<SEC-DOCUMENT>0001144204-18-064759.txt : 20181217
<SEC-HEADER>0001144204-18-064759.hdr.sgml : 20181217
<ACCEPTANCE-DATETIME>20181217070607
ACCESSION NUMBER:		0001144204-18-064759
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20181217
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20181217
DATE AS OF CHANGE:		20181217

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Protalix BioTherapeutics, Inc.
		CENTRAL INDEX KEY:			0001006281
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				650643773
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-33357
		FILM NUMBER:		181237010

	BUSINESS ADDRESS:	
		STREET 1:		2 SNUNIT ST
		STREET 2:		SCIENCE PARK, POB 455
		CITY:			CARMIEL
		STATE:			L3
		ZIP:			20100
		BUSINESS PHONE:		972-4-988-9488

	MAIL ADDRESS:	
		STREET 1:		2 SNUNIT ST
		STREET 2:		SCIENCE PARK, POB 455
		CITY:			CARMIEL
		STATE:			L3
		ZIP:			20100

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ORTHODONTIX INC
		DATE OF NAME CHANGE:	19980422

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	EMBASSY ACQUISITION CORP
		DATE OF NAME CHANGE:	19960124
</SEC-HEADER>
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<TYPE>8-K
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<DESCRIPTION>8-K
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>UNITED STATES</B></P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&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; text-align: center"><B>FORM 8-K</B></P>

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

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

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

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Date of Report (Date of Earliest Event
Reported): December 17, 2018</B></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; text-align: center"><FONT STYLE="font-size: 14pt"><B>Protalix
BioTherapeutics, Inc.</B></FONT></P>

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

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

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    <TD STYLE="vertical-align: top; text-align: center; width: 32%"><FONT STYLE="font-size: 10pt"><B>Delaware</B></FONT></TD>
    <TD STYLE="vertical-align: bottom; width: 2%">&nbsp;</TD>
    <TD STYLE="vertical-align: top; text-align: center; width: 32%"><FONT STYLE="font-size: 10pt"><B>001-33357</B></FONT></TD>
    <TD STYLE="vertical-align: bottom; width: 2%">&nbsp;</TD>
    <TD STYLE="vertical-align: top; text-align: center; width: 32%"><FONT STYLE="font-size: 10pt"><B>65-0643773</B></FONT></TD></TR>
<TR>
    <TD STYLE="vertical-align: top">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(State or other jurisdiction</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>of incorporation)</B></P></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: top; text-align: center"><FONT STYLE="font-size: 10pt"><B>(Commission File Number)</B></FONT></TD>
    <TD STYLE="vertical-align: bottom"></TD>
    <TD STYLE="vertical-align: top">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(IRS Employer</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Identification No.)</B></P></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
<TR>
    <TD STYLE="vertical-align: top; text-align: center; width: 50%"><FONT STYLE="font-size: 10pt"><B>2 Snunit Street</B></FONT></TD>
    <TD STYLE="vertical-align: top; text-align: center; width: 50%"><FONT STYLE="font-size: 10pt"><B>20100</B></FONT></TD></TR>
<TR>
    <TD STYLE="vertical-align: top; text-align: center"><FONT STYLE="font-size: 10pt"><B>Science Park, POB 455</B></FONT></TD>
    <TD STYLE="vertical-align: top; text-align: center">&nbsp;</TD></TR>
<TR>
    <TD STYLE="vertical-align: top; text-align: center"><FONT STYLE="font-size: 10pt"><B>Carmiel, Israel</B></FONT></TD>
    <TD STYLE="vertical-align: top; text-align: center">&nbsp;</TD></TR>
<TR>
    <TD STYLE="vertical-align: top; text-align: center"><FONT STYLE="font-size: 10pt"><B>(Address of principal executive offices)</B></FONT></TD>
    <TD STYLE="vertical-align: top; text-align: center"><FONT STYLE="font-size: 10pt"><B>(Zip Code)</B></FONT></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Registrant&rsquo;s telephone number,
including area code +972-4-988-9488</B></P>

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

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





<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 13.7pt 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 13.7pt 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 13.7pt 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 (<I>see</I>
General Instruction A.2. below):</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 13.7pt 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left"><FONT STYLE="font-family: Wingdings">&#168;</FONT></TD><TD STYLE="text-align: justify">Written communication pursuant to Rule 425 under the
Securities Act (17 CFR 230.425)</TD>
</TR></TABLE>

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

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left"><FONT STYLE="font-family: Wingdings">&#168;</FONT></TD><TD STYLE="text-align: justify">Soliciting material pursuant to Rule 14a-12 under
the Exchange Act (17 CFR 240.14a-12)</TD>
</TR></TABLE>

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

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left"><FONT STYLE="font-family: Wingdings">&#168;</FONT></TD><TD STYLE="text-align: justify">Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b))</TD>
</TR></TABLE>

