Sodium Hyaluronate

Development Services Span Tech Transfer, Process Assessment and Method Validation for Fill and Finish of NRS-033 for Planned Phase 2 Trial Lifecore to Leverage Differentiated Capabilities and Knowledge in Fill and Finish to Support Nirsum’s NIH-Funded NRS-033 Development Program CHASKA, Minn., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Lifecore Biomedical, Inc. (NASDAQ: LFCR) (“Lifecore”), a fully integrated contract development and manufacturing organization (“CDMO”), today announced that it has been selected by Nirsum Laboratories, Inc. (“Nirsum”) to provide CDMO services focused on supporting Nirsum’s clinical development of its lead development candidate, NRS-033. The activities to be conducted under the agreement include the assessment and technology transfer of the fill and finish process for NRS-033. These assessments will rely upon Lifecore’s differentiated expertise in the fill and finish of sterile injectable pharmaceutical products, potentially allowing Lifecore to create an overarching development and commercialization plan for the entire fill and finish process for NRS-033. NRS-033 is a novel treatment for opioid use disorder (OUD) and alcohol use disorder (AUD). NRS-033, which is wholly owned and internally discovered by Nirsum, is currently entering Phase 2 clinical development. The newly signed agreement will position Lifecore to provide Nirsum with filled syringes for use in clinical development of NRS-033. “With growing concerns about opioid and alcohol addiction in the U.S. and beyond, we’re grateful for the opportunity to support Nirsum on this important and promising treatment. Our agreement will enable Lifecore to apply our experience with complex formulations to the assessment, enhancement and validation of the fill and finish process for NRS-033,” said Paul Josephs, chief executive officer of Lifecore. “We are excited to add Nirsum to our growing list of customers and appreciative that their team has entrusted us to collaborate with them on these activities.” “We believe that opioid and alcohol use disorders are enormous unmet needs, each with just a few decades-old, FDA-approved treatment options available. We believe NRS-033 will be a key innovation, solving the critical problem of short therapeutic retention of available therapies that results in high relapse rates for abstinence-seeking patients with OUD and AUD. By improving therapeutic retention with NRS-033, Nirsum aims to give hope to the millions of Americans with OUD and AUD,” said Nikej Shah, M.D., chief executive officer of Nirsum Labs. “We are excited to begin our work with Lifecore to potentially help bring our important therapy through further clinical development and commercialization.” About Lifecore Biomedical Lifecore Biomedical, Inc. (Nasdaq: LFCR) is a fully integrated contract development and manufacturing organization (CDMO) that offers highly differentiated capabilities in the development, fill and finish of sterile injectable pharmaceutical products in syringes, vials, and cartridges, including complex formulations. As a leading manufacturer of premium, injectable-grade hyaluronic acid, Lifecore brings more than 40 years of expertise as a partner for global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories to bring their innovations to market. For more information about the company, visit Lifecore’s website at www.lifecore.com. About Nirsum Labs Nirsum Laboratories, Inc. is a development stage biotechnology company committed to making addiction curable. Nirsum is developing NRS-033 in OUD and AUD, which are high unmet needs with pressing public health urgency. NRS-033’s development is funded in part through a Cooperative Agreement with the United States National Institutes of Health (HEAL Initiative award UH3DA048234 and U01DA061643). For more information about the company, visit Nirsum’s website at www.nirsum.com. Important Cautions Regarding Forward-Looking Statements This press release contains forward-looking statements regarding future events and our future results that are subject to the safe harbor created under the Private Securities Litigation Reform Act of 1995 and other safe harbors under the Securities Act of 1933 and the Securities Exchange Act of 1934. Words such as “anticipate”, “estimate”, “expect”, “project”, “plan”, “intend”, “believe”, “may”, “might”, “will”, “should”, “can have”, “likely” and similar expressions are used to identify forward-looking statements. In addition, all statements regarding our anticipated future operating and financial expectations, customer opportunities and relationships, and potential market size or opportunities for customer products are forward-looking statements. All forward-looking statements involve certain risks and uncertainties that could cause actual results to differ materially, including such factors among others, as the company’s ability to successfully enact its business strategies, including with respect to installation, capacity generation and its ability to attract demand for its services, and its ability expand its relationship with its existing customers or attract new customers; the scope or anticipated markets for any products to be manufactured by Lifecore, the abiltiy for customers to obtain regulatory approvals on their anticipated timing, or at all, the nature of the competitive landscape for us or our customers, the impact of inflation on Lifecore’s business and financial condition; changes in business conditions and general economic conditions both domestically and globally, including rising interest rates and fluctuation in foreign currency exchange rates; Lifecore’s ability to access sufficient capital to fund its business strategies; and other risk factors set forth from time to time in Lifecore’s SEC filings, including, but not limited to, the Annual Report on Form 10-K for the year ended May 26, 2024 (the “2024 10-K”). For additional information about factors that could cause actual results to differ materially from those described in the forward-looking statements, please refer to our filings with the Securities and Exchange Commission, including the risk factors contained in the 2024 10-K. Forward-looking statements represent management’s current expectations as of the date hereof and are inherently uncertain. Except as required by law, we do not undertake any obligation to update forward-looking statements made by us to reflect subsequent events or circumstances.

