<SEC-DOCUMENT>0001104659-20-059085.txt : 20200511
<SEC-HEADER>0001104659-20-059085.hdr.sgml : 20200511
<ACCEPTANCE-DATETIME>20200511065814
ACCESSION NUMBER:		0001104659-20-059085
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20200511
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20200511
DATE AS OF CHANGE:		20200511

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:		20862542

	BUSINESS ADDRESS:	
		STREET 1:		2 SNUNIT ST
		STREET 2:		SCIENCE PARK, POB 455
		CITY:			CARMIEL
		STATE:			L3
		ZIP:			2161401
		BUSINESS PHONE:		972-4-988-9488

	MAIL ADDRESS:	
		STREET 1:		2 SNUNIT ST
		STREET 2:		SCIENCE PARK, POB 455
		CITY:			CARMIEL
		STATE:			L3
		ZIP:			2161401

	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>tm2018938d1_8k.htm
<DESCRIPTION>8-K
<TEXT>
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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> <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">&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): May 11, 2020</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>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>

<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>



<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
<TR>
    <TD>&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD COLSPAN="3">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
<TR>
    <TD STYLE="vertical-align: top; text-align: center"><B>Delaware</B></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="vertical-align: top; text-align: center"><B>001-33357</B></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: top; text-align: center"><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)</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD COLSPAN="3" 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.)</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P></TD></TR>
<TR>
    <TD COLSPAN="3">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD COLSPAN="3">&nbsp;</TD></TR>
<TR>
    <TD COLSPAN="3" STYLE="vertical-align: top; text-align: center"><B>2 Snunit Street</B></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="vertical-align: top; text-align: center"><B>2161401</B></TD></TR>
<TR>
    <TD COLSPAN="3" STYLE="vertical-align: top; text-align: center"><B>Science Park, POB 455</B></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="vertical-align: top; text-align: center">&nbsp;</TD></TR>
<TR>
    <TD COLSPAN="3" STYLE="vertical-align: top; text-align: center"><B>Carmiel, Israel</B></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="vertical-align: top; text-align: center">&nbsp;</TD></TR>
<TR>
    <TD COLSPAN="3" STYLE="vertical-align: top; text-align: center"><B>(Address of principal executive offices)</B></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="vertical-align: top; text-align: center"><B>(Zip Code)</B></TD></TR>
<TR>
    <TD STYLE="width: 34%">&nbsp;</TD>
    <TD STYLE="width: 1%">&nbsp;</TD>
    <TD STYLE="width: 17%">&nbsp;</TD>
    <TD STYLE="width: 1%">&nbsp;</TD>
    <TD STYLE="width: 17%">&nbsp;</TD>
    <TD STYLE="width: 1%">&nbsp;</TD>
    <TD STYLE="width: 29%">&nbsp;</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 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">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>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif"><FONT STYLE="font-family: Wingdings">&#168;</FONT>&#9;</FONT>Written
communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</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="font-family: Times New Roman, Times, Serif"><FONT STYLE="font-family: Wingdings">&#168;</FONT>&#9;</FONT>Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</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="font-family: Times New Roman, Times, Serif"><FONT STYLE="font-family: Wingdings">&#168;</FONT>&#9;</FONT>Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(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"><FONT STYLE="font-family: Times New Roman, Times, Serif"><FONT STYLE="font-family: Wingdings">&#168;</FONT>&#9;</FONT>Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</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>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: bottom">
    <TD STYLE="width: 39%; border: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center">Title of each class</TD>
    <TD STYLE="width: 18%; border-top: Black 1pt solid; border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center">Trading Symbol(s)</TD>
    <TD STYLE="width: 43%; border-top: Black 1pt solid; border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center">Name of each exchange on which registered</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center">Common stock, $0.001 par value</TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center">PLX</TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center">NYSE American</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.3in 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 0.3in 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: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="font-family: Wingdings">&#168;</FONT></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"></P>

