<SEC-DOCUMENT>0001144204-14-038202.txt : 20140625
<SEC-HEADER>0001144204-14-038202.hdr.sgml : 20140625
<ACCEPTANCE-DATETIME>20140618073833
ACCESSION NUMBER:		0001144204-14-038202
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20140618
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20140618
DATE AS OF CHANGE:		20140618

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Protalix BioTherapeutics, Inc.
		CENTRAL INDEX KEY:			0001006281
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				650643773
		STATE OF INCORPORATION:			FL
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-33357
		FILM NUMBER:		14926717

	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>v381670_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.&nbsp;&nbsp;20549</B></P>

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<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>FORM 8-K</B></P>

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<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>CURRENT REPORT</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Pursuant to Section 13 or 15(d) of</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>the Securities Exchange Act of 1934</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Date of Report (Date of Earliest Event
Reported): June 18, 2014</B></P>

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

<P STYLE="font: 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>

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    <td style="vertical-align: top; text-align: center"><font style="font: 10pt Times New Roman, Times, Serif"><b>Florida</b></font></td>
    <td style="vertical-align: bottom">&nbsp;</td>
    <td style="vertical-align: top; text-align: center"><font style="font: 10pt Times New Roman, Times, Serif"><b>001-33357</b></font></td>
    <td style="vertical-align: bottom">&nbsp;</td>
    <td style="vertical-align: top; text-align: center"><font style="font: 10pt Times New Roman, Times, Serif"><b>65-0643773</b></font></td></tr>
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        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>(State or other jurisdiction</b></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>of incorporation)</b></P></td>
    <td style="vertical-align: bottom">&nbsp;</td>
    <td style="vertical-align: top; text-align: center"><font style="font: 10pt Times New Roman, Times, Serif"><b>(Commission File Number)</b></font></td>
    <td style="vertical-align: bottom">&nbsp;</td>
    <td style="vertical-align: top">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>(IRS Employer</b></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>Identification No.)</b></P></td></tr>
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    <td style="vertical-align: top; text-align: center"><font style="font: 10pt Times New Roman, Times, Serif"><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: 10pt Times New Roman, Times, Serif"><b>20100</b></font></td></tr>
<tr>
    <td style="vertical-align: top; text-align: center"><font style="font: 10pt Times New Roman, Times, Serif"><b>Science Park, POB 455</b></font></td>
    <td style="vertical-align: bottom">&nbsp;</td>
    <td style="vertical-align: top">&nbsp;</td></tr>
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    <td style="vertical-align: top; text-align: center"><font style="font: 10pt Times New Roman, Times, Serif"><b>Carmiel, Israel</b></font></td>
    <td style="vertical-align: bottom">&nbsp;</td>
    <td style="vertical-align: top">&nbsp;</td></tr>
<tr>
    <td style="vertical-align: top; text-align: center"><font style="font: 10pt Times New Roman, Times, Serif"><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: 10pt Times New Roman, Times, Serif"><b>(Zip Code)</b></font></td></tr>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Registrant&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; text-align: center"><B>(Former name or former address, if changed
since last report.)</B></P>

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



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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;Check the appropriate box below if
the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions
(see General Instruction A.2. below):</P>

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    <td style="width: 3%"><font style="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Wingdings">&#168;</FONT></font></td>
    <td style="width: 97%"><font style="font: 10pt Times New Roman, Times, Serif">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</font></td></tr>
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    <td style="width: 3%"><FONT STYLE="font-family: Wingdings">&#168;</FONT></td>
    <td style="width: 97%"><font style="font: 10pt Times New Roman, Times, Serif">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</font></td></tr>
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    <td style="width: 3%"><FONT STYLE="font-family: Wingdings">&#168;</FONT></td>
    <td style="width: 97%"><font style="font: 10pt Times New Roman, Times, Serif">Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</font></td></tr>
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<tr style="vertical-align: top">
    <td style="width: 3%"><FONT STYLE="font-family: Wingdings">&#168;</FONT></td>
    <td style="width: 97%"><font style="font: 10pt Times New Roman, Times, Serif">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</font></td></tr>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Item 8.01. Other Events</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">On June 18, 2014, Protalix BioTherapeutics, Inc. (the &ldquo;Company&rdquo;) issued a press release <FONT STYLE="font: 10pt Times New Roman, Times, Serif">announcing
that the first Gaucher patient has been enrolled in the Company's phase IIa clinical trial of oral glucocerebrosidase (GCD) (PRX-112)
for the treatment of Gaucher disease. A copy of the press release is filed as Exhibit 99.1.</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"><B>Item 9.01.&nbsp;&nbsp;Financial Statements and Exhibits</B></P>

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

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<TD STYLE="width: 0in"></TD><TD STYLE="width: 0.5in; text-align: left"><B>(d)</B></TD><TD STYLE="text-align: justify"><B>Exhibits</B></TD>
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<TD STYLE="width: 0in"></TD><TD STYLE="width: 0.5in; text-align: left">99.1</TD><TD STYLE="text-align: justify">Press release dated June 18, 2014</TD>
</TR></TABLE>