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

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

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left"><FONT STYLE="font-family: Wingdings">&#168;</FONT></TD><TD STYLE="text-align: justify">Pre-commencement communications pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e-4(c))</TD>
</TR></TABLE>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 21.85pt 0pt 0">Indicate by check mark whether the registrant is
an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR &sect;230.405) or Rule 12b-2 of the Securities
Exchange Act of 1934 (17 CFR &sect;240.12b-2).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 21.85pt 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 4in; text-align: right; text-indent: 0.5in">Emerging growth
company <FONT STYLE="font-family: Times New Roman, Times, Serif"><FONT STYLE="font-family: Wingdings">&#168;</FONT></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 4in; text-align: center; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. <FONT STYLE="font-family: Times New Roman, Times, Serif"><FONT STYLE="font-family: Wingdings">&#168;</FONT></FONT></P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Item&nbsp;8.01. Other Events </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">On December 17, 2018, the Company issued a press release announcing
<FONT STYLE="color: #333333">the completion of enrollment for the Company&rsquo;s BRIDGE phase III clinical trial of pegunigalsidase
alfa (PRX-102) for the treatment of Fabry disease. Additionally, the Company provided an update on the enrollment for its BALANCE
and BRIGHT phase III clinical trials</FONT>. A copy of the press release is attached as Exhibit&nbsp;99.1 to this Current Report
on Form 8-K and is incorporated herein by reference.</P>

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

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

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

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<TD STYLE="width: 0.5in; text-align: left"><B>(d)</B></TD><TD STYLE="text-align: justify"><B>Exhibits</B></TD>
</TR></TABLE>

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<TD STYLE="width: 0.5in; text-align: left"><A HREF="tv509254_ex99-1.htm" STYLE="-sec-extract: exhibit">99.1</A></TD><TD STYLE="text-align: justify"><A HREF="tv509254_ex99-1.htm" STYLE="-sec-extract: exhibit">Press release dated December 17, 2018.</A></TD>
</TR></TABLE>

<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; text-align: center">&nbsp;</P>

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

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

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

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

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

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<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD COLSPAN="2"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>PROTALIX BIOTHERAPEUTICS, INC.</B></FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 50%">&nbsp;</TD>
    <TD STYLE="width: 5%">&nbsp;</TD>
    <TD STYLE="width: 45%">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Date: December 17, 2018</FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">By: </FONT></TD>
    <TD STYLE="border-bottom: Black 1pt solid"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">/s/ Moshe Manor</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Name: </FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Moshe Manor</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Title:</FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">President and</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Chief Executive Officer</FONT></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;&nbsp;</P>

