<SEC-DOCUMENT>0001104659-19-054507.txt : 20191017
<SEC-HEADER>0001104659-19-054507.hdr.sgml : 20191017
<ACCEPTANCE-DATETIME>20191017084305
ACCESSION NUMBER:		0001104659-19-054507
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20191017
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20191017
DATE AS OF CHANGE:		20191017

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:		191154065

	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>tm1920403d1_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; 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;&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 17, 2019</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"></P>

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<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"><FONT STYLE="font-size: 14pt"><B>Protalix
BioTherapeutics, Inc.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(Exact name of registrant as specified
in its charter) </B></P>

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

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<TR>
    <TD STYLE="vertical-align: top; text-align: center; width: 32%"><B>Delaware</B></TD>
    <TD STYLE="vertical-align: bottom; width: 2%">&nbsp;</TD>
    <TD STYLE="vertical-align: top; text-align: center; width: 32%"><B>001-33357</B></TD>
    <TD STYLE="vertical-align: bottom; width: 2%">&nbsp;</TD>
    <TD STYLE="vertical-align: top; text-align: center; width: 32%"><B>65-0643773</B></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)&nbsp;</B></P></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: top; text-align: center"><B>(Commission File Number)</B></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.)&nbsp;</B></P></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
<TR>
    <TD STYLE="vertical-align: top; text-align: center; width: 66%"><B>2 Snunit Street</B></TD>
    <TD STYLE="vertical-align: bottom; width: 2%">&nbsp;</TD>
    <TD STYLE="vertical-align: top; text-align: center; width: 32%"></TD></TR>
<TR>
    <TD STYLE="vertical-align: top; text-align: center"><B>Science Park, POB 455</B></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"><B>Carmiel, Israel</B></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: top; text-align: center"><B>20100</B></TD></TR>
<TR>
    <TD STYLE="vertical-align: top; text-align: center"><B>(Address of principal executive offices)</B></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: top; text-align: center"><B>(Zip Code)</B></TD></TR>
</TABLE>


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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>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>

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<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">Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (<I>see</I> General Instruction
A.2. below):</P>

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

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 28.6pt"></TD><TD STYLE="width: 21.6pt"><FONT STYLE="font-family: Wingdings">&uml;</FONT></TD><TD>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" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 28.6pt"></TD><TD STYLE="width: 21.6pt"><FONT STYLE="font-family: Wingdings">&uml;</FONT></TD><TD>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" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 28.6pt"></TD><TD STYLE="width: 21.6pt"><FONT STYLE="font-family: Wingdings">&uml;</FONT></TD><TD>Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</TD></TR></TABLE>

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

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 28.6pt"></TD><TD STYLE="width: 21.6pt"><FONT STYLE="font-family: Wingdings">&uml;</FONT></TD><TD>Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</TD></TR></TABLE>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: right; text-indent: -3em; margin-right: 8pt">Emerging growth
company <FONT STYLE="font-family: Times New Roman, Times, Serif"><FONT STYLE="font-family: Wingdings">&#168;</FONT></FONT></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. <FONT STYLE="font-family: Times New Roman, Times, Serif">&#9744;</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; text-align: center"><B>Securities registered pursuant to Section
12(b) of the Act:</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"></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 32%; border-bottom: Black 1pt solid; text-align: center">Title of each class</TD>
    <TD STYLE="width: 2%">&nbsp;</TD>
    <TD STYLE="width: 32%; border-bottom: Black 1pt solid; text-align: center">Trading Symbol(s)</TD>
    <TD STYLE="width: 2%">&nbsp;</TD>
    <TD STYLE="width: 32%; border-bottom: Black 1pt solid; text-align: center">Name of each exchange on which registered</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="text-align: center">Common stock, $0.001 par value</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center">PLX</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center">NYSE American</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"></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"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; margin-left: 0in; text-indent: 0in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><BR STYLE="clear: both">
</B></FONT><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; margin-left: 0in; text-indent: 0in; text-align: justify"><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 October&nbsp;17, 2019, Protalix BioTherapeutics, Inc. (the
 &ldquo;Company&rdquo;) issued a press release announcing positive 12-month on-treatment data from the first 16 out of the 22 adult
patients enrolled in its BRIDGE Phase III study, an open label switch-over study evaluating the safety and efficacy of pegunigalsidase
alfa (PRX-102), 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 two years and on a stable dose for at least six months. Pegunigalsidase alfa is the Company&rsquo;s plant cell-expressed
recombinant, PEGylated, cross<FONT STYLE="color: #333333">-</FONT>linked &alpha;<FONT STYLE="color: #333333">-</FONT>galactosidase<FONT STYLE="color: #333333">-</FONT>A
drug candidate. A copy of the press release is attached as Exhibit&nbsp;99.1 to this Current Report on Form 8<FONT STYLE="color: #333333">-</FONT>K
and is incorporated herein by reference.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; margin-left: 0in; text-indent: 0in; text-align: justify"><B>Item
9.01 Financial Statements and Exhibits</B></P>

