Protalix BioTherapeutics Reports 2019 First Quarter Results and Provides Corporate Update

Protalix BioTherapeutics

Reports 2019 First Quarter Results and Provides Corporate Update

CARMIEL, Israel, May

6, 2019 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company

focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based

expression system, ProCellEx , today announced its financial results for the three months ended

March 31, 2019 and provided a corporate update.

"In the first three months of 2019, we

have continued to execute on enrollment in our PRX-102 studies and have worked to prepare ourselves for a potential accelerated

approval path," said Mr. Moshe Manor, Protalix's President and Chief Executive Officer. "In addition, we are

encouraged by the initial pharmacokinetic (PK) data from our BRIGHT study, which were presented at the 15th Annual WORLDSymposiumTM

2019 in February 2019, that demonstrate the potential for PRX-102 to be infused once-monthly, compared to the current treatment

regimen of every two weeks."

First Quarter 2019 and Recent Clinical and

Corporate Highlights

First Quarter 2019 Financial Results

Conference Call and Webcast Information

The Company will host a conference call on Monday,

May 6, 2019, at 8:30 am ET to review the clinical, corporate and financial highlights.

To participate in the conference call, please

dial the following numbers prior to the start of the call: United States: +1-844-358-6760; International: +1-478-219-0004.

Conference ID number 6169584.

The conference call will also be broadcast live

and available for replay for two weeks on the Company's website, www.protalix.com, in the Events Calendar of the Investors

section. Please access the Company's website at least 15 minutes ahead of the conference to register, download, and install

any necessary audio software.

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 . 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: pegunigalsidase alfa, 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;

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

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 "expect," "anticipate,"

"believe," "estimate," "project," "plan," "should" 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 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; 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 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 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'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'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. 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.

Marcy Nanus, Managing

Protalix BioTherapeutics, Inc.

PROTALIX BIOTHERAPEUTICS, INC.

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PROTALIX BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

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