<SEC-DOCUMENT>0001144204-16-117891.txt : 20160810
<SEC-HEADER>0001144204-16-117891.hdr.sgml : 20160810
<ACCEPTANCE-DATETIME>20160810073923
ACCESSION NUMBER:		0001144204-16-117891
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20160810
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20160810
DATE AS OF CHANGE:		20160810

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:		161819979

	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>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>v446567_8k.htm
<DESCRIPTION>FORM 8-K
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<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: 0pt 0; text-align: center"><B>Washington, D.C. 20549</B></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: 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: 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; 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 13 or 15(d) of </B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; text-align: center; margin-bottom: 0pt">&nbsp;</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): August 10, 2016</B></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: 24pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Protalix BioTherapeutics, Inc.</B></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>

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    <TD STYLE="width: 32%">&nbsp;</td>
    <TD STYLE="vertical-align: bottom; width: 2%">&nbsp;</td>
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<tr>
    <TD STYLE="vertical-align: top; text-align: center"><font style="font-size: 10pt"><b>Delaware</b></font></td>
    <TD STYLE="vertical-align: bottom">&nbsp;</td>
    <TD STYLE="vertical-align: top; text-align: center"><font style="font-size: 10pt"><b>001-33357</b></font></td>
    <TD STYLE="vertical-align: bottom">&nbsp;</td>
    <TD STYLE="vertical-align: top; text-align: center"><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>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</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">&nbsp;</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>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P></td></tr>
</table>
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<tr>
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    <TD STYLE="vertical-align: bottom; width: 2%">&nbsp;</td>
    <TD STYLE="width: 49%">&nbsp;</td></tr>
<tr>
    <TD STYLE="vertical-align: top; text-align: center"><font style="font-size: 10pt"><b>2 Snunit Street</b></font></td>
    <TD STYLE="vertical-align: bottom">&nbsp;</td>
    <TD STYLE="vertical-align: top; text-align: center"><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: bottom">&nbsp;</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: bottom">&nbsp;</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: bottom">&nbsp;</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; text-indent: 0.5in">&nbsp;</P>

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

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

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

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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">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: 4%"><font style="font-family: Wingdings; font-size: 10pt">&uml;</font></td>
    <td><font style="font-size: 10pt">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </font></td></tr>
<tr style="vertical-align: top">
    <td><font style="font-family: Wingdings; font-size: 10pt">&uml;</font></td>
    <td><font style="font-size: 10pt">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) </font></td></tr>
<tr style="vertical-align: top">
    <td><font style="font-family: Wingdings; font-size: 10pt">&uml;</font></td>
    <td><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>
<tr style="vertical-align: top">
    <td><font style="font-family: Wingdings; font-size: 10pt">&uml;</font></td>
    <td><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>
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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 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 August 10, 2016, Protalix BioTherapeutics, Inc. (the
&ldquo;Company&rdquo;) issued a press release announcing additional positive data from its phase I/II clinical trial of
PRX-102 for the treatment of Fabry disease. PRX-102 is a recombinant, plant cell expressed, pegylated, modified version of
the human alpha-Galactosidase-A enzyme. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by
reference herein.</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: 0in"></TD><TD STYLE="width: 0.5in; text-align: left"><B>(d)</B></TD><TD STYLE="text-align: justify"><B>Exhibits</B></TD>
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<TD STYLE="width: 0in"></TD><TD STYLE="width: 0.75in; text-align: left">99.1</TD><TD STYLE="text-align: justify">Press release dated August 10, 2016.</TD>
</TR></TABLE>

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<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>

