<SEC-DOCUMENT>0001144204-18-052605.txt : 20181005
<SEC-HEADER>0001144204-18-052605.hdr.sgml : 20181005
<ACCEPTANCE-DATETIME>20181005070831
ACCESSION NUMBER:		0001144204-18-052605
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20181005
ITEM INFORMATION:		Regulation FD Disclosure
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20181005
DATE AS OF CHANGE:		20181005

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:		181109269

	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>tv504325_8k.htm
<DESCRIPTION>FORM 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>

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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): October 5, 2018</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"><FONT STYLE="font-size: 16pt"><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; text-align: center">&nbsp;</P>

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<TR>
    <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: 1%">&nbsp;</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: bottom; width: 1%">&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>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></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>&nbsp;</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="width: 48%">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; width: 4%">&nbsp;</TD>
    <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>
</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>

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<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in; text-align: left"><FONT STYLE="font-family: Wingdings">&uml;</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: 0.5in"></TD><TD STYLE="width: 0.25in; text-align: left"><FONT STYLE="font-family: Wingdings">&uml;</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: 0.5in"></TD><TD STYLE="width: 0.25in; text-align: left"><FONT STYLE="font-family: Wingdings">&uml;</FONT></TD><TD STYLE="text-align: justify">Pre-commencement communication pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b))</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: 0.5in"></TD><TD STYLE="width: 0.25in; text-align: left"><FONT STYLE="font-family: Wingdings">&uml;</FONT></TD><TD STYLE="text-align: justify">Pre-commencement communication 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: center; 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: Wingdings">&#168;</FONT></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 7.01. <FONT STYLE="font-family: Times New Roman, Times, Serif">Regulation
FD Disclosure</FONT></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 October 5, 2018, Protalix BioTherapeutics, Inc. (the &ldquo;Company&rdquo;)
issued a press release announcing that positive preliminary data from the BRIDGE study of pegunigalsidase alfa (PRX-102) for the
treatment of Fabry disease will be presented today at the 1st Canadian Symposium on Lysosomal Diseases 2018 which is taking place
October 5-6, 2018 at the OLT Gouverneur Hotel in Sherbrooke, Quebec. <FONT STYLE="color: #333333">An oral presentation titled,
 &ldquo;Pegunigalsidase Alfa-a Novel Enzyme Replacement Therapy for the Treatment of Fabry Disease: Preliminary Results from the
Phase III Bridge Study,&rdquo; will be presented by Dr. Michael L. West, Professor, Division of Nephrology, Department of Medicine,
Dalhousie University, Halifax, Nova Scotia, today, Friday, October 5 at 10:15 am ET.</FONT> A copy of the press release is furnished
as Exhibit 99.1 to this Current Report on Form 8-K.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">In accordance with General Instruction B.2 of Form 8-K, the
information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be &ldquo;filed&rdquo; for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended (the &ldquo;Exchange Act&rdquo;), or otherwise subject to the
liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under
the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such
filing.</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>

<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: 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: 0.5in; text-align: left"><A HREF="tv504325_ex99-1.htm" STYLE="-sec-extract: exhibit">99.1</A></TD><TD STYLE="text-align: justify"><A HREF="tv504325_ex99-1.htm" STYLE="-sec-extract: exhibit">Press release dated October 5, 2018.</A></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"></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>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; text-indent: 0; margin-top: 0pt; margin-bottom: 6pt">&nbsp;</P>

<TABLE BORDER="0" CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif">
<TR>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD COLSPAN="2"><B>PROTALIX BIOTHERAPEUTICS, INC.</B></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: October 5, 2018</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><P STYLE="margin-top: 0; margin-bottom: 0">Name:</P>
        <P STYLE="margin-top: 0; margin-bottom: 0">Title:</P>
        <P STYLE="margin-top: 0; margin-bottom: 0">&nbsp;</P></TD>
    <TD STYLE="vertical-align: top; border-top: #000000 1px solid">Moshe Manor<BR>President and <BR>
Chief Executive Officer</TD></TR>
</TABLE>

