1. CARMIEL, Israel, Feb. 23, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research focused healthcare Group (Chiesi Group), today announced positive topline results from the BRIGHT Phase III clinical trial evaluating pegunigalsidase alfa (PRX–102), 2 mg/kg, administered every four weeks, for the potential treatment of Fabry disease. PRX–102 is the Company's plant cell-expressed recombinant, PEGylated, cross-linked…

    CARMIEL, Israel, Feb. 23, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research focused healthcare Group (Chiesi Group), today announced positive topline results from the BRIGHT Phase III clinical trial evaluating pegunigalsidase alfa (PRX–102), 2 mg/kg, administered every four weeks, for the potential treatment of Fabry disease. PRX–102 is the Company's plant cell-expressed recombinant, PEGylated, cross-linked α–galactosidase–A product candidate.

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    The BRIGHT study is a Phase III 12-month, open-label, switch-over study designed to evaluate the safety, efficacy and pharmacokinetics of PRX–102 treatment, 2 mg/kg every four weeks, in up to 30 patients with Fabry disease previously treated with a commercially available enzyme replacement therapy (ERT) (agalsidase alfa – Replagal® or agalsidase beta – Fabrazyme®), for at least three years and on a stable dose administered every two weeks.

    Topline results indicate that 2 mg/kg of PRX–102 administered by intravenous infusion every four weeks was found to be well tolerated among treated patients, and stable clinical presentation was maintained in adult Fabry patients. No new patients developed treatment-induced anti-drug antibodies (ADA) following the switch to PRX–102 treatment.

    "We are excited to share these topline results from the BRIGHT study, our third consecutive positive clinical trial of PRX–102, following the Phase I/II and the BRIDGE clinical studies. The results indicate that this investigational therapy is well tolerated and potentially an effective treatment for adult patients living with Fabry disease," said Einat Brill Almon, Ph.D., Protalix's Senior Vice President and Chief Development Officer. "We are encouraged to see that all of the patients who completed this study chose to enroll in the long-term extension study. Currently, 80% of the patients enrolled in the BRIGHT study have been treated with this treatment regimen for over two years. We look forward to advancing this study and further evaluating the results."

    "These results demonstrate the potential of PRX–102 to be an important treatment option for the Fabry community and that the 2 mg/kg of PRX–102 every four weeks regimen may offer meaningful benefits to both patients and physicians. Treating physicians will be empowered with a potential additional treatment regimen, shown to be well tolerated, that they can offer to Fabry patients, pending approval of PRX-102," said Dror Bashan, Protalix's President and Chief Executive Officer. "We are gratified to have a strong balance sheet supporting our development efforts and look forward to executing and delivering on a year rich with value enhancing milestones."

    The BRIGHT study enrolled 30 adult patients (24 males and 6 females). The most common Fabry disease symptoms were acroparesthesia, heat intolerance, angiokeratomas and hypohydrosis. All 30 patients received at least one dose of PRX–102, and 29 patients (mean [SD] age was 40.5 [11.3] years, ranging from 19 to 58 years) completed the 12-month study. Of these 29 patients, 28 received the intended regimen of 2 mg/kg every four weeks throughout the study, while one patient was switched to PRX–102 1 mg/kg every two weeks per protocol. One patient withdrew from the study after the first infusion due to a traffic accident.

    Following screening, patients were enrolled and switched from their then current ERT to intravenous (IV) infusions of 2 mg/kg of PRX–102 every four weeks for 52 weeks (a total of 14 infusions). First infusions of PRX-102 were administered under controlled conditions at the investigation site. Based on the protocol-specified criteria, patients were able to receive their PRX-102 infusions at a home care setup once the Investigator and Sponsor Medical Monitor agreed that it was safe to do so. Safety and efficacy exploratory endpoints were assessed throughout the 52-week study.

    Study outcome measures showed plasma lyso–Gb3 concentrations remained stable during the study with a mean change of 3.01 nM from baseline (19.36 nM) to Week 52 (22.23 nM). Mean absolute change of eGFR values were stable during the 52–week treatment period, with a mean change from baseline of –1.27 mL/min/1.73 m2.

    "Patients participating in the BRIGHT study have expressed their satisfaction with the once every four weeks regimen," said John Bernat, M.D., Ph.D., University of Iowa and a Principal Investigator in the BRIGHT study. "Infusions of 2 mg/kg once every four weeks has the potential to enable patients to maintain their clinical status while reducing their number of treatments by half."

    Following a survey of participants using the Quality of Life EQ-5D-5L questionnaire, responses indicate that patient perception of their own health remained high and stable throughout the 52–week study duration, with overall health mean (SE) scores of 78.3 (3.1) and 82.1 (2.9) at baseline and Week 52, respectively, in a 0 to 100 scale. Using the short-form Brief Pain Inventory (BPI) questionnaire, approximately 75% of study participants had an improvement or no change in average pain severity at Week 52 (compared to baseline). The short-form BPI interference items also remained stable during the study. Pain-related results indicate that there was no increase and/or relapse in pain. No Fabry clinical events were reported during the study.

    "Of the 30 patients enrolled, 20 patients remained negative for anti-drug antibodies throughout the course of treatment. Of the 10 patients who were initially positive for anti-drug antibodies, four became negative for neutralizing antibodies at 12 months, suggesting tolerization by these patients," added Dr. Almon. "We find this immunogenicity data very encouraging and supportive to the positive benefit-risk profile of PRX–102."

    "On behalf of our team at Chiesi, we are grateful to the patients, families, and investigators for their time and participation in this study," said Giacomo Chiesi, head of Chiesi Global Rare Diseases. "Their dedication has helped move this Phase III program forward and these topline data are another important milestone in our collected effort to make PRX–102 available to Fabry patients in need as rapidly as possible."

    The Company intends to report final data on the BRIGHT study in the second half of 2021, and to present these findings at an appropriate medical conference.

    About Fabry Disease

    Fabry disease is an X-linked inherited disease that results from deficient activity of the lysosomal α–Galactosidase–A enzyme resulting in progressive accumulation of abnormal deposits of a fatty substance called globotriaosylceramide (Gb3) in blood vessel walls throughout a person's body. Fabry disease occurs in one person per 40,000 to 60,000. Fabry patients inherit a deficiency of the α–Galactosidase–A enzyme, which is normally responsible for the breakdown of Gb3. The abnormal storage of Gb3 increases with time and, accordingly, Gb3 accumulates, primarily in the blood and in the blood vessel walls. The ultimate consequences of Gb3 deposition range from episodes of pain and impaired peripheral sensation to end-organ failure – particularly of the kidneys, but also of the heart and the cerebrovascular system.

    About PRX-102

    PRX–102 (pegunigalsidase alfa) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α–Galactosidase–A enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. In clinical studies, PRX–102 has been observed to have a circulatory half-life of approximately 80 hours. The Company designed PRX–102 to potentially address the continued unmet clinical need in Fabry patients.

    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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed treatment of Fabry disease; OPRX–106, an orally–delivered anti-inflammatory treatment; alidornase alfa or PRX–110, for the treatment of various human respiratory diseases or conditions; PRX–115, a plant cell-expressed recombinant PEGylated Uricase for the treatment of gout; 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, and with SarcoMed USA, Inc. for the worldwide development and commercialization of PRX–110 for use in the treatment of any human respiratory disease or condition including, but not limited to, sarcoidosis, pulmonary fibrosis, and other related diseases via inhaled delivery.

    About Chiesi Global Rare Diseases

    Chiesi Global Rare Diseases is a business unit of the Chiesi Group established in February 2020 and focused on research and development of treatments for rare and ultra-rare disorders. The Global Rare Diseases unit works in collaboration with Chiesi Group to harness the full resources and capabilities of our global network to bring innovative new treatment options to people living with rare diseases, many of whom have limited or no treatments available. The unit is also a dedicated partner with global leaders in patient advocacy, research and patient care. For more information visit www.chiesiglobalrarediseases.com.

    About Chiesi Group

    Based in Parma, Italy, Chiesi Farmaceutici is an international research-focused healthcare group with 85 years of experience in the pharmaceutical industry and a global presence in 29 countries. Chiesi researches, develops, and markets innovative drugs in the respiratory therapeutics, specialist medicine, and rare disease areas. Its R&D organization is headquartered in Parma (Italy), and is integrated with R&D groups in France, the USA, the UK, and Sweden to advance Chiesi's pre-clinical, clinical, and registration programs. Chiesi employs nearly 6,000 people.

    Chiesi Group is a certified Benefit corporation. For more information, please visit www.chiesi.com.

    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," "may," "plan," "will," "would," "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; 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 slower than expected rates of patient recruitment; risks associated with the novel coronavirus disease (COVID–19) outbreak, which may adversely impact our business, preclinical studies and clinical trials; risks related to any transactions we may effect in the public or private equity markets to raise capital to finance future research and development activities, general and administrative expenses and working capital; 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 our collaborators, distributors or partners; risks related to the amount and sufficiency of our cash and cash equivalents; 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; 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.

    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    +1-646-627-8390

     

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  2. CARMIEL, Israel, Feb. 18, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced it has completed a raise bringing in gross proceeds of approximately $40 million, before deducting the underwriting discount and estimated expenses of the offering. BofA Securities acted as book-running manager for the offering with Oppenheimer & Co. acting as co-manager.

    "I am very proud of our team for all our accomplishments this past year, especially having executed on our strategic plans during the global pandemic. We are on a new trajectory as a company with the potential upcoming commercial launch in a significant market with a new, exciting treatment option for patients, if approved; a pipeline of proprietary assets designed to enhance shareholder value supported by a strong balance sheet allowing us to execute on our strategic goals," said Dror Bashan, President and Chief Executive Officer of Protalix.

    Eyal Rubin, Chief Financial Officer of Protalix added, "With this financing, we were able to accomplish our goal of bringing in new institutional investors to the Company while strengthening our balance sheet to accelerate clinical trial development. We are grateful for the commitment and the confidence in our strategic plans and goals and look forward to continuing to execute and achieve our milestones planned for this year."

    Protalix intends to use the net proceeds from the offering to fund clinical trials for its product candidates, to fund its research and development activities and for working capital and other general corporate purposes.

    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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed treatment of Fabry disease; OPRX–106, an orally–delivered anti-inflammatory treatment; alidornase alfa or PRX-110, for the treatment of various human respiratory diseases or conditions; PRX–115, a plant cell-expressed recombinant PEGylated Uricase for the treatment of gout; 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, and with SarcoMed USA, Inc. for the worldwide development and commercialization of PRX–110 for use in the treatment of any human respiratory disease or condition including, but not limited to, sarcoidosis, pulmonary fibrosis, and other related diseases via inhaled delivery.

    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: 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; 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 slower than expected rates of patient recruitment; risks associated with the novel coronavirus disease (COVID–19) outbreak, which may adversely impact our business, preclinical studies and clinical trials; risks related to any transactions we may effect in the public or private equity markets to raise capital to finance future research and development activities, general and administrative expenses and working capital; 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 our collaborators, distributors or partners; risks related to the amount and sufficiency of our cash and cash equivalents; 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; 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.

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    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    +1-646-627-8390

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  3. CARMIEL, Israel, Feb. 11, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE:PLX, TASE: PLX))) (the "Company"), 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 announced the pricing of its previously announced underwritten public offering of 7,608,695 shares of its common stock at a public offering price of $4.60 per share. The Company granted the underwriters in the offering a 30-day option to purchase up to an additional 1,141,304 shares of its common stock. The offering is subject to customary closing conditions and is expected to close on February 17, 2021.  

    Protalix Biotherapeutics Logo

    The Company…

    CARMIEL, Israel, Feb. 11, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE:PLX, TASE: PLX))) (the "Company"), 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 announced the pricing of its previously announced underwritten public offering of 7,608,695 shares of its common stock at a public offering price of $4.60 per share. The Company granted the underwriters in the offering a 30-day option to purchase up to an additional 1,141,304 shares of its common stock. The offering is subject to customary closing conditions and is expected to close on February 17, 2021.  

    Protalix Biotherapeutics Logo

    The Company estimates that the net proceeds from the offering, after deducting the underwriting discount but not other estimated offering expenses payable by the Company, will be approximately $32.9 million.

    BofA Securities is acting as the book-running manager and Oppenheimer & Co. is acting as the co-manager for the offering. The Company expects to use the net proceeds from the offering to fund clinical trials for its product candidates, to fund its research and development activities and for working capital and general corporate purposes.

    The offering is being made pursuant to an effective shelf registration statement. Before you invest, you should read the base prospectus in such shelf registration statement, the preliminary prospectus supplement and other documents the Company has filed with the U.S. Securities and Exchange Commission (the "SEC") for more information about the Company and the offering. The offering may be made only by means of a prospectus supplement and an accompanying prospectus, copies of which may be obtained by visiting EDGAR on the SEC's website at http://www.sec.gov or by sending a request to the offices of BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte NC 28255-0001, Attention: Prospectus Department, or by email at .

    This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, any of the securities, nor shall there be any sale of these securities, in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed treatment of Fabry disease; OPRX–106, an orally–delivered anti-inflammatory treatment; alidornase alfa or PRX-110, for the treatment of various human respiratory diseases or conditions; PRX–115, a plant cell-expressed recombinant PEGylated Uricase for the treatment of gout; 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, and with SarcoMed USA, Inc. for the worldwide development and commercialization of PRX–110 for use in the treatment of any human respiratory disease or condition including, but not limited to, sarcoidosis, pulmonary fibrosis, and other related diseases via inhaled delivery.

    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," "may," "plan," "will," "would," "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. For a discussion of other risks and uncertainties which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other reports filed with the SEC. We caution readers not to place undue reliance upon any forward-looking statements as 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.

    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    +1-646-627-8390

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  4. CARMIEL, Israel, Feb. 11, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced that it intends to make a public offer of 6,500,000 shares of its common stock. In connection with the offering, the Company intends to grant the underwriter a 30-day option to purchase up to an additional 975,000 shares of its common stock.

    Protalix Biotherapeutics Logo

    BofA Securities is acting as the book-running manager and Oppenheimer & Co. is acting as the co-manager for the offering. The Company expects to use the net proceeds from the offering…

    CARMIEL, Israel, Feb. 11, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced that it intends to make a public offer of 6,500,000 shares of its common stock. In connection with the offering, the Company intends to grant the underwriter a 30-day option to purchase up to an additional 975,000 shares of its common stock.

    Protalix Biotherapeutics Logo

    BofA Securities is acting as the book-running manager and Oppenheimer & Co. is acting as the co-manager for the offering. The Company expects to use the net proceeds from the offering to fund clinical trials for its product candidates, to fund its research and development activities and for working capital and general corporate purposes.

    The offering is being made pursuant to an effective shelf registration statement. Before you invest, you should read the base prospectus in such shelf registration statement, the preliminary prospectus supplement and other documents the Company has filed with the U.S. Securities and Exchange Commission (the "SEC") for more information about the Company and the offering. The offering may be made only by means of a prospectus supplement and an accompanying prospectus, copies of which may be obtained by visiting EDGAR on the SEC's website at http://www.sec.gov or by sending a request to the offices of BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte NC 28255-0001, Attention: Prospectus Department, or by email at .

    This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, any of the securities, nor shall there be any sale of these securities, in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed treatment of Fabry disease; OPRX–106, an orally–delivered anti-inflammatory treatment; alidornase alfa or PRX-110, for the treatment of various human respiratory diseases or conditions; PRX–115, a plant cell-expressed recombinant PEGylated Uricase for the treatment of gout; 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, and with SarcoMed USA, Inc. for the worldwide development and commercialization of PRX–110 for use in the treatment of any human respiratory disease or condition including, but not limited to, sarcoidosis, pulmonary fibrosis, and other related diseases via inhaled delivery.

    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," "may," "plan," "will," "would," "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. For a discussion of other risks and uncertainties which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other reports filed with the SEC. We caution readers not to place undue reliance upon any forward-looking statements as 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.

    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    +1-646-627-8390

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  5. CARMIEL, Israel, Feb. 11, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced an exclusive worldwide license agreement with SarcoMed USA Inc. for alidornase alfa, or PRX–110, for use in the treatment of any human respiratory disease or condition including, but not limited to, sarcoidosis, pulmonary fibrosis, and other related diseases via inhaled delivery. Alidornase alfa is the Company's proprietary chemically-modified plant cell–expressed recombinant form of human deoxyribonuclease I (DNase I…

    CARMIEL, Israel, Feb. 11, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced an exclusive worldwide license agreement with SarcoMed USA Inc. for alidornase alfa, or PRX–110, for use in the treatment of any human respiratory disease or condition including, but not limited to, sarcoidosis, pulmonary fibrosis, and other related diseases via inhaled delivery. Alidornase alfa is the Company's proprietary chemically-modified plant cell–expressed recombinant form of human deoxyribonuclease I (DNase I), administered through inhalation. SarcoMed USA was formed in 2017 to investigate if a novel DNase 1 compound could influence the chronic pulmonary inflammation seen in pulmonary sarcoidosis patients.

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    Under the terms of the agreement, SarcoMed will be responsible for the identification and selection of pharmaceutical candidates under the license, and the clinical research and development of such candidates. Protalix is entitled to an initial cash payment of $3.5 million, subject to certain conditions, and to additional regulatory and commercial milestone payments and tiered royalties on net sales of products that are commercialized under the license agreement. In addition to the foregoing, the parties have agreed to commence negotiation of clinical and commercial supply agreements for alidornase alfa. As part of the arrangement, the parties have agreed to negotiate and sign a supply agreement within 60 days of the execution of the license agreement, and SarcoMed USA has the right to terminate the license agreement if the parties do not successfully do so.

    "We are pleased to partner with SarcoMed USA, a privately-held company led by professionals with a wealth of experience in the research and development of pharmaceuticals," commented Dror Bashan, Protalix's President and Chief Executive Officer. "Most patients with pulmonary sarcoidosis do not show symptoms and do not realize they have the disease until it has progressed to later stages. Currently available treatment options vary significantly from patient to patient, and the treatments generally either control symptoms or improve the patient's lung function. A treatment that both controls symptoms and improves the patient's lung function is needed in the market today. We believe PRX-110 has the potential to be an exciting treatment option. Also, we believe this transaction further validates and enhances our development pipeline of drug candidates that can be produced through ProCellEx."