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<TD STYLE="width: 0in"></TD><TD STYLE="width: 1in; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Item 8.01</B></FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt"><B> Other Events</B></FONT></TD>
</TR></TABLE>
<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">&nbsp;&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">On May&nbsp;11, 2020, Protalix BioTherapeutics, Inc.,
a Delaware corporation (the &ldquo;Company&rdquo;), issued a press release announcing positive topline results from its Phase&nbsp;III
BRIDGE clinical trial of pegunigalsidase alfa, or PRX-102. Pegunigalsidase alfa is the Company&rsquo;s plant cell-expressed recombinant,
PEGylated, cross-linked &alpha;-galactosidase-A product candidate under development for the treatment of Fabry disease. 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;&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></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: 1in; text-align: left"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Item 9.01</B></FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt"><B> Financial Statements and Exhibits</B></FONT></TD>
</TR></TABLE>
<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">&nbsp;&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></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: 1in; text-align: left"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>(d)</B></FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt"><B> Exhibits</B></FONT></TD>
</TR></TABLE>


<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"></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: 1in; text-align: left"><A HREF="tm2018938d1_ex99-1.htm" STYLE="-sec-extract: exhibit"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B></B>99.1</FONT></A></TD><TD STYLE="text-align: justify"><A HREF="tm2018938d1_ex99-1.htm" STYLE="-sec-extract: exhibit"><FONT STYLE="font-size: 10pt">Press release dated May&nbsp;11, 2020.</FONT></A></TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

<P STYLE="margin: 0">&nbsp;</P>

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<P STYLE="margin: 0">&nbsp;</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">&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"><FONT STYLE="font-size: 10pt">Date: May&nbsp;11, 2020</FONT></TD>
    <TD COLSPAN="2" STYLE="text-align: justify"><FONT STYLE="font-size: 10pt"><B>PROTALIX BIOTHERAPEUTICS, INC.</B></FONT></TD></TR>
<TR>
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD COLSPAN="2" STYLE="text-align: justify">&nbsp;</TD></TR>
<TR>
    <TD STYLE="width: 53%; text-align: justify">&nbsp;</TD>
    <TD STYLE="width: 5%; text-align: justify"><FONT STYLE="font-size: 10pt">By:</FONT></TD>
    <TD STYLE="border-bottom: Black 1pt solid; width: 42%; text-align: justify"><FONT STYLE="font-size: 10pt">&nbsp;/s/ Dror Bashan<U>&#9;</U></FONT></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>


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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>tm2018938d1_ex99-1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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<P STYLE="margin: 0"></P>

<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: 14pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Protalix BioTherapeutics Announces Positive
Topline Results from the BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment
of Fabry Disease</B></P>

