Protalix BioTherapeutics Reports First Quarter 2016 Financial Results and Provides Corporate Update Advanced Discussions with FDA regarding SPA for Phase III Clinical Trial of PRX-102 Expected to Commence around Mid-Year

Protalix BioTherapeutics Reports First

Quarter 2016 Financial Results and Provides Corporate Update

Advanced Discussions with FDA regarding

SPA for Phase III Clinical Trial of PRX-102

Expected to Commence around Mid-Year

Phase II Clinical Trial of PRX-110 in

Cystic Fibrosis Patients to commence by Mid-Year

Phase II Clinical Trial of PRX-106 in

Ulcerative Colitis Patients to commence around Mid-Year

Strong Cash Position; finances the Company

into 2018, through significant milestones

CARMIEL, Israel, May 9, 2016 -- Protalix BioTherapeutics, Inc.

(NYSE MKT:PLX) (TASE:PLX), today announced financial results for the fiscal quarter ended March 31, 2016 and provided a corporate

"Over the past few months, Protalix has made great strides

towards moving PRX-102 into phase III development," said Moshe Manor, Protalix's President and Chief Executive Officer.

"We filed a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA), and have since been in close

contact with the agency to implement its feedback. We anticipate completing the SPA with the FDA around mid-year 2016, and announcing

the commencement of our phase III clinical development program for PRX-102 shortly thereafter. Additionally, we met with the European

Medicines Agency (EMA), and we expect to reach and announce a clear path forward for PRX-102 in the European Union as well by mid-year."

"We are also very excited about the advancement of our

PRX-110 and PRX-106 product candidates into advanced clinical trials in patients. Given results from earlier trials, both drug

candidates have the potential to bring significant benefit to currently underserved patient populations worldwide."

Financial Results for the Period Ended March 31, 2016

First Quarter Clinical and Corporate Highlights

About Protalix BioTherapeutics, Inc.

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(R). 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 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. 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; OPRX-106, an orally-delivered

anti-inflammatory treatment; PRX-110 for the treatment of Cystic Fibrosis; and others.

Forward-Looking Statements

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 "anticipate," "believe," "estimate," "expect,"

"plan" and "intend" 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 preclinical and clinical trials which may be caused

by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing

issues; lack of effectiveness during clinical trials; inability to monitor patients adequately during or after treatment; inability

or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; and lack of sufficient

funding to finance clinical trials; the risk that the results of the clinical trials of our product candidates will not support

our claims of 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 the amount and sufficiency of our cash and cash equivalents;

risks relating to the compliance by Funda o Oswaldo Cruz with its purchase obligations and related milestones under

our supply and technology transfer agreement; risks related to the commercialization efforts for taliglucerase alfa in Brazil;

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.

The Trout Group, LLC

Source: Protalix BioTherapeutics, Inc.

BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEET

(U.S. dollars in thousands)

BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(U.S. dollars in thousands, except share and per share data)