New Members Strengthen Board of Directors CHAPEL HILL, NC / ACCESSWIRE / November 25, 2024 / Doron Therapeutics, a clinical-stage biotech company focusing on degenerative musculoskeletal conditions, today announced it has successfully raised an aggregate $11 million as an initial Series A round to take MOTYS™ into Phase 3 clinical studies. SPRIM Global Investments (SGI), a prominent health sciences investment firm, is leading the round.Doron's most advanced product, MOTYS™, is an intra-articular biologic drug developed for the management of symptomatic knee osteoarthritis. Data from a Phase 2 clinical trial were recently presented on podium at the Osteoarthritis Research Society International (OARSI) World Congress 2024 in Vienna, Austria - where MOTYS™ was identified as a highly promising program to address the significant impact of debilitating osteoarthritis.With compelling pre-clinical evidence of superiority when compared to currently available therapies, including steroids and hyaluronic acid, a robust CMC package and clinical data from over 350 patients, MOTYS™ is being developed to provide potent and durable effects from a single injection.As part of the Series A financing, Doron is also adding two new board members. Karen Zaderej, who previously served as chief executive officer and as chairman of the board of directors of Axogen Inc. from 2010, led the company's transformation from a start-up to a public company. Her experience advancing Avance Nerve Graft®, a biologically active human tissue graft, through BLA submission will be invaluable to Doron. Also joining the board is Tassos Konstantinou, SPRIM's managing director, an investment professional with life science venture capital and business development experience that brings a broad and diversified global perspective."We are excited for Doron to join our portfolio of companies - and see a great opportunity for their program to be successful and disrupt the vast and growing global market of osteoarthritis," said Michael Shleifer, managing partner of SPRIM."We are grateful to our Series A investors, for their confidence in our initiative," said Alessandra Pavesio, chief executive officer and co-founder of Doron. "This is an exciting time for Doron as we progress our lead product into Phase 3 clinical studies. The unmet need for non-surgical interventions in osteoarthritis is immense and growing. We believe MOTYS™ will allow patients to have reduced pain and regain function, allowing them the opportunity to get back to healthy and active lives."About OsteoarthritisOA is the most common form of arthritis, affecting millions of people worldwide. It occurs when the protective cartilage that cushions the ends of the bones wears down over time. This can lead to pain, stiffness, and swelling in the joints, most commonly in the knees, hips, hands and spine. Risk factors include age, sex, obesity and a history of participation in active sports. Women are more likely to develop OA.About Doron TherapeuticsDoron Therapeutics is a clinical-stage biotechnology company that has developed a Phase 3 ready, intra-articular biologic drug derived from placental tissue. The lead product, MOTYS™, includes a host of beneficial growth factors with pre-clinical data that suggests potent anti-inflammatory, tissue-protective and regenerative capabilities pivotal to treating the progressive and degenerative disease of osteoarthritis.About SPRIM Global InvestmentsSPRIM Global Investments (SGI) is a leading health sciences venture capital firm with deep industry expertise and decades of operating experience across 17 countries. SGI invests in biotechnology, digital health and R&D service companies to commercialize the newest technologies and accelerate innovations that are the future of health around the world.Media Contact:Sarah CaleyHead of Business Development and StrategyDoron Therapeutics[email protected]Contact InformationSarah Caley Head of Business Development[email protected]SOURCE: Doron TherapeuticsSource: Doron Therapeutics