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<SEC-DOCUMENT>0000950123-10-025421.txt : 20100317
<SEC-HEADER>0000950123-10-025421.hdr.sgml : 20100317
<ACCEPTANCE-DATETIME>20100317074931
ACCESSION NUMBER:		0000950123-10-025421
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20100317
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20100317
DATE AS OF CHANGE:		20100317

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:		10687477

	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>y03222e8vk.htm
<DESCRIPTION>FORM 8-K
<TEXT>
<HTML>
<HEAD>
<TITLE>e8vk</TITLE>
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<BODY bgcolor="#FFFFFF">
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<DIV style="font-family: 'Times New Roman',Times,serif">


<DIV style="width: 100%; border-bottom: 2pt solid black; font-size: 1pt">&nbsp;</DIV>
<DIV style="width: 100%; border-bottom: 1pt solid black; font-size: 1pt">&nbsp;</DIV>








<DIV align="center" style="font-size: 14pt; margin-top: 12pt"><B>UNITED STATES<BR>
SECURITIES AND EXCHANGE COMMISSION</B>
</DIV>

<DIV align="center" style="font-size: 12pt"><B>Washington, D.C. 20549</B>
</DIV>

<DIV align="center" style="font-size: 12pt"><B><DIV align="center"><DIV style="font-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></DIV></B>
</DIV>

<DIV align="center" style="font-size: 18pt; margin-top: 12pt"><B>FORM 8-K</B>
</DIV>


<DIV align="center" style="font-size: 12pt; margin-top: 12pt"><B><DIV align="center"><DIV style="font-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></DIV></B>
</DIV>


<DIV align="center" style="font-size: 12pt; margin-top: 12pt"><B>CURRENT REPORT<BR>
Pursuant to Section&nbsp;13 or 15(d) of<BR>
the Securities Exchange Act of 1934</B>
</DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><B>
Date of Report (Date of Earliest Event Reported): March&nbsp;17, 2010 (March&nbsp;17, 2010)</B>
</DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><B>
<DIV align="center"><DIV style="font-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></DIV></B>
</DIV>

<DIV align="center" style="font-size: 24pt; margin-top: 12pt"><B>Protalix BioTherapeutics, Inc.</B>
</DIV>

<DIV align="center" style="font-size: 10pt">
<B>(Exact name of registrant as specified in its charter)</B></DIV>


<DIV align="center" style="font-size: 10pt">
<DIV align="center"><DIV style="font-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></DIV></DIV>


<DIV align="center">
<TABLE style="font-size: 10pt" cellspacing="0" border="0" cellpadding="0" width="100%">
<!-- Begin Table Head -->
<TR valign="bottom">
    <TD width="30%">&nbsp;</TD>
    <TD width="5%">&nbsp;</TD>
    <TD width="30%">&nbsp;</TD>
    <TD width="5%">&nbsp;</TD>
    <TD width="30%">&nbsp;</TD>
</TR>
<!-- End Table Head -->
<!-- Begin Table Body -->
<TR valign="bottom">
    <TD align="center" valign="top"><B>Florida</B> <BR>
<B>(State or other jurisdiction <BR>
of incorporation)</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>001-33357</B> <BR>
<B>(Commission File Number)</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>65-0643773<BR>
(IRS Employer<BR>
Identification No.)</B></TD>
</TR>
<!-- End Table Body -->
</TABLE>
</DIV>

<DIV align="center">
<TABLE style="font-size: 10pt" cellspacing="0" border="0" cellpadding="0" width="100%">
<!-- Begin Table Head -->
<TR valign="bottom">
    <TD width="47%">&nbsp;</TD>
    <TD width="5%">&nbsp;</TD>
    <TD width="47%">&nbsp;</TD>
</TR>
<!-- End Table Head -->
<!-- Begin Table Body -->
<TR valign="bottom">
    <TD align="center" valign="top"><B>2 Snunit Street</B> <BR>
<B>Science Park, POB 455<BR>
Carmiel, Israel<BR>
(Address of principal executive offices)</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>20100<BR>
(Zip Code)</B></TD>
</TR>
<!-- End Table Body -->
</TABLE>
</DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 12pt">
<B>Registrant&#146;s telephone number, including area code &#043;972-4-988-9488</B></DIV>


<DIV align="center" style="font-size: 10pt; margin-top: 12pt">
<B>(Former name or former address, if changed since last report.)</B></DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 6pt">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):</DIV>

