<SEC-DOCUMENT>0001144204-16-122387.txt : 20160901
<SEC-HEADER>0001144204-16-122387.hdr.sgml : 20160901
<ACCEPTANCE-DATETIME>20160901080021
ACCESSION NUMBER:		0001144204-16-122387
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20160901
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20160901
DATE AS OF CHANGE:		20160901

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			AmpliPhi Biosciences Corp
		CENTRAL INDEX KEY:			0000921114
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				911549568
		STATE OF INCORPORATION:			WA
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-37544
		FILM NUMBER:		161864562

	BUSINESS ADDRESS:	
		STREET 1:		3579 VALLEY CENTRE DRIVE
		CITY:			SAN DIEGO
		STATE:			CA
		ZIP:			92130
		BUSINESS PHONE:		804-827-2524

	MAIL ADDRESS:	
		STREET 1:		3579 VALLEY CENTRE DRIVE
		CITY:			SAN DIEGO
		STATE:			CA
		ZIP:			92130

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	TARGETED GENETICS CORP /WA/
		DATE OF NAME CHANGE:	19940331
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>v448196_8k.htm
<DESCRIPTION>FORM 8-K
<TEXT>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 18pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>UNITED STATES</B></P>

<P STYLE="font: 18pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>SECURITIES AND EXCHANGE COMMISSION</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Washington, DC 20549</B></P>

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

<P STYLE="font: 18pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>FORM 8-K</B></P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Pursuant to Section&nbsp;13 or 15(d)
of the</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Securities Exchange Act of 1934</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Date of report (Date of earliest event
reported): September 1, 2016 </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Commission File Number: 001-37544 </B></P>

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

<P STYLE="font: 18pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><FONT STYLE="text-transform: uppercase"><B>AmpliPhi
Biosciences Corporation</B> </FONT></P>

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

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

<TABLE CELLSPACING="0" CELLPADDING="0" ALIGN="CENTER" STYLE="font: 10pt Times New Roman, Times, Serif; width: 85%; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 49%; font-size: 10pt; text-align: center"><FONT STYLE="font-size: 10pt"><B>Washington</B></FONT></TD>
    <TD STYLE="width: 2%; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 49%; font-size: 10pt; text-align: center"><FONT STYLE="font-size: 10pt"><B>91-1549568</B></FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="font-size: 10pt; text-align: center"><FONT STYLE="font-size: 10pt"><B>(State or other jurisdiction of incorporation
or <BR>
organization)</B></FONT></TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center"><FONT STYLE="font-size: 10pt"><B>(IRS Employer Identification No.)</B></FONT></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>3579 Valley Centre Drive, Suite 100</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>San Diego, California 92130</B></P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>(858) 829-0829</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>(Registrant&rsquo;s Telephone number)</B></P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>(Former Name or Former Address, if Changed
Since Last Report)</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">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 (see General Instruction
A.2. below):</P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.5in; font-size: 10pt"><FONT STYLE="font-family: Wingdings; font-size: 10pt">&uml;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="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; text-indent: 0.5in">&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="font-size: 10pt; width: 0.5in"><FONT STYLE="font-family: Wingdings; font-size: 10pt">&uml;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="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; text-indent: 0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.5in; font-size: 10pt"><FONT STYLE="font-family: Wingdings; font-size: 10pt">&uml;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="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; text-indent: 0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.5in; font-size: 10pt"><FONT STYLE="font-family: Wingdings; font-size: 10pt">&uml;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="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; text-indent: 0.5in">&nbsp;</P>


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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;&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: 1in; font-size: 10pt"><FONT STYLE="font-size: 10pt"><B>Item&nbsp;8.01</B></FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-size: 10pt"><B>Other Events. </B></FONT></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24.5pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; text-align: left; margin-bottom: 0pt; text-indent: 0.5in">We are filing certain information for the
purpose of updating the description of our business contained in our other filings with the Securities and Exchange Commission.
A copy of this additional disclosure is attached as Exhibit 99.1 to this report and incorporated herein by reference.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24.5pt">&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: 1in; font-size: 10pt"><FONT STYLE="font-size: 10pt"><B>Item 9.01</B></FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: justify"><FONT STYLE="font-size: 10pt"><B>Financial Statements and Exhibits.</B></FONT></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><B>&nbsp;</B></P>

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<TD STYLE="width: 0in"></TD><TD STYLE="width: 0.25in; text-align: left"><B>(d)</B></TD><TD STYLE="text-align: justify"><B>Exhibits.</B></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="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: bottom">
    <TD NOWRAP STYLE="width: 1in">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; border-bottom: black 1pt solid"><B>Exhibit No.</B></P></TD>
    <TD STYLE="width: 0.15in; font-size: 10pt">&nbsp;</TD>
    <TD NOWRAP>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; border-bottom: black 1pt solid"><B>Description</B></P></TD></TR>
<TR>
    <TD NOWRAP STYLE="vertical-align: top; font-size: 10pt; text-align: center; padding-top: 3pt"><FONT STYLE="font-size: 10pt">99.1</FONT></TD>
    <TD STYLE="vertical-align: bottom; font-size: 10pt; padding-top: 3pt">&nbsp;</TD>
    <TD STYLE="vertical-align: top; font-size: 10pt; padding-top: 3pt"><FONT STYLE="font-size: 10pt">Company Disclosure</FONT></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>


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

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

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

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

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<TR STYLE="vertical-align: top">
    <TD><FONT STYLE="font-size: 10pt">Date: September 1, 2016</FONT></TD>
    <TD COLSPAN="2"><FONT STYLE="font-size: 10pt"><B>AmpliPhi Biosciences Corporation</B></FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD COLSPAN="2">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 50%">&nbsp;</TD>
    <TD STYLE="width: 1%"><FONT STYLE="font-size: 10pt">By: </FONT></TD>
    <TD STYLE="width: 49%; border-bottom: black 1pt solid"><FONT STYLE="font-size: 10pt">/s/ Steve R. Martin</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-size: 10pt">Name:&nbsp;&nbsp;</FONT></TD>
    <TD><FONT STYLE="font-size: 10pt">Steve R. Martin</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-size: 10pt">Title: </FONT></TD>
    <TD><FONT STYLE="font-size: 10pt">Chief Financial Officer</FONT></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>


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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: bottom">
    <TD NOWRAP STYLE="width: 1in">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; border-bottom: black 1pt solid"><B>Exhibit No.</B></P></TD>
    <TD STYLE="width: 0.15in">&nbsp;</TD>
    <TD NOWRAP>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; border-bottom: black 1pt solid"><B>Description</B></P></TD></TR>
<TR>
    <TD NOWRAP STYLE="vertical-align: top; text-align: center; padding-top: 3pt"><FONT STYLE="font-size: 10pt">99.1</FONT></TD>
    <TD STYLE="vertical-align: bottom; padding-top: 3pt">&nbsp;</TD>
    <TD STYLE="vertical-align: top; padding-top: 3pt"><FONT STYLE="font-size: 10pt">Company Disclosure</FONT></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