    On July 21, 2020, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for alidornase alfa for the treatment of sarcoidosis. The FDA grants Orphan Drug Designation to drugs or biologics intended to treat or prevent rare diseases or conditions that affect fewer than 200,000 individuals in the United States.

    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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed treatment of Fabry disease; OPRX–106, an orally–delivered anti-inflammatory treatment; alidornase alfa or PRX-110, for the treatment of various human respiratory diseases or conditions; PRX–115, a plant cell-expressed recombinant PEGylated Uricase for the treatment of gout; 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.

    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: risks related to SarcoMed's and Protalix's compliance with the terms and conditions of the license agreement between the parties, and to their performance under the arrangement; risks related to SarcoMed's successful identification and development of product candidates under the license agreement; failure or delay in the commencement or completion of preclinical and clinical trials; risks associated with the novel coronavirus disease (COVID–19) outbreak, which may adversely impact our business, preclinical studies and clinical trials; risks related to any transactions we may effect in the public or private equity markets to raise capital to finance future research and development activities, general and administrative expenses and working capital; 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 our collaborators, distributors or partners; risks related to the amount and sufficiency of our cash and cash equivalents; 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; 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.

    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    +1-646-627-8390

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  6. CARMIEL, Israel, and BOSTON, Feb. 10, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), today announced that final results from the Phase III BRIDGE clinical trial (NCT03018730) of pegunigalsidase alfa (PRX–102), an investigational therapy in development for the potential treatment of Fabry disease, will be presented at the 17th Annual WORLDSymposium 2021, a research…

    CARMIEL, Israel, and BOSTON, Feb. 10, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), today announced that final results from the Phase III BRIDGE clinical trial (NCT03018730) of pegunigalsidase alfa (PRX–102), an investigational therapy in development for the potential treatment of Fabry disease, will be presented at the 17th Annual WORLDSymposium 2021, a research conference dedicated to lysosomal diseases being held virtually February 8–12, 2021.

     

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    The final results, which were first announced in December 2020, will be presented in both an oral and a poster presentation by Prof. Ales Linhart, MD, Charles University, Praha, Czech Republic, a principal investigator in the Phase III clinical trials of PRX–102 for the potential treatment of Fabry disease. The Company has already announced the schedule of the presentations.

    The BRIDGE clinical trial was a Phase III 12 month open label, single arm switch over study evaluating the safety and efficacy of pegunigalsidase alfa, 1 mg/kg infused every two weeks, in up to 22 Fabry patients previously treated with agalsidase alfa, marketed by Takeda Pharmaceutical Company Limited (formerly Shire Plc) as Replagal®, for at least two years and on a stable dose for at least six months. Replagal is not approved in the United States.

    The data to be presented by Prof. Linhart showed substantial improvement in renal function as measured by mean annualized estimated Glomerular Filtration Rate (eGFR slope) in both male and female patients who were switched from agalsidase alfa to pegunigalsidase alfa.

    Twenty of twenty-two patients completed the 12-month treatment duration, 18 of which opted to roll over to a long-term extension study and continue to be treated with pegunigalsidase alfa.

    In the BRIDGE study, the mean annualized eGFR slope of the study participants improved from -5.90 mL/min/1.73m2/year while on agalsidase alfa to -1.19 mL/min/1.73m2/year on PRX-102 in all patients. Male patients improved from -6.36 mL/min/1.73m2/year to –1.73 mL/min/1.73m2/year and female patients improved from -5.03 mL/min/1.73m2/year to –0.21 mL/min/1.73m2/year. Following the switch to pegunigalsidase alfa there was a decrease in patients with progressing or fast progressing kidney disease, and the majority of patients achieved a stable status post-switch.

    An immunogenicity assessment indicated that four out of 20 patients (20%) developed persistent antidrug antibodies over the course of the study, of which two had neutralizing activity.

    Baseline characteristics of the 20 patients that completed the study, ranging from ages 28 to 60 years, were as follows: mean eGFR 75.87 mL/min/1.73m2 in males, and 86.14 mL/min/1.73m2 in females and plasma lyso-Gb3 mean levels were 51.81 nM and 13.81 nM in males and females, respectively. While lyso-Gb3 levels remain slightly high, particularly within the male cohort, continuous reduction in lyso-Gb3 levels was observed of 19.55 nM (32.35%) in males and 4.57 nM (29.81%) in females.

    "The final analysis of the BRIDGE Study in Fabry patients previously treated with agalsidase alfa demonstrates a potential benefit of pegunigalsidase alfa on renal function," said Prof. Linhart.

    Pegunigalsidase alfa was well tolerated in the study, with all adverse events being transient in nature without sequelae. Among the 22 patients enrolled in the BRIDGE study, the majority of treatment emergent adverse events were mild or moderate in severity (96.9%), with two patients (9.1%) withdrawing from the therapy due to hypersensitivity reaction that was resolved. The most common moderate treatment emergent adverse events were nasopharyngitis, headache and dyspnea.

    Additional details can be found on the WORLDSymposium website at https://worldsymposia.org/. Copies of the presentation materials will be made available on Protalix's website under the Presentations tab in the Investors section at the time of the poster session.

    About Fabry Disease

    Fabry disease is an X-linked inherited disease that results from deficient activity of the lysosomal α-Galactosidase-A enzyme resulting in progressive accumulation of abnormal deposits of a fatty substance called globotriaosylceramide (Gb3) in blood vessel walls throughout a person's body.

    Fabry disease occurs in one person per 40,000 to 60,000. Fabry patients inherit a deficiency of the α-Galactosidase-A enzyme, which is normally responsible for the breakdown of Gb3. The abnormal storage of Gb3 increases with time and, accordingly, Gb3 accumulates, primarily in the blood and in the blood vessel walls. The ultimate consequences of Gb3 deposition range from episodes of pain and impaired peripheral sensation to end-organ failure – particularly of the kidneys, but also of the heart and the cerebrovascular system.

    About Pegunigalsidase Alfa

    Pegunigalsidase alfa (PRX-102) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α-Galactosidase-A enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. In clinical studies, PRX–102 has been observed to have a circulatory half-life of approximately 80 hours. PRX–102 has been designed to potentially address the continued unmet clinical need in Fabry patients.

    About Chiesi Global Rare Diseases

    Chiesi Global Rare Diseases is a business unit of the Chiesi Group established in February 2020 and focused on research and development of treatments for rare and ultra-rare disorders. The Global Rare Diseases unit works in collaboration with Chiesi Group to harness the full resources and capabilities of our global network to bring innovative new treatment options to people living with rare diseases, many of whom have limited or no treatments available. The unit is also a dedicated partner with global leaders in patient advocacy, research and patient care. For more information visit www.chiesiglobalrarediseases.com.

    About Chiesi Group

    Based in Parma, Italy, Chiesi Farmaceutici is an international research-focused healthcare group with 85 years of experience in the pharmaceutical industry and a global presence in 29 countries. Chiesi researches, develops, and markets innovative drugs in the respiratory therapeutics, specialist medicine, and rare disease areas. Its R&D organization is headquartered in Parma (Italy), and is integrated with R&D groups in France, the USA, the UK, and Sweden to advance Chiesi's pre-clinical, clinical, and registration programs. Chiesi employs nearly 6,000 people.

    Chiesi Group is a certified Benefit corporation. For more information, please visit www.chiesi.com.

    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 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 U.S. Food and Drug Administration 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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed 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 Global Rare Diseases, both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.

    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: 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; 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 slower than expected rates of patient recruitment; risks associated with the novel coronavirus disease (COVID–19) outbreak, which may adversely impact our business, preclinical studies and 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 our ability to maintain and manage our relationship with Chiesi Farmaceutici and any other collaborator, distributor or partner; risks related to the amount of our future revenues and expenditures; the risk that despite the FDA's grant of fast track designation for PRX–102, 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; 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 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.

    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    646-627-8390

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  7. CARMIEL, Israel, Feb. 1, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced that it will deliver an oral presentation and a poster presentation at the 17th Annual WORLDSymposium, a research conference dedicated to lysosomal diseases being held virtually February 8-12, 2021. The oral and poster presentations will highlight data generated from the Company's BRIDGE Phase III 12 month open-label, single arm switch-over study evaluating the safety and efficacy of pegunigalsidase alfa.

    CARMIEL, Israel, Feb. 1, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced that it will deliver an oral presentation and a poster presentation at the 17th Annual WORLDSymposium, a research conference dedicated to lysosomal diseases being held virtually February 8-12, 2021. The oral and poster presentations will highlight data generated from the Company's BRIDGE Phase III 12 month open-label, single arm switch-over study evaluating the safety and efficacy of pegunigalsidase alfa.

    Presentation Details:

    Title: Switching from agalsidase alfa to pegunigalsidase alfa to treat patients with Fabry disease: 1 year of treatment data from BRIDGE, a phase 3 open-label study

    Presenter: Ales Linhart, MD, Charles University, Praha, Czech Republic, a principal investigator in the Company's Phase III clinical trials of PRX-102 for the potential treatment of Fabry disease

    Date/Time: The oral presentation is scheduled for Wednesday, February 10, 2021 at 1:24 PM EST

    The poster presentation is scheduled for Wednesday, February 10, 2021 from 2:30 to 3:30 PM EST (Poster # 141)

    Additional details can be found on the WORLDSymposium website at https://worldsymposia.org/. Copies of the presentation materials will be made available on the Company's website under the Presentations tab in the Investors section at the time of the poster session.

    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 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 U.S. Food and Drug Administration 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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α-Galactosidase-A protein for the proposed 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 Global Rare Diseases, both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.

    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    646-627-8390

     

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  8. CARMIEL, Israel, Jan. 4, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced that the Company's management will participate in virtual 1x1 investor meetings at the 10th Annual LifeSci Partners Corporate Access Event and present a corporate overview at the H.C. Wainwright BioConnect 2021 Conference. Details regarding the two events are as follows:

    10th Annual LifeSci Partners Corporate Access Event

    The Company will be participating in virtual 1x1 investor meetings at the 10th Annual LifeSci Partners…

    CARMIEL, Israel, Jan. 4, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced that the Company's management will participate in virtual 1x1 investor meetings at the 10th Annual LifeSci Partners Corporate Access Event and present a corporate overview at the H.C. Wainwright BioConnect 2021 Conference. Details regarding the two events are as follows:

    10th Annual LifeSci Partners Corporate Access Event

    The Company will be participating in virtual 1x1 investor meetings at the 10th Annual LifeSci Partners Corporate Access Event which is taking place virtually on January 6-8 and 11-14, 2021. To request a meeting, please use the following registration link: http://lifesci.events/LifeSci2021.

    H.C. Wainwright BioConnect 2021 Conference

    Dror Bashan, the Company's President and Chief Executive Officer, has recorded a presentation that will be available for the H.C. Wainwright Bioconnect 2021 Conference on Monday, January 11, 2021 at 6:00 AM, Eastern Time. The conference will be held virtually on January 11-14, 2021. Mr. Bashan's presentation will be available for on-demand viewing by registered attendees at the following website: https://tinyurl.com/yde8jk95. Those interested in registering for the conference can do so here: https://hcwevents.com/bioconnect.

    A webcast of the presentation will also be available at www.protalix.com on the event calendar page, https://protalixbiotherapeutics.gcs-web.com/events0. A replay of the presentation will be archived and available for at least 15 days following the presentation.

    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 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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α-Galactosidase-A protein for the proposed treatment of Fabry disease; OPRX-106, an orally-delivered anti-inflammatory treatment; alidornase alfa for the treatment of Cystic Fibrosis; PRX–115, a plant cell-expressed recombinant PEGylated Uricase for the treatment of gout; and others. Protalix has partnered with Chiesi Global Rare Diseases, both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.

    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    +1-646-627-8390

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  9. CARMIEL, Israel, Dec. 30, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced the following letter from its President and Chief Executive Officer, Dror Bashan, to its shareholders and the investment community.

    Protalix Biotherapeutics Logo

    Dear Protalix shareholders,

    As we look forward to 2021 with great anticipation, I want to take a moment to reflect on our transformational accomplishments this past year, which has been unlike any we could have imagined. Together with our development and commercialization partner, Chiesi Global…

    CARMIEL, Israel, Dec. 30, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced the following letter from its President and Chief Executive Officer, Dror Bashan, to its shareholders and the investment community.

    Protalix Biotherapeutics Logo

    Dear Protalix shareholders,

    As we look forward to 2021 with great anticipation, I want to take a moment to reflect on our transformational accomplishments this past year, which has been unlike any we could have imagined. Together with our development and commercialization partner, Chiesi Global Rare Diseases, we submitted to the U.S. Food and Drug Administration (FDA) a Biologics License Application (BLA) for PRX–102 for the treatment of adult patients with Fabry disease, bringing us one step closer to the anticipated commercialization of this important treatment option. We also solidified our financial foundation and advanced our pipeline of candidates utilizing ProCellEx®, our proprietary protein expression system platform technology. At the same time, we continued to seek multiple collaborative partnerships to complement our core platform. Despite the many external challenges we faced this year, our team has been committed to accomplishing our goals and remained focused, and we persevered to position us for another year of value-adding milestones and transformational catalysts.

    Advancing PRX-102 (pegunigalsidase alfa) for the treatment of Fabry Disease

    Following the successful outcome of our Phase I/II clinical study of PRX–102, in May 2020, we, together with Chiesi, submitted the PRX–102 BLA to the FDA. The FDA accepted the filing under its Accelerated Approval pathway and granted Priority Review designation to PRX–102. The action date under the Prescription Drug User Fee Act (PDUFA) for the BLA has been updated to April 27, 2021.

    Fabry disease represents a tremendous opportunity in a multi-billion dollar market ready for a potential better treatment option. We believe PRX–102, if approved, will meaningfully improve the quality of life for many Fabry patients and, together with Chiesi, we are preparing for the anticipated commercial launch.

    Our PRX–102 phase III development program consists of three studies: the BRIDGE study; the BRIGHT study; and the BALANCE study. The BRIDGE and BRIGHT studies have been completed. Topline results of the data generated in the BRIDGE Study, which we released in May this year, showed substantial improvement in renal function, as measured by mean annualized estimated Glomerular Filtration Rate (eGFR slope), and an amelioration of the course of disease in both male and female Fabry patients who were switched from agalsidase alfa to PRX–102. Agalsidase alfa is marketed by Takeda Pharmaceutical Company Limited (Shire Plc) as Replagal®. Earlier today, we announced final results from our BRIDGE study, and we anticipate an announcement of the topline data from our BRIGHT study in the first quarter of 2021. We expect interim results from our BALANCE study in the first half of 2021.

    We look forward to commercializing PRX-102 assuming the anticipated approval of the BLA in the second half of 2021.

    Partnerships and Collaborations

    This year, we continued expanding our relationships with other companies to leverage our pipeline through strong partnerships and collaborations.

    In July 2020 we entered into a non-binding term sheet with SarcoMed USA Inc. The arrangement, if consummated, will relate to the development and commercialization of PRX–110 (alidornase alfa) for the treatment of pulmonary sarcoidosis and related diseases. We expect to be able to provide an update regarding SarcoMed USA in the next few weeks.

    Earlier in the year, in March 2020, we announced an agreement with Kirin Holdings Company, Limited (Kirin) to conduct a feasibility study to evaluate production of a novel complex protein utilizing ProCellEx. We received a non-refundable payment of $1.0 million and Kirin will provide research funding to conduct cell-line engineering and protein expression studies on the target protein.

    Solid Financial Balance Sheet Supporting Corporate Strategy

    We raised approximately $44 million in March 2020 from the sale of common stock and warrants in a private placement to certain existing and new institutional and other accredited investors.

    Subsequent to the completion of the private placement, we established an at-the-market (ATM) offering through Bank of America Securities Inc. through which we have the ability to raise up to $30 million. This transaction signifies the quality of the banking counterparties that were eager to work with us in this process and indicative of the growing interest in Protalix from institutional investors.

    Enhanced Management Team

    We continued adding to the senior executive management team with the appointment of Yael Hayon, Ph.D. as Vice President, Research and Development. Dr. Hayon is an important addition to the team as we advance our pipeline, bringing to the company over a decade of pharmaceutical research and development experience in both the scientific operations and administrative functions.

    Looking Forward

    We believe we are well positioned for success with an anticipated commercial product launch planned in a multi-billion dollar target market, a solid financial base to support growth and a pipeline of potential opportunities. We are excited to welcome 2021 and look forward to a bright future as a company. I thank our employees for their tireless efforts to get us to this point, as well as the physicians and patients who have participated and are participating in our trials.

    Finally, we would like to thank you, our shareholders, for your support and we look forward to sharing our future successes with you.

    Sincerely,

    Dror Bashan, President & Chief Executive Officer, Director

    Protalix Biotherapeutics, Inc.

    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 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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed 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 Global Rare Diseases, both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.

    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: 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; 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 slower than expected rates of patient recruitment; risks associated with the novel coronavirus disease (COVID-19) outbreak, which may adversely impact our business, preclinical studies and 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 our ability to maintain and manage our relationship with Chiesi Farmaceutici and any other collaborator, distributor or partner; risks related to the amount of our future revenues and expenditures; the risk that despite the FDA's grant of fast track designation for PRX-102, 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; 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 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.

    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    646-627-8390

     

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    SOURCE Protalix BioTherapeutics, Inc.

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  10. CARMIEL, Israel and BOSTON, Dec. 30, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), today announced final study results from the BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease. Pegunigalsidase alfa is a plant cell-expressed recombinant, PEGylated, cross-linked α-galactosidase-A product candidate…

    CARMIEL, Israel and BOSTON, Dec. 30, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), today announced final study results from the BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease. Pegunigalsidase alfa is a plant cell-expressed recombinant, PEGylated, cross-linked α-galactosidase-A product candidate under development for the treatment of Fabry disease. Topline results from the BRIDGE study were announced in May 2020.