<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: 0in"></TD><TD STYLE="width: 0.55in; 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>

<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: 0.55in; text-align: left"><A HREF="tm1920403d1_ex99-1.htm" STYLE="-sec-extract: exhibit">99.1</A></TD><TD STYLE="text-align: justify"><A HREF="tm1920403d1_ex99-1.htm" STYLE="-sec-extract: exhibit">Press release dated October&nbsp;17, 2019.</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"><B>&nbsp;</B></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>&nbsp;</B></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">&nbsp;</P>

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

<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%; background-color: white">
<TR>
    <TD STYLE="text-align: justify">Date: October&nbsp;17, 2019</TD>
    <TD COLSPAN="2" STYLE="text-align: justify"><B>PROTALIX BIOTHERAPEUTICS, INC.</B></TD></TR>
<TR>
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD COLSPAN="2" STYLE="text-align: justify">&nbsp;</TD></TR>
<TR>
    <TD STYLE="width: 50%; text-align: justify">&nbsp;</TD>
    <TD STYLE="width: 3%; text-align: justify">By:</TD>
    <TD STYLE="width: 47%">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; border-bottom: Black 0.5pt solid">/s/ Dror
        Bashan</P></TD></TR>
<TR>
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Name: Dror Bashan</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Title: President and Chief Executive Officer</P></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 3.5in; text-align: justify; text-indent: -3.5in">&nbsp;</P>