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

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<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>v448196_ex99-1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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<P STYLE="margin: 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right"><B>Exhibit 99.1</B></P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">We are a biotechnology company focused on the discovery, development
and commercialization of novel phage therapeutics. Phage therapeutics use bacteriophages, a family of viruses, to kill pathogenic
bacteria. Phages have powerful and highly selective mechanisms of action that permit them to target and kill specific bacteria.
We believe that phages represent a promising means to treat bacterial infections, especially those that have developed resistance
to current therapies, including the so-called multi-drug-resistant or &ldquo;superbug&rdquo; strains of bacteria.&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">Our goal is to be the leading developer of phage therapeutics.
We are combining our expertise in the manufacture of drug-quality bacteriophages and our proprietary approach and expertise in
identifying, characterizing and developing naturally occurring bacteriophages with that of our collaboration partners in bacteriophage
biology, synthetic biology and manufacturing, to develop second-generation bacteriophage products.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The extensive use of antibiotics since their discovery in the
1940s has resulted in drug resistance among many disease-causing bacteria. According to the U.S. Centers for Disease Control and
Prevention, or CDC, resistance to antibiotics threatens to reverse many of the key medical advances of the last half-century. Examples
of clinically important microbes that are rapidly developing resistance to available antimicrobials include bacteria that cause
skin, bone, lung and bloodstream infections (e.g., <I>S. aureus</I> and methicillin-resistant <I>S. aureus</I>, or MRSA), pneumonia
and lung infections in both community and hospital settings and cystic fibrosis patients (e.g., <I>A. baumanii, P. aeruginosa,</I>
and <I>K. pneumoniae</I>), meningitis (e.g., <I>S. pneumonia</I>), urinary tract and gastrointestinal infections (e.g., <I>E. coli</I>
and <I>C. difficile</I>). As phages kill bacteria in ways entirely unlike the mechanisms used by traditional antibiotics, we believe
that multi-drug resistant bacteria will be susceptible to phage therapy. Furthermore, should resistant bacteria emerge or evolve,
we believe it will remain possible to identify phages that can effectively kill these resistant bacteria.</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">Our lead product candidate is AB-SA01, for the treatment of
<I>S. aureus</I> infections, including MRSA. We also have another product candidate in earlier stage development, AB-PA01 for the
treatment of <I>P. aeruginosa</I> infections, and an additional discovery program, AB-CD01 for the treatment of <I>C. difficile</I>
infections.</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">We are developing our phage product candidates using a proprietary
discovery and development platform, which is designed for rapid identification, characterization and manufacturing of multiple
phage therapeutics. Each product candidate combines several carefully chosen phages, which target a specific disease-causing bacteria
such as <I>S. aureus, P. aeruginosa</I>, and <I>C. difficile</I>. We believe that the combination of our platform, our manufacturing
capability, our understanding of the regulatory and development requirements of bacteriophage therapeutics, and the clinical and
scientific expertise of our collaboration partners may enable the rapid advancement of phage therapeutics through the clinic and
the regulatory approval process.</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">In June 2013, we entered into a cooperative research and development
agreement, or Research and Development Agreement, with the United States Army Medical Research and Materiel Command focusing on
developing bacteriophage therapeutics to treat <I>S. aureus</I>, <I>E. coli</I> and <I>P. aeruginosa</I> infections. Under this
Research and Development Agreement, we completed enrollment of a Phase 1 safety study of AB-SA01 for the treatment of wounds infected
with <I>S. aureus</I> in July 2016. We expect to report top-line results by the end of the third quarter of 2016, with the complete
study report expected by the end of 2016.</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">In September 2013, we entered into a license agreement, or the
Leicester License Agreement, with the University of Leicester to develop a phage therapy to kill certain types of <I>C. difficile</I>.
Pursuant to the Leicester License Agreement, we may be obligated to pay the University of Leicester a single digit royalty and
an aggregate of up to &pound;575,000 in milestone payments.</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">In November 2015, our Australian subsidiary, AmpliPhi Australia
Pty Ltd, entered into a clinical trial research agreement with the University of Adelaide and the Queen Elizabeth Hospital, both
of Adelaide, SA, Australia, to conduct a Phase 1 clinical trial titled &ldquo;A Phase 1 Investigator Initiated Study to Evaluate
the Safety, Tolerability and Preliminary Effectiveness of AB-SA01 in Patients with Chronic Rhinosinusitis Associated with <I>S.
aureus</I> infection&rdquo;. The University of Adelaide will sponsor the clinical trial while we will supply AB-SA01 and control
the trial protocol. This clinical trial will primarily measure the safety and tolerability of AB-SA01 and will secondarily examine
the presence of <I>S. aureus </I>and symptoms assessed by the patient as well as by the physician using standard questionnaires
used by physicians to assess treatment efficacy. We plan to enroll nine patients, divided into three cohorts. The first cohort
received a twice daily dose of AB-SA01 for seven days. The second cohort received the same dose twice daily for 14 days. The third
cohort will receive a higher dose of AB-SA01 twice daily for 14 days. Patients will be monitored an additional 30 days following
their last day of treatment. Patient screening for this clinical trial commenced in late 2015 and the first patient was dosed in
January 2016. The first and second cohorts have been completed and the first subject in the third cohort has completed dosing.
Two subjects remain to be dosed in the final cohort and we expect to report data from this first clinical trial in the second half
of 2016. We are planning a Phase 2 trial in chronic rhinosinusitis patients, to commence in the second half of 2017.</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">In January 2016, we entered into an Asset Purchase Agreement
with Novolytics Ltd., which we refer to as the Novolytics Purchase Agreement, to purchase certain tangible and intangible assets.
Pursuant to the Novolytics Purchase Agreement, we acquired all rights, title and interest to two families of patents. The first
patent family is titled &ldquo;Anti-bacterial compositions&rdquo; and has been granted in Australia and China with prosecution
pending in the United States and other countries. The second patent family is titled &ldquo;Novel bacteriophages&rdquo; and the
prosecution is pending in the United States and other countries. We also received clinical isolates for <I>S. aureus</I> which
will bolster our libraries of clinically relevant strains. Additionally, we received know-how relating to certain formulation processes.
We also have access to all previous dialogue between Novolytics and various regulatory organizations including the United Kingdom
Medicines and Healthcare Products Regulatory Agency, or MHRA.</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>The Need for New Anti-Infective Therapies</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">The rapid and continuous emergence of antibiotic-resistant bacteria
has become a global crisis. Despite this crisis, the number of novel anti-infective therapies currently in development is at historically-low
levels. The CDC estimates that more than two million people in the United States acquire an antibiotic-resistant infection each
year and more than 23,000 of these prove fatal. It is estimated that 50% of hospital-acquired infections are resistant to first-line
anti-infective therapies. The cumulative annual cost for treating resistant bacterial infections in the United States alone is
estimated to be $20 billion, while the global antibiotics market opportunity was estimated to be $40.3 billion in 2015.</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">The CDC&rsquo;s latest report on the matter, <I>Antibiotic Resistance
Threats in the United States, 2013</I>, notes that there are &ldquo;potentially catastrophic consequences of inaction&rdquo; and
ranks <I>C. difficile</I> as belonging to the highest tier of threat, or &ldquo;Urgent Threats.&rdquo; Despite the potential market
opportunity, only two New Drug Applications, or NDAs, for antibacterial drugs were approved by the FDA between 2010 and 2012 compared
to 18 in the period between 1980 and 1984. One of the primary recommendations of the CDC is the development of new antimicrobials
to diversify treatment options.</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>Product Candidates</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>AB-SA01: Infections Caused by S. aureus &nbsp;</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">By screening our proprietary library of phage samples against
a panel of <I>S. aureus</I> bacteria, collected from around the world, we have selected a phage product candidate mix that has
demonstrated, in <I>in vitro</I> studies, greater than 92% efficacy with high overlap against a global diversity panel that includes
some of the most virulent isolates of <I>S. aureus</I>, including MRSA isolates. The three phage constituents of AB-SA01 were selected
for their ability to target the greatest number of bacterial isolates in the collection and maximal complementation. Complementation,
defined as the percentage of <I>S. aureus</I> isolates susceptible to more than one phage, is emphasized in product selection to
reduce risk of the emergence of bacterial resistance.</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">In connection with our Research and Development Agreement with
the U.S. Army Medical Research and Materiel Command, we are developing AB-SA01 to treat acute and chronic infections caused by
<I>S. aureus</I>, including infections caused by MRSA strains of the same bacterium. MRSA infections are one of the most common
causes of hospital-acquired (nosocomial) infections. The CDC estimates that more than 850,000 patients were treated for <I>S. aureus</I>
infections of the skin or soft tissue in 2013 and, due to failure of first line treatment, more than 50% of these patients required
a second-line treatment and approximately 35% of them required a third-line treatment. Global Data estimates the market for MRSA
infection treatments alone was more than $2.7 billion in 2007. This market is forecasted to grow to more than $3.5 billion by 2019.</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">Also in connection with our Research and Development Agreement
with the U.S. Army, we submitted a pre-IND briefing package to the FDA to obtain their feedback on our Chemistry, Manufacturing
and Controls, or CMC, program and plans for our first human clinical trial of AB-SA01 for the treatment of <I>S. aureus</I> infections
of wound and skin. The FDA concurred with our plan for progressing this bacteriophage product candidate into clinical trials, specifically
agreeing with the proposed manufacturing process and product specifications and not requiring non-clinical toxicology data to initiate
our first Phase 1 clinical trial. We initiated the Phase 1 clinical trial in May 2016 and completed enrollment in July 2016. We
expect the complete study report to be available before the end of 2016.</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">In December 2015, we opened a clinical trial at the University
of Adelaide Queen Elizabeth Hospital to evaluate the safety and preliminary efficacy of AB-SA01 in chronic rhinosinusitis patients
infected with <I>S. aureus</I>. The first patient in this clinical trial was dosed in January 2016, and we have continued to dose
additional patients and completed the first two cohorts in July 2016. We expect to complete enrollment of the last two patients
during the third quarter of 2016 and report data from this first clinical trial by the end of 2016. We expect to initiate a Phase
2 trial of AB-SA01 in the second half of 2017 and to complete that trial within approximately 12 months thereafter.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>AB-PA01: Lung Infections in Cystic Fibrosis (CF) Patients
Caused by P. aeruginosa</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">We are initially developing AB-PA01 for the treatment of <I>P.
aeruginosa</I>, the most prevalent bacterial infection in cystic fibrosis, or CF, patients and the one that leads to the highest
mortality and is the primary cause of lung infection in approximately 80% of CF patients ages 25 to 34, causing an estimated 450
deaths per year in the United States. To develop our product candidates, we have created a global diversity panel of relevant clinical
isolates (bacteria isolated from patients) from clinics around the globe. These diversity panels have been screened against our
phage libraries, which are isolated and characterized according to our set of proprietary discovery protocols. We have demonstrated,
in <I>in vitro</I> and <I>in vivo</I> studies, that our proprietary phage mix is able to effectively kill targeted bacteria. Furthermore,
our phage mixes are selected to exhibit a high degree of overlap, defined as the number of bacteria targeted by more than one phage
in the product. We believe that high overlap is an important factor in preventing bacteria from developing resistance to our phage
product candidates.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Similar to work described above for <I>S. aureus</I>, we have
tested over 400 clinical <I>P. aeruginosa</I> clinical isolates. As an example, initial host range testing was performed with a
reference panel of 67 CF isolates. AB-PA01 showed an activity of 95.5% (64/67) with 87.5% (56/64) of the positives isolates hit
by more than one phage in the mix.</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">In collaboration with Institut Pasteur (Paris, France) and also
with the Brompton Hospital, Imperial College (London, United Kingdom), we have demonstrated in the preclinical studies that phages
can effectively treat infections in animal models of acute <I>P. aeruginosa</I> lung infections. In one such study, we inoculated
eight mice and treated them with either PBS (control group), our phage mix, or with an antibiotic.</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">Bacterial counts and the number of bacteriophage infection units
detected by assay, or phage titers, were measured in these animals after 24 hours, and the results demonstrated that our phage
mix effectively lowered the bacterial counts, or CFU, in the mouse lung to levels comparable to antibiotic treatment (PBS vs. antibiotic,
p=0.0003; PBS vs. bacteriophage, p=0.0003). A p-value is a statistical measure of the probability that the difference in two values
could have occurred by chance. The smaller the p-value, the lower the likelihood is that the difference occurred by chance, or
the greater our confidence is that the results are statistically significant. Furthermore, it was evident that phage replicated
to high levels in the infected lung.</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">An additional preclinical study conducted at the Institut Pasteur
in mice (12 mice in each of the treatment and control groups) demonstrated the ability of our phage mix to reach the lung within