     

    Protalix Biotherapeutics Logo

     

    The BRIDGE study was a Phase III 12 month open-label, single arm switch-over study evaluating the safety and efficacy of pegunigalsidase alfa, 1 mg/kg infused every two weeks, in up to 22 Fabry patients previously treated with agalsidase alfa, marketed by Takeda Pharmaceutical Company Limited (formerly Shire Plc) as Replagal®, for at least two years and on a stable dose for at least six months.

    Final results of the data generated in the study showed substantial improvement in renal function as measured by mean annualized estimated Glomerular Filtration Rate (eGFR slope) in both male and female patients who were switched from agalsidase alfa to PRX-102.

    Twenty of twenty-two patients completed the 12-month treatment duration. Eighteen of the patients who completed the study opted to roll over to a long-term extension study and continue to be treated with PRX-102.

    As announced in May 2020, in the study, the mean annualized eGFR slope of the study participants improved from -5.90 mL/min/1.73m2/year while on agalsidase alfa to -1.19 mL/min/1.73m2/year on PRX-102 in all patients. Male patients improved from -6.36 mL/min/1.73m2/year to -1.73 mL/min/1.73m2/year and female patients improved from -5.03 mL/min/1.73m2/year to -0.21 mL/min/1.73m2/year.

    Following the switch to PRX-102, there was a decrease in patients with progressing or fast progressing kidney disease, and most patients achieved a stable status post-switch.

    PRX-102 was well-tolerated in the study, with all adverse events being transient in nature without sequelae. Of the 22 patients enrolled in the BRIDGE study, the majority of treatment emergent adverse events were mild or moderate in severity, with two patients (9.1%) withdrawing from the therapy due to hypersensitivity reaction that was resolved. The most common moderate treatment emergent adverse events were nasopharyngitis, headache and dyspnea.

    An immunogenicity assessment indicated that four out of 20 patients (20%) developed persistent antidrug antibodies over the course of the study, of which two had neutralizing activity.

    Baseline characteristics of the 20 patients that completed the study, ranging from ages 28 to 60 years, were as follows: mean eGFR 75.87 mL/min/1.73m2 in males, and 86.14 mL/min/1.73m2 in females and plasma lyso-Gb3 mean levels were 51.81 nM and 13.81 nM in males and females, respectively. While lyso-Gb3 levels remain slightly high, particularly within the male cohort, continuous reduction in lyso-Gb3 levels was observed of 19.55nM (32.35%) in males and 4.57nM (29.81%) in females.

    "We are excited to have completed the final analysis of our Phase III BRIDGE study," said Dror Bashan, Protalix's President and Chief Executive Officer. "We anticipate that the BRIDGE study results will be used to support the filing of a Marketing Authorization Application (MAA) with the European Medicines Agency, and having completed the analysis, we have taken an important step in the preparations for the application."

    The Phase III clinical development program consists of three studies, the BRIDGE study, the BALANCE study and the BRIGHT study. The ongoing BALANCE study is a fully enrolled, randomized, double blind, head-to-head, active control study which aims to demonstrate PRX-102's superiority in renal function as measured by the comparison of the mean annualized change (slope) in estimated glomerular filtration rate (eGFRCKD-EPI) between treatment groups over 24 months of treatment as compared to agalsidase beta, marketed by Sanofi Genzyme as Fabrazyme®. The BRIGHT study is a fully enrolled open-label, switch-over study designed to evaluate the safety, efficacy and pharmacokinetics of PRX-102, 2 mg/kg dosed once every 4 weeks, and to assess whether patients maintain clinical stability as measured by certain Fabry disease parameters after being switched to this regimen from an enzyme replacement therapy (ERT), agalsidase alfa or agalsidase beta, dosed every two weeks. The treatment period of the BRIGHT study was completed in July 2020.

    "These important final results confirm the topline results announced last May," said Einat Brill Almon, Ph.D., Protalix's Senior Vice President and Chief Development Officer. "We look forward to the continued findings from our other ongoing Phase III studies of PRX-102, with the final results from the BRIGHT study expected in the first quarter of 2021, and interim results from the BALANCE study expected in the first half of 2021."

    In May 2020, Protalix and Chiesi Global Rare Diseases announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease via the FDA's Accelerated Approval pathway. Subsequently, the FDA accepted the BLA and granted Priority Review designation for PRX-102 for the proposed treatment of adult patients with Fabry disease. The FDA also indicated in the BLA filing communication letter that it is not currently planning to hold an advisory committee meeting to discuss the application. The action date under the Prescription Drug User Fee Act (PDUFA) for the BLA has been updated to April 27, 2021.

    "It is clear that many people who are living with Fabry disease are seeking new treatments," said Giacomo Chiesi, Head of Chiesi Global Rare Diseases. "We continue to be encouraged by the clinical data generated by this robust Phase III program and look forward to advancing through the final stages of the regulatory review process in the U.S."

    Additional Details about the BRIDGE Study

    Patients in the BRIDGE study were screened and evaluated over three months while continuing agalsidase alfa treatment. Following the screening period, each patient was enrolled and switched from agalsidase alfa treatment to receive intravenous infusions of PRX-102, 1 mg/kg every two weeks, for 12 months. Patients had the option to receive PRX-102 infusions in a home care setting based on infusion tolerability and country regulation.

    About Fabry Disease

    Fabry disease is an X-linked inherited disease that results from deficient activity of the lysosomal α-Galactosidase-A enzyme resulting in progressive accumulation of abnormal deposits of a fatty substance called globotriaosylceramide (Gb3) in blood vessel walls throughout a person's body. Fabry disease occurs in one person per 40,000 to 60,000. Fabry patients inherit a deficiency of the α-Galactosidase-A enzyme, which is normally responsible for the breakdown of Gb3. The abnormal storage of Gb3 increases with time and, accordingly, Gb3 accumulates, primarily in the blood and in the blood vessel walls. The ultimate consequences of Gb3 deposition range from episodes of pain and impaired peripheral sensation to end-organ failure – particularly of the kidneys, but also of the heart and the cerebrovascular system.

    About Pegunigalsidase Alfa

    Pegunigalsidase alfa (PRX-102) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α-Galactosidase-A enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. In clinical studies, PRX-102 has been observed to have a circulatory half-life of approximately 80 hours. The Company designed PRX-102 to potentially address the continued unmet clinical need in Fabry patients.

    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 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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α-Galactosidase-A protein for the proposed 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 Global Rare Diseases, both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.

    About Chiesi Global Rare Diseases

    Chiesi Global Rare Diseases is a business unit of the Chiesi Group established in February 2020 and focused on research and development of treatments for rare and ultra-rare disorders. The Global Rare Diseases unit works in collaboration with Chiesi Group to harness the full resources and capabilities of our global network to bring innovative new treatment options to people living with rare diseases, many of whom have limited or no treatments available. The unit is also a dedicated partner with global leaders in patient advocacy, research and patient care. For more information visit www.chiesiglobalrarediseases.com.

    About Chiesi Group

    Based in Parma, Italy, Chiesi Farmaceutici is an international research-focused healthcare group with 85 years of experience in the pharmaceutical industry and a global presence in 29 countries. Chiesi researches, develops, and markets innovative drugs in the respiratory therapeutics, specialist medicine, and rare disease areas. Its R&D organization is headquartered in Parma (Italy), and is integrated with R&D groups in France, the USA, the UK, and Sweden to advance Chiesi's pre-clinical, clinical, and registration programs. Chiesi employs nearly 6,000 people.

    Chiesi Group is a certified Benefit corporation. For more information, please visit www.chiesi.com.  

    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: 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; 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 slower than expected rates of patient recruitment; risks associated with the novel coronavirus disease (COVID-19) outbreak, which may adversely impact our business, preclinical studies and 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 our ability to maintain and manage our relationship with Chiesi Farmaceutici and any other collaborator, distributor or partner; risks related to the amount of our future revenues and expenditures; the risk that despite the FDA's grant of fast track designation for PRX-102, 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; 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 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.

    Logo - https://mma.prnewswire.com/media/999479/Protalix_Biotherapeutics_Logo.jpg

    Logo - https://mma.prnewswire.com/media/1173320/Chiesi_Global_Rare_Diseases.jpg

     

    Chiesi Global Rare Diseases Logo

     

    Investor Contact

    Chuck Padala, Managing Director 

    LifeSci Advisors

    +1-646-627-8390

    Chiesi Group Media Contact

    Valentina Biagini

    Senior Group Communication Manager Chiesi Group 



    Chiesi USA Media Contact

    Bill Berry

    BERRY & COMPANY PUBLIC RELATIONS, LLC 

    +1-212 253-8881

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    SOURCE Protalix BioTherapeutics, Inc.; Chiesi

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  11. CARMIEL, Israel, Nov. 27, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company's Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for the proposed treatment of adult patients…

    CARMIEL, Israel, Nov. 27, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company's Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for the proposed treatment of adult patients with Fabry disease. The FDA extended the PDUFA action date by three months to April 27, 2021, from January 27, 2021.

    As previously announced, the FDA accepted the BLA, granted Priority Review designation under FDA's Accelerated Approval pathway, and indicated that it is not currently planning to hold an advisory committee meeting to discuss the application. Priority Review is granted to therapies that the FDA determines have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

    The BLA submission includes a comprehensive set of preclinical, clinical, and manufacturing data compiled from the Company's completed Phase I/II clinical trial of pegunigalsidase alfa, including the related extension study succeeding the Phase I/II clinical trial, interim clinical data from the Phase III BRIDGE switch-over study and safety data from the Company's on-going clinical studies of PRX–102 in patients receiving 1 mg/kg every other week.

    About Pegunigalsidase Alfa

    Pegunigalsidase alfa (PRX–102) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α-Galactosidase-A enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. In clinical studies, PRX–102 has been observed to have a circulatory half-life of approximately 80 hours. The Company designed PRX–102 to potentially address the continued unmet clinical need in Fabry patients.

    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 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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed 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 Global Rare Diseases, both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.

    About Chiesi Global Rare Diseases

    Chiesi Global Rare Diseases is a business unit of the Chiesi Group established in February 2020 and focused on research and development of treatments for rare and ultra-rare disorders. The Global Rare Diseases unit works in collaboration with Chiesi Group to harness the full resources and capabilities of our global network to bring innovative new treatment options to people living with rare diseases, many of whom have limited or no treatments available. The unit is also a dedicated partner with global leaders in patient advocacy, research and patient care. For more information visit www.chiesiglobalrarediseases.com.

    About Chiesi Group

    Based in Parma, Italy, Chiesi Farmaceutici is an international research-focused healthcare group with 85 years of experience in the pharmaceutical industry and a global presence in 29 countries. Chiesi researches, develops, and markets innovative drugs in the respiratory therapeutics, specialist medicine, and rare disease areas. Its R&D organization is headquartered in Parma (Italy), and is integrated with R&D groups in France, the USA, the UK, and Sweden to advance Chiesi's pre-clinical, clinical, and registration programs. Chiesi employs nearly 6,000 people. Chiesi Group is a certified Benefit Corporation. For more information www.chiesi.com.

    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: Risks related to the timing, progress and likelihood of final approval by the FDA of the BLA for PRX–102, by the PDUFA date or at all, which was accepted by the FDA and granted Priority Review designation in August 2020 and, if approved, whether the use of PRX–102 will be commercially successful; 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 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; risks associated with the novel coronavirus disease (COVID–19) outbreak, which may adversely impact our business, preclinical studies and 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 our ability to maintain and manage our relationship with Chiesi Farmaceutici and any other collaborator, distributor or partner; risks related to the amount of our future revenues and expenditures, and related milestones under our supply and technology transfer agreement; the risk that despite the FDA's grant of Fast Track designation for PRX–102, 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; our dependence on performance by third party providers of services and supplies, including without limitation, clinical trial services; 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.

    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    +1-646-627-8390

    Media Contact

    Bill Berry

    Berry & Company Public Relations

    +1-917-846-3862

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/protalix-biotherapeutics-and-chiesi-global-rare-diseases-announce-extension-of-pdufa-date-for-pegunigalsidase-alfa-for-the-proposed-treatment-of-fabry-disease-301181112.html

    SOURCE Protalix BioTherapeutics, Inc.; Chiesi

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  12. CARMIEL, Israel, Nov. 5, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced that Dror Bashan, the Company's President and Chief Executive Officer will present at the H.C. Wainwright 6th Annual Israel Conference on Thursday, November 12, 2020 at 7:30 AM, Eastern Standard Time. The conference will be held virtually on November 12, 2020.

    Protalix_Biotherapeutics_Logo

    A live webcast of the presentation will be available at www.protalix.com on the event calendar page, https://protalixbiotherapeutics.gcs-web.com/events0?c=101161&p=irol-calendar

    CARMIEL, Israel, Nov. 5, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced that Dror Bashan, the Company's President and Chief Executive Officer will present at the H.C. Wainwright 6th Annual Israel Conference on Thursday, November 12, 2020 at 7:30 AM, Eastern Standard Time. The conference will be held virtually on November 12, 2020.

    Protalix_Biotherapeutics_Logo

    A live webcast of the presentation will be available at www.protalix.com on the event calendar page, https://protalixbiotherapeutics.gcs-web.com/events0?c=101161&p=irol-calendar. A replay of the presentation will be archived and available for at least 15 days following the presentation.

    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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed 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 Global Rare Diseases, both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.

    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    +1-646-627-8390

    Cision View original content:http://www.prnewswire.com/news-releases/protalix-biotherapeutics-to-present-at-the-hc-wainwright-6th-annual-israel-conference-301166949.html

    SOURCE Protalix BioTherapeutics, Inc.

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  13. CARMIEL, Israel, Oct. 29, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced that it has rescheduled today's conference call due to technical issues with a third-party provider. The rescheduled call to discuss the financial results and provide a general business update will take place on Friday, October 30, 2020 at 8:30 a.m. Eastern Daylight Time (EDT). The Company reported financial results for the third quarter ended September 30, 2020, and provided a business update on recent corporate and clinical…

    CARMIEL, Israel, Oct. 29, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced that it has rescheduled today's conference call due to technical issues with a third-party provider. The rescheduled call to discuss the financial results and provide a general business update will take place on Friday, October 30, 2020 at 8:30 a.m. Eastern Daylight Time (EDT). The Company reported financial results for the third quarter ended September 30, 2020, and provided a business update on recent corporate and clinical developments in a press release issued earlier today.

    Rescheduled Conference Call and Webcast Information:

    Friday, October 30, 2020, 8:30 a.m. Eastern Daylight Time (EDT)

    Domestic: 877-423-9813

    International: 201-689-8573

    Conference ID: 13712792

    The conference call will be webcast live from the Company's website and will be available via the following links:

    Webcast Details:

    Company Link: https://protalixbiotherapeutics.gcs-web.com/events0 

    Webcast Link: https://tinyurl.com/y2k6q9lk

    Conference ID: 13712792

    Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

    The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company's website, at the above link.

    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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed 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 Global Rare Diseases, both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.

    Logo - https://mma.prnewswire.com/media/999479/Protalix_Biotherapeutics_Logo.jpg

    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    +1-646-627-8390

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/protalix-biotherapeutics-to-reschedule-third-quarter-2020-financial-results-and-business-update-call-for-friday-october-30-301163240.html

    SOURCE Protalix BioTherapeutics, Inc.

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  14. CARMIEL, Israel, Oct. 29, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 third quarter ended September 30, 2020, and provided a business update on recent corporate and clinical developments.

     

    Protalix Biotherapeutics Logo

     

    "This quarter, we delivered on another important milestone for the Company with the FDA's acceptance of, and grant of Priority Review designation to, the biologics license application (BLA) submitted for PRX–102 for the treatment of Fabry disease," said Dror Bashan, Protalix's…

    CARMIEL, Israel, Oct. 29, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 third quarter ended September 30, 2020, and provided a business update on recent corporate and clinical developments.

     

    Protalix Biotherapeutics Logo

     

    "This quarter, we delivered on another important milestone for the Company with the FDA's acceptance of, and grant of Priority Review designation to, the biologics license application (BLA) submitted for PRX–102 for the treatment of Fabry disease," said Dror Bashan, Protalix's President and Chief Executive Officer. "We continue to build-out our clinical data profile for PRX–102. The last patient has completed treatment in the BRIGHT study, and we expect to report top-line data from the study by the end of the first quarter, 2021. We remain focused on advancing our earlier stage pipeline as well. We are proud of our team's continued dedication and collaboration in progressing on our corporate mission during these challenging times of the pandemic."

    Recent Business Highlights

    • Announced U.S. Food and Drug Administration (FDA) acceptance of the BLA submitted for PRX–102 (pegunigalsidase alfa) for the treatment of adult patients with Fabry disease and grant of Priority Review designation to the BLA. The BLA was submitted under the FDA's accelerated approval pathway in collaboration with the Company's development and commercialization partner, Chiesi Global Rare Diseases. The FDA indicated in its communications that it is not currently planning to hold an advisory committee meeting to discuss the application.



    • The FDA set an action date of January 27, 2021 under the Prescription Drug User Fee Act (PDUFA) for the BLA. The FDA advised that, as part of its review of the BLA application, it requires an inspection of the Company's manufacturing facility and that of a third party in Europe that performs fill and finish processes for PRX–102. Due to COVID-19 related FDA travel restrictions, the FDA has advised that it may be unable to conduct the inspections prior to the PDUFA date. Together with Chiesi, the Company is diligently exploring potential alternatives that would enable the FDA to meet its timeline. As part of such efforts, Chiesi submitted a request to the FDA for a Type A meeting. The Company anticipates an FDA response to this request during the first week of November 2020.



    • Disclosed the completion of the patient treatment period for the Company's phase III BRIGHT clinical trial of PRX–102 for the treatment of Fabry disease. The trial was designed to evaluate the safety and efficacy of 2 mg/kg PRX–102 infused every four weeks, in Fabry patients. The Company expects to report top-line results from the trial by the end of the first quarter, 2021.



    • Announced the launch of an Expanded Access Program in the United States for PRX–102 allowing a broader group of physicians and patients, beyond those in the Company's phase III clinical program, access to PRX–102.



