CARMIEL, Israel, Dec. 23, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE-American: 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 stockholders.

December 23, 2024

Dear Protalix Stockholders,

As we conclude 2024, I am filled with a sense of accomplishment as well as excitement for the year ahead. This past year, Protalix has achieved significant milestones that position our company for long-term growth. The success we have achieved this year is a direct result of our team's hard work and dedication. We're proud to share these accomplishments with you.

PARMA, Italy and CARMIEL Israel, Dec. 9, 2024 /PRNewswire/ -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, and Protalix BioTherapeutics, Inc. (NYSE American: 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 European Medicines Agency (EMA) has validated the Variation Submission for pegunigalsidase alfa ▼ to label a less frequent dosing regimen at a dose of 2 mg/kg body weight administered every four weeks in adult patients with Fabry disease. The currently approved dose of pegunigalsidase alfa is 1 mg/kg administered every two weeks.

Company to host conference call and webcast today at 8:30 a.m. EST

CARMIEL, Israel, Nov. 14, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE-American: 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 quarter ended September 30, 2024, and provided a business and clinical update.

"We are pleased to report that all eight cohorts of our phase I first-in-human study of PRX-115, our recombinant uricase candidate being developed for the treatment of uncontrolled gout, are now complete," said Dror Bashan, Protalix's President and Chief Executive Officer. "Preliminary results from this study, being presented today and this week in a late-breaking poster at ACR Convergence 2024, are encouraging and demonstrate the potential of PRX-115 to be a promising uric-acid lowering treatment option for individuals with gout. We are actively planning a phase II clinical trial of PRX-115 in gout patients and expect to initiate the study in the second half of 2025."

Company to host conference call and webcast at 8:30 a.m. EST

CARMIEL, Israel, Nov. 7, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: 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 quarter ended September 30, 2024 and provide a business and clinical update on November 14, 2024.

CARMIEL, Israel, Oct. 25, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: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 data from the phase I clinical trial of PRX-115, the Company's recombinant PEGylated uricase product candidate in development for the treatment of uncontrolled gout, will be presented in a late-breaking poster at the American College of Rheumatology (ACR) Convergence 2024, being held November 14-19, 2024 at the Walter E. Washington Convention Center in Washington, D.C.

CARMIEL, Israel, Sept. 4, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: 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 26th Annual Global Investment Conference which is being held on September 9–11, 2024 at the Lotte New York Palace Hotel, New York City, NY.

Company is debt-free with no outstanding notes

Balance sheet provides sufficient runway for ongoing operations

CARMIEL, Israel, Sept. 3, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: 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 repaid in full all of the outstanding principal and interest payable under its 7.50% Senior Secured Convertible Promissory Notes. The repayment of the convertible notes at maturity was financed entirely with available cash.

Company to host conference call and webcast today at 8:30 a.m. EDT

CARMIEL, Israel, Aug. 14, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: 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 quarter ended June 30, 2024, and provided a business update.

"In the second quarter, Protalix has made meaningful progress on our early-stage pipeline," said Dror Bashan, Protalix's President and Chief Executive Officer. "Results from the first seven cohorts of the phase I clinical trial of PRX-115 for the treatment of uncontrolled gout are encouraging, and we anticipate topline results from all eight cohorts to be available in the third quarter of 2024. Based on the safety results to date, we have initiated preparations for a phase II clinical trial of PRX-115 in uncontrolled gout patients. Our strong balance sheet enables repayment of our convertible notes due September 2024 while maintaining ongoing operations and executing on our corporate strategy."

Event will take place on Wednesday, June 26, 2024 in New York

CARMIEL, Israel, June 13, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: 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 host an in-person investor day at the Lotte Palace New York Hotel in New York on Wednesday, June 26, 2024 at 8:30 a.m. Eastern Daylight Time (EDT).

Corporate presentation scheduled for Monday, June 3, 2024 at 2:30 P.M. PDT

CARMIEL, Israel, May 29, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: 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 Dror Bashan, its President and Chief Executive Officer, will present at the upcoming 2024 BIO International Convention June 3 - 6, 2024, in San Diego, California. Mr. Bashan will provide senior biotech executives, business development leaders and investors with an update on corporate matters. The presentation will take place on June 3, 2024 at 2:30 p.m. PDT in Theater 1.

Company to host conference call and webcast today at 8:30 a.m. EDT

CARMIEL, Israel, May 10, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: 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 quarter ended March 31, 2024, and provided a business and clinical update.

"We are pleased to announce that initial top-line results from the first seven cohorts of the first-in-human phase I clinical trial of our recombinant uricase candidate, PRX-115, are encouraging, enabling us to expand into an eighth cohort and to begin planning a phase II trial," said Dror Bashan, Protalix's President and Chief Executive Officer. "We will analyze and announce the full results from the expanded trial following the completion of the new cohort. We believe that our strong cash position is sufficient to enable the repayment of our convertible notes due September 2024, and for our ongoing operations."

Company to host conference call and webcast at 8:30 a.m. EDT

CARMIEL, Israel, May 3, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: 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 quarter ended March 31, 2024 and provide a business and clinical update on May 10, 2024.

Company to host conference call and webcast today at 8:30 a.m. EDT

CARMIEL, Israel, March 14, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: 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 fiscal year ended December 31, 2023, and provided a business update.

"2023 was a significant year for Protalix, as we received regulatory approvals of Elfabrio for the treatment of adult patients with Fabry disease and advanced our growing pipeline," said Dror Bashan, Protalix's President and Chief Executive Officer. "As the second drug produced through our proven protein expression platform, Elfabrio's approval is a welcome milestone for Fabry disease patients and their families. Our commercial partner Chiesi Global Rare Diseases is continuing to position Elfabrio for global success, with launches underway in the United States, the European Union, the UK and additional markets where approvals were granted. As we continue to provide Chiesi with operational support for its activities, we have turned our attention to developing our innovative pipeline. For example, PRX-115, our proprietary recombinant PEGylated uricase for the treatment of severe gout, is currently being studied in a first-in-human phase I clinical trial. We anticipate that results from the trial will be published in the second quarter of 2024. As a company powered by a professional team and solid financials, and with the potential for revenue growth, we are poised for an exciting future and look forward to making a positive impact on patients' lives and delivering long-term value to our stockholders."

Company to host conference call and webcast at 8:30 a.m. EDT

CARMIEL, Israel, March 7, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: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 fiscal year ended December 31, 2023 and provide a business update on Thursday, March 14, 2024.

Corporate presentation scheduled for Monday, February 26, 2024 at 1:00 PM ET

CARMIEL, Israel, Feb. 23, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: 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 attend and present at the 2024 BIO CEO & Investor Conference taking place February 26-27, 2024 at the New York Marriott Marquis in New York City.