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    <TD COLSPAN="3" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left; vertical-align: top"><FONT STYLE="font-size: 10pt">PROTALIX
    BIOTHERAPEUTICS, INC.</FONT></TD>
    <TD><FONT STYLE="font-size: 10pt">&nbsp;</FONT></TD></TR>
<TR STYLE="vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; vertical-align: top"><FONT STYLE="font-size: 10pt">&nbsp;</FONT></TD>
    <TD STYLE="text-align: left; vertical-align: top"><FONT STYLE="font-size: 10pt">&nbsp;</FONT></TD><TD STYLE="text-align: left; vertical-align: top"><FONT STYLE="font-size: 10pt">&nbsp;</FONT></TD>
    <TD STYLE="text-align: left; vertical-align: top"><FONT STYLE="font-size: 10pt">&nbsp;</FONT></TD>
    <TD><FONT STYLE="font-size: 10pt">&nbsp;</FONT></TD></TR>
<TR STYLE="vertical-align: bottom">
    <TD STYLE="width: 50%; font: 10pt Times New Roman, Times, Serif; padding-bottom: 1pt; text-align: left; vertical-align: top"><FONT STYLE="font-size: 10pt">Date:
    August 10, 2016</FONT></TD>
    <TD STYLE="width: 3%; font: 10pt Times New Roman, Times, Serif; padding-bottom: 1pt; text-align: left; vertical-align: top"><FONT STYLE="font-size: 10pt">By:</FONT></TD><TD STYLE="width: 1%; font: 10pt Times New Roman, Times, Serif; padding-bottom: 1pt; text-align: left; vertical-align: top"><FONT STYLE="font-size: 10pt">&nbsp;</FONT></TD>
    <TD STYLE="width: 31%; font: 10pt Times New Roman, Times, Serif; text-align: left; padding-bottom: 1pt; border-bottom: Black 1pt solid; vertical-align: top"><FONT STYLE="font-size: 10pt">/s/
    Moshe Manor</FONT></TD>
    <TD STYLE="width: 15%"><FONT STYLE="font-size: 10pt">&nbsp;</FONT></TD></TR>
<TR STYLE="vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; vertical-align: top"><FONT STYLE="font-size: 10pt">&nbsp;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; vertical-align: top"><FONT STYLE="font-size: 10pt">Name:</FONT></TD><TD STYLE="text-align: left; vertical-align: top"><FONT STYLE="font-size: 10pt">&nbsp;</FONT></TD>
    <TD STYLE="text-align: left; vertical-align: top"><FONT STYLE="font-size: 10pt">Moshe Manor</FONT></TD>
    <TD><FONT STYLE="font-size: 10pt">&nbsp;</FONT></TD></TR>
<TR STYLE="vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: -3.5in; padding-left: 3.5in; text-align: left; vertical-align: top"><FONT STYLE="font-size: 10pt">&nbsp;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; vertical-align: top"><FONT STYLE="font-size: 10pt">Title:</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; vertical-align: top"><FONT STYLE="font-size: 10pt">&nbsp;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; vertical-align: top"><FONT STYLE="font-size: 10pt">President
    and <BR> Chief Executive Officer</FONT></TD>
    <TD><FONT STYLE="font-size: 10pt">&nbsp;</FONT></TD></TR>
</TABLE>


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<DESCRIPTION>EXHIBIT 99.1
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<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; text-align: right"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center; background-color: white"><B>Protalix BioTherapeutics
Announces Additional Positive Data from its </B><BR>
<B>Phase I/II Clinical Trial for PRX-102 for the Treatment of Fabry Disease</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">CARMIEL,&nbsp;Israel,&nbsp;August 10,
2016&nbsp;(GLOBE NEWSWIRE) --&nbsp;Protalix BioTherapeutics, Inc.&nbsp;(NYSE MKT:PLX) (TASE:PLX), announced today additional positive
data from its phase I/II clinical trial of PRX-102 for the treatment of Fabry disease. PRX-102 is a recombinant, plant cell expressed,
pegylated, modified version of the human alpha-Galactosidase-A enzyme.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&ldquo;We are pleased to announce additional positive results
from our phase I/II Fabry clinical trial,&rdquo; said Moshe Manor, Protalix&rsquo;s President and Chief Executive Officer. &ldquo;The
efficacy results seen to date continue to be very strong with improvements or stabilization in efficacy demonstrated across all
disease parameters giving us confidence in our phase III head-to-head study comparing PRX-102 versus Fabrazyme&reg;. The safety
data is remarkable with all adverse events being mild to moderate and transient by nature and with antibodies decreasing or being
eliminated for the very few patients who tested positive. We believe the product profile for PRX-102 has the potential to be highly
differentiated from currently available enzyme replacement therapies for Fabry disease and could impact significantly the lives
of patients suffering from this rare, genetic disease.&rdquo;</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 phase I/II clinical trial is an open-label, dose-ranging
study designed to treat up to 18 na&iuml;ve male and female adult patients. The three dose cohorts include 0.2 mg/kg, 1mg/kg and
2mg/kg with intravenous infusions of PRX-102 every two weeks.</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 efficacy and safety analysis of the phase I/II clinical
trial includes data from all 16 enrolled patients (9 male and 7 female) who completed the 12-month treatment period and, of more
importance, a subset analysis of 10 patients who met the classic Fabry disease criteria (9 male and 1 female). The classic Fabry
patient population is the most common Fabry patient population studied and reported on in the scientific and medical literature,
and is the population to be evaluated in the Company&rsquo;s phase III pivotal trial. Classic Fabry disease is characterized by
having less than 30% residual enzyme activity, and typical manifestations involve neurological, skin, ophthalmic and Fabry-specific
biomarkers.</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; background-color: white"><B><U>Efficacy Results</U></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">Improvements or stabilization in efficacy
were demonstrated across all disease parameters. Reductions of plasma Lyso-Gb3 ranged from 66.7 to 22.6 ng/ml in all patients and
from 102.0 to 33.1 ng/ml in classic patients. Stable kidney function was also observed, as measured by estimated glomerular filtration
rate (eGFR), with change from mean eGFR value of 110.78 at base line to 110.23 after 12 months for all patients, and from mean
eGFR value of 117.37 to 117.36 for classic patients. All patients had stable cardiac function as measured by left ventricular mass
(LVM) and left ventricular mass index (LVMI). The detailed results, as a percentage of change from base line, for both all patients
and for the classic Fabry patient subset are presented in the following chart.</P>