<P STYLE="font: 14pt 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="font-size: 10pt"><I>Phase III
BRIDGE open-label, switch-over clinical trial met </I></FONT><I>main objectives <FONT STYLE="font-size: 10pt">for<BR>
safety and efficacy</FONT></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; background-color: white"><I>Topline analysis
indicates substantial improvement in renal function as measured by mean annualized estimated Glomerular Filtration Rate (eGFR slope)
in patients switched from agalsidase alfa to pegunigalsidase alfa (PRX-102)</I></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><I>A decline trend in patients&rsquo; renal
function on agalsidase alfa was attenuated and improved to be similar to normal renal function decline when switched to 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"><B>CARMIEL, Israel, </B>May 11, 2020 /PRNewswire/ -- Protalix
BioTherapeutics, Inc. (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 topline results from its Phase&nbsp;III BRIDGE clinical trial of pegunigalsidase alfa, or PRX-102. Pegunigalsidase
alfa is the Company&rsquo;s plant cell-expressed recombinant, PEGylated, cross-linked &alpha;-galactosidase-A product candidate
under development for the treatment of Fabry disease.</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 BRIDGE study was a Phase&nbsp;III 12 month open-label, single
arm switch-over study evaluating the safety and efficacy of pegunigalsidase alfa, 1&nbsp;mg/kg infused every two weeks, in up to
22&nbsp;Fabry patients previously treated with agalsidase alfa, marketed by Takeda Pharmaceutical Company Limited (Shire Plc) as
Replagal<SUP>&reg;</SUP>, for at least two years and on a stable dose for at least six months.</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">Topline results of the data generated in the study showed substantial
improvement in renal function as measured by mean annualized estimated Glomerular Filtration Rate (eGFR slope) in both male and
female patients who were switched from agalsidase alfa to PRX-102. Consistent with previously announced interim data, PRX-102 was
found to be well tolerated, with all adverse events being transient in nature without sequelae. Twenty-two patients were enrolled
in the study; two of those patients withdrew early from the study due to hypersensitivity reaction, and 20 of the patients successfully
completed the 12-month treatment duration. Eighteen of the patients who completed the study opted to roll over to a long-term extension
study and continue to be treated with PRX-102.</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">In the study, the mean annualized eGFR
slope of the study participants improved from -5.90&nbsp;mL/min/1.73m<SUP>2</SUP>/year while on agalsidase alfa to -1.19&nbsp;mL/min/1.73m<SUP>2</SUP>/year
on PRX-102 in all patients. Male patients improved from -6.36&nbsp;mL/min/1.73m<SUP>2</SUP>/year to -1.73&nbsp;mL/min/1.73m<SUP>2</SUP>/year
and female patients improved from -5.03&nbsp;mL/min/1.73m<SUP>2</SUP>/year to -0.21&nbsp;mL/min/1.73m<SUP>2</SUP>/year.</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">Baseline characteristics of the
patients, ranging from ages 24 to 60 years, were as follows: mean eGFR 75.87 mL/min/1.73m<SUP>2 </SUP>in males and 86.14
mL/min/1.73m<SUP>2</SUP> in females and plasma lyso-Gb3 mean levels were 51.81 nM and 13.81 nM in males and females,
respectively. While lyso-Gb3 levels remain slightly high, particularly within the male cohort, continuous reduction in
lyso-Gb3 levels was observed of 19.55nM (32.35%) in males and 4.57nM (29.81%) in females.</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">&ldquo;The final analysis of the BRIDGE
Study in Fabry patients previously treated with agalsidase alfa demonstrate a positive potential benefit of pegunigalsidase alfa
on renal function,&rdquo; said Dr. Ales Linhart of Charles University in Prague, Czech Republic, a principal investigator in the
BRIDGE 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;The completion of our Phase III BRIDGE study and its
subsequent analysis mark a significant milestone towards our goal to establish PRX-102 as a new treatment option for Fabry disease,&rdquo;
said Dror Bashan, Protalix&rsquo;s President and Chief Executive Officer. &ldquo;We are encouraged that the BRIDGE study successfully
met its main objectives for safety and efficacy, and we are further motivated to continue our work in progressing pegunigalsidase
alfa.&rdquo;</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">&ldquo;Our BRIDGE study, together with our other two ongoing
fully enrolled Phase&nbsp;III clinical trials, the BALANCE study and the BRIGHT study, represents what we believe to be the most
comprehensive and robust Phase III clinical program for Fabry disease currently in progress,&rdquo; continued Mr. Bashan. &ldquo;As
the first of our three studies to complete Phase III, we believe the BRIDGE study findings support that PRX-102 has the potential
to be an important enzyme replacement therapy for the treatment of Fabry disease.&rdquo;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The ongoing BALANCE study is a fully enrolled, randomized,
double blind, head-to-head, active control study which aims to demonstrate PRX-102&rsquo;s superiority in renal function as
measured by the comparison of the mean annualized change (slope) in estimated glomerular filtration rate
(eGFR<SUB>CKD-EPI</SUB>) between treatment groups over 24 months of treatment as compared to agalsidase beta, marketed by
Sanofi Genzyme as Fabrazyme<SUP>&reg;</SUP>. The BRIGHT study is a fully enrolled open-label, switch-over study designed to
evaluate the safety, efficacy and pharmacokinetics of PRX-102, 2 mg/kg dosed once every 4 weeks, and to assess whether
patients maintain clinical stability as measured by certain Fabry disease parameters after being switched to this regimen
from an enzyme replacement therapy (ERT), agalsidase alfa or agalsidase beta, dosed every two weeks.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&ldquo;We previously announced positive
interim results from 16 Fabry patients after six and twelve months in the BRIDGE study. These final results not only indicate that
our findings are durable and consistent with previous analyses, but also demonstrate the important potential benefit of pegunigalsidase
alfa on renal function for Fabry patients,&rdquo; said Einat Brill Almon, Ph.D., Protalix&rsquo;s Senior Vice President, Product
Development. &ldquo;We look forward to the continued findings from our other ongoing Phase&nbsp;III studies of PRX-102, with the
final results from the BRIGHT study expected in the fourth quarter of 2020, and interim results from the BALANCE study expected
in the first half of 2021.&rdquo;</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">As previously announced, the Company
and its collaboration partner for PRX-102, Chiesi Farmaceutici S.p.A., or Chiesi, plan the submission of a BLA for PRX-102 via
the FDA&rsquo;s Accelerated Approval pathway in the second quarter of 2020. The Company and Chiesi have experienced minor delays
in completing the submission due to the novel coronavirus disease (COVID-19) outbreak and other reasons, and the Company anticipates
providing further updates regarding the planned submission by the end of the current month.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Additional Details about the BRIDGE Study</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; background-color: white">Patients in the BRIDGE study were screened
and evaluated over three months while continuing agalsidase alfa treatment. Following the screening period, each patient was enrolled
and switched from agalsidase alfa treatment to receive intravenous infusions of PRX-102, 1&nbsp;mg/kg every two weeks, for 12 months.
Patients had the option to receive PRX-102 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;&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 &alpha;-Galactosidase-A enzyme 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 to 60,000. Fabry patients inherit a deficiency of the &alpha;-Galactosidase-A enzyme, 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>

