<SEC-DOCUMENT>0001144204-15-005162.txt : 20150202
<SEC-HEADER>0001144204-15-005162.hdr.sgml : 20150202
<ACCEPTANCE-DATETIME>20150202070723
ACCESSION NUMBER:		0001144204-15-005162
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20150202
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20150202
DATE AS OF CHANGE:		20150202

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:		15564850

	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
<SEQUENCE>1
<FILENAME>v400116_8k.htm
<DESCRIPTION>FORM 8-K
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<P STYLE="font: 18pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>UNITED STATES</B></P>

<P STYLE="font: 18pt 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>

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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: 0pt 0; 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: 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; text-indent: 0.5in">&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): February 2, 2015</B></P>

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<P STYLE="font: 24pt Times New Roman, Times, Serif; margin: 0pt 0; 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="vertical-align: top; text-align: center"><font style="font-size: 10pt"><b>Florida</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>
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        <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"></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></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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    <td style="width: 48%">&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>
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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>Registrant's telephone number, including
area code +972-4-988-9488</B></P>

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<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; 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">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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<tr style="vertical-align: top">
    <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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<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 February 2, 2015, Protalix BioTherapeutics, Inc. (the &ldquo;Company&rdquo;)
issued a press release announcing <FONT STYLE="background-color: white">that the Company has completed enrollment in its phase
I/II clinical trial of PRX-102 for the treatment of Fabry disease. </FONT>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>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">99.1&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Press
release dated February 2, 2015</P>



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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="2"><B>PROTALIX BIOTHERAPEUTICS, INC.</TD></TR>
<TR>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD COLSPAN="2">&nbsp;</TD></TR>
<TR>
    <TD STYLE="vertical-align: top; width: 50%">Date: February 2, 2015</TD>
    <TD STYLE="width: 4%">By:&nbsp;</TD>
    <TD STYLE="vertical-align: top; width: 46%">/s/ Moshe Manor</TD></TR>
<TR>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD>Name:<BR>
Title:</TD>
    <TD STYLE="vertical-align: top; border-top: #000000 1px solid">Moshe Manor<BR>President
and Chief Executive Officer</TD></TR>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>v400116_ex99-1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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<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"><FONT STYLE="background-color: white"><B>Protalix
BioTherapeutics Completes Enrollment in Phase I/II Clinical Trial</B></FONT><BR>
<FONT STYLE="background-color: white"><B>of PRX-102 for Fabry Disease</B></FONT></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"><FONT STYLE="background-color: white"><B><I>Interim
Efficacy and Safety Results to be Presented at WORLD Symposium</I></B></FONT></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"><FONT STYLE="background-color: white">CARMIEL,&nbsp;</FONT>Israel<FONT STYLE="background-color: white">,&nbsp;</FONT>February
2, 2015<FONT STYLE="background-color: white">&nbsp;--&nbsp;</FONT>Protalix BioTherapeutics, Inc.<FONT STYLE="background-color: white">&nbsp;(NYSE
MKT:PLX) (TASE:PLX), announced today that the Company has completed enrollment in its phase I/II clinical trial of PRX-102 for
the treatment of Fabry disease. All patients that completed the trial have opted to continue to receive PRX-102 in an open-label
extension trial. PRX-102 is a proprietary plant cell-expressed, chemically modified recombinant alpha-galactosidase-A enzyme that
is designed to be a more stable enzyme than currently marketed enzyme replacement therapies for Fabry disease. </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"><FONT STYLE="background-color: white">&ldquo;The enthusiasm
surrounding this open label study continues to mount, as evidenced by physicians&rsquo; reactions to the interim data from the
0.2mg/kg dosing cohort,&rdquo; said Mr. Moshe Manor, President and Chief Executive Officer of Protalix BioTherapeutics. &ldquo;Not
only has PRX-102 shown benefits across all disease parameters, including remarkable results in pain, PRX-102 has also shown exciting
cardiac and kidney function at only six months of treatment. We look forward to reporting additional interim results, including
patient by patient data and cardiac and renal functions, at the WORLD Symposium.&rdquo;</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"><FONT STYLE="background-color: white">On February 12, 2015 at
10:45AM ET Dr. Ozlem Goker-Alpan, President and Chief Medical Officer of the Center for Clinical Trials, O&amp;O Alpan, LLC., and
Director of the Lysosomal Research and Treatment Unit, will present interim results from the phase I/II trial in an oral presentation
titled, &ldquo;Novel treatment for Fabry disease, IV administration of plant derived &alpha;-GAL-A enzyme phase 1/2 safety and
efficacy study: interim clinical report&rdquo; at the Lysosomal Disease Network WORLD Symposium in Orlando, FL. </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"><FONT STYLE="background-color: white">Additionally, the Company
expects to report interim results from the 1mg/kg cohort in the third quarter of 2015, and full top-line results from all dosing
cohorts in the fourth quarter of 2015. Management will request an end of Phase II meeting with the U.S. Food and Drug Administration
in the fourth quarter of 2015, and anticipates initiating a phase III pivotal trial in early 2016.</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"><FONT STYLE="background-color: white">The phase I/II clinical
trial of PRX-102 is an open-label, dose-ranging study treating 18 na&iuml;ve male and female patients with Fabry disease. &nbsp;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.</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; background-color: white"><FONT STYLE="background-color: white"><B>About
Protalix</B>&nbsp;<B>BioTherapeutics, Inc.</B></FONT></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"><FONT STYLE="background-color: white">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's unique expression system presents a proprietary
method for developing recombinant proteins in a cost-effective, industrial-scale manner.&nbsp;Protalix's first product manufactured
by ProCellEx, taliglucerase alfa, was approved for marketing by the&nbsp;U.S. Food and Drug Administration(FDA) in&nbsp;May 2012,
by&nbsp;Israel's&nbsp;Ministry of Health&nbsp;in&nbsp;September 2012, by the&nbsp;Brazilian National Health Surveillance Agency&nbsp;(ANVISA)
in&nbsp;March 2013, by the&nbsp;Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS) in&nbsp;April 2013,
by the&nbsp;Australian Therapeutic Goods Administration(TGA) in&nbsp;May 2014&nbsp;and by the regulatory authorities of other countries.&nbsp;Marketing
applications for taliglucerase alfa have been filed in additional territories as well.&nbsp;Protalix has partnered with&nbsp;Pfizer
Inc. for the worldwide development and commercialization of taliglucerase alfa, excluding&nbsp;Israel&nbsp;and&nbsp;Brazil, where
Protalix retains full rights.&nbsp;Protalix'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-112, an orally-delivered glucocerebrosidase
enzyme that is produced and encapsulated within carrot cells, also for the treatment of Gaucher disease; PRX-106, an orally-delivered
treatment for the treatment of Inflammatory Bowel Disease; PRX-110 for the treatment of Cystic Fibrosis; and others.</FONT></P>

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

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><FONT STYLE="background-color: white"><B>Forward-Looking
Statements</B></FONT></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"><FONT STYLE="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 &quot;anticipate,&quot;
&quot;believe,&quot; &quot;estimate,&quot; &quot;expect,&quot; &quot;plan&quot; and &quot;intend&quot; 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.</FONT></P>

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

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><FONT STYLE="background-color: white">Marcy
Nanus<BR>
The Trout Group, LLC<BR>
646-378-2927<BR>
mnanus@troutgroup.com</FONT></P>

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

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