PLX Protalix BioTherapeutics Inc. (DE)

1.52
-0.06  -4%
Previous Close 1.58
Open 1.55
52 Week Low 1.4601
52 Week High 7.02
Market Cap $69,246,103
Shares 45,556,647
Float 39,987,633
Enterprise Value $59,437,536
Volume 407,671
Av. Daily Volume 1,927,147
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Upcoming Catalysts

Drug Stage Catalyst Date
Pegunigalsidase alfa (PRX-102) - BALANCE
Fabry disease
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Pegunigalsidase alfa (PRX-102)
Fabry disease
CRL
CRL
CRL announced April 28, 2021.
Pegunigalsidase alfa (PRX-102) - BRIGHT
Fabry disease
Phase 3
Phase 3
Phase 3 top-line data released February 23, 2021. Safety, efficacy and pharmacokinetics goals met.
Pegunigalsidase alfa
Fabry disease
Phase 3
Phase 3
Phase 3 final data presented February 10, 2021 - key objectives for safety and efficacy.
Taliglucerase alfa
Gaucher disease
Approved
Approved
Approved May 1, 2012.

Latest News

  1. CARMIEL, Israel, Aug. 2, 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 a Type A Meeting request has been submitted to the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) dated April 27, 2021 regarding the Biologics License Application (BLA) for pegunigalsidase alfa (PRX-102) for the proposed treatment of adult patients with Fabry disease. The Type A Meeting is expected to occur within 30 days of the FDA's receipt of the meeting request.

    Protalix BioTherapeutics Logo

    About Protalix

    CARMIEL, Israel, Aug. 2, 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 a Type A Meeting request has been submitted to the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) dated April 27, 2021 regarding the Biologics License Application (BLA) for pegunigalsidase alfa (PRX-102) for the proposed treatment of adult patients with Fabry disease. The Type A Meeting is expected to occur within 30 days of the FDA's receipt of the meeting request.

    Protalix BioTherapeutics Logo

    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 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 stabilized version of the recombinant human a-Galactosidase–A protein for the treatment of Fabry disease; 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 refractory gout; PRX–119, a plant cell-expressed long action DNase I for the treatment of NETs-related diseases; 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 Disclaimer

    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: the risks that the FDA may not grant the Type A Meeting on a timely manner; risks related to the timing and progress of the preparation of an updated BLA addressing the complete response letter; risks related to the timing, progress and likelihood of final approval by the FDA of a resubmitted BLA for PRX-102 and, if approved, whether the use of PRX 102 will be commercially successful; failure or delay in the commencement or completion of our preclinical studies 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 or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; and inability to monitor patients adequately during or after treatment; delays in the approval or potential rejection of any applications we file with the FDA, European Medicines Agency or other health regulatory authorities, and other risks relating to the review process; risks associated with the novel coronavirus disease, or 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 the applicable claims of safety or efficacy, or 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; 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 Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    +1-646-627-8390

    Cision View original content:https://www.prnewswire.com/news-releases/protalix-biotherapeutics-announces-submission-of-type-a-meeting-request-to-the-fda-301345922.html

    SOURCE Protalix BioTherapeutics, Inc.

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  2. CARMIEL, Israel, June 28, 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 Dror Bashan, the Company's President and Chief Executive Officer along with Eyal Rubin, the Company's Chief Financial Officer, will participate in a fireside chat discussion hosted by Zacks Investment Research's John Vandermosten.

    Protalix Biotherapeutics Logo

    The event will be held virtually on the Zoom platform, and management invites investors to participate via the webcast and conference details below:

    Webcast Details:

    CARMIEL, Israel, June 28, 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 Dror Bashan, the Company's President and Chief Executive Officer along with Eyal Rubin, the Company's Chief Financial Officer, will participate in a fireside chat discussion hosted by Zacks Investment Research's John Vandermosten.