two hours of being delivered by oral administration. The phage levels increased between two and six hours post-treatment, and the
results were statistically significant (p-value &lt;0.001). These results demonstrate that when orally administered in mice, phages
not only reached the lungs, but were also able to infect and multiply in target bacteria.</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">In a separate <I>in vivo</I> study of acute <I>P. aeruginosa</I>
infection of the mouse lung conducted at the Brompton Clinic, results demonstrated that our phage mix reduced CFU levels upon simultaneous
intranasal administration (six mice in each of the treatment and control groups) and also when administered 24 hours post-bacterial
infection (seven mice in the treatment group and eight mice in the control group) using a standard strain of <I>P. aeruginosa</I>,
Pa01.</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">We were granted an advisory meeting with the MHRA in the first
quarter of 2014 to discuss our plans and intend to move the AB-PA01 compound into additional preclinical testing in preparation
for a Phase 1/2 clinical trial in CF patients. We also sought advice on the acceptability of CMC plans. The MHRA concurred with
our approach and plans as presented, including a first-in-man dose ranging clinical trial in CF patients. We have completed product
candidate selection and are currently conducting manufacturing process development and scale-up with the goal of initiating inhalation
toxicology studies in the first quarter of 2017 and completing such studies within approximately six months thereafter. We plan
to initiate a Phase 1 single-ascending dose study in CF patients during the second half of 2017 and currently expect to complete
that study within approximately 12 months thereafter.</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">We are also currently evaluating our <I>P. aeruginosa</I> phages
in preclinical animal models of chronic rhinosinusitis in collaboration with the University of Adelaide. Pending the outcome of
this study, we also expect to move AB-PA01 into a chronic rhinosinusitis study in Australia in the second half of 2017. We expect
the study to be similar in design to our current Phase 1 study of AB-SA01 in chronic rhinosinusitis, except the AB-PA01 study will
target <I>P. aeruginosa</I> in chronic rhinosinusitis patients.</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">If we achieve successful proof of concept studies, we may consider
developing this compound for the treatment of other acute and chronic lung infections, such as ventilator associated bacterial
pneumonia, or VABP, and chronic obstructive pulmonary disease, or COPD. <I>P. aeruginosa </I>is the predominant pathogen in these
indications.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>AB-CD01: Gastrointestinal (GI) Infection Caused by C.
difficile, or CDI</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">From 2000 through 2007, deaths in the United States from CDI
increased over 400%. Over 90% of such deaths occur in hospitalized or confined patients over the age of 65. Global Data estimates
that the major European Union and United States markets for CDI therapies grew to more than $314 million in 2011 and they are expected
to grow to more than $500 million by 2019.</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">According to the CDC almost 250,000 people each year require
hospitalization for CDI and at least 14,000 people die each year in the United States from CDI. The CDC also estimates that 20-40%
of CDI recurs with standard antibiotic treatment. We are actively working with researchers at the University of Leicester to develop
a phage therapeutic that targets and kills <I>C. difficile</I>. We believe that orally delivered phages are well suited to treat
CDI. Within this collaboration, researchers at the University of Leicester have discovered phages that have been shown to be effective
<I>in vitro</I> and <I>in vivo</I> against clinically-relevant strains of <I>C. difficile</I> isolated from around the world. These
same researchers have also shown phage cocktails to be effective in preventing <I>C. difficile </I>biofilm formation <I>in vitro</I>.
While current pathogenic strains of <I>C. difficile</I> are not yet antibiotic-resistant, the CDC has categorized <I>C. difficile</I>
as an urgent threat and has stated that CDI requires urgent and aggressive action. We believe that there is a significant market
opportunity for our product in treating this infection.</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">Preclinical studies are underway to select and optimize our
phage cocktail and manufacturing strains as well as evaluate efficacy in animal models.</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>Prior Clinical Development</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">In 2010, our wholly owned subsidiary, Biocontrol Ltd, reported
a double-blind placebo-controlled, randomized Phase 1/2 clinical trial targeting chronic ear infections (otitis) caused by <I>P.
aeruginosa</I>. To our knowledge, this was the first randomized placebo-controlled efficacy trial of bacteriophage therapy. Results
were published demonstrating decreasing levels of <I>P. aeruginosa</I> in the ear and improvement of clinical condition with a
single input dose of 2.4 nanograms of bacteriophage preparation. While this was a small trial (n=24), changes from baseline at
the end of the trial in the test group (n=12) were statistically significant for both clinical condition (p=0.001) and bacterial
load (p=0.016). No significant changes were seen in the control group (n=12) compared to baseline at the end of the trial. Difference
between test and control groups was statistically significant by analysis by covariance on day 21 for bacterial count (p=0.0365).
These results will need to be validated in larger well-controlled trials.<B>&nbsp;</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Anti-Infective Therapeutics Market</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">The market opportunity for antibiotics is large, with the market
estimated to reach $40.3 billion in annual sales globally in 2015. Almost one in every five deaths worldwide occurs as a result
of infection and, according to the World Health Organization, or WHO, many bacterial infections will become difficult or impossible
to cure as the efficacy of current antibiotic drugs wanes. Despite the advances in antimicrobial and vaccine development, infectious
diseases still remain as the third-leading cause of death in the United States and the second-leading cause of death worldwide.</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">The number of new antibiotics approved by the FDA and other
global regulatory authorities has declined consistently over the last two decades. According to the PEW Charitable Trusts report,
as of March 2016 there are an estimated 37 new antibiotics in clinical development for the U.S. market. Historically, the success
rate from Phase 1 to marketing approval is only 1 in 5 for infectious disease products. We therefore believe there is a need for
new approaches to treat serious bacterial infections. Hospital-acquired (nosocomial) infections are a major healthcare problem
throughout the world, affecting developed countries as well as resource-poor countries. The WHO reports that hospital-acquired
infections are among the major causes of death and increased morbidity among hospitalized patients and estimates that more than
1.4 million people per year worldwide suffer from infectious complications from a hospital stay.</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">A recent CDC report also cites that in the United States, between
5 and 10% of all patients admitted to a hospital will be affected by a hospital-acquired infection during their stay, typically
requiring extended stays and additional care. There is also a significant risk of death from such infections. In the United States,
the CDC estimates that approximately 99,000 people die from hospital-acquired infections each year. The Cystic Fibrosis Foundation
estimates that <I>P. aeruginosa</I> accounts for 10% of all hospital-acquired infections.</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">Compounding the above situations is the alarming and continuing
rise in the prevalence of antibiotic-resistant bacterial infections. This, coupled with the lack of new antibiotics in current
discovery and development pipelines, has generated a significant clinical management problem worldwide, leading to increases in
morbidity and mortality due to these antibiotic-resistant bacteria as well as increases in healthcare costs.</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">The first of these antibiotic-resistant infections to reach
epidemic proportions was caused by the Gram-positive bacterium <I>S. aureus</I>. <I>S. aureus</I> resistance to a broad range of
antibiotics has necessitated the use of expensive and potentially toxic &ldquo;drugs of last resort&rdquo;, most notably vancomycin.
Antibiotic-resistant forms of <I>S. aureus</I>, usually termed MRSA, VISA (vancomycin-intermediate <I>S. aureus</I>), or VRSA (vancomycin-resistant
<I>S. aureus</I>), can be extremely challenging to treat. Although several antibiotics targeting <I>S. aureus</I> have been developed,
rapidly developing bacterial resistance has been noted for all of these including linezolid, daptomycin and tigecycline. On the
basis of historical evidence, resistance to these existing products is likely to increase over time, and this picture is further
complicated by the reduced efficacy of conventional antibiotics against <I>Staphylococcus</I> biofilms.</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">Typically, <I>S. aureus</I> infection causes a variety of suppurative
(pus-forming) infections and toxinoses (lesions) in humans. It causes superficial skin lesions such as boils, styes and furuncles;
more serious infections such as pneumonia, mastitis, phlebitis, meningitis and urinary tract infections; and deep-seated infections,
such as osteomyelitis and endocarditis. <I>S. aureus</I> is the leading cause of wound infections, in particular, hospital-acquired
(nosocomial) infection of surgical wounds and infections associated with indwelling medical devices. <I>S. aureus </I>is the leading
pathogen in healthcare-associated infections in the United States as a whole, accounting for 30.4% of surgical site infections,
or SSI, and 15.6% of such infections overall.</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">Infections also occur in connection with CF, which is a genetic
disease affecting primarily Caucasians of northern European descent. According to the Cystic Fibrosis Foundation, there are approximately
50,000 cases of CF in North America and Europe. <I>P. aeruginosa</I> opportunistically infects the mucous membranes, primarily
the lungs, of CF patients and quickly grows out of control, resulting in pneumonia. <I>P. aeruginosa</I> infections are notoriously
resistant to known antibiotics, and treatment may be further complicated by the formation of biofilms. Biofilms are organized structures
of microorganisms growing on solid surfaces (such as lung tissue) and often limit access of antibiotics to the covered tissues.
Since phages attack bacteria in a manner independent of chemical antibiotic resistance mechanisms and can infect bacteria growing
in biofilms, we believe that <I>P. aeruginosa</I> infection among CF patients represents a compelling indication to pursue. The
availability of <I>Pseudomonas</I>-specific phages along with validated animal models of <I>P. aeruginosa</I> lung infections has
contributed to the development of our bacteriophage program in CF.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Anti-Infective Treatments with Bacteriophages</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Background</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">The dramatic rise in antibiotic resistance, the appearance of
an increasing number of new &ldquo;superbugs&rdquo; and the lack of new antibiotics in the pipeline has prompted calls to action
from many of the world&rsquo;s major health bodies such as the CDC and the WHO, who warn of an &ldquo;antibiotic cliff&rdquo; and
a &ldquo;post-antibiotic era.&rdquo; In 2009, the European Antimicrobial Resistance Surveillance System, or EARSS, concluded that
&ldquo;the loss of effective antimicrobial therapy increasingly threatens the delivery of crucial health services in hospitals
and in the community.&rdquo; This conclusion was reinforced by The Antimicrobial Availability Task Force, or AATF, of the Infectious
Diseases Society of America, or IDSA, and the European Centre for Disease Prevention and Control, or ECDC, in conjunction with
the European Medicine Agency, or EMA. Clearly, there is a pressing need to find alternative antibacterial therapies.</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">Bacteriophage therapy has the potential to be an alternative
method of treating bacterial infection. Phages are ubiquitous environmental viruses that grow only within bacteria. The name &ldquo;bacteriophage&rdquo;
translates as &ldquo;eaters of bacteria&rdquo; and reflects the fact that as they grow, phages kill the bacterial host by multiplying
inside and then bursting through the cell membrane in order to release the next generation of phages. Phages can differ substantially
in morphology and each phage is active against a specific range of a given bacterial species. Phages were first discovered in 1915
at the Institut Pasteur and were shown to kill bacteria taken from patients suffering from dysentery. Furthermore, it was noted
that phage numbers rose as patients recovered from infection, suggesting a direct association.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Life Cycle of a Bacteriophage</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"><IMG SRC="image_001.jpg" ALT="http:||www.sec.gov|Archives|edgar|data|921114|000114420415031219|tpg53.jpg" STYLE="height: 141px; width: 577px"></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">Until the discovery of effective antibiotics, phages were used
as an effective means of combating bacterial infection. When broad-spectrum antibiotics came into common use in the early 1940s,
phages were considered unnecessary, with antibiotics being seen for many years as the answer to bacterial disease. This attitude
persisted until the development of the wide-ranging, and in some cases total, resistance to antibiotics seen within the last 10
years.&nbsp;&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">Phages have the potential to provide both an alternative to,
and a synergistic approach with, antibiotic therapy. Since they use different mechanisms of action, phages are unaffected by resistance
to conventional antibiotics. Phages containing certain enzymes also have the ability to disrupt bacterial biofilms, thus potentiating
the effect of chemical antibiotics when used in combination with them.&nbsp;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Our Strategy</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">Our strategy is to use techniques of modern biotechnology and
current state-of-the-art practices for drug development in concert with existing regulatory guidance to develop a pipeline of bacteriophage
products that will destroy bacteria such as MRSA, which are resistant to antibiotics. Our business strategy will apply state-of-the-art
techniques in molecular biology and in clinical trial design to build upon the long successful history of using phages therapeutically
to treat and cure infections.</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">We supplement our internal resources with world-class scientific
and medical collaborations throughout the world. For example, through a collaboration with The University of Adelaide in Australia,
we conducted preclinical studies showing the ability of <I>S.&nbsp;aureus</I> phage preparations to kill clinical isolates from
61 patients demonstrating efficacy of greater than 90%. Furthermore, a <I>S. aureus</I> mixture was shown to be safe and efficacious
in a preclinical sheep model of chronic rhinosinusitis. This program continues to progress and a clinical trial of patients at
