size: 10pt; text-align: left; text-indent: -9pt; padding-left: 9pt">Belmont Ventures, Inc.(1)</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">1,562,500</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">3.5%</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">312,500</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">1,250,000</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">2.8%</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: rgb(204,255,204)">
    <TD STYLE="font-size: 10pt; text-align: left; text-indent: -9pt; padding-left: 9pt">Capital Ventures International(2)</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">150,000</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">150,000</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">0</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: White">
    <TD STYLE="font-size: 10pt; text-align: left; text-indent: -9pt; padding-left: 9pt">Carruthers Living Trust UAD 4/1/04(3)</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">100,000</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">100,000</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">0</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: rgb(204,255,204)">
    <TD STYLE="font-size: 10pt; text-align: left; text-indent: -9pt; padding-left: 9pt">Chulick Family Trust(4)</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">93,750</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">93,750</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">0</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: White">
    <TD STYLE="font-size: 10pt; text-align: left; text-indent: -9pt; padding-left: 9pt">John LaGratta</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">300,000</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">100,000</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">200,000</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: rgb(204,255,204)">
    <TD STYLE="font-size: 10pt; text-align: left; text-indent: -9pt; padding-left: 9pt">Stephen S. Lipton</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">15,000</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">15,000</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">0</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: White">
    <TD STYLE="font-size: 10pt; text-align: left; text-indent: -9pt; padding-left: 9pt">Mintz and Co.(5)</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">31,250</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">31,250</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">0</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: rgb(204,255,204)">
    <TD STYLE="font-size: 10pt; text-align: left; text-indent: -9pt; padding-left: 9pt">Sean E. McCance</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">62,500</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">62,500</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">0</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: White">
    <TD STYLE="font-size: 10pt; text-align: left; text-indent: -9pt; padding-left: 9pt">Richard Molinsky</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">30,000</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">30,000</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">0</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: rgb(204,255,204)">
    <TD STYLE="font-size: 10pt; text-align: left; text-indent: -9pt; padding-left: 9pt">MSD Credit Opportunity Master Fund, L.P.(6)</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">2,100,000</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">4.7%</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">2,100,000</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">0</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: White">
    <TD STYLE="font-size: 10pt; text-align: left; text-indent: -9pt; padding-left: 9pt">Richard R. Redmond</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">31,250</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">31,250</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">0</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: rgb(204,255,204)">
    <TD STYLE="font-size: 10pt; text-align: left; text-indent: -9pt; padding-left: 9pt">Dominick Ruggiero</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">50,000</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">50,000</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">0</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: White">
    <TD STYLE="font-size: 10pt; text-align: left; text-indent: -9pt; padding-left: 9pt">Smokeshire Partners LLC(7)</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">62,500</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">62,500</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">0</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: rgb(204,255,204)">
    <TD STYLE="font-size: 10pt; text-align: left; text-indent: -9pt; padding-left: 9pt">Louis Vigden</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">30,000</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">30,000</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">0</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: White">
    <TD STYLE="font-size: 10pt; text-align: left; text-indent: -9pt; padding-left: 9pt">Laurence Zalk</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">50,000</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">50,000</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">0</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: rgb(204,255,204)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Griffin Securities, Inc.(8) <BR></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">411,834</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">*</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">311,834</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">100,000</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">*</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Adrian Z. Stecyk (9) <BR></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">723,667</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">1.6%</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">623,667</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">100,000</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">*</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: rgb(204,255,204)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">Salvatore Saraceno(10) <BR></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">7,500</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">*</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">7,500</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">0</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">*</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: White">
    <TD STYLE="font-size: 10pt; text-indent: -9pt; padding-left: 9pt">George Stephenson(11)</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">4,688</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">4,688</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">0</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">*</TD></TR>
</TABLE>



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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">*less than 1%</P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 5%; padding-right: 0.8pt; text-align: justify">(1)</TD>
    <TD STYLE="width: 95%; padding-right: 0.8pt; text-align: justify">Joel C. Flint is the authorized agent for Belmont Ventures and as such has voting and investment power over the shares listed.</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt; text-align: justify">(2)</TD>
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0; text-align: justify">Heights Capital Management, Inc.
        is the authorized agent for Capital Ventures International (&ldquo;CVI&rdquo;), has discretionary authority to vote and dispose
        of the shares held by CVI and may be deemed to be the beneficial owner of these shares. Martin Kobinger, in his capacity as Investment
        Manager of Heights Capital Management, Inc, may also be deemed to have investment discretion and voting power over the shares held
        by CVI. Mr. Kobinger disclaims any such beneficial ownership of these shares.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0; text-align: justify">&nbsp;</P></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 1.6pt; text-align: justify">(3)</TD>
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0; text-align: justify">James L. Carruthers, Jr. is trustee
        of the Caruthers Living Trust and as such has voting and investment power over the shares listed.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0; text-align: justify">&nbsp;</P></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 1.6pt; text-align: justify">(4)</TD>
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0; text-align: justify">John Chulick and Kathi Chulick
        are trustees of the Chulick Family Trust and as such have voting and investment power over the shares listed.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0; text-align: justify">&nbsp;</P></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 1.6pt; text-align: justify">(5)</TD>
    <TD STYLE="text-align: justify">Mintz and Co. is the record and direct beneficial owner of the shares of common stock. Lowell A. Mintz is the senior partner of, and may be deemed to have or share voting and dispositive power over, and/or beneficially own securities owned by, Mintz and Co.</TD></TR>
</TABLE>

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

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

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

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

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 5%; padding-right: 1.6pt; font-size: 10pt; text-align: justify">(6)</TD>
    <TD STYLE="width: 95%; font-size: 10pt; text-align: justify">MSD Credit Opportunity Master Fund, L.P. is the record and direct beneficial owner of the securities. MSDC Management, L.P. is the investment manager of, and may be deemed to have or share voting and dispositive power over, and/or beneficially own securities owned by, MSD Credit Opportunity Master Fund L.P. MSDC Management (GP), LLC is the general partner of, and may be deemed to have or share voting and dispositive power over, and/or beneficially own securities owned by, MSDC Management, L.P. Each of Glenn R. Fuhrman, John C. Phelan and Marc R. Lisker is a manager of MSDC Management (GP) and may be deemed to have or share voting and/or dispositive power over, and beneficially own, the common stock beneficially owned by MSDC Management(GP) Each of Mr. Fuhrman, Mr. Phelan and Mr. Lisker disclaim beneficial ownership of such common stock, except to the extent of the pecuniary interest of such person in such shares.</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 1.6pt; font-size: 10pt; text-align: justify">&nbsp;</TD>
    <TD STYLE="padding-right: 1.6pt; font-size: 10pt; text-align: justify">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 1.6pt; font-size: 10pt; text-align: justify">(7)</TD>
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Smokeshire Partners, LLC is the
record and direct beneficial owner of the shares of common stock. Mintz and Co. is the manager of, and may be deemed to have or
share voting and dispositive power over, and/or beneficially own securities owned by, Smokeshire Partners, LLC. Lowell A. Mintz
is the senior partner of, and may be deemed to have or share voting and dispositive power over, and/or beneficially own securities
owned by, Mintz and Co.</P></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 1.6pt; font-size: 10pt; text-align: justify">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0; text-align: justify">(8)&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0; text-align: justify; text-indent: 0.5in">&nbsp;</P></TD>
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0; text-align: justify">Includes 311,834 shares
of our common stock issuable upon exercise of the Agent Warrants issued to Griffin Securities, Inc. (&ldquo;Griffin&rdquo;), as
our placement agent in our October 2012 Private Placement and 100,000 shares of our common stock issuable upon exercise of warrants
issued to Griffin for financial advisory services in accordance with the terms of a financial advisory agreement we entered into
with Griffin in December 2011. Griffin is a registered broker-dealer that served as the placement agent in connection with our
October 2012 Private Placement. Adrian Stecyk is the Chief Executive Officer of Griffin and an affiliate of a registered-broker-dealer.
Mr. Stecyk has voting and dispositive power with respect to the warrants and the underlying shares.</P></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0; text-align: justify">(9)</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0; text-align: justify">&nbsp;</P></TD>
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0; text-align: justify">Includes 411,834 shares of
        common stock issuable upon exercise of the Agent Warrants issued to Griffin and financial advisor warrants issued to Griffin
        and         311,833         shares         of         common stock         issuable         upon exercise of warrants issued
        to Mr.         Stecyk. Mr. Stecyk         has voting and         dispositive         power with respect to         the
        warrants and               the underlying         shares.&nbsp;</P></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0; text-align: justify">(10)</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0; text-align: justify">&nbsp;</P></TD>
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0; text-align: justify">Consists of shares of
common stock issuable upon exercise of the Agent Warrants issued to Mr. Saraceno. Mr. Saraceno is an employee of Griffin. Griffin
is a registered broker-dealer that served as the placement agent in connection with our October 2012 Private Placement.&nbsp;</P></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 1.6pt; font-size: 10pt; text-align: justify">&nbsp;</TD>
    <TD STYLE="padding-right: 1.6pt; font-size: 10pt; text-align: justify">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0; text-align: justify">(11)</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0; text-align: justify">&nbsp;</P></TD>
    <TD STYLE="padding-right: 1.6pt; font-size: 10pt; text-align: justify">Consists of shares of common stock issuable upon exercise of the Agent Warrants issued to Mr. Stephenson.&nbsp; Mr. Stephenson is an employee of Griffin. &nbsp;Griffin is a registered broker-dealer that served as the placement agent in connection with our October 2012 Private Placement.</TD></TR>
</TABLE>


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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Selling Stockholders will determine
at what price they may sell the offered Shares, and such sales may be made at prevailing market prices, or at privately negotiated
prices.<B>&nbsp;</B></P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We are registering the shares of common
stock previously issued to the Selling Stockholders to permit the resale of these shares of common stock by the holders of the
common stock from time to time after the date of this prospectus. We will not receive any of the proceeds from the sale by the
Selling Stockholders of the shares of common stock. We will bear all fees and expenses incident to our obligation to register the
shares of common stock.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Selling Stockholders, or their pledges,
donees, transferees, or any of their successors in interest selling shares received from a Selling Stockholder as a gift, partnership
distribution or other non-sale related transfer after the date of this prospectus, may sell all or a portion of the shares of common
stock beneficially owned by them and offered hereby from time to time directly or through one or more underwriters, broker-dealers
or agents. If the shares of common stock are sold through underwriters or broker-dealers, the Selling Stockholders will be responsible
for underwriting discounts or commissions or agent's commissions. The shares of common stock may be sold in one or more transactions
at fixed prices, at prevailing market prices at the time of the sale, at varying prices determined at the time of sale, or at negotiated
prices. The Selling Stockholders will act independently of us in making decisions with respect to the timing, manner and size of
each sale. These sales may be affected in transactions, which may involve crosses or block transactions,</P>

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

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

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 5%">&bull;</TD>
    <TD STYLE="text-align: justify; width: 95%">on any national securities exchange or quotation service on which the securities may be listed or quoted at the time of sale;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&bull;</TD>
    <TD STYLE="text-align: justify">in the over-the-counter market;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&bull;</TD>
    <TD STYLE="text-align: justify">in transactions otherwise than on these exchanges or systems or in the over-the-counter market;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&bull;</TD>
    <TD STYLE="text-align: justify">through the writing of options, whether such options are listed on an options exchange or otherwise;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&bull;</TD>
    <TD STYLE="text-align: justify">ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&bull;</TD>
    <TD STYLE="text-align: justify">block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&bull;</TD>
    <TD STYLE="text-align: justify">purchases by a broker-dealer as principal and resale by the broker-dealer for its account;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&bull;</TD>
    <TD STYLE="text-align: justify">an exchange distribution in accordance with the rules of the applicable exchange;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&bull;</TD>
    <TD STYLE="text-align: justify">privately negotiated transactions;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&bull;</TD>
    <TD STYLE="text-align: justify">short sales;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&bull;</TD>
    <TD STYLE="text-align: justify">through the distribution of the common stock by any Selling Stockholders to its partners, members or Stockholders;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&bull;</TD>
    <TD STYLE="text-align: justify">through one or more underwritten offerings on a firm commitment or best efforts basis;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&bull;</TD>
    <TD STYLE="text-align: justify">sales pursuant to Rule 144;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&bull;</TD>
    <TD STYLE="text-align: justify">broker-dealers may agree with the Selling Stockholders to sell a specified number of such shares at a stipulated price per share;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&bull;</TD>
    <TD STYLE="text-align: justify">a combination of any such methods of sale; and</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&bull;</TD>
    <TD STYLE="text-align: justify">any other method permitted pursuant to applicable law.</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Selling Stockholders may also transfer
the Shares by gift. The Selling Stockholders may engage brokers and dealers, and any brokers or dealers may arrange for other brokers
or dealers to participate in effecting sales of the Shares. These brokers, dealers or underwriters may act as principals, or as
an agent of a Selling Stockholder. Broker-dealers may agree with a Selling Stockholder to sell a specified number of the Shares
at a stipulated price per security. If the broker-dealer is unable to sell the Shares acting as agent for a Selling Stockholder,
it may purchase as principal any unsold Shares at the stipulated price. Broker-dealers who acquire Shares as principals may thereafter
resell the Shares from time to time in transactions in any stock exchange or automated interdealer quotation system on which the
Shares are then listed, at prices and on terms then prevailing at the time of sale, at prices related to the then-current market
price or in negotiated transactions. Broker-dealers may use block transactions and sales to and through broker-dealers, including
transactions of the nature described above.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Selling Stockholders may also sell
the Shares in accordance with Rule 144 under the Securities Act, rather than pursuant to this prospectus, regardless of whether
the Shares are covered by this prospectus.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If the Selling Stockholders effect such
transactions by selling shares of common stock to or through underwriters, broker-dealers or agents, such underwriters, broker-dealers
or agents may receive commissions in the form of discounts, concessions or commissions from the Selling Stockholders or commissions
from purchasers of the shares of common stock for whom they may act as agent or to whom they may sell as principal (which discounts,
concessions or commissions as to particular underwriters, broker-dealers or agents may be in excess of those customary in the types
of transactions involved). In connection with sales of the shares of common stock or otherwise, the Selling Stockholders may enter
into hedging transactions with broker-dealers, which may in turn engage in short sales of the shares of common stock in the course
of hedging in positions they assume. The Selling Stockholders may also sell shares of common stock short and deliver shares of
common stock covered by this prospectus to close out short positions and to return borrowed shares in connection with such short
sales. The Selling Stockholders may also loan or pledge shares of common stock to broker-dealers that in turn may sell such shares.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Selling Stockholders may pledge or
grant a security interest in some or all of the shares of common stock owned by them and, if they default in the performance of
their secured obligations, the pledgees or secured parties may offer and sell the shares of common stock from time to time pursuant
to this prospectus or any amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act
amending, if necessary, the list of Selling Stockholders to include the pledgee, transferee or other successors in interest as
Selling Stockholders under this prospectus. The Selling Stockholders also may transfer and donate the shares of common stock in
other circumstances in which case the transferees, donees, pledgees or other successors in interest will be the selling beneficial
owners for purposes of this prospectus.</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In addition, a Selling Stockholder may,
from time to time, sell the Shares short, and, in those instances, this prospectus may be delivered in connection with the short
sales and the Shares offered under this prospectus may be used to cover short sales.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Selling Stockholders and any broker-dealer
participating in the distribution of the shares of common stock may be deemed to be &ldquo;underwriters&rdquo; within the meaning
of the Securities Act, and any commission paid, or any discounts or concessions allowed to, any such broker-dealer may be deemed
to be underwriting commissions or discounts under the Securities Act. At the time a particular offering of the shares of common
stock is made, a prospectus supplement, if required, will be distributed which will set forth the aggregate amount of shares of
common stock being offered and the terms of the offering, including the name or names of any broker-dealers or agents, any discounts,
commissions and other terms constituting compensation from the Selling Stockholders and any discounts, commissions or concessions
allowed or reallowed or paid to broker-dealers. The Selling Stockholders may indemnify any broker-dealer that participates in transactions
involving the sale of the shares of common stock against certain liabilities, including liabilities arising under the Securities
Act.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Under the securities laws of some states,
the shares of common stock may be sold in such states only through registered or licensed brokers or dealers. In addition, in some
states the shares of common stock may not be sold unless such shares have been registered or qualified for sale in such state or
an exemption from registration or qualification is available and is complied with.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">There can be no assurance that any Selling
Stockholder will sell any or all of the shares of common stock registered pursuant to the registration statement, of which this
prospectus forms a part.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Selling Stockholders and any other
person participating in such distribution will be subject to applicable provisions of the Exchange Act of 1934 and the rules and
regulations thereunder, including, without limitation, Regulation M of the Exchange Act of 1934, which may limit the timing of
purchases and sales of any of the shares of common stock by the Selling Stockholders and any other participating person. Regulation
M may also restrict the ability of any person engaged in the distribution of the shares of common stock to engage in market-making
activities with respect to the shares of common stock. All of the foregoing may affect the marketability of the shares of common
stock and the ability of any person or entity to engage in market-making activities with respect to the shares of common stock.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The shares of common stock offered hereby
were originally issued to the Selling Stockholders pursuant to an exemption from the registration requirements of the Securities
Act. We agreed to register the shares of common stock under the Securities Act, and to keep the registration statement of which
this prospectus is a part effective until the earlier of the date on which the Selling Stockholders have sold all of the securities
or one year after the shares were acquired by the Selling Stockholder. We will pay all expenses of the registration of the shares
of common stock pursuant to the Registration Rights Agreement, estimated to be <FONT STYLE="color: black">$30,000</FONT> in total,
including, without limitation, Commission filing fees and expenses of compliance with state securities or &ldquo;Blue Sky&rdquo;
laws; <I>provided</I>,<I> however</I>, that a Selling Stockholder will pay all underwriting discounts and selling commissions,
if any. We will indemnify the Selling Stockholders against liabilities, including some liabilities under the Securities Act, in
accordance with the Registration Rights Agreement, or the Selling Stockholders will be entitled to contribution. We may be indemnified
by the Selling Stockholders against civil liabilities, including liabilities under the Securities Act, that may arise from any
written information furnished to us by the Selling Stockholder specifically for use in this prospectus, in accordance with Registration
Rights Agreement, or we may be entitled to contribution.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Once sold under the registration statement,
of which this prospectus forms a part, the shares of common stock will be freely tradable in the hands of persons other than our
affiliates.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: -1.25pt">&nbsp;</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our authorized capital consists of 100
million shares of common stock, par value $0.001 per share, and 10 million shares of preferred stock, par value $0.001 per share.
As of December 7, 2012, 44,332,748 shares of common stock and no shares of preferred stock were  outstanding.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>Common Stock</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Holders of shares of common stock have
the right to cast one vote for each share of common stock in their name on the books of our company, whether represented in person
or by proxy, on all matters submitted to a vote of holders of common stock, including election of directors. There is no right
to cumulative voting in election of directors. Except where a greater requirement is provided by statute, by our articles of incorporation,
or by our bylaws, the presence, in person or by proxy duly authorized, of the one or more holders of a majority of the outstanding
shares of our common stock constitutes a quorum for the transaction of business. The vote by the holders of a majority of outstanding
shares is required to effect certain fundamental corporate changes such as liquidation, merger, or amendment of our articles of
incorporation.</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">There are no restrictions in our articles
of incorporation or bylaws that prevent us from declaring dividends. We have not declared any dividends, and we do not plan to
declare any dividends in the foreseeable future.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Holders of shares of our common stock are
not entitled to preemptive or subscription or conversion rights, and no redemption or sinking fund provisions are applicable to
our common stock. All outstanding shares of common stock are, and the shares of common stock sold in the offering will when issued
be fully paid and non-assessable.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 23pt; text-align: justify; text-indent: -23pt"><B><I>&nbsp;</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 23pt; text-align: justify; text-indent: -23pt"><B><I>Outstanding
Warrants</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As of November 29, 2012, we had issued and
outstanding a total of 1,632,501 and 1,432,501 warrants, respectively, to purchase our common stock outstanding at a weighted-average
price of $1.99 and $1.96, respectively. Included in the number of outstanding warrants are (a) Agent Warrants to acquire an aggregate
of 635,855 shares of our common stock at an exercise price of $1.60 per share for a five year period (subject to a cashless exercise
provision) we issued to Griffin and its designees in connection with the closing of our October 2012 Private Placement on October
30, 2012, the underlying shares of which are being registered under the registration statement of which this prospectus forms a
part; and (b) additional warrants to acquire 100,000 shares of our common stock issued to our Griffin in December 2012 for financial
advisory services in accordance with the terms of our financial advisory agreement we entered into with them.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Contingent Share Issuance-Intrexon &ndash; First Exclusive
Channel Collaboration Agreement</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On December 7, 2011, pursuant to the First
Stock Issuance Agreement between us and Intrexon, we issued to Intrexon 3,123,558 shares of our common stock as a technology access
fee, in consideration for the execution and delivery of the First Chanel Agreement we entered into with Intrexon. We also agreed
to issue additional shares of our common stock to Intrexon upon dosing of the first patient in our sponsored Phase II clinical
trial in the United States, or similar study as the parties may agree in a country other than the United States, of a product under
the First Channel Agreement. Upon satisfaction of such contingency, we agreed to issue to Intrexon an additional 3,123,558 shares
of common stock, subject to certain adjustments, for a purchase price equal to the $0.001 par value of such shares, which issuance
was deemed paid in partial consideration for the execution and delivery of the First Channel Agreement.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Under the First Stock Purchase Agreement,
Intrexon is entitled, at its election, to (i) participate in our future securities offerings that constitute &ldquo;Qualified Financings&rdquo;
and purchase securities equal to 19.99% of the number of shares of common stock or other securities sold in such offering. For
this purpose, a &ldquo;Qualified Financing&rdquo; means a sale of common stock or equity securities convertible into common stock
in a public or private offering, raising gross proceeds of at least $5,000,000, where the sale of shares is either registered under
the Securities Act, at the time of issuance or we agrees to register the resale of such shares, and (ii) without restriction, purchase
an additional number of shares of common stock in the open market, or otherwise, that do not exceed an additional 10% of the number
of shares of common stock then issued and outstanding; Intrexon waived its right to participate in the October 2012 Private Placement
..</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On August 6, 2012, we expanded our relationship
with Intrexon and entered into the Second Channel Agreement with Intrexon that governs a &ldquo;channel collaboration&rdquo; arrangement
in which we will use Intrexon&rsquo;s technology relating to the identification, design and production of human antibodies and
DNA vectors for the development and commercialization of a series of monoclonal antibody therapies for the treatment of certain
serious infectious diseases (collectively, the &ldquo;Program&rdquo;). On October 16, 2012, we issued 3,552,210 shares of our common
stock to Intrexon which issuance is deemed paid in partial consideration for the execution and delivery of the Second Channel Agreement.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We also agreed upon the filing of an Investigational
New Drug application with the U.S. Food and Drug Administration for a Synthetic Product (as defined in the agreement), or alternatively
the filing of the first equivalent regulatory filing with a foreign regulatory agency (both as applicable, the &ldquo;IND Milestone
Event&rdquo;), to pay Intrexon either (i) two million dollars ($2M) in cash, or (ii) that number of shares of common stock (the
&ldquo;IND Milestone Shares&rdquo;) having a fair market value equaling two million dollars ($2M) where such fair market value
is determined using published market data of the share price for common stock at the close of market on the business day immediately
preceding the date of public announcement of attainment of the IND Milestone Event.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We also agreed upon the first to occur
of either first commercial sale of a Synthetic Product in a country or the granting of the regulatory approval of that Synthetic
Product (both as applicable, the &ldquo;Approval Milestone Event&rdquo;), to pay to Intrexon either (i) three million dollars ($3M)
in cash, or (ii) that number of shares of common stock (the &ldquo;Approval Milestone Shares&rdquo;) having a fair market value
equaling three million dollars ($3M) where such fair market value is determined using published market data of the share price
for common stock at the close of market on the business day immediately preceding the date of public announcement of attainment
of the Approval Milestone Event.</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We has also agreed that we will pay an
optional and varying fee whereby we remit a payment, in cash or equity at our sole discretion, to Intrexon calculated as a multiple
of the number of targets in excess of three (3) total that we desire to elect (the &ldquo;Field Expansion Fee&rdquo;). The Field
Expansion Fee must be paid completely in either common stock or cash, and will comprise either (i) two million dollars ($2M) in
cash for each target in excess of three (3) total that we will elect, or (ii) that number of shares of common stock (the &ldquo;Field
Expansion Fee Shares&rdquo;) having a fair market value equaling two million dollars ($2M) for each such target that we will elect
in excess of three where such fair market value is determined using published market data establishing the volume-weighted average
price for a share of common stock over the thirty (30) day period immediately preceding the date of the Field Expansion Fee Closing.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>Prev Contingent Share Issuances </B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On November 28, 2012, a closing was held
for the transaction contemplated by the Prev Agreement we entered into with Prev pursuant to which we acquired the <I>C. diff</I> program assets of Prev, including pre-Investigational
New Drug (IND) package, Phase I and Phase II clinical data, manufacturing process data and all issued and pending U.S. and international
patents.&nbsp; Pursuant to the Prev Agreement, we paid Prev an initial cash payment of $100,000 upon execution of the Prev Agreement
and at closing paid an additional cash payment of $135,000 and issued 625,000 unregistered shares of our common stock to Prev.&nbsp;
In addition, upon the achievement of the milestones set forth below, Prev may be entitled to receive additional consideration payable
50% in cash and 50% in our stock, subject to Prev&rsquo;s option to receive the entire payment in shares of our stock, with the
exception of the first milestone payments to be paid in cash: (i) upon commencement of an IND; (ii) upon commencement of a Phase
I clinical trial; (iii) upon commencement of a Phase II clinical trial; (iv) upon commencement of a Phase III clinical trial; (v)
upon Biologic License Application (BLA) filing in the U.S. and for territories outside of the U.S. (as defined in the Prev Agreement);
and (vi) upon BLA approval in the U.S. and upon approval in territories outside the-U.S.&nbsp; The future stock issuances are subject
to prior approval of the NYSE MKT, LLC. No royalties are payable to Prev under the Prev Agreement.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In connection with the October 2012 Private
Placement, we entered into a registration rights agreement with each of the Selling Stockholders (the &ldquo;Registration Rights
Agreement&rdquo;). The Registration Rights Agreement requires us to file a registration statement (the &ldquo;Registration Statement&rdquo;)
with the Commission within 45 days of the closing date of the October 2012 Private Placement (the &ldquo;Filing Date&rdquo;) for
the resale by the Selling Stockholders of all of the Registrable Securities. We agreed to use our commercially reasonable efforts
to cause the Registration Statement to be declared effective by the Commission no later than 90 days after the closing date of
the October 2012 Private Placement (the &ldquo;Effectiveness Date&rdquo;) subject to certain adjustments. Upon the occurrence of
an Event, including, but not limited to, that the Registration Statement is not declared effective prior to the Effectiveness Date,
we will be required to pay liquidated damages to each of the Selling Stockholders equal to 1.5% of the aggregate purchase price
paid by such Selling Stockholders for the Registrable Securities upon the date of the Event and then monthly thereafter until the
earlier of: (i) the Event is cured, or (ii) the Registrable Securities are eligible for resale without subsequent registration
under the Securities Act. In no event shall the aggregate amount of liquidated damages payable to each of the Selling Stockholders
exceed in the aggregate 10% of the aggregate purchase price paid by such Selling Stockholders for the Registrable Securities. We
also agreed to use our commercially reasonable efforts to keep the Registration Statement effective for resales until the earlier
of the date that all of the shares of our common stock included in the Registration Statement have been resold thereunder or under
Rule 144 promulgated under the Securities Act. The registration rights agreement contains cross-indemnification provisions between
us and the Selling Stockholders.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In connection with the transactions contemplated
by the Second Stock Issuance Agreement, and pursuant to the First Amendment to Registration Rights Agreement executed and delivered
by the parties in August 2012 (the &ldquo;First Amendment to Registration Rights Agreement&rdquo;), the Company agreed to file
a &ldquo;resale&rdquo; registration statement registering the resale of the shares issued and to be issued under the Second Stock
Issuance Agreement on or prior to April 30, 2013. Under that agreement, we are obligated to use our reasonable best efforts to
cause the &ldquo;resale&rdquo; registration statement to be declared effective as promptly as practicable after filing and to maintain
the effectiveness of the registration statement until all securities therein are sold or are otherwise can be sold pursuant to
Rule 144, without any restrictions. In addition, we also entered into a Joinder Agreement with a certain purchaser in the October
2012 Private Placement that is an affiliate of Intrexon pursuant to which such party agreed to be bound by the terms of and join
Intrexon as a party to the First Amendment to Registration Rights Agreement.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In connection with the transactions contemplated
by the First Stock Purchase Agreement, and pursuant to the Registration Rights Agreement executed and delivered by us to Intrexon,
we agreed to file a &ldquo;resale&rdquo; registration statement registering the resale of the First Tranche Shares within 120 days
of the closing date of such issuance. The registration statement registering such shares was declared effective on April 13, 2012,
but is no longer valid due to certain issues regarding the failure of our prior auditor to follow proper partner rotation. Intrexon
has agreed not to require us to file a post effective registration statement on Form S-1 with respect to the First Tranche Shares
and instead has agreed to wait until we are once again S-3 eligible to require registration of such shares.</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>Preferred Stock</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our Board of Directors has the authority,
without action by our stockholders, to designate and issue up to 10 million shares of preferred stock in one or more series or
classes and to designate the rights, preferences and privileges of each series or class, which may be greater than the rights of
our common stock. We do not have any shares of preferred stock either designated or outstanding. It is not possible to state the
actual effect of the issuance of any shares of preferred stock upon the rights of holders of our common stock until our Board of
Directors determines the specific rights of the holders of the preferred stock. However, the effects might include:</P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR>
    <TD STYLE="width: 5%">&nbsp;</TD>
    <TD STYLE="vertical-align: top; width: 2%">&bull;</TD>
    <TD STYLE="vertical-align: top; width: 1%">&nbsp;</TD>
    <TD STYLE="vertical-align: top">restricting dividends on our common stock;</TD></TR>
<TR>
    <TD>&nbsp;</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD></TR>
<TR>
    <TD>&nbsp;</TD>
    <TD STYLE="vertical-align: top">&bull;</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD STYLE="vertical-align: top">diluting the voting power of our common stock;</TD></TR>
<TR>
    <TD>&nbsp;</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD></TR>
<TR>
    <TD>&nbsp;</TD>
    <TD STYLE="vertical-align: top">&bull;</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD STYLE="vertical-align: top">impairing liquidation rights of our common stock; or</TD></TR>
<TR>
    <TD>&nbsp;</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD></TR>
<TR>
    <TD>&nbsp;</TD>
    <TD STYLE="vertical-align: top">&bull;</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD STYLE="vertical-align: top">delaying or preventing a change in control of us without further action by our stockholders.</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The Board of Directors&rsquo; authority to issue preferred stock
without stockholder approval could make it more difficult for a third-party to acquire control of our company, and could discourage
such attempt. We have no present plans to issue any shares of preferred stock.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>Listing of Common Stock </I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our common stock is currently traded on
the NYSE MKT, LLC under the trading symbol &ldquo;SYN.&rdquo;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>Transfer Agent</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We have retained Corporate Stock Transfer
as our transfer agent. They are located at 3200 Cherry Creek Drive, Denver, Colorado 80209. Their telephone number is (303) 282-4800
and facsimile is (303) 282-5800.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The financial statements as of December
31, 2011 and 2010 and for the years then ended included in this Form S-1 Registration Statement have been so included in reliance
on the reports of Berman &amp; Company, P.A., an independent registered public accounting firm, given on the authority of said
firm as experts in auditing and accounting.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>DISCLOSURE OF COMMISSION POSITION ON
INDEMNIFICATION</B></P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our Articles of Incorporation provide that
no officer or director shall be personally liable to us or our stockholders for monetary damages except as provided pursuant to
the Nevada Revised Statutes. Our bylaws and Articles of Incorporation also provide that we will indemnify and hold harmless each
person who serves at any time as a director, officer, employee or agent of us from and against any and all claims, judgments and
liabilities to which such person shall become subject by reason of the fact that he is or was a director, officer, employee or
agent of us, and shall reimburse such person for all legal and other expenses reasonably incurred by him or her in connection with
any such claim or liability. We also have the power to defend such person from all suits or claims in accordance with the Nevada
Revised Statutes. The rights accruing to any person under our bylaws and Articles of Incorporation do not exclude any other right
to which any such person may lawfully be entitled, and we may indemnify or reimburse such person in any proper case, even though
not specifically provided for by the bylaws and Articles of Incorporation.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Insofar as indemnification for liabilities
arising under the Securities Act may be permitted to directors, officers and controlling persons of the small business issuer pursuant
to the foregoing provisions, or otherwise, we have 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 small business issuer for expenses incurred or paid by a director, officer
or controlling person of the small business issuer 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, we will, unless in the opinion
of our counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question
whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final
adjudication of such issue.</P>