    Protalix Biotherapeutics Logo

    The event will be held virtually on the Zoom platform, and management invites investors to participate via the webcast and conference details below:

    Webcast Details:

    Wednesday, June 30, 2021, 9:00 a.m. Eastern Daylight Time (EDT)

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

    Webcast Link: https://bit.ly/2T5C6sp

    Conference ID:  861 1349 0096

    Conference Call Details:

    New York:  +1 646 558 8656

    Israel:  +972 55 330 1762 or +972 3 978 6688

    Conference ID:  861 1349 0096

    Local dial-in numbers for other locations: https://us02web.zoom.us/u/kdf9JTByF4

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

    A replay will be available 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 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 stabilized version of the recombinant human a-Galactosidase–A protein for the treatment of Fabry disease; 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 refractory gout; PRX–119, a plant cell-expressed long action DNase I for the treatment of NETs-related diseases; 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.

    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    646-627-8390

     

    Cision View original content:https://www.prnewswire.com/news-releases/protalix-biotherapeutics-to-participate-in-a-fireside-chat-on-june-30-2021-301320837.html

    SOURCE Protalix Biotherapeutics Inc.

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  3. CARMIEL, Israel and BOSTON, June 2, 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 healthare Group (Chiesi Group), today provided an update regarding the clinical development of pegunigalsidase alfa (PRX–102) for the proposed treatment of Fabry disease.

    Protalix Biotherapeutics Logo

    Conference Call

    Protalix will host a conference call today, June 2, 2021, at 8:30 am Eastern Daylight Time, to review regulatory matters related to…

    CARMIEL, Israel and BOSTON, June 2, 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 healthare Group (Chiesi Group), today provided an update regarding the clinical development of pegunigalsidase alfa (PRX–102) for the proposed treatment of Fabry disease.

    Protalix Biotherapeutics Logo

    Conference Call

    Protalix will host a conference call today, June 2, 2021, at 8:30 am Eastern Daylight Time, to review regulatory matters related to the development of PRX-102. To participate in the conference call, please dial the following numbers prior to the start of the call:

    Conference Call Details:

    Wednesday, June 2, 2021, 8:30 am Eastern Daylight Time (EDT)

    Domestic: 1-877-423-9813

    International: 1-201-689-8573

    Conference ID: 13720271

    The conference call will also be webcast live from the Protalix website and will be available via the following links:

    Webcast Details:

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

    Webcast Link:  https://tinyurl.com/42857k4w 

    Conference ID: 13720271

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

    PRX-102 Development Program Update

    PRX–102 is currently being studied in the pivotal Phase III BALANCE clinical trial and in two ongoing long-term extension studies, all of which are part of the overall clinical development of PRX–102 for the proposed treatment of Fabry disease. The BALANCE study is a 24–month, randomized, double-blind, active control study of PRX–102 in Fabry patients with impaired renal function and is designed to evaluate the safety and efficacy of 1 mg/kg of PRX–102 dosed every two weeks compared to agalsidase beta (Fabrazyme®). The study enrolled 78 patients who were randomized on a 2:1 scheme. The BALANCE study is ongoing and assignment to treatment arm remains blinded.

    The primary endpoint of the interim analysis is the comparison of mean annualized changes (slope) of the eGFR (CKD-EPI) after completion of at least 12 months of treatment between the two treatment arms. The interim efficacy analysis was conducted on two pre-defined analysis sets: Intention to Treat (ITT), consisting of all randomized patients who received at least one dose (77 patients), considered as the primary analysis for this interim review; and the Per Protocol (PP), consisting of all patients who completed at least 12 months of treatment with no major protocol violations (74 patients). The patient population (ITT analysis set) of the study is comprised of 47 males (61%) and 30 females (39%) with a mean age of 44.3 years.

    The initial top-line results show that the lower boundary of the confidence interval for the mean difference between the two treatments was below the non-inferiority margin pre-specified for this interim analysis in the ITT analysis set and above such limit in the PP analysis set. At the time of this analysis, two patients discontinued participation due to treatment emergent adverse events (TEAEs). Of these two patients, one discontinued participation due to a related adverse event. No deaths were registered. Overall, safety data appears favorable and consistent with what was observed in previous clinical studies with PRX-102. Unblinded final data is anticipated to be released in the second quarter of 2022 after all remaining patients have completed the 24-month treatment period.