    • Launched an at-the-market equity offering program with BofA Securities enabling the Company to sell up to $30 million shares of common stock according to the terms and conditions set forth in its agreement with BofA Securities. The program provides the Company with greater capital-raising flexibility as it executes on its commercialization and development plans.

     

    Third Quarter 2020 Financial Highlights

    The Company recorded revenues from selling goods of $3.3 million during the three months ended September 30, 2020, a decrease of $1.8 million, or 36%, compared to revenues of $5.1 million for the same period of 2019. The decrease resulted primarily from a timing difference in sales to Brazil in 2020 compared to 2019, which was partially offset by an increase in sales to Pfizer Inc.

    Revenues from license and R&D services for the three months ended September 30, 2020 were $7.5 million, a decrease of $1.6 million, or 18%, compared to $9.1 million for the same period of 2019. Revenues from license and R&D services are comprised primarily of revenues the Company recognized in connection with its license and supply agreements with Chiesi. The decrease is primarily due to the completion of two out of the three phase III clinical trials of PRX–102 as well as lower costs related to the Company's phase III BALANCE clinical trial of PRX–102 for the treatment of Fabry disease.

    Cost of goods sold for the three months ended September 30, 2020 was $2.9 million, a decrease of $0.3 million, or 11%, compared to $3.2 million for the same period of 2019. The decrease is primarily due to a change in the cost structure as well as lower royalties paid to the Israeli Innovation Authority.

    Research and development expenses for the three months ended September 30, 2020 were $7.7 million, a decrease of $2.3 million, or 23%, compared to $10.0 million for the same period of 2019. The decrease is primarily due to the completion of two out of the three phase III clinical trials of PRX–102 and reduced costs related to the BALANCE study as well as a decrease in costs related to manufacturing of the Company's drug in development as some of the manufactured drug product and related costs have been recorded as inventory.

    Selling, general and administrative expenses for the three months ended September 30, 2020 were $2.8 million, an increase of $0.2 million, or 9%, compared to $2.6 million for the same period of 2019.

    Financial expenses net for the three months ended September 30, 2020 were $1.9 million, a decrease of $0.1 million, or 8%, compared to $2.0 million for the same period of 2019.

    Cash, cash equivalents and short-term bank deposits were approximately $41.3 million at September 30, 2020.

    Conference Call and Webcast Information:

    The Company will host a conference call on Thursday, October 29, 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: 13711708

    The conference call will be webcast live from the Company's website and will be available via the following links:

    Company Link: https://protalixbiotherapeutics.gcs-web.com/events0 

    Webcast Link: https://tinyurl.com/y2z676dk 

    Conference ID: 13711708

    Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

    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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed 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 Global Rare Diseases, both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.

    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: Risks related to the timing, progress and likelihood of final approval by the FDA of the BLA for PRX–102, by the PDUFA date or at all, which was accepted by the FDA and granted Priority Review designation in August 2020 and, if approved, whether the use of PRX–102 will be commercially successful; 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; and inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; risks associated with the novel coronavirus disease (COVID–19) outbreak, which may adversely impact our business, preclinical studies and clinical trials; risks related to the amount and sufficiency of our cash and cash equivalents; 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; risks related to any transactions we may effect in the public or private equity markets to raise capital to finance future research and development activities, general and administrative expenses and working capital; 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 successful conclusion of our negotiations with the Brazilian Ministry of Health regarding the purchase of BioManguinhos alfataliglicerase generally; risks related to our commercialization efforts for BioManguinhos alfataliglicerase in Brazil; risks relating to the compliance by Fundação Oswaldo Cruz with its purchase obligations and related milestones under our supply and technology transfer agreement; the risk that despite the FDA's grant of fast track designation for PRX–102, 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; 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.

    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    +1-646-627-8390

    PROTALIX BIOTHERAPEUTICS, INC.



    CONDENSED CONSOLIDATED BALANCE SHEETS



    (U.S. dollars in thousands)



    (Unaudited)



























    September 30, 2020



    December 31, 2019

















    ASSETS































    CURRENT ASSETS:















    Cash and cash equivalents



    $

    13,533



    $

    17,792



    Short-term bank deposits





    27,760





    -



    Accounts receivable – Trade





    3,146





    4,700



    Other assets





    2,612





    1,832



    Inventories





    13,281





    8,155



    Total current assets



    $

    60,332



    $

    32,479



















    NON-CURRENT ASSETS:















    Funds in respect of employee rights upon retirement





    1,639



    $

    1,963



    Property and equipment, net





    4,639





    5,273



    Operating lease right of use assets





    5,700





    5,677



    Total non-current assets



    $

    11,978



    $

    12,913



    Total assets



    $

    72,310



    $

    45,392



















    LIABILITIES NET OF CAPITAL DEFICIENCY































    CURRENT LIABILITIES:















    Accounts payable and accruals:















    Trade



    $

    8,351



    $

    6,495



    Other





    13,347





    11,905



    Operating lease liabilities





    1,176





    1,139



    Contracts liability





    16,720





    16,335



    Promissory note





    4,301





    4,301



    Total current liabilities



    $

    43,895



    $

    40,175



















    LONG TERM LIABILITIES:















    Convertible notes



    $

    53,505



    $

    50,957



    Contracts liability





    1,533





    16,980



    Liability for employee rights upon retirement





    2,088





    2,565



    Operating lease liabilities





    4,558





    4,528



    Other long term liabilities





    46





    509



    Total long term liabilities



    $

    61,730



    $

    75,539



    Total liabilities



    $

    105,625



    $

    115,714



















    COMMITMENTS































    CAPITAL DEFICIENCY





    (33,315)





    (70,322)



    Total liabilities net of capital deficiency



    $

    72,310



    $

    45,392



     

     

    PROTALIX BIOTHERAPEUTICS, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

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

    (Unaudited)































    Nine Months Ended



    Three Months Ended





    September 30,

    2020



    September 30,

    2019



    September 30,

    2020



    September 30,

    2019

    REVENUES FROM SELLING GOODS



    $

    11,975



    $

    12,086



    $

    3,296



    $

    5,126

    REVENUES FROM LICENSE AND R&D SERVICES





    31,428





    24,848





    7,494





    9,122

    TOTAL REVENUE





    43,403





    36,934





    10,790





    14,248

    COST OF GOODS SOLD





    (8,121)





    (7,945)





    (2,868)





    (3,205)

    RESEARCH AND DEVELOPMENT EXPENSES, NET (1)





    (27,214)





    (35,021)





    (7,688)





    (10,000)

    SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (2)





    (8,197)





    (6,885)





    (2,816)





    (2,587)

    OPERATING LOSS





    (129)





    (12,917)





    (2,582)





    (1,544)

    FINANCIAL EXPENSES





    (7,150)





    (5,877)





    (1,973)





    (2,050)

    FINANCIAL INCOME





    359





    227





    118





    34

    FINANCIAL EXPENSES - NET





    (6,791)





    (5,650)





    (1,855)





    (2,016)

    NET LOSS FOR THE PERIOD



    $

    (6,920)



    $

    (18,567)



    $

    (4,437)



    $

    (3,560)

    NET LOSS PER SHARE OF COMMON STOCK-BASIC AND

    DILUTED



    $

    (0.25)



    $

    (1.25)



    $

    (0.14)



    $

    (0.24)

    WEIGHTED AVERAGE NUMBER OF SHARES OF

    COMMON STOCK USED IN COMPUTING LOSS PER SHARE –

    BASIC AND DILUTED





    27,758,104





    14,838,213





    32,863,788





    14,838,213

    (1) Includes share-based compensation



    $

    635



    $

    426



    $

    562



    $

    110

    (2) Includes share-based compensation



    $

    1,477



    $

    173



    $

    852



    $

    86

     

     

    Cision View original content:http://www.prnewswire.com/news-releases/protalix-biotherapeutics-reports-third-quarter-2020-financial-results-and-provides-business-update-301162734.html

    SOURCE Protalix BioTherapeutics, Inc.

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  15. CARMIEL, Israel, Oct. 26, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced that on Wednesday, October 28, 2020, at 10:00 a.m. EDT, it will participate in the Virtual KOL Roundtable, covering both the Company and pegunigalsidase alfa, or PRX–102, the Company's lead drug candidate for the treatment of Fabry Disease. The KOL Roundtable is taking place virtually on Tuesday, October 27 through Thursday, October 29.

     

    Protalix Biotherapeutics Logo

     

    The Company's Roundtable presentation will be a live video webcast, moderated

    CARMIEL, Israel, Oct. 26, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced that on Wednesday, October 28, 2020, at 10:00 a.m. EDT, it will participate in the Virtual KOL Roundtable, covering both the Company and pegunigalsidase alfa, or PRX–102, the Company's lead drug candidate for the treatment of Fabry Disease. The KOL Roundtable is taking place virtually on Tuesday, October 27 through Thursday, October 29.

     

    Protalix Biotherapeutics Logo

     

    The Company's Roundtable presentation will be a live video webcast, moderated discussion for up to one hour. Representing the Company will be Dror Bashan, the Company's President and Chief Executive Officer, and Eyal Rubin, the Company's Sr. Vice President and Chief Financial Officer, who will be joined by KOL David G. Warnock, M.D., University of Alabama at Birmingham, who will discuss the current treatment landscape, as well as the unmet medical need for treating Fabry patients.

    David Warnock, M.D. received a BA degree in 1966 from the University of California at Berkeley and received his M.D. degree in 1970 from the University of California, San Francisco. Following a fellowship at the NIH, his positions included Section Chief at the San Francisco VA Medical Center, Director of Nephrology at the University of Alabama at Birmingham (UAB) from 1988 to 2008, and Director of the Office of Human Research at UAB from 2005 to 2008. He served as the Marie K Ingalls Professor of Medicine and the Hilda B. Anderson Endowed Professor in Nephrology at UAB and became an Emeritus Professor of Medicine at UAB in October 2015. Dr. Warnock's focus is on the genetic and environmental factors that contribute to hypertension and chronic kidney disease. The spectrum extends from basic studies of salt and water transport systems to population-based studies of the prevalence of CKD and the association with stroke and heart disease. Another focus is inherited disorders of renal function, with a current emphasis on the renal manifestations of Fabry disease. Additional research interests include acid-base physiology, sodium transport mechanisms, chronic kidney disease, diabetes and kidney disease, and inherited renal diseases. Dr. Warnock has been actively treating Fabry disease since 2001. He started the first US patient on commercial enzyme replacement therapy (Fabrazyme®) in April 2003. He served on the Genzyme/Sanofi North American Fabry Registry Advisory Board as well as their International Advisory Board from 2003 – 2018. Dr. Warnock has been working with the Company as an advisor since 2015. He has published extensively about the diagnosis and management of Fabry disease.

    The Company's Roundtable presentation will be webcast live from the Company's website and will be available via the following links:

    Webcast Details:

    Company Link: https://protalixbiotherapeutics.gcs-web.com/events0

    Webcast Link: https://tinyurl.com/y5k635xy

    Please access the websites at least 15 minutes ahead of the presentation to register, download, and install any necessary audio software.

    The presentation will be available for replay for two weeks on the Events Calendar of the Investors section of the Company's website, at the above link.

    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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed 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 Global Rare Diseases, both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.

    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 are 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.

    Logo - https://mma.prnewswire.com/media/999479/Protalix_Biotherapeutics_Logo.jpg

    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    646-627-8390

     

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  16. CARMIEL, Israel, Oct. 22, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced that it will release its financial results for the third quarter 2020 and business update on Thursday, October 29, 2020. The Company's management will host a conference call to discuss the financial results and provide a general business update at 8:30 a.m. Eastern Daylight Time (EDT).

    Conference Call Details:

    Thursday, October 29, 2020, 8:30 a.m. Eastern Daylight Time (EDT)

    Domestic: 877-423-9813

    International: 201-689-8573

    Conference ID: 13711708

    The conference call will be webcast live from the Company's website and will be available via the following links:

    Webcast Details:

    Company Link: https://protalixbiotherapeutics.gcs-web.com/events0 

    Webcast Link: https://tinyurl.com/y2z676dk 

    Conference ID: 13711708

    Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

    The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company's website, at the above link.

    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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed 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 Global Rare Diseases, both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.

    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    646-627-8390

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  17. - Access the event and schedule of presenting companies at virtualinvestorco.com -

    - Live video webcast roundtable discussions with members of Management and Key Opinion Leaders from each participating company -

    PITTSTOWN, NJ / ACCESSWIRE / October 20, 2020 / JTC Team ("JTC"), a fully integrated corporate communications firm, today announced they will host the Virtual Investor KOL Roundtable on October 27th, 28th, and 29th, 2020 with company presentations each day. The KOL Roundtable event will feature public companies across the life sciences industry. As part of the virtual video event, JTC will host a moderated, in-depth discussion with members of the Management team from each participating company along with Key Opinion Leaders over the three-day…

    - Access the event and schedule of presenting companies at virtualinvestorco.com -

    - Live video webcast roundtable discussions with members of Management and Key Opinion Leaders from each participating company -

    PITTSTOWN, NJ / ACCESSWIRE / October 20, 2020 / JTC Team ("JTC"), a fully integrated corporate communications firm, today announced they will host the Virtual Investor KOL Roundtable on October 27th, 28th, and 29th, 2020 with company presentations each day. The KOL Roundtable event will feature public companies across the life sciences industry. As part of the virtual video event, JTC will host a moderated, in-depth discussion with members of the Management team from each participating company along with Key Opinion Leaders over the three-day event.

    Investors and interested parties can access the event schedule and individual company webcast details at www.virtualinvestorco.com.

    In addition to the KOL roundtable discussions, each management team will be available for 1x1 virtual meetings from qualified members of the investment community which can be requested through the event website or by emailing a request to .

    The presenting company schedule for the KOL Roundtable series is:

    Tuesday, October 27, 2020

    Wednesday, October 28, 2020

    Thursday, October 29, 2020

    For more information about the event, please visit the conference website at virtualinvestorco.com or contact .

    About JTC Team

    JTC is a fully integrated corporate communications firm that is dedicated to helping you tell your story to the right audiences in order to build awareness and achieve your goals. JTC was founded over 8 years ago and has developed a reputation of excellence for executing on robust communication strategies that deliver results. The Company's client roster over the years has included both public and private companies across the Life Sciences and Technology industries to help them establish and execute their corporate communications, raise awareness and build shareholder value. For more information, please visit www.jtcir.com or connect with the company on Twitter and LinkedIn.

    Contact:

    Jenene Thomas
    JTC Team, LLC
    T: +1 (833) 475-8247

    SOURCE: JTC Team, LLC



    View source version on accesswire.com:
    https://www.accesswire.com/611314/JTC-Team-to-Host-Virtual-Investor-KOL-Roundtable-on-October-27th-28th-and-29th

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  18. BOSTON and CARMIEL, Israel, Oct. 2, 2020 /PRNewswire/ -- Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare group (Chiesi Group), and Protalix BioTherapeutics, Inc. (NYSE: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 announced the launch of an Expanded Access Program (EAP) in the United States for pegunigalsidase alfa for the proposed treatment of Fabry disease. A biologics license application (BLA) for pegunigalsidase alfa is currently under review by the U.S. Food and Drug Administration (FDA…

    BOSTON and CARMIEL, Israel, Oct. 2, 2020 /PRNewswire/ -- Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare group (Chiesi Group), and Protalix BioTherapeutics, Inc. (NYSE: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 announced the launch of an Expanded Access Program (EAP) in the United States for pegunigalsidase alfa for the proposed treatment of Fabry disease. A biologics license application (BLA) for pegunigalsidase alfa is currently under review by the U.S. Food and Drug Administration (FDA). This EAP will run concurrently with Protalix's ongoing Phase III clinical program.

    "The launch of this Expanded Access Program for pegunigalsidase alfa is another example of Chiesi's and Protalix's shared commitment to support patients whose condition cannot be adequately treated by currently available FDA-approved therapies for Fabry disease," said Marcel van Kuijck, Ph.D., Global Head of Medical Affairs at Chiesi Global Rare Diseases.

    "We are excited that a broader group of physicians and patients beyond those in our Phase III program will have access to pegunigalsidase alfa, and that such support to Fabry patients in the U.S. is available prior to FDA's final review," added Raul Chertkoff, M.D., Vice President and Chief Medical Officer at Protalix.

    The EAP is open to patients with a clinical diagnosis of Fabry disease who, in the opinion of the treating physician, have no comparable or satisfactory alternative treatment options with currently available FDA-approved therapies for Fabry disease. Other eligibility criteria apply. Patients participating in the EAP will receive infusions of pegunigalsidase alfa every two weeks at 1mg/kg body weight. Information related to adverse events and other limited data will be collected from participants.

    "The National Fabry Disease Foundation and the Fabry community are very excited about the launch of Chiesi's Expanded Access Program for pegunigalsidase alfa for the treatment of Fabry disease," said Jerry Walter, Founder and President, National Fabry Disease Foundation. "As the number of people diagnosed with Fabry disease continues to exceed predictions, access to treatment through Expanded Access Programs can play an important role in helping as many eligible patients as possible access the treatment they need."

    Pegunigalsidase alfa is an investigational product and currently not approved by the FDA. The effectiveness and safety of pegunigalsidase alfa have not been reviewed or approved by the FDA. Before FDA review and approval, no conclusions can be drawn on pegunigalsidase alfa's efficacy and safety profile. When seeking expanded access, treating physicians should consider all possible risks of treatment with pegunigalsidase alfa. Access must be compliant with all applicable federal and state laws and regulations. Investigators should not seek reimbursement for product provided to patients who participate in a government-funded insurance program.

    In August 2020, the FDA accepted the pegunigalsidase alfa BLA and granted Priority Review designation for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease. Concurrently with the EAP, pegunigalsidase alfa is being evaluated by Protalix BioTherapeutics in patients with Fabry disease under an open Investigational New Drug application in the Phase III BALANCE, BRIGHT and BRIDGE clinical trials and other related open label studies.

    The Expanded Access Program is listed on ClinicalTrials.gov Identifier: NCT04552691 (https://clinicaltrials.gov/ct2/show/NCT04552691). Additional information on Chiesi's Expanded Access policy is available at https://www.chiesiusa.com/sustainability/expanded-access-programs/. Treating physicians must submit requests on behalf of their patients for consideration via the EAP request portal at https://chiesi.versaic.com.

