<SEC-DOCUMENT>0001144204-15-054121.txt : 20150909
<SEC-HEADER>0001144204-15-054121.hdr.sgml : 20150909
<ACCEPTANCE-DATETIME>20150909070647
ACCESSION NUMBER:		0001144204-15-054121
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20150909
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20150909
DATE AS OF CHANGE:		20150909

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:			FL
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-33357
		FILM NUMBER:		151097917

	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>v419959_8k.htm
<DESCRIPTION>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-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Washington, D.C. 20549</B></P>

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

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

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<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>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): September 9, 2015</B></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; text-align: center; margin-bottom: 0pt">&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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<tr>
    <TD STYLE="vertical-align: top; text-align: center; width: 33%"><font style="font-size: 10pt"><b>Florida</b></font></td>
    <TD STYLE="vertical-align: top; text-align: center; width: 34%"><font style="font-size: 10pt"><b>001-33357</b></font></td>
    <TD STYLE="vertical-align: top; text-align: center; width: 33%"><font style="font-size: 10pt"><b>65-0643773</b></font></td></tr>
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    <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: top; text-align: center"><font style="font-size: 10pt"><b>(Commission File Number)</b></font></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>
<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%">
<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>
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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>Registrant&rsquo;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; 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-top: 0pt; text-align: center; margin-bottom: 0pt">&nbsp;</P>



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<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: 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>

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    <td style="width: 4%"><font style="font: 10pt Wingdings">&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: 10pt Wingdings">&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: 10pt Wingdings">&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: 10pt Wingdings">&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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<TD STYLE="width: 0in"></TD><TD STYLE="width: 1in; text-align: left"><B>Item 8.01.</B></TD><TD STYLE="text-align: justify"><B>Other Events</B></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">On September 9, 2015, Protalix BioTherapeutics, Inc. (the &ldquo;Company&rdquo;)
issued a press release announcing positive interim data from the Company&rsquo;s phase I/II clinical trial of 1mg/kg of PRX-102
for the treatment of Fabry disease. 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>

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<TD STYLE="width: 0in"></TD><TD STYLE="width: 1in; text-align: left"><B>Item 9.01.</B></TD><TD STYLE="text-align: justify"><B>Financial Statements and Exhibits</B></TD>
</TR></TABLE>

<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>
</TR></TABLE>

<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: 1in; text-align: left">99.1</TD><TD STYLE="text-align: justify">Press release dated September 9, 2015</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>