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

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

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The validity of our common stock offered hereby will be passed
upon for us by Gracin &amp; Marlow, LLP, New York, New York.</P>

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

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

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

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We are subject to the informational requirements
of the Exchange Act of 1934, and file annual and current reports, proxy statements and other information with the Commission. These
reports, proxy statements and other information filed by us can be read and copied at the Commission&rsquo;s Public Reference Room
at 100 F Street, N.W., Washington, D.C. 20549. You may obtain information on the operation of the Public Reference Room by calling
the Commission at 1-800-SEC-0330.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Commission also maintains a website
that contains reports, proxy statements, information statements and other information concerning our company located at http://www.sec.gov.
This prospectus does not contain all the information required to be included in the registration statement (including the exhibits),
which we have filed with the Commission under the Securities Act and to which reference is made in this prospectus.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">You may obtain, free of charge, a copy of any of our filings
by writing or calling us at the following address and telephone number: 617 Detroit Street, Suite 100, Ann Arbor, Michigan 48104
or calling (734) 332-7800.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>INCORPORATION OF CERTAIN INFORMATION
BY REFERENCE</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Commission allows us to &ldquo;incorporate
by reference&rdquo; into this prospectus the information we file with it, which means that we can disclose important information
to you by referring you to those documents. Information incorporated by reference is considered to be part of this prospectus,
except for any information that is superseded by information included directly in this prospectus. Any statement contained in this
prospectus or a document incorporated by reference in this prospectus will 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 subsequently filed document that
is incorporated by reference in this prospectus modifies or superseded the statement. Any statement so modified or superseded will
not be deemed, except as so modified or superseded, to constitute a part of this prospectus. We incorporate by reference the documents
listed below (excluding any portions of such documents that have been &ldquo;furnished&rdquo; but not &ldquo;filed&rdquo; for purposes
of the Securities Act).</P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR>
    <TD STYLE="width: 5%">&nbsp;</TD>
    <TD STYLE="vertical-align: top; width: 2%">&bull;</TD>
    <TD STYLE="vertical-align: top; width: 1%">&nbsp;</TD>
    <TD STYLE="vertical-align: top; text-align: justify">Our Annual Report on Form 10-K/A for the year ended December 31, 2011, filed with the Commission on March 30, 2012, as amended on May 11, 2012;</TD></TR>
<TR>
    <TD>&nbsp;</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD STYLE="vertical-align: top; text-align: justify">&nbsp;</TD></TR>
<TR>
    <TD>&nbsp;</TD>
    <TD STYLE="vertical-align: top">&bull;</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD STYLE="vertical-align: top; text-align: justify">Our Definitive Proxy Statement on Schedule 14A, filed with the Commission on January 4, 2012 and September 11, 2012;</TD></TR>
<TR>
    <TD>&nbsp;</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD STYLE="vertical-align: top; text-align: justify">&nbsp;</TD></TR>
<TR>
    <TD>&nbsp;</TD>
    <TD STYLE="vertical-align: top">&bull;</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD STYLE="vertical-align: top; text-align: justify">Our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2012, June 30, 2012 and September 30, 2012, filed with the Commission on May 15, 2012 and August 14, 2012, as amended on September 11, 2012, and November 14, 2012, respectively; and</TD></TR>
<TR>
    <TD>&nbsp;</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD STYLE="vertical-align: top; text-align: justify">&nbsp;</TD></TR>
<TR>
    <TD>&nbsp;</TD>
    <TD STYLE="vertical-align: top">&bull;</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD STYLE="vertical-align: top; text-align: justify">Our Current Reports on Form 8-K, filed December 6, 2012, December 3, 2012, November 14, 2012, November 13, 2012, October 31, 2012, October 17, 2012, October 5, 2012, August 14, 2012, August 9, 2012, July 18, 2012, July 10, 2012, June 18, 2012, May 15, 2012, May 11, 2012, May 3, 2012, April 24, 2012, March 30, 2012, March 12, 2012, February 16, 2012, February 13, 2012, February 7, 2012, February 6, 2012 and our amendment to a Current Report on Form 8-K filed February 3, 2012 and May 30, 2012.</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We will provide a copy of any and all of
the information that is incorporated by reference in this prospectus to any person, including a beneficial owner, to whom a prospectus
is delivered, without charge, upon written or oral request. Written requests for copies should be directed to Attention: C. Evan
Ballantyne, Chief Financial Officer, Synthetic Biologics, Inc. 617 Detroit Street, Suite 100, Ann Arbor, Michigan, 48104. Telephone
requests for copies should be directed to the Chief Financial Officer at (734) 332-7800.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We maintain an Internet website at <FONT STYLE="color: black">www.syntheticbiologics.com</FONT>
where the incorporated reports listed above can be accessed. Neither this website nor the information on this website is included
or incorporated in, or is a part of, this prospectus or any supplement to the prospectus.</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;<IMG SRC="s1_logo.jpg" ALT=""></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>4,260,855 SHARES OF COMMON STOCK</B></P>

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

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

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

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

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>December &nbsp;&nbsp;&nbsp;&nbsp;, 2012</B></P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Neither we nor the Selling Stockholders
have authorized any dealer, salesperson or other person to give any information or to make any representations not contained in
this prospectus or any prospectus supplement. You must not rely on any unauthorized information. This prospectus is not an offer
to sell these securities in any jurisdiction where an offer or sale is not permitted. The information in this prospectus is current
as of the date of this prospectus. You should not assume that this prospectus is accurate as of any other date.</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>PART II - INFORMATION NOT REQUIRED IN
PROSPECTUS</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>ITEM 13. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We estimate that expenses in connection
with the distribution described in this registration statement (other than brokerage commissions, discounts or other expenses relating
to the sale of the shares of common stock underlying the Warrants by the selling security holders) will be as set forth below.
We will pay all of the expenses with respect to the distribution, and such amounts, with the exception of the Securities and Exchange
Commission registration fee, are estimates.</P>

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

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
<TR STYLE="vertical-align: bottom; background-color: rgb(204,255,204)">
    <TD STYLE="width: 87%; font-size: 10pt; text-align: left">SEC registration fee</TD><TD STYLE="width: 1%; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="width: 1%; font-size: 10pt; text-align: left">$</TD><TD STYLE="width: 10%; font-size: 10pt; text-align: right">929.89</TD><TD STYLE="width: 1%; font-size: 10pt; text-align: left">&nbsp;</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: White">
    <TD STYLE="font-size: 10pt; text-align: left">Accounting fees and expenses</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: left"></TD><TD STYLE="font-size: 10pt; text-align: right">2,500.00</TD><TD STYLE="font-size: 10pt; text-align: left">&nbsp;</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: rgb(204,255,204)">
    <TD STYLE="font-size: 10pt; text-align: left">Legal fees and expenses</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: left"></TD><TD STYLE="font-size: 10pt; text-align: right">20,000.00</TD><TD STYLE="font-size: 10pt; text-align: left">&nbsp;</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: White">
    <TD STYLE="font-size: 10pt; text-align: left">Printing and related expenses</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: left"></TD><TD STYLE="font-size: 10pt; text-align: right">2,000.00</TD><TD STYLE="font-size: 10pt; text-align: left">&nbsp;</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: rgb(204,255,204)">
    <TD STYLE="font-size: 10pt; text-align: left">Transfer agent fees and expenses</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: left"></TD><TD STYLE="font-size: 10pt; text-align: right">2,000.00</TD><TD STYLE="font-size: 10pt; text-align: left">&nbsp;</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: White">
    <TD STYLE="font-size: 10pt; padding-bottom: 1pt">Miscellaneous</TD><TD STYLE="font-size: 10pt; padding-bottom: 1pt">&nbsp;</TD>
    <TD STYLE="border-bottom: Black 1pt solid; font-size: 10pt; text-align: left"></TD><TD STYLE="border-bottom: Black 1pt solid; font-size: 10pt; text-align: right">2,570.11</TD><TD STYLE="padding-bottom: 1pt; font-size: 10pt; text-align: left">&nbsp;</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: rgb(204,255,204)">
    <TD STYLE="font-size: 10pt; padding-bottom: 2.5pt">Total</TD><TD STYLE="font-size: 10pt; padding-bottom: 2.5pt">&nbsp;</TD>
    <TD STYLE="border-bottom: Black 2.5pt double; font-size: 10pt; text-align: left">$</TD><TD STYLE="border-bottom: Black 2.5pt double; font-size: 10pt; text-align: right">30,000.00</TD><TD STYLE="padding-bottom: 2.5pt; font-size: 10pt; text-align: left">&nbsp;</TD></TR>
</TABLE>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>ITEM 14. INDEMNIFICATION OF DIRECTORS AND OFFICERS</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Under the provisions of Section 78.138
of Nevada Revised Statutes and our Articles of Incorporation, we may indemnify our directors, officers, employees and agents and
maintain liability insurance for those persons. Section 78.138 provides that a corporation may indemnify a person made a party
to a proceeding because the person is or was a director against liability incurred in the proceeding if the person's conduct was
in good faith. In the case of conduct in an official capacity with the corporation, the person may be indemnified if the person
reasonably believed that such conduct was in the corporation's best interests. In all other cases, the corporation may indemnify
the person if the person reasonably believed that such conduct was at least not opposed to the corporation's best interests. In
the case of any criminal proceeding, the person may be indemnified if the person had no reasonable cause to believe the person's
conduct was unlawful.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our Articles of Incorporation and Bylaws,
each as amended, obligate us to indemnify our directors and officers to the fullest extent permitted under Nevada law. We have
purchased directors' and officers' liability insurance policies for our directors and officers.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In the employment agreement that we entered
into with all of our executive officers, we agreed to indemnify our officers for all claims arising out of performance of their
duties as officers of the company, other than those arising out of his breach of the agreement or his gross negligence or willful
misconduct.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Insofar as indemnification for liabilities
for damages arising under the Securities Act may be permitted to our directors, officers, and controlling persons pursuant to the
foregoing provision, or otherwise, we have been advised that in the opinion of the Securities and Exchange Commission such indemnification
is against public policy as expressed in the Securities Act and is, therefore, unenforceable.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>ITEM 15. RECENT SALES OF UNREGISTERED
SECURITIES</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The following information sets forth certain
information with respect to all securities which we have sold during the last three years.&nbsp;&nbsp;We did not pay any commissions
in connection with any of these sales.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">During the fourth quarter of 2009, we issued
104,633 shares of common stock, in connection with the exercise of stock options, for proceeds of $27,834 and issued 3,066 shares
of common stock for consulting fees, having a fair value of $65,786 ($0.28 per share), based on the quoted closing trading prices.
These offerings and sales of shares qualified for exemption under Section 4(2) of the Securities Act since the issuances did not
involve a public offering. The offerings were not a public offering as defined in Section 4(2) because the offer and sale was made
to an insubstantial number of persons and because of the manner of the offering. This offering was done with no general solicitation
or advertising by us. Based on an analysis of the above factors, we met the requirements to qualify for exemption under Section
4(2) of the Securities Act for these sales.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">During the first three months of 2010,
we issued a total of 33,118 shares of our common stock to two consultants for services rendered. These offerings and sales of shares
qualified for exemption under Section 4(2) of the Securities Act since the issuances did not involve a public offering. The offerings
were not a public offering as defined in Section 4(2) because the offer and sale was made to an insubstantial number of persons
and because of the manner of the offering. This offering was done with no general solicitation or advertising by us. Based on an
analysis of the above factors, we met the requirements to qualify for exemption under Section 4(2) of the Securities Act for these
sales.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In July 2010, we issued warrants to the
placement agent and its designees in connection with our sale of shares of our common stock pursuant to our registration statement
on Form S-3. The warrants are exercisable for 60,606 shares of common stock at an exercise price of $1.32 for a period of five
years. The sale of such shares was exempt from registration under the Securities Act in reliance upon Section 4(2) thereof since
the issuances did not involve a public offering. The issuances were not a public offering as defined in Section 4(2) because the
offer and sale was made to an insubstantial number of persons and because of the manner of the issuances. These issuances were
done with no general solicitation or advertising by us. Based on an analysis of the above factors, we met the requirements to qualify
for exemption under Section 4(2) of the Securities Act for these sales.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In October of 2010, we issued 52,180 shares
of common stock to Thomas Jefferson University having a fair value of $41,250 ($0.79 per share) and 28,855 shares of common stock
to the University of Southern California having a fair value of $29,087 ($1.01 per share) in payment for licensing fees. The fair
value of these issuances was based upon the quoted closing price. These issuances and sales of shares qualified for exemption under
Section 4(2) of the Securities Act since the issuances did not involve a public offering. The issuances were not a public offering
as defined in Section 4(2) because the offer and sale was made to an insubstantial number of persons and because of the manner
of the issuances. These issuances were done with no general solicitation or advertising by us. Based on an analysis of the above
factors, we met the requirements to qualify for exemption under Section 4(2) of the Securities Act for these sales.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On July 28, 2011, we exchanged the warrant
issued in connection with the April 6, 2011 financing for a new warrant with substantially the same terms as the original warrant.
We exchanged our warrant with existing security holders and no remuneration or commission was paid in reliance on Section 3(a)(9)
of the Securities Act.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On August 2, 2011, we issued 130,000 shares
of our common stock to Chardan Capital Markets, LLC (Chardan) as compensation for the execution and delivery of a Financial Advisory
Agreement that we entered into with Chardan on June 3, 2011. The offer and issuance of the shares of common stock have not been
registered under the Securities Act, and therefore such shares of common stock may not be offered or sold in the U.S. absent registration
or an applicable exemption from registration requirements. This issuance and sale of shares qualified for exemption under Section
4(2) of the Securities Act since the issuance did not involve a public offering. The issuance was not a public offering as defined
in Section 4(2) because the offer and sale was made to an insubstantial number of persons and because of the manner of the issuance.
This issuance was done with no general solicitation or advertising by us. Based on an analysis of the above factors, we met the
requirements to qualify for exemption under Section 4(2) of the Securities Act for these sales.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On August 10, 2011, we entered into an
agreement to exchange the warrants issued in connection with the January 28, 2011 financing for new warrants. We exchanged our
warrant with existing security holders and no remuneration or commission was paid in reliance on Section 3(a)(9) of the Securities
Act.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On December 7, 2011 a closing was held
for the transaction previously announced on November 21, 2011 between us and Intrexon. We issued 3,123,558 shares of our common
stock at a purchase price equal to the $0.001 par value of such shares, which issuance is also deemed paid in partial consideration
for the execution and delivery of the exclusive channel collaboration agreement, dated November 18, 2011, between us and Intrexon.
This issuance and sale of shares qualified for exemption under Section 4(2) of the Securities Act since the issuance did not involve
a public offering. The issuance was not a public offering as defined in Section 4(2) because the offer and sale was made to an
insubstantial number of persons and because of the manner of the issuance. This issuance was done with no general solicitation
or advertising by us. Based on an analysis of the above factors, we met the requirements to qualify for exemption under Section
4(2) of the Securities Act for these sales.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In February 2012, we issued five year warrants
exercisable at the closing price of our common stock on the date of issue for 100,000 shares of our common stock to Griffin Securities,
Inc. (&ldquo;Griffin&rdquo;) as compensation for the execution and delivery of a Financial Advisory Agreement that we entered into
with Griffin on December 20, 2011. This issuance and sale of warrants qualified for exemption under Section 4(2) of the Securities
Act since the issuance did not involve a public offering. The issuance was not a public offering as defined in Section 4(2) because
the offer and sale was made to an insubstantial number of persons and because of the manner of the issuance. This issuance was
done with no general solicitation or advertising by us. Based on an analysis of the above factors, we met the requirements to qualify
for exemption under Section 4(2) of the Securities Act for these sales.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On May 14, 2012, we issued 257,143 shares
of common stock to an investor upon exercise of warrants in reliance upon Section 3(a)(9) of the Securities Act.</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On July 13, 2012, we issued 94,391 shares
of common stock to an investor upon exercise of warrants in reliance upon Section 3(a)(9) of the Securities Act.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On October 16, 2012 a closing was held
for the transaction previously announced on August 8, 2012 between us and Intrexon. We issued 3,552,210 shares of our common stock
(the &ldquo;Intrexon Shares&rdquo;) at a purchase price equal to the $0.001 par value of such shares, which issuance is also deemed
paid in partial consideration for the execution and delivery of the Exclusive Channel Collaboration Agreement, dated August 6,
2012, between ourselves and Intrexon. The offer and issuance of the Intrexon Shares have not been registered under the Securities
Act, as amended, and therefore may not be offered or sold in the United States absent registration or an applicable exemption from
registration requirements. For this issuance, we are relying on the exemption from federal registration under Section 4(2) of the
Securities Act, based on our belief that the offer and sale of the Intrexon Shares does not involve a public offering as Intrexon
is an &ldquo;accredited investor&rdquo; as defined under Section 501 promulgated under the Securities Act and no general solicitation
has been involved in the offering.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In September 2012, we issued warrants to
a consultant exercisable for up to 250,000 shares of our common stock upon attainment of certain stock price milestones in accordance
with the terms of a consulting agreement for a financial communications program. Upon initiation of the program, 50,000 of the
performance warrants vested. The performance warrant is exercisable for a period of two years from the date of issuance at an exercise
price equal to the price of the Company&rsquo;s common stock on the date of execution of the agreement, March 15, 2012. This issuance
and sale of warrants qualified for exemption under Section 4(2) of the Securities Act since the issuance did not involve a public
offering. The issuance was not a public offering as defined in Section 4(2) because the offer and sale was made to an insubstantial
number of persons and because of the manner of the issuance. This issuance was done with no general solicitation or advertising
by us. Based on an analysis of the above factors, we met the requirements to qualify for exemption under Section 4(2) of the Securities
Act for these sales.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On October 30, 2012, we issued 6,750,000
shares of our common stock at a price per share of $1.60 for aggregate gross proceeds of $10,800,000 to certain accredited investors.
In connection with the offering, we also issued to Griffin and its designees, five-year warrants to purchase up to 635,855 shares
of our common stock with an exercise price of $1.60 per share. The offer and issuance of such shares of common stock and the shares
of common stock underlying such warrants have not been registered under the Securities Act, as amended, and therefore may not be
offered or sold in the United States absent registration or an applicable exemption from registration requirements. For these issuances,
we are relying on the exemption from federal registration under Section 4(2) and Regulation D of the Securities Act, based on our
belief that the offer and sale of such shares of common stock and the shares of common stock underlying such warrants do not involve
a public offering as the purchasers of the common stock and placement agent are &ldquo;accredited investors&rdquo; as defined under
Section 501 promulgated under the Securities Act and no general solicitation has been involved in the offering.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On November 28, 2012, we issued 625,000
in partial consideration for the acquisition of certain assets. The offer and issuance of such shares of common stock have not
been registered under the Securities Act, as amended, and therefore may not be offered or sold in the United States absent registration
or an applicable exemption from registration requirements. For these issuances, we are relying on the exemption from federal registration
under Section 4(2) and Regulation D of the Securities Act, based on our belief that the offer and sale of such shares of common
stock do not involve a public offering as the purchaser of the common stock and all of the members of the purchaser are &ldquo;accredited
investors&rdquo; as defined under Section 501 promulgated under the Securities Act and no general solicitation has been involved
in the offering.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>ITEM 16. EXHIBITS</B></P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">3.1</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Certificate of Incorporation, as amended (Incorporated by reference to (i)&nbsp;Exhibit 3.1 of the Registrant&rsquo;s Current Report on Form 8-K filed October 16, 2008, (ii)&nbsp;Exhibit&nbsp;3.1 of the Registrant&rsquo;s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2001 filed August 14, 2001 and (iii)&nbsp;Exhibits 3.1, 4.1 and 4.2 of the Registrant&rsquo;s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 1998 filed August 14, 1998)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">3.2</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Articles of Merger (Incorporated by reference to Exhibit 3.1 of the Registrant&rsquo;s Current Report on Form 8-K filed October 19, 2009.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">3.3</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Certificate of Merger filed with the Secretary of State of Delaware (Incorporated by reference to Exhibit 3.2 of the Registrant&rsquo;s Current Report on Form 8-K filed October 19, 2009.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">3.4</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Articles of Incorporation filed with the Nevada Secretary of State (Incorporated by reference to Exhibit 3.3 of the Registrant&rsquo;s Current Report on Form 8-K filed October 19, 2009.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">3.5</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">By-Laws (Incorporated by reference to (i) Exhibit 3.4 of the Registrant&rsquo;s Current Report on Form 8-K filed October 19, 2009 and (ii) Exhibit 3.1 of the Registrant&rsquo;s Current Report on Form 8-K filed June 3, 2010. )</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">3.6</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Amended and Restated Bylaws Adopted and Effective October 31, 2011 (Incorporated by reference to Exhibit 3.1 of the Registrant&rsquo;s Current Report on Form 8-K filed November 2, 2011.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

