<SEC-DOCUMENT>0001144204-18-061119.txt : 20181121
<SEC-HEADER>0001144204-18-061119.hdr.sgml : 20181121
<ACCEPTANCE-DATETIME>20181121070526
ACCESSION NUMBER:		0001144204-18-061119
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20181121
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20181121
DATE AS OF CHANGE:		20181121

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Synthetic Biologics, Inc.
		CENTRAL INDEX KEY:			0000894158
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				133808303
		STATE OF INCORPORATION:			NV
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-12584
		FILM NUMBER:		181196991

	BUSINESS ADDRESS:	
		STREET 1:		9605 MEDICAL CENTER DRIVE
		STREET 2:		SUITE 270
		CITY:			ROCKVILLE
		STATE:			MD
		ZIP:			20850
		BUSINESS PHONE:		(734) 332-7800

	MAIL ADDRESS:	
		STREET 1:		9605 MEDICAL CENTER DRIVE
		STREET 2:		SUITE 270
		CITY:			ROCKVILLE
		STATE:			MD
		ZIP:			20850

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ADEONA PHARMACEUTICALS, INC.
		DATE OF NAME CHANGE:	20081027

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	PIPEX PHARMACEUTICALS, INC.
		DATE OF NAME CHANGE:	20061214

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	SHEFFIELD PHARMACEUTICALS INC
		DATE OF NAME CHANGE:	19970730
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>tv507729_8k.htm
<DESCRIPTION>8-K
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<!-- Field: Rule-Page --><DIV ALIGN="LEFT" STYLE="margin-top: 12pt; margin-bottom: 3pt"><DIV STYLE="font-size: 1pt; border-top: Black 2pt solid; border-bottom: Black 1pt solid; width: 100%">&nbsp;</DIV></DIV><!-- Field: /Rule-Page -->

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

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<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">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>FORM 8-K</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: center"><B>CURRENT REPORT</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: center"><B>Pursuant to Section 13 or 15(d)</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>of the Securities Exchange Act of 1934</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: center">Date of Report (Date of earliest event reported):
November 21, 2018</P>

<P STYLE="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"><FONT STYLE="font-size: 14pt"><B>SYNTHETIC
BIOLOGICS, INC.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Exact name of registrant as specified in
its charter)</P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 32%; border-bottom: black 1pt solid; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Nevada</FONT></TD>
    <TD STYLE="width: 2%; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 32%; border-bottom: black 1pt solid; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">001-12584</FONT></TD>
    <TD STYLE="width: 2%; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 32%; border-bottom: black 1pt solid; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">13-3808303</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(State or other jurisdiction of incorporation)</FONT></TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(Commission File No.)</FONT></TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(IRS Employer Identification No.)</FONT></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">9605 Medical Center Drive, Suite 270</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Rockville, MD 20850</P>

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

<P STYLE="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">Registrant&rsquo;s telephone number, including
area code: (301) 417-4364</P>

<P STYLE="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">N/A</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Former name or former address, if changed
since last 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; text-align: justify">Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:</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%">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 48px">&nbsp;</TD>
    <TD STYLE="width: 24px"><FONT STYLE="font-family: Wingdings; font-size: 10pt">&uml;</FONT></TD>
    <TD STYLE="text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</FONT></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 48px">&nbsp;</TD>
    <TD STYLE="width: 24px"><FONT STYLE="font-family: Wingdings; font-size: 10pt">&uml;</FONT></TD>
    <TD STYLE="text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</FONT></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 48px">&nbsp;</TD>
    <TD STYLE="width: 24px"><FONT STYLE="font-family: Wingdings; font-size: 10pt">&uml;</FONT></TD>
    <TD STYLE="text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</FONT></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 48px">&nbsp;</TD>
    <TD STYLE="width: 24px"><FONT STYLE="font-family: Wingdings; font-size: 10pt">&uml;</FONT></TD>
    <TD STYLE="text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</FONT></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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

<P STYLE="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: right"><FONT STYLE="font-family: Times New Roman, Times, Serif">Emerging
growth company </FONT><FONT STYLE="font-family: Wingdings">&uml;</FONT></P>

<P STYLE="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"><FONT STYLE="font-family: Times New Roman, Times, Serif">If
an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. </FONT><FONT STYLE="font-family: Wingdings">&uml;</FONT></P>