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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: 10pt Times New Roman, Times, Serif">Date: September 9, 2015</FONT></TD>
    <TD><FONT STYLE="font: 10pt Times New Roman, Times, Serif">By:</FONT></TD>
    <TD STYLE="border-bottom: Black 1pt solid"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">/s/ Moshe Manor</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Name: Moshe Manor</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Title: President and</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font: 10pt Times New Roman, Times, Serif">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
<SEQUENCE>2
<FILENAME>v419959_ex99-1.htm
<DESCRIPTION>EXHIBIT 99.1
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<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">Exhibit 99.1</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: center"><B>Protalix BioTherapeutics Reports Positive
Phase I/II Interim Clinical Data on the 1mg/kg Cohort of PRX-102 for Fabry Disease</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Positive efficacy data across all disease
parameters</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">Positive safety data with low level of antibody
formation</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">End of Phase II meeting with FDA scheduled
before year end</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">CARMIEL, Israel, September 9, 2015 (GLOBE NEWSWIRE) -- Protalix
BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today positive interim data from the Company&rsquo;s phase I/II clinical
trial of 1mg/kg of PRX-102 for the treatment of Fabry disease. PRX-102 is a recombinant plant cell expressed, chemically modified
version of the human alpha-Galactosidase-A enzyme.</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">&ldquo;We are very pleased with the positive results from the
1mg cohort for PRX-102,&rdquo; commented Mr. Moshe Manor, Protalix&rsquo;s President and Chief Executive Officer. &ldquo;The efficacy
results for the 1mg/kg cohort appear even more robust than those previously announced for the 0.2mg cohort, while maintaining a
favorable safety profile with a very low level of antibody formation.&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 of PRX-102 for the treatment of
Fabry disease is an open-label, dose-ranging study treating up to 18 na&iuml;ve male and female adult patients. The three dose
cohorts include dosage groups of 0.2 mg/kg, 1mg/kg and 2mg/kg with intravenous infusions of PRX-102 every two weeks, with a six-month
efficacy follow up period.</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">This interim analysis includes 6 patients enrolled in the 1mg/kg
dose group at six months of treatment. The interim safety analysis includes 18 patients enrolled in three dose cohorts of 0.2mg/kg,
1mg/kg and 2mg/kg.</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>Interim Efficacy Results</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">Based on an analysis of kidney biopsies with randomized blinded
scoring (n=4), PRX-102 demonstrated a reduction in renal peritubular capillary Gb3 of 86% using a quantitative Barisoni Lipid Inclusion
Scoring System (BLISS).</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">Reductions of plasma Lyso-Gb3 and plasma Gb3 concentrations
were also observed.&nbsp; Males (n=4) demonstrated a -67.5 ng/mL and a -5.3 &micro;g/mL change, Females (n=2) demonstrated a -9.2
ng/mL mean change in Lyso-Gb3 and a -0.23 &micro;g/mL mean change in plasma Gb3, respectively.</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">Furthermore, all patients had stable cardiac function after
only six months, as measured by left ventricular mass (LVM), left ventricular mass index (LVMI) and ejection fraction (EF). Stable
kidney function was also observed, as measured by estimated glomerular filtration rate (eGFR) and urine protein.</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>Safety Results</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 safety analysis for adverse events represents a total of
15 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, and only three patients, or approximately 19%, developed antibodies.</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">&ldquo;The data presented from the 1mg cohort of PRX-102 continues
to be very encouraging,&rdquo; said Dr. Derralynn Hughes of the Lysosomal Storage Disease Unit, Institute of Immunity and Transplantation,
Royal Free London NHS Foundation Trust, London, UK, and a principal investigator in the PRX-102 clinical trial. &ldquo;Significant
improvement in Gb3 levels with stability in renal function and cardiac parameters were observed after a relatively short period
of time with low antibody formation.&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">Raphael Schiffmann, M.D., M.H.Sc., an investigator with the
Institute of Metabolic Disease, Baylor Research Institute, Dallas, TX, stated, &ldquo;The data presented from the 1mg/kg cohort
of PRX-102 continues to be very promising with a significant potential for improvement over the currently approved enzyme replacement
therapies for Fabry disease. As PRX-102 has a different chemical structure with a different PK profile, which is probably the cause
for the very low formation of antibodies, it has the potential for reduced immunogenicity as demonstrated in this interim report.
Renal disease represents one of the main causes of morbidity and mortality among Fabry patients, and may not be adequately controlled
by current standard of care. As a principal investigator in the ongoing clinical study, I am very encouraged when eGFR levels are
kept stable.&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">Enrollment in the phase I/II clinical trial of PRX-102 was completed
in early February 2015. All patients that completed the trial opted to continue to receive PRX-102 in an open-label extension study.
The Company expects to report longer term data of the first 0.2mg/kg cohort by the end of this month and to report full top-line
results from all dosing cohorts in the fourth quarter of 2015. The Company scheduled an End of Phase II meeting with the Food and
Drug Administration before year-end to discuss the design of the pivotal phase III trial, which the Company expects to start in
early 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"><B>About 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">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 Israel&rsquo;s Ministry of Health,
by the Brazilian National Health Surveillance Agency (ANVISA) and by the regulatory authorities of other countries. Marketing applications
for taliglucerase alfa have been filed in additional territories as well. Protalix has partnered with Pfizer Inc. for the worldwide
development and commercialization of taliglucerase alfa, excluding Israel and 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; PRX-106, an orally-delivered antiTNF; PRX-110 for the treatment of Cystic Fibrosis;
and others.<FONT STYLE="font: 10pt Times New Roman, Times, Serif"> </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>About Baylor Research Institute</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">Established in 1984 in Dallas, Texas, Baylor Research Institute
(BRI) promotes and supports research to bring innovative treatments from the laboratory workbench to the patient bedside. &nbsp;To
achieve this bench-to-bedside concept, BRI focuses on basic science, clinical trials, healthcare effectiveness and quality of care
research. &nbsp;Today, BRI is conducting more than 930 active research protocols with 400 research investigators, spanning more
than 22 medical specialties, and has research and development projects in areas ranging from human immunology and orphan metabolic
diseases to diabetes, cardio-vascular disease and many other unmet medical 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"><B>Forward-Looking Statements</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">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;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. 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. 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 FDA 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 U.S. Securities and Exchange Commission. 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">&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>CONTACT: Investor Contact</B></P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">646-378-2927</P>

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

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


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