<DIV align="left" style="margin-top: 6pt">
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt; background: transparent; color: #000000">
<TR>
    <TD width="3%"></TD>
    <TD width="1%"></TD>
    <TD></TD>
</TR>

<TR>
    <TD valign="top"><FONT face="Wingdings">&#111;</FONT></TD>
    <TD>&nbsp;</TD>
    <TD>Written communications pursuant to Rule&nbsp;425 under the Securities Act (17 CFR 230.425)
</TD>
</TR>
</TABLE>
</DIV>

<DIV align="left" style="margin-top: 6pt">
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt; background: transparent; color: #000000">
<TR>
    <TD width="3%"></TD>
    <TD width="1%"></TD>
    <TD></TD>
</TR>

<TR>
    <TD valign="top"><FONT face="Wingdings">&#111;</FONT></TD>
    <TD>&nbsp;</TD>
    <TD>Soliciting material pursuant to Rule&nbsp;14a-12 under the Exchange Act (17 CFR 240.14a-12)
</TD>
</TR>
</TABLE>
</DIV>

<DIV align="left" style="margin-top: 6pt">
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt; background: transparent; color: #000000">
<TR>
    <TD width="3%"></TD>
    <TD width="1%"></TD>
    <TD></TD>
</TR>

<TR>
    <TD valign="top"><FONT face="Wingdings">&#111;</FONT></TD>
    <TD>&nbsp;</TD>
    <TD>Pre-commencement communications pursuant to Ruled-2(b)
</TD>
</TR>
</TABLE>
</DIV>

<DIV align="left" style="margin-top: 6pt">
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt; background: transparent; color: #000000">
<TR>
    <TD width="3%"></TD>
    <TD width="1%"></TD>
    <TD></TD>
</TR>

<TR>
    <TD valign="top"><FONT face="Wingdings">&#111;</FONT></TD>
    <TD>&nbsp;</TD>
    <TD>Pre-commencement communications pursuant to Rulee-4(c)
</TD>
</TR>
</TABLE>
</DIV>


<DIV style="width: 100%; border-bottom: 1pt solid black; margin-top: 10pt; font-size: 1pt">&nbsp;</DIV>
<DIV style="width: 100%; border-bottom: 2pt solid black; font-size: 1pt">&nbsp;</DIV>







<P align="center" style="font-size: 10pt"><!-- Folio -->&nbsp;<!-- /Folio -->
</DIV>

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<DIV style="font-family: 'Times New Roman',Times,serif">



<!-- link2 "Item&nbsp;8.01. Other Events" -->

<DIV align="left" style="margin-top: 12pt">
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt; background: transparent; color: #000000">
<TR>
    <TD width="3%"></TD>
    <TD width="1%"></TD>
    <TD></TD>
</TR>
<TR valign="top">
    <TD nowrap align="left"><B>Item&nbsp;8.01.</B></TD>
    <TD>&nbsp;</TD>
    <TD><B>Other Events</B></TD>
</TR>
</TABLE>
</DIV>
<DIV align="left" style="font-size: 10pt; margin-top: 6pt">On March&nbsp;17, 2010, Protalix BioTherapeutics, Inc. (the &#147;Company&#148;) issued a press release announcing
that it has initiated a phase I clinical trial of PRX-105, the Company&#146;s plant cell expressed
pegylated recombinant human acetylcholinesterase product candidate in development for biodefense
indications. A copy of the press release is attached hereto as Exhibit&nbsp;99.1.</DIV>

<!-- link2 "Item&nbsp;9.01. Financial Statements and Exhibits" -->

<DIV align="left" style="margin-top: 12pt">
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt; background: transparent; color: #000000">
<TR>
    <TD width="3%"></TD>
    <TD width="1%"></TD>
    <TD></TD>
</TR>
<TR valign="top">
    <TD nowrap align="left"><B>Item&nbsp;9.01.</B></TD>
    <TD>&nbsp;</TD>
    <TD><B>Financial Statements and Exhibits</B></TD>
</TR>
</TABLE>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>(d)&nbsp;Exhibits</B>
</DIV>