<P STYLE="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;&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Item 8.01 Other Events</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On November 21, 2018, Synthetic Biologics,
Inc. (the &ldquo;Company&rdquo;) issued a press release announcing that it has successfully completed an End-of-Phase 2 meeting
with the U.S. Food and Drug Administration (FDA) to discuss development of SYN-004 (ribaxamase) for the prevention of antibiotic-mediated
<I>Clostridium difficile</I> infection. Pursuant to the meeting, the FDA has proposed criteria for Phase 3 clinical efficacy and
safety which, if achieved, may support submission for marketing approval of SYN-004 (ribaxamase) on the basis of a single Phase
3 clinical trial. Final agreement on these criteria is contingent on FDA evaluation of a detailed Phase 3 clinical trial protocol</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The press release attached as Exhibit 99.1
to this Current Report on Form 8-K, which is incorporated herein by reference includes &ldquo;safe harbor&rdquo; language pursuant
to the Private Securities Litigation Reform Act of 1995, as amended, indicating that certain statements contained in the press
release are &ldquo;forward-looking&rdquo; rather than historical.</P>



<P STYLE="font: 10pt 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 Company undertakes no duty or obligation
to update or revise information included in this Current Report on Form 8-K or the press release attached as Exhibit 99.1 hereto.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">(d) Exhibits</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>&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; width: 4%">&nbsp;</TD>
    <TD STYLE="width: 90%">&nbsp;</TD></TR>
<TR STYLE="vertical-align: bottom">
    <TD STYLE="white-space: nowrap">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; border-bottom: black 1pt solid">Exhibit<BR>
        No.</P></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;&nbsp;</FONT></TD>
    <TD STYLE="white-space: nowrap">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; border-bottom: black 1pt solid">Description</P></TD></TR>
<TR>
    <TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD COLSPAN="2">&nbsp;</TD></TR>
<TR>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><A HREF="tv507729_ex99-1.htm" STYLE="-sec-extract: exhibit"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">99.1</FONT></A></TD>
    <TD STYLE="vertical-align: bottom; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="vertical-align: top; font-size: 10pt"><A HREF="tv507729_ex99-1.htm" STYLE="-sec-extract: exhibit"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Press release issued by Synthetic Biologics, Inc. dated November 21, 2018</FONT></A></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;<B>&nbsp;</B></P>


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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.</P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Dated: November 21, 2018</FONT></TD>
    <TD COLSPAN="3"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">SYNTHETIC BIOLOGICS, INC.</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 50%">&nbsp;</TD>
    <TD STYLE="width: 5%">&nbsp;</TD>
    <TD STYLE="width: 5%">&nbsp;</TD>
    <TD STYLE="width: 40%">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">By:</FONT></TD>
    <TD COLSPAN="2" STYLE="border-bottom: black 1pt solid"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">/s/ Steven A. Shallcross</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Name: </FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Steven A. Shallcross</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Title:</P></TD>
    <TD><P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Interim Chief Executive Officer and Chief Financial
Officer</P></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;&nbsp;</P>


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<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: center"><B>EXHIBIT INDEX</B></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="vertical-align: bottom; width: 15%; border-bottom: black 1pt solid; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Exhibit</B></FONT><BR>
<FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Number</B></FONT></TD>
    <TD STYLE="vertical-align: top; width: 5%">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; width: 80%; border-bottom: black 1pt solid"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Description</B></FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="text-align: center"><A HREF="tv507729_ex99-1.htm" STYLE="-sec-extract: exhibit"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">99.1&nbsp;</FONT></A></TD>
    <TD>&nbsp;</TD>
    <TD><A HREF="tv507729_ex99-1.htm" STYLE="-sec-extract: exhibit"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Press release issued by Synthetic Biologics, Inc. dated November 21, 2018</FONT></A></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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

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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>tv507729_ex99-1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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<P STYLE="margin: 0">&nbsp;</P>

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

<P STYLE="margin: 0; text-align: right">&nbsp;</P>

<P STYLE="margin-top: 0; margin-bottom: 0; text-align: center"><IMG SRC="image_001.jpg" ALT="">&nbsp;</P>

<P STYLE="margin: 0; text-align: right">&nbsp;</P>

<P STYLE="margin: 0; text-align: right"></P>

<P STYLE="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Synthetic Biologics Announces Positive Outcome of End-of-Phase 2 Meeting with FDA</P>

<P STYLE="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">on SYN-004 (ribaxamase) Development</P>

<P STYLE="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><I>-- <FONT STYLE="font-family: Times New Roman, Times, Serif">Single
Phase 3 Clinical Trial May be Sufficient for Approval </FONT></I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><I>for Prevention of Antibiotic-Mediated
Clostridium difficile Infection (CDI) -- </I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><I>-- SYN-004 (ribaxamase) is in Development
as Potentially the First Intervention </I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><I>Designed to Specifically Prevent Antibiotic
Damage to the Microbiome -- </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">&nbsp;</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>Rockville, MD, November 21, 2018 &ndash;
</B><U>Synthetic Biologics, Inc.</U> (NYSE American: SYN), a late-stage clinical company developing therapeutics designed to preserve
the microbiome to protect and restore the health of patients, today announced that it has successfully completed an End-of-Phase
2 meeting with the U.S. Food and Drug Administration (FDA) to discuss development of SYN-004 (ribaxamase) for the prevention of
antibiotic-mediated <I>Clostridium difficile</I> infection (CDI). Pursuant to the meeting, the FDA has proposed criteria for Phase
3 clinical efficacy and safety which, if achieved, may support submission for marketing approval of ribaxamase on the basis of
a single Phase 3 clinical trial. Final agreement on these criteria is contingent on FDA evaluation of a detailed Phase 3 clinical
trial protocol.</P>