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

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

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

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<TR STYLE="vertical-align: bottom">
    <TD STYLE="width: 30%; font-size: 10pt; border-bottom: Black 1pt solid; text-align: left">% change &plusmn;SE</TD><TD STYLE="width: 1%; font-size: 10pt; padding-bottom: 1pt; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 13%; font-size: 10pt; border-bottom: Black 1pt solid; text-align: center">eGFR</TD><TD STYLE="width: 1%; font-size: 10pt; padding-bottom: 1pt; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 13%; font-size: 10pt; border-bottom: Black 1pt solid; text-align: center">LVM</TD><TD STYLE="width: 1%; font-size: 10pt; padding-bottom: 1pt; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 13%; font-size: 10pt; border-bottom: Black 1pt solid; text-align: center">LVMI</TD><TD STYLE="width: 1%; font-size: 10pt; padding-bottom: 1pt; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 13%; font-size: 10pt; border-bottom: Black 1pt solid; text-align: center">Gb3</TD><TD STYLE="width: 1%; font-size: 10pt; padding-bottom: 1pt; text-align: center">&nbsp;</TD>
    <TD STYLE="border-bottom: Black 1pt solid; font-size: 10pt; text-align: center; width: 13%">&nbsp;lyso</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font-size: 10pt; text-align: left; padding-bottom: 1pt">All Patients (n=16)</TD><TD STYLE="font-size: 10pt; padding-bottom: 1pt; text-align: center">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; padding-bottom: 1pt; text-align: center">-0.5 &plusmn;2.1</TD><TD STYLE="font-size: 10pt; padding-bottom: 1pt; text-align: center">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; padding-bottom: 1pt; text-align: center">-0.0 &plusmn;2.5</TD><TD STYLE="font-size: 10pt; padding-bottom: 1pt; text-align: center">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; padding-bottom: 1pt; text-align: center">&nbsp;&nbsp;&nbsp;0.4 &plusmn;2.6</TD><TD STYLE="font-size: 10pt; padding-bottom: 1pt; text-align: center">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; padding-bottom: 1pt; text-align: center">-22.2 &plusmn; 6.1</TD><TD STYLE="font-size: 10pt; padding-bottom: 1pt; text-align: center">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; padding-bottom: 1pt; text-align: center">-48.9 &plusmn; 5.7</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: White">
    <TD STYLE="font-size: 10pt; text-align: left; padding-bottom: 1pt">Classic Patients (n=10)</TD><TD STYLE="font-size: 10pt; padding-bottom: 1pt; text-align: center">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; padding-bottom: 1pt; text-align: center">-0.1&plusmn;2.2</TD><TD STYLE="font-size: 10pt; padding-bottom: 1pt; text-align: center">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; padding-bottom: 1pt; text-align: center">-2.6 &plusmn;3.4</TD><TD STYLE="font-size: 10pt; padding-bottom: 1pt; text-align: center">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; padding-bottom: 1pt; text-align: center">-3.1 &plusmn;3.1</TD><TD STYLE="font-size: 10pt; padding-bottom: 1pt; text-align: center">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; padding-bottom: 1pt; text-align: center">-33.3 &plusmn; 7.6</TD><TD STYLE="font-size: 10pt; padding-bottom: 1pt; text-align: center">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; padding-bottom: 1pt; text-align: center">-57.6 &plusmn; 6.8</TD></TR>
</TABLE>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">The eGRF data in the foregoing table
was measured using the Chronic Kidney Disease Epidemiology Collaboration analysis (CKD-EPI), which is the analysis the Company
is using in its phase III pivotal trial of PRX-102, based on discussions with the U.S. Food and Drug Administration. The eGFR slope
for all patients (n=16) using CKD-EPI was -2.9 (BL-77.7-156.3). The eGFR slope for classic Fabry patients (n=10) was -1.8 (BL 82.4-156.3).
According to a published report, an annualized rate of eGFR change of -3.8 (BL 49-170) was observed in a study of the effect of
Fabrazyme on the classic Fabry patient population using CKD-EPI analysis with similar base line of eGFR. The Company&rsquo;s previously
reported interim results for eGFR were analyzed using the MDRD equation, which is an older method and not commonly used in the
clinical setting. Using MDRD, the eGFR slope is -3.25 for all patients (previously reported as -0.32), and -1.70 for classic patients.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">PRX-102 also demonstrated, using the
well-established BPI index, a substantial improvement in all pain parameters for all patients in the study, and an even more pronounced
improvement in classic Fabry patients, as indicated below:</P>