    About Fabry Disease

    Fabry disease is an X-linked inherited disease that results from deficient activity of the lysosomal α–Galactosidase–A enzyme resulting in progressive accumulation of abnormal deposits of a fatty substance called globotriaosylceramide (Gb3) in blood vessel walls throughout a person's body. Fabry disease occurs in one person per 40,000 to 60,000. Fabry patients inherit a deficiency of the α–Galactosidase–A enzyme, which is normally responsible for the breakdown of Gb3. The abnormal storage of Gb3 increases with time and, accordingly, Gb3 accumulates, primarily in the blood and in the blood vessel walls. The ultimate consequences of Gb3 deposition range from episodes of pain and impaired peripheral sensation to end-organ failure – particularly of the kidneys, but also of the heart and the cerebrovascular system.

    About Pegunigalsidase Alfa

    Pegunigalsidase alfa is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α-Galactosidase-A enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties.

    About Chiesi Global Rare Diseases

    Chiesi Global Rare Diseases is a business unit of the Chiesi Group established in February 2020 and focused on research and development of treatments for rare and ultra-rare disorders. The Global Rare Diseases unit works in collaboration with Chiesi Group to harness the full resources and capabilities of our global network to bring innovative new treatment options to people living with rare diseases, many of whom have limited or no treatments available. The unit is also a dedicated partner with global leaders in patient advocacy, research and patient care. For more information visit www.chiesiglobalrarediseases.com.

    About Chiesi Group

    Based in Parma, Italy, Chiesi Farmaceutici is an international research-focused healthcare group with 85 years of experience in the pharmaceutical industry and a global presence in 29 countries. Chiesi researches, develops, and markets innovative drugs in the respiratory therapeutics, specialist medicine, and rare disease areas. Its R&D organization is headquartered in Parma (Italy), and is integrated with R&D groups in France, the USA, the UK, and Sweden to advance Chiesi's pre-clinical, clinical, and registration programs. Chiesi employs nearly 6,000 people. Chiesi Group is a certified Benefit corporation. For more information, please visit www.chiesi.com.

    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 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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed 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 Global Rare Diseases, both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.

    Protalix BioTherapeutics 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: that the FDA might not grant marketing approval for pegunigalsidase alfa by the PDUFA date or at all and, if approved, whether pegunigalsidase alfa will have significant limitations on its use or be commercially successful; risk that the FDA will request additional data or other conditions of the BLA filing for Accelerated Approval of PRX–102; 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; and inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; risks associated with the novel coronavirus disease (COVID–19) outbreak, which may adversely impact our business, preclinical studies and 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 our ability to maintain and manage our relationship with any collaborator, distributor or partner; 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.

    Protalix BioTherapeutics Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    +1-646-627-8390

     

    Chiesi Group Media Contact

    Valentina Biagini

    Senior Group Communication Manager Chiesi Group

    Chiesi USA Media Contact

    Jenna Urban

    BERRY & COMPANY PUBLIC RELATIONS, LLC

    T: 212 253-8881

     

    PP-I-0032 V1.0

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  19. CARMIEL, Israel, Sept. 8, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced that it received, on September 3, 2020, notification from the NYSE American LLC (the "NYSE American") that the Company has regained compliance with all of the continued listing standards set forth in Part 10 of the NYSE American Company Guide (the "Company Guide"). Specifically, that the Company has resolved the continued listing deficiency with respect to Sections 1003(a)(i) – (iii) of the Company Guide.

     

    Protalix Biotherapeutics Logo

     

    The Company…

    CARMIEL, Israel, Sept. 8, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced that it received, on September 3, 2020, notification from the NYSE American LLC (the "NYSE American") that the Company has regained compliance with all of the continued listing standards set forth in Part 10 of the NYSE American Company Guide (the "Company Guide"). Specifically, that the Company has resolved the continued listing deficiency with respect to Sections 1003(a)(i) – (iii) of the Company Guide.

     

    Protalix Biotherapeutics Logo

     

    The Company previously received a deficiency letter from the NYSE American dated August 26, 2019, stating that the Company was not in compliance with the continued listing standards as set forth in Section 1003(a)(i) – (iii) of the Company Guide. As a result of management's efforts to regain compliance, the NYSE American has informed the Company that it is back in compliance with all of the continued listing standards by meeting the requirements of the $50 million market capitalization exemption in Section 1003(a) of the Company Guide from the stockholders' equity requirement. At the opening of trading on September 4, 2020, the below compliance (".BC") indicator was no longer disseminated and the Company was removed from the list of NYSE American noncompliant issuers on the NYSE American's website.

    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.

    Pegunigalsidase alfa, Protalix's main investigational new drug product, is a modified version of the recombinant human α–Galactosidase–A protein for the proposed treatment of Fabry disease. The FDA has accepted a Biologics License Application (BLA), and granted Priority Review designation, for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease. The BLA was submitted via the FDA's Accelerated Approval pathway. 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.

    In addition, Protalix's development pipeline consists of other proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets.

    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: that the FDA might not grant marketing approval for PRX–102 by the PDUFA date or at all and, if approved, whether PRX–102 will have significant limitations on its use or be commercially successful; risk that the FDA will request additional data or other conditions of the Biologics License Application (BLA) filing for Accelerated Approval of PRX–102; 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; and inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; risks associated with the novel coronavirus disease (COVID–19) outbreak, which may adversely impact our business, preclinical studies and 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 our ability to maintain and manage our relationship with any collaborator, distributor or partner; risks related to the amount and sufficiency of our cash and cash equivalents; 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 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.

    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    +1-646-627-8390

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  20. CARMIEL, Israel, Sept. 8, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced that Dror Bashan, the Company's President and Chief Executive Officer will present in the H.C. Wainwright 22nd Annual Global Investment Virtual Conference on Tuesday, September 15, 2020 at 12:00 PM, Eastern Time. The conference will be held virtually on September 14-16, 2020.

     

    Protalix Biotherapeutics Logo

     

    A live webcast of the presentation will be available at www.protalix.com on the event calendar page, https://tinyurl.com/y5l9u4gr. A replay of the…

    CARMIEL, Israel, Sept. 8, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced that Dror Bashan, the Company's President and Chief Executive Officer will present in the H.C. Wainwright 22nd Annual Global Investment Virtual Conference on Tuesday, September 15, 2020 at 12:00 PM, Eastern Time. The conference will be held virtually on September 14-16, 2020.

     

    Protalix Biotherapeutics Logo

     

    A live webcast of the presentation will be available at www.protalix.com on the event calendar page, https://tinyurl.com/y5l9u4gr. A replay of the presentation will be archived and available for at least 15 days following the presentation.

    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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed 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.

    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    +1-646-627-8390

    Cision View original content:http://www.prnewswire.com/news-releases/protalix-biotherapeutics-to-present-in-the-hc-wainwright-22nd-annual-global-investment-virtual-conference-301125354.html

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  21. CARMIEL, Israel,, Aug. 24, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced completion of the treatment period of its Phase III BRIGHT clinical trial of pegunigalsidase alfa, or PRX–102, for the proposed treatment of Fabry disease. The Company is currently working with its service providers to complete the final monitoring visits necessary for final analysis of the data; however, many sites are still impacted by ongoing local and state restrictions and precautions due to the COVID-19 pandemic…

    CARMIEL, Israel,, Aug. 24, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced completion of the treatment period of its Phase III BRIGHT clinical trial of pegunigalsidase alfa, or PRX–102, for the proposed treatment of Fabry disease. The Company is currently working with its service providers to complete the final monitoring visits necessary for final analysis of the data; however, many sites are still impacted by ongoing local and state restrictions and precautions due to the COVID-19 pandemic. The Company anticipates announcing top-line results in the fourth quarter of 2020 once this process is completed.

    "Completion of the BRIGHT study marks another important key milestone in our pursuit of an alternative dose and regimen of pegunigalsidase alfa for the proposed treatment of Fabry disease," said Dror Bashan, President and Chief Executive Officer of Protalix BioTherapeutics. "We eagerly anticipate announcement of top-line data, and are working towards the completion of the final monitoring visits as quickly as possible. Our challenge now is to continue the work to finalize these last details with the ongoing headwinds from COVID-19. I am very proud of our team's execution in completing the study and am confident in their ability to have the final data as expeditiously as possible."

    Mr. Bashan continued, "The BRIGHT study is the second Phase III study of PRX–102 in Fabry patients that we have completed as part of our comprehensive PRX–102 development program. We announced positive results earlier this year from our Phase III BRIDGE clinical trial, and we anticipate results from an interim analysis of our Phase III BALANCE clinical trial in the first half of 2021. In addition, earlier this month, we announced the filing of the PRX–102 BLA by the U.S. Food and Drug Administration with a PDUFA target date of January 27, 2021."

    "Completion of the treatment period of the BRIGHT study represents another important milestone in the effort to advance this development program, and we are grateful to all of the patients and clinicians who have been dedicated to moving this program forward in spite of the challenges of COVID-19," said Giacomo Chiesi, Head of Chiesi Global Rare Diseases. "Pending regulatory approval, Chiesi is taking all steps necessary to be able to make PRX-102 available to patients as rapidly as possible."

    About the Phase III BRIGHT Study

    The BRIGHT study is a phase III, open label, switch over study to assess the safety, efficacy and pharmacokinetics of pegunigalsidase alfa (PRX–102) 2 mg/kg administered by intravenous infusion every four weeks for 52 weeks in patients with Fabry disease currently treated with enzyme replacement therapy (ERT): agalsidase alfa or agalsidase beta.

    About Fabry Disease

    Fabry disease is an X-linked inherited disease that results from deficient activity of the lysosomal α–Galactosidase–A enzyme resulting in progressive accumulation of abnormal deposits of a fatty substance called globotriaosylceramide (Gb3) in blood vessel walls throughout a person's body. Fabry disease occurs in one person per 40,000 to 60,000. People living with Fabry inherit a deficiency of the α–Galactosidase–A enzyme, which is normally responsible for the breakdown of Gb3. The abnormal storage of Gb3 increases with time, accumulating primarily in blood and in blood vessel walls. The ultimate consequences of Gb3 deposition range from episodes of pain and impaired peripheral sensation to end-organ failure – particularly of the kidneys, but also of the heart and the cerebrovascular system.

    About Pegunigalsidase Alfa

    Pegunigalsidase alfa (PRX–102) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α-Galactosidase-A enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. In clinical studies, PRX–102 has been observed to have a circulatory half-life of approximately 80 hours. The Company designed PRX–102 to potentially address the continued unmet clinical need in Fabry patients.

    About Chiesi Global Rare Diseases

    Chiesi Global Rare Diseases is a business unit of the Chiesi Group established in February 2020 and focused on research and development of treatments for rare and ultra-rare disorders. The Global Rare Diseases unit works in collaboration with Chiesi Group to harness the full resources and capabilities of our global network to bring innovative new treatment options to people living with rare diseases, many of whom have limited or no treatments available. The unit is also a dedicated partner with global leaders in patient advocacy, research and patient care. For more information visit www.chiesiglobalrarediseases.com.

    About Chiesi Group

    Based in Parma, Italy, Chiesi Farmaceutici is an international research-focused healthcare group with 85 years of experience in the pharmaceutical industry and a global presence in 29 countries. Chiesi researches, develops, and markets innovative drugs in the respiratory therapeutics, specialist medicine, and rare disease areas. Its R&D organization is headquartered in Parma (Italy), and is integrated with R&D groups in France, the USA, the UK, and Sweden to advance Chiesi's pre-clinical, clinical, and registration programs. Chiesi employs nearly 6,000 people. Chiesi Group is a certified Benefit Corporation. For more information www.chiesi.com.

    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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed 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.

    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: that the FDA might not grant marketing approval for PRX–102 by the PDUFA date or at all and, if approved, whether PRX–102 will may have significant limitations on its use or be commercially successful; risk that the FDA will request additional data or other conditions of the Biologics License Application (BLA) filing for Accelerated Approval of PRX–102; 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; and inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; risks associated with the novel coronavirus disease (COVID–19) outbreak, which may adversely impact our business, preclinical studies and 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 our ability to maintain and manage our relationship with any collaborator, distributor or partner; risks related to the amount and sufficiency of our cash and cash equivalents; 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.

    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    +1-646-627-8390

    Media Contact

    Brian Pinkston

    LaVoieHealthScience

    +1-857-588-3347

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/protalix-biotherapeutics-announces-completion-of-the-treatment-period-for-its-phase-iii-bright-clinical-trial-of-pegunigalsidase-alfa-prx-102-for-the-proposed-treatment-of-fabry-disease-301116942.html

    SOURCE Protalix BioTherapeutics, Inc.; Chiesi

    View Full Article Hide Full Article
  22. CARMIEL, Israel, Aug. 11, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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, or the Company, together with its development and commercialization partner Chiesi Global Rare Diseases, a unit of Chiesi, an international research-focused healthcare group, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted Priority Review designation for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease. The BLA was submitted…

    CARMIEL, Israel, Aug. 11, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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, or the Company, together with its development and commercialization partner Chiesi Global Rare Diseases, a unit of Chiesi, an international research-focused healthcare group, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted Priority Review designation for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease. The BLA was submitted via the FDA's Accelerated Approval pathway. Pegunigalsidase alfa is the Company's purposefully designed, long-acting recombinant, PEGylated, cross-linked α-galactosidase-A investigational product candidate. The FDA set an action date of January 27, 2021, under the Prescription Drug User Fee Act (PDUFA). The FDA also indicated in the BLA filing communication letter that it is not currently planning to hold an advisory committee meeting to discuss the application.

    Priority Review is granted to therapies that the FDA determines have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. This designation shortens the FDA review period following the acceptance of the BLA to six months compared to 10 months under standard review. Pegunigalsidase alfa was granted Fast Track designation by the FDA in January 2018.

    The BLA submission includes a comprehensive set of preclinical, clinical and manufacturing data compiled from the Company's completed Phase I/II clinical trial of pegunigalsidase alfa, including the related extension study succeeding the Phase I/II clinical trial, interim clinical data from the Phase III BRIDGE switch-over study and safety data from the Company's on-going clinical studies of PRX–102 in patients receiving 1 mg/kg every other week.

    "The FDA's acceptance of the BLA and grant of priority review for PRX-102 are significant achievements for Protalix and Chiesi, and represent a crucial step forward as we look to establish a new treatment option to the Fabry patient community," said Dror Bashan, Protalix's President and Chief Executive Officer. "Based on the encouraging results for PRX-102 we have seen to date, we are eager to continue discussions with the FDA and to continue our other development efforts for PRX-102, as marketing approval of PRX-102 is our top priority."

    "PRX-102 represents an important advance in research with the potential to deliver significant advantages to patients with Fabry disease," said Giacomo Chiesi, Head of Global Rare Diseases. "We are very encouraged by the strong interest in this therapy among both patients and clinicians and we look forward to the prospect of making it available to patients around the world who can benefit from treatment."

    About Fabry Disease

    Fabry disease is an X-linked inherited disease that results from deficient activity of the lysosomal α–Galactosidase–A enzyme resulting in progressive accumulation of abnormal deposits of a fatty substance called globotriaosylceramide (Gb3) in blood vessel walls throughout a person's body. Fabry disease occurs in one person per 40,000 to 60,000. Fabry patients inherit a deficiency of the α–Galactosidase–A enzyme, which is normally responsible for the breakdown of Gb3. The abnormal storage of Gb3 increases with time and, accordingly, Gb3 accumulates, primarily in the blood and in the blood vessel walls. The ultimate consequences of Gb3 deposition range from episodes of pain and impaired peripheral sensation to end-organ failure – particularly of the kidneys, but also of the heart and the cerebrovascular system.

    About Pegunigalsidase Alfa

    Pegunigalsidase alfa (PRX–102) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α-Galactosidase-A enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. In clinical studies, PRX–102 has been observed to have a circulatory half-life of approximately 80 hours. The Company designed PRX–102 to potentially address the continued unmet clinical need in Fabry patients.

    About Chiesi Global Rare Diseases

    Chiesi Global Rare Diseases is a business unit of the Chiesi Group established in February 2020 and focused on research and development of treatments for rare and ultra-rare disorders. The Global Rare Diseases unit works in collaboration with Chiesi Group to harness the full resources and capabilities of our global network to bring innovative new treatment options to people living with rare diseases, many of whom have limited or no treatments available. The unit is also a dedicated partner with global leaders in patient advocacy, research and patient care. For more information visit www.chiesiglobalrarediseases.com.

    About Chiesi Group

    Based in Parma, Italy, Chiesi Farmaceutici is an international research-focused healthcare group with 85 years of experience in the pharmaceutical industry and a global presence in 29 countries. Chiesi researches, develops, and markets innovative drugs in the respiratory therapeutics, specialist medicine, and rare disease areas. Its R&D organization is headquartered in Parma (Italy), and is integrated with R&D groups in France, the USA, the UK, and Sweden to advance Chiesi's pre-clinical, clinical, and registration programs. Chiesi employs nearly 6,000 people. Chiesi Group is a certified Benefit Corporation. For more information www.chiesi.com.

    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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed treatment of Fabry disease; OPRX–106, an orally-delivered anti-inflammatory treatment; alidornase alfa for the treatment of Cystic Fibrosis; PRX–115, a plant cell-expressed recombinant PEGylated Uricase for the treatment of gout; 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.

    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: that the FDA might not grant marketing approval for PRX–102 by the PDUFA date or at all and, if approved, whether PRX–102 will may have significant limitations on its use or be commercially successful; 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 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; risks associated with the novel coronavirus disease (COVID–19) outbreak, which may adversely impact our business, preclinical studies and 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 our ability to maintain and manage our relationship with Chiesi Farmaceutici and any other collaborator, distributor or partner; risks related to the amount of our future revenues and expenditures; the risk that despite the FDA's grant of Fast Track designation for PRX-102, 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; our dependence on performance by third party providers of services and supplies, including without limitation, clinical trial services; 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 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.