the University of Adelaide&rsquo;s Queen Elizabeth Hospital with treatment refractory chronic rhinosinusitis patients infected
with<I> S. aureus</I> commenced in late 2015 and the first patient was dosed in January 2016. More recently, we tested 90 <I>S.
aureus</I> clinical isolates from chronic rhinosinusitis patients located in Belgium and showed similar efficacy to isolates obtained
from Australian patients, highlighting the diverse geographic activity of our phage cocktail.</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">In collaboration with the U.S. Army, we completed enrollment
of a Phase 1 safety study in July 2016 that we believe will support the further development of a treatment for <I>S. aureus</I>
infections for wound and skin infections.</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">We collaborate with the Royal Brompton Hospital in London where
we have demonstrated that a candidate phage product can survive nebulization, was effective in killing over 83% of recent clinical
<I>P. aeruginosa</I> isolates, and in preclinical mouse models demonstrated that a phage mixture dose-dependently clears <I>P.
aeruginosa</I> infection from the lung and reduced inflammation.</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>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">We have completed selection of the phages for drug product
selection for AB-PA01, and in conjunction with the Brompton Hospital, we would expect to conduct a Phase 1/2 study using AB-PA01
to treat CF patients with <I>P. aeruginosa</I> lung infections.</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>Acquisitions</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">In January 2011, we completed the acquisition of Biocontrol
Ltd, with the goal of developing their phage therapy programs using funding from the sale of our legacy gene therapy assets. Under
the terms of our acquisition of Biocontrol Ltd, we issued 456,344 shares of our common stock to the stockholders of Biocontrol
Ltd with a total fair value of approximately $8.6 million as of January 6, 2011, resulting in Biocontrol&rsquo;s former stockholders
owning approximately 50% of our outstanding equity securities at the time. As a condition to closing the acquisition, Biocontrol
Ltd raised approximately &pound;200,000 (US$310,000) in working capital for use by us.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 5.4pt 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 5.4pt 0pt 0; text-align: justify">In November 2012, we completed
the acquisition of Special Phage Holdings Pty Ltd, a company based in Australia, which we refer to as SPH, with the goal of combining
SPH&rsquo;s research on addressing the rapidly escalating problem of antibiotic resistance through the development of a series
of bacteriophage-based treatments into our own development programs. We acquired SPH in exchange for shares of our common stock
pursuant to the terms of a Stockholder Sale Agreement and a Managers Warranty Deed.</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">In connection with our acquisition of SPH, we entered into certain
other arrangements, including the repayment under a Loan Repayment Deed (as amended) of a $770,000 loan originally made by Cellabs
Pty Ltd, or Cellabs, an Australian company, to SPH, a consulting agreement with Dr. Anthony Smithyman and the payment of $3,017
per month to Cellabs for our laboratory space in Australia through December 31, 2015. Under the terms of the Loan Repayment Deed,
the loan from Cellabs to SPH was to be repaid and fully satisfied partly in cash and partly by issuing 40,000 shares of our common
stock to Cellabs. As of December 31, 2015, $350,000 has been paid by us to Cellabs and all 40,000 shares have been issued. We paid
the remaining balance of $200,000 under the terms of the Loan Repayment Deed in December 2013. The SPH acquisition also included
several phage therapy projects which had reached the pre-clinical or animal study stage, including the Brompton Hospital CF study,
the Adelaide University MRSA chronic rhinosinusitis study and the University of Leicester <I>C. difficile</I> project. We believe
that acquisition of SPH brought substantial phage scientific expertise and know-how to us.</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">In January 2016, we entered the Novolytics Purchase Agreement,
pursuant to which we acquired all rights, title and interest to two families of patents. The first patent family is titled &ldquo;Anti-bacterial
compositions&rdquo; and has been granted in Australia and China, with prosecution pending in the United States and other countries.
The second patent family is titled &ldquo;Novel bacteriophages&rdquo; and the prosecution is pending in the United States and other
countries. We also received clinical isolates for <I>S. aureus</I> which will bolster our libraries of clinically relevant strains.
Additionally, we received know-how relating to certain formulation processes. We also have access to all previous dialogue between
Novolytics and various regulatory organizations including the MHRA.</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">In connection with the Novolytics Purchase Agreement, we paid
cash to Novolytics to cover expenses incurred in connection with winding up its phage-related business, as well as warrants to
the stockholders of Novolytics to purchase up to an aggregate of 170,000 shares of our common stock, each with an exercise price
of $12.00 per share. Pursuant to the terms of the Novolytics Purchase Agreement, we granted certain registration rights covering
the resale of the shares of common stock underlying such warrants.</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>Strategic Alliances and Research and License Agreements</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">As discussed below, we have established collaborations with
the U.S. Army and the University of Leicester, which provide us with access to the considerable scientific, developmental, and
regulatory capabilities of our collaborators. We believe that our collaborations contribute to our ability to rapidly advance our
product candidates, build our product platform and concurrently progress a wide range of discovery and development programs.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Global R&amp;D Agreement with U.S. Army</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">In June 2013, we entered into a Research and Development Agreement
with the U.S. Army Medical Research and Materiel Command. The Research and Development Agreement focuses on developing bacteriophage
therapeutics to treat at least three types of infections: <I>S. aureus</I>, <I>E. coli</I> and <I>P. aeruginosa</I>. The initial
indication will be wounds and skin infections from <I>S. aureus</I>, which is the leading pathogen in healthcare-associated infections
in the United States as a whole, accounting for 30.4% of surgical site infections.</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">We retain global regulatory ownership and commercial rights
to all products developed by us under the Research and Development Agreement. The U.S. Army Medical Research and Materiel Command
will have the right to retain a non-exclusive license to use any products developed by or on behalf of the U.S. Government for
non-commercial uses. We also have the rights to exclusively license any intellectual property developed by the U.S. Army Medical
Research and Materiel Command under the collaboration on terms to be agreed upon.</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">The Research and Development Agreement expires in June 2018
and can be terminated by either the U.S. Army Medical Research and Materiel Command or us upon 60 days&rsquo; written notice to
the other party at any time.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>University of Leicester Development Agreements</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">In April and September 2013, we entered into a collaboration
agreement and a license agreement, respectively, with the University of Leicester to develop a phage therapy that targets and kills
<I>C. difficile</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">Under these agreements, which we refer to collectively as the
Leicester Development Agreements, we are funding the University of Leicester to carry out <I>in vitro</I> studies and animal model
development work to identify bacteriophage to resolve <I>C. difficile</I> infections. We have licensed related patents, materials
and know-how from the University of Leicester. Under the Leicester Development Agreements, the University of Leicester will provide
the bacteriophage and act as overall project coordinator for preclinical studies. All rights, title and interest to any intellectual
property developed under the Leicester Development Agreements belong to us. Under the Leicester License Agreement, we have exclusive
rights to certain patents and materials owned by the University of Leicester, as well as non-exclusive licenses to related know-how.</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">The collaboration agreement expires in November 2018 and is
terminable by either party upon (a) material breach by the other party, subject to a 90-day cure period, (b) the inability of the
principal investigator to continue the collaboration or (c) our bankruptcy or winding up of our operations or, commencing on November
13, 2016, with 180 days&rsquo; notice.</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">Pursuant to the Leicester License Agreement, we paid an up-front
fee and will pay the University of Leicester royalties based on product sales and make certain milestone payments based on product
development. We are also required to pay minimum annual fees, which reduce future milestone payments. In the event that we sublicense
a product created under the Leicester Development Agreements, we have agreed to pay the University of Leicester certain milestone
payments or a certain percentage of any sublicense revenue received by us for the attainment of such milestone, as well as a certain
percentage of all royalty payments we receive from any sublicensees.</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">The license agreement expires on the later of the expiration
of the licensed patents or September 2028, and is terminable by us at any time upon 60 days&rsquo; notice, by the University of
Leicester (a) if we legally challenge the validity or ownership of any of the licensed patents, (b) if we fail to pay the fees,
milestones or royalties due under the license agreement or (c) if we fail to make substantial commercial process and agree with
Leicester that we will be unable to do so. The license agreement is also terminable by either party upon the material breach by
the other party (subject to a 30-day cure period) or upon the other party&rsquo;s bankruptcy or insolvency.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>License Agreement with United Kingdom Secretary of State
for the Department of Health</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">In January 2011, upon completion of our acquisition of Biocontrol
Ltd., we assumed a license agreement entered into in March 2007 between Biocontrol Ltd. and the Health Protection Agency, Centre
for Emergency Preparedness and Response, to use certain intellectual property rights to develop treatments for bacterial biofilm
infections. The agreement was subsequently assigned to the United Kingdom Secretary of State for the Department of Health, or DoH.</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">Under the license agreement, we have obtained exclusive rights
to a patent portfolio related to the use of bacteriophages combined with biofilm-disrupting agents in treating biofilm infections.
In consideration for the exclusive license, we may be required to pay to the DoH certain milestone payments in the aggregate of
up to &pound;10,000 per product, as well as single digit percentage royalty on net sales of products incorporating licensed intellectual
property.</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">The license agreement shall remain in full force and effect
until the expiration of the last patent exclusively licensed under the license agreement. If we default on any milestone or royalty
payments, or upon breach by us of certain other terms of the license agreement, the DoH may either terminate the license agreement
immediately upon written notice or modify the license to be non-exclusive upon 30 days&rsquo; written notice.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>General</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">Our goal is to obtain, maintain and enforce patent protection
for our product candidates, formulations, processes, methods and any other proprietary technologies, preserve our trade secrets
and operate without infringing on the proprietary rights of other parties, both in the United States and in other countries. Our
policy is to actively seek to obtain, where appropriate, the broadest intellectual property protection possible for our current
product candidates and any future product candidates, proprietary information and proprietary technology through a combination
of contractual arrangements and patents, both in the United States and abroad. However, patent protection may not afford us with
complete protection against competitors who seek to circumvent our patents.</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">We also depend upon the skills, knowledge, experience and know-how
of our management and research and development personnel, as well as that of our advisors, consultants and other contractors. To
help protect our proprietary know-how, which is not patentable, and for inventions for which patents may be difficult to enforce,
we currently and will in the future rely on trade secret protection and confidentiality agreements to protect our interests. To
this end, we require all of our employees, consultants, advisors and other contractors to enter into confidentiality agreements
that prohibit the disclosure of confidential information and, where applicable, require disclosure and assignment to us of the
ideas, developments, discoveries and inventions important to our business.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">As of August 17, 2016, we owned or had exclusive license rights
to a total of 65 patents and applications: five U.S. patents, seven U.S. patent applications, 37 foreign patents, and 16 foreign
patent applications, expiring on various dates between 2024 and 2036. These patents and applications cover our lead phage-therapeutic
programs and use thereof, the sequential use of bacteriophages in combination with conventional antibiotics, genetic sequence variations,
biofilm disrupting agents, methods to reduce antibiotic resistance, methods to design therapeutic combination panels of bacteriophage,
disinfection methods using bacteriophages, and bacteriophage mutants having increased bacterial host spectra.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>US 7758856 and national patents within the EU deriving
from PCT WO2004062677; Bacteriophage for the treatment of bacterial biofilms</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">Under an existing license from the United Kingdom Secretary
of State for the Department of Health (DoH), we have exclusive rights to a patent portfolio related to the use of bacteriophages
combined with biofilm-disrupting agents in treating biofilm infections. This portfolio includes one issued patent in the United
States and a patent granted in Europe (EP1587520 is validated in France, Germany, Netherlands, Switzerland, Liechtenstein and the
United Kingdom). Claims issued in these patents include those directed to compositions and methods related to agents that are able
to facilitate the penetration of biofilms, and their combination with therapeutic bacteriophage preparations. The U.S. patent is
expected to expire in December 2026 (absent any extensions). The foreign patents are expected to expire in January 2024 (absent
any extensions).</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>US 7807149, US 8105579, US 8388946, continuation application