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

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">3.7</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Certificate of Amendment to Articles of Incorporation (Incorporated by reference to Exhibit 3.1 of the Registrant&rsquo;s Current Report on Form 8-K filed February 16, 2012.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">4.1</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Form of Warrant Certificate (Incorporated by reference to Exhibit 4.1 to the Registrant&rsquo;s Current Report on Form 8-K filed December 1, 2006.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">*4.2</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">2001 Stock Incentive Plan (Incorporated by reference to Exhibit 4.1 of the Registrant&rsquo;s Registration Statement on Form S-8 filed January 18, 2008.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">*4.3</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">2007 Stock Incentive Plan (Incorporated by reference to Exhibit 4.2 of the Registrant&rsquo;s Registration Statement on Form S-8 filed January 18, 2008.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">*4.4</TD>
    <TD STYLE="width: 91%">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.6pt 0pt 0">2010 Stock Incentive Plan (Incorporated by
reference to Exhibit 4.1 of the Registrant&rsquo;s Registration Statement on Form S-8 filed November 29, 2010.)&nbsp;</P></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">4.5</TD>
    <TD STYLE="padding-right: 0.8pt">Form of Warrant Certificate issued to Enclave Capital LLC (Incorporated by reference to Exhibit 4.1 of the Registrant's Current Report on Form 8-K filed July 6, 2010.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">4.6</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Form of Warrant to Purchase Common Stock issued January 2011(Incorporated by reference to Exhibit 10.3 of the Registrant&rsquo;s Current Report on Form 8-K filed February 2, 2011.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">4.7</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Form of Warrant to Purchase common stock issued April 2011(Incorporated by reference to Exhibit 10.3 of the Registrant&rsquo;s Current Report on Form 8-K filed April 6, 2011.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">4.8</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Form of Exchange Warrant to Purchase Common Stock issued in exchange of the Warrant issued April 2011(Incorporated by reference to Exhibit 4.1 of the Registrant&rsquo;s Quarterly Report on Form 10-Q for the quarter ended June 30, 2011 filed August 15, 2011.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">4.9</TD>
    <TD STYLE="width: 91%">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.8pt 0pt 0">Form of Exchange Warrant to Purchase Common Stock
        issued in exchange of the Warrant issued February 2011(Incorporated by reference to Exhibit 4.2 of the Registrant&rsquo;s Quarterly
        Report on Form 10-Q for the quarter ended June 30, 2011 filed August 15, 2011.)</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.8pt 0pt 0">&nbsp;</P></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt; text-align: justify">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">4.10</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: justify">Form of Warrant to Purchase Common Stock issued February 2012 (Incorporated by reference to Exhibit 4.10 of the Registrant&rsquo;s Annual Report on Form 10-K for the year ended December 31, 2011 filed March 30, 2012.)</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt; text-align: justify">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: justify">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt; text-align: justify">&nbsp;</TD>
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.8pt 0pt 0">4.11&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.8pt 0pt 0"></P></TD>
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.8pt 0pt 0">Form of Warrant to Purchase Common Stock
(Incorporated by reference to Exhibit 4.10 of the Registrant&rsquo;s Annual Report on Form 10-K filed March 30, 2012.)</P></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt; text-align: justify">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt; text-align: justify">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">4.12</TD>
    <TD STYLE="padding-right: 0.8pt">Form of Placement Agent Warrant issued in October
        2012 (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed October 31, 2012.)</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt; text-align: justify">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt; text-align: justify">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">4.13</TD>
    <TD STYLE="padding-right: 0.8pt">Form of Warrant Certificate issued to Redington, Inc.(1)</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt; text-align: justify">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt; text-align: justify">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">5.1</TD>
    <TD STYLE="padding-right: 0.8pt">Legal Opinion of Gracin &amp; Marlow, LLP (1)</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt; text-align: justify">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">10.1</TD>
    <TD STYLE="padding-right: 0.8pt">Unit Purchase Agreement (Incorporated by reference to Exhibit 10.1 to the Registrant&rsquo;s Current Report on Form 8-K filed December 1, 2006.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">10.2</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">License Agreement between The Regents of the University of California and Epitope Pharmaceuticals, Inc. (Incorporated by reference to the Registrant&rsquo;s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2008 filed November 14, 2008.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt; text-align: justify">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">*10.3</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt; text-align: justify">Form of Director/Officer Indemnification Agreement (Incorporated by reference to Exhibit 10.1 of the Registrant&rsquo;s Current Report on Form 8-K filed January 6, 2009.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">10.4</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Warrant Cancellation and Registration Rights Agreement between Accredited Adventures Capital LLC and Adeona (Incorporated by reference to Exhibit 10.1 of the Registrant&rsquo;s Current Report on Form 8-K filed January 20, 2009.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

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

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">10.5</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Stock Purchase Agreement with Neil O. Colwell and Connie Colwell&nbsp;(Incorporated by reference to Exhibit 10.1 of the Registrant&rsquo;s Current Report on Form 8-K filed April 16, 2009.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">10.6</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Escrow Agreement Nayaran Torke (Incorporated by reference to Exhibit 10.5 of the Registrant&rsquo;s Current Report on Form 8-K filed July 16, 2009.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">10.7</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Consulting Agreement with Nayaran Torke (Incorporated by reference to Exhibit 10.4 of the Registrant&rsquo;s Current Report on Form 8-K filed July 16, 2009.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">10.8</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Purchase Agreement 1st Amendment HartLab LLC (Incorporated by reference to Exhibit 10.2 of the Registrant&rsquo;s Current Report on Form 8-K filed July 16, 2009.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">10.9</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Purchase Agreement 2nd Amendment Hartlab LLC (Incorporated by reference to Exhibit 10.3 of the Registrant&rsquo;s Current Report on Form 8-K filed July 16, 2009.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">10.10</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Agreement and Plan of Reincorporation Merger (Incorporated by reference to Exhibit 1.1 of the Registrant&rsquo;s Current Report on Form 8-K filed October 19, 2009.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">*10.11</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Employment Agreement with James S. Kuo, M.D., (Incorporated by reference to Exhibit 10.1 of the Registrant&rsquo;s Current Report on Form 8-K filed February 9, 2010.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">*10.12</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Separation Agreement with Max Lyons (Incorporated by reference to Exhibit 10.2 of the Registrant&rsquo;s Current Report on Form 8-K filed February 9, 2010.)</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">10.13</TD>
    <TD STYLE="padding-right: 0.8pt">Sublicense Agreement between Meda AB, Adeona Pharmaceuticals, Inc. and Pipex Therapeutics, Inc. (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed May 11, 2010.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">10.14</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Non-Disturbance Agreement among Pipex Therapeutics, Inc., Mclean Hospital Corp and Meda AB (Incorporated by reference to Exhibit 10.2 of the Registrant&rsquo;s Current Report on Form 8-K filed May 11, 2010.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt; text-align: justify">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">10.15</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt; text-align: justify">Placement Agent Agreement with Enclave Capital LLC (Incorporated by reference to Exhibit 1.1 of the Registrant&rsquo;s Current Report on Form 8-K filed July 6, 2010.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt; text-align: justify">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">10.16</TD>
    <TD STYLE="width: 91%">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.8pt 0pt 0; text-align: justify">Common Stock Purchase Agreement
        with Seaside 88, LP (Incorporated by reference to Exhibit 10.1 of the Registrant&rsquo;s Current Report on Form 8-K filed July
        6, 2010.)</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.8pt 0pt 0; text-align: justify">&nbsp;</P></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.8pt 0pt 0; text-align: justify">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.8pt 0pt 0; text-align: justify">&nbsp;</P></TD>
    <TD STYLE="padding-right: 0.8pt">10.17</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: justify">Agreement with Chardan Capital Markets, LLC (Incorporated by reference to Exhibit 10.1 of the Registrant&rsquo;s Current Report on Form 8-K filed February 2, 2011.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in"></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">10.18</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Securities Purchase Agreement with investors (Incorporated by reference to Exhibit 10.2 of the Registrant&rsquo;s Current Report on Form 8-K filed February 2, 2011.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">10.19</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">McLean Hospital Corporation Exclusive License Agreement (Incorporated by reference to Exhibit 10.21 of the Registrant&rsquo;s Annual Report on Form 10-K filed March 31, 2011)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">10.20</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Agreement with Chardan Capital Markets, LLC (Incorporated by reference to Exhibit 10.1 of the Registrant&rsquo;s Current Report on Form 8-K filed April 6, 2011.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">10.21</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Securities Purchase Agreement with investors (Incorporated by reference to Exhibit 10.2 of the Registrant&rsquo;s Current Report on Form 8-K filed April 6, 2011.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">10.22</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Exchange Agreement with respect to Warrant issued April 2011(Incorporated by reference to Exhibit 10.1 of the Registrant&rsquo;s Quarterly Report on Form 10-Q for the quarter ended June 30, 2011 filed August 15, 2011.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">10.23</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Exchange Agreement with respect to Warrant issued February 2011(Incorporated by reference to Exhibit 10.2 of the Registrant&rsquo;s Quarterly Report on Form 10-Q for the quarter ended June 30, 2011 filed August 15, 2011.)</TD></TR>
</TABLE>

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

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

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

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt; width: 8%">10.24</TD>
    <TD STYLE="padding-right: 0.8pt; width: 91%">Exclusive Channel Collaboration Agreement with Intrexon Corporation (Incorporated by reference to Exhibit 10.1 of the Registrant&rsquo;s Current Report on Form 8-K filed November 21, 2011.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">10.25</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Stock Purchase Agreement with Intrexon Corporation (Incorporated by reference to Exhibit 10.2 of the Registrant&rsquo;s Current Report on Form 8-K filed November 21, 2011.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">10.26</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Registration Rights Agreement with Intrexon Corporation (Incorporated by reference to Exhibit 10.3 of the Registrant&rsquo;s Current Report on Form 8-K filed November 21, 2011.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">*10.27</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Employment Agreement with Jeffrey Riley (Incorporated by reference to Exhibit 10.1 of the Registrant&rsquo;s Current Report on Form 8-K filed February 6, 2012.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">10.28</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Consulting Agreement with Dr. James Kuo (Incorporated by reference to Exhibit 10.2 of the Registrant&rsquo;s Current Report on Form 8-K filed February 6, 2012.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">*10.29</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Employment Agreement with C. Evan Ballantyne (Incorporated by reference to Exhibit 10.1 of the Registrant&rsquo;s Current Report on Form 8-K filed February 7, 2012.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">*10.30</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Employment Agreement with Steve H. Kanzer (Incorporated by reference to Exhibit 10.30 of the Registrant's Annual&nbsp;Report on Form 10-K for the year ended December 31, 2011 filed March 30, 2012.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">10.31</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Membership Interest Purchase Agreement by and among Synthetic Biologics, Inc., Hartlab LLC, and Adeona Clinical Laboratory, LLC, dated as of March 7, 2012 (Incorporated by reference to Exhibit 10.1 of the Registrant&rsquo;s Current Report on Form 8-K filed March 12, 2012.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">10.32</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Pledge and Security Agreement between Synthetic Biologics, Inc. and Hartlab, LLC dated as of March 7, 2012 (Incorporated by reference to Exhibit 10.1 of the Registrant&rsquo;s Current Report on Form 8-K filed March 12, 2012.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;&nbsp;</P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">10.33&nbsp;&nbsp;&nbsp;&nbsp;</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Non-Recourse Promissory Note between Synthetic Biologics, Inc. and Hartlab, LLC dated as of March 7, 2012 (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed March 12, 2012.)</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">10.34&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">Financial Advisory Agreement with Griffin Securities, Inc. (Incorporated by reference to Exhibit 10.34 of the Registrant&rsquo;s Annual Report on Form 10-K for the year ended December 31, 2011 filed March 30, 2012.)</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD STYLE="padding-right: -0.9pt; text-align: justify">10.35</TD>
    <TD STYLE="padding-right: -0.9pt; text-align: justify">Exclusive Channel Collaboration Agreement by and between Synthetic Biologics, Inc. and Intrexon Corporation dated as of August 6, 2012 (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed August 9, 2012.)</TD></TR>
</TABLE>


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

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

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%">&nbsp;</TD>
    <TD STYLE="width: 8%; padding-right: 0.8pt">10.36</TD>
    <TD STYLE="width: 91%; padding-right: 0.8pt">Stock Issuance Agreement by and between Synthetic Biologics, Inc. and Intrexon Corporation dated as of August 6, 2012 (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed August 9, 2012.)</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD STYLE="padding-right: 5.4pt; padding-left: 5.4pt">&nbsp;</TD>
    <TD STYLE="padding-right: 5.4pt; padding-left: 5.4pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">10.37</TD>
    <TD STYLE="padding-right: 0.8pt">First Amendment to Registration Rights Agreement by and between Synthetic Biologics, Inc. and Intrexon Corporation dated as of August 6, 2012 (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed August 9, 2012.)</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD STYLE="padding-right: 5.4pt; padding-left: 5.4pt">&nbsp;</TD>
    <TD STYLE="padding-right: 5.4pt; padding-left: 5.4pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">10.38</TD>
    <TD STYLE="padding-right: 0.8pt">Form of Stock Purchase Agreement dated October 25, 2012 (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed October 31, 2012.)</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">10.39</TD>
    <TD STYLE="padding-right: 0.8pt">Form of Registration Rights Agreement dated October 25, 2012 (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed October 31, 2012.)</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">10.40</TD>
    <TD STYLE="padding-right: 0.8pt">Joinder Agreement dated October 25, 2012 (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed October 31, 2012.)</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">10.41</TD>
    <TD STYLE="padding-right: 0.8pt">Asset Purchase Agreement between Synthetic Biologics, Inc. and Prev ABR LLC dated as of November 8, 2012 (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed November 13, 2012.)</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="text-align: center">*</TD>
    <TD STYLE="padding-right: 0.8pt">10.42</TD>
    <TD STYLE="padding-right: 0.8pt">Amendment to Employment Agreement with Steve H. Kanzer  (1)</TD></TR>
</TABLE>

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

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

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt; width: 8%">21</TD>
    <TD STYLE="padding-right: 0.8pt; width: 91%">List of Subsidiaries (Incorporated by reference to Exhibit 10.34 of the Registrant&rsquo;s Annual Report on Form 10-K filed March 30, 2012.)</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">23.1</TD>
    <TD STYLE="padding-right: 0.8pt">Consent of Independent Registered Accounting Firm (1)</TD></TR>
</TABLE>


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

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 1%">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt; width: 8%">23.2</TD>
    <TD STYLE="width: 91%">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.8pt 0pt 0">Consent of Gracin &amp; Marlow, LLP (Included in its
        opinion filed as Exhibit 5.1)</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.8pt 0pt 0">&nbsp;</P></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;24</TD>
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.8pt 0pt 0">Power of Attorney (Included on signature page)</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.8pt 0pt 0">&nbsp;</P></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt; width: 1%">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt; text-align: center; width: 8%">(1)</TD>
    <TD STYLE="padding-right: 0.8pt; width: 91%">Filed herewith.</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">* Management contract or compensatory plan or arrangement required
to be identified pursuant to Item 15(a)(3) of this report</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>ITEM 28. UNDERTAKINGS</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Insofar as indemnification for liabilities
arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrants, pursuant to
the provisions described under Item&nbsp;15 or otherwise, the Registrant has been advised that in the opinion of the Securities
and Exchange Commission such indemnification by it is against public policy as expressed in the Securities Act and is, therefore,
unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant
of expenses incurred or paid by a director, officer or controlling person of the Registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered,
the Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court
of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities
Act and will be governed by the final adjudication of such issue.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The undersigned Registrant hereby undertakes:</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">(1) To file, during any period in which
offers or sales are being made, a post-effective amendment to this registration statement:</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">(i) to include any prospectus required
by Section&nbsp;10(a)(3) of the Securities Act;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">(ii) to reflect in the prospectus any acts
or events arising after the effective date of this 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 this 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 a prospectus filed with the Commission pursuant to Rule 424(b) under the Securities Act if,
in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set
forth in the &ldquo;Calculation of Registration Fee&rdquo; table in the effective registration statement); and</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">(iii) to include any material information
with respect to the plan of distribution not previously disclosed in this registration statement or any material change to such
information in this registration statement; provided, however, that subparagraphs (i), (ii)&nbsp;and (iii)&nbsp;do not apply if
the information required to be included in a post-effective amendment by those subparagraphs is contained in periodic reports filed
with or furnished to the Commission by the Registrant pursuant to Section&nbsp;13 or Section&nbsp;15(d) of the Securities Exchange
Act of 1934, that are incorporated by reference in this registration statement, or is contained in a form of prospectus filed pursuant
to Rule 424(b) that is part of the registration statement.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">(3) To remove from registration, by means
of a post-effective amendment, any of the securities being registered which remain unsold at the termination of the offering.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">(4) That, for the purpose of determining
liability under the Securities Act to any purchaser:</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">(i) if the Registrant is relying on Rule
430B: (A)&nbsp;each prospectus filed by the Registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration
statement as of the date the filed prospectus was deemed part of and included in the registration statement; and (B)&nbsp;each
prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on
Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x)&nbsp;for the purpose of providing the information
required by section 10(a) of the Securities Act shall be deemed to be part of and included in the registration statement as of
the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of
securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any
person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement
relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration
statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by
reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with
a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement
or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date;
or</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">(ii) if the Registrant is subject to Rule
430C, each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration
statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included
in the registration statement as of the date it is first used after effectiveness. Provided, however, that no statement made in
a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed
incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to
a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the registration
statement or prospectus that was part of the registration statement or made in any such document immediately prior to such date
of first use.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">(5) That, for the purpose of determining
liability under the Securities Act to any purchaser in the initial distribution of the securities the undersigned Registrant undertakes
that in a primary offering of securities of the undersigned Registrant pursuant to this registration statement, regardless of the
underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means
of any of the following communications, the undersigned Registrant will be a seller to the purchaser and will be considered to
offer or sell such securities to such purchaser: (i)&nbsp;any preliminary prospectus or prospectus of the undersigned Registrant
relating to the offering required to be filed pursuant to Rule 424; (ii)&nbsp;any free writing prospectus relating to the offering
prepared by or on behalf of the undersigned Registrant or used or referred to by the undersigned Registrant; (iii)&nbsp;the portion
of any other free writing prospectus relating to the offering containing material information about the undersigned Registrant
or its securities provided by or on behalf of the undersigned Registrant; and (iv)&nbsp;any other communication that is an offer
in the offering made by the undersigned Registrant to the purchaser.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">(6) That, for purposes of determining any
liability under the Securities Act, each filing of the Registrant&rsquo;s annual report pursuant to Section&nbsp;13(a) or Section&nbsp;15(d)
of the Securities Exchange Act of 1934 that is incorporated by reference in this registration statement shall be deemed to be a
new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be
deemed to be the initial bona fide offering thereof.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">(7) That for purposes of determining any
liability under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statement
in reliance upon Rule 430A and contained in a form of prospectus filed by the Registrant pursuant to Rule 424(b)(1) or (4)&nbsp;or
497(h) under the Securities Act of 1933 shall be deemed to be part of this registration statement as of the time it was declared
effective.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">(8) That, for the purpose of determining
any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be
a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall
be deemed to be the initial bona fide offering thereof.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">(9) To file an application for the purpose
of determining the eligibility of the trustee to act under subsection (a)&nbsp;of Section&nbsp;310 of the Trust Indenture Act in
accordance with the rules and regulations prescribed by the Commission under Section&nbsp;305(b)(2) of the Securities Act.</P>