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


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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>tm1920403d1_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"><B>Exhibit 99.1</B></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: right">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Protalix BioTherapeutics Announces Positive
12-Month Interim Data from the<BR>
BRIDGE Phase&nbsp;III Open Label Switch-Over Study of pegunigalsidase alfa<BR>
for the Treatment of 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"><I>12-Months On-treatment Data Indicate
Significant Improvement in Kidney Function in Patients Switched from agalsidase alfa (Replagal<SUP>&reg;</SUP>) to pegunigalsidase
alfa (PRX-102)</I></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"><I>100% of the &ldquo;progressing&rdquo;
patients and 66.7% in the &ldquo;fast progressing&rdquo; patients achieved the proposed therapeutic goals after switching to pegunigalsidase
alfa</I></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"><I>The switch to pegunigalsidase alfa was
well tolerated</I></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; background-color: white"><B>CARMIEL,&nbsp;Israel</B>,&nbsp;October&nbsp;17,
2019&nbsp;/PRNewswire/&nbsp;--&nbsp;Protalix BioTherapeutics, Inc.&nbsp;(NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the
development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx<SUP>&reg;</SUP>
plant cell-based protein expression system, today announced positive 12-month on-treatment data from the first 16 out of the 22
adult patients enrolled in its BRIDGE Phase III study.</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 previously announced positive preliminary results
from 16 patients after six months in the BRIDGE study in September 2018, and these new results, after 12 months of treatment, further
suggest the strong potential benefit of pegunigalsidase alfa on renal function for Fabry patients,&rdquo; said Raul Chertkoff,
M.D., Protalix&rsquo;s Vice President, Medical Affairs.</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">The BRIDGE study is an open label switch-over
study evaluating the safety and efficacy of pegunigalsidase alfa (PRX-102), 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 two years and on a stable dose for at least
six months. Patients are screened and evaluated over three months while continuing agalsidase alfa treatment. Following the screening
period, each patient was enrolled and switched from Replagal treatment to receive intravenous (IV) infusions of pegunigalsidase
alfa 1 mg/kg every two weeks for 12 months. Patients have the option to receive pegunigalsidase alfa infusions in a home care setting
based on infusion tolerability and country regulation.</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 12-month interim data from the
first 16 of 22 adult patients enrolled (9 males and 7 females) demonstrate a mean improvement in kidney function, in both male
and female patients, when switched from agalsidase alfa to pegunigalsidase alfa.</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>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">One hundred percent of the progressing
patients, those with an estimated Glomerular Filtration Rate (eGFR) slope between -5 and -3 mL/min/1.73 m<SUP>2</SUP>/year, and
66.7% in the fast progressing group, with an eGFR slope &lt; -5 mL/min/1.73 m<SUP>2</SUP>/year, achieved the proposed therapeutic
goals (eGFR slope &ge; -3 mL/min/1.73 m<SUP>2</SUP>/year for progressing patients, and &ge; -5 mL/min/1.73m<SUP>2</SUP>/year or
more than 50% decrease in progression for fast progressing patients) after switching to pegunigalsidase alfa. The majority of the
patients who completed the study rolled over to a long-term extension study, continuing to be treated with pegunigalsidase alfa.</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">In the study, after one year, the
mean annualized eGFR slope improved from -5.10 mL/min/1.73m<SUP>2</SUP>/year while on agalsidase alfa to -0.23 mL/min/1.73m<SUP>2</SUP>/year
on pegunigalsidase alfa. Baseline characteristics of these patients, ages 27 to 60 years, were: mean eGFR 75.45 in males and 85.78
mL/min/1.73m<SUP>2</SUP> in females, annualized pre-switching eGFR slope was -5.04 and -5.18 mL/min/1.73m<SUP>2</SUP>/year, in
males and females respectively, mean residual leucocytes enzymatic activity 5.9% of lab normal mean in males and 27.9% in females,
and plasma lyso-Gb3 mean levels 53.6 and 13.8 nM, in males and females, respectively.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">Pegunigalsidase alfa was found to be
well tolerated in the study, with all adverse events being transient in nature without sequelae. Most of the patients who were
eligible for home care therapy per country regulation were treated under a home care arrangement in which certain of the scheduled
infusions were performed at the patients&rsquo; home.</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 Fabry Disease</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">Fabry disease is an X-linked inherited disease that results
from deficient activity of the lysosomal enzyme alpha galactosidase A resulting in progressive accumulation of abnormal deposits
of a fatty substance called globotriaosylceramide (Gb<SUB>3</SUB>) in blood vessel walls throughout a person&rsquo;s body. Fabry
disease occurs in one person per 40,000. Fabry patients inherit a deficiency of the enzyme alpha-galactosidase-A, which is normally
responsible for the breakdown of Gb<SUB>3</SUB>. The abnormal storage of Gb<SUB>3</SUB> increases with time and, accordingly, Gb<SUB>3</SUB>
accumulates, primarily in the blood and in the blood vessel walls. The ultimate consequences of Gb<SUB>3</SUB> deposition range
from episodes of pain and impaired peripheral sensation to end-organ failure &ndash; particularly of the kidneys, but also of the
heart and the cerebrovascular system.</P>