and national filings deriving from PCT WO2005009451; Bacteriophage containing therapeutic agents</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">Through our wholly owned subsidiary, Biocontrol Ltd, we own
three granted U.S. patents and one pending U.S. continuation patent application (US 13/757655) with claims directed generally to
bacteriophage compositions, therapeutic methods of using bacteriophages, and methods of treating bacterial infections by sequentially
administering bacteriophages in combination with conventional antibiotics. The pending U.S. continuation application relates generally
to panels of bacteriophages with different strain specificities for bacterial infections. Corresponding patents have been granted
in Australia (AU2004258731), Europe (EP1663265 and EP2570130 &ndash; both patents are validated in the United Kingdom, Switzerland,
Liechtenstein, Germany, Spain, France, Italy and the Netherlands), Japan (JP5731727 and JP5856556) and Canada (CA2533352). Claims
issued in these patents include those directed to therapeutic and non-therapeutic applications of bacteriophage and the sequential
use of antibiotics to treat bacterial infections. U.S. patents are expected to expire from July 2024 to March 2027 (absent any
extensions). The foreign patents are expected to expire in July 2024 to March 2027 (absent any extensions).</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>US 8475787, continuation application and national filings
deriving from PCT WO2008110840; Beneficial effects of bacteriophage treatment</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">Through our wholly owned subsidiary, Biocontrol Ltd, we own
one granted U.S. patent (8475787), and one pending continuation application (14/625049). This patent family broadly relates to
bacteriophage-induced induction of antibiotic sensitivity in a bacterial target, such as <I>P. aeruginosa</I>. The granted U.S.
patent is expected to expire in July 2029 (absent any extensions). Corresponding patents have been granted in Australia (AU2008224651)
and Europe (EP2136826 &ndash; validated in the United Kingdom, Switzerland/Liechtenstein, Germany, Spain, France, Italy and the
Netherlands), and Allowance Notices issued in respect of our Japanese applications JP2010/521428 and JP2014/157433. A related Canadian
application (CA2680108) is currently pending. Foreign patents in this family are expected to expire in March 2028 (absent any extensions).</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>PCT WO2013/164640 (United Kingdom earliest priority filing
1207910.9); Therapeutic bacteriophage compositions</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">Through our wholly owned subsidiary, Biocontrol Ltd, we own
a Patent Cooperation Treaty, or PCT, application relating to the design of effective bacteriophage combinations and elimination
of antagonistic effects between said bacteriophage. The PCT application published on November 7, 2013, and following International
Preliminary Examination a positive patentability opinion issued. National/regional phase applications are currently pending in
the U.S. (US14/398384), Canada (CA2871986), Europe (EP2874635), Japan (JP2015/523850), and Australia (AU2013255583). Patents issuing
from this PCT, if any, are expected to expire in May 2032 (absent any extensions).</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>PCT WO2009/044163 (United Kingdom earliest priority filing
0719438.4); Anti-bacterial compositions</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">Pursuant to the terms of the Asset Purchase Agreement with Novolytics
Ltd., we acquired and currently own one U.S. continuation application (14/686315), relating to methods for killing/treating <I>Staphylococcus
aureus</I> and MRSA, among other bacteria, using a combined bacteriophage K and bacteriophage P68 composition. A corresponding
patent has been granted in Australia (AU2008306626) and China (CN101835384) and related applications are pending in Australia (AU2015264918),
Japan (JP2015/007087), Canada (CA2700646) and Europe (EP2197284). The granted foreign patents are expected to expire October 2028
(absent any extensions).</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>PCT WO2013/068743 (United Kingdom priority filing 1119167.3);
Novel bacteriophages</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">Pursuant to the terms of the Asset Purchase Agreement with Novolytics
Ltd., we acquired and currently own a U.S. patent application (14/356869) relating to <I>Staphylococcus aureus </I>and MRSA therapeutics,
and in particular Phage K mutants capable of targeting an increased number of <I>Staphylococcus aureus </I>strains when compared
to wild-type Phage K, as well as uses of said mutant. Related applications are also pending in Australia (AU2012335397), Canada
(CA2890450), Japan (JP 2014/533943) and Europe (EP2776559). Any granted patents will expire in November 2033.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>US 15/237496 (converted from United States provisional
filing 62/204915); Therapeutic bacteriophage compositions</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">We own U.S. patent application 15/237496, which is directed
to our AB-SA01 bacteriophage panel, mutants thereof, and methods of treating <I>Staphylococcus aureus </I>infections (including
MRSA) comprising the use of same. Corresponding foreign applications are being pursued by way of a parallel PCT application. Any
granted patent is expected to expire in August 2036 (absent extensions).</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">Our success in preserving market exclusivity for our product
candidates relies on patent protection, including extensions to this where appropriate, and on data exclusivity relating to an
approved biologic. This may be extended by orphan drug and/or pediatric use protection where appropriate. Once any regulatory period
of data exclusivity expires, depending on the status of our patent coverage, we may not be able to prevent others from marketing
and selling biosimilar versions of our product candidates. We are also dependent upon the diligence of our appointed agents in
national jurisdictions, acting for and on our behalf, which manage the prosecution of pending domestic and foreign patent applications
and maintain granted domestic and foreign patents.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Competition</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">We operate in highly competitive segments of the biotechnology
and biopharmaceutical markets. We face competition from many different sources, including commercial pharmaceutical and biotechnology
enterprises, academic institutions, government agencies and private and public research institutions all seeking to develop novel
treatment modalities for bacterial infections. Many of our competitors have significantly greater financial, product development,
manufacturing and marketing resources than we do. Large pharmaceutical companies have extensive experience in clinical development
and obtaining regulatory approval for drugs. In addition, many universities and private and public research institutes are active
in antibacterial research, some in direct competition with us. We also may compete with these organizations to recruit scientists
and clinical development personnel.</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">There are a handful of small biotechnology companies developing
bacteriophage products to treat human diseases. Other than our ongoing clinical trials there is, to our knowledge, one corporate-sponsored
clinical trial currently enrolling. A French biotechnology company, Pherecydes Pharma, is acting as clinical trial sponsor of a
Phase 1/2 clinical trial in Europe of a phage therapy for the treatment of burn wounds infected with either <I>E. coli</I> and
<I>P. aeruginosa</I>, referred to as PhagoBurn. This clinical trial is a randomized, multi-center open label study to assess tolerance
and efficacy of local treatment with a bacteriophage cocktail. A multi-center clinical trial also sponsored by Pherecydes Pharma
evaluating a bacteriophage cocktail versus placebo for diabetic foot ulcers, is listed on clinicaltrials.gov as active but not
yet enrolling. To our knowledge, a small number of biotechnology companies, including Synthetic Genomics and LytPhage, Inc., as
well as academic institutions, have earlier stage discovery programs utilizing synthetic biology approaches to genetically modify
bacteriophages to remove or input genes to improve therapeutic properties such as increases to the bacterial host range to infect
a larger number of bacterial strains and decrease the need for using multiple phages in a product.</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">A related approach to treating <I>Staphylococcus</I> infections
is being pursued by Contrafect Corporation using a bacteriophage lysin (a hydrolytic enzyme produced by bacteriophages) to treat
<I>S. aureus </I>bacteremia (infection in the blood). Contrafect has recently completed a Phase 1 intravenous single dose escalation
study in healthy volunteers.</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">Our bacteriophage programs may compete with or be synergistic
with currently approved antibiotics, and experimental approaches such as novel antibiotics, antimicrobial peptides, antimicrobial
vaccines, metals, antisense, monoclonal antibodies and possibly microbiome manipulation. For example, Seres Therapeutics is developing
a single-dose capsule (SER-109) consisting of bacterial spores to treat recurrent CDI (<I>Clostridium difficile</I> infection).
In May 2015, Seres initiated a multi-center, randomized, placebo-controlled Phase 2 clinical trial, to assess the efficacy and
safety of SER-109. SER-109, or similar products that may be in development by third parties, could prove to be competitive to or
used in conjunction with a bacteriophage therapeutic approach.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">We have developed our own manufacturing capabilities at a facility
in Ljubljana, Slovenia that is leased by our wholly owned subsidiary, AmpliPhi, Biotehnolo&scaron;ke Raziskave in Razvoj, d.o.o.
We believe that our facility complies with applicable cGMP regulations, which require, among other things, quality control and
quality assurance as well as the corresponding maintenance of records and documentation. Pharmaceutical product manufacturers and
other entities involved in the manufacture and distribution of approved pharmaceutical products are required to register their
establishments with the FDA, and certain state agencies, including the applicable government agency where the facility is located,
and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws.</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">After conducting a global search, we elected to proceed with
establishing a wholly owned cGMP compliant manufacturing facility in Ljubljana, Slovenia. Upon final product selection, we plan
to manufacture each of our product candidates in this facility. We have been able to access and hire highly skilled process development
and phage manufacturing expertise and believe that we have control of our proprietary platform from phage identification through
final product fill and finish. Our facility is comprised of approximately 4,000 sq. ft. of laboratory and office space, where we
produce cGMP clinical trial supplies for our current and planned clinical trials. We believe this facility will be sufficient to
meet our manufacturing needs through initial Phase&nbsp;3 clinical trials. Our current formulation for AB-SA01 is intended for
sinonasal or topical delivery via a nasal wash solution or dressed bandage. We plan to further optimize future formulations of
our product candidates.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></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">Our facility in Ljubljana, Slovenia is subject to inspection
and regulation by JAZMP, the Slovenian agency that regulates and supervises pharmaceutical products in Slovenia. Discovery of problems
with a product after approval may result in restrictions on a product, manufacturer or holder of an approved New Drug Application/Biologics
License Application, including withdrawal of the product from the market. In addition, changes to the manufacturing process generally
require prior regulatory approval before being implemented and other types of changes to the approved product, such as adding new
indications and additional labeling claims, are also subject to further regulatory review and approval, including approval by the
FDA.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Commercialization and Marketing</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">We have full worldwide commercial rights to all of our phage-based
product candidates to treat drug-resistant bacterial infections, including our product candidates: AB-PA01 for the treatment of
CF patients with <I>P. aeruginosa</I> lung infections; AB-SA01, for the treatment of <I>S. aureus</I> infections; and AB-CD01 for
the prevention or treatment of <I>C. difficile</I> infections. We believe we can maximize the value of our company by retaining
substantial global commercialization rights to these product candidates and, where appropriate, entering into partnerships to develop
and commercialize our other product candidates. We plan to build a successful commercial enterprise using a sales team in the United
States and possibly other major markets and with partners in other territories.</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">We have not yet established a sales, marketing or product distribution
infrastructure because our lead candidates are still in early clinical development. We generally expect to retain commercialization
and co-commercialization rights in the United States for all of our product candidates for which we receive marketing approvals.
Subject to receiving marketing approvals, we intend to explore building the necessary marketing and sales infrastructure to market
and sell our current product candidates. We also intend to explore the use of a variety of distribution agreements and commercial
partnerships in those territories where we do not establish a sales force for any of our product candidates that obtain marketing
approval.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Government Regulation and Product Approval</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Government authorities in the United States, at the federal,
state and local level, and other countries extensively regulate, among other things, the research, development, testing, manufacture,
quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring
and reporting, marketing and export and import of products such as those we are developing.<B><I>&nbsp;</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>United States Product Development Process</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">In the United States, the FDA regulates biological products
under the Federal Food, Drug and Cosmetic Act, or FDCA, and the Public Health Service Act, or the PHS Act, and related regulations.
Biological products are also subject to other federal, state and local statutes and regulations. The process of obtaining regulatory
approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the
expenditure of substantial time and financial resources. Failure to comply with the applicable United States requirements at any
time during the product development process or approval process, or after approval, may subject an applicant to administrative
or judicial sanctions. FDA sanctions could include refusal to approve pending applications, withdrawal of an approval, a clinical
hold, warning letters, product recalls, product seizures, total or partial suspension of production or distribution injunctions,
fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties. Any agency or judicial enforcement
action could have a material adverse effect on us. The process required by the FDA before a biological product may be marketed
in the United States generally includes the following:</P>