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

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

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Pursuant to the requirements of the Securities
Act of 1933, the Registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing
on the Form&nbsp;S-1 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Ann Arbor, State of Michigan, December 13, 2012.</P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="padding-right: 2.8pt">SYNTHETIC BIOLOGICS, INC.</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 52%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 3%; padding-right: 0.8pt">By:</TD>
    <TD STYLE="width: 30%; border-bottom: black 1pt solid; padding-right: 0.8pt">/s/ Jeffrey Riley</TD>
    <TD STYLE="width: 15%; padding-right: 0.8pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="padding-right: 2.8pt">Jeffrey Riley</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="padding-right: 2.8pt">Chief Executive Officer and Director</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="padding-right: 2.8pt">(Principal Executive Officer)</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="padding-right: 2.8pt">Date: December 13, 2012</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 52%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 3%; padding-right: 0.8pt">By:</TD>
    <TD STYLE="width: 30%; border-bottom: black 1pt solid; padding-right: 0.8pt">/s/ C. Evan Ballantyne</TD>
    <TD STYLE="width: 15%; padding-right: 0.8pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="padding-right: 2.8pt">C. Evan Ballantyne</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="padding-right: 2.8pt">Chief Financial Officer</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="padding-right: 2.8pt">(Principal Financial and Principal Accounting Officer)</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="padding-right: 2.8pt">Date: December 13, 2012</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We, the undersigned hereby severally constitute
and appoint each of Jeffrey Riley and C. Evan Ballantyne our true and lawful attorney and agent, with full power to each to sign
for us, and in our names in the capacities indicated below, any and all amendments to this registration statement, any subsequent
registration statements pursuant to Rule 462 of the Securities Act of 1933, as amended, and to file the same, with all exhibits
thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact
and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to
be done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and
confirming all that said attorneys-in-fact and agents, or any of them or their or his or her substitute or substitutes, may lawfully
do or cause to be done by virtue hereof. This power of attorney may be executed in counterparts.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Pursuant to the requirements of the Securities
Act 1933, this report has been signed by the following persons on behalf of the Registrant and in the capacities and on the dates
indicated.</P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 19%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 3%; padding-right: 0.8pt">By:</TD>
    <TD STYLE="width: 43%; border-bottom: black 1pt solid; padding-right: 0.8pt">/s/ Jeffrey Riley</TD>
    <TD STYLE="width: 34%; padding-right: 0.8pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">Date: December 13, 2012</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="padding-right: 2.8pt">Jeffrey Riley</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="padding-right: 2.8pt">Chief Executive Officer and Director</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="padding-right: 2.8pt">(Principal Executive Officer)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 19%; padding-right: 0.8pt">Date: December 13, 2012</TD>
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 3%; padding-right: 0.8pt">By:</TD>
    <TD STYLE="width: 43%; border-bottom: black 1pt solid; padding-right: 0.8pt">/s/ Jeffrey J. Kraws</TD>
    <TD STYLE="width: 34%; padding-right: 0.8pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="padding-right: 2.8pt">Jeffrey J. Kraws</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="padding-right: 2.8pt">Chairman</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 19%; padding-right: 0.8pt">Date: December 13, 2012</TD>
    <TD STYLE="width: 1%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 3%; padding-right: 0.8pt">By:</TD>
    <TD STYLE="width: 43%; border-bottom: black 1pt solid; padding-right: 0.8pt">/s/ Steve H. Kanzer</TD>
    <TD STYLE="width: 34%; padding-right: 0.8pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="padding-right: 2.8pt">Steve H. Kanzer</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="padding-right: 2.8pt">Director</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="padding-right: 2.8pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">Date: December 13, 2012</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">By:</TD>
    <TD STYLE="border-bottom: black 1pt solid; padding-right: 0.8pt">/s/ Scott L. Tarriff</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="padding-right: 2.8pt">Scott L. Tarriff</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="padding-right: 2.8pt">Director</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="padding-right: 2.8pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">Date: December 13, 2012</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">By:</TD>
    <TD STYLE="border-bottom: black 1pt solid; padding-right: 0.8pt">/s/ Jeffrey Wolf</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="padding-right: 2.8pt">Jeffrey Wolf</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="padding-right: 2.8pt">Director</TD></TR>
</TABLE>
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{"company-data": {"conformed-name": "Synthetic Biologics, Inc.", "cik": "0000894158", "assigned-sic": "2834", "irs-number": "133808303", "state-of-incorporation": "NV", "fiscal-year-end": "1231"}, "filing-values": {"form-type": "S-1", "act": "33", "file-number": "333-185457", "film-number": "121261916"}, "business-address": {"street1": "3985 RESEARCH PARK DRIVE,", "street2": "SUITE 200", "city": "ANN ARBOR", "state": "MI", "zip": "48108", "phone": "(734) 332-7800"}, "mail-address": {"street1": "3985 RESEARCH PARK DRIVE,", "street2": "SUITE 200", "city": "ANN ARBOR", "state": "MI", "zip": "48108"}, "former-company": [{"former-conformed-name": "ADEONA PHARMACEUTICALS, INC.", "date-changed": "20081027"}, {"former-conformed-name": "PIPEX PHARMACEUTICALS, INC.", "date-changed": "20061214"}, {"former-conformed-name": "SHEFFIELD PHARMACEUTICALS INC", "date-changed": "19970730"}]}
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
SYNTHETIC BIOLOGICS, INC.
(Exact Name of Registrant as Specified in
Its Charter)
Nevada
(State or Other Jurisdiction of Incorporation
or Organization)
2834
(Primary Standard Industrial
Classification Code Number)
13-3808303
(I.R.S. Employer Identification No.)
617 Detroit Street, Suite 100
Ann Arbor, MI 48104
(734) 332-7800
(Address and telephone number of principal
executive offices)
Jeffrey Riley
President and Chief Executive Officer
Synthetic Biologics, Inc.
617 Detroit Street, Suite 100
Ann Arbor, MI 48104
(734) 332-7800
(Name, address and telephone
number of agent for service)
Copy to:
Leslie Marlow, Esq.
Gracin & Marlow, LLP
The Chrysler Building
405 Lexington Avenue, 26th Floor
New York, New York 10174
(212) 907-6457
Approximate Date of Proposed Sale to the
Public: From time to time after the date this registration statement becomes effective.
If
any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under
the Securities Act of 1933, check the following box.
x
If this Form is filed to register additional
securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement for the same offering.
¨
If this Form is a post-effective amendment
filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement
number of the earlier effective registration statement for the same offering.
¨
If this Form is a post-effective amendment
filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement
number of the earlier effective registration statement for the same offering.
¨
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 of 1934.
Large accelerated filer
¨
Accelerated filer
¨
Non-accelerated filer
¨
Smaller reporting company
x
(Do not check if a smaller reporting company)
CALCULATION OF REGISTRATION FEE
Title of Each Class of
Securities to be Registered
Amount to be
Registered (1)(2)
Proposed Maximum
Offering
Price per Security(3)
Proposed Maximum
Aggregate
Offering Price
Amount of
Registration
Fee
Common stock, par value $.001 per share
4,260,855 shares
$
1.60
$
6,817,368
$
929.89
(1)
Pursuant to Rule 416 under the Securities
Act of 1933, as amended (the "Securities Act"), the shares being registered hereunder include such indeterminate number
of shares of our Common Stock as may be issuable with respect to the shares being registered hereunder to prevent dilution by
reason of any stock dividend, stock split, recapitalization or other similar transaction.
(2)
4,260,855 shares of common stock are to be offered by the Selling
        Stockholders named herein and were acquired in connection with a private placement consummated by the Registrant, of which 3,625,000
        shares of common stock are currently issued and outstanding and 635,855 are shares of common stock issuable upon exercise of warrants.
(3)
Estimated solely for the purpose of calculating
    the registration fee in accordance with Rule 457(c) of the Securities Act based upon a $1.60 per share average of high and
    low prices of the registrant's common stock on the NYSE MKT, LLC on December 11, 2012.
The Registrant hereby amends this
registration statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a
further amendment which specifically states that this registration statement shall thereafter become effective in accordance with
Section 8(a) of the Securities Act or until the registration statement shall become effective on such date as the Commission, acting
pursuant to said Section 8(a), may determine.
THE INFORMATION CONTAINED IN THIS PROSPECTUS
IS NOT COMPLETE AND MAY BE CHANGED. THESE SECURITIES MAY NOT BE SOLD UNTIL THE REGISTRATION STATEMENT FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION IS DECLARED EFFECTIVE. THIS PROSPECTUS IS NOT AN OFFER TO SELL THESE SECURITIES AND IT IS NOT SOLICITING
AN OFFER TO BUY THESE SECURITIES IN ANY STATE WHERE THE OFFER OR SALE IS NOT PERMITTED.
SUBJECT TO COMPLETION, DATED DECEMBER
13, 2012
PRELIMINARY PROSPECTUS
SYNTHETIC BIOLOGICS, INC.
4,260,855
Shares of Common Stock
This prospectus relates to the resale by
the investors listed in the section titled "Selling Stockholders", and we refer to the investors as the Selling Stockholders
(the "Selling Stockholders") of up to 4,260,855 shares of our common stock, par value $0.001 per share (the "Shares"),
of which 3,625,000 shares of common stock are currently outstanding and 635,855 shares of common stock are issuable upon exercise
of warrants (the "Agent Warrants"). The shares and warrants were acquired by the Selling Stockholders in connection
with a private placement offering we completed on October 30, 2012 (the "October 2012 Private Placement"). We are registering
the resale of the Shares as required by the Registration Rights Agreement we entered into with the Selling Stockholders in connection
with the October 2012 Private Placement (the "Registration Rights Agreement").
The Selling Stockholders may offer and
sell or otherwise dispose of the Shares described in this prospectus from time to time through public or private transaction at
prevailing market prices, at prices related to such prevailing market prices, at varying prices determined at the time of sale,
at negotiated prices, or at fixed prices. See "Plan of Distribution" beginning on page 20 for more information.
We will not receive any of the proceeds
from the Shares sold by the Selling Stockholders.
Our common stock became eligible for trading
on the NYSE MKT, LLC October 16, 2008.  Our common stock is eligible for quotation on the NYSE MKT, LLC under the symbol "SYN".
The closing price of our stock on December 11, 2012 was $1.60.
Investing in our securities involves a high degree of risk.
See "
Risk Factors
" beginning on page 7 of this prospectus for more information.
Neither the Securities and Exchange Commission
nor any state securities commission has approved or disapproved of these securities or determined if this prospectus or the prospectus
to which it relates is truthful or complete. Any representation to the contrary is a criminal offense.
The date of this prospectus is December
__, 2012.
TABLE OF CONTENTS
Page
ABOUT THIS PROSPECTUS
1
ABOUT FORWARD LOOKING STATEMENTS
1
PROSPECTUS SUMMARY
2
THE OFFERING
6
RISK FACTORS
7
USE OF PROCEEDS
18
SELLING STOCKHOLDERS
18
DETERMINATION OF OFFERING PRICE
20
PLAN OF DISTRIBUTION
20
DESCRIPTION OF SECURITIES
22
EXPERTS
25
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES
25
LEGAL MATTERS
26
WHERE YOU CAN FIND MORE INFORMATION
27
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
27
PART II
29
ABOUT THIS PROSPECTUS
You should rely only on the information
contained or incorporated by reference in this prospectus. Neither we nor the Selling Stockholders have authorized anyone to provide
you with information that is different from such information. If anyone provides you with different or inconsistent information,
you should not rely on it. The Selling Stockholders are offering to sell common stock only in jurisdictions where offers and sales
are permitted. You should not assume that the information we have included in this prospectus is accurate as of any date other
than the date of this prospectus or that any information we have incorporated by reference is accurate as of any date other than
the date of the document incorporated by reference. Our business, financial condition, results of operations and prospects may
have changed since that date.
The distribution of this prospectus and
the issuance of the common stock in certain jurisdictions may be restricted by law. Persons outside the United States who come
into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the issuance of the
common stock and the distribution of this prospectus outside the United States. This prospectus does not constitute, and may not
be used in connection with, an offer to sell, or a solicitation of an offer to buy, the common stock offered by this prospectus
by any person in any jurisdiction in which it is unlawful for such person to make such an offer or solicitation.
It is important for you to read and consider
all of the information contained in this prospectus in making your investment decision. To understand the offering fully and for
a more complete description of the offering you should read this entire document carefully, including particularly the "Risk
Factors" section beginning on page 7. You also should read and consider the information in the documents to which we have
referred you in the sections entitled "Where You Can Find Additional Information" and "Incorporation of Certain
Information by Reference".
As used in this prospectus, unless the
context requires otherwise, the terms "we", "us", "our", or "the Company" refer
to Synthetic Biologics, Inc. and its subsidiaries on a consolidated basis. References to "Selling Stockholders" refer
to those stockholders listed herein under "Selling Stockholders" and their successors, assignees and permitted transferees.
ABOUT FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking
statements within the meaning of Section 27A of the Securities Act, about the Company and its subsidiaries. These forward-looking
statements are intended to be covered by the safe harbor for forward-looking statements provided by the Private Securities Litigation
Reform Act of 1995. Forward-looking statements are not statements of historical fact, and can be identified by the use of forward-looking
terminology such as "believes", "expects", "may", "will", "could",
"should", "projects", "plans", "goal", "targets", "potential",
"estimates", "pro forma", "seeks", "intends", or "anticipates" or the
negative thereof or comparable terminology. Forward-looking statements include discussions of strategy, financial projections,
guidance and estimates (including their underlying assumptions), statements regarding plans, objectives, expectations or consequences
of various transactions, and statements about the future performance, operations, products and services of the Company and its
subsidiaries. We caution our stockholders and other readers not to place undue reliance on such statements.
Our businesses and operations are and will
be subject to a variety of risks, uncertainties and other factors. Consequently, actual results and experience may materially differ
from those contained in any forward-looking statements. Such risks, uncertainties and other factors that could cause actual results
and experience to differ from those projected include, but are not limited to, the risk factors set forth in the section entitled
"Risk Factors" beginning on page 7 of this prospectus and elsewhere in the documents incorporated by reference in
this prospectus, including our Annual Report on Form 10-K/A for the year ended December 31, 2011.
All written or oral forward-looking statements
attributable to us or any person acting on our behalf made after the date of this prospectus are expressly qualified in their entirety
by the risk factors and cautionary statements contained in and incorporated by reference into this prospectus. Unless legally required,
we do not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances
after the date of this prospectus or to reflect the occurrence of unanticipated events.
1
PROSPECTUS SUMMARY
This summary highlights information
contained elsewhere in this prospectus; it does not contain all of the information you should consider before investing in our
common stock. You should read the entire prospectus before making an investment decision.
Company Overview
We are a biotechnology company focused
on the development of synthetic biologics and innovative medicines for serious infections and diseases. We are developing a biologic
for the prevention of
C. diff
infection, and a series of monoclonal antibodies (mAbs) for the treatment of serious infectious
diseases, including
Acinetobacter
. We are also developing a synthetic DNA-based therapy for the treatment of pulmonary arterial
hypertension (PAH). In addition, we are developing a drug candidate for the treatment of relapsing-remitting multiple sclerosis
(MS) and cognitive dysfunction in MS, and designing a clinical development pathway for the treatment of amyotrophic lateral sclerosis
(ALS), and, have partnered the development of a treatment for fibromyalgia. We are also evaluating additional in-licensing opportunities.
Product Pipeline:
Infectious Disease Programs:
•
In November 2012, we acquired a series of beta-lactamase compounds (P1A, P2A and P3A) and related assets targeting the prevention of
Clostridium difficile
(
C. diff
)
infection, the leading cause of hospital acquired infections (HAI), that may occur secondary to treatment with antibiotics. The assets include a pre-Investigational New Drug (IND) package, Phase I and Phase II clinical data, manufacturing process data and all issued and pending U.S. and international patents intended to support an IND and Biologic License Application (BLA) with the FDA. Utilizing the newly acquired biologic compounds, we intend to develop a proprietary oral beta-lactamase enzyme product candidate, SYN-004. When co-administered with certain beta-lactam antibiotics, it is expected that SYN-004 can degrade the antibiotic and preserve the balance of the patient's gastrointestinal (GI) microflora, thus preventing opportunistic
C. diff
infection (CDI). Beta-lactam antibiotics are a mainstay in hospital infection management and include both penicillins and cephalosporins. In 2011, an estimated 8.7 million Americans were administered intravenous beta-lactam antibiotics.
•
In August 2012, we entered into
        a second worldwide exclusive channel collaboration with Intrexon Corporation (Intrexon) through which we intend to develop and
        commercialize a series of mAb therapies for the treatment of certain infectious diseases not adequately addressed by existing therapies.
        Utilizing Intrexon's comprehensive suite of proprietary technologies, including the mAbLogix™ and LEAP™ platforms,
        we intend to target three infectious disease indications as part of the Intrexon collaboration. In September 2012, we initiated
        efforts to develop our first mAb therapy for the treatment of acinetobacter infections. Many strains of
Acinetobacter
are
        multidrug-resistant and pose an increasing global threat to hospitalized patients, wounded military personnel and those affected
        by natural disasters. A treatment for acinetobacter infections represents a multi-billion dollar market opportunity.
(mAbLogix™ and LEAP™
        are registered trademarks of Intrexon Corporation)
2
Synthetic Biologic Program:
•
Our synthetic DNA-based product candidate is intended to treat PAH, a serious life-threatening lung disease. This product is designed to deliver DNA that encodes a therapeutic protein called prostacyclin synthase (PGIS) locally to the pulmonary arteries of PAH patients via a single procedure, and, via an oral daily pill, control the long-term local expression of such therapeutic protein. We are developing this initial product candidate pursuant a global exclusive channel collaboration that we entered into with Intrexon in November 2011. As part of this collaboration, we have access to Intrexon's UltraVector
®
platform and RheoSwitch Therapeutic System
®
for this product application. We anticipate that by continuously producing and delivering prostacyclin directly where it is needed, in the pulmonary arteries of PAH patients, this product candidate may overcome the dose limiting side effects of systemic prostacyclin treatments for PAH, a mainstay of PAH treatment. According to GlobalData, the global market for PAH treatments is estimated to exceed $3.6 billion by 2015.
(UltraVector
®
and RheoSwitch Therapeutic
System
®
are registered trademarks of Intrexon Corporation)
Multiple Sclerosis Program:
•
Trimesta
TM
(oral estriol) is being developed as an oral once-daily treatment for relapsing-remitting MS in women. Patient enrollment of 164 patients is complete in this randomized, double-blind, placebo-controlled Phase II clinical trial being conducted at 15 centers in the U.S. Patients are being dosed and monitored for two years. This clinical trial is supported by grants exceeding $8 million, which should be sufficient to fund the trial through completion. Current sales of injectable disease-modifying therapies for MS are estimated at $8.9 billion annually. According to various reports, sales of oral disease-modifying therapies for MS, of which Trimesta™, if and when approved, would be in such class, are anticipated to grow from $500 million in 2010 to $5 billion annually by 2017.
•
Trimesta
TM
is also being developed for the treatment of cognitive dysfunction in female MS patients. In January 2012, patient enrollment began in a randomized, double-blind, placebo-controlled Phase II clinical trial being conducted at University of California, Los Angeles (UCLA). Patient recruitment and enrollment into this trial is ongoing. The majority of the costs of this trial are being funded by grants from foundations and charitable organizations and we have pledged approximately $500,000 to UCLA to partially fund this trial payable over three years. An estimated 50-65% of MS patients are expected to develop disabilities due to cognitive dysfunction and there is currently no approved treatment.
Other Programs:
•
AEN-100 (gastroretentive zinc acetate) is a novel formulation of zinc acetate that may be used for the treatment of ALS, also known as Lou Gehrig's disease. Previous investigator studies have suggested that alterations in the handling and disposition of zinc ions in the brain may be important in the initiation and development of ALS. We are currently collaborating with the investigator and, based on feedback from the United States Food & Drug Administration (FDA), intend to design a clinical development pathway for AEN-100 in the treatment of ALS. There is only one approved therapy for ALS, the efficacy of which is considered to be marginal. Based on an estimated annual price of $10,000 per ALS patient, we estimate that the total market potential in the U.S. is $300 million.
•
Effirma
TM
(flupirtine) is being developed for the treatment of fibromyalgia by Meda AB (Meda), a multi-billion dollar international pharmaceutical company. On May 6, 2010, we entered into a sublicense agreement with Meda covering all of our patents' rights on the use of flupirtine for fibromyalgia in the U.S., Canada and Japan. According to Meda's 2011 Annual Report filed in May 2012, flupirtine for fibromyalgia is currently in Phase II development. The sublicense agreement provides that all ongoing and future development costs are to borne by Meda and we are entitled to receive certain payments if milestones are achieved and royalties on sales. Based on an estimated annual price of $1,200 per fibromyalgia patient, we estimate that the total market potential in the U.S. is $6 billion.
Recent Developments
On November 18, 2011, we entered
into a Channel Agreement with Intrexon (the "Initial Channel Agreement") that governs an "exclusive channel
collaboration" arrangement in which we intend to use Intrexon's technology directed towards the production of
PGIS, through the use of
in vivo
conditionally regulated embedded controllable bioreactors for the treatment of PAH.
The Initial Channel Agreement establishes committees comprised of our and Intrexon representatives that will govern
activities related to the PAH program in the areas of project establishment, chemistry, manufacturing and controls, clinical
and regulatory matters, commercialization efforts and intellectual property. As partial consideration for execution of the
Initial Channel Agreement, we entered into a Stock Purchase Agreement with Intrexon (the Initial Stock Purchase
Agreement") pursuant to which we issued to Intrexon a number of shares of our common stock equal to 9.995% of the
number of shares of our common stock issued and outstanding following and giving effect to such issuance (the "First
Tranche") at a purchase price equal to the $0.001 par value of such shares, which issuance was deemed paid in partial
consideration for the execution and delivery of the Initial Channel Agreement. We also agreed to issue additional shares of
our common stock to Intrexon upon dosing of the first patient in a Phase II clinical trial sponsored by us in the U.S., or
similar study as the parties may agree in a country other than the U.S.
3
On December 21, 2011, we announced that
the Board of Directors had taken several actions to prioritize our focus on our entry into the emerging field of synthetic biology.
In connection with the change in business focus on March 8, 2012, we entered into a Membership Interest Purchase Agreement, and
certain related agreements, pursuant to which we sold all of our interest in the Adeona Clinical Laboratory (the "Lab")
to Hartlab, LLC, an entity controlled by the Lab's former owner, in consideration for (i) the immediate assignment of the
Lab's outstanding accounts receivable up through the date of closing, plus (ii) Seven Hundred Thousand Dollars ($700,000)
payable pursuant to the terms of a two-year non-recourse promissory note secured by all of the assets of the Lab.
On February 15, 2012, upon stockholder
approval, we amended our Articles of Incorporation to change our name to Synthetic Biologics, Inc. Our common stock continues trade
on the NYSE MKT (formerly the NYSE Amex and American Stock Exchange), under the symbol "SYN". Prior to this time and
since October 16, 2008, our name was Adeona Pharmaceuticals, Inc. and we traded on the NYSE MKT stock exchange under the symbol
"AEN". We are incorporated in the State of Nevada. We continue to maintain our principal executive offices in Ann Arbor,
MI, and are currently located at 617 Detroit Street, Suite 100
,
Ann Arbor, MI 48104.
On August 6, 2012, we expanded our relationship
with Intrexon and entered into a Second Channel Agreement with Intrexon (the "Second Channel Agreement") that governs
an "exclusive channel collaboration" arrangement in which we will use Intrexon's technology relating to the identification,
design and production of human antibodies and DNA vectors for the development and commercialization of a series of monoclonal antibody
therapies for the treatment of certain serious infectious diseases (the "Program"). The Second Channel Agreement establishes
committees comprised of our and Intrexon representatives that will govern activities related to the Program in the areas of project
establishment, chemistry, manufacturing and controls, clinical and regulatory matters, commercialization efforts and intellectual
property.
On October 16, 2012, a closing was held
for the transaction contemplated by the Second Channel Agreement. Pursuant to the terms of a Stock Issuance Agreement with Intrexon
(the "Second Stock Purchase Agreement"), we issued 3,552,210 shares of our common stock, $0.001 par value, which issuance
is also deemed paid in partial consideration for the execution and delivery of the Second Channel Agreement, dated August 6, 2012,
between ourselves and Intrexon. We also agreed to register the shares issued to Intrexon in accordance with the First Amendment
to Registration Rights Agreement.
On October 25, 2012, we entered into a
Stock Purchase Agreement (the "Purchase Agreement") with certain accredited investors, which include the Selling Stockholders
(the "Purchasers"), pursuant to which we agreed to sell to the Purchasers in a private placement an aggregate of 6,750,000
shares of our common stock at a price per share of $1.60 (the "Common Shares") for aggregate gross proceeds of $10.8
million and net proceeds of $10.1 million. On October 30, 2012, we completed the October 2012 Private Placement. We intend to use
the net proceeds from the October 2012 Private Placement to develop our monoclonal antibody and synthetic DNA programs through
our exclusive channel collaborations with Intrexon, and for general corporate purposes, including the execution of our business
plan and expansion of our pipeline.
In connection with the October 2012 Private
Placement, we also entered into a registration rights agreement with the Selling Stockholders (the "Registration Rights Agreement").
The Registration Rights Agreement requires that we file a registration statement (the "Initial Registration Statement")
with the Securities and Exchange Commission (the "Commission") within forty-five (45) days of the closing date of the
October 2012 Private Placement (the "Filing Date") for the resale by the Selling Stockholders of all of the Common
Shares owned by the Selling Stockholders and all shares of Common Stock issuable upon any stock split, dividend or other distribution,
recapitalization or similar event with respect thereto (the "Registrable Securities"). The Initial Registration Statement
must be declared effective by the Commission within ninety (90) days of the closing date of the October 2012 Private Placement
(the "Effectiveness Date") subject to certain adjustments. Upon the occurrence of certain events (each an "Event"),
including, but not limited to, that the Initial Registration Statement is not filed prior to the Filing Date, we will be required
to pay to each of the Selling Stockholders liquidated damages of 1.5% of their aggregate purchase price upon the date of the Event
and then monthly thereafter until the Event is cured. In no event will the aggregate amount of liquidated damages payable
to the Selling Stockholders exceed in the aggregate 10% of the aggregate purchase price paid by such Selling Stockholder for the
Registrable Securities.
4
In connection with the October 2012 Private
Placement, we also entered into an agreement with a certain Purchaser that is an affiliate of Intrexon (the "Joinder Agreement")
pursuant to which such Purchaser agreed to be bound by the terms of and join Intrexon as a party to its registration rights agreement
with us entered into in connection with the Second Channel Agreement.
Griffin Securities, Inc. ("Griffin")
served as the placement agent for the October 2012 Private Placement. In consideration for services rendered by Griffin in the
October 2012 Private Placement, we agreed to (i) pay to Griffin cash commissions equal to 6.0% of the gross proceeds received in
the October 2012 Private Placement, (ii) issue to Griffin, or its designee, the Agent Warrants, which are five-year warrants to
purchase 635,855 shares of our common stock with an exercise price of $1.60 per share; and (iii) reimburse Griffin for its reasonable
actual out-of-pocket expenses incurred in connection with the October 2012 Private Placement, including reasonable legal fees and
disbursements. The Agent Warrants also provide for the same registration rights and obligations, and are subject to certain limitations,
as set forth in the Registration Rights Agreement with respect to the Common Shares underlying such warrant.
On November 28, 2012, a closing was
held for the transaction contemplated by the Asset Purchase Agreement (the "Prev Agreement") we entered into with
Prev ABR LLC ("Prev"), pursuant to which we acquired the
C. diff
program assets of Prev, including
pre-Investigational New Drug (IND) package, Phase I and Phase II clinical data, manufacturing process data and all issued and
pending U.S. and international patents.  Pursuant to the Prev Agreement, we paid Prev an initial cash payment of
$100,000 upon execution of the Prev Agreement and at closing paid an additional cash payment of $135,000 and issued 625,000
unregistered shares of our common stock to Prev.  In addition, upon the achievement of the milestones set forth below,
Prev may be entitled to receive additional consideration payable 50% in cash and 50% in our stock, subject to Prev's
option to receive the entire payment in shares of our stock, with the exception of the first milestone payments to be paid in
cash: (i) upon commencement of an IND; (ii) upon commencement of a Phase I clinical trial; (iii) upon commencement of a Phase
II clinical trial; (iv) upon commencement of a Phase III clinical trial; (v) upon Biologic License Application (BLA) filing
in the U.S. and for territories outside of the U.S. (as defined in the Prev Agreement); and (vi) upon BLA approval in the
U.S. and upon approval in territories outside the-U.S.  The future stock issuances are subject to prior approval of the
NYSE MKT, LLC. No royalties are payable to Prev under the Prev Agreement. The Prev Agreement also provides that Prev has a
right to the return to it of all assets acquired by us under the Prev Agreement if on or prior to the date that is (i) thirty
(30) months after the execution of the Prev Agreement, we have not initiated toxicology studies in non-rodent models or (ii)
thirty six (36) months have not filed an IND under the program related to the assets and such failure is not due to action or
inaction of Prev or breach of its representations or warranties or covenants or if there is a change of control as defined in
the Prev Agreement and after such change of control the assets are not further developed; provided however that such thirty
(30) and thirty six (36) month periods can be extended by us for an additional twelve (12) months upon payment of a cash
milestone payment.
To date, we have financed our operations