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

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

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

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    <td style="width: 50%"><font style="font: 10pt Times New Roman, Times, Serif"><b>PROTALIX BIOTHERAPEUTICS, INC.</b></font></td></tr>
<tr>
    <td>&nbsp;</td>
    <td>&nbsp;</td></tr>
<tr>
    <td><font style="font: 10pt Times New Roman, Times, Serif">Date: June 18, 2014</font></td>
    <td><FONT STYLE="font: 10pt Times New Roman, Times, Serif">By:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<U>/s/
David Aviezer, Ph.D.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</U></FONT></td></tr>
<tr>
    <td>&nbsp;</td>
    <td>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Name:&nbsp;&nbsp;&nbsp; David Aviezer, Ph.D.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Title: &nbsp;&nbsp;&nbsp;&nbsp; President and Chief Executive
        Officer</P></td></tr>
<tr>
    <td>&nbsp;</td>
    <td>&nbsp;</td></tr>
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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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<FILENAME>v381670_ex99-1.htm
<DESCRIPTION>EXHIBIT 99.1
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right">Exhibit 99.1</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white"><B>Protalix BioTherapeutics
Initiates Phase II Study with PRX-112, an Orally-Administered</B><BR>
<B>Enzyme Replacement Therapy for the Treatment of Gaucher Disease</B></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; background-color: white">CARMIEL, Israel, June 18, 2014 /GlobeNewswire
/Protalix BioTherapeutics, Inc. (NYSE MKT:PLX, TASE:PLX), announced today that the first Gaucher patient has been enrolled in the
Company's phase IIa clinical trial of oral glucocerebrosidase (GCD), or oral GCD (PRX-112), for the treatment of Gaucher disease.
Oral GCD is the Company&rsquo;s proprietary plant cell expressed form of an active glycosylated glucocerebrosidase enzyme (GCD)
that is naturally encapsulated within carrot cells and administered orally. The Company expects the trial to be completed during
the third quarter of 2014.</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 phase IIa trial is a 28 day open-label,
sequential dose escalation study to evaluate the safety of oral PRX-112 and study the dose dependant pharmacokinetics of Oral GCD
in 10 na&iuml;ve adult Gaucher patients. Subjects will receive once daily oral administrations of oral GCD for five consecutive
days at each dose, with a two-day washout period between doses.</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 a phase I study conducted year end
2013, oral GCD was found to be safe and well tolerated in all 16 patients across all of the three doses tested. There were no drug-related
serious adverse reactions reported, and no patient discontinued the study prematurely. Presence of the GCD enzyme was detected
in patients' blood circulation and the enzyme demonstrated biological activity. With a daily oral administration of oral GCD, the
Company expects to achieve a steady state level of active GCD enzyme in the blood circulation of patients similar to the physiological
state in healthy individuals.</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;Following the completion of
our phase I trial of oral GCD last year, we were encouraged to see the clinical proof of concept demonstrated in the study and
we look forward to continuing the development of an oral enzyme treatment for Gaucher patients,&rdquo; commented Dr. David Aviezer,
Protalix&rsquo;s President and Chief Executive Officer. &ldquo;We believe oral delivery of GCD has the potential to improve patients&rsquo;
quality of life and possibly clinical maintenance while maintaining the efficacy and safety of an enzyme treatment.&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"><B>About Protalix</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Protalix is a biopharmaceutical company focused on the development
and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system,
ProCellEx&reg;. Protalix's unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective,
industrial-scale manner. Protalix's first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by
the U.S. Food and Drug Administration (FDA) in May 2012, by Israel's Ministry of Health in September 2012, by the Brazilian National
Health Surveillance Agency (ANVISA) in March 2013, by the Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS)
in April 2013, by the Australian Therapeutic Goods Administration (TGA) in May 2014 and by the regulatory authorities of other
countries. Marketing applications for taliglucerase alfa have been filed in additional territories as well. Protalix has partnered
with Pfizer Inc. for the worldwide development and commercialization of taliglucerase alfa, excluding Israel and Brazil, where
Protalix retains full rights. Protalix's development pipeline includes the following product candidates: PRX-102, a modified version
of the recombinant human alpha-GAL-A protein for the treatment of Fabry disease; PRX-112, an orally-delivered glucocerebrosidase
enzyme that is produced and encapsulated within carrot cells, for the treatment of Gaucher disease; pr-antiTNF, a similar plant
cell version of etanercept (Enbrel&reg;) for the treatment of certain immune and inflammatory diseases, such as rheumatoid arthritis,
Crohn's disease, colitis, psoriasis and other autoimmune and inflammatory disorders; PRX-110 for the treatment of Cystic Fibrosis;
and others.</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"></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 &quot;anticipate,&quot; &quot;believe,&quot; &quot;estimate,&quot; &quot;expect,&quot;
&quot;plan&quot; and &quot;intend&quot; and other words or phrases of similar import are intended to identify forward-looking statements.
These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience
and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as
to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause material differences
include, among others: failure or delay in the commencement or completion of our clinical trials which may be caused by several
factors, including: unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; slower
than expected rates of patient recruitment; inability to monitor patients adequately during or after treatment; inability or unwillingness
of medical investigators and institutional review boards to follow our clinical protocols; and lack of sufficient funding to finance
clinical trials; the risk that the results of the clinical trials of our product candidates will not support our claims of safety
or efficacy, that our product candidates will not have the desired effects or will be associated with undesirable side effects
or other unexpected characteristics; our dependence on performance by third party providers of services and supplies, including
without limitation, clinical trial services; delays in our preparation and filing of applications for regulatory approval; delays
in the approval or potential rejection of any applications we file with the FDA or other health regulatory authorities, and other
risks relating to the review process; the inherent risks and uncertainties in developing drug platforms and products of the type
we are developing; the impact of development of competing therapies and/or technologies by other companies and institutions; potential
product liability risks, and risks of securing adequate levels of product liability and other necessary insurance coverage; and
other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this release are valid
only as of the date hereof and we disclaim any obligation to update this information.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Investor Contact</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">Tricia Truehart<BR>
The Trout Group, LLC<BR>
646-378-2953<BR>
ttruehart@troutgroup.com</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>Media Contact</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">Kari Watson<BR>
MacDougall Biomedical Communications<BR>
781-235-3060<BR>
kwatson@macbiocom.com</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>Source: Protalix BioTherapeutics, Inc. </B></P>

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



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