    Based on the interim analysis of the 12-month data generated from the BALANCE study, and in combination with previously reported positive data from the Phase III BRIGHT and BRIDGE clinical trials of PRX–102, Protalix and Chiesi intend to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the review of PRX–102 for the proposed treatment of Fabry disease.

    "We look forward to submission of the MAA to EMA for the European Union and to continuing to work with the FDA toward approval in the United States," said Dror Bashan, Protalix's President and Chief Executive Officer. "These regulatory milestones are currently our primary focus."

    "The BALANCE study continues as planned through its 24-month treatment duration to support its final analysis. Based on the entire clinical development program, which includes the BRIGHT and BRIDGE studies, we believe that PRX–102 has the potential to become an important treatment option for both male and female Fabry patients. The BRIGHT and BRIDGE studies have been completed and the studies met the defined endpoints," continued Mr. Bashan.

    In addition to the BALANCE study, the PRX-102 clinical program currently includes extension studies for patients who completed the BRIDGE, BRIGHT and BALANCE studies, as well as a Phase I/II clinical trial of PRX–102. Currently, more than 100 patients who participated in such studies continue to be treated in the extension studies, and additional patients completing the BALANCE study are expected to join the extension studies.

    "We thank the patients and clinicians participating in our completed and ongoing clinical studies evaluating PRX-102. As we plan for MAA submission in the EU, we remain committed to advancing our development program for PRX-102 in the United States while also making access to therapy available to eligible patients through our U.S. expanded access program," said Giacomo Chiesi, head of Chiesi Global Rare Diseases.

    Regarding the regulatory process in the United States, Protalix and Chiesi plan to submit a Type–A meeting request with the FDA to discuss the path for approval of PRX–102.

    About Pegunigalsidase Alfa (PRX–102)

    Pegunigalsidase alfa (PRX–102) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant a-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. Protalix 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 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 stabilized version of the recombinant human a-Galactosidase–A protein for the treatment of Fabry disease; 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 refractory gout; PRX–119, a plant cell-expressed long action DNase I for the treatment of NETs-related diseases; 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.

    Protalix BioTherapeutics Forward-Looking Statements Disclaimer

    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: risks related to the timing and progress of the preparation of an updated BLA addressing the complete response letter; risks related to the timing, progress and likelihood of final approval by the FDA of a resubmitted BLA for PRX–102 and, if approved, whether the use of PRX–102 will be commercially successful; failure or delay in the commencement or completion of our preclinical studies 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 or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; and inability to monitor patients adequately during or after treatment; delays in the approval or potential rejection of any applications we file with the FDA, EMA or other health regulatory authorities, and other risks relating to the review process; risks associated with the novel coronavirus disease, or 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 the applicable claims of safety or efficacy, or 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; 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 Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    +1-646-627-8390

    Chiesi Global Rare Diseases Media Contact

    Jenna Urban

    Berry & Company Public Relations

    +1-212-253-8881

     

    Chiese Logo

     

    Cision View original content:http://www.prnewswire.com/news-releases/protalix-biotherapeutics-and-chiesi-global-rare-diseases-provide-update-regarding-clinical-development-of-prx-102-for-treatment-of-fabry-disease-301303773.html

    SOURCE Protalix BioTherapeutics, Inc. and Chiesi

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  4. CARMIEL, Israel, May 14, 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 reported financial results for the first quarter ended March 31, 2021 and provided a business update.

    Protalix Biotherapeutics Logo

    "While the receipt of the Complete Response Letter last month from the FDA was disappointing, we are encouraged that the FDA did not report any potential safety or efficacy concerns for PRX-102," said Dror Bashan, Protalix's President and Chief Executive Officer. "We are working closely with the FDA and anticipate the required inspection…

    CARMIEL, Israel, May 14, 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 reported financial results for the first quarter ended March 31, 2021 and provided a business update.