primarily through public and private sales of our common stock, and we expect to continue to seek to obtain the required capital
in a similar manner. We have incurred an accumulated deficit of $56.9 million through September 30, 2012. We cannot provide any
assurance that we will be able to achieve profitability on a sustained basis, if at all, obtain the required funding, obtain the
required regulatory approvals, or complete additional corporate partnering or acquisition transactions.
The description set forth above of the agreements is intended
to be a summary of the terms of the agreements that are material to a purchaser of our common stock. It does not purport to be
complete and is subject to and qualified in its entirety by reference to the complete text of each agreement filed as exhibits
to our Current Reports on Form 8-K.
Corporate and Other Information
Our predecessor, Sheffield Pharmaceuticals,
Inc. was incorporated in 1986, and in 2006 engaged in a reverse merger with Pipex Therapeutics, Inc., a Delaware corporation formed
in 2001. After the merger, we changed our name to Pipex Pharmaceuticals, Inc., and in October 2008 we changed our name to Adeona
Pharmaceuticals, Inc. On October 15, 2009, we reincorporated in the State of Nevada. After reprioritizing our focus on the emerging
area of synthetic biologics and entering into a collaboration with Intrexon, on February 15, 2012, we amended our Articles of Incorporation
to change our name to Synthetic Biologics, Inc.
Our executive offices are located at 617
Detroit Street, Suite 100, Ann Arbor, Michigan 48104, and our telephone number is (734) 332-7800. Our website address is www.syntheticbiologics.com.
The information on our website is not incorporated by reference into this prospectus, and you should not consider it part of this
prospectus.
For a complete description of our business,
financial condition, results of operations and other important information, we refer you to our filings with the Commission that
are incorporated by reference in this prospectus, including our Annual Report on Form 10-K/A for the year ended December 31, 2011.
For instructions on how to find copies of these documents, see "Where You Can Find Additional Information."
5
THE OFFERING
Issuer
Synthetic Biologics, Inc.
Securities offered
This prospectus covers the sale of up to 4,260,855 shares of common stock, of which 3,625,000 shares of common stock are currently outstanding and 635,855 shares of common stock are issuable upon exercise of Agent Warrants.
Common stock to be  outstanding
44,332,748 shares
Use of Proceeds
We will not receive proceeds from the sale or other disposition of the shares of common stock covered by this prospectus.  We will receive $1,017,368 if the Agent Warrants are exercised in full for cash; however, these warrants contain a cashless exercise feature.  See "Use of Proceeds".
Risk Factors
You should carefully read and consider the information set forth under "Risk Factors," together with all of the other information set forth in this prospectus, before deciding to invest in shares of our common stock.
NYSE MKT symbol
Our common stock is listed on the NYSE MKT, LLC under the symbol "SYN".
The number of shares of common stock outstanding after the offering
is based on 44,332,748 shares outstanding as of December 7, 2012 and excludes:
•
1,632,501 shares of common stock issuable upon the exercise of warrants with a weighted average exercise price of $3.10 per share;
•
4,383,746 shares of common stock issuable upon the exercise of options with a weighted average exercise price of $1.77 per share; and
•
934,821 shares of common stock reserved for
future grants and awards under our equity incentive plans.
6
RISK FACTORS
Investing in our common stock involves
a high degree of risk, and you should be able to bear the complete loss of your investment. You should carefully consider the risks
described below, the other information in this prospectus and the documents incorporated by reference herein when evaluating our
company and our business. If any of the following risks actually occur, our business could be harmed. In such case, the trading
price of our common stock could decline and investors could lose all or a part of the money paid to buy our common stock.
RISKS RELATING TO OUR BUSINESS
We will need to raise additional
capital to operate our business.
With the exception of the three months
ended June 30, 2010, we have experienced significant losses since inception and have a significant accumulated deficit. We expect
to incur additional operating losses in the future and therefore our cumulative losses to increase. To date, other than the licensing
fee we received from Meda AB for the development and commercialization of Effirma (flupirtine) for fibromyalgia in the U.S., Canada
and Japan and limited laboratory revenues from Adeona Clinical Laboratory, which we have recently sold, we have generated very
minimal revenues. Inasmuch as our sole source of revenue (with the exception of the Meda licensing fee) has been our laboratory
revenue and our laboratory was sold recently, we do not expect to derive revenue from any source in the near future until we or
our partners successfully commercialize our products. As of September 30, 2012, our accumulated deficit totaled approximately $56.9
million on a consolidated basis. Until such time as we receive approval from the FDA and other regulatory authorities for our product
candidates, we will not be permitted to sell our products and therefore will not have product revenues from the sale of products.
For the foreseeable future we will have to fund all of our operations and capital expenditures from equity and debt offerings,
cash on hand, licensing fees and grants. If our current cash, cash equivalents and short-term investments are not sufficient to
sustain our operations, we will need to seek additional sources of financing and such additional financing may not be available
on favorable terms, if at all. Our recent loss of S-3 eligibility due to the failure of Berman & Company, P.A. to follow proper
partner rotation procedures may also negatively affect our ability to raise capital. If we do not succeed in raising additional
funds on acceptable terms, we may be unable to complete planned preclinical and clinical trials or obtain approval of our product
candidates from the FDA and other regulatory authorities. In addition, we could be forced to delay, discontinue or curtail product
development, forego sales and marketing efforts, and forego licensing in attractive business opportunities. Any additional sources
of financing will likely involve the issuance of our equity or debt securities, which will have a dilutive effect on our stockholders.
We have not been able to sustain
profitability.
Other than with respect to the three months
ended June 30, 2010, we have a history of losses and we have incurred and continue to incur substantial losses and negative
operating cash flow. Even if we succeed in developing and commercializing one or more of our product candidates, we may still incur
substantial losses for the foreseeable future and may not sustain profitability. We also expect to continue to incur significant
operating and capital expenditures and anticipate that our expenses will substantially increase in the foreseeable future as we
do the following:
●
continue to undertake preclinical development and clinical trials for our product candidates;
●
expand our research activities with Intrexon relating to monoclonal antibodies for infectious diseases;
●
seek regulatory approvals for our product candidates;
●
develop our product candidates for commercialization;
●
implement additional internal systems and infrastructure;
●
lease additional or alternative office facilities; and
●
hire additional personnel, including members of our management team.
We may experience negative cash flow for
the foreseeable future as we fund our technology development with capital expenditures. 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. Our failure to achieve or maintain profitability could negatively impact the value of our common stock and underlying
securities.
7
Our research and development efforts
may not succeed in developing commercially successful products and technologies, which may limit our ability to achieve profitability.
We must continue to explore opportunities
that may lead to new products and technologies. To accomplish this, we must commit substantial efforts, funds, and other resources
to research and development. A high rate of failure is inherent in the research and development of new products and technologies.
Any such expenditures that we make will be made without any assurance that our efforts will be successful. Failure can occur at
any point in the process, including after significant funds have been invested.
Regardless of whether our clinical trials
are deemed to be successful, promising new product candidates may fail to reach the market or may only have limited commercial
success because of efficacy or safety concerns, failure to achieve positive clinical outcomes, inability to obtain necessary regulatory
approvals or satisfy regulatory criteria, limited scope of approved uses, excessive costs to manufacture, the failure to establish
or maintain intellectual property rights, or infringement of the intellectual property rights of others. Even if we successfully
develop new products or enhancements, they may be quickly rendered obsolete by changing customer preferences, changing industry
standards, or competitors' innovations. Innovations may not be quickly accepted in the marketplace because of, among other things,
entrenched patterns of clinical practice or uncertainty over third-party reimbursement. We cannot state with certainty when or
whether any of our products under development will be launched, whether we will be able to develop, license, or otherwise acquire
drug candidates or products, or whether any products will be commercially successful. Failure to launch successful new products
or new indications for existing products may cause our products to become obsolete, which may limit our ability to achieve profitability.
The technology on which our channel
partnering arrangements with Intrexon is based on early stage technology.
We have an exclusive channel collaboration
arrangement with Intrexon that contemplates the use of Intrexon's transgene engineering platform technology and regulatory
control technology for the
in vivo
cellular production of PGIS, a specific effector enzyme that regulates the production
of prostacyclin. Such technologies have a limited history of use in the design and development of human therapeutic product candidates
and may therefore involve unanticipated risks or delays.
On August 8, 2012, we announced an additional
exclusive channel collaboration with Intrexon relating to the design, production, testing and commercialization of monoclonal antibodies
for the treatment of certain infectious diseases. Although monoclonal antibody therapeutics are well established in the biotechnology
and pharmaceutical sectors, their use for the treatment of infectious disease is extremely limited. In order for monoclonal antibodies
to be effective for infectious diseases, they must not only properly target the organism of interest (or its toxins), but may also
need to overcome defenses and forms of resistance of such organisms. To accomplish this may require the use of more than one specific
monoclonal antibody, and mixtures of different monoclonal antibodies, which may create additional unforeseen complications, including
increased manufacturing complexity and expense. In order to be competitive, monoclonal antibodies will be required to be produced
at a low enough cost of goods in order to be profitably marketed. We have very limited development and manufacturing experience
in the field of monoclonal antibodies and infectious disease. We cannot assure that any monoclonal antibody candidates will provide
satisfactory in vitro and in vivo nonclinical results sufficient to warrant the expense of cGMP manufacture and clinical testing
in human clinical trials.
DNA-based therapy has not yet been
proven to be successful.
The FDA has not yet approved any human
DNA-based therapy product for sale. The field of DNA-based therapy, also referred to as gene therapy or gene transfer, is experimental
and has not yet proven successful in many clinical trials. Clinical trials with DNA-based therapy have encountered a multitude
of significant technical problems in the past, including, unintended integration with host DNA, poor levels of protein expression,
transient protein expression, viral overload, immune reactions to either viral capsids utilized to deliver DNA, DNA itself, proteins
expressed or cells transfected with DNA. There can be no assurance that our preclinical animals studies or human clinical trials
will be successful or that we will receive the regulatory approvals necessary to initiate such studies. To the extent that we utilize
viral constructs or other systems to deliver our DNA-based therapies and the same or similar delivery systems demonstrate unanticipated
and/or unacceptable side effects in preclinical or clinical trials conducted by ourselves or others we may be forced to, or elect
to, discontinue development of such product candidates.
We may not generate additional revenue
from our relationships with our corporate collaborators.
On May 6, 2010, we entered into a sublicense
agreement with Meda AB whereby we may receive milestone payments totaling $17.5 million (including an upfront payment of $2.5 million
that has already been received), plus royalties on our flupirtine program. There can be no assurance that Meda AB will successfully
develop flupirtine for fibromyalgia in the U.S., Canada or Japan that would allow us to receive such additional $15 million in
milestone payments and royalties on sales in connection with such agreement. The successful achievement of the various milestones
set forth in the sublicense agreement is not within our control and we will be dependent upon Meda AB for achievement of such milestones.
According to Meda's 2011 Annual Report filed in May 2012, flupirtine for fibromyalgia is in Phase II development.
8
We have experienced several management
changes.
We have had significant changes in management
in the past few years. Jeffrey Riley was appointed Chief Executive Officer and President on February 3, 2012. Effective February
6, 2012, C. Evan Ballantyne was appointed Chief Financial Officer. James S. Kuo, M.D., served as Chief Executive Officer and President
from February 6, 2010 until February 3, 2012. Changes in our key positions, as well as additions of new personnel and departures
of existing personnel, can be disruptive, might lead to additional departures of existing personnel and could have a material adverse
effect on our business, operating results, financial results and internal controls over financial reporting.
We may not be able to retain rights
licensed to us by others to commercialize key products and may not be able to establish or maintain the relationships we need to
develop, manufacture, and market our products.
In addition to our own patent applications,
we also currently rely on licensing agreements with third party patent holders/licensors for our products. We have an exclusive
license agreement with the McLean Hospital relating to the use of flupirtine to treat fibromyalgia which was sublicensed to Meda
AB and an exclusive license agreement with the Regents of the University of California relating to our Trimesta technology. Each
of these agreements requires us or our sublicensee to use our best efforts to commercialize each of the technologies as well as
meet certain diligence requirements and timelines in order to keep the license agreement in effect. In the event we or our sublicensee
are not able to meet our diligence requirements, we may not be able to retain the rights granted under our agreements or renegotiate
our arrangement with these institutions on reasonable terms, or at all. Furthermore, we currently have very limited product development
capabilities, and limited marketing or sales capabilities. For us to research, develop, and test our product candidates, we would
need to contract with outside researchers, in most cases those parties that did the original research and from whom we have licensed
the technologies. Our exclusive channel collaboration agreements with Intrexon provide that Intrexon may terminate such agreement
if we do not perform certain specified requirements, including developing therapies considered superior.
We can give no assurances that any of our
issued patents licensed to us or any of our other patent applications will provide us with significant proprietary protection or
be of commercial benefit to us. Furthermore, the issuance of a patent is not conclusive as to its validity or enforceability, nor
does the issuance of a patent provide the patent holder with freedom to operate without infringing the patent rights of others.
We will incur additional expenses
in connection with our exclusive channel collaboration arrangements with Intrexon.
Pursuant to our exclusive channel collaborations
with Intrexon, we are responsible for future research and development expenses of product candidates developed under each such
collaboration, the effect of which has and will continue to increase the level of our overall research and development expenses
going forward. Although all manufacturing, preclinical studies and human clinical trials are expensive and difficult to design
and implement, costs associated with the manufacturing, research and development of biologic product candidates are generally greater
in comparison to small molecule product candidates. We have added additional personnel and expect to add additional personnel to
support our exclusive channel collaborations with Intrexon.
Because our collaborations with Intrexon
are relatively new, we have only recently assumed development responsibility and costs associated with such programs. In addition,
because development activities are determined pursuant to a joint steering committees comprised of Intrexon and ourselves and we
have limited experience, future development costs associated this program may be difficult to anticipate and exceed our expectations.
Our actual cash requirements may vary materially from our current expectations for a number of other factors that may include,
but are not limited to, unanticipated technical challenges, changes in the focus and direction of our development activities or
adjustments necessitated by changes in the competitive landscape in which we operate. If we are unable to continue to financially
support such collaborations due to our own working capital constraints, we may be forced to delay our activities. If we are unable
to obtain additional financing on terms acceptable to us or at all, we may be forced to seek licensing partners or discontinue
development.
Developments by competitors may render
our products or technologies obsolete or non-competitive.
Companies that currently sell or are developing
both generic and proprietary products to treat serious diseases include: Actelion Pharmaceuticals, Bayer Health Care, Biogen Idec,
Eli Lilly & Co., Genzyme, GlaxoSmithKline Pharmaceuticals, Merck & Co., Pfizer, Novartis, Teva Pharmaceuticals and United
Therapeutics. Companies that currently sell or are developing both generic and proprietary products to treat infectious diseases
include: MedImmune, Pfizer, Cubist, Optimer Pharmaceuticals, Symphogen, Merus, GlaxoSmithKline Pharmaceuticals, Merck & Co.
and Novartis. Many of our competitors have significant financial and human resources. The pulmonary arterial hypertension market
is highly competitive and several different product classes currently compete in this space, including prostacyclin-based therapies,
endothelin receptor antagonists and phosphodiesterase type 5 inhibitors. Prostacyclin-based therapies for PAH are available in
a number of delivery formats, including intravenous, subcutaneous and inhaled routes and an oral prostacyclin-based product candidate
is currently under NDA review in the U.S. The infectious disease market is highly competitive with many generic and proprietary
intravenous and oral formulations available to physicians and their patients. As monoclonal antibodies, we currently do not expect
to be able to deliver our infectious disease candidates via the oral route and may thus be limited to the in-patient and/or acute
treatment setting. In addition, academic research centers may develop technologies that compete with our Trimesta, sustained-release
zinc preparation - AEN-100, and flupirtine technologies. Should clinicians or regulatory authorities view these therapeutic regiments
as more effective than our products, this might delay or prevent us from obtaining regulatory approval for our products, or it
might prevent us from obtaining favorable reimbursement rates from payers, such as Medicare, Medicaid and private insurers.
9
We operate in a highly competitive
environment
.
The pharmaceutical and biotechnology industries,
including the monoclonal antibody industry, are characterized by rapidly evolving technology and intense competition. Our competitors
include major multi-national pharmaceutical companies and biotechnology companies developing both generic and proprietary therapies
to treat serious diseases. Many of these companies are well-established and possess technical, human, research and development,
financial, and sales and marketing resources significantly greater than ours. In addition, many of our potential competitors have
formed strategic collaborations, partnerships and other types of joint ventures with larger, well established industry competitors
that afford these companies potential research and development and commercialization advantages in the therapeutic areas we are
currently pursuing.
Academic research centers, governmental
agencies and other public and private research organizations are also conducting and financing research activities which may produce
products directly competitive to those being developed by us. In addition, many of these competitors may be able to obtain patent
protection, obtain FDA and other regulatory approvals and begin commercial sales of their products before us.
Competitors could develop and/or
gain FDA approval of our products for a different indication.
Since we do not have composition of matter
patent claims for flupirtine, estriol or zinc acetate, others may obtain approvals for other uses of these products that are not
covered by our issued or pending patents. For example, the active ingredients in both Effirma (flurpirtine) and Trimesta (oral
estriol) have been approved for marketing in overseas countries for different uses and an oral immediate release form of zinc is
approved in the U.S. and Europe for the treatment of Wilson's disease. Other companies, including the original developers
or licensees or affiliates may seek to develop Effirma or Trimesta or their respective active ingredient(s) for other uses in the
U.S. or any country we are seeking approval for. We cannot provide any assurances that any other company may obtain FDA approval
for products that contain flupirtine, estriol or zinc in various formulations or delivery systems that might adversely affect our
ability or the ability of Meda to develop and market these products in the U.S. We are aware that other companies have intellectual
property protection using the active ingredients and have conducted clinical trials of flupirtine, estriol and zinc for different
applications than what we are developing. Many of these companies may have more resources than us. We cannot provide any assurances
that our products will be FDA-approved prior to our competitors.
If a product containing our active ingredients
is already marketed or if the FDA approves other products containing our active ingredients in the future to treat indications,
physicians may elect to prescribe and substitute a competitor's products to treat the diseases for which we are intending
to commercialize; this is commonly referred to as "off-label" use. While under FDA regulations a competitor is not
allowed to promote off-label uses of its product, the FDA does not regulate the practice of medicine and, as a result, cannot direct
physicians to select certain products for their patients. Consequently, we might be limited in our ability to prevent off-label
use of a competitor's product to treat the diseases we are intending to commercialize, even if we have issued method of use
patents for that indication. If we are not able to obtain and enforce our patents, if any, or otherwise receive orphan drug protection
in the case of ALS, a competitor could develop and commercialize similar products for the same indications that we are pursuing.
We cannot provide any assurances that a competitor will not obtain FDA approval for a product that contains the same active ingredients
as our products.
We rely on method patents and patent
applications and various regulatory exclusivities to protect some of our product candidates and our ability to compete may be limited
or eliminated if we are not able to protect our products.
Our competitiveness may be adversely affected
if we are unable to protect our proprietary technologies. We do not have composition of matter patents for Trimesta or Effirma,
or their respective active ingredients estriol and flupirtine. We rely on issued patent and pending patent applications for use
of Trimesta to treat MS (issued U.S. Patent No. 6,936,599) and various other therapeutic indications, which have been exclusively
licensed to us. We have exclusively licensed an issued patent for the treatment of fibromyalgia with flupirtine, which we have
sublicensed to Meda AB.
Our AEN-100 drug candidate (gastroretentive
zinc acetate) is the subject of U.S. and international pending patent applications, such as published U.S. patent application Ser.
No. 11/621,962 and corresponding international applications that claim priority to January 10, 2006 as well as additional patent
applications. On October 26, 2011, we received a final rejection letter with regard to U.S. patent application Ser. No. 11/621,962.
On February 15, 2012, we filed a Request for Continued Examination.
10
The patent positions of pharmaceutical
companies are uncertain and may involve complex legal and factual questions. We may incur significant expense in protecting our
intellectual property and defending or assessing claims with respect to intellectual property owned by others. Any patent or other
infringement litigation by or against us could cause us to incur significant expense and divert the attention of our management.
Others may file patent applications or
obtain patents on similar technologies or compounds that compete with our products. We cannot predict how broad the claims in any
such patents or applications will be, and whether they will be allowed. Once claims have been issued, we cannot predict how they
will be construed or enforced. We may infringe intellectual property rights of others without being aware of it. If another party
claims we are infringing their technology, we could have to defend an expensive and time consuming lawsuit, pay a large sum if
we are found to be infringing, or be prohibited from selling or licensing our products unless we obtain a license or redesign our
product, which may not be possible.
We also rely on trade secrets and proprietary
know-how to develop and maintain our competitive position. Some of our current or former employees, consultants, scientific advisors,
current or prospective corporate collaborators, may unintentionally or willfully disclose our confidential information to competitors
or use our proprietary technology for their own benefit. Furthermore, enforcing a claim alleging the infringement of our trade
secrets would be expensive and difficult to prove, making the outcome uncertain. Our competitors may also independently develop
similar knowledge, methods, and know-how or gain access to our proprietary information through some other means.
We may fail to retain or recruit
necessary personnel, and we may be unable to secure the services of consultants.
As of November 30, 2012, we had twelve
employees. We have also engaged clinical consultants to advise us on our clinical programs and regulatory consultants to advise
us on our dealings with the FDA and other foreign regulatory authorities. We have been and will be required to retain additional
consultants and employees in order to fulfill our obligations under our exclusive channel collaborations with Intrexon. Our future
performance will depend in part on our ability to successfully integrate newly hired officers into our management team and our
ability to develop an effective working relationship among senior management.
Certain of our directors, scientific
advisors, and consultants serve as officers, directors, scientific advisors, or consultants of other biopharmaceutical or biotechnology
companies that might be developing competitive products to ours. Other than corporate opportunities, none of our directors are
obligated under any agreement or understanding with us to make any additional products or technologies available to us. Similarly,
we can give no assurances, and we do not expect and stockholders should not expect, that any biomedical or pharmaceutical product
or technology identified by any of our directors or affiliates in the future would be made available to us other than corporate
opportunities. We can give no assurances that any such other companies will not have interests that are in conflict with our interests.
Losing key personnel or failing to recruit
necessary additional personnel would impede our ability to attain our development objectives. There is intense competition for
qualified personnel in the drug-development field, and we may not be able to attract and retain the qualified personnel we would
need to develop our business.
We rely on independent organizations, advisors,
and consultants to perform certain services for us, including handling substantially all aspects of regulatory approval, clinical
management, manufacturing, marketing, and sales. We expect that this will continue to be the case. Such services may not always
be available to us on a timely basis when we need them.
If the parties we depend on for supplying
our drug substance raw materials and certain manufacturing-related services do not timely supply these products and services, it
may delay or impair our ability to develop, manufacture and market our products.
We rely on suppliers for our drug substance
raw materials and third parties for certain manufacturing-related services to produce material that meets appropriate content,
quality and stability standards and use in clinical trials of our products and, after approval, for commercial distribution. We
have not yet established a cGMP manufacturer for neither our DNA-based nor monoclonal antibody therapies. Our AEN-100 product candidate
has limited stability data to date and is the subject of ongoing stability studies. To succeed, clinical trials require adequate
supplies of drug substance and drug product, which may be difficult or uneconomical to procure or manufacture. We and our suppliers
and vendors may not be able to (i) produce our drug substance or drug product to appropriate standards for use in clinical studies,
(ii) perform under any definitive manufacturing, supply or service agreements with us, or (iii) remain in business for a sufficient
time to successfully produce and market our product candidates. If we do not maintain important manufacturing and service relationships,
we may fail to find a replacement supplier or required vendor or develop our own manufacturing capabilities which could delay or
impair our ability to obtain regulatory approval for our products and substantially increase our costs or deplete profit margins,
if any. If we do find replacement manufacturers and vendors, we may not be able to enter into agreements with them on terms and
conditions favorable to us and, there could be a substantial delay before a new facility could be qualified and registered with
the FDA and foreign regulatory authorities.
11
If successful large-scale manufacturing
of DNA-based products is not possible, we or our collaborators may be unable to manufacture enough of our product candidates to
achieve regulatory approval or market our DNA-based products.
Few companies to date have demonstrated
successful large-scale manufacturing of DNA-based products, including those that have had significantly more resources than us
and it is anticipated that significant challenges will be faced in the scale-up of our manufacturing process for commercial production.
There are a limited number of contract manufacturers qualified to perform large-scale manufacturing of DNA-based products. We or
our collaborators may be unable to manufacture commercial-scale quantities of DNA-based products or receive appropriate government
approvals on a timely basis or at all. Failure to successfully manufacture or obtain appropriate government approvals on a timely
basis or at all would prevent us from achieving our business objectives.
Clinical trials are very expensive,
time-consuming, and difficult to design and implement.
Human clinical trials are very expensive
and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The clinical trial
process is also time-consuming. We estimate that clinical trials of our product candidates would take at least several years to
complete. Furthermore, failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon or
repeat clinical trials. Commencement and completion of clinical trials may be delayed by several factors, including:
●
obtaining an IND application with the FDA to commence clinical trials;
●
identification of, and acceptable arrangements with, one or more clinical sites;
●
obtaining IRB approval to commence clinical trials;
●
unforeseen safety issues;
●
determination of dosing;
●
lack of effectiveness during clinical trials;
●
slower than expected rates of patient recruitment;
●
inability to monitor patients adequately during or after treatment;
●
inability or unwillingness of medical investigators to follow our clinical protocols; and
●
unwillingness of the FDA or IRBs to permit the clinical trials to be initiated.
In addition, we, IRBs or the FDA may suspend our clinical trials
at any time if it appears that we are exposing participants to unacceptable health risks or if IRBs or the FDA finds deficiencies
in our submissions or conduct of our trials.
The results of our clinical trials
may not support our product candidate claims and the results of preclinical studies and completed clinical trials are not necessarily
predictive of future results.
To date, long-term safety and efficacy
have not yet been demonstrated in clinical trials for any of our diagnostic product candidates. Favorable results in our early
studies or trials may not be repeated in later studies or trials. Even if our clinical trials are initiated and completed as planned,
we cannot be certain that the results will support our product candidate claims. Success in preclinical testing and Phase II clinical
trials does not ensure that later Phase II or Phase III clinical trials will be successful. We cannot be sure that the results
of later clinical trials would replicate the results of prior clinical trials and preclinical testing. In particular, the limited
results that we have obtained for our diagnostic tests may not predict results from studies in larger numbers of subjects drawn
from more diverse populations over a longer period of time. Clinical trials may fail to demonstrate that our product candidates
are safe for humans and effective for indicated uses. Any such failure could cause us or our sublicensee to abandon a product candidate
and might delay development of other product candidates. Preclinical and clinical results are frequently susceptible to varying