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

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in; padding-bottom: 2pt"></TD><TD STYLE="width: 0.25in; text-align: left; padding-bottom: 2pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-bottom: 2pt">completion of preclinical laboratory tests, animal
studies and formulation studies according to good laboratory practice requirements, or GLP, or other applicable regulations;</TD>
</TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in; padding-top: 2pt; padding-bottom: 2pt"></TD><TD STYLE="width: 0.25in; text-align: left; padding-top: 2pt; padding-bottom: 2pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-top: 2pt; padding-bottom: 2pt">submission to the FDA of an IND, which must become
effective before human clinical trials may begin in the United States;</TD>
</TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in; padding-top: 2pt; padding-bottom: 2pt"></TD><TD STYLE="width: 0.25in; text-align: left; padding-top: 2pt; padding-bottom: 2pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-top: 2pt; padding-bottom: 2pt">performance of adequate and well-controlled human
clinical trials according to the FDA&rsquo;s regulations commonly referred to as good clinical practices, or GCPs, and any additional
requirements for the protection of human research subjects and their health information, to establish the safety and efficacy
of the proposed biological product for its intended use or uses;</TD>
</TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in; padding-top: 2pt; padding-bottom: 2pt"></TD><TD STYLE="width: 0.25in; text-align: left; padding-top: 2pt; padding-bottom: 2pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-top: 2pt; padding-bottom: 2pt">submission to the FDA of a Biologics License Application,
or BLA, for a new biological product;</TD>
</TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in; padding-top: 2pt; padding-bottom: 2pt"></TD><TD STYLE="width: 0.25in; text-align: left; padding-top: 2pt; padding-bottom: 2pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-top: 2pt; padding-bottom: 2pt">satisfactory completion of an FDA inspection of the
manufacturing facility or facilities where the biological product is produced to assess compliance with the FDA&rsquo;s cGMP regulations,
to assure that the facilities, methods and controls are adequate to preserve the biological product&rsquo;s identity, strength,
quality and purity;</TD>
</TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in; padding-top: 2pt; padding-bottom: 2pt"></TD><TD STYLE="width: 0.25in; text-align: left; padding-top: 2pt; padding-bottom: 2pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-top: 2pt; padding-bottom: 2pt">potential FDA audit of the nonclinical study sites
and clinical trial sites that generated the data in support of the BLA; and</TD>
</TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in; padding-top: 2pt"></TD><TD STYLE="width: 0.25in; text-align: left; padding-top: 2pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-top: 2pt">FDA review and approval, or licensure, of the BLA
which must occur before a biological product can be marketed or sold.</TD>
</TR></TABLE>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The lengthy process of seeking required approvals and the continuing
need for compliance with applicable statutes and regulations require the expenditure of substantial resources even when approvals
are inherently uncertain.</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">The strategies, nature, and technologies of bacteriophage products
are different from the conventional antibiotic therapy products. From the regulatory requirements established to ensure the safety,
efficacy and quality of bacteriophage preparations, there are several major points to consider during the development, manufacturing,
characterization, preclinical study and clinical trial of bacteriophage. The major issues include:</P>

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

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in; padding-bottom: 2pt"></TD><TD STYLE="width: 0.25in; text-align: left; padding-bottom: 2pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-bottom: 2pt">bacteriophage preparation design (single agent versus
phage mixes and wild-type phage versus genetically engineered phage);</TD>
</TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in; padding-top: 2pt; padding-bottom: 2pt"></TD><TD STYLE="width: 0.25in; text-align: left; padding-top: 2pt; padding-bottom: 2pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-top: 2pt; padding-bottom: 2pt">proof of concept in development of bacteriophage products;</TD>
</TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in; padding-top: 2pt; padding-bottom: 2pt"></TD><TD STYLE="width: 0.25in; text-align: left; padding-top: 2pt; padding-bottom: 2pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-top: 2pt; padding-bottom: 2pt">selectivity of bacteriophage replication and targeting
to specific species of bacteria;</TD>
</TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in; padding-top: 2pt; padding-bottom: 2pt"></TD><TD STYLE="width: 0.25in; text-align: left; padding-top: 2pt; padding-bottom: 2pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-top: 2pt; padding-bottom: 2pt">relevant animal models in preclinical studies; and</TD>
</TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in; padding-top: 2pt"></TD><TD STYLE="width: 0.25in; text-align: left; padding-top: 2pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-top: 2pt">clinical safety and efficacy.</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">Before testing any compounds with potential therapeutic value
in humans, the biological product candidate enters the preclinical testing stage. Preclinical tests include laboratory evaluations
of product biology, toxicity and formulation, as well as animal studies to assess the potential safety and activity of the biological
product candidate. The conduct of the preclinical tests must comply with federal regulations and requirements including GLP. The
sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data, any available
clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND. The IND automatically becomes effective
30 days after receipt by the FDA, unless the FDA places the IND on a clinical hold within that 30 day time period. In such a case,
the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. The FDA may also impose
clinical holds on a product candidate at any time before or during clinical trials due to safety concerns or non-compliance. Accordingly,
we cannot be certain that submission of an IND will result in the FDA allowing clinical trials to begin, or that, once begun, issues
will not arise that suspend or terminate such clinical trial.</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">Clinical trials involve the administration of the product candidate
to healthy volunteers or patients under the supervision of qualified investigators, generally physicians not employed by the sponsor.
Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures,
subject inclusion and exclusion criteria and the parameters to be used to monitor subject safety. Each protocol must be submitted
to the FDA. Clinical trials must be conducted in accordance with GCP requirements. Further, each clinical trial must be reviewed
and approved by an independent institutional review board, or IRB, or ethics committee if conducted outside of the U.S., at or
servicing each institution at which the clinical trial will be conducted. An IRB or ethics committee is charged with protecting
the welfare and rights of trial participants and considers such items as whether the risks to individuals participating in the
clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB or ethics committee also approves
the informed consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor
the clinical trial until completed. We intend to use third-party Clinical Research Organizations, or CROs, to administer and conduct
our planned clinical trials and will rely upon such CROs, as well as medical institutions, clinical investigators and consultants,
to conduct our trials in accordance with our clinical protocols. The failure by any of such third parties to meet expected timelines,
adhere to our protocols or meet regulatory standards could adversely impact the subject product development program and we remain
legally responsible for compliance with applicable laws and regulations governing the conduct of these clinical 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">Human clinical trials are typically conducted in three sequential
phases that may overlap or be combined:</P>