    Investor Contact:

    Chuck Padala, Managing Director

    LifeSci Advisors

    +1-646-627-8390

    Media Contact:

    Brian Pinkston

    LaVoieHealthScience

    +1-857-588-3347

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/protalix-biotherapeutics-and-chiesi-global-rare-diseases-announce-us-food-and-drug-administration-acceptance-of-biologics-license-application-bla-for-pegunigalsidase-alfa-for-the-proposed-treatment-of-fabry-disease-and-grants--301109844.html

    SOURCE Protalix BioTherapeutics, Inc.

    View Full Article Hide Full Article
  23. CARMIEL, Israel, Aug. 10, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 second quarter ended June 30, 2020, and provided a business update on recent corporate and clinical developments.

     

    Protalix Biotherapeutics Logo

     

    "This quarter, we delivered on two very important milestones for the company: announcing positive topline results in our BRIDGE phase III clinical trial of PRX–102 for the treatment of Fabry disease and subsequent BLA submission to the U.S. Food and Drug Administration (FDA). We were…

    CARMIEL, Israel, Aug. 10, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 second quarter ended June 30, 2020, and provided a business update on recent corporate and clinical developments.

     

    Protalix Biotherapeutics Logo

     

    "This quarter, we delivered on two very important milestones for the company: announcing positive topline results in our BRIDGE phase III clinical trial of PRX–102 for the treatment of Fabry disease and subsequent BLA submission to the U.S. Food and Drug Administration (FDA). We were able to accomplish these goals even as we faced the challenging headwinds from the global COVID-19 pandemic, and I am very proud of our entire team for their commitment and dedication," said Dror Bashan, Protalix's President and Chief Executive Officer. "As we look towards an exciting second half of the year, we are continuing to build Protalix for the long term. We augmented our research and development team with highly qualified and seasoned veterans to support and enhance our pipeline, and we announced a new partnership to explore the development of PRX–110." Mr. Bashan concluded, "We are gratified to have a balance sheet supporting our strategic plans and look forward to continuing to execute as we move towards the anticipated commercial launch of PRX–102 for the treatment of Fabry disease."

    Recent Business Highlights

    • Submitted a Biologics License Application (BLA) to the FDA for PRX–102 (pegunigalsidase alfa) for the treatment of adult patients with Fabry disease on May 27, 2020. The BLA was submitted under the FDA's accelerated approval pathway in collaboration with the Company's development and commercialization partner, Chiesi Farmaceutici S.p.A. On July 28, 2020, the FDA informed Chiesi that the BLA had been filed for review and that the FDA was working on the 74-day letter. In addition, the FDA informed Chiesi that no "Refuse To File" will be issued for the PRX-102 BLA.



    • Announced positive topline results from our BRIDGE Phase III clinical trial of PRX–102 for the treatment of Fabry disease. The study was an open-label, switch-over trial designed to evaluate the safety and efficacy of 1 mg/kg PRX–102 infused every two weeks, in Fabry patients. The trial met its main objectives for safety and efficacy, and topline analysis indicated substantial improvement in renal function as measured by mean annualized estimated Glomerular Filtration Rate (eGFR slope) in patients switched from agalsidase alfa to PRX–102.



    • Enhanced the executive management team with the appointment of Yael Hayon, Ph.D. as Vice President, Research and Development. Dr. Hayon brings over a decade of pharmaceutical research and development experience in both the scientific operations and administrative functions.



    • Entered into a non-binding term sheet with SarcoMed USA, Inc. to explore the development and commercialization of PRX–110 (alidornase alfa) in the treatment of Pulmonary Sarcoidosis and related diseases. SarcoMed USA was formed in 2017 to investigate if a novel DNase 1 compound could influence the chronic pulmonary inflammation seen in Pulmonary Sarcoidosis patients.

    Second Quarter 2020 Financial Highlights

    The Company recorded revenues from selling goods of $3.6 million during the three months ended June 30, 2020, an increase of $0.2 million, or 6%, compared to revenues of $3.4 million for the same period of 2019.

    Revenues from license and R&D services for the three months ended June 30, 2020, were $7.3 million, a decrease of $1.5 million, or 17%, compared to revenues of $8.8 million for the same period of 2019. Revenues from license and R&D services are comprised primarily of revenues the Company recognized in connection with its license and supply agreements with Chiesi. The decrease is primarily due to the completion of two out of the three phase III clinical trials of PRX–102 as well as lower costs related to the Company's phase III BALANCE clinical trial of PRX-102 for the treatment of Fabry disease.

    Cost of goods sold was $1.8 million for the three months ended June 30, 2020, a decrease of $0.9 million, or 32%, from cost of goods sold of $2.7 million for the same period of 2019. The decrease is primarily due to a change in the cost structure as well as lower royalties paid to the Israeli Innovation Authority.

    Research and development expenses were $9.2 million for the three months ended June 30, 2020, a decrease of $4.1 million, or 31%, compared to $13.3 million of research and development expenses for the same period of 2019. The decrease is primarily due to the completion of two out of the three phase III clinical trials of PRX–102 and reduced costs related to the Company's phase III BALANCE clinical trial as well as a decrease in costs related to manufacturing of the Company's drug in development as some of the manufactured drug product and related costs have been recorded as inventory.

    Selling, general and administrative expenses were $2.2 million for the three months ended June 30, 2020, an increase of $0.1 million, or 6%, compared to $2.1 million for the same period of 2019.

    Cash and cash equivalents at June 30, 2020 was $4.8 million, with $35.2 million in bank deposits.

    Conference Call and Webcast Information

    The Company will host a conference call on Monday, August 10, 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:  

    13706783

    Webcast: 

    https://tinyurl.com/y3cuc7gw

    The conference call will be broadcast live and also 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.

    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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed treatment of Fabry disease; OPRX–106, an orally-delivered anti-inflammatory treatment; alidornase alfa for the treatment of Cystic Fibrosis; PRX–115, a plant cell-expressed recombinant PEGylated Uricase for the treatment of gout; 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.

    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: 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 and, if approved, whether PRX–102 will be commercially successful; 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; and inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; risks associated with the novel coronavirus disease (COVID–19) outbreak, which may adversely impact our business, preclinical studies and clinical trials; risks related to any transactions we may effect in the public or private equity markets to raise capital to finance future research and development activities, general and administrative expenses and working capital; 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 amount and sufficiency of our cash and cash equivalents; risks related to the successful conclusion of our negotiations with the Brazilian Ministry of Health regarding the purchase of BioManguinhos alfataliglicerase generally; risks related to our commercialization efforts for BioManguinhos alfataliglicerase in Brazil; risks relating to the compliance by Fundação 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; the risk that despite the FDA's grant of fast track designation for PRX–102, 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.

    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    +1-646-627-8390

    Media Contact

    Brian Pinkston

    LaVoieHealthScience

    +1-857-588-3347

     

     

    PROTALIX BIOTHERAPEUTICS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS



    (U.S. dollars in thousands)



    (Unaudited)



























    June 30, 2020







    December 31, 2019



    ASSETS



































    CURRENT ASSETS: 

















      Cash and cash equivalents..............................................................................................



    $

    4,843





    $

    17,792



    Short-term bank deposits…………………………………………………





    30,147







    -



      Accounts receivable – Trade......................................................................................





    5,262







    4,700



      Other assets................................................................................................................





    2,893







    1,832



      Inventories.................................................................................................................





    11,065







    8,155



    Total current assets..................................................................................................



    $

    54,210





    $

    32,479





















    NON-CURRENT ASSETS: 



































         Long-term bank deposits.............................................................................................



    $

    5,025







    -



         Funds in respect of employee rights upon retirement..................................................





    2,005





    $

    1,963



         Property and equipment, net........................................................................................





    4,793







    5,273



         Operating lease right of use assets..............................................................................





    5,677







    5,677



            Total non-current assets...........................................................................................



    $

    17,500





    $

    12,913



    Total assets...............................................................................................................



    $

    71,710





    $

    45,392





















    LIABILITIES NET OF CAPITAL DEFICIENCY



































    CURRENT LIABILITIES: 

















      Accounts payable and accruals: 

















    Trade.........................................................................................................................



    $

    6,707





    $

    6,495



    Other.........................................................................................................................





    11,910







    11,905



          Operating lease liabilities





    1,145







    1,139



          Contracts liability.........................................................................................................





    18,352







    16,335



          Promissory note...........................................................................................................





    4,301







    4,301



            Total current liabilities...............................................................................................



    $

    42,415





    $

    40,175





















    LONG TERM LIABILITIES:

















     Convertible notes..........................................................................................................



    $

    52,622





    $

    50,957



     Contracts liability..........................................................................................................





    4,122







    16,980



     Liability for employee rights upon retirement................................................................





    2,665







    2,565



     Operating lease liabilities...............................................................................................





    4,526







    4,528



     Other long term liabilities..............................................................................................





    124







    509



    Total long term liabilities...........................................................................................



    $

    64,059





    $

    75,539



    Total liabilities...........................................................................................................



    $

    106,474





    $

    115,714





















    COMMITMENTS



































    CAPITAL DEFICIENCY..............................................................................................





    (34,764)







    (70,322)



    Total liabilities net of capital deficiency.....................................................................



    $

    71,710





    $

    45,392



     

     

    PROTALIX BIOTHERAPEUTICS, INC.

    CONDENSED
     CONSOLIDATED STATEMENTS OF OPERATIONS



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



    (Unaudited)





















    Six Months Ended





    Three Months Ended







    June 30, 2020





    June 30, 2019





    June 30, 2020





    June 30, 2019



    Revenues from selling goods



    $

    8,679





    $

    6,960





    $

    3,648





    $

    3,430



    Revenues from license and R&D services





    23,934







    15,726







    7,319







    8,817



    Total revenue





    32,613







    22,686







    10,967







    12,247



    Cost of goods sold





    (5,253)







    (4,740)







    (1,827)







    (2,695)



    Research and development expenses, net (1)





    (19,526)







    (25,021)







    (9,186)







    (13,323)



    Selling, general and administrative expenses (2)





    (5,381)







    (4,298)







    (2,194)







    (2,068)



    Operating income (loss)





    2,453







    (11,373)







    (2,240)







    (5,839)



    Financial expenses





    (5,177)







    (3,827)







    (1,948)







    (1,907)



    Financial income





    241







    193







    38







    3



    Financial expenses, net





    (4,936)







    (3,634)







    (1,910)







    (1,904)



    Net loss for the period



    $

    (2,483)





    $

    (15,007)





    $

    (4,150)





    $

    (7,743)



    Loss per share of common stock - basic and diluted



    $

    (0.12)





    $

    (1.01)





    $

    (0.13)





    $

    (0.52)



    Weighted average number of shares of common

































         stock used in computing loss per share –

































         basic and diluted





    19,923,935







    14,838,213







    32,442,636







    14,838,213



         (1) Includes share-based compensation



    $

    73





    $

    316





    $

    (5)





    $

    138



         (2) Includes share-based compensation



    $

    625





    $

    87





    $

    272





    $

    (25)



     

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  24. CARMIEL, Israel, Aug. 6, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced that Dror Bashan, the Company's President and Chief Executive Officer, and Eyal Rubin, the Company's Sr. Vice President and Chief Financial Officer, will participate in the BTIG Virtual Biotechnology Conference. The conference is taking place virtually on Monday, August 10 through Tuesday, August 11.

     

    Protalix Biotherapeutics Logo

     

    Mr. Bashan will provide a corporate presentation in a fireside chat format on Monday, August 10 at 2:00 pm ET. A live webcast…

    CARMIEL, Israel, Aug. 6, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced that Dror Bashan, the Company's President and Chief Executive Officer, and Eyal Rubin, the Company's Sr. Vice President and Chief Financial Officer, will participate in the BTIG Virtual Biotechnology Conference. The conference is taking place virtually on Monday, August 10 through Tuesday, August 11.

     

    Protalix Biotherapeutics Logo

     

    Mr. Bashan will provide a corporate presentation in a fireside chat format on Monday, August 10 at 2:00 pm ET. A live webcast of the fireside chat will be available at www.protalix.com, on the event calendar page under the Investors tab and at the following link: http://wsw.com/webcast/btig/plx/. A replay of the webcast will be available for at least 15 days following the presentation.

    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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed treatment of Fabry disease; OPRX–106, an orally-delivered anti-inflammatory treatment; alidornase alfa for the treatment of Cystic Fibrosis; and PRX-115, a plant cell-expressed recombinant PEGylated Uricase for the treatment of gout. 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.

    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    +1-646-627-8390

    Media Contact

    Brian Pinkston

    LaVoieHealthScience

    +1-857-588-3347

     

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  25. CARMIEL, Israel, Aug. 3, 2020 /PRNewswire/Protalix BioTherapeutics, Inc. (NYSE: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 announced that it will release its financial results for the second quarter 2020 and business update on Monday, August 10, 2020. The Company's management will host a conference call to discuss the financial results and provide a general business update at 8:30 a.m. Eastern Daylight Time (EDT).

     

    Protalix Biotherapeutics Logo

     

    Conference Call Details:
    Monday, August 10, 2020, 8:30 a.m. Eastern Daylight Time (EDT)
    Domestic: 877-423-9813
    International: 201-689-8573
    Conference…

    CARMIEL, Israel, Aug. 3, 2020 /PRNewswire/Protalix BioTherapeutics, Inc. (NYSE: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 announced that it will release its financial results for the second quarter 2020 and business update on Monday, August 10, 2020. The Company's management will host a conference call to discuss the financial results and provide a general business update at 8:30 a.m. Eastern Daylight Time (EDT).

     

    Protalix Biotherapeutics Logo

     

    Conference Call Details:

    Monday, August 10, 2020, 8:30 a.m. Eastern Daylight Time (EDT)

    Domestic: 877-423-9813

    International: 201-689-8573

    Conference ID: 13706783

    Webcast Details:

    Webcast Link: https://tinyurl.com/y3cuc7gw

    Conference
    ID: 13706783

    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.

    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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed 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.

    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    646-627-8390

    Media Contact

    Brian Pinkston

    LaVoieHealthScience

    857-588-3347

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  26. CARMIEL, Israel, July 23, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced that it has entered into a non-binding term sheet with SarcoMed USA Inc. The arrangement, if consummated, would relate to the development and commercialization of PRX–110, or alidornase alfa, for the treatment of Pulmonary Sarcoidosis and related diseases. SarcoMed USA was formed in 2017 to investigate if a novel DNase 1 compound could influence the chronic pulmonary inflammation seen in Pulmonary Sarcoidosis patients.

     

    CARMIEL, Israel, July 23, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced that it has entered into a non-binding term sheet with SarcoMed USA Inc. The arrangement, if consummated, would relate to the development and commercialization of PRX–110, or alidornase alfa, for the treatment of Pulmonary Sarcoidosis and related diseases. SarcoMed USA was formed in 2017 to investigate if a novel DNase 1 compound could influence the chronic pulmonary inflammation seen in Pulmonary Sarcoidosis patients.

     

    Protalix Biotherapeutics Logo

     

    On July 21, 2020, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for alidornase alfa for the treatment of Sarcoidosis. The FDA grants Orphan Drug Designation to drugs or biologics intended to treat or prevent rare diseases or conditions that affect fewer than 200,000 individuals in the United States.

    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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed 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.

    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: our ability to execute a license agreement with SarcoMed USA with terms and conditions acceptable to us, if at all;  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; and inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; risks associated with the novel coronavirus disease (COVID–19) outbreak, which may adversely impact our business, preclinical studies and clinical trials; risks related to any transactions we may effect in the public or private equity markets to raise capital to finance future research and development activities, general and administrative expenses and working capital; 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 any collaborator, distributor or partner; risks related to the amount and sufficiency of our cash and cash equivalents; 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.

    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    +1-646-627-8390

    Media Contact

    Brian Pinkston

    LaVoieHealthScience

    +1-857-588-3347

     

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  27. CARMIEL, Israel, June 8, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE:PLX) (TASE: PLX) today announced the appointment of Yael Hayon, Ph.D. as the Company's new Vice President, Research and Development, effective July 5, 2020. On June 2, 2020, Yoseph Shaaltiel, Ph.D. retired from his position as the Company's Executive Vice President, Research and Development, effective June 15, 2020.

    "Yossi's incredible scientific and entrepreneurial vision led to his founding of Protalix," said Zeev Bronfeld, Chairman of Protalix's Board of Directors. "Yossi's efforts resulted in the development of ProCellEx®, our proprietary plant cell-based protein expression system which we use to produce taliglucerase alfa, an approved treatment for Gaucher disease, pegunigalsidase alfa, our investigational treatment for Fabry disease which is in the latter stages of clinical development and our other investigational drug candidates. The Board of Directors and I are immensely grateful to Yossi for his knowledge, leadership, integrity and professionalism in building Protalix from its founding days to where it is today. We wish him all the best in his future endeavors."

    "I am delighted that Yael is joining the Protalix team where she will bring valuable and diverse research & development experience and knowledge," said Dror Bashan, Protalix's President and Chief Executive Officer. "We are greatly thankful to Yossi for his exceptional efforts in founding and building Protalix, and wish him great success in the future."

    Dr. Hayon brings to the Company over a decade of experience in pharmaceutical research and development, both in the scientific operations and the administrative functions. She most recently served as Vice President of Clinical Affairs of Syqe Medical Ltd., Tel-Aviv, where she, among other things, established the clinical and medical global strategy, and was responsible for providing strategic input on the regulatory development plan. Prior to her role at Syqe Medical, Dr. Hayon served as the Head of R&D Israeli Site of LogicBio Therapeutics, Inc., Cambridge, Massachusetts, where she managed LogicBio's Israeli-based Research and Development facility and was involved in strategic decision-making. From 2014 through 2016 she served as the R&D Manager, Stem Cell Medicine Ltd., Jerusalem, Israel. Dr. Hayon holds a Ph.D. in Neurobiology/Hematology, and an MS.c. in Neurobiology, both from the Hebrew University Faculty of Medicine, Jerusalem, Israel.

    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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed 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.

    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: that the FDA might not grant marketing approval for PRX–102 in the currently anticipated timeline or at all and, if approved, whether PRX–102 will be commercially successful; failure or delay in the commencement or completion of our preclinical and clinical trials; risks associated with the novel coronavirus disease (COVID–19) outbreak, which may adversely impact our business, preclinical studies and clinical trials; 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; 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.