interpretations that may delay, limit or prevent regulatory approvals or commercialization. Any delay in, or termination of, our
clinical trials would delay our obtaining FDA approval for the affected product candidate and, ultimately, our ability to commercialize
that product candidate.
We depend on third parties, including
researchers and sublicensees, who are not under our control.
Since we have in-licensed some of our product
candidates, have sublicensed a product candidate and have collaboration agreements for the development of other product candidates,
we depend upon our sublicensee and independent investigators and scientific collaborators, such as universities and medical institutions
or private physician scientists, to conduct our preclinical and clinical trials under agreements with us. These collaborators are
not our employees and we cannot control the amount or timing of resources that they devote to our programs or the timing of their
procurement of clinical-trial data or their compliance with applicable regulatory guidelines. Should any of these scientific inventors/advisors
or those of our sublicensee become disabled or die unexpectedly, or should they fail to comply with applicable regulatory guidelines,
we or our sublicensee may be forced to scale back or terminate development of that program. They may not assign as great a priority
to our programs or pursue them as diligently as we would if we were undertaking those programs ourselves. Failing to devote sufficient
time and resources to our drug-development programs, or substandard performance and failure to comply with regulatory guidelines,
could result in delay of any FDA applications and our commercialization of the drug candidate involved.
12
These collaborators may also have relationships
with other commercial entities, some of which may compete with us. Our collaborators assisting our competitors at our expense could
harm our competitive position. For example, we are highly dependent on scientific collaborators for our Trimesta development program.
Specifically, all of the clinical trials have been conducted under physician-sponsored IND applications, not corporate-sponsored
INDs. Generally, we have experienced difficulty in collecting data generated from these physician-sponsored clinical trials for
our programs. We cannot provide any assurances that we will not experience any additional delays in the future.
We are also highly dependent on government
and private grants to fund certain of our clinical trials for our product candidates. For example, Trimesta (oral estriol) has
received grants totaling over $8 million, predominantly from the Southern California Chapter of the NMSS and the National
Institutes of Health which funds a majority of the ongoing clinical trial in relapsing-remitting MS for women. Although we believe
that the grant funding received to date is sufficient to complete the current clinical trial based upon current cost estimates,
if we experience any additional unanticipated costs or require further clinical trials, and our scientific collaborator is unable
to maintain or receive additional grants, we might be forced to scale back or terminate the development of this product candidate.
We will also need to cross reference our IND with the inventor/IND holder for this program should we elect to file our own corporate
IND for our Trimesta (oral estriol) program. The on-going and future development and commercialization of Effirma (flupirtine)
for fibromyalgia is the responsibility of Meda AB and no assurance can be given that Meda will gain the FDA's acceptance
of the NDA or obtain NDA approval from the FDA of flupirtine for fibromyalgia.
Our AEN-100 program for ALS is reliant
on the investigator-initiated IND of PNA. The planned clinical trial that we intend to conduct with PNA is still the subject of
further protocol development. In addition, we may need to conduct additional clinical or non-clinical studies to support a New
Drug Application or to support further clinical trials. Any additional studies of AEN-100 may produce unanticipated and unacceptable
safety, tolerability or bioavailability results that may substantially delay further development work of the planned clinical trial.
With respect to our synthetic biologic
product candidates, we are dependent upon Intrexon's synthetic biology facilities and capabilities as we have no such facilities
and capabilities of our own. We are also reliant on their vector engineering platform, gene expression switch technology, monoclonal
antibody discovery, production cell line development and know-how. If any of the foregoing were to become inaccessible or terminated,
it would be difficult for us to develop and commercialize our synthetic biologic product candidates.
We may incur substantial costs as
a result of litigation or other proceedings relating to patent and other intellectual property rights, as well as costs associated
with lawsuits.
If any other person files patent applications,
or is issued patents, claiming technology also claimed by us in pending applications, we may be required to participate in interference
proceedings in the U.S. Patent and Trademark Office to determine priority of invention. We, or our licensors, may also need to
participate in interference proceedings involving our issued patents and pending applications of another entity.
The intellectual property environment in
the area of DNA-based therapeutics is particularly complex, constantly evolving and highly fragmented. Other companies and institutions
have issued patents and have filed or will file patent applications that may issue into patents that cover or attempt to cover
genes, vectors, cell lines, and methods of making and using DNA and DNA-based therapy products used in, or similar to our product
candidate, and technologies. The same is true of the monoclonal antibody field in terms of methods of producing monoclonal antibodies
for human use. We have not conducted freedom-to-use patent searches on all aspects of our product candidates or potential product
candidates, and we may be unaware of relevant patents and patent applications of third parties. In addition, the freedom-to-use
patent searches that have been conducted may not have identified all relevant issued patents or pending patents. We cannot provide
assurance that our proposed products in this area will not ultimately be held to infringe one or more valid claims owned by third
parties which may exist or come to exist in the future or that in such case we will be able to obtain a license from such parties
on acceptable terms.
We cannot guarantee that the practice of
our technologies will not conflict with the rights of others. In some foreign jurisdictions, we could become involved in opposition
proceedings, either by opposing the validity of another's foreign patent or by persons opposing the validity of our foreign
patents.
We may also face frivolous litigation or
lawsuits from various competitors or from litigious securities attorneys. The cost to us of any litigation or other proceeding
relating to these areas, even if deemed frivolous or resolved in our favor, could be substantial and could distract management
from our business. Uncertainties resulting from initiation and continuation of any litigation could have a material adverse effect
on our ability to continue our operations.
If we infringe the rights of others
we could be prevented from selling products or forced to pay damages.
If our products, methods, processes, and
other technologies are found to infringe the proprietary rights of other parties, we could be required to pay damages, or we may
be required to cease using the technology or to license rights from the prevailing party. Any prevailing party may be unwilling
to offer us a license on commercially acceptable terms.
13
RISKS RELATING TO OUR STOCK
We will seek to raise additional
funds in the future, which may be dilutive to stockholders or impose operational restrictions.
We expect to seek to raise additional capital
in the future to help fund development of our proposed products. If we raise additional capital through the issuance of equity
or of debt securities, the percentage ownership of our current stockholders will be reduced. We may also enter into strategic transactions,
issue equity as part of license issue fees to our licensors, compensate consultants or settle outstanding payables using equity
that may be dilutive. Our stockholders may experience additional dilution in net book value per share and any additional equity
securities may have rights, preferences and privileges senior to those of the holders of our common stock.
We are substantially controlled by
our current officers, directors, and principal stockholders.
Currently, our directors, executive officers,
and principal stockholders beneficially own a substantial number of shares of our common stock. As a result, they will be able
to exert substantial influence over the election of our Board of Directors and the vote on issues submitted to our stockholders.
Our executive officers and directors beneficially owned approximately 8.7 million shares of our common stock, including stock options
and warrants exercisable within 60 days of December 1, 2012. Our executive officers, directors and principal stockholders together
beneficially owned approximately 18.5 million shares of our common stock, including the stock options and warrants exercisable
within 60 days of December 1, 2012. Because our common stock has from time to time been "thinly traded", the sale of
a substantial number of shares by our executive officers, directors and principal stockholders would have an adverse effect on
the market for our stock and our share price.
Our shares of common stock are from
time to time thinly traded, so stockholders may be unable to sell at or near ask prices or at all if they need to sell shares to
raise money or otherwise desire to liquidate their shares.
Our common stock has from time to time
been "thinly-traded," meaning that the number of persons interested in purchasing our common stock at or near ask prices
at any given time may be relatively small or non-existent. This situation is attributable to a number of factors, including the
fact that we are a small company that is relatively unknown to stock analysts, stock brokers, institutional investors and others
in the investment community that generate or influence sales volume, and that even if we came to the attention of such persons,
they tend to be risk-averse and would be reluctant to follow an unproven company such as ours or purchase or recommend the purchase
of our shares until such time as we became more seasoned and viable. As a consequence, there may be periods of several days or
more when trading activity in our shares is minimal or non-existent, as compared to a seasoned issuer which has a large and steady
volume of trading activity that will generally support continuous sales without an adverse effect on share price. We cannot give
stockholders any assurance that a broader or more active public trading market for our common shares will develop or be sustained,
or that current trading levels will be sustained.
We cannot assure you that the common stock will be liquid
or that it will remain listed on the NYSE MKT.
We cannot assure you that we will be able
to maintain the continued listing standards of the NYSE MKT (formerly the NYSE Amex and the American Stock Exchange). The NYSE
MKT requires companies to meet certain continued listing criteria including certain minimum stockholders' equity and equity
prices per share as outlined in the NYSE MKT Exchange Company Guide. We may not be able to maintain such minimum stockholders'
equity or prices per share or may be required to effect a reverse stock split to maintain such minimum prices and/or issue additional
equity securities in exchange for cash or other assets, if available, to maintain certain minimum stockholders' equity required
by the NYSE MKT. If we are delisted from the NYSE MKT then our common stock will trade, if at all, only on the over-the-counter
market, such as the OTC Bulletin Board securities market, and then only if one or more registered broker-dealer market makers comply
with quotation requirements. In addition, delisting of our common stock could depress our stock price, substantially limit liquidity
of our common stock and materially adversely affect our ability to raise capital on terms acceptable to us, or at all. Delisting
from the NYSE MKT could also have other negative results, including the potential loss of confidence by suppliers and employees,
the loss of institutional investor interest and fewer business development opportunities. In order to remain listed on NYSE MKT,
we are required to maintain a minimum stockholders' equity of $6 million. The net proceeds of $10.1 million from our recent
financing increased our stockholders' equity well above the minimum requirement of $6 million. However, we could be subject
to certain additional regulatory requirements or additional inquiries from the NYSE MKT, because our stockholders' equity
at September 30, 2012 was $5.4 million.
There may be issuances of shares
of preferred stock in the future.
Although we currently do not have preferred
shares outstanding, the Board of Directors could authorize the issuance of a series of preferred stock that would grant holders
preferred rights to our assets upon liquidation, the right to receive dividends before dividends would be declared to common stockholders,
and the right to the redemption of such shares, possibly together with a premium, prior to the redemption of the common stock.
To the extent that we do issue preferred stock, the rights of holders of common stock could be impaired thereby, including without
limitation, with respect to liquidation.
14
Our failure to fulfill all of our registration requirements
may cause us to suffer liquidated damages, which may be very costly.
The Registration Rights Agreement that
we entered into in connection with the October 2012 Private Placement requires that we file the Initial Registration Statement
with the Commission on or prior to the Filing Date and that the Initial Registration Statement is declared effective by the Commission
on or prior to the Effectiveness Date subject to certain adjustments. Upon the occurrence of an Event, including, but not limited
to, that the Initial Registration Statement is not filed prior to the Filing Date or declared effective prior to the Effectiveness
Date, the Company will be required to pay to each of the Purchasers liquidated damages of 1.5% of their aggregate purchase price
upon the date of the Event and then monthly thereafter until the Event is cured. In no event will the aggregate amount of liquidated
damages payable to each of the Purchasers exceed in the aggregate 10% of the aggregate purchase price paid by such Purchaser. In
addition, pursuant to the terms of the registration rights agreement that we entered into with Intrexon and an affiliated entity,
we are required to file a registration statement with respect to securities issued to them within a certain time period and maintain
the effectiveness of such registration statement. The failure to do so could result in the payment of damages by us. There can
be no assurance as to when the Initial Registration Statement will be declared effective or that we will be able to maintain the
effectiveness of any registration statement, and therefore there can be no assurance that we will not incur penalties or damages
with respect to such agreements.
RISKS RELATED TO OUR INDUSTRY
We are subject to government regulation,
compliance with which can be costly and difficult.
In the U.S., the formulation, manufacturing,
packaging, storing, labeling, promotion, advertising, distribution and sale of our products are subject to regulation by various
governmental agencies, including (1) the FDA, (2) the Federal Trade Commission, or FTC, (3) the Consumer Product Safety Commission,
or CPSC, (4) the U.S. Department of Agriculture, or USDA. Our proposed activities may also be regulated by various agencies of
the states, localities and foreign countries in which our proposed products may be manufactured, distributed and sold. The FDA,
in particular, regulates the formulation, manufacture and labeling of over-the-counter, or OTC drugs, prescription drugs, conventional
foods, dietary supplements, and cosmetics such as those that we intend to distribute. FDA regulations require us and our suppliers
to meet relevant cGMP regulations for the preparation, packing, labeling, and storage of all drugs and foods.
Any products manufactured or distributed
by us pursuant to FDA approvals are subject to pervasive and continuing FDA regulation, including record-keeping requirements,
reporting of adverse experiences, submitting periodic reports, drug sampling and distribution requirements, manufacturing or labeling
changes, record-keeping requirements, and compliance with FDA promotion and advertising requirements. Drug manufacturers and their
subcontractors are required to register their facilities with the FDA and state agencies, and are subject to periodic unannounced
inspections for GMP compliance, imposing procedural and documentation requirements upon us and third-party manufacturers. Failure
to comply with these regulations could result, among other things, in suspension of regulatory approval, recalls, suspension of
production or injunctions, seizures, or civil or criminal sanctions. We cannot be certain that we or our present or future subcontractors
will be able to comply with these regulations.
The FDA regulates prescription drug labeling
and promotion activities. The FDA actively enforces regulations prohibiting the marketing of products for unapproved uses. The
FDA permits the promotion of drugs for unapproved uses in certain circumstances, subject to stringent requirements. We and our
product candidates are subject to a variety of state laws and regulations which may hinder our ability to market our products.
Whether or not FDA approval has been obtained, approval by foreign regulatory authorities must be obtained prior to commencing
clinical trials, and sales and marketing efforts in those countries. These approval procedures vary in complexity from country
to country, and the processes may be longer or shorter than that required for FDA approval. We may incur significant costs to comply
with these laws and regulations now or in the future.
We intend to develop our zinc candidate,
AEN-100, as a drug and intend to file an IND with the FDA in order to conduct necessary clinical trials to support new medical
claims and ultimately file one or more NDA with respect to such products which would subject us to time, expense and uncertainty
associated with achieving approval of such NDA by the FDA.
The FDA, comparable foreign regulators
and state and local pharmacy regulators impose substantial requirements upon clinical development, manufacture and marketing of
pharmaceutical products. These and other entities regulate research and development and the testing, manufacture, quality control,
safety, effectiveness, labeling, storage, record keeping, approval, advertising, and promotion of our products. The drug approval
process required by the FDA under the Food, Drug, and Cosmetic Act generally involves:
●
preclinical laboratory and animal tests;
●
submission of an IND, prior to commencing human clinical trials;
●
adequate and well-controlled human clinical trials to establish safety and efficacy for intended use;
●
submission to the FDA of an NDA or Biologics License Application (BLA); and
●
FDA review and approval of an NDA or BLA.
15
The testing and approval process requires
substantial time, effort, and financial resources, and we cannot be certain that any approval will be granted on a timely basis,
if at all.
Preclinical tests include laboratory evaluation
of the product candidate, its chemistry, formulation and stability, and animal studies to assess potential safety and efficacy.
Certain preclinical tests must be conducted in compliance with good laboratory practice regulations. Violations of these regulations
can, in some cases, lead to invalidation of the studies, requiring them to be replicated. In some cases, long-term preclinical
studies are conducted concurrently with clinical studies.
We will submit the preclinical test results,
together with manufacturing information and analytical data, to the FDA as part of an IND, which must become effective before we
begin human clinical trials. The IND automatically becomes effective 30 days after filing, unless the FDA raises questions about
conduct of the trials outlined in the IND and imposes a clinical hold, in which case, the IND sponsor and FDA must resolve the
matters before clinical trials can begin. It is possible that our submission may not result in FDA authorization to commence clinical
trials.
Clinical trials must be supervised by a
qualified investigator in accordance with good clinical practice (GCP) regulations, which include informed consent requirements.
An independent IRB at each medical center reviews and approves and monitors the study, and is periodically informed of the study's
progress, adverse events and changes in research. Progress reports are submitted annually to the FDA and more frequently if adverse
events occur.
Human clinical trials of drug candidates
typically have three sequential phases that may overlap:
Phase I: The drug is initially tested
in healthy human subjects or patients for safety, dosage tolerance, absorption, metabolism, distribution, and excretion.
Phase II: The drug is studied in a
limited patient population to identify possible adverse effects and safety risks, determine efficacy for specific diseases and
establish dosage tolerance and optimal dosage.
Phase III: When Phase II evaluations
demonstrate that a dosage range is effective with an acceptable safety profile, Phase III trials to further evaluate dosage,
clinical efficacy and safety, are undertaken in an expanded patient population, often at geographically dispersed sites.
We cannot be certain that we will successfully
complete Phase I, Phase II, or Phase III testing of our product candidates within any specific time period, if at all. Furthermore,
the FDA, an IRB or the IND sponsor may suspend clinical trials at any time on various grounds, including a finding that subjects
or patients are exposed to unacceptable health risk. Concurrent with these trials and studies, we also develop chemistry and physical
characteristics data and finalize a manufacturing process in accordance with good manufacturing practice (GMP) requirements. The
manufacturing process must conform to consistency and quality standards, and we must develop methods for testing the quality, purity,
and potency of the final products. Appropriate packaging is selected and tested, and chemistry stability studies are conducted
to demonstrate that the product does not undergo unacceptable deterioration over its shelf-life. Results of the foregoing are submitted
to the FDA as part of a NDA (or BLA in case of biologic products) for marketing and commercial shipment approval. The FDA reviews
each NDA or BLA submitted and may request additional information.
Once the FDA accepts the NDA or BLA for
filing, it begins its in-depth review. The FDA has substantial discretion in the approval process and may disagree with our interpretation
of the data submitted. The process may be significantly extended by requests for additional information or clarification regarding
information already provided. As part of this review, the FDA may refer the application to an appropriate advisory committee, typically
a panel of clinicians. Manufacturing establishments often are inspected prior to NDA or BLA approval to assure compliance with
GMPs and with manufacturing commitments made in the application.
Submission of an NDA or BLA with clinical
data requires payment of a fee. In return, the FDA assigns a goal of ten months for issuing its "complete response,"
in which the FDA may approve or deny the NDA or BLA, or require additional clinical data. Even if these data are submitted, the
FDA may ultimately decide the NDA or BLA does not satisfy approval criteria. If the FDA approves the NDA or BLA, the product becomes
available for physicians prescription. Product approval may be withdrawn if regulatory compliance is not maintained or safety problems
occur. The FDA may require post-marketing studies, also known as phase IV studies, as a condition of approval, and requires surveillance
programs to monitor approved products that have been commercialized. The agency has the power to require changes in labeling or
prohibit further marketing based on the results of post-marketing surveillance.
16
Satisfaction of these and other regulatory
requirements typically takes several years, and the actual time required may vary substantially based upon the type, complexity
and novelty of the product. Government regulation may delay or prevent marketing of potential products for a considerable period
of time and impose costly procedures on our activities. We cannot be certain that the FDA or other regulatory agencies will approve
any of our products on a timely basis, if at all. Success in preclinical or early-stage clinical trials does not assure success
in later-stage clinical trials. Data obtained from preclinical and clinical activities are not always conclusive and may be susceptible
to varying interpretations that could delay, limit or prevent regulatory approval. Even if a product receives regulatory approval,
the approval may be significantly limited to specific indications or uses.
Even after regulatory approval is obtained,
later discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal
of the product from the market. Delays in obtaining, or failures to obtain regulatory approvals would have a material adverse effect
on our business.
The FDA's policies may change, and
additional government regulations may be enacted which could prevent or delay regulatory approval of our potential products. Increased
attention to the containment of health care costs worldwide could result in new government regulations materially adverse to our
business. We cannot predict the likelihood, nature or extent of adverse governmental regulation that might arise from future legislative
or administrative action, either in the U.S. or abroad.
We do not have a guarantee of patent
restoration and marketing exclusivity of the ingredients for our drugs even if we are granted FDA approval of our products.
The U.S. Drug Price Competition and Patent
Term Restoration Act of 1984 (Hatch-Waxman) permits the FDA to approve Abbreviated New Drug Applications (ANDAs) for generic versions
of innovator drugs, as well as NDAs with less original clinical data, and provides patent restoration and exclusivity protections
to innovator drug manufacturers. The ANDA process permits competitor companies to obtain marketing approval for drugs with the
same active ingredient and for the same uses as innovator drugs, but does not require the conduct and submission of clinical studies
demonstrating safety and efficacy. As a result, a competitor could copy any of our drugs and only need to submit data demonstrating
that the copy is bioequivalent to gain marketing approval from the FDA. Hatch-Waxman requires a competitor that submits an ANDA,
or otherwise relies on safety and efficacy data for one of our drugs, to notify us and/or our business partners of potential infringement
of our patent rights. We and/or our business partners may sue the company for patent infringement, which would result in a 30-month
stay of approval of the competitor's application. The discovery, trial and appeals process in such suits can take several
years. If the litigation is resolved in favor of the generic applicant or the challenged patent expires during the 30-month period,
the stay is lifted and the FDA may approve the application. Hatch-Waxman also allows competitors to market copies of innovator
products by submitting significantly less clinical data outside the ANDA context. Such applications, known as "505(b)(2)
NDAs" or "paper NDAs," may rely on clinical investigations not conducted by or for the applicant and for which
the applicant has not obtained a right of reference or use and are subject to the ANDA notification procedures described above.
The law also permits restoration of a portion
of a product's patent term that is lost during clinical development and NDA review, and provides statutory protection, known
as exclusivity, against FDA approval or acceptance of certain competitor applications. Restoration can return up to five years
of patent term for a patent covering a new product or its use to compensate for time lost during product development and regulatory
review. The restoration period is generally one-half the time between the effective date of an IND and submission of an NDA, plus
the time between NDA submission and its approval (subject to the five-year limit), and no extension can extend total patent life
beyond 14 years after the drug approval date. Applications for patent term extension are subject to U.S. Patent and Trademark Office
(USPTO) approval, in conjunction with FDA. Approval of these applications takes at least nine months, and there can be no guarantee
that it will be given at all.
Hatch-Waxman also provides for differing
periods of statutory protection for new drugs approved under an NDA. Among the types of exclusivity are those for a "new
molecular entity" and those for a new formulation or indication for a previously-approved drug. If granted, marketing exclusivity
for the types of products that we are developing, which include only drugs with innovative changes to previously-approved products
using the same active ingredient, would prohibit the FDA from approving an ANDA or 505(b)(2) NDA relying on our safety and efficacy
data for three years. This three-year exclusivity, however, covers only the innovation associated with the original NDA. It does
not prohibit the FDA from approving applications for drugs with the same active ingredient but without our new innovative change.
These marketing exclusivity protections do not prohibit the FDA from approving a full NDA, even if it contains the innovative change.
17
USE OF PROCEEDS
All of the shares of common stock covered
by this prospectus are being sold by the Selling Stockholders. See "Selling Stockholders" on page 18. We will not
receive any proceeds from these sales of shares of our common stock. A portion of the Shares covered by this prospectus are issuable
upon exercise of the Agent Warrants to purchase our common stock. Upon any exercise of the Agent Warrants for cash, such Selling
Stockholders would pay us the exercise price of the warrants. Cash received from exercise of Agent Warrants will be used for general
corporate purposes. Additionally, the Agent Warrants are exercisable on a cashless basis. If any Agent Warrants are exercised on
a cashless basis, we would not receive any cash payment from such Selling Stockholders upon any exercise of such Agent Warrants.
The Selling Stockholders will pay any underwriting
discounts and commissions and expenses incurred by the Selling Stockholders for brokerage, accounting, tax, or legal services or
any other expenses incurred by the Selling Stockholders in disposing of the Shares. We will bear all other costs, fees, and expenses
incurred in effecting the registration of the Shares covered by this prospectus, including, without limitation, all registration
and filing fees, and fees and expenses of our counsel and our accountants.
SELLING STOCKHOLDERS
We have prepared this prospectus to allow
the Selling Stockholders or their successors, assignees or other permitted transferees to sell or otherwise dispose of, from time
to time, up to 4,260,855 shares of our common stock. This prospectus covers the offer and disposition by the Selling Stockholders
identified below, or their transferee(s), of a total of 4,260,855 shares of our common stock. Of the shares of common stock being
offered under this prospectus 3,625,000 were acquired by the purchasers in our October 2012 Private Placement and 635,855 shares
are able to be acquired pursuant to the Agent Warrants we issued in connection with our October 2012 Private Placement, which Agent
Warrants are currently exercisable.
The Shares sold to the Selling Stockholders
in the October 2012 Private Placement were sold pursuant to an exemption from registration provided by Rule 506 of Regulation D
under the Securities Act. In connection therewith, the investors made to us certain representations, warranties, covenants, and
conditions customary for private placement investments.
The table below presents information
regarding the Selling Stockholders and the Shares that they may sell or otherwise dispose of from time to time under this
prospectus. The table is based on information supplied to us by the Selling Stockholders and reflects holdings as of December
7, 2012. Percentages of beneficial ownership are based upon 44,332,748 shares of common stock outstanding as of
December  7, 2012. Beneficial ownership is determined under Section 13(d) of the Securities Exchange Act of 1934
(the "Exchange Act of 1934") and generally includes voting or investment power with respect to securities and
including any securities that grant the Selling Stockholders the right to acquire common stock within 60 days of December 7,
2012. Unless otherwise noted, each person or group identified possesses sole voting and investment power with respect to the
Shares, subject to community property laws where applicable.
We do not know when or in what amounts
the Selling Stockholders may sell or otherwise dispose of the Shares covered hereby. We currently have no agreements, arrangements
or understandings with the Selling Stockholders regarding the sale of any of the Shares by them other than the registration rights
agreements described below. The Selling Stockholders might not sell any or all of the Shares covered by this prospectus or may
sell or dispose of some or all of the Shares other than pursuant to this prospectus. Because the Selling Stockholders may not sell
or otherwise dispose of some or all of the Shares covered by this prospectus and because there are currently no agreements, arrangements
or understandings with respect to the sale or other disposition of any of the Shares, we cannot estimate the number of the Shares
that will be held by the Selling Stockholders after completion of the offering.
Each Selling Stockholder has indicated
to us that neither it nor any of its affiliates has held any position or office or had any other material relationship with us
in the past three years except as described in the footnotes to the table.
The Shares being offered under this prospectus
may be offered for sale from time to time during the period the registration statement of which this prospectus is a part remains
effective, by or for the accounts of the Selling Stockholders named below.
The Selling Stockholders, or their partners,
pledgees, donees, transferees or other successors that receive the Shares and their corresponding registration in accordance with
the registration rights agreement to which the Selling Stockholder is party (each also a Selling Stockholder for purposes of this
prospectus), may sell up to all of the Shares shown in the table below under the heading "Total Shares Offered By Selling
Stockholder in the Offering Covered by this Prospectus" pursuant to this Prospectus in one or more transactions from time
to time as described below under "Plan of Distribution." However, the Selling Stockholders are not obligated to sell
any of the Shares offered by this prospectus.
18
Information about the Selling Stockholders may change from time
to time. Any changed information with respect to which we are given notice will be included in prospectus supplements.