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

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in; padding-bottom: 2pt"></TD><TD STYLE="width: 0.25in; text-align: left; padding-bottom: 2pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-bottom: 2pt">Phase 1: The product candidate is initially introduced
into healthy human subjects and tested primarily for safety and dosage tolerance. Absorption, metabolism, distribution and excretion
may also be tested.</TD>
</TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in; padding-top: 2pt; padding-bottom: 2pt"></TD><TD STYLE="width: 0.25in; text-align: left; padding-top: 2pt; padding-bottom: 2pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-top: 2pt; padding-bottom: 2pt">Phase 2: The product candidate is evaluated in a limited
patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product
candidate for specific targeted diseases and to determine dosage tolerance, optimal dosage and dosing schedule.</TD>
</TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in; padding-top: 2pt"></TD><TD STYLE="width: 0.25in; text-align: left; padding-top: 2pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-top: 2pt">Phase 3: Clinical trials are undertaken to further
evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical trial sites.
These clinical trials are intended to establish the overall risk/benefit ratio of the product and provide an adequate basis for
product labeling. Generally, two adequate and well-controlled Phase 3 clinical trials are required by the FDA and other regulatory
authorities for approval of a marketing application.</TD>
</TR></TABLE>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Post-approval studies, or Phase 4 clinical trials, may be requested
by the FDA as a condition of approval and are conducted after initial marketing approval. These studies are used to gain additional
experience from the treatment of patients in the intended therapeutic indication.</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">Progress reports detailing the results of the clinical trials
must be submitted at least annually to the FDA and written safety reports must be submitted to the FDA and the investigators for
serious and unexpected adverse events or any finding from tests in laboratory animals that suggest that there may be a significant
risk for human subjects. The FDA or the sponsor or, if used, its data safety monitoring board may suspend a clinical trial at any
time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health
risk. Similarly, an IRB or ethics committee can suspend or terminate approval of a clinical trial at its institution if the clinical
trial is not being conducted in accordance with the IRB&rsquo;s or ethics committee&rsquo;s requirements or if the pharmaceutical
product has been associated with unexpected serious harm to patients. Suspension of a clinical trial due to safety risks attributed
to the investigational product will result in termination of the trial and possibly others that are underway.</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">Concurrent with clinical trials, companies usually complete
additional animal studies and must also develop additional information about the physical characteristics of the product candidate
as well as finalize a process for manufacturing the product candidate in commercial quantities in accordance with cGMP requirements.
To help reduce the risk of the introduction of adventitious agents or other impurities with the use of biological products, the
PHS Act emphasizes the importance of manufacturing control for products whose attributes cannot be precisely defined. The manufacturing
process must be capable of consistently producing quality batches of the product candidate and, among other things, the sponsor
must develop methods for testing the identity, strength, quality, potency, and purity of the final biological product. Additionally,
appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the biological product
candidate does not undergo unacceptable deterioration over its shelf life.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>United States Review and Approval Processes</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">In order to obtain approval to market a biological product in
the United States, a BLA that provides data establishing to the FDA&rsquo;s satisfaction the safety and effectiveness of the investigational
product candidate for the proposed indication must be submitted to the FDA. The application includes all data available from nonclinical
studies and clinical trials, including negative or ambiguous results as well as positive findings, together with detailed information
relating to the product&rsquo;s manufacture and composition, and proposed labeling, among other things. The testing and approval
processes require substantial time and effort and there can be no assurance that the FDA will accept the BLA for filing and, even
if filed, 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">Each BLA must be accompanied by a significant user fee. The
FDA adjusts the user fees on an annual basis.. Fee waivers or reductions are available in certain circumstances, including a waiver
of the application fee for the first application filed by a small business. Additionally, no user fees are assessed on BLAs for
products designated as orphan drugs, unless the product also includes a non-orphan indication.</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">The FDA has 60 days from its receipt of a BLA to determine whether
the application will be accepted for filing based on the agency&rsquo;s threshold determination that the application is sufficiently
complete to permit substantive review. The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at
the time of submission and may request additional information. In this event, the BLA must be resubmitted with the additional information.
The resubmitted application also is subject to review before the FDA accepts it for filing. After the BLA is accepted for filing,
the FDA reviews it to determine, among other things, whether the proposed product is safe and effective for its intended use, has
an acceptable purity profile, and whether the product is being manufactured in accordance with cGMP to assure and preserve the
product&rsquo;s identity, safety, strength, quality, potency, and purity. The FDA may refer applications for novel product candidates
or those that present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians
and other experts, for review, evaluation and a recommendation as to whether the application should be approved and, if so, under
what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully
when making decisions. The FDA may ultimately decide that the BLA does not satisfy the criteria for approval. If a product receives
regulatory approval, the approval may be significantly limited to specific diseases and dosages or the indications for use may
otherwise be limited, which could restrict the commercial value of the product. Further, the FDA may require that certain contraindications,
warnings or precautions be included in the product labeling.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Special FDA Expedited Review and Approval Programs</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The FDA has various programs, including Fast Track designation,
accelerated approval and priority review, that are intended to expedite the process for the development and FDA review of drugs
that are intended for the treatment of serious or life threatening diseases or conditions and demonstrate the potential to address
unmet medical needs. The purpose of these programs is to provide important new drugs and biological products to patients earlier
than under standard FDA review procedures.</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">To be eligible for a Fast Track designation, the FDA must determine,
based on the request of a sponsor, that a product is intended to treat a serious or life threatening disease or condition and demonstrates
the potential to address an unmet medical need, or if the drug or biological product qualifies as a qualified infectious disease
product under the Generating Antibiotic Incentives Now Act, or GAIN Act. The FDA will determine that a product will fill an unmet
medical need if it will provide a therapy where none exists or provide a therapy that may be potentially superior to existing therapy
based on efficacy or safety factors. We intend to request Fast Track designation for our product candidates if applicable.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Specifically, new drugs and biological products are eligible
for Fast Track designation if they are intended to treat a serious or life-threatening condition and demonstrate the potential
to address unmet medical needs for the condition. Fast Track designation applies to the combination of the product and the specific
indication for which it is being studied. The sponsor of a new drug or biological may request the FDA to designate the drug or
biologic as a Fast Track product at any time during the clinical development of the product. Unique to a Fast Track product, the
FDA may consider for review sections of the marketing application on a rolling basis before the complete application is submitted,
if the sponsor provides a schedule for the submission of the sections of the application, the FDA agrees to accept sections of
the application and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of
the first section of the application.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Any product submitted to the FDA for marketing, including under
a Fast Track program, may be eligible for other types of FDA programs intended to expedite development and review, such as priority
review and accelerated approval. Any product is eligible for priority review if it has the potential to provide safe and effective
therapy where no satisfactory alternative therapy exists or a significant improvement in the treatment, diagnosis or prevention
of a disease compared to marketed products. The FDA will attempt to direct additional resources to the evaluation of an application
for a new drug or biological product designated for priority review in an effort to facilitate the review. Additionally, a product
may be eligible for accelerated approval. Drug or biological products studied for their safety and effectiveness in treating serious
or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may receive accelerated
approval, which means that they may be approved on the basis of adequate and well-controlled clinical trials establishing that
the product has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit, or on the basis of an
effect on a clinical endpoint other than survival or irreversible morbidity or mortality, that is reasonably likely to predict
an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity or prevalence
of the condition and the availability or lack of alternative treatments.</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">As a condition of approval, the FDA may require a sponsor of
a drug or biological product receiving accelerated approval to perform post-marketing studies to verify and describe the predicted
effect on irreversible morbidity or mortality or other clinical endpoint, and the drug or biological product may be subject to
accelerated withdrawal procedures. In addition, the FDA currently requires as a condition for accelerated approval pre-approval
of promotional materials, which could adversely impact the timing of the commercial launch of the product. Fast Track designation,
priority review and accelerated approval do not change the standards for approval but may expedite the development or approval
process.</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">A sponsor can also request designation of a product candidate
as a &ldquo;breakthrough therapy.&rdquo; A breakthrough therapy is defined as a drug or biological product that is intended, alone
or in combination with one or more other drugs or biological products, to treat a serious or life-threatening disease or condition,
and preliminary clinical evidence indicates that the biological product or drug may demonstrate substantial improvement over existing
therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
Drugs or biological products designated as breakthrough therapies are also eligible for accelerated approval. The FDA must take
certain actions, such as holding timely meetings and providing advice, intended to expedite the development and review of an application
for approval of a breakthrough therapy. We intend to request &ldquo;breakthrough therapy&rdquo; designation for our product candidates
if applicable.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Even if a product qualifies for one or more of these programs,
the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA
review or approval will not be shortened.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Patent Term Restoration and Marketing Exclusivity</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">Depending upon the timing, duration and specifics of FDA approval
of our drugs, some of our U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent
Term Restoration Act of 1984, referred to as the Hatch Waxman Amendments. The Hatch Waxman Amendments permit a patent restoration
term of up to five years as compensation for patent term lost during product development and the FDA regulatory review process.
However, patent term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the product&rsquo;s
approval date. The patent term restoration period is generally one half the time between the effective date of an IND, and the
submission date of an NDA or BLA, plus the time between the submission date of an NDA or BLA and the approval of that application.
Only one patent applicable to an approved drug is eligible for the extension, and the extension must be applied for prior to expiration
of the patent. The United States Patent and Trademark Office, in consultation with the FDA, reviews and approves the application
for any patent term extension or restoration.</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">Pediatric exclusivity is a type of marketing exclusivity available
in the U.S. under the Best Pharmaceuticals for Children Act, or BPCA, which provides for an additional six months of marketing
exclusivity may be available if a sponsor conducts clinical trials in children in response to a written request from the FDA, or
a Written Request. If the Written Request does not include clinical trials in neonates, the FDA is required to include its rationale
for not requesting those clinical trials. The FDA may request studies on approved or unapproved indications in separate Written