    Protalix Biotherapeutics Logo

    "While the receipt of the Complete Response Letter last month from the FDA was disappointing, we are encouraged that the FDA did not report any potential safety or efficacy concerns for PRX-102," said Dror Bashan, Protalix's President and Chief Executive Officer. "We are working closely with the FDA and anticipate the required inspection and subsequent assessment will be completed once the FDA's travel restrictions are lifted. We continue to advance our earlier stage pipeline and anticipate continued progress throughout 2021. We are grateful for the support of our clinicians, patients, shareholders, Board members, employees and external partners and look forward to building stockholder value," concluded Mr. Bashan.

    2021 First Quarter and Recent Business Update

    Regulatory Updates

    • On April 28, 2021, the Company, together with its development and commercialization partner, Chiesi Farmaceutici S.p.A., or Chiesi, announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa, or PRX–102, for the proposed treatment of adult patients with Fabry disease. The CRL did not report any concerns relating to the potential safety or efficacy of PRX-102 in the submitted data package. In the CRL the FDA noted an inspection of the Company's manufacturing facility in Carmiel, Israel, including the FDA's subsequent assessment of any related findings is required before the FDA can approve the BLA. Due to travel restrictions relating to the COVID-19 pandemic, the FDA was unable to conduct the required inspection during the review cycle. The FDA explained that it will continue to monitor the public health situation as well as travel restrictions, and is actively working to schedule outstanding inspections.

    Clinical Advancements

    • On February 23, 2021, the Company, together with Chiesi, announced positive topline results from the phase III BRIGHT clinical trial, a 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®). 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.

    Corporate & Financial Developments

    • Given the receipt of the CRL, the Company believes that it is prudent to secure short-term funds in order to continue development of PRX-102 while waiting for the FDA's required inspection and subsequent assessment described in the CRL. To do so, on May 13, 2021, the Company and Chiesi entered into a binding term sheet pursuant to which they amended the two exclusive license and supply agreements for PRX–102 in order to provide the Company with near-term capital. Chiesi agreed to make a $10.0 million milestone payment to the Company before the end of  the second quarter in exchange for a $25.0 million reduction in a longer-term regulatory milestone payment in the Ex-US Exclusive License and Supply Agreement. All other regulatory and commercial milestone payments remain unchanged. The Company and Chiesi also agreed to negotiate certain manufacturing related matters.
    • On February 18, 2021, the Company announced the closing of a public offering of common stock raising gross proceeds of approximately $40.2 million before deducting the underwriting discount and estimated expenses of the offering.
    • On February 10, 2021, the Company entered into an exclusive partnership with SarcoMed USA Inc. for the worldwide development and commercialization of 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.

    Financial Results

    For the three months ended March 31, 2021, compared to the three months ended March 31, 2020

    • The Company recorded revenues from selling goods of $4.5 million during the three months ended March 31, 2021, a decrease of $0.5 million, or 10%, compared to revenues of $5.0 million for the same period of 2020. The decrease of $3.0 million in sales to Brazil was partially offset by an increase of $2.5 million in sales to Pfizer Inc. or Pfizer.
    • Revenue from licenses and R&D services was $6.8 million for the three months ended March 31, 2021, a decrease of $9.8 million, or 59%, compared to revenues from license and R&D services of $16.6 million for the same period in 2020. Revenues from license and R&D services are comprised primarily of revenues we recognized in connection with the license and supply agreements with Chiesi. The decrease resulted primarily from revenues for the three months ended March 31, 2020 recognized in connection with an updated costs estimation throughout the trials until completion, made in 2020, in the amount of $6.7 million and from revenues recognized in connection with the progress of our clinical trials that have been completed during 2020.
    • Cost of goods sold was $4.8 million for the three months ended March 31, 2021, an increase of $1.4 million, or 41%, from cost of goods sold of $3.4 million for the same period in 2020. The increase in cost of goods sold was primarily the result of higher manufacturing costs.
    • Research and development expenses were $7.1 million for the three months ended March 31, 2021, a decrease of $3.2 million, or 31%, compared to $10.3 million of research and development expenses for the same period of 2020. 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. The Company expects research and development expenses to continue to be its primary expense as it enters into a more advanced stage of preclinical and clinical trials for certain of its product candidates.
    • Selling, general and administrative expenses were $3.1 million for the three months ended March 31, 2021, a decrease of $0.1 million, or 3%, compared to $3.2 million for the same period of 2020.
    • Financial expenses, net were $1.8 million for the three months ended March 31, 2021, a decrease of $1.2 million, or 40%, compared to financial expenses net of $3.0 million for the same period of 2020. The decrease resulted primarily from a decrease in expenses related to the Company's outstanding convertible notes equal to $1.3 million.
    • Cash, cash equivalents and short-term bank deposits were approximately $70.4 million on March 31, 2021. During the first quarter of 2021, the Company raised gross proceeds of $8.8 million from the sale of common stock under its ATM program and gross proceeds of $40.2 million via the public offering of its common stock.
    • Net loss for the three months ended March 31, 2021 was approximately $5.5 million, or $0.14 per share, basic and diluted, compared to a net income of $1.7 million, or $0.10 per share, basic and diluted, for the same period in 2020.