<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 Pegunigalsidase Alfa</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; background-color: white">Pegunigalsidase alfa (PRX-102) is an
investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant &alpha;-Galactosidase-A
enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with
unique pharmacokinetic parameters. In clinical studies, PRX-102 has been observed to have a circulatory half-life of approximately
80 hours. The Company designed PRX-102 to potentially address the continued unmet clinical need in Fabry patients.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><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<SUP>&reg;</SUP>. Protalix was the first company to gain U.S.&nbsp;Food and Drug Administration (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.</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&rsquo;s first product manufactured by ProCellEx, taliglucerase
alfa, was approved for marketing by the 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">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Protalix&rsquo;s development pipeline consists of proprietary,
potentially clinically superior versions of recombinant therapeutic proteins that target established pharmaceutical markets, including
the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human &alpha;-Galactosidase-A protein
for the proposed treatment of Fabry disease; OPRX-106, an orally-delivered anti-inflammatory treatment; alidornase alfa for the
treatment of Cystic Fibrosis; and others. 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>

<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>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;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: 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; 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;
and inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; risks
associated with the novel coronavirus disease (COVID-19) outbreak, which may adversely impact our business, preclinical studies
and 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; 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 of our future revenues and expenditures; the risk
that despite the FDA&rsquo;s grant of fast track designation for PRX-102, 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; 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.&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>

<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; color: #373737"><B>Investor Contact</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #373737">Chuck Padala, Managing
Director</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #373737">LifeSci Advisors</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #373737">646-627-8390</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #00837E"><U>chuck@lifesciadvisors.com</U></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #00837E">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #373737"><B>Media Contact</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #373737">Brian Pinkston</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #373737">LaVoieHealthScience</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #373737">857-588-3347</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><FONT STYLE="color: Blue"><U>bpinkston@lavoiehealthscience.com</U></FONT></P>

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

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