    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    +1-646-627-8390

    Media Contact

    Brian Pinkston

    LaVoieHealthScience

    +1-857-588-3347

     

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  28. CARMIEL, Israel, June 1, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 first quarter ended March 31, 2020, and provided a business update on recent corporate and clinical developments. The Company's management will discuss the financial results and provide a clinical, corporate and financial highlights on a conference call and live webcast scheduled for Monday, June 1, 2020 at 8:30 am Eastern Daylight Time (EDT).

    Protalix_Biotherapeutics_Logo

    "The first quarter of 2020 has most certainly been transformational…

    CARMIEL, Israel, June 1, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 first quarter ended March 31, 2020, and provided a business update on recent corporate and clinical developments. The Company's management will discuss the financial results and provide a clinical, corporate and financial highlights on a conference call and live webcast scheduled for Monday, June 1, 2020 at 8:30 am Eastern Daylight Time (EDT).

    Protalix_Biotherapeutics_Logo

    "The first quarter of 2020 has most certainly been transformational for Protalix, despite the COVID-19 pandemic that affected the global markets," said Dror Bashan, Protalix's President and Chief Executive Officer. "I am proud to say that despite the pandemic, Protalix was able to keep the company running smoothly and adapt quickly to the changing environment."

    "During the quarter, we were able to close a $43.7 million private placement," he continued. "Furthermore, the topline results from the completion of our Phase III BRIDGE study and the subsequent BLA submission for PRX–102 announced in May prove that Protalix has actually gained momentum by leaning into this unprecedented challenge. I am convinced now more than ever that our team is positioned for long-term success and look forward to continuing our momentum through the rest of this year and into 2021."

    Conference Call and Webcast Information

    The Company will host a conference call on Monday, June 1, 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:  

    13704328

    Webcast: 

    https://tinyurl.com/yc32s9jn 

    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.

    First Quarter 2020 and Recent Business Highlights

    Clinical and Regulatory Advancements

    • On May 28, 2020, the Company and its development and collaboration partner, Chiesi Global Rare Diseases, a unit of Chiesi Farmaceutici S.p.A., or Chiesi, announced the submission on May 27, 2020 of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for pegunigalsidase alfa, or PRX–102, for the treatment of adult patients with Fabry disease via the FDA's Accelerated Approval pathway. PRX–102 was granted Fast Track designation by the FDA in January 2018. Upon the BLA approval, if approved, the Company will be eligible to receive a milestone payment from Chiesi.
    • On May 11, 2020, the Company announced positive topline results following the completion of its Phase III BRIDGE clinical trial of PRX–102 for the treatment of Fabry disease. The Phase III BRIDGE clinical trial, a 12-month open-label, single arm switch-over study evaluating the safety and efficacy of PRX–102, 1 mg/kg infused every two weeks, met its main objectives for safety and efficacy, and topline analysis indicated substantial improvement in renal function as measured by mean annualized estimated Glomerular Filtration Rate (eGFR slope) in patients switched from agalsidase alfa to PRX–102.
    • On February 6, 2020, Protalix and Chiesi announced the receipt of an agreement letter from the FDA for the Initial Pediatric Study Plan (iPSP) for PRX-102 for the treatment of Fabry disease, outlining an agreed-upon approach to address the needs of pediatric Fabry patients.

    Corporate & Financial Developments

    • On March 16, 2020, the Company announced that it has agreed to conduct a feasibility study with Kirin Holdings Company, Limited, or Kirin, to evaluate the production of a novel complex protein utilizing ProCellEx. The Company received a non-refundable payment of $1.0 million and Kirin will provide research funding for the Company's scientists to conduct cell line engineering and protein expression studies on the target protein.
    • On March 12, 2020, the Company entered into securities purchase agreements with certain existing and new institutional and other accredited investors in a private placement. Pursuant to such agreements, the Company issued and sold to the purchasers an aggregate of approximately 17.6 million unregistered shares of its common stock at a price per share of $2.485, or aggregate net committed proceeds equal to approximately $41.3 million. Each share of the Company's common stock issued in the transaction was accompanied by a warrant to purchase an additional share of common stock at an exercise price equal to $2.36.

    Financial Results

    For the three months ended March 31, 2020, compared to the three months ended March 31, 2019

    • The Company recorded revenues from selling goods of $5.0 million during the three months ended March 31, 2020, an increase of $1.5 million, or 43%, compared to revenues of $3.5 million for the same period of 2019. The increase resulted primarily from an increase of $0.8 million in sales of drug product to Brazil as well as an increase of $0.7 million in sales of drug substance to Pfizer Inc.
    • Revenues from license and R&D services for the three months ended March 31, 2020, were $16.6 million, an increase of $9.7 million, or 140%, compared to revenues of $6.9 million for the same period of 2019. Revenues from the license agreements represent the revenues recognized in connection with previously announced agreements with Chiesi. The increase is primarily due to revenues recognized in connection with the progress of the Company's clinical trial that have been performed, and with revenues recognized in connection with an updated costs estimation throughout the trials until completion in the amount of $6.7 million.
    • Cost of goods sold was $3.4 million for the three months ended March 31, 2020, an increase of $1.4 million, or 68%, from cost of goods sold of $2.0 million for the same period of 2019. The increase is primarily due to an increase in sales of goods.
    • Research and development expenses were $10.3 million for the three months ended March 31, 2020, a decrease of $1.4 million, or 12%, compared to $11.7 million of research and development expenses for the same period of 2019. The decrease was primarily due to a decrease in costs related to manufacturing of our drug in development.
    • Selling, general and administrative expenses were $3.2 million for the three months ended March 31, 2020, an increase of $1.0 million, or 43%, compared to $2.2 million for the same period of 2019. The increase resulted primarily from a $0.6 million increase in compensation related costs and a $0.2 million increase in professional fees.
    • Net income for the three months ended March 31, 2020 was $1.7 million, or $0.10 per share, basic and diluted, compared to a net loss of $7.3 million, or $0.50 per share, basic and diluted, for the same period of 2019.

    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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed 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.

    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: 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 and, if approved, whether PRX–102 will be commercially successful; 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; and inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; risks associated with the novel coronavirus disease (COVID–19) outbreak, which may adversely impact our business, preclinical studies and clinical trials; risks related to any transactions we may effect in the public or private equity markets to raise capital to finance future research and development activities, general and administrative expenses and working capital; 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 amount and sufficiency of our cash and cash equivalents; risks related to the ultimate purchase by Fundação Oswaldo Cruz of BioManguinhos 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 BioManguinhos alfataliglicerase generally; risks related to our commercialization efforts for BioManguinhos alfataliglicerase in Brazil; risks relating to the compliance by Fundação 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; the risk that despite the FDA's grant of fast track designation for PRX–102, 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.

     

    PROTALIX BIOTHERAPEUTICS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (U.S. dollars in thousands)

    (Unaudited)













    March 31, 2020




    December 31, 2019


    ASSETS


















    CURRENT ASSETS: 









      Cash and cash equivalents..............................................................................................


    $

    14,166



    $

    17,792


    Short-term bank deposits………………………………………………….



    22,509




    -


      Accounts receivable – Trade......................................................................................



    8,876




    4,700


      Other assets................................................................................................................



    2,728




    1,832


      Inventories.................................................................................................................



    9,488




    8,155


    Total current assets..................................................................................................


    $

    57,767



    $

    32,479











    NON-CURRENT ASSETS: 


















         Long-term bank deposits.............................................................................................


    $

    12,505




    -


         Funds in respect of employee rights upon retirement..................................................



    1,879



    $

    1,963


         Property and equipment, net........................................................................................



    5,012




    5,273


         Operating lease right of use assets..............................................................................



    5,713




    5,677


            Total non-current assets...........................................................................................


    $

    25,109



    $

    12,913


    Total assets...................................................................................................................


    $

    82,876



    $

    45,392











    LIABILITIES NET OF CAPITAL DEFICIENCY


















    CURRENT LIABILITIES: 









      Accounts payable and accruals: 









    Trade.........................................................................................................................


    $

    9,430



    $

    6,495


    Other.........................................................................................................................



    13,757




    11,905


          Operating lease liabilities



    1,126




    1,139


          Contracts liability.........................................................................................................



    19,014




    16,335


          Promissory Note..........................................................................................................



    4,301




    4,301


    Total current liabilities...............................................................................................


    $

    47,628



    $

    40,175











    LONG TERM LIABILITIES:









     Convertible notes..........................................................................................................


    $

    51,777



    $

    50,957


     Contracts liability..........................................................................................................



    7,130




    16,980


     Liability for employee rights upon retirement................................................................



    2,531




    2,565


     Operating lease liabilities...............................................................................................



    4,481




    4,528


     Other long term liabilities..............................................................................................



    210




    509


    Total long term liabilities...........................................................................................


    $

    66,129



    $

    75,539


    Total liabilities...........................................................................................................


    $

    113,757



    $

    115,714











    COMMITMENTS


















    CAPITAL DEFICIENCY..............................................................................................



    (30,881)




    (70,322)


    Total liabilities net of capital deficiency.....................................................................


    $

    82,876



    $

    45,392


     

     

    PROTALIX BIOTHERAPEUTICS, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

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

    (Unaudited)







    Three Months Ended




    March 31, 2020



    March 31, 2019


    REVENUES FROM SELLING GOODS


    $

    5,031



    $

    3,530


    REVENUES FROM LICENSE AND R&D SERVICES



    16,615




    6,909


    TOTAL REVENUE



    21,646




    10,439


    COST OF GOODS SOLD



    (3,426)




    (2,045)


    RESEARCH AND DEVELOPMENT EXPENSES, NET (1)



    (10,340)




    (11,698)


    SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (2)



    (3,187)




    (2,230)


    OPERATING INCOME (LOSS)



    4,693




    (5,534)


    FINANCIAL EXPENSES



    (3,229)




    (1,920)


    FINANCIAL INCOME



    203




    190


    FINANCIAL EXPENSES, NET



    (3,026)




    (1,730)


    NET INCOME (LOSS) FOR THE PERIOD


    $

    1,667



    $

    (7,264)


    EARNINGS (LOSS) PER SHARE OF COMMON STOCK – BASIC AND









    DILUTED


    $

    0.10




    (0.50 )


    WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK









      USED IN COMPUTING EARNINGS (LOSS) PER SHARE-









      BASIC AND DILUTED



    17,381,074




    14,838,213


    (1) Includes share-based compensation


    $

    78



    $

    178


    (2) Includes share-based compensation


    $

    353



    $

    112


     

     

    Investor Contact
    Chuck Padala, Managing Director
    LifeSci Advisors
    +1-646-627-8390

    Media Contact
    Brian Pinkston
    LaVoieHealthScience
    +1-857-588-3347

    Cision View original content:http://www.prnewswire.com/news-releases/protalix-biotherapeutics-reports-first-quarter-2020-financial-results-and-business-update-301068400.html

    SOURCE Protalix Biotherapeutics Inc.

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  29. CARMIEL, Israel, May 28, 2020 /PRNewswire/ --  Protalix BioTherapeutics, Inc. (NYSE: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, or the Company, together with its development and commercialization partner Chiesi Global Rare Diseases, a unit of Chiesi, an international research-focused healthcare group, today announced the submission on May 27, 2020 of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease via the FDA's Accelerated Approval pathway…

    CARMIEL, Israel, May 28, 2020 /PRNewswire/ --  Protalix BioTherapeutics, Inc. (NYSE: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, or the Company, together with its development and commercialization partner Chiesi Global Rare Diseases, a unit of Chiesi, an international research-focused healthcare group, today announced the submission on May 27, 2020 of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease via the FDA's Accelerated Approval pathway. Pegunigalsidase alfa, or PRX-102, was granted Fast Track designation by the FDA in January 2018. Pegunigalsidase alfa is the Company's purposefully-designed, long-acting recombinant, PEGylated, cross-linked α-galactosidase-A investigational product candidate.

    The BLA submission includes a comprehensive set of preclinical, clinical and manufacturing data compiled from the Company's completed Phase I/II clinical trial of pegunigalsidase alfa, including the related extension study succeeding the Phase I/II clinical trial, interim clinical data from the Phase III BRIDGE switch-over study and safety data from the Company's on-going clinical studies of PRX‑102. Upon the BLA approval, if approved, the Company will be eligible to receive a milestone payment from Chiesi.

    "We are grateful for the assistance the FDA provided leading up to the submission of this BLA via the Accelerated Approval pathway, and we look forward, together with Chiesi, to working with the FDA as we seek marketing approval for PRX‑102," said Dror Bashan, Protalix's President and Chief Executive Officer. "Together with Chiesi, we thank the investigators and study participants who have made reaching this milestone possible and have supported Protalix in our commitment to bringing this new treatment option to the Fabry patient community."

    "The submission of this BLA to the FDA represents a significant milestone for our Global Rare Diseases division that was established earlier this year to strengthen Chiesi's focus on making a difference for patients living with rare diseases around the world," said Giacomo Chiesi, head of Chiesi Global Rare Diseases. "Our partnership and active collaboration with Protalix are a great example showing how we can leverage Chiesi's global reach and decades of experience in drug development to support patients and their families living with Fabry disease and many other devastating rare diseases."

    About Fabry Disease

    Fabry disease is an X-linked inherited disease that results from deficient activity of the lysosomal α‑Galactosidase‑A enzyme resulting in progressive accumulation of abnormal deposits of a fatty substance called globotriaosylceramide (Gb3) in blood vessel walls throughout a person's body. Fabry disease occurs in one person per 40,000 to 60,000. Fabry patients inherit a deficiency of the α‑Galactosidase‑A enzyme, which is normally responsible for the breakdown of Gb3. The abnormal storage of Gb3 increases with time and, accordingly, Gb3 accumulates, primarily in the blood and in the blood vessel walls. The ultimate consequences of Gb3 deposition range from episodes of pain and impaired peripheral sensation to end-organ failure – particularly of the kidneys, but also of the heart and the cerebrovascular system.

    About Pegunigalsidase Alfa

    Pegunigalsidase alfa (PRX‑102) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α-Galactosidase-A enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. In clinical studies, PRX‑102 has been observed to have a circulatory half-life of approximately 80 hours. The Company designed PRX‑102 to potentially address the continued unmet clinical need in Fabry patients.

    About Chiesi Global Rare Diseases

    Chiesi Global Rare Diseases is a business unit of the Chiesi Group established in February 2020 and focused on research and development of treatments for rare and ultra-rare disorders. The Global Rare Diseases unit works in collaboration with Chiesi Group to harness the full resources and capabilities of our global network to bring innovative new treatment options to people living with rare diseases, many of whom have limited or no treatments available. The unit is also a dedicated partner with global leaders in patient advocacy, research and patient care.

    About Chiesi Group

    Based in Parma, Italy, Chiesi Farmaceutici is an international research-focused healthcare group with 85 years of experience in the pharmaceutical industry and a global presence in 29 countries. Chiesi researches, develops, and markets innovative drugs in the respiratory therapeutics, specialist medicine, and rare disease areas. Its R&D organization is headquartered in Parma (Italy), and is integrated with R&D groups in France, the USA, the UK, and Sweden to advance Chiesi's pre-clinical, clinical, and registration programs. Chiesi employs nearly 6,000 people. Chiesi Group is a certified Benefit Corporation. For more information www.chiesi.com

    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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α‑Galactosidase‑A protein for the proposed 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.

    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: that the FDA might not grant marketing approval for PRX‑102 in the currently anticipated timeline or at all and, if approved, whether PRX‑102 will be commercially successful; 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; risks associated with the novel coronavirus disease (COVID‑19) outbreak, which may adversely impact our business, preclinical studies and 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 our ability to maintain and manage our relationship with Chiesi Farmaceutici and any other collaborator, distributor or partner; risks related to the amount of our future revenues and expenditures; the risk that despite the FDA's grant of Fast Track designation for PRX-102, 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; our dependence on performance by third party providers of services and supplies, including without limitation, clinical trial services; 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 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.

    Investor Contact
    Chuck Padala, Managing Director
    LifeSci Advisors
    646-627-8390

    Media Contact
    Brian Pinkston
    LaVoieHealthScience
    857-588-3347

     

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    SOURCE Protalix BioTherapeutics, Inc.

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  30. CARMIEL, Israel, May 22, 2020 Protalix BioTherapeutics, Inc. (NYSE: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 announced that it will release its financial results for the first quarter 2020 and business update on Monday, June 1, 2020. The Company's management will host a conference call to discuss the financial results and provide a general business update at 8:30 a.m. Eastern Daylight Time (EDT).

    Conference Call Details:
    Monday, June 1, 2020, 8:30 a.m. Eastern Daylight Time (EDT)
    Domestic: 877-423-9813
    International: 201-689-8573
    Conference ID: 13704328

    Webcast Details:
    Webcast Link: https://tinyurl.com/yc32s9jn
    Conference ID: 13704328

    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.

    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 versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α‑Galactosidase‑A protein for the proposed 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.

    Investor Contact
    Chuck Padala, Managing Director
    LifeSci Advisors
    +1-646-627-8390

    Media Contact
    Brian Pinkston
    LaVoieHealthScience
    +1-857-588-3347

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/protalix-biotherapeutics-to-hold-first-quarter-2020-financial-results-and-business-update-conference-call-on-june-1-2020-301064204.html

    SOURCE Protalix BioTherapeutics, Inc.

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  31. CARMIEL, Israel, May 11, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced positive topline results from its Phase III BRIDGE clinical trial of pegunigalsidase alfa, or PRX-102. Pegunigalsidase alfa is the Company's plant cell-expressed recombinant, PEGylated, cross-linked α-galactosidase-A product candidate under development for the treatment of Fabry disease.

    The BRIDGE study was a Phase III 12 month open-label, single arm switch-over study evaluating the safety and efficacy of pegunigalsidase alfa, 1 mg/kg infused every two weeks, in up to 22 Fabry patients previously treated with agalsidase alfa, marketed by Takeda Pharmaceutical Company Limited (Shire Plc) as Replagal®, for at least two years and on a stable dose for at least six months.