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

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
<TR STYLE="vertical-align: bottom">
    <TD STYLE="font-size: 10pt">&nbsp;</TD><TD STYLE="font-size: 10pt; padding-bottom: 1pt">&nbsp;</TD>
    <TD COLSPAN="2" STYLE="font-size: 10pt; text-align: center; border-bottom: Black 1pt solid">Worse Pain</TD><TD STYLE="padding-bottom: 1pt; font-size: 10pt">&nbsp;</TD><TD STYLE="font-size: 10pt; padding-bottom: 1pt">&nbsp;</TD>
    <TD COLSPAN="2" STYLE="font-size: 10pt; text-align: center; border-bottom: Black 1pt solid">Average Pain</TD><TD STYLE="padding-bottom: 1pt; font-size: 10pt">&nbsp;</TD><TD STYLE="font-size: 10pt; padding-bottom: 1pt">&nbsp;</TD>
    <TD COLSPAN="2" STYLE="font-size: 10pt; text-align: center; border-bottom: Black 1pt solid">Pain Interference</TD><TD STYLE="padding-bottom: 1pt; font-size: 10pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="width: 58%; font-size: 10pt; text-align: left; padding-bottom: 1pt">All Patients</TD><TD STYLE="width: 1%; font-size: 10pt; padding-bottom: 1pt">&nbsp;</TD>
    <TD STYLE="width: 1%; padding-bottom: 1pt; font-size: 10pt; text-align: left">&nbsp;</TD><TD STYLE="width: 11%; padding-bottom: 1pt; font-size: 10pt; text-align: right">-29</TD><TD STYLE="width: 1%; padding-bottom: 1pt; font-size: 10pt; text-align: left">%</TD><TD STYLE="width: 1%; font-size: 10pt; padding-bottom: 1pt">&nbsp;</TD>
    <TD STYLE="width: 1%; padding-bottom: 1pt; font-size: 10pt; text-align: left">&nbsp;</TD><TD STYLE="width: 11%; padding-bottom: 1pt; font-size: 10pt; text-align: right">-26</TD><TD STYLE="width: 1%; padding-bottom: 1pt; font-size: 10pt; text-align: left">%</TD><TD STYLE="width: 1%; font-size: 10pt; padding-bottom: 1pt">&nbsp;</TD>
    <TD STYLE="width: 1%; padding-bottom: 1pt; font-size: 10pt; text-align: left">&nbsp;</TD><TD STYLE="width: 11%; padding-bottom: 1pt; font-size: 10pt; text-align: right">-39</TD><TD STYLE="width: 1%; padding-bottom: 1pt; font-size: 10pt; text-align: left">%</TD></TR>
<TR STYLE="vertical-align: bottom; background-color: White">
    <TD STYLE="font-size: 10pt; text-align: left; padding-bottom: 1pt">Classic Fabry Patients</TD><TD STYLE="font-size: 10pt; padding-bottom: 1pt">&nbsp;</TD>
    <TD STYLE="padding-bottom: 1pt; font-size: 10pt; text-align: left">&nbsp;</TD><TD STYLE="padding-bottom: 1pt; font-size: 10pt; text-align: right">-38</TD><TD STYLE="padding-bottom: 1pt; font-size: 10pt; text-align: left">%</TD><TD STYLE="font-size: 10pt; padding-bottom: 1pt">&nbsp;</TD>
    <TD STYLE="padding-bottom: 1pt; font-size: 10pt; text-align: left">&nbsp;</TD><TD STYLE="padding-bottom: 1pt; font-size: 10pt; text-align: right">-41</TD><TD STYLE="padding-bottom: 1pt; font-size: 10pt; text-align: left">%</TD><TD STYLE="font-size: 10pt; padding-bottom: 1pt">&nbsp;</TD>
    <TD STYLE="padding-bottom: 1pt; font-size: 10pt; text-align: left">&nbsp;</TD><TD STYLE="padding-bottom: 1pt; font-size: 10pt; text-align: right">-44</TD><TD STYLE="padding-bottom: 1pt; font-size: 10pt; text-align: left">%</TD></TR>
</TABLE>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><B><U>Safety Results</U></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">The safety analysis for adverse events
represents a total of 26.2 patient years. PRX-102 was well tolerated, with the majority of adverse events being mild and moderate.
Only one of the patients evaluated for safety experienced hypersensitivity. Only three patients developed antibodies and, after