<DIV align="center">
<TABLE style="font-size: 10pt" cellspacing="0" border="0" cellpadding="0" width="100%">
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    <TD width="84%">&nbsp;</TD>
</TR>
<!-- End Table Head -->
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<TR valign="bottom">
    <TD nowrap align="right" valign="top">&nbsp;</TD>
    <TD align="right" valign="top">99.1</TD>
    <TD nowrap valign="top">&nbsp;</TD>
    <TD valign="top" style="font-size: 10pt">&nbsp;</TD>
    <TD valign="top" style="font-size: 10pt"><DIV style="margin-left:0px; text-indent:-0px">Press release dated March&nbsp;17, 2010.</DIV></TD>
</TR>
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</TABLE>
</DIV>


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<DIV style="font-family: 'Times New Roman',Times,serif">



<!-- link1 " SIGNATURES" -->

<DIV align="center" style="font-size: 10pt; margin-top: 18pt"><B>SIGNATURES</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">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.</DIV>


<TABLE width="100%" border="0" cellspacing="0" cellpadding="0" style="font-size: 10pt">
<TR>
    <TD width="48%">&nbsp;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD width="35%">&nbsp;</TD>
    <TD width="15%">&nbsp;</TD>
</TR>
<TR>
    <TD valign="top" align="left">&nbsp;</TD>
    <TD colspan="3" align="left"><B>PROTALIX BIOTHERAPEUTICS, INC.</B><BR>
&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR><TR>
    <TD align="left">Date: March 17, 2010&nbsp;</TD>
    <TD valign="top">By:&nbsp;&nbsp;</TD>
    <TD colspan="2" style="border-bottom: 1px solid #000000" align="left">/s/ David Aviezer
&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR><TR>
    <TD align="left">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD valign="top">Name:&nbsp;&nbsp;</TD>
    <TD align="left">David Aviezer, Ph.D.&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR><TR>
    <TD align="left">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD valign="top">Title:&nbsp;&nbsp;</TD>
    <TD align="left">President and<BR>
Chief Executive Officer&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR>
<TR>
    <TD colspan="5">&nbsp;</TD>
</TR>
</TABLE>

<P align="center" style="font-size: 10pt"><!-- Folio -->3<!-- /Folio -->
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<DESCRIPTION>EX-99.1
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<DIV align="right" style="font-size: 10pt; margin-top: 12pt">Exhibit&nbsp;99.1
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>Protalix Initiates a Phase I Clinical Trial of Acetylcholinesterase for Biodefense Indications</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">CARMIEL, Israel, March&nbsp;17: Protalix BioTherapeutics, Inc. (NYSE-Amex: PLX) announced today that it
has initiated a phase I clinical trial of PRX-105, the Company&#146;s plant cell expressed pegylated
recombinant human acetylcholinesterase product candidate in development for biodefense indications.
The trial is designed to study the safety of PRX-105 by administering a bolus intravenous
injection of PRX-105 in healthy volunteers. The U.S. Food and Drug Administration (FDA)&nbsp;and
the Israeli Ministry of Health have each accepted the Company&#146;s exploratory Investigational New
Drug application to commence the phase I clinical trial of PRX-105. Pre-clinical studies have
previously indicated that PRX-105 successfully protects animals exposed to organophosphate nerve
gas agent analogs, in both the prophylactic and post-exposure settings. In addition, the safety of
PRX-105 has been demonstrated in a well-controlled study in rodents performed under good laboratory
practices.</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Before applying for marketing approval from the FDA and comparable foreign regulatory authorities,
the Company will be required to perform additional safety studies in healthy volunteers, as well as
additional studies in animals. Efficacy trials of PRX-105 in humans (phase II and phase III) are
not required given the nature of the indication for which PRX-105 is being developed.</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Nerve gas agents, such as organophosphates, bind to, and inhibit, the action of
acetylcholinesterase, an endogenous enzyme that breaks down the neurotransmitter, acetylcholine, in
humans. The loss of the acetylcholinesterase function results in an accumulation of toxic levels
of acetylcholine, which has deleterious effects on major organ systems, including the heart, lung
and central nervous system. PRX-105 acts as a bioscavenger of the organophosphates that affect the
acetylcholinesterase, thereby causing a re-balancing of acetylcholine levels.</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">&#147;We are excited that a second product candidate produced through our ProCellEx&#153; protein expression
system has advanced to the clinical stage,&#148; said Dr.&nbsp;David Aviezer, President and Chief Executive
Officer of Protalix. &#147;The treatment options currently available to victims of nerve gas attacks
are limited and current rescue therapies have significant, life threatening side effects which give
rise to the urgent need for an alternative biological solution, as recently indicated by U.S.
government agencies.&#148;</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">The PRX-105 program is being conducted in collaboration with Professor Hermona Soreq, from the
Hebrew University in Jerusalem, Israel, a world leader in the field of acetylcholinesterase
research, and based on patents that were licensed to Protalix Ltd. by Yissum, the Technology
Transfer Company of the Hebrew University. &#147;The acetylcholinesterase project is important project
to me, both as an inventor and as a scientist, as Protalix is developing the acetylcholinesterase
in its facility in Carmiel, Israel, and the protein appears to be available for use for multiple
clinical needs, especially in the neurological degenerative disease area,&#148; said Professor
Soreq.</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">The Company is in discussions with both civil and military agencies in the United States and Israel
with respect to this project.</DIV>


