Protalix Biotherapeutics and Secarna Pharmaceuticals Enter into Collaboration and Option Agreement

As part of the collaboration, Protalix has selected pharmaceutical targets with fundamental biological roles in rare renal indications and Secarna will apply OligoCreator^®, its proprietary AI-empowered oligonucleotide discovery and development platform, to design and profile ASO candidates against those targets. By jointly applying their research and development expertise, it is the Companies' goal to advance the programs from preclinical stage to clinical trials. Under the terms of the collaboration agreement, Secarna grants Protalix an option to an exclusive, worldwide milestone and royalty bearing license to further develop, market and commercialize therapeutic programs.

"This collaboration represents our first expansion into the rare kidney disease space leveraging RNA technologies, demonstrating the implementation of our previously updated research strategy," said Dror Bashan, Protalix's President and Chief Executive Officer. "We have started to leverage our development experience to increase our footprint as a rare disease therapeutics company. Secarna has established itself as a high-quality, innovative partner in the oligonucleotide field, and we are pleased to join forces to explore new biological pathways and advance promising targets toward clinical development, addressing significant unmet medical needs."

"We are truly excited to collaborate with Protalix, a company with a strong track record in developing and bringing therapies for rare diseases to the market," said Konstantin Petropoulos, Ph.D., Secarna Pharmaceuticals' Chief Executive Officer. "This collaboration combines Secarna's proven expertise in rapidly generating high-quality antisense candidates with Protalix's deep expertise in advancing programs to patients worldwide. Together, we aim to bring forward precise and differentiated oligonucleotide therapies for people affected by severe kidney disorders."

About Protalix BioTherapeutics, Inc.

Protalix is a biopharmaceutical company focused on the discovery, development, production and commercialization of innovative therapeutics for rare diseases. Protalix has researched, developed and currently manufactures two enzyme replacement therapies that are currently available in multiple markets. These therapies are recombinant therapeutic proteins expressed through Protalix's proprietary plant cell-based expression system, ProCellEx^®. ProCellEx is a unique plant cell-based system that enables Protalix to produce recombinant proteins in an industrial-scale manner with no exposure to mammalian cells. Protalix is 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 has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa, Elelyso^®, for the treatment of Gaucher disease, excluding in Brazil where Protalix retains full rights.

Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio^® which was approved by both the FDA and the European Medicines Agency (EMA) in May 2023. Protalix's development pipeline includes, among others, two proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets: PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of uncontrolled gout; and PRX–119, a plant cell-expressed long-acting DNase I for the treatment of NETs-related diseases. To learn more, please visit www.protalix.com.

About Secarna Pharmaceuticals

Secarna Pharmaceuticals is a biopharmaceutical company redefining the discovery and development of best-in-class oligonucleotide therapeutics, offering hope to patients facing conditions that are beyond the reach of current approaches and modalities. With the Company's proprietary AI-empowered OligoCreator^® platform, which includes multiple delivery technologies, Secarna identifies and characterizes oligonucleotide therapeutics with unparalleled speed and excellent safety and efficacy. By delivering these novel therapeutics to the cells, organs, or tissues where they are needed, targeted oligonucleotide therapies have the potential to revolutionize treatments for a wide range of difficult-to-treat disorders. Secarna's unique OligoCreator^® platform is leveraged to transform untreatable conditions into treatable ones, profoundly changing the future of medicine. www.secarna.com 

Protalix Cautionary Statement regarding 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 "anticipate," "believe," "estimate," "expect," "can," "continue," "could," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" 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 Protalix's current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause material differences include, among others: risks related to the ability to realize the anticipated benefits of the collaboration and option agreement, including the possibility that the expected benefits will not be realized or will not be realized within the expected time period; the uncertainties inherent in the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates; risks associated with initial, preliminary or interim data; the possible disruption of Protalix's operations due to military actions conducted by Israel with the Hamas terrorist organization located in the Gaza Strip, the Hezbollah in Lebanon, the Houthis which control parts of Yemen, Iran and others, including as a result of the disruption of the operations of certain regulatory authorities and of certain of Protalix's suppliers, collaborative partners, licensees, clinical trial sites, distributors and customers, and the risk that the current hostilities will result in a greater regional conflict; risks related to Protalix's expectations with respect to the projected market for the indications targeted in the collaboration; 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 relating to Protalix's evaluation and pursuit of strategic partnerships; risks relating to Protalix's ability to manage its relationship with its collaborators, distributors or partners; risks related to the amount and sufficiency of Protalix's cash and cash equivalents and short-term bank deposits; Protalix's 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; potential product liability risks, and risks of securing adequate levels of related insurance coverage; the possibility of infringing a third-party's patents or other intellectual property rights and the uncertainty of obtaining patents covering Protalix's products and processes and successfully enforcing Protalix's intellectual property rights against third-parties; and other factors described in Protalix's filings with the U.S. Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and Protalix disclaims any obligation to update this information, except as may be required by law.

Investor Contact--Protalix BioTherapeutics, Inc.

Mike Moyer, Managing Director
LifeSci Advisors
+1-617-308-4306
mmoyer@lifesciadvisors.com

Secarna Contact

Konstantin Petropoulos, PhD, MBA
CEO
Phone: +49 (0)89 215 46 375
info@secarna.com
LinkedIn  Secarna Pharmaceuticals

Media Inquiries--Secarna

MC Services AG
Anne Hennecke/Lydia Robinson-Garcia
+49 (0)211 52 92 52 15
secarna@mc-services.eu

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SOURCE Protalix BioTherapeutics, Inc.; Secarna Pharmaceuticals