Selling Stockholder
Shares
Beneficially
Owned Before
the
    Sale of all Shares Covered by this Prospectus
Percentage of
Beneficial
Ownership
Before
the
    Sale of all Shares Covered by this Prospectus
Total Shares
Offered
By Selling
Stockholder in the Offering Covered by this Prospectus
Shares
Beneficially
Owned After
the
    Sale of all Shares Covered by this Prospectus
Percentage of
Beneficial
Ownership
After
the
    Sale of all Shares Covered by this Prospectus
Allen Adler
193,750
*
93,750
100,000
*
Helen Hartnett, IRA Custodian
31,250
*
31,250
0
*
Roger J. LaGratta, IRA Custodian
227,500
*
187,500
40,000
*
Eugene Mark Landry, IRA Custodian
31,250
*
31,250
0
*
Barry Peters Roth IRA Custodian
31,250
*
31,250
0
*
Christopher Basta
31,250
*
31,250
0
*
Belmont Ventures, Inc.(1)
1,562,500
3.5%
312,500
1,250,000
2.8%
Capital Ventures International(2)
150,000
*
150,000
0
*
Carruthers Living Trust UAD 4/1/04(3)
100,000
*
100,000
0
*
Chulick Family Trust(4)
93,750
*
93,750
0
*
John LaGratta
300,000
*
100,000
200,000
*
Stephen S. Lipton
15,000
*
15,000
0
*
Mintz and Co.(5)
31,250
*
31,250
0
*
Sean E. McCance
62,500
*
62,500
0
*
Richard Molinsky
30,000
*
30,000
0
*
MSD Credit Opportunity Master Fund, L.P.(6)
2,100,000
4.7%
2,100,000
0
*
Richard R. Redmond
31,250
*
31,250
0
*
Dominick Ruggiero
50,000
*
50,000
0
*
Smokeshire Partners LLC(7)
62,500
*
62,500
0
*
Louis Vigden
30,000
*
30,000
0
*
Laurence Zalk
50,000
*
50,000
0
*
Griffin Securities, Inc.(8)
411,834
*
311,834
100,000
*
Adrian Z. Stecyk (9)
723,667
1.6%
623,667
100,000
*
Salvatore Saraceno(10)
7,500
*
7,500
0
*
George Stephenson(11)
4,688
*
4,688
0
*
*less than 1%
(1)
Joel C. Flint is the authorized agent for Belmont Ventures and as such has voting and investment power over the shares listed.
(2)
Heights Capital Management, Inc.
        is the authorized agent for Capital Ventures International ("CVI"), has discretionary authority to vote and dispose
        of the shares held by CVI and may be deemed to be the beneficial owner of these shares. Martin Kobinger, in his capacity as Investment
        Manager of Heights Capital Management, Inc, may also be deemed to have investment discretion and voting power over the shares held
        by CVI. Mr. Kobinger disclaims any such beneficial ownership of these shares.
(3)
James L. Carruthers, Jr. is trustee
        of the Caruthers Living Trust and as such has voting and investment power over the shares listed.
(4)
John Chulick and Kathi Chulick
        are trustees of the Chulick Family Trust and as such have voting and investment power over the shares listed.
(5)
Mintz and Co. is the record and direct beneficial owner of the shares of common stock. Lowell A. Mintz is the senior partner of, and may be deemed to have or share voting and dispositive power over, and/or beneficially own securities owned by, Mintz and Co.
19
(6)
MSD Credit Opportunity Master Fund, L.P. is the record and direct beneficial owner of the securities. MSDC Management, L.P. is the investment manager of, and may be deemed to have or share voting and dispositive power over, and/or beneficially own securities owned by, MSD Credit Opportunity Master Fund L.P. MSDC Management (GP), LLC is the general partner of, and may be deemed to have or share voting and dispositive power over, and/or beneficially own securities owned by, MSDC Management, L.P. Each of Glenn R. Fuhrman, John C. Phelan and Marc R. Lisker is a manager of MSDC Management (GP) and may be deemed to have or share voting and/or dispositive power over, and beneficially own, the common stock beneficially owned by MSDC Management(GP) Each of Mr. Fuhrman, Mr. Phelan and Mr. Lisker disclaim beneficial ownership of such common stock, except to the extent of the pecuniary interest of such person in such shares.
(7)
Smokeshire Partners, LLC is the
record and direct beneficial owner of the shares of common stock. Mintz and Co. is the manager of, and may be deemed to have or
share voting and dispositive power over, and/or beneficially own securities owned by, Smokeshire Partners, LLC. Lowell A. Mintz
is the senior partner of, and may be deemed to have or share voting and dispositive power over, and/or beneficially own securities
owned by, Mintz and Co.
(8)
Includes 311,834 shares
of our common stock issuable upon exercise of the Agent Warrants issued to Griffin Securities, Inc. ("Griffin"), as
our placement agent in our October 2012 Private Placement and 100,000 shares of our common stock issuable upon exercise of warrants
issued to Griffin for financial advisory services in accordance with the terms of a financial advisory agreement we entered into
with Griffin in December 2011. Griffin is a registered broker-dealer that served as the placement agent in connection with our
October 2012 Private Placement. Adrian Stecyk is the Chief Executive Officer of Griffin and an affiliate of a registered-broker-dealer.
Mr. Stecyk has voting and dispositive power with respect to the warrants and the underlying shares.
(9)
Includes 411,834 shares of
        common stock issuable upon exercise of the Agent Warrants issued to Griffin and financial advisor warrants issued to Griffin
        and         311,833         shares         of         common stock         issuable         upon exercise of warrants issued
        to Mr.         Stecyk. Mr. Stecyk         has voting and         dispositive         power with respect to         the
        warrants and               the underlying         shares.
(10)
Consists of shares of
common stock issuable upon exercise of the Agent Warrants issued to Mr. Saraceno. Mr. Saraceno is an employee of Griffin. Griffin
is a registered broker-dealer that served as the placement agent in connection with our October 2012 Private Placement.
(11)
Consists of shares of common stock issuable upon exercise of the Agent Warrants issued to Mr. Stephenson.  Mr. Stephenson is an employee of Griffin.  Griffin is a registered broker-dealer that served as the placement agent in connection with our October 2012 Private Placement.
DETERMINATION OF OFFERING PRICE
The Selling Stockholders will determine
at what price they may sell the offered Shares, and such sales may be made at prevailing market prices, or at privately negotiated
prices.
PLAN OF DISTRIBUTION
We are registering the shares of common
stock previously issued to the Selling Stockholders to permit the resale of these shares of common stock by the holders of the
common stock from time to time after the date of this prospectus. We will not receive any of the proceeds from the sale by the
Selling Stockholders of the shares of common stock. We will bear all fees and expenses incident to our obligation to register the
shares of common stock.
The Selling Stockholders, or their pledges,
donees, transferees, or any of their successors in interest selling shares received from a Selling Stockholder as a gift, partnership
distribution or other non-sale related transfer after the date of this prospectus, may sell all or a portion of the shares of common
stock beneficially owned by them and offered hereby from time to time directly or through one or more underwriters, broker-dealers
or agents. If the shares of common stock are sold through underwriters or broker-dealers, the Selling Stockholders will be responsible
for underwriting discounts or commissions or agent's commissions. The shares of common stock may be sold in one or more transactions
at fixed prices, at prevailing market prices at the time of the sale, at varying prices determined at the time of sale, or at negotiated
prices. The Selling Stockholders will act independently of us in making decisions with respect to the timing, manner and size of
each sale. These sales may be affected in transactions, which may involve crosses or block transactions,
20
•
on any national securities exchange or quotation service on which the securities may be listed or quoted at the time of sale;
•
in the over-the-counter market;
•
in transactions otherwise than on these exchanges or systems or in the over-the-counter market;
•
through the writing of options, whether such options are listed on an options exchange or otherwise;
•
ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;
•
block trades in which the broker-dealer will attempt to sell the shares 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;
•
short sales;
•
through the distribution of the common stock by any Selling Stockholders to its partners, members or Stockholders;
•
through one or more underwritten offerings on a firm commitment or best efforts basis;
•
sales pursuant to Rule 144;
•
broker-dealers may agree with the Selling Stockholders to sell a specified number of such shares at a stipulated price per share;
•
a combination of any such methods of sale; and
•
any other method permitted pursuant to applicable law.
The Selling Stockholders may also transfer
the Shares by gift. The Selling Stockholders may engage brokers and dealers, and any brokers or dealers may arrange for other brokers
or dealers to participate in effecting sales of the Shares. These brokers, dealers or underwriters may act as principals, or as
an agent of a Selling Stockholder. Broker-dealers may agree with a Selling Stockholder to sell a specified number of the Shares
at a stipulated price per security. If the broker-dealer is unable to sell the Shares acting as agent for a Selling Stockholder,
it may purchase as principal any unsold Shares at the stipulated price. Broker-dealers who acquire Shares as principals may thereafter
resell the Shares from time to time in transactions in any stock exchange or automated interdealer quotation system on which the
Shares are then listed, at prices and on terms then prevailing at the time of sale, at prices related to the then-current market
price or in negotiated transactions. Broker-dealers may use block transactions and sales to and through broker-dealers, including
transactions of the nature described above.
The Selling Stockholders may also sell
the Shares in accordance with Rule 144 under the Securities Act, rather than pursuant to this prospectus, regardless of whether
the Shares are covered by this prospectus.
If the Selling Stockholders effect such
transactions by selling shares of common stock to or through underwriters, broker-dealers or agents, such underwriters, broker-dealers
or agents may receive commissions in the form of discounts, concessions or commissions from the Selling Stockholders or commissions
from purchasers of the shares of common stock for whom they may act as agent or to whom they may sell as principal (which discounts,
concessions or commissions as to particular underwriters, broker-dealers or agents may be in excess of those customary in the types
of transactions involved). In connection with sales of the shares of common stock or otherwise, the Selling Stockholders may enter
into hedging transactions with broker-dealers, which may in turn engage in short sales of the shares of common stock in the course
of hedging in positions they assume. The Selling Stockholders may also sell shares of common stock short and deliver shares of
common stock covered by this prospectus to close out short positions and to return borrowed shares in connection with such short
sales. The Selling Stockholders may also loan or pledge shares of common stock to broker-dealers that in turn may sell such shares.
The Selling Stockholders may pledge or
grant a security interest in some or all of the shares of common stock owned by them and, if they default in the performance of
their secured obligations, the pledgees or secured parties may offer and sell the shares of common stock from time to time pursuant
to this prospectus or any amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act
amending, if necessary, the list of Selling Stockholders to include the pledgee, transferee or other successors in interest as
Selling Stockholders under this prospectus. The Selling Stockholders also may transfer and donate the shares of common stock in
other circumstances in which case the transferees, donees, pledgees or other successors in interest will be the selling beneficial
owners for purposes of this prospectus.
21
In addition, a Selling Stockholder may,
from time to time, sell the Shares short, and, in those instances, this prospectus may be delivered in connection with the short
sales and the Shares offered under this prospectus may be used to cover short sales.
The Selling Stockholders and any broker-dealer
participating in the distribution of the shares of common stock may be deemed to be "underwriters" within the meaning
of the Securities Act, and any commission paid, or any discounts or concessions allowed to, any such broker-dealer may be deemed
to be underwriting commissions or discounts under the Securities Act. At the time a particular offering of the shares of common
stock is made, a prospectus supplement, if required, will be distributed which will set forth the aggregate amount of shares of
common stock being offered and the terms of the offering, including the name or names of any broker-dealers or agents, any discounts,
commissions and other terms constituting compensation from the Selling Stockholders and any discounts, commissions or concessions
allowed or reallowed or paid to broker-dealers. The Selling Stockholders may indemnify any broker-dealer that participates in transactions
involving the sale of the shares of common stock against certain liabilities, including liabilities arising under the Securities
Act.
Under the securities laws of some states,
the shares of common stock may be sold in such states only through registered or licensed brokers or dealers. In addition, in some
states the shares of common stock may not be sold unless such shares have been registered or qualified for sale in such state or
an exemption from registration or qualification is available and is complied with.
There can be no assurance that any Selling
Stockholder will sell any or all of the shares of common stock registered pursuant to the registration statement, of which this
prospectus forms a part.
The Selling Stockholders and any other
person participating in such distribution will be subject to applicable provisions of the Exchange Act of 1934 and the rules and
regulations thereunder, including, without limitation, Regulation M of the Exchange Act of 1934, which may limit the timing of
purchases and sales of any of the shares of common stock by the Selling Stockholders and any other participating person. Regulation
M may also restrict the ability of any person engaged in the distribution of the shares of common stock to engage in market-making
activities with respect to the shares of common stock. All of the foregoing may affect the marketability of the shares of common
stock and the ability of any person or entity to engage in market-making activities with respect to the shares of common stock.
The shares of common stock offered hereby
were originally issued to the Selling Stockholders pursuant to an exemption from the registration requirements of the Securities
Act. We agreed to register the shares of common stock under the Securities Act, and to keep the registration statement of which
this prospectus is a part effective until the earlier of the date on which the Selling Stockholders have sold all of the securities
or one year after the shares were acquired by the Selling Stockholder. We will pay all expenses of the registration of the shares
of common stock pursuant to the Registration Rights Agreement, estimated to be
$30,000
in total,
including, without limitation, Commission filing fees and expenses of compliance with state securities or "Blue Sky"
laws;
provided
,
however
, that a Selling Stockholder will pay all underwriting discounts and selling commissions,
if any. We will indemnify the Selling Stockholders against liabilities, including some liabilities under the Securities Act, in
accordance with the Registration Rights Agreement, or the Selling Stockholders will be entitled to contribution. We may be indemnified
by the Selling Stockholders against civil liabilities, including liabilities under the Securities Act, that may arise from any
written information furnished to us by the Selling Stockholder specifically for use in this prospectus, in accordance with Registration
Rights Agreement, or we may be entitled to contribution.
Once sold under the registration statement,
of which this prospectus forms a part, the shares of common stock will be freely tradable in the hands of persons other than our
affiliates.
DESCRIPTION OF SECURITIES
Our authorized capital consists of 100
million shares of common stock, par value $0.001 per share, and 10 million shares of preferred stock, par value $0.001 per share.
As of December 7, 2012, 44,332,748 shares of common stock and no shares of preferred stock were  outstanding.
Common Stock
Holders of shares of common stock have
the right to cast one vote for each share of common stock in their name on the books of our company, whether represented in person
or by proxy, on all matters submitted to a vote of holders of common stock, including election of directors. There is no right
to cumulative voting in election of directors. Except where a greater requirement is provided by statute, by our articles of incorporation,
or by our bylaws, the presence, in person or by proxy duly authorized, of the one or more holders of a majority of the outstanding
shares of our common stock constitutes a quorum for the transaction of business. The vote by the holders of a majority of outstanding
shares is required to effect certain fundamental corporate changes such as liquidation, merger, or amendment of our articles of
incorporation.
22
There are no restrictions in our articles
of incorporation or bylaws that prevent us from declaring dividends. We have not declared any dividends, and we do not plan to
declare any dividends in the foreseeable future.
Holders of shares of our common stock are
not entitled to preemptive or subscription or conversion rights, and no redemption or sinking fund provisions are applicable to
our common stock. All outstanding shares of common stock are, and the shares of common stock sold in the offering will when issued
be fully paid and non-assessable.
Warrants
Outstanding
Warrants
As of November 29, 2012, we had issued and
outstanding a total of 1,632,501 and 1,432,501 warrants, respectively, to purchase our common stock outstanding at a weighted-average
price of $1.99 and $1.96, respectively. Included in the number of outstanding warrants are (a) Agent Warrants to acquire an aggregate
of 635,855 shares of our common stock at an exercise price of $1.60 per share for a five year period (subject to a cashless exercise
provision) we issued to Griffin and its designees in connection with the closing of our October 2012 Private Placement on October
30, 2012, the underlying shares of which are being registered under the registration statement of which this prospectus forms a
part; and (b) additional warrants to acquire 100,000 shares of our common stock issued to our Griffin in December 2012 for financial
advisory services in accordance with the terms of our financial advisory agreement we entered into with them.
Contingent Share Issuance-Intrexon – First Exclusive
Channel Collaboration Agreement
On December 7, 2011, pursuant to the First
Stock Issuance Agreement between us and Intrexon, we issued to Intrexon 3,123,558 shares of our common stock as a technology access
fee, in consideration for the execution and delivery of the First Chanel Agreement we entered into with Intrexon. We also agreed
to issue additional shares of our common stock to Intrexon upon dosing of the first patient in our sponsored Phase II clinical
trial in the United States, or similar study as the parties may agree in a country other than the United States, of a product under
the First Channel Agreement. Upon satisfaction of such contingency, we agreed to issue to Intrexon an additional 3,123,558 shares
of common stock, subject to certain adjustments, for a purchase price equal to the $0.001 par value of such shares, which issuance
was deemed paid in partial consideration for the execution and delivery of the First Channel Agreement.
Equity Participation Right-Intrexon
Under the First Stock Purchase Agreement,
Intrexon is entitled, at its election, to (i) participate in our future securities offerings that constitute "Qualified Financings"
and purchase securities equal to 19.99% of the number of shares of common stock or other securities sold in such offering. For
this purpose, a "Qualified Financing" means a sale of common stock or equity securities convertible into common stock
in a public or private offering, raising gross proceeds of at least $5,000,000, where the sale of shares is either registered under
the Securities Act, at the time of issuance or we agrees to register the resale of such shares, and (ii) without restriction, purchase
an additional number of shares of common stock in the open market, or otherwise, that do not exceed an additional 10% of the number
of shares of common stock then issued and outstanding; Intrexon waived its right to participate in the October 2012 Private Placement
..
Second Exclusive Channel Collaboration Agreement
On August 6, 2012, we expanded our relationship
with Intrexon and entered into the Second Channel Agreement with Intrexon that governs a "channel collaboration" arrangement
in which we will use Intrexon's technology relating to the identification, design and production of human antibodies and
DNA vectors for the development and commercialization of a series of monoclonal antibody therapies for the treatment of certain
serious infectious diseases (collectively, the "Program"). On October 16, 2012, we issued 3,552,210 shares of our common
stock to Intrexon which issuance is deemed paid in partial consideration for the execution and delivery of the Second Channel Agreement.
We also agreed upon the filing of an Investigational
New Drug application with the U.S. Food and Drug Administration for a Synthetic Product (as defined in the agreement), or alternatively
the filing of the first equivalent regulatory filing with a foreign regulatory agency (both as applicable, the "IND Milestone
Event"), to pay Intrexon either (i) two million dollars ($2M) in cash, or (ii) that number of shares of common stock (the
"IND Milestone Shares") having a fair market value equaling two million dollars ($2M) where such fair market value
is determined using published market data of the share price for common stock at the close of market on the business day immediately
preceding the date of public announcement of attainment of the IND Milestone Event.
We also agreed upon the first to occur
of either first commercial sale of a Synthetic Product in a country or the granting of the regulatory approval of that Synthetic
Product (both as applicable, the "Approval Milestone Event"), to pay to Intrexon either (i) three million dollars ($3M)
in cash, or (ii) that number of shares of common stock (the "Approval Milestone Shares") having a fair market value
equaling three million dollars ($3M) where such fair market value is determined using published market data of the share price
for common stock at the close of market on the business day immediately preceding the date of public announcement of attainment
of the Approval Milestone Event.
23
We has also agreed that we will pay an
optional and varying fee whereby we remit a payment, in cash or equity at our sole discretion, to Intrexon calculated as a multiple
of the number of targets in excess of three (3) total that we desire to elect (the "Field Expansion Fee"). The Field
Expansion Fee must be paid completely in either common stock or cash, and will comprise either (i) two million dollars ($2M) in
cash for each target in excess of three (3) total that we will elect, or (ii) that number of shares of common stock (the "Field
Expansion Fee Shares") having a fair market value equaling two million dollars ($2M) for each such target that we will elect
in excess of three where such fair market value is determined using published market data establishing the volume-weighted average
price for a share of common stock over the thirty (30) day period immediately preceding the date of the Field Expansion Fee Closing.
Prev Contingent Share Issuances
On November 28, 2012, a closing was held
for the transaction contemplated by the Prev Agreement we entered into with Prev pursuant to which we acquired the
C. diff
program assets of Prev, including pre-Investigational
New Drug (IND) package, Phase I and Phase II clinical data, manufacturing process data and all issued and pending U.S. and international
patents.  Pursuant to the Prev Agreement, we paid Prev an initial cash payment of $100,000 upon execution of the Prev Agreement
and at closing paid an additional cash payment of $135,000 and issued 625,000 unregistered shares of our common stock to Prev. 
In addition, upon the achievement of the milestones set forth below, Prev may be entitled to receive additional consideration payable
50% in cash and 50% in our stock, subject to Prev's option to receive the entire payment in shares of our stock, with the
exception of the first milestone payments to be paid in cash: (i) upon commencement of an IND; (ii) upon commencement of a Phase
I clinical trial; (iii) upon commencement of a Phase II clinical trial; (iv) upon commencement of a Phase III clinical trial; (v)
upon Biologic License Application (BLA) filing in the U.S. and for territories outside of the U.S. (as defined in the Prev Agreement);
and (vi) upon BLA approval in the U.S. and upon approval in territories outside the-U.S.  The future stock issuances are subject
to prior approval of the NYSE MKT, LLC. No royalties are payable to Prev under the Prev Agreement.
Registration Rights
In connection with the October 2012 Private
Placement, we entered into a registration rights agreement with each of the Selling Stockholders (the "Registration Rights
Agreement"). The Registration Rights Agreement requires us to file a registration statement (the "Registration Statement")
with the Commission within 45 days of the closing date of the October 2012 Private Placement (the "Filing Date") for
the resale by the Selling Stockholders of all of the Registrable Securities. We agreed to use our commercially reasonable efforts
to cause the Registration Statement to be declared effective by the Commission no later than 90 days after the closing date of
the October 2012 Private Placement (the "Effectiveness Date") subject to certain adjustments. Upon the occurrence of
an Event, including, but not limited to, that the Registration Statement is not declared effective prior to the Effectiveness Date,
we will be required to pay liquidated damages to each of the Selling Stockholders equal to 1.5% of the aggregate purchase price
paid by such Selling Stockholders for the Registrable Securities upon the date of the Event and then monthly thereafter until the
earlier of: (i) the Event is cured, or (ii) the Registrable Securities are eligible for resale without subsequent registration
under the Securities Act. In no event shall the aggregate amount of liquidated damages payable to each of the Selling Stockholders
exceed in the aggregate 10% of the aggregate purchase price paid by such Selling Stockholders for the Registrable Securities. We
also agreed to use our commercially reasonable efforts to keep the Registration Statement effective for resales until the earlier
of the date that all of the shares of our common stock included in the Registration Statement have been resold thereunder or under
Rule 144 promulgated under the Securities Act. The registration rights agreement contains cross-indemnification provisions between
us and the Selling Stockholders.
In connection with the transactions contemplated
by the Second Stock Issuance Agreement, and pursuant to the First Amendment to Registration Rights Agreement executed and delivered
by the parties in August 2012 (the "First Amendment to Registration Rights Agreement"), the Company agreed to file
a "resale" registration statement registering the resale of the shares issued and to be issued under the Second Stock
Issuance Agreement on or prior to April 30, 2013. Under that agreement, we are obligated to use our reasonable best efforts to
cause the "resale" registration statement to be declared effective as promptly as practicable after filing and to maintain
the effectiveness of the registration statement until all securities therein are sold or are otherwise can be sold pursuant to
Rule 144, without any restrictions. In addition, we also entered into a Joinder Agreement with a certain purchaser in the October
2012 Private Placement that is an affiliate of Intrexon pursuant to which such party agreed to be bound by the terms of and join
Intrexon as a party to the First Amendment to Registration Rights Agreement.
In connection with the transactions contemplated
by the First Stock Purchase Agreement, and pursuant to the Registration Rights Agreement executed and delivered by us to Intrexon,
we agreed to file a "resale" registration statement registering the resale of the First Tranche Shares within 120 days
of the closing date of such issuance. The registration statement registering such shares was declared effective on April 13, 2012,
but is no longer valid due to certain issues regarding the failure of our prior auditor to follow proper partner rotation. Intrexon
has agreed not to require us to file a post effective registration statement on Form S-1 with respect to the First Tranche Shares
and instead has agreed to wait until we are once again S-3 eligible to require registration of such shares.
24
Preferred Stock
Our Board of Directors has the authority,
without action by our stockholders, to designate and issue up to 10 million shares of preferred stock in one or more series or
classes and to designate the rights, preferences and privileges of each series or class, which may be greater than the rights of
our common stock. We do not have any shares of preferred stock either designated or outstanding. It is not possible to state the
actual effect of the issuance of any shares of preferred stock upon the rights of holders of our common stock until our Board of
Directors determines the specific rights of the holders of the preferred stock. However, the effects might include:
•
restricting dividends on our common stock;
•
diluting the voting power of our common stock;
•
impairing liquidation rights of our common stock; or
•
delaying or preventing a change in control of us without further action by our stockholders.
The Board of Directors' authority to issue preferred stock
without stockholder approval could make it more difficult for a third-party to acquire control of our company, and could discourage
such attempt. We have no present plans to issue any shares of preferred stock.
Listing of Common Stock
Our common stock is currently traded on
the NYSE MKT, LLC under the trading symbol "SYN."
Transfer Agent
We have retained Corporate Stock Transfer
as our transfer agent. They are located at 3200 Cherry Creek Drive, Denver, Colorado 80209. Their telephone number is (303) 282-4800
and facsimile is (303) 282-5800.
EXPERTS
The financial statements as of December
31, 2011 and 2010 and for the years then ended included in this Form S-1 Registration Statement have been so included in reliance
on the reports of Berman & Company, P.A., an independent registered public accounting firm, given on the authority of said
firm as experts in auditing and accounting.
DISCLOSURE OF COMMISSION POSITION ON
INDEMNIFICATION
FOR SECURITIES ACT LIABILITIES
Our Articles of Incorporation provide that
no officer or director shall be personally liable to us or our stockholders for monetary damages except as provided pursuant to
the Nevada Revised Statutes. Our bylaws and Articles of Incorporation also provide that we will indemnify and hold harmless each
person who serves at any time as a director, officer, employee or agent of us from and against any and all claims, judgments and
liabilities to which such person shall become subject by reason of the fact that he is or was a director, officer, employee or
agent of us, and shall reimburse such person for all legal and other expenses reasonably incurred by him or her in connection with
any such claim or liability. We also have the power to defend such person from all suits or claims in accordance with the Nevada
Revised Statutes. The rights accruing to any person under our bylaws and Articles of Incorporation do not exclude any other right
to which any such person may lawfully be entitled, and we may indemnify or reimburse such person in any proper case, even though
not specifically provided for by the bylaws and Articles of Incorporation.
Insofar as indemnification for liabilities
arising under the Securities Act may be permitted to directors, officers and controlling persons of the small business issuer pursuant
to the foregoing provisions, or otherwise, we have 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 small business issuer for expenses incurred or paid by a director, officer
or controlling person of the small business issuer 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, we will, unless in the opinion
of our 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.
25
LEGAL MATTERS
The validity of our common stock offered hereby will be passed
upon for us by Gracin & Marlow, LLP, New York, New York.
26
WHERE YOU CAN FIND MORE INFORMATION
We are subject to the informational requirements
of the Exchange Act of 1934, and file annual and current reports, proxy statements and other information with the Commission. These
reports, proxy statements and other information filed by us can be read and copied at the Commission's Public Reference Room
at 100 F Street, N.W., Washington, D.C. 20549. You may obtain information on the operation of the Public Reference Room by calling
the Commission at 1-800-SEC-0330.
The Commission also maintains a website
that contains reports, proxy statements, information statements and other information concerning our company located at http://www.sec.gov.
This prospectus does not contain all the information required to be included in the registration statement (including the exhibits),
which we have filed with the Commission under the Securities Act and to which reference is made in this prospectus.
You may obtain, free of charge, a copy of any of our filings
by writing or calling us at the following address and telephone number: 617 Detroit Street, Suite 100, Ann Arbor, Michigan 48104
or calling (734) 332-7800.
INCORPORATION OF CERTAIN INFORMATION
BY REFERENCE
The Commission allows us to "incorporate
by reference" into this prospectus the information we file with it, which means that we can disclose important information
to you by referring you to those documents. Information incorporated by reference is considered to be part of this prospectus,
except for any information that is superseded by information included directly in this prospectus. Any statement contained in this
prospectus or a document incorporated by reference in this prospectus will 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 subsequently filed document that
is incorporated by reference in this prospectus modifies or superseded the statement. Any statement so modified or superseded will
not be deemed, except as so modified or superseded, to constitute a part of this prospectus. We incorporate by reference the documents
listed below (excluding any portions of such documents that have been "furnished" but not "filed" for purposes
of the Securities Act).
•
Our Annual Report on Form 10-K/A for the year ended December 31, 2011, filed with the Commission on March 30, 2012, as amended on May 11, 2012;
•
Our Definitive Proxy Statement on Schedule 14A, filed with the Commission on January 4, 2012 and September 11, 2012;
•