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

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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>tv504325_ex99-1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 3.5in; text-align: right; text-indent: -3.5in">Exhibit 99.1</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 3.5in; text-align: right; text-indent: -3.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; color: #222222"><B>Protalix BioTherapeutics
Presents Positive Preliminary Data from the BRIDGE Study of pegunigalsidase alfa</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; color: #222222"><B>for the Treatment of Fabry Disease at the<BR>
1st Canadian Symposium on Lysosomal Diseases 2018</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 0.5in 0pt 0; text-align: center; text-indent: 0.5in; color: #333333"><I>~Preliminary
Results Indicate Significant Improvement in Kidney Function in Patients Switched</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.5in 0pt 0; text-align: center; text-indent: 0.5in; color: #333333"><I>from agalsidase alfa (Replagal&reg;) to pegunigalsidase
alfa (PRX-102)~</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.5in 0pt 0; text-align: center; text-indent: 0.5in; color: #333333">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.5in 0pt 0; text-align: center; text-indent: 0.5in; color: #333333"><I>A
deterioration trend in patients&rsquo; kidney function on agalsidase alfa (Replagal&reg;) was reversed to an</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.5in 0pt 0; text-align: center; text-indent: 0.5in; color: #333333"><I>improvement trend
when switched to pegunigalsidase alfa (PRX-102)</I></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.5in 0pt 0; text-align: center; text-indent: 0.5in; color: #333333"><I>Presentation
with full data to be held at the 1st Canadian Symposium on Lysosomal Diseases 2018</I></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333">CARMIEL,&nbsp;Israel,&nbsp;October 5, 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<SUP>&reg;</SUP>, today announced that positive preliminary data from the BRIDGE study of pegunigalsidase alfa (PRX-102)
for the treatment of Fabry disease will be presented today at the 1st Canadian Symposium on Lysosomal Diseases 2018. The symposium
will take place October 5-6, 2018 at the OLT Gouverneur Hotel in Sherbrooke, Quebec. An oral presentation titled, &ldquo;Pegunigalsidase
Alfa-a Novel Enzyme Replacement Therapy for the Treatment of Fabry Disease: Preliminary Results from the Phase III Bridge Study,&rdquo;
will be presented by Dr. Michael L. West, Professor, Division of Nephrology, Department of Medicine, Dalhousie University, Halifax,
Nova Scotia, today, Friday, October 5 at 10:15 am ET. The slides from Dr. West&rsquo;s presentation will be available on the Company&rsquo;s
website after the presentation.</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; color: #333333">The BRIDGE study is an open
label switch over study evaluating the safety and efficacy of pegunigalsidase alfa, 1 mg/kg infused every two weeks, in up to 22
Fabry patients currently treated with agalsidase alfa (Replagal<SUP>&reg;</SUP>) 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 on agalsidase alfa. Following the screening
period, each patient was enrolled and switched from Replagal treatment to receive intravenous (IV) infusions of PRX-102 1 mg/kg
every two weeks for 12 months. Patients can receive PRX-102 infusions at a home care setup based on the infusion tolerability.
The Company anticipates completing patient enrollment in the BRIDGE trial in the fourth quarter of 2018.</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; color: #333333">As previously announced by
the Company, preliminary data from the first sixteen patients enrolled in the trial demonstrated an improvement in kidney function,
in both male and female Fabry patients, when switched from agalsidase alfa to pegunigalsidase alfa. Based on available historical
serum creatinine and study 3 month screening period values for approximately 2 years while treated with agalsidase alfa before
switching to pegunigalsidase alfa treatment, the annualized estimated glomerular filtration rate (eGFR) slope for patients on Replagal
was (negative) &ndash; -6.8ml/min/1.73m2. The mean eGFR slope for the same patients following six months of treatment with pegunigalsidase
alfa was changed to be (positive) &ndash; +3.7ml/min/1.73m2. These results are statistically significant with a p-value of 0.015.
Baseline characteristics of these patients were: mean estimated glomerular filtration rate (eGFR) 75.40 and 86.03 mL/min/1.73m2
for males and females, with annualized eGFR slope of -8.0 and -5.1 mL/min/1.73m2/year, respectively. This improvement in kidney
function (e.g., eGFR) over time may potentially result in the delay or prevention of kidney failure in these populations.</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; color: #333333">The enzyme has been well tolerated
in the study, with all adverse events being transient in nature without sequelae. Most of the patients who are eligible for home
care therapy per country regulation are being treated under a home care arrangement in which certain of the scheduled infusions
are performed at the patients&rsquo; home, and the first patient who concluded the study has opted to enroll in a long-term extension
study and continues to be treated with PRX-102.</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333">&ldquo;These results are very encouraging and
show that pegunigalsidase alfa (PRX-102) has the potential to provide a better enzyme replacement therapy for Fabry patients. I
am excited to be a part of this trial, and I look forward to continuing to work with Protalix as pegunigalsidase alfa progresses
through its potential approval and availability for the treatment of Fabry patients,&rdquo; said Dr. Michael West, Professor, Division
of Nephrology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia.</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333">In addition, in vitro analysis of PRX-102 in
both human plasma and in lysosomal-like conditions shows significantly longer stability of enzyme activity compared to both commercially-available
enzyme replacement therapies (ERTs). In lysosomal-like conditions, approximately 84% of PRX-102&rsquo;s activity was shown to have
been preserved after 10 days compared to approximately 1% remaining enzyme activity in each of the commercially available ERTs.
These results were statistically significant with a p-value of 0.01 (Kizhner&nbsp;T., et al (2015) Molecular Genetics and Metabolism
114: 259&ndash;267).</P>

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<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 for Fabry disease. In pre-clinical and clinical studies, PRX-102 demonstrated
higher stability in plasma, a longer half-life and higher exposure in Fabry patients, and a reduction in Gb3 in kidney biopsies
in treatment na&iuml;ve Fabry patients.</P>

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<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>

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<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;. 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.
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 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; 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.&nbsp; The terms &ldquo;expect,&rdquo; &ldquo;anticipate,
 &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.&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 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: 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&nbsp;Oswaldo Cruz&nbsp;of alfataliglicerase pursuant to the stated purchase intentions of the&nbsp;Brazilian
Ministry of Health&nbsp;of the stated amounts, if at all; risks related to the successful conclusion of our negotiations with the&nbsp;Brazilian
Ministry of Health&nbsp;regarding the purchase of alfataliglicerase generally; risks related to our commercialization efforts for
alfataliglicerase in&nbsp;Brazil; risks relating to the compliance by Funda&ccedil;&atilde;o&nbsp;Oswaldo Cruz&nbsp;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&nbsp;FDA&nbsp;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&nbsp;FDA&nbsp;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&nbsp;U.S. Securities and Exchange Commission.&nbsp; 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.</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>

<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">Marcy Nanus, Managing
Director<BR>
Solebury Trout&nbsp;<BR>
646-378-2927<BR>
mnanus@soleburytrout.com</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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