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<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; background-color: white"><B>About pegunigalsidase alfa (PRX</B>-<B>102)</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 Company&rsquo;s proprietary pegunigalsidase
alfa is an investigational, plant cell culture expressed enzyme, and a chemically modified stabilized version of, the recombinant
alpha-Galactosidase-A protein. Protein sub-units are covalently bound via chemical cross-linking using short PEG moeity, resulting
in a more stable molecule with different pharmacokinetic parameters compared to the current available versions of the enzyme. In
clinical studies, pegunigalsidase alfa has been observed to have a favorable circulatory half-life of approximately 80 hours. In
addition, in a Fabry mouse model, pegunigalsidase alfa was observed to have favorable levels of enzyme activity in target organs
affected by Fabry disease. The Company designed pegunigalsidase alfa to potentially address the continued unmet clinical need in
Fabry patients of continuous disease progression, infusion reaction and immunogenicity.</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"><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">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<SUP>&reg;</SUP>. Protalix
was the first company to gain FDA approval of a protein produced through plant cell-based in suspension expression system. Protalix&rsquo;s
unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix&rsquo;s
pipeline consists of proprietary, potentially clinically superior versions of recombinant therapeutic proteins that target established
pharmaceutical markets.</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">Protalix&rsquo;s first product manufactured
by ProCellEx, taliglucerase alfa, was approved for marketing by the U.S.&nbsp;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.</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">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, in Phase&nbsp;III clinical trials (BALANCE, BRIDGE and BRIGHT studies); and OPRX-106, an orally
delivered anti-inflammatory treatment, and alidornase alfa for the treatment of Cystic Fibrosis, both in Phase&nbsp;II clinical
trials. Protalix has partnered with Chiesi Farmaceutici S.p.A., both in the United States and outside 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"><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"></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. The terms &ldquo;expect,&rdquo; &ldquo;anticipate,&rdquo; &ldquo;believe,&rdquo;
 &ldquo;estimate,&rdquo; &ldquo;project,&rdquo; &ldquo;plan,&rdquo; &ldquo;should&rdquo; and &ldquo;intend,&rdquo; and other words
or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject
to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the
statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery
and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings
for the clinical trial. Factors that might cause material differences include, among others: risks related to our ability to identify
and complete strategic alternatives on attractive terms or at all within the time period required to regain compliance with the
continued listing standards of the NYSE American; risks related to our ability to continue as a going concern absent a refinancing
or restructuring; risks related to any transactions we may effect in the public or private equity markets to raise capital to finance
future activities; failure or delay in the commencement or completion of our preclinical and clinical trials which may be caused
by several factors, including: risks that the FDA will not accept an application for accelerated approval of PRX--102 with the
data generated to date or will request additional data or other conditions of our submission of any application for accelerated
approval of PRX-102; risks related to our ability to continue as a going concern absent access to sources of capital we will need
to finance future research and development activities, general and administrative expenses and working capital; risks related to
any capital raising transactions we may effect in the public or private equity markets to raise capital to finance future research
and development activities, general and administrative expenses and working capital; slower than expected rates of patient recruitment;
unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to monitor patients
adequately during or after treatment; inability or unwillingness of medical investigators and institutional review boards to follow
our clinical protocols; and lack of sufficient funding to finance clinical trials; the risk that the results of the clinical trials
of our product candidates will not support our claims of superiority, safety or efficacy, that our product candidates will not
have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; risks related
to our ability to maintain and manage our relationship with Chiesi Farmaceutici and any other collaborator, distributor or partner;
risks related to the amount and sufficiency of our cash and cash equivalents; risks related to the ultimate purchase by Funda&ccedil;&atilde;o
Oswaldo Cruz of alfataliglicerase pursuant to the stated purchase intentions of the Brazilian Ministry of Health of the stated
amounts, if at all; risks related to the successful conclusion of our negotiations with the Brazilian Ministry of Health regarding
the purchase of alfataliglicerase generally; risks related to our commercialization efforts for alfataliglicerase in Brazil; risks
relating to the compliance by Funda&ccedil;&atilde;o Oswaldo Cruz with its purchase obligations and related milestones under our
supply and technology transfer agreement; risks related to the amount and sufficiency of our cash and cash equivalents; risks related
to the amount of our future revenues, operations and expenditures; the risk that despite the FDA&rsquo;s grant of fast track designation
for pegunigalsidase alfa for the treatment of Fabry disease, we may not experience a faster development process, review or approval
compared to applications considered for approval under conventional FDA procedures; risks related to the FDA&rsquo;s ability to
withdraw the fast track designation at any time; risks relating to our ability to make scheduled payments of the principal of,
to pay interest on or to refinance our outstanding notes or any other indebtedness; our dependence on performance by third party
providers of services and supplies, including without limitation, clinical trial services; delays in our preparation and filing
of applications for regulatory approval; delays in the approval or potential rejection of any applications we file with the FDA
or other health regulatory authorities, and other risks relating to the review process; our ability to identify suitable product
candidates and to complete preclinical studies of such product candidates; the inherent risks and uncertainties in developing drug
platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other
companies and institutions; potential product liability risks, and risks of securing adequate levels of product liability and other
necessary insurance coverage; and other factors described in our filings with the U.S.&nbsp;Securities and Exchange Commission.
The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information,
except as may be required by law.</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><B>Investor Contact<BR>
</B>Chuck Padala, Managing Director<B><BR>
</B>LifeSci Advisors<B><BR>
</B>646-627-8390<B><BR>
</B>chuck@lifesciadvisors.com</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><B>Media Contact<BR>
</B>Doug Russell <B><BR>
</B>LaVoieHealthScience<B><BR>
</B>617-953-0120<B><BR>
</B>drussell@lavoiehealthscience.com</P>

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

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