<P STYLE="font: 10pt 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">&ldquo;We are very pleased with the productive
advice we have received from the FDA during our recent End-of-Phase 2 meeting,&rdquo; said Steven A. Shallcross, Interim Chief
Executive Officer and Chief Financial Officer. &ldquo;Having a clear path forward in the form of a Phase 3 clinical program for
ribaxamase is an exciting and important milestone for our company and should be highly beneficial in our ongoing strategic partnering
discussions.&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">Synthetic Biologics, in consultation with
the FDA, has confirmed the key elements of the Phase 3 clinical program to support a marketing application for ribaxamase, the
Company&rsquo;s first-in-class oral enzyme designed to degrade certain intravenous (IV) beta-lactam antibiotics within the gastrointestinal
(GI) tract to prevent microbiome damage, <I>Clostridium difficile</I> infection (CDI), overgrowth of pathogenic organisms and the
emergence of antimicrobial resistance (AMR). The proposed ribaxamase Phase 3 clinical program will entail a single, global, event-driven
clinical trial with a fixed maximum number of patients for total enrollment and will evaluate the potential efficacy and safety
of ribaxamase in a broad patient population by enrolling patients with a variety of underlying infections treated with a range
of IV beta-lactam antibiotics.</P>

<P STYLE="font: 10pt 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 primary efficacy endpoint of the Phase
3 clinical trial will be the reduction in the incidence of CDI at one month after the last drug dose in the ribaxamase treatment
group versus placebo. The Company also confirmed that the FDA agreed to a primary safety endpoint of noninferiority in mortality
between the ribaxamase treatment group versus placebo at 3 months post-randomization. The designation of efficacy and safety as
separate and decoupled endpoints is critical for clinical studies of this nature, where the underlying population, regardless of
treatment group, is projected to have a comparatively high incidence of safety events that may significantly dilute the smaller
number of CDI events.</P>

<P STYLE="font: 10pt 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">Synthetic Biologics anticipates initiating
the Phase 3 clinical program after securing additional potential financing via a strategic partnership. In parallel, the Company
is evaluating opportunities to advance ribaxamase through the pursuit of a more focused clinical indication in a specialty patient
population with multiple potential disease endpoints associated with IV beta-lactam-induced gut microbiome damage. Such a dual
approach is designed to advance ribaxamase in areas of clear unmet medical need while also expanding upon ribaxamase&rsquo;s current
data set and providing further validation for use in the broader indication for the prevention of CDI.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>About <I>Clostridium difficile </I>infection</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"><I>Clostridium difficile</I> infection (CDI) is a leading hospital
acquired infection in the U.S., with more than 453,000<SUP>1</SUP> patients diagnosed annually. CDI results in approximately 29,000
deaths<SUP>1</SUP>, $5.4<SUP>2</SUP> billion in additional healthcare costs, as well as significant and sometimes prolonged illness.
Approximately 1 in 5 CDI patients experience at least one CDI recurrence<SUP>3</SUP>.</P>

<P STYLE="font: 10pt 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>About SYN-004 (ribaxamase) and the Phase
2b proof-of-concept clinical trial</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">SYN-004 (ribaxamase) is a first-in-class
oral enzyme prophylactic therapy designed to degrade certain IV beta-lactam antibiotics within the GI tract and maintain the natural
balance of the gut microbiome for the prevention of <I>Clostridium difficile</I> infection (CDI), overgrowth of pathogenic organisms
and the emergence of antimicrobial resistance (AMR). A previously completed randomized, double-blind, placebo-controlled Phase
2b proof-of-concept clinical trial of 412 patients met its primary endpoint of significantly reducing <I>C. difficile</I> infection
(CDI). Preliminary analysis of the data indicated seven confirmed cases of CDI in the placebo group compared to two cases in the
ribaxamase treatment group. Patients receiving ribaxamase achieved a 71.4% relative risk reduction (p-value=0.045) in CDI rates
compared to patients receiving placebo.</P>