    Topline results of the data generated in the study showed substantial improvement in renal function as measured by mean annualized estimated Glomerular Filtration Rate (eGFR slope) in both male and female patients who were switched from agalsidase alfa to PRX-102. Consistent with previously announced interim data, PRX-102 was found to be well tolerated, with all adverse events being transient in nature without sequelae. Twenty-two patients were enrolled in the study; two of those patients withdrew early from the study due to hypersensitivity reaction, and 20 of the patients successfully completed the 12-month treatment duration. Eighteen of the patients who completed the study opted to roll over to a long-term extension study and continue to be treated with PRX-102.

    In the study, the mean annualized eGFR slope of the study participants improved from ‑5.90 mL/min/1.73m2/year while on agalsidase alfa to -1.19 mL/min/1.73m2/year on PRX-102 in all patients. Male patients improved from -6.36 mL/min/1.73m2/year to ‑1.73 mL/min/1.73m2/year and female patients improved from ‑5.03 mL/min/1.73m2/year to ‑0.21 mL/min/1.73m2/year.

    Baseline characteristics of the patients, ranging from ages 24 to 60 years, were as follows: mean eGFR 75.87 mL/min/1.73m2 in males and 86.14 mL/min/1.73m2 in females and plasma lyso-Gb3 mean levels were 51.81 nM and 13.81 nM in males and females, respectively. While lyso-Gb3 levels remain slightly high, particularly within the male cohort, continuous reduction in lyso-Gb3 levels was observed of 19.55nM (32.35%) in males and 4.57nM (29.81%) in females.

    "The final analysis of the BRIDGE Study in Fabry patients previously treated with agalsidase alfa demonstrate a positive potential benefit of pegunigalsidase alfa on renal function," said Dr. Ales Linhart of Charles University in Prague, Czech Republic, a principal investigator in the BRIDGE study.

    "The completion of our Phase III BRIDGE study and its subsequent analysis mark a significant milestone towards our goal to establish PRX-102 as a new treatment option for Fabry disease," said Dror Bashan, Protalix's President and Chief Executive Officer. "We are encouraged that the BRIDGE study successfully met its main objectives for safety and efficacy, and we are further motivated to continue our work in progressing pegunigalsidase alfa."

    "Our BRIDGE study, together with our other two ongoing fully enrolled Phase III clinical trials, the BALANCE study and the BRIGHT study, represents what we believe to be the most comprehensive and robust Phase III clinical program for Fabry disease currently in progress," continued Mr. Bashan. "As the first of our three studies to complete Phase III, we believe the BRIDGE study findings support that PRX-102 has the potential to be an important enzyme replacement therapy for the treatment of Fabry disease."

    The ongoing BALANCE study is a fully enrolled, randomized, double blind, head-to-head, active control study which aims to demonstrate PRX‑102's superiority in renal function as measured by the comparison of the mean annualized change (slope) in estimated glomerular filtration rate (eGFRCKD-EPI) between treatment groups over 24 months of treatment as compared to agalsidase beta, marketed by Sanofi Genzyme as Fabrazyme®. The BRIGHT study is a fully enrolled open-label, switch-over study designed to evaluate the safety, efficacy and pharmacokinetics of PRX‑102, 2 mg/kg dosed once every 4 weeks, and to assess whether patients maintain clinical stability as measured by certain Fabry disease parameters after being switched to this regimen from an enzyme replacement therapy (ERT), agalsidase alfa or agalsidase beta, dosed every two weeks.

    "We previously announced positive interim results from 16 Fabry patients after six and twelve months in the BRIDGE study. These final results not only indicate that our findings are durable and consistent with previous analyses, but also demonstrate the important potential benefit of pegunigalsidase alfa on renal function for Fabry patients," said Einat Brill Almon, Ph.D., Protalix's Senior Vice President, Product Development. "We look forward to the continued findings from our other ongoing Phase III studies of PRX‑102, with the final results from the BRIGHT study expected in the fourth quarter of 2020, and interim results from the BALANCE study expected in the first half of 2021."

    As previously announced, the Company and its collaboration partner for PRX‑102, Chiesi Farmaceutici S.p.A., or Chiesi, plan the submission of a BLA for PRX-102 via the FDA's Accelerated Approval pathway in the second quarter of 2020. The Company and Chiesi have experienced minor delays in completing the submission due to the novel coronavirus disease (COVID-19) outbreak and other reasons, and the Company anticipates providing further updates regarding the planned submission by the end of the current month.

    Additional Details about the BRIDGE Study

    Patients in the BRIDGE study were screened and evaluated over three months while continuing agalsidase alfa treatment. Following the screening period, each patient was enrolled and switched from agalsidase alfa treatment to receive intravenous infusions of PRX-102, 1 mg/kg every two weeks, for 12 months. Patients had the option to receive PRX-102 infusions in a home care setting based on infusion tolerability and country regulation.

    About Fabry Disease

    Fabry disease is an X-linked inherited disease that results from deficient activity of the lysosomal α‑Galactosidase‑A enzyme resulting in progressive accumulation of abnormal deposits of a fatty substance called globotriaosylceramide (Gb3) in blood vessel walls throughout a person's body. Fabry disease occurs in one person per 40,000 to 60,000. Fabry patients inherit a deficiency of the α‑Galactosidase‑A enzyme, which is normally responsible for the breakdown of Gb3. The abnormal storage of Gb3 increases with time and, accordingly, Gb3 accumulates, primarily in the blood and in the blood vessel walls. The ultimate consequences of Gb3 deposition range from episodes of pain and impaired peripheral sensation to end-organ failure – particularly of the kidneys, but also of the heart and the cerebrovascular system.

    About Pegunigalsidase Alfa

    Pegunigalsidase alfa (PRX‑102) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α-Galactosidase-A enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. In clinical studies, PRX‑102 has been observed to have a circulatory half-life of approximately 80 hours. The Company designed PRX‑102 to potentially address the continued unmet clinical need in Fabry patients.

    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 α‑Galactosidase‑A protein for the proposed 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.

    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: 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; risks associated with the novel coronavirus disease (COVID-19) outbreak, which may adversely impact our business, preclinical studies and 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 our ability to maintain and manage our relationship with Chiesi Farmaceutici and any other collaborator, distributor or partner; risks related to the amount of our future revenues and expenditures; the risk that despite the FDA's grant of fast track designation for PRX-102, 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; 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 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.

    Investor Contact
    Chuck Padala, Managing Director
    LifeSci Advisors
    646-627-8390  

    Media Contact
    Brian Pinkston
    LaVoieHealthScience
    857-588-3347

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  32. CARMIEL, Israel, March 18, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced that it has completed a $43.7 million private placement of common stock and warrants. In connection with the offering, the Company issued 17,604,423 unregistered shares of the Company's common stock at a purchase price per share of $2.485 and warrants to purchase an additional 17,604,423 shares of common stock at an exercise price of $2.36 per share. Net proceeds to the Company from the private placement are expected to…

    CARMIEL, Israel, March 18, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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 announced that it has completed a $43.7 million private placement of common stock and warrants. In connection with the offering, the Company issued 17,604,423 unregistered shares of the Company's common stock at a purchase price per share of $2.485 and warrants to purchase an additional 17,604,423 shares of common stock at an exercise price of $2.36 per share. Net proceeds to the Company from the private placement are expected to be approximately $41 million, after deducting advisory fees and other estimated offering expenses. Rosario Capital and Houlihan Lokey Capital Inc. served as financial advisors in the private placement.

    Protalix Biotherapeutics Logo

    The Company intends to use the net proceeds from the financing to advance the Company's clinical programs of PRX-102, the Company's product candidate under development for the treatment of Fabry disease, as well as to further develop its early stage pipeline of therapeutics, and for general corporate purposes.

    "We appreciate the confidence expressed by our new and existing stockholders in Protalix's commitment to bring important treatment options to the Fabry patient community," said Dror Bashan, Protalix's President and Chief Executive Officer. "This funding gives us the runway and ability to complete our pivotal Phase III BALANCE clinical trial of PRX-102, as well as pursue strategic opportunities to bring additional value to the Company and its stockholders."

    Neither the shares of the Company's common stock nor the warrants sold in the private placement have been registered under the U.S. Securities Act of 1933 (the "Securities Act") or applicable state securities laws, and accordingly may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company agreed to file a registration statement with the U.S. Securities and Exchange Commission registering the resale of the shares of common stock issued in the private placement, including the shares of common stock issuable upon exercise of the warrants.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

    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 α-Galactosidase-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.

    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: 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; 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 Fundação Oswaldo Cruz of alfataliglicerase pursuant to the stated purchase intentions of the Brazilian Ministry of Health of the stated amounts, if at all; 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.

    Logo - https://mma.prnewswire.com/media/999479/Protalix_Biotherapeutics_Logo.jpg

    Investor Contact
    Chuck Padala, Managing Director
    LifeSci Advisors
    +1-646-627-8390

    Media Contact
    Brian Pinkston
    LaVoieHealthScience
    +1-857-588-3347

     

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  33. CARMIEL, Israel, March 16, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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, announced today that it has agreed to conduct a feasibility study with Kirin Holdings Company, Limited (Kirin) to evaluate the production of a novel complex protein utilizing ProCellEx®. Kirin will provide research funding for Protalix scientists to conduct cell line engineering and protein expression studies on the target protein.

    Upon successful completion of the study, Kirin and Protalix anticipate holding discussions regarding the licensing of the ProCellEx technology and expression cells to Kirin for the continued development of the product.

    "We are pleased to announce this project with Kirin, which marks the start of a positive new relationship between our two companies," said Dror Bashan, President and Chief Executive Officer of Protalix. "This new study provides Protalix with another great opportunity to apply our scientific expertise and our proprietary ProCellEx protein expression technology in the study and production of a new and novel complex protein. We look forward to working with the scientists at Kirin on this exciting new project."

    "The ProCellEx platform is of significant strategic interest for Kirin, and our advanced expertise in plant cell culture technology aligns well with their overall corporate vision," continued Mr. Bashan. "We look forward to the success of this feasibility study, and to the possibility of further collaboration with Kirin in their pursuit of creating a more prosperous world for future generations."

    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 α‑Galactosidase‑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.

    About Kirin Holdings Company, Ltd.

    Aiming to become a global leader in creating shared value (CSV), the Kirin Group is striving to create value in business domain spanning from food & beverages to pharmaceuticals under its long-term management vision, Kirin Group Vision 2027. Kirin brings joy to society by crafting food and healthcare products inspired by the blessings of nature and the insights of our customers.

    For more information, visit the Kirin website at https://www.kirinholdings.co.jp/english/

    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: failure or delay in the commencement or completion of our preclinical and clinical trials which may be caused by several factors, including: risk that the feasibility study will not produce the anticipated results; risks related to the progress of our research and development efforts; risks related to our ability to maintain and manage our relationship with any collaborator or partner; risks related to the amount of our future revenues and expenditures; our dependence on performance by third party providers of services and supplies; 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.

    Investor Contact
    Chuck Padala, Managing Director
    LifeSci Advisors
    +1-646-627-8390

    Media Contact
    Brian Pinkston
    LaVoieHealthScience
    +1-857-588-3347

     

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  34. CARMIEL, Israel, March 12, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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.

    Protalix_Biotherapeutics_Logo

    "2019 was a pivotal year for Protalix, as we successfully expanded on our strong foundation and…

    CARMIEL, Israel, March 12, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: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.

    Protalix_Biotherapeutics_Logo

    "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

    • The Company and its collaboration partner, Chiesi Farmaceutici S.p.A., or Chiesi, plan the submission of a BLA for PRX-102 via the FDA's Accelerated Approval pathway in the second quarter of 2020, based on data from the completed Phase I/II clinical trial of PRX-102 for the treatment of Fabry disease and the ongoing Phase III BRIDGE clinical trial.
      Results from the Company's Phase I/II clinical trial of PRX-102 were published in an article in the May 2019 edition of the Journal of Inherited Metabolic Disease.
    • The Company announced positive 12-month interim on-treatment data from the BRIDGE study. The interim data demonstrate a mean improvement in kidney function in both male and female patients when switched from agalsidase alfa (Replagal®) to PRX-102. The data will be included in the anticipated BLA filing to help to support the application.
    • The Company and Chiesi announced the completion of enrollment in the Phase III BALANCE clinical trial. The head-to-head BALANCE study is designed to evaluate the safety and efficacy of PRX-102 compared to agalsidase beta (Fabrazyme®) on renal function in Fabry patients with progressing kidney disease previously treated with agalsidase beta. To date, more than 66 patients are being treated in the Company's various extension studies after opting to continue treatment with PRX-102 after completion of an initial study.
    • Enrollment was completed in the Phase III BRIGHT clinical trial of PRX- 102, via intravenous infusions of 2 mg/kg administered every 4 weeks. Preliminary pharmacokinetic (PK) data showed PRX-102 to be well-tolerated; and infusion of 2 mg/kg PRX-102 administered every 4 weeks resulted in the presence of continuous active enzyme throughout the entire infusion interval. Infusions every 2 weeks is the current standard of care for the treatment of Fabry disease.

    Corporate & Financial Developments

    • The Company yesterday successfully secured securities purchase agreements to raise proceeds equal to $43.7 million through a private financing with a number of leading Israeli and U.S.- based investors, including Psagot Investment House, More Investment House, Highbridge Capital, UBS O'Connor, Rosalind Capital, and Alrov Properties and Lodging, among others. Rosario Capital and Houlihan Lokey served as financial advisors in the private placement.
    • In December 2019, the Company held a special meeting of stockholders to propose the following two critical financial amendments, which stockholders ultimately approved:
      • A reverse stock split (1-for-10); and
      • A reduction in the total number of shares of the Company's common stock that the Company is authorized to issue from 350 million to 120 million shares.
    • In December 2019, the Company enhanced its Board of Directors with addition of two accomplished biopharmaceutical executives, Pol F. Boudes, M.D., and Gwen A. Melincoff.
    • In August 2019, the Company's Board of Directors unanimously elected Zeev Bronfeld, an independent director, as Chairman of the Board.
    • In July 2019, the Company appointed Eyal Rubin as Senior Vice President and Chief Financial Officer.
    • In May 2019, the Company appointed Dror Bashan as President and Chief Executive Officer.

    Regulatory Advancements

    • In February 2020, Protalix and Chiesi announced the receipt of an agreement letter from the FDA for the Initial Pediatric Study Plan (iPSP) for PRX-102 for the treatment of Fabry disease, outlining an agreed-upon approach to address the needs of pediatric Fabry patients.

    Financial Results

    For the year ended December 31, 2019, compared to the year ended December 31, 2018

    • The Company recorded revenues from selling goods of $15.9 million for the year ended December 31, 2019, an increase of $6.9 million, or 77%, compared to revenues of $9.0 million for the same period of 2018. The increase is primarily due to higher sales of Elelyso® in Brazil as well as an increase in sales of drug substance to Pfizer.
    • Research and development expenses, net, were $44.6 million for the year ended December 31, 2019, an increase of $11.3 million, or 34%, compared to $33.3 million for the same period of 2018. The increase resulted primarily from an increase of $9.1 million in clinical trial related costs as well as a decrease of $2.1 million in grants received from the Israeli Innovation Authority.
    • Selling, general and administrative expenses were $9.9 million for the year ended December 31, 2019, a decrease of $1.0 million, or 9%, compared to $10.9 million for the same period of 2018. The decrease resulted primarily from costs related to the Company's U.S. Exclusive License and Supply Agreement that the Company entered into in 2018, which were not incurred in 2019.
    • Net loss was $18.3 million for the year ended December 31, 2019, or $1.23 per share, basic and diluted, compared to a net loss of $26.5 million, or $1.80 per share, basic and diluted, for the same period of 2018.
    • At December 31, 2019, the Company had $17.8 million in cash and cash equivalents.

    For the three months ended December 31, 2019, compared to the three months ended December 31, 2018

    • The Company recorded revenues from selling goods of $3.8 million during the three-month period ended December 31, 2019, an increase of $2.0 million, or 111%, compared to revenues of $1.8 million for the same period of 2018. The increase is primarily due to higher sales of drug substance to Pfizer Inc. as well as higher sales of Elelyso® in Brazil.
    • Research and development expenses, net, were $9.6 million for the three-month period ended each of December 31, 2019 and December 31, 2018.
    • Selling, general and administrative expenses were $3.0 million for the three-month period ended December 31, 2019, an increase of $0.8 million, or 36%, compared to $2.2 million for the same period in 2018. The increase is primarily due to costs related to the efforts to evaluate and pursue strategic alternatives, business development advisory fees, and legal fees and costs related to replacement of the Chief Executive Officer.
    • Net profit for the three months ended December 31, 2019 was $0.3 million, or $0.02 per share, basic and diluted, compared to a net loss of $5.4 million, or $0.4 per share, basic and diluted, for 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 α-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 alfa.

    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 Fundação 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.



    PROTALIX BIOTHERAPEUTICS, INC.
    CONSOLIDATED BALANCE SHEETS
    (U.S. dollars in thousands)





    December 31,




    2018



    2019


    ASSETS


















    CURRENT ASSETS:           









    Cash and cash equivalents  


    $

    37,808



    $

    17,792


    Accounts receivable – Trade               



    4,729




    4,700


    Other assets             



    1,877




    1,832


    Inventories              



    8,569




    8,155


    Total current assets


    $

    52,983



    $

    32,479











    NON-CURRENT ASSETS:


















    Funds in respect of employee rights upon retirement  


    $

    1,758



    $

    1,963


    Property and equipment, net            



    6,390




    5,273


    Operating lease right of use assets   



    -




    5,677


    Total assets             


    $

    61,131



    $

    45,392











    LIABILITIES NET OF CAPITAL DEFICIENCY   


















    CURRENT LIABILITIES:                









    Accounts payable and accruals:        









    Trade        


    $

    5,211



    $

    6,495


    Other        



    10,274




    11,905


     Operating lease liabilities



    -




    1,139


     Contracts liability              



    9,868




    16,335


     Promissory note         



    -




    4,301


    Total current liabilities          


    $

    25,353



    $

    40,175