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Protalix BioTherapeutics Reports Fourth Quarter and Full Year 2019 Financial and Business Results Conference call and live webcast scheduled for Thursday, March 12th, 2020 at 8:30 am

Key Takeaway: Protalix BioTherapeutics Reports Fourth Quarter and Full Year 2019 Financial and Business Results Conference call and live webcast scheduled for Thursday, March 12th, 2020 at 8:30 am EDT CARMIEL, Israel, March 12, 2020 -- Protalix BioTherapeutics, Inc. (NYSE American: PLX)

Full Press Release Details

Protalix BioTherapeutics Reports Fourth
Quarter and Full Year 2019
Financial and Business Results
Conference call and live webcast scheduled
for Thursday, March 12th, 2020 at 8:30 am EDT
CARMIEL, Israel, March 12, 2020 -- Protalix BioTherapeutics,
Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization
of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system,
today reported financial results for the fourth quarter and full year ended December 31, 2019, and provided a business update on
recent corporate and clinical developments. The Company will discuss the clinical, corporate and financial highlights on a conference
call and live webcast, scheduled for Thursday, March 12th, 2020 at 8:30 am EDT.
"2019 was a pivotal year for Protalix, as we successfully
expanded on our strong foundation and entered into a new phase of development as a world-class recombinant therapeutic company,"
said Dror Bashan, Protalix's President and Chief Executive Officer. "With this continued forward momentum toward commercialization
of our Fabry program, we believe Protalix is positioned for both near- and long-term success," he continued.
"We are increasingly enthusiastic about our PRX-102 asset
now that we have three ongoing, fully-enrolled Phase III clinical trials of PRX-102, and as we anticipate our BLA submission to
the U.S. Food and Drug Administration under the Accelerated Approval pathway next quarter," added Mr. Bashan. "Furthermore,
we anticipate the final results of our BRIDGE and BRIGHT trials in the first and second halves of 2020, respectively, which will
further support our portfolio of data regarding PRX-102. Protalix is firing on all cylinders right now, and the energy among the
entire staff reached a new pinnacle in 2019."
"We anticipate 2020 to be a banner year for Protalix as
we increase our focus on advancing our clinical pipeline, expanding sales in Brazil of Elelyso , our enzyme replacement
therapy for the treatment of Gaucher disease, and leveraging commercial opportunities to expand our global footprint in the treatment
of Fabry disease," he concluded.
Conference Call and Webcast Information
The Company will host a conference call on Thursday, March 12,
2020, at 8:30 am, Eastern Daylight Time, 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:
Domestic: 877-423-9813
International: 201-689-8573
Conference ID: 13699970
Webcast: http://public.viavid.com/index.php?id=138400
The conference call will also be broadcast live and will be
available for replay for two weeks in the Events Calendar of the Investors section of the Company's website, www.protalix.com.
Please access the Company's website at least 15 minutes ahead of the conference call in order to register, download and
install any necessary audio software.
2019 Full-Year and Recent Business Highlights
Clinical Advancements
Corporate & Financial Developments
Regulatory Advancements
For the year ended December 31, 2019, compared to the year
ended December 31, 2018
For the three months ended December 31, 2019, compared to
the three months ended December 31, 2018
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 . Protalix was the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein
produced through plant cell-based in suspension expression system. Protalix's unique expression system represents a new method
for developing recombinant proteins in an industrial-scale manner.
Protalix's first product manufactured by ProCellEx, taliglucerase
alfa, was approved for marketing by the 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 consists of proprietary,
potentially clinically superior versions of recombinant therapeutic proteins that target established pharmaceutical markets, including
the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human -Galactosidase-A protein
for the treatment of Fabry disease in Phase III clinical trials (BALANCE, BRIDGE and BRIGHT studies); 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
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 "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: the timing of the closing of the PIPE financing, if at all; our inability,
or the inability of the investors, to satisfy the conditions to closing for the PIPE financing; risks related to our ability to
identify and complete strategic alternatives on attractive terms or at all within the time period required to regain compliance
with the continued listing standards of the NYSE American; risks related to our ability to continue as a going concern absent a
refinancing or restructuring; risks related to any transactions we may effect in the public or private equity markets to raise
capital to finance future research and development, general and administrative expenses and working capital activities; 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; and inability or unwillingness of medical investigators and
institutional review boards to follow our clinical protocols; 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 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 the amount of our future revenues 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; 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.
Chuck Padala, Managing Director
Last updated: Mar 12, 2020