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<DIV style="font-family: 'Times New Roman',Times,serif">




<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>About Protalix</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Protalix is a biopharmaceutical company focused on the development and commercialization of
proprietary recombinant therapeutic proteins expressed through its proprietary plant cell based
expression system. Protalix&#146;s ProCellEx&#153; presents a proprietary method for the expression of
recombinant proteins that the Company believes will allow for the industrial-scale production of
recombinant therapeutic proteins in an environment free of mammalian components and viruses.
Protalix is also advancing additional recombinant biopharmaceutical drug development programs.
Taliglucerase alfa is an enzyme replacement therapy in development under a Special Protocol
Assessment with the FDA for Gaucher disease. In August&nbsp;2009, the FDA granted orphan drug status
and fast track designation to taliglucerase alfa for the treatment of Gaucher disease and Protalix
filed a rolling NDA submission with the FDA in December&nbsp;2009. In November&nbsp;2009, Protalix granted
Pfizer Inc. exclusive, worldwide rights to develop and commercialize taliglucerase alfa for the
treatment of Gaucher disease, except in Israel. Protalix retained the right to commercialize
taliglucerase alfa in Israel.</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>Safe Harbor Statement:</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">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. 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, risks relating to: the
successful preclinical development of our product candidates; the completion of clinical trials;
the review process of the FDA, the EMEA, other foreign regulatory bodies and other governmental
regulatory bodies, including the FDA&#146;s and the EMEA&#146;s review of any filings we make in connection
with the treatment protocol; delays in the FDA&#146;s, the EMEA&#146;s or other health regulatory
authorities&#146; approval of any applications we file or refusals to approve such filings; refusals by
such regulatory authorities to approve the marketing and sale of a drug product even after
acceptance of an application we file for any such drug product; the identification of lead
compounds; the risk that we may fail to satisfy certain conditions relating to grants we have
received from the Office of the Chief Scientist of Israel&#146;s Ministry of Industry, Trade and Labor
which may lead to our being required to refund grants previously received together with interest
and penalties; the risk that the Office of the Chief Scientist may not deliver to us all of the
funds awarded to us; uncertainties related to the ability to attract and retain partners for our
technologies and products under development; and other factors described in our filings with the
U.S. Securities and Exchange Commission. Companies in the pharmaceutical and biotechnology
industries have suffered significant setbacks in advanced or late-stage clinical trials, even after
obtaining promising earlier trial results or in preliminary findings for such clinical trials.
Further, even if favorable testing data is generated by clinical trials of drug products, the FDA,
EMEA or any other foreign regulatory authority may not accept or approve an NDA filed by a
pharmaceutical or biotechnology company for such drug product. Failure to obtain approval from the
FDA, EMEA or any other foreign regulatory authority of any of our drug</DIV>


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<DIV align="left" style="font-size: 10pt; margin-top: 6pt">candidates in a timely manner, if at all, will severely undermine our business and results of
operation by reducing our potential marketable products and our ability to generate corresponding
product revenues.</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">The statements in this release are valid only as of the date hereof and we disclaim any obligation
to update this information.</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><B>Investor Contact:</B><BR>
Marcy Nanus<BR>
The Trout Group, LLC<BR>
Telephone: 646-378-2927<BR>
Email: mnanus@troutgroup.com

</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><B>Media Contact:</B><BR>
Brad Miles<BR>
BMC Communications Group, LLC<BR>
Telephone: 212-477-9007 x17<BR>
Email: brad@bmccommunications.com

</DIV>


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