competing 12 months of treatment, one of those three patients has now tested negative for antibodies further supporting the potential
of an immune tolerance phenomenon associated with the PRX-102 enzyme. Accordingly, the previously reported 19% incidence of treatment-induced
anti-drug antibodies is now only 13%. Moreover, titers of the other two positive patients that developed antibodies have continued
to decline over time.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">Currently, all 16 patients enrolled
in the trial continue to receive 1 mg/kg of PRX-102 in an open label extension trial. The Company is recruiting patients for the
phase III pivotal trial in centers recently opened in the United States.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>About Protalix&nbsp;BioTherapeutics, Inc.</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">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;. Protalix&rsquo;s unique expression system presents a proprietary method for developing recombinant proteins in
a cost-effective, industrial-scale manner. Protalix&rsquo;s first product manufactured by ProCellEx, taliglucerase alfa, was approved
for marketing by the U.S. Food and Drug Administration (FDA) in May 2012 and, subsequently, by the regulatory authorities of other
countries. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa,
excluding Brazil, where Protalix retains full rights. Protalix&rsquo;s development pipeline includes the following product candidates:
PRX-102, 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; PRX-110 for the treatment of Cystic Fibrosis; and others.</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; background-color: white"><B>Forward-Looking Statements</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">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.&nbsp;The terms &ldquo;anticipate,&rdquo; &ldquo;believe,&rdquo; &ldquo;estimate,&rdquo;
&ldquo;expect,&rdquo; &ldquo;plan&rdquo; and &ldquo;intend&rdquo; and other words or phrases of similar import are intended to
identify forward-looking statements.&nbsp;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.&nbsp;These statements are based
on our current beliefs and expectations as to such future outcomes.&nbsp;Drug discovery and development involve a high degree of
risk.&nbsp;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: unforeseen safety issues; determination
of dosing issues; lack of effectiveness during clinical trials; slower than expected rates of patient recruitment; inability to
monitor patients adequately during or after treatment; inability or unwillingness of medical investigators 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 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; 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&nbsp;FDA&nbsp;or other health regulatory authorities, and other risks relating to the review process; 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&nbsp;U.S.
Securities and Exchange Commission.&nbsp;The statements in this release are valid only as of the date hereof and we disclaim any
obligation to update this information.</P>

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

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">646-378-2927</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="color: Blue"><U>mnanus@troutgroup.com</U></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"><B>Source: Protalix BioTherapeutics, Inc.</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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