Requests. The issuance of a Written Request does not require the sponsor to undertake the described clinical trials.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Biologics Price Competition and Innovation Act of 2009</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">The Patient Protection and Affordable Care Act, which included
the Biologics Price Competition and Innovation Act of 2009, or BPCIA, amended the PHSA to create an abbreviated approval pathway
for two types of &ldquo;generic&rdquo; biologics&mdash;biosimilars and interchangeable biologic products, and provides for a twelve
year data exclusivity period for the first approved biological product, or reference product, against which a biosimilar or interchangeable
application is evaluated; however if pediatric clinical trials are performed and accepted by the FDA, the twelve year data exclusivity
period will be extended for an additional six months. A biosimilar product is defined as one that is highly similar to a reference
product notwithstanding minor differences in clinically inactive components and for which there are no clinically meaningful differences
between the biological product and the reference product in terms of the safety, purity and potency of the product. An interchangeable
product is a biosimilar product that may be substituted for the reference product without the intervention of the health care provider
who prescribed the reference product.</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">The biosimilar applicant must demonstrate that the product is
biosimilar based on data from (1) analytical studies showing that the biosimilar product is highly similar to the reference product;
(2) animal studies (including toxicity); and (3) one or more clinical trials to demonstrate safety, purity and potency in one or
more appropriate conditions of use for which the reference product is approved. In addition, the applicant must show that the biosimilar
and reference products have the same mechanism of action for the conditions of use on the label, route of administration, dosage
and strength, and the production facility must meet standards designed to assure product safety, purity and potency.</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">An application for a biosimilar product may not be submitted
until four years after the date on which the reference product was first approved. The first approved interchangeable biologic
product will be granted an exclusivity period of up to one year after it is first commercially marketed, but the exclusivity period
may be shortened under certain circumstances. The FDA has issued a number of final and draft guidances in order to implement the
law. The guidance documents provide FDA&rsquo;s current thinking on approaches to demonstrating that a proposed biological product
is biosimilar to a reference product. The FDA intends to issue additional guidance documents in the future, and has identified
considerations in demonstrating interchangeability to a reference product, labeling and nonproprietary naming as several of the
issues that it hopes to address in calendar year 2015. Nonetheless, the absence of final guidance documents covering all biosimilars
issues does not prevent a sponsor from seeking licensure of a biosimilar under the BPCIA, and the FDA has already approved two
biosimilar applications in the United States.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>FDA Post-Approval Requirements</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">Maintaining substantial compliance with applicable federal,
state, local, and foreign statutes and regulations requires the expenditure of substantial time and financial resources. Rigorous
and extensive FDA regulation of new products continues after approval, particularly with respect to cGMP. We will rely on third
parties for the production of commercial quantities of any products that we may commercialize. We and third party manufacturers
of our products are required to comply with applicable requirements in the cGMPs, including quality control and quality assurance
and maintenance of records and documentation. We cannot be certain that we or our present or future suppliers will be able to comply
with the cGMP and other FDA requirements. Other post-approval requirements applicable to biological products include reporting
of cGMP deviations that may affect the identity, potency, purity and overall safety of a distributed product, record-keeping requirements,
reporting of adverse effects, reporting updated safety and efficacy information, and complying with electronic record and signature
requirements. After a BLA is approved, the product also may be subject to official lot release. As part of the manufacturing process,
the manufacturer is required to perform certain tests on each lot of the product before it is released for distribution. If the
product is subject to official release by the FDA, the manufacturer submits samples of each lot of product to the FDA together
with a release protocol showing a summary of the history of manufacture of the lot and the results of all of the manufacturer&rsquo;s
tests performed on the lot. The FDA also may perform certain confirmatory tests on lots of some products, such as viral vaccines,
before releasing the lots for distribution by the manufacturer. In addition, the FDA conducts laboratory research related to the
regulatory standards on the safety, purity, potency, and effectiveness of biological products.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Discovery of previously unknown problems or the failure to comply
with the applicable regulatory requirements, by us or our suppliers, may result in restrictions on the marketing of a product or
withdrawal of the product from the market as well as possible civil or criminal sanctions and adverse publicity. FDA sanctions
could include refusal to approve pending applications, withdrawal of an approval, clinical hold, warning or untitled letters, product
recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government
contracts, mandated corrective advertising or communications with doctors, debarment, restitution, disgorgement of profits, or
civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us.</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">Biological product manufacturers and other entities involved
in the manufacture and distribution of approved products are required to register their facilities with the FDA and certain state
agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMPs and
other laws. In addition, changes to the manufacturing process or facility generally require prior FDA approval before being implemented
and other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject
to further FDA review and approval.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Labeling, Marketing and Promotion</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">The FDA closely regulates the labeling, marketing and promotion
of drugs and biological products, including direct-to-consumer advertising, promotional activities involving the internet, and
industry-sponsored scientific and educational activities. While doctors are free to prescribe any product approved by the FDA for
any use, a company can only make claims relating to safety and efficacy of a product that are consistent with FDA approval, and
the company is allowed to actively market a product only for the particular use and treatment approved by the FDA. In addition,
any claims we make for our products in advertising or promotion must be appropriately balanced with important safety information
and otherwise be adequately substantiated. Failure to comply with these requirements can result in adverse publicity, warning letters,
corrective advertising, injunctions and potential civil and criminal penalties.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Other Healthcare Laws and Compliance Requirements</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">In the United States, our activities are potentially subject
to regulation by various federal, state and local authorities in addition to the FDA, including the Centers for Medicare and Medicaid
Services, other divisions of the United States Department of Health and Human Services (e.g., the Office of Inspector General),
the United States Department of Justice and individual United States Attorney offices within the Department of Justice and state
and local governments.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>International Regulation</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">In addition to regulations in the United States, we will be
subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of our future products.
Our manufacturing facility in Ljubljana, Slovenia is subject to inspection and regulation by JAZMP, the Slovenian agency that regulates
and supervises pharmaceutical products in Slovenia. Whether or not we obtain FDA approval for a product, we must obtain approval
of a product by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing
of the product in those countries. The approval process varies from country to country, and the time may be longer or shorter than
that required for FDA approval. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement
vary greatly from country to country.</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">Under European Union regulatory systems, marketing authorizations
may be submitted either under a centralized or a mutual recognition procedure. The centralized procedure, which is compulsory for
medicinal products produced by biotechnology or those medicinal products containing new active substances for specific indications
such as the treatment of AIDS, cancer, neurodegenerative disorders, diabetes, viral diseases and designated orphan medicines and
optional for other medicines which are highly innovative. Under the centralized procedure, a marketing application is submitted
to the European Medicines Agency where it will be evaluated by the Committee for Medicinal Products for Human Use and a favorable
opinion typically results in the grant by the European Commission of a single marketing authorization that is valid for all European
Union member states within 67 days of receipt of the opinion. The initial marketing authorization is valid for five years, but
once renewed is usually valid for an unlimited period.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Pricing and Reimbursement</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">Although none of our product candidates has been commercialized
for any indication, if they are approved for marketing, commercial success of our product candidates will depend, in part, upon
the availability of third-party reimbursement from payors at the federal, state and private levels. Third-party payors include
government healthcare programs, such as Medicare and Medicaid, private health insurers and managed-care plans. We anticipate third
party payors will provide reimbursement for our products. However, these third party payors are increasingly challenging the price
and examining the cost effectiveness of medical products and services. In addition, significant uncertainty exists as to the reimbursement
status of newly approved healthcare products. We may need to conduct expensive pharmacoeconomic studies in order to demonstrate
the cost effectiveness of our products. Our product candidates may not be considered cost effective. It is time consuming and expensive
for us to seek reimbursement from third party payors. Reimbursement may not be available or sufficient to allow us to sell our
products on a competitive and profitable basis.</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">We expect that there will continue to be a number of federal
and state proposals to implement governmental pricing controls and limit the growth of healthcare costs, including the cost of
prescription drugs. For example, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability
Reconciliation Act of 2010 (collectively, ACA) enacted in March 2010, was expected to have a significant impact on the health care
industry. ACA has resulted in expanded coverage for the uninsured and is expected to help contain overall healthcare costs. With
regard to pharmaceutical products, among other things, ACA is expected to expand and increase industry rebates for drugs covered
under Medicaid programs and make changes to the coverage requirements under the Medicare Part D program. We cannot predict the
impact of ACA on pharmaceutical companies as many of the ACA reforms require the promulgation of detailed regulations implementing
the statutory provisions which has not yet occurred. In addition, although the United States Supreme Court upheld the constitutionality
of most of the ACA, some states have stated their intentions to not implement certain sections of ACA and some members of Congress
are still working to repeal ACA. These challenges add to the uncertainty of the changes enacted as part of ACA.</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">In addition, in some foreign countries, the proposed pricing
for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing vary widely from country
to country. For example, the European Union provides options for its member states to restrict the range of medicinal products
for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human
use. A member state may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect
controls on the profitability of the company placing the medicinal product on the market. There can be no assurance that any country
that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing
arrangements for any of our products. Historically, products launched in the European Union do not follow price structures of the
U.S. and generally tend to be significantly lower.<B>&nbsp;</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Employees</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">As of August 1, 2016, we had 32 full-time employees.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Facilities</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">Our principal offices occupy approximately 1,000 square feet
of leased office space pursuant to a month-to-month sublease, located at 3579 Valley Centre Drive, Suite 100, San Diego, California
92130. We also lease approximately 700 square feet of lab space in Richmond, Virginia, approximately 5,000 square feet of lab space
in Brookvale, Australia, and approximately 6,000 square feet of lab and office space in Ljubljana, Slovenia. We believe our facilities
are adequate for our current and near-term needs.</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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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
