Protalix BioTherapeutics Reports 2018 Third Quarter Results and Provides Corporate Update

Protalix BioTherapeutics Reports 2018

Third Quarter Results and Provides Corporate Update

CARMIEL, Israel, November 7, 2018 -- GlobeNewswire /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 and nine months ended September 30, 2018, and provided a corporate update.

"In the third quarter we achieved two important milestone

events for pegunigalsidase alfa, or PRX-102, our differentiated enzyme replacement therapy in development for the treatment of

Fabry disease. First, we expanded our partnership with Chiesi Farmaceutici S.p.A. to include exclusive rights to commercialize

and develop PRX-102 in the United States, which significantly strengthened our financial position. Second, we reported positive

preliminary results from our BRIDGE study on key kidney function," commented Moshe Manor, Protalix's President and

Chief Executive Officer. "Based on the promising preliminary BRIDGE study results, and taking into account the newly issued

guidance from the U.S. Food and Drug Administration (FDA), we plan to engage with the FDA during the first half of 2019 to discuss

the most optimal regulatory path forward for PRX-102. While we continue to enroll patients in all of our currently ongoing Fabry

disease studies, we believe that with over 110 Fabry patients enrolled across the studies included in our PRX-102 clinical program

to date, we have a sufficient number of patients for expedited review, including filing an application for accelerated approval,"

continued Mr. Manor.

2018 Third Quarter Highlights

Financial Results for the Nine Months ended September 30,

Conference Call and Webcast Information

The Company will host a conference

call on Wednesday, November 7, 2018 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 8567317.

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

BioTherapeutics, Inc.

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 alfa.

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 "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. 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 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.

Source: Protalix BioTherapeutics,

PROTALIX BIOTHERAPEUTICS, INC.

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BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

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