<P STYLE="font: 10pt 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>About Synthetic Biologics, Inc.</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">Synthetic Biologics, Inc. (NYSE American:
SYN) is a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of
patients. The Company's lead candidates are: (1) SYN-004 (ribaxamase) which is designed to protect the gut microbiome from the
effects of certain commonly used intravenous (IV) beta-lactam antibiotics to prevent microbiome damage, <I>C. difficile</I> infection
(CDI), overgrowth of pathogenic organisms and the emergence of antimicrobial resistance (AMR), and (2) SYN-010 which is intended
to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome
with constipation (IBS-C). The Company&rsquo;s preclinical pursuits include an oral formulation of the enzyme intestinal alkaline
phosphatase (IAP) to treat both local GI and systemic diseases as well as monoclonal antibody therapies for the prevention and
treatment of pertussis, and novel discovery stage biotherapeutics for the treatment of phenylketonuria (PKU). For more information,
please visit Synthetic Biologics' website at <U>www.syntheticbiologics.com</U>.</P>

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


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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><I>This release contains forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements
can be identified by terminology such as &quot;may,&quot; &quot;should,&quot; &quot;potential,&quot; &quot;continue,&quot; &quot;expects,&quot;
&quot;anticipates,&quot; &quot;intends,&quot; &quot;plans,&quot; &quot;believes,&quot; &quot;estimates,&quot; and similar expressions,
and includes statements regarding a single Phase 3 clinical trial being sufficient for approval for prevention of antibiotic-mediated
clostridium difficile infection, the achievement of the FDA proposed criteria for Phase 3 clinical efficacy and safety supporting
submission for marketing approval of SYN-004 (ribaxamase) on the basis of a single Phase 3 clinical trial, having a clear path
forward in the form of a Phase 3 clinical program for SYN-004 being highly beneficial in our ongoing strategic partnering discussions,
the anticipated initiation of the Phase 3 clinical program after securing additional potential financing via a strategic partnership,
development of SYN-004 (ribaxamase) as potentially the first intervention designed to specifically to prevent antibiotic damage
to the microbiome, opportunities that would enable the advancement of SYN-004 through the pursuit of a more focused clinical indication
in a specialty patient population with multiple potential disease endpoints associated with IV beta-lactam-induced gut microbiome
damage and the potential benefits of SYN-004 and SYN-010.&nbsp; These forward-looking statements are based on management's expectations
and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are
difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those
set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially
from current expectations include, among others, Synthetic Biologics' ability to design a Phase 3 trial with the co-primary endpoints
and receive FDA approval for such design, Synthetic Biologics' ability to initiate the Phase 3 clinical program after securing
additional financing via a strategic partnership, Synthetic Biologics'&nbsp;ability to establish a path forward to develop ribaxamase
and conduct a robust, controlled and well-designed clinical trial that may provide sufficient efficacy and safety data to support
a pathway towards marketing approval for ribaxamase, Synthetic Biologics' ability to regain compliance with the continued listing
standards of the NYSE American by September 2, 2019, Synthetic Biologics'&nbsp;ability to comply with other continued listing requirements
of the NYSE American, the ability of its product candidates to demonstrate safety and effectiveness, as well as results that are
consistent with prior results, Synthetic Biologics' clinical trials continuing enrollment as expected, a failure to receive the
necessary regulatory approvals for commercialization of Synthetic Biologics' therapeutics, including approval of proposed trial
designs, a failure of Synthetic Biologics' clinical trials, and those conducted by investigators, for SYN-004 and SYN-010 to be
commenced or completed on time or to achieve desired results and benefits, a failure of Synthetic Biologics' clinical trials to
continue enrollment as expected or receive anticipated funding, a failure of Synthetic Biologics to successfully develop, market
or sell its products, Synthetic Biologics' inability to maintain its material licensing agreements, or a failure by Synthetic Biologics
or its strategic partners to successfully commercialize products, Synthetic Biologics&rsquo; ability to achieve acceptance of its
product candidates in the marketplace and the successful development, marketing or sale of Synthetic Biologics' products by competitors
that render Synthetic Biologics' products obsolete or non-competitive, the continued maintenance and growth of Synthetic Biologics'&nbsp;patent
estate, Synthetic Biologics becoming and remaining profitable, Synthetic Biologics'&nbsp;ability to obtain or maintain the capital
or grants necessary to fund its research and development activities, a loss of any of Synthetic Biologics'&nbsp;key scientists
or management personnel and other factors described in Synthetic Biologics' most recent Form 10-K and its other filings with the
SEC, including subsequent periodic reports on Forms 10-Q and 8-K. The information in this release is provided only as of the date
of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release
on account of new information, future events, or otherwise, except as required by law.</I></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>For further information, please contact:</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">Synthetic Biologics, Inc. (Corporate and
Investors)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Vincent I. Perrone, Director, Corporate Communication, (240)
660-2000, <U>info@syntheticbiologics.com</U></P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Gregory Kelley, Senior Vice President, (404) 836-2302, <U>gregory.kelley@ogilvy.com</U></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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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