Our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2012, June 30, 2012 and September 30, 2012, filed with the Commission on May 15, 2012 and August 14, 2012, as amended on September 11, 2012, and November 14, 2012, respectively; and
•
Our Current Reports on Form 8-K, filed December 6, 2012, December 3, 2012, November 14, 2012, November 13, 2012, October 31, 2012, October 17, 2012, October 5, 2012, August 14, 2012, August 9, 2012, July 18, 2012, July 10, 2012, June 18, 2012, May 15, 2012, May 11, 2012, May 3, 2012, April 24, 2012, March 30, 2012, March 12, 2012, February 16, 2012, February 13, 2012, February 7, 2012, February 6, 2012 and our amendment to a Current Report on Form 8-K filed February 3, 2012 and May 30, 2012.
We will provide a copy of any and all of
the information that is incorporated by reference in this prospectus to any person, including a beneficial owner, to whom a prospectus
is delivered, without charge, upon written or oral request. Written requests for copies should be directed to Attention: C. Evan
Ballantyne, Chief Financial Officer, Synthetic Biologics, Inc. 617 Detroit Street, Suite 100, Ann Arbor, Michigan, 48104. Telephone
requests for copies should be directed to the Chief Financial Officer at (734) 332-7800.
We maintain an Internet website at
www.syntheticbiologics.com
where the incorporated reports listed above can be accessed. Neither this website nor the information on this website is included
or incorporated in, or is a part of, this prospectus or any supplement to the prospectus.
27
4,260,855 SHARES OF COMMON STOCK
SYNTHETIC BIOLOGICS, INC.
PROSPECTUS
December     , 2012
Neither we nor the Selling Stockholders
have authorized any dealer, salesperson or other person to give any information or to make any representations not contained in
this prospectus or any prospectus supplement. You must not rely on any unauthorized information. This prospectus is not an offer
to sell these securities in any jurisdiction where an offer or sale is not permitted. The information in this prospectus is current
as of the date of this prospectus. You should not assume that this prospectus is accurate as of any other date.
28
PART II - INFORMATION NOT REQUIRED IN
PROSPECTUS
ITEM 13. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
We estimate that expenses in connection
with the distribution described in this registration statement (other than brokerage commissions, discounts or other expenses relating
to the sale of the shares of common stock underlying the Warrants by the selling security holders) will be as set forth below.
We will pay all of the expenses with respect to the distribution, and such amounts, with the exception of the Securities and Exchange
Commission registration fee, are estimates.
SEC registration fee
$
929.89
Accounting fees and expenses
2,500.00
Legal fees and expenses
20,000.00
Printing and related expenses
2,000.00
Transfer agent fees and expenses
2,000.00
Miscellaneous
2,570.11
Total
$
30,000.00
ITEM 14. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Under the provisions of Section 78.138
of Nevada Revised Statutes and our Articles of Incorporation, we may indemnify our directors, officers, employees and agents and
maintain liability insurance for those persons. Section 78.138 provides that a corporation may indemnify a person made a party
to a proceeding because the person is or was a director against liability incurred in the proceeding if the person's conduct was
in good faith. In the case of conduct in an official capacity with the corporation, the person may be indemnified if the person
reasonably believed that such conduct was in the corporation's best interests. In all other cases, the corporation may indemnify
the person if the person reasonably believed that such conduct was at least not opposed to the corporation's best interests. In
the case of any criminal proceeding, the person may be indemnified if the person had no reasonable cause to believe the person's
conduct was unlawful.
Our Articles of Incorporation and Bylaws,
each as amended, obligate us to indemnify our directors and officers to the fullest extent permitted under Nevada law. We have
purchased directors' and officers' liability insurance policies for our directors and officers.
In the employment agreement that we entered
into with all of our executive officers, we agreed to indemnify our officers for all claims arising out of performance of their
duties as officers of the company, other than those arising out of his breach of the agreement or his gross negligence or willful
misconduct.
Insofar as indemnification for liabilities
for damages arising under the Securities Act may be permitted to our directors, officers, and controlling persons pursuant to the
foregoing provision, or otherwise, we have been advised that in the opinion of the Securities and Exchange Commission such indemnification
is against public policy as expressed in the Securities Act and is, therefore, unenforceable.
ITEM 15. RECENT SALES OF UNREGISTERED
SECURITIES
The following information sets forth certain
information with respect to all securities which we have sold during the last three years.  We did not pay any commissions
in connection with any of these sales.
During the fourth quarter of 2009, we issued
104,633 shares of common stock, in connection with the exercise of stock options, for proceeds of $27,834 and issued 3,066 shares
of common stock for consulting fees, having a fair value of $65,786 ($0.28 per share), based on the quoted closing trading prices.
These offerings and sales of shares qualified for exemption under Section 4(2) of the Securities Act since the issuances did not
involve a public offering. The offerings were not a public offering as defined in Section 4(2) because the offer and sale was made
to an insubstantial number of persons and because of the manner of the offering. This offering was done with no general solicitation
or advertising by us. Based on an analysis of the above factors, we met the requirements to qualify for exemption under Section
4(2) of the Securities Act for these sales.
29
During the first three months of 2010,
we issued a total of 33,118 shares of our common stock to two consultants for services rendered. These offerings and sales of shares
qualified for exemption under Section 4(2) of the Securities Act since the issuances did not involve a public offering. The offerings
were not a public offering as defined in Section 4(2) because the offer and sale was made to an insubstantial number of persons
and because of the manner of the offering. This offering was done with no general solicitation or advertising by us. Based on an
analysis of the above factors, we met the requirements to qualify for exemption under Section 4(2) of the Securities Act for these
sales.
In July 2010, we issued warrants to the
placement agent and its designees in connection with our sale of shares of our common stock pursuant to our registration statement
on Form S-3. The warrants are exercisable for 60,606 shares of common stock at an exercise price of $1.32 for a period of five
years. The sale of such shares was exempt from registration under the Securities Act in reliance upon Section 4(2) thereof since
the issuances did not involve a public offering. The issuances were not a public offering as defined in Section 4(2) because the
offer and sale was made to an insubstantial number of persons and because of the manner of the issuances. These issuances were
done with no general solicitation or advertising by us. Based on an analysis of the above factors, we met the requirements to qualify
for exemption under Section 4(2) of the Securities Act for these sales.
In October of 2010, we issued 52,180 shares
of common stock to Thomas Jefferson University having a fair value of $41,250 ($0.79 per share) and 28,855 shares of common stock
to the University of Southern California having a fair value of $29,087 ($1.01 per share) in payment for licensing fees. The fair
value of these issuances was based upon the quoted closing price. These issuances and sales of shares qualified for exemption under
Section 4(2) of the Securities Act since the issuances did not involve a public offering. The issuances were not a public offering
as defined in Section 4(2) because the offer and sale was made to an insubstantial number of persons and because of the manner
of the issuances. These issuances were done with no general solicitation or advertising by us. Based on an analysis of the above
factors, we met the requirements to qualify for exemption under Section 4(2) of the Securities Act for these sales.
On July 28, 2011, we exchanged the warrant
issued in connection with the April 6, 2011 financing for a new warrant with substantially the same terms as the original warrant.
We exchanged our warrant with existing security holders and no remuneration or commission was paid in reliance on Section 3(a)(9)
of the Securities Act.
On August 2, 2011, we issued 130,000 shares
of our common stock to Chardan Capital Markets, LLC (Chardan) as compensation for the execution and delivery of a Financial Advisory
Agreement that we entered into with Chardan on June 3, 2011. The offer and issuance of the shares of common stock have not been
registered under the Securities Act, and therefore such shares of common stock may not be offered or sold in the U.S. absent registration
or an applicable exemption from registration requirements. This issuance and sale of shares qualified for exemption under Section
4(2) of the Securities Act since the issuance did not involve a public offering. The issuance was not a public offering as defined
in Section 4(2) because the offer and sale was made to an insubstantial number of persons and because of the manner of the issuance.
This issuance was done with no general solicitation or advertising by us. Based on an analysis of the above factors, we met the
requirements to qualify for exemption under Section 4(2) of the Securities Act for these sales.
On August 10, 2011, we entered into an
agreement to exchange the warrants issued in connection with the January 28, 2011 financing for new warrants. We exchanged our
warrant with existing security holders and no remuneration or commission was paid in reliance on Section 3(a)(9) of the Securities
Act.
On December 7, 2011 a closing was held
for the transaction previously announced on November 21, 2011 between us and Intrexon. We issued 3,123,558 shares of our common
stock at a purchase price equal to the $0.001 par value of such shares, which issuance is also deemed paid in partial consideration
for the execution and delivery of the exclusive channel collaboration agreement, dated November 18, 2011, between us and Intrexon.
This issuance and sale of shares qualified for exemption under Section 4(2) of the Securities Act since the issuance did not involve
a public offering. The issuance was not a public offering as defined in Section 4(2) because the offer and sale was made to an
insubstantial number of persons and because of the manner of the issuance. This issuance was done with no general solicitation
or advertising by us. Based on an analysis of the above factors, we met the requirements to qualify for exemption under Section
4(2) of the Securities Act for these sales.
In February 2012, we issued five year warrants
exercisable at the closing price of our common stock on the date of issue for 100,000 shares of our common stock to Griffin Securities,
Inc. ("Griffin") as compensation for the execution and delivery of a Financial Advisory Agreement that we entered into
with Griffin on December 20, 2011. This issuance and sale of warrants qualified for exemption under Section 4(2) of the Securities
Act since the issuance did not involve a public offering. The issuance was not a public offering as defined in Section 4(2) because
the offer and sale was made to an insubstantial number of persons and because of the manner of the issuance. This issuance was
done with no general solicitation or advertising by us. Based on an analysis of the above factors, we met the requirements to qualify
for exemption under Section 4(2) of the Securities Act for these sales.
On May 14, 2012, we issued 257,143 shares
of common stock to an investor upon exercise of warrants in reliance upon Section 3(a)(9) of the Securities Act.
30
On July 13, 2012, we issued 94,391 shares
of common stock to an investor upon exercise of warrants in reliance upon Section 3(a)(9) of the Securities Act.
On October 16, 2012 a closing was held
for the transaction previously announced on August 8, 2012 between us and Intrexon. We issued 3,552,210 shares of our common stock
(the "Intrexon Shares") at a purchase price equal to the $0.001 par value of such shares, which issuance is also deemed
paid in partial consideration for the execution and delivery of the Exclusive Channel Collaboration Agreement, dated August 6,
2012, between ourselves and Intrexon. The offer and issuance of the Intrexon Shares have not been registered under the Securities
Act, as amended, and therefore may not be offered or sold in the United States absent registration or an applicable exemption from
registration requirements. For this issuance, we are relying on the exemption from federal registration under Section 4(2) of the
Securities Act, based on our belief that the offer and sale of the Intrexon Shares does not involve a public offering as Intrexon
is an "accredited investor" as defined under Section 501 promulgated under the Securities Act and no general solicitation
has been involved in the offering.
In September 2012, we issued warrants to
a consultant exercisable for up to 250,000 shares of our common stock upon attainment of certain stock price milestones in accordance
with the terms of a consulting agreement for a financial communications program. Upon initiation of the program, 50,000 of the
performance warrants vested. The performance warrant is exercisable for a period of two years from the date of issuance at an exercise
price equal to the price of the Company's common stock on the date of execution of the agreement, March 15, 2012. This issuance
and sale of warrants qualified for exemption under Section 4(2) of the Securities Act since the issuance did not involve a public
offering. The issuance was not a public offering as defined in Section 4(2) because the offer and sale was made to an insubstantial
number of persons and because of the manner of the issuance. This issuance was done with no general solicitation or advertising
by us. Based on an analysis of the above factors, we met the requirements to qualify for exemption under Section 4(2) of the Securities
Act for these sales.
On October 30, 2012, we issued 6,750,000
shares of our common stock at a price per share of $1.60 for aggregate gross proceeds of $10,800,000 to certain accredited investors.
In connection with the offering, we also issued to Griffin and its designees, five-year warrants to purchase up to 635,855 shares
of our common stock with an exercise price of $1.60 per share. The offer and issuance of such shares of common stock and the shares
of common stock underlying such warrants have not been registered under the Securities Act, as amended, and therefore may not be
offered or sold in the United States absent registration or an applicable exemption from registration requirements. For these issuances,
we are relying on the exemption from federal registration under Section 4(2) and Regulation D of the Securities Act, based on our
belief that the offer and sale of such shares of common stock and the shares of common stock underlying such warrants do not involve
a public offering as the purchasers of the common stock and placement agent are "accredited investors" as defined under
Section 501 promulgated under the Securities Act and no general solicitation has been involved in the offering.
On November 28, 2012, we issued 625,000
in partial consideration for the acquisition of certain assets. The offer and issuance of such shares of common stock have not
been registered under the Securities Act, as amended, and therefore may not be offered or sold in the United States absent registration
or an applicable exemption from registration requirements. For these issuances, we are relying on the exemption from federal registration
under Section 4(2) and Regulation D of the Securities Act, based on our belief that the offer and sale of such shares of common
stock do not involve a public offering as the purchaser of the common stock and all of the members of the purchaser are "accredited
investors" as defined under Section 501 promulgated under the Securities Act and no general solicitation has been involved
in the offering.
ITEM 16. EXHIBITS
3.1
Certificate of Incorporation, as amended (Incorporated by reference to (i) Exhibit 3.1 of the Registrant's Current Report on Form 8-K filed October 16, 2008, (ii) Exhibit 3.1 of the Registrant's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2001 filed August 14, 2001 and (iii) Exhibits 3.1, 4.1 and 4.2 of the Registrant's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 1998 filed August 14, 1998)
3.2
Articles of Merger (Incorporated by reference to Exhibit 3.1 of the Registrant's Current Report on Form 8-K filed October 19, 2009.)
3.3
Certificate of Merger filed with the Secretary of State of Delaware (Incorporated by reference to Exhibit 3.2 of the Registrant's Current Report on Form 8-K filed October 19, 2009.)
3.4
Articles of Incorporation filed with the Nevada Secretary of State (Incorporated by reference to Exhibit 3.3 of the Registrant's Current Report on Form 8-K filed October 19, 2009.)
3.5
By-Laws (Incorporated by reference to (i) Exhibit 3.4 of the Registrant's Current Report on Form 8-K filed October 19, 2009 and (ii) Exhibit 3.1 of the Registrant's Current Report on Form 8-K filed June 3, 2010. )
3.6
Amended and Restated Bylaws Adopted and Effective October 31, 2011 (Incorporated by reference to Exhibit 3.1 of the Registrant's Current Report on Form 8-K filed November 2, 2011.)
31
3.7
Certificate of Amendment to Articles of Incorporation (Incorporated by reference to Exhibit 3.1 of the Registrant's Current Report on Form 8-K filed February 16, 2012.)
4.1
Form of Warrant Certificate (Incorporated by reference to Exhibit 4.1 to the Registrant's Current Report on Form 8-K filed December 1, 2006.)
*4.2
2001 Stock Incentive Plan (Incorporated by reference to Exhibit 4.1 of the Registrant's Registration Statement on Form S-8 filed January 18, 2008.)
*4.3
2007 Stock Incentive Plan (Incorporated by reference to Exhibit 4.2 of the Registrant's Registration Statement on Form S-8 filed January 18, 2008.)
*4.4
2010 Stock Incentive Plan (Incorporated by
reference to Exhibit 4.1 of the Registrant's Registration Statement on Form S-8 filed November 29, 2010.)
4.5
Form of Warrant Certificate issued to Enclave Capital LLC (Incorporated by reference to Exhibit 4.1 of the Registrant's Current Report on Form 8-K filed July 6, 2010.)
4.6
Form of Warrant to Purchase Common Stock issued January 2011(Incorporated by reference to Exhibit 10.3 of the Registrant's Current Report on Form 8-K filed February 2, 2011.)
4.7
Form of Warrant to Purchase common stock issued April 2011(Incorporated by reference to Exhibit 10.3 of the Registrant's Current Report on Form 8-K filed April 6, 2011.)
4.8
Form of Exchange Warrant to Purchase Common Stock issued in exchange of the Warrant issued April 2011(Incorporated by reference to Exhibit 4.1 of the Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2011 filed August 15, 2011.)
4.9
Form of Exchange Warrant to Purchase Common Stock
        issued in exchange of the Warrant issued February 2011(Incorporated by reference to Exhibit 4.2 of the Registrant's Quarterly
        Report on Form 10-Q for the quarter ended June 30, 2011 filed August 15, 2011.)
4.10
Form of Warrant to Purchase Common Stock issued February 2012 (Incorporated by reference to Exhibit 4.10 of the Registrant's Annual Report on Form 10-K for the year ended December 31, 2011 filed March 30, 2012.)
4.11
Form of Warrant to Purchase Common Stock
(Incorporated by reference to Exhibit 4.10 of the Registrant's Annual Report on Form 10-K filed March 30, 2012.)
4.12
Form of Placement Agent Warrant issued in October
        2012 (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed October 31, 2012.)
4.13
Form of Warrant Certificate issued to Redington, Inc.(1)
5.1
Legal Opinion of Gracin & Marlow, LLP (1)
10.1
Unit Purchase Agreement (Incorporated by reference to Exhibit 10.1 to the Registrant's Current Report on Form 8-K filed December 1, 2006.)
10.2
License Agreement between The Regents of the University of California and Epitope Pharmaceuticals, Inc. (Incorporated by reference to the Registrant's Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2008 filed November 14, 2008.)
*10.3
Form of Director/Officer Indemnification Agreement (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed January 6, 2009.)
10.4
Warrant Cancellation and Registration Rights Agreement between Accredited Adventures Capital LLC and Adeona (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed January 20, 2009.)
32
10.5
Stock Purchase Agreement with Neil O. Colwell and Connie Colwell (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed April 16, 2009.)
10.6
Escrow Agreement Nayaran Torke (Incorporated by reference to Exhibit 10.5 of the Registrant's Current Report on Form 8-K filed July 16, 2009.)
10.7
Consulting Agreement with Nayaran Torke (Incorporated by reference to Exhibit 10.4 of the Registrant's Current Report on Form 8-K filed July 16, 2009.)
10.8
Purchase Agreement 1st Amendment HartLab LLC (Incorporated by reference to Exhibit 10.2 of the Registrant's Current Report on Form 8-K filed July 16, 2009.)
10.9
Purchase Agreement 2nd Amendment Hartlab LLC (Incorporated by reference to Exhibit 10.3 of the Registrant's Current Report on Form 8-K filed July 16, 2009.)
10.10
Agreement and Plan of Reincorporation Merger (Incorporated by reference to Exhibit 1.1 of the Registrant's Current Report on Form 8-K filed October 19, 2009.)
*10.11
Employment Agreement with James S. Kuo, M.D., (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed February 9, 2010.)
*10.12
Separation Agreement with Max Lyons (Incorporated by reference to Exhibit 10.2 of the Registrant's Current Report on Form 8-K filed February 9, 2010.)
10.13
Sublicense Agreement between Meda AB, Adeona Pharmaceuticals, Inc. and Pipex Therapeutics, Inc. (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed May 11, 2010.)
10.14
Non-Disturbance Agreement among Pipex Therapeutics, Inc., Mclean Hospital Corp and Meda AB (Incorporated by reference to Exhibit 10.2 of the Registrant's Current Report on Form 8-K filed May 11, 2010.)
10.15
Placement Agent Agreement with Enclave Capital LLC (Incorporated by reference to Exhibit 1.1 of the Registrant's Current Report on Form 8-K filed July 6, 2010.)
10.16
Common Stock Purchase Agreement
        with Seaside 88, LP (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed July
        6, 2010.)
10.17
Agreement with Chardan Capital Markets, LLC (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed February 2, 2011.)
10.18
Securities Purchase Agreement with investors (Incorporated by reference to Exhibit 10.2 of the Registrant's Current Report on Form 8-K filed February 2, 2011.)
10.19
McLean Hospital Corporation Exclusive License Agreement (Incorporated by reference to Exhibit 10.21 of the Registrant's Annual Report on Form 10-K filed March 31, 2011)
10.20
Agreement with Chardan Capital Markets, LLC (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed April 6, 2011.)
10.21
Securities Purchase Agreement with investors (Incorporated by reference to Exhibit 10.2 of the Registrant's Current Report on Form 8-K filed April 6, 2011.)
10.22
Exchange Agreement with respect to Warrant issued April 2011(Incorporated by reference to Exhibit 10.1 of the Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2011 filed August 15, 2011.)
10.23
Exchange Agreement with respect to Warrant issued February 2011(Incorporated by reference to Exhibit 10.2 of the Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2011 filed August 15, 2011.)
33
10.24
Exclusive Channel Collaboration Agreement with Intrexon Corporation (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed November 21, 2011.)
10.25
Stock Purchase Agreement with Intrexon Corporation (Incorporated by reference to Exhibit 10.2 of the Registrant's Current Report on Form 8-K filed November 21, 2011.)
10.26
Registration Rights Agreement with Intrexon Corporation (Incorporated by reference to Exhibit 10.3 of the Registrant's Current Report on Form 8-K filed November 21, 2011.)
*10.27
Employment Agreement with Jeffrey Riley (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed February 6, 2012.)
10.28
Consulting Agreement with Dr. James Kuo (Incorporated by reference to Exhibit 10.2 of the Registrant's Current Report on Form 8-K filed February 6, 2012.)
*10.29
Employment Agreement with C. Evan Ballantyne (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed February 7, 2012.)
*10.30
Employment Agreement with Steve H. Kanzer (Incorporated by reference to Exhibit 10.30 of the Registrant's Annual Report on Form 10-K for the year ended December 31, 2011 filed March 30, 2012.)
10.31
Membership Interest Purchase Agreement by and among Synthetic Biologics, Inc., Hartlab LLC, and Adeona Clinical Laboratory, LLC, dated as of March 7, 2012 (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed March 12, 2012.)
10.32
Pledge and Security Agreement between Synthetic Biologics, Inc. and Hartlab, LLC dated as of March 7, 2012 (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed March 12, 2012.)
10.33
Non-Recourse Promissory Note between Synthetic Biologics, Inc. and Hartlab, LLC dated as of March 7, 2012 (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed March 12, 2012.)
10.34
Financial Advisory Agreement with Griffin Securities, Inc. (Incorporated by reference to Exhibit 10.34 of the Registrant's Annual Report on Form 10-K for the year ended December 31, 2011 filed March 30, 2012.)
10.35
Exclusive Channel Collaboration Agreement by and between Synthetic Biologics, Inc. and Intrexon Corporation dated as of August 6, 2012 (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed August 9, 2012.)
10.36
Stock Issuance Agreement by and between Synthetic Biologics, Inc. and Intrexon Corporation dated as of August 6, 2012 (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed August 9, 2012.)
10.37
First Amendment to Registration Rights Agreement by and between Synthetic Biologics, Inc. and Intrexon Corporation dated as of August 6, 2012 (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed August 9, 2012.)
10.38
Form of Stock Purchase Agreement dated October 25, 2012 (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed October 31, 2012.)
10.39
Form of Registration Rights Agreement dated October 25, 2012 (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed October 31, 2012.)
10.40
Joinder Agreement dated October 25, 2012 (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed October 31, 2012.)
10.41
Asset Purchase Agreement between Synthetic Biologics, Inc. and Prev ABR LLC dated as of November 8, 2012 (Incorporated by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K filed November 13, 2012.)
*
10.42
Amendment to Employment Agreement with Steve H. Kanzer  (1)
34
21
List of Subsidiaries (Incorporated by reference to Exhibit 10.34 of the Registrant's Annual Report on Form 10-K filed March 30, 2012.)
23.1
Consent of Independent Registered Accounting Firm (1)
23.2
Consent of Gracin & Marlow, LLP (Included in its
        opinion filed as Exhibit 5.1)
24
Power of Attorney (Included on signature page)
(1)
Filed herewith.
* Management contract or compensatory plan or arrangement required
to be identified pursuant to Item 15(a)(3) of this report
ITEM 28. UNDERTAKINGS
Insofar as indemnification for liabilities
arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrants, pursuant to
the provisions described under Item 15 or otherwise, the Registrant has been advised that in the opinion of the Securities
and Exchange Commission such indemnification by it is against public policy as expressed in the Securities Act and is, therefore,
unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant
of expenses incurred or paid by a director, officer or controlling person of the Registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered,
the Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court
of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities
Act and will be governed by the final adjudication of such issue.
The undersigned Registrant 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 acts
or events arising after the effective date of this 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 this 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 a prospectus filed with the Commission pursuant to Rule 424(b) under the Securities Act if,
in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set
forth in the "Calculation of Registration Fee" table in the effective registration statement); and
(iii) to include any material information
with respect to the plan of distribution not previously disclosed in this registration statement or any material change to such
information in this registration statement; provided, however, that subparagraphs (i), (ii) and (iii) do not apply if
the information required to be included in a post-effective amendment by those subparagraphs is contained in periodic reports filed
with or furnished to the Commission by the Registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange
Act of 1934, that are incorporated by reference in this registration statement, or is contained in a form of prospectus filed pursuant
to Rule 424(b) that is part of 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.
(4) That, for the purpose of determining
liability under the Securities Act to any purchaser:
35
(i) if the Registrant is relying on Rule
430B: (A) each prospectus filed by the Registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration
statement as of the date the filed prospectus was deemed part of and included in the registration statement; and (B) each
prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on
Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information
required by section 10(a) of the Securities Act shall be deemed to be part of and included in the registration statement as of
the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of
securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any
person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement
relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration
statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by
reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with
a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement
or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date;
or
(ii) if the Registrant is subject to Rule
430C, each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration
statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included
in the registration statement as of the date it is first used after effectiveness. Provided, however, that no statement made in
a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed
incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to
a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the registration
statement or prospectus that was part of the registration statement or made in any such document immediately prior to such date
of first use.
(5) That, for the purpose of determining
liability under the Securities Act to any purchaser in the initial distribution of the securities the undersigned Registrant undertakes
that in a primary offering of securities of the undersigned Registrant pursuant to this registration statement, regardless of the
underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means
of any of the following communications, the undersigned Registrant will be a seller to the purchaser and will be considered to
offer or sell such securities to such purchaser: (i) any preliminary prospectus or prospectus of the undersigned Registrant
relating to the offering required to be filed pursuant to Rule 424; (ii) any free writing prospectus relating to the offering
prepared by or on behalf of the undersigned Registrant or used or referred to by the undersigned Registrant; (iii) the portion
of any other free writing prospectus relating to the offering containing material information about the undersigned Registrant
or its securities provided by or on behalf of the undersigned Registrant; and (iv) any other communication that is an offer
in the offering made by the undersigned Registrant to the purchaser.
(6) That, for purposes of determining any
liability under the Securities Act, each filing of the Registrant's annual report pursuant to Section 13(a) or Section 15(d)
of the Securities Exchange Act of 1934 that is incorporated by reference in this registration statement shall be deemed to be a
new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be
deemed to be the initial bona fide offering thereof.
(7) That for purposes of determining any
liability under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statement
in reliance upon Rule 430A and contained in a form of prospectus filed by the Registrant pursuant to Rule 424(b)(1) or (4) or
497(h) under the Securities Act of 1933 shall be deemed to be part of this registration statement as of the time it was declared
effective.
(8) That, for the purpose of determining
any liability under the Securities Act, each post-effective amendment that contains a form of prospectus 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.
(9) To file an application for the purpose
of determining the eligibility of the trustee to act under subsection (a) of Section 310 of the Trust Indenture Act in
accordance with the rules and regulations prescribed by the Commission under Section 305(b)(2) of the Securities Act.
36
SIGNATURES
Pursuant to the requirements of the Securities
Act of 1933, the Registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing
on the Form S-1 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Ann Arbor, State of Michigan, December 13, 2012.
SYNTHETIC BIOLOGICS, INC.
By:
/s/ Jeffrey Riley
Jeffrey Riley
Chief Executive Officer and Director
(Principal Executive Officer)
Date: December 13, 2012
By:
/s/ C. Evan Ballantyne
C. Evan Ballantyne
Chief Financial Officer
(Principal Financial and Principal Accounting Officer)
Date: December 13, 2012
37
POWER OF ATTORNEY
We, the undersigned hereby severally constitute
and appoint each of Jeffrey Riley and C. Evan Ballantyne our true and lawful attorney and agent, with full power to each to sign
for us, and in our names in the capacities indicated below, any and all amendments to this registration statement, any subsequent
registration statements pursuant to Rule 462 of the Securities Act of 1933, as amended, and to file the same, with all exhibits
thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact
and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to
be done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and
confirming all that said attorneys-in-fact and agents, or any of them or their or his or her substitute or substitutes, may lawfully
do or cause to be done by virtue hereof. This power of attorney may be executed in counterparts.
Pursuant to the requirements of the Securities
Act 1933, this report has been signed by the following persons on behalf of the Registrant and in the capacities and on the dates
indicated.
By:
/s/ Jeffrey Riley
Date: December 13, 2012
Jeffrey Riley
Chief Executive Officer and Director
(Principal Executive Officer)
Date: December 13, 2012
By:
/s/ Jeffrey J. Kraws
Jeffrey J. Kraws
Chairman
Date: December 13, 2012
By:
/s/ Steve H. Kanzer
Steve H. Kanzer
Director
Date: December 13, 2012
By:
/s/ Scott L. Tarriff
Scott L. Tarriff
Director
Date: December 13, 2012
By:
/s/ Jeffrey Wolf
Jeffrey Wolf
Director
38