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<TYPE>EX-99.1
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<FILENAME>tv509254_ex99-1.htm
<DESCRIPTION>EXHIBIT 99.1
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<P STYLE="margin: 0">&nbsp;</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; color: #222222"><B>Protalix BioTherapeutics
Announces the Completion of Enrollment in the<BR>
Phase III BRIDGE Clinical Trial of pegunigalsidase alfa for the Treatment of Fabry Disease</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; color: #222222">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333">CARMIEL,&nbsp;Israel,&nbsp;December 17, 2018&nbsp;(GLOBENEWSWIRE)
--&nbsp;Protalix BioTherapeutics, Inc.&nbsp;(NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development
and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system,
ProCellEx&reg;, today announced the completion of enrollment for the BRIDGE phase III clinical trial of pegunigalsidase alfa (PRX-102)
for the treatment of Fabry disease. Additionally, the Company provided an update on the enrollment for the BALANCE and BRIGHT phase
III clinical trials which, collectively with the BRIDGE study, comprise the phase III clinical development program for PRX-102
for the treatment of Fabry disease. The BRIGHT study is approximately 90% enrolled and the BALANCE study is approximately 70% enrolled.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333">&ldquo;In September 2018, we reported encouraging,
positive interim results from the BRIDGE study and look forward to continue releasing additional data in 2019,&rdquo; commented
Moshe Manor, Protalix&rsquo;s President and Chief Executive Officer. &ldquo;Based on the promising preliminary BRIDGE study results,
and taking into account the newly issued guidance from the&nbsp;U.S. Food and Drug Administration&nbsp;(FDA), we plan to meet
with the&nbsp;FDA&nbsp;during the first quarter of 2019 to discuss the most optimal regulatory path forward for PRX-102. While
we continue to enroll patients in the BRIGHT and BALANCE Fabry disease studies, we believe that with the patients enrolled across
the studies included in our PRX-102 clinical program to date, there is a sufficient number of patients to support expedited review,
including the potential for filing an application for accelerated approval,&rdquo; continued Mr. Manor.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333">The BRIDGE study is an open label switch over
study evaluating the safety and efficacy of PRX-102 in patients with Fabry disease currently treated with agalsidase alfa for at
least 2 years and on a stable dose for at least 6 months. Patients are screened and evaluated over 3 months while continuing treatment
with agalsidase alfa. Following the screening period, patients are enrolled and switched from agalsidase alfa treatment to intravenous
(IV) infusions of 1 mg/kg of PRX-102 every two weeks for 12 months.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333">PRX-102 is the Company&rsquo;s plant cell-expressed
recombinant, PEGylated, cross-linked &alpha;-galactosidase-A product candidate for the treatment of Fabry disease.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #333333"><B>About&nbsp;Protalix
BioTherapeutics, Inc.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #333333">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #333333">Protalix is a biopharmaceutical
company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary
plant cell-based expression system, ProCellEx&reg;.&nbsp; Protalix&rsquo;s unique expression system presents a proprietary method
for developing recombinant proteins in a cost-effective, industrial-scale manner.&nbsp; Protalix&rsquo;s first product manufactured
by ProCellEx, taliglucerase alfa, was approved for marketing by the&nbsp;U.S. Food and Drug Administration&nbsp;(FDA) in&nbsp;May
2012&nbsp;and, subsequently, by the regulatory authorities of other countries.&nbsp; Protalix has licensed to&nbsp;Pfizer Inc.&nbsp;the
worldwide development and commercialization rights for taliglucerase alfa, excluding&nbsp;Brazil, where Protalix retains full rights.&nbsp;
Protalix&rsquo;s development pipeline includes the following product candidates: pegunigalsidase alfa, a modified version of the
recombinant human alpha-GAL-A protein for the treatment of Fabry disease; OPRX-106, an orally-delivered anti-inflammatory treatment;
alidornase alfa for the treatment of Cystic Fibrosis; and others.&nbsp; Protalix has partnered with Chiesi Farmaceutici S.p.A.,
both in&nbsp;the United States&nbsp;and outside&nbsp;the United States, for the development and commercialization of pegunigalsidase
alfa.</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #333333"><B>Forward-Looking
Statements</B></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><FONT STYLE="color: #333333">To the
extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made
pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms &ldquo;expect,&rdquo;
&ldquo;anticipate,&rdquo; &ldquo;believe,&rdquo; &ldquo;estimate,&rdquo; &ldquo;project,&rdquo; &ldquo;plan,&rdquo; &ldquo;should&rdquo;
and &ldquo;intend&rdquo; and other words or phrases of similar import are intended to identify forward-looking statements. These
forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and
results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to
such future outcomes. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may
be different than the preliminary findings for the clinical trial. Factors that might cause material differences include, among
others: failure or delay in the commencement or completion of our preclinical and clinical trials which may be caused by several
factors, including: </FONT><FONT STYLE="color: #222222">risks that the FDA will not accept an application for accelerated approval
of PRX-102 with the data generated to date or will request additional data or other conditions of our submission of any application
for accelerated approval of PRX-102; </FONT><FONT STYLE="color: #333333">slower than expected rates of patient recruitment; unforeseen
safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to monitor patients adequately
during or after treatment; inability or unwillingness of medical investigators and institutional review boards to follow our clinical
protocols; and lack of sufficient funding to finance clinical trials; the risk that the results of the clinical trials of our product
candidates will not support our claims of superiority, safety or efficacy, that our product candidates will not have the desired
effects or will be associated with undesirable side effects or other unexpected characteristics; risks related to our ability to
maintain and manage our relationship with Chiesi Farmaceutici and any other collaborator, distributor or partner; risks related
to the amount and sufficiency of our cash and cash equivalents; risks related to the ultimate purchase by Funda&ccedil;&atilde;o
Oswaldo Cruz of alfataliglicerase pursuant to the stated purchase intentions of the Brazilian Ministry of Health of the stated
amounts, if at all; risks related to the successful conclusion of our negotiations with the Brazilian Ministry of Health regarding
the purchase of alfataliglicerase generally; risks related to our commercialization efforts for alfataliglicerase in Brazil; risks
relating to the compliance by Funda&ccedil;&atilde;o Oswaldo Cruz with its purchase obligations and related milestones under our
supply and technology transfer agreement; risks related to the amount and sufficiency of our cash and cash equivalents; risks related
to the amount of our future revenues, operations and expenditures; the risk that despite the FDA&rsquo;s grant of fast track designation
for pegunigalsidase alfa for the treatment of Fabry disease, we may not experience a faster development process, review or approval
compared to applications considered for approval under conventional FDA procedures; risks related to the FDA&rsquo;s ability to
withdraw the fast track designation at any time; risks relating to our ability to make scheduled payments of the principal of,
to pay interest on or to refinance our outstanding notes or any other indebtedness; our dependence on performance by third party
providers of services and supplies, including without limitation, clinical trial services; delays in our preparation and filing
of applications for regulatory approval; delays in the approval or potential rejection of any applications we file with the FDA
or other health regulatory authorities, and other risks relating to the review process; our ability to identify suitable product
candidates and to complete preclinical studies of such product candidates; the inherent risks and uncertainties in developing drug
platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other
companies and institutions; potential product liability risks, and risks of securing adequate levels of product liability and other
necessary insurance coverage; and other factors described in our filings with the U.S. Securities and Exchange Commission. The
statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information,
except as may be required by law.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #333333"><B>Investor Contact</B></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #333333">Marcy Nanus, Managing
Director<BR>
Solebury Trout&nbsp;<BR>
646-378-2927<BR>
<U>mnanus@soleburytrout.com</U></P>

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

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