    Conference Call and Webcast Information

    The Company will host a conference call today, May 14, 2021 at 8:30 am Eastern Daylight Time, to review the clinical, corporate, and financial highlights, which will also be available by webcast. To participate in the conference call, please dial the following numbers prior to the start of the call:

    Conference Call Details:

    Friday, May 14, 2021, 8:30 a.m. Eastern Daylight Time (EDT)

    Domestic:  877-423-9813

    International:  201-689-8573

    Conference ID:  13719725

    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/bnd6y9ch 

    Conference ID:  13719725

    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 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 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 stabilized version of the recombinant human α–Galactosidase–A protein for the treatment of Fabry disease; 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 refractory gout; PRX–119, a plant cell-expressed long action DNase I for the treatment of NETs-related diseases; 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. 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 and progress of the preparation of an updated BLA addressing the complete response letter; risks related to the timing, progress and likelihood of final approval by the FDA of a resubmitted BLA for PRX–102 and, if approved, whether the use of PRX-102 will be commercially successful; the risk that the FDA, the European Medicines Agency, or EMA, or other foreign regulatory authorities may not accept or approve a marketing application the Company files for any of its product candidates; failure or delay in the commencement or completion of our preclinical studies 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 or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; and inability to monitor patients adequately during or after treatment; risks relating to the Company's ability to make required payments under its outstanding convertible notes or any other indebtedness as they come due and the Company's ability to obtain additional financing and raise capital as necessary should the regulatory approval process become more extended; risks associated with the novel coronavirus disease, or 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; risk of significant lawsuits, including stockholder litigation, which is common in the life sciences sector; the risk that the results of the clinical trials of our product candidates will not support the applicable claims of safety or efficacy, or 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; 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, EMA 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

    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)























    March 31, 2021



    December 31, 2020



















    ASSETS































    CURRENT ASSETS:















    Cash and cash equivalents



    $

    19,830



    $

    18,265



    Short-term bank deposits





    50,600





    20,280



    Accounts receivable – Trade





    4,599





    2,000



    Other assets





    1,754





    2,096



    Inventories





    13,915





    13,082



    Total current assets



    $

    90,698



    $

    55,723



















    NON-CURRENT ASSETS:















    Funds in respect of employee rights upon retirement



     

    $

    1,776



    $

    1,799



    Property and equipment, net





    4,828





    4,845



    Operating lease right of use assets





    5,490





    5,567



    Total assets



    $

    102,792



    $

    67,934



















    LIABILITIES AND STOCKHOLDERS' EQUITY (NET OF CAPITAL DEFICIENCY)































    CURRENT LIABILITIES:















    Accounts payable and accruals:















    Trade



    $

    6,376



    $

    7,221



    Other





    15,167





    13,926



    Operating lease liabilities





    1,386





    1,420



    Contracts liability





    2,560





    5,394



    Convertible notes





    55,372





    54,427



    Promissory note











    4,086



    Total current liabilities



    $

    80,861



    $

    86,474



















    LONG TERM LIABILITIES:















    Contracts liability





    858





    1,716



    Liability for employee rights upon retirement





    2,224





    2,263



    Operating lease liabilities





    4,319





    4,467



    Other long term liabilities





    26





    51



    Total long term liabilities



    $

    7,427



    $

    8,497



    Total liabilities



    $

    88,288



    $

    94,971



















    STOCKHOLDERS' EQUITY (CAPITAL DEFICIENCY)





    14,504





    (27,037)



    Total liabilities and stockholders' equity (net of capital deficiency)



    $

    102,792



    $

    67,934



     

     

     

    PROTALIX BIOTHERAPEUTICS, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

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

    (Unaudited)























    Three Months Ended







    March 31, 2021



    March 31, 2020



    REVENUES FROM SELLING GOODS



    $

    4,511



    $

    5,031



    REVENUES FROM LICENSE AND R&D SERVICES





    6,809





    16,615



    TOTAL REVENUE





    11,320





    21,646



    COST OF GOODS SOLD (1)





    (4,765)





    (3,426)



    RESEARCH AND DEVELOPMENT EXPENSES, NET (2)





    (7,122)





    (10,340)



    SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (3)





    (3,138)





    (3,187)



    OPERATING INCOME (LOSS)





    (3,705)





    4,693



    FINANCIAL EXPENSES





    (2,156)





    (3,229)



    FINANCIAL INCOME





    335





    203



    FINANCIAL EXPENSES – NET





    (1,821)





    (3,026)



    OTHER INCOME





    51









    NET INCOME (LOSS) FOR THE PERIOD



    $

    (5,475)



    $

    1,667



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



    $

    (0.14)



    $

    0.10



    WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK















    USED IN COMPUTING EARNINGS (LOSS) PER SHARE – BASIC AND DILUTED





    39,933,972





    17,381,074



    (1) Includes share-based compensation



    $

    109



    $





    (2) Includes share-based compensation



    $

    210



    $

    78



    (3) Includes share-based compensation



    $

    497



    $

    353



     

    Cision View original content:http://www.prnewswire.com/news-releases/protalix-biotherapeutics-reports-first-quarter-2021-financial-results-and-business-update-301291572.html

    SOURCE Protalix BioTherapeutics, Inc.

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  5. CARMIEL, Israel, May 7, 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 release its financial results for the first quarter 2021 and business update on Friday, May 14, 2021. The Company's management will host a conference call to discuss the financial results and provide a business update on recent corporate and clinical developments at 8:30 a.m. Eastern Daylight Time (EDT).

    Protalix Biotherapeutics Logo

    Conference Call Details:

    Friday, May 14, 2021, 8:30 a.m. Eastern Daylight Time (EDT)
    Domestic:  877-423-9813…

    CARMIEL, Israel, May 7, 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 release its financial results for the first quarter 2021 and business update on Friday, May 14, 2021. The Company's management will host a conference call to discuss the financial results and provide a business update on recent corporate and clinical developments at 8:30 a.m. Eastern Daylight Time (EDT).

    Protalix Biotherapeutics Logo

    Conference Call Details:

    Friday, May 14, 2021, 8:30 a.m. Eastern Daylight Time (EDT)

    Domestic:  877-423-9813

    International:  201-689-8573

    Conference ID:  13719725

    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/bnd6y9ch

    Conference ID:  13719725

    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 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 stabilized version of the recombinant human α–Galactosidase–A protein for the treatment of Fabry disease; 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 refractory gout; PRX–119, a plant cell-expressed long action DNase I for the treatment of NETs-related diseases; 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.

    Investor Contact

    Chuck Padala, Managing Director

    LifeSci Advisors

    646-627-8390

    Cision View original content:http://www.prnewswire.com/news-releases/protalix-biotherapeutics-to-hold-first-quarter-2021-financial-and-business-results-conference-call-on-may-14-2021-301286669.html

    SOURCE Protalix BioTherapeutics, Inc.

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