Mesenchymal stem cell therapy (Longeveron)

MIAMI, Fla., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapies for life-threatening, rare pediatric and chronic aging-related conditions, today announced that its Chief Science Officer, Dr. Joshua Hare, and Chief Medical Officer, Dr. Nataliya Agafonova, will speak on multiple panel discussions at the Global CardioVascular Clinical Trialists (CVCT) Forum taking place December 8-10, 2025 in Washington, D.C. The CVCT Forum seeks to promote rigorous evidence generation and accelerate the global impact of cardiovascular clinical trials. Panel Discussions – December 8, 2025 Cell Therapy Heart Failure Trials – Cells Deliver and Disease Specific Strategies Is Cell Delivery Route Important? Intravenous Delivery of Cells/Cell Products: The Magic Bullet? Dr. Joshua Hare What Type of Cells? Mesenchymal Stem Cell Therapy for Dilated Cardiomyopathy: Lessons from POSEIDON and the PATH AHEAD – Dr. Joshua Hare How to Streamline Cell Therapy Innovation, Not Compromising the Level of Evidence The CVCT Multi-Stakeholder Think Tank Debate Dr. Nataliya Agafonova, Panelist About Longeveron Inc. Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is laromestrocel (Lomecel-B®), an allogeneic mesenchymal stem cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Laromestrocel has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, and Pediatric Dilated Cardiomyopathy (DCM). Laromestrocel development programs have received five distinct and important FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program - Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram. Investor and Media Contact: Derek Cole Investor Relations Advisory Solutions derek.cole@iradvisory.com Photos accompanying this announcement are available at https://www.globenewswire.com/NewsRoom/AttachmentNg/e9e96d9c-d6c3-4aec-ba85-36631b520211 https://www.globenewswire.com/NewsRoom/AttachmentNg/f106bde7-972a-4687-a91e-03e924f409fc

The patent relates to methods of administering therapeutically effective amounts of isolated allogeneic mesenchymal stem cells (MSCs) to patients with aging-related frailty with inflammaging and also to treat patients with non-ischemic dilated cardiomyopathy Non-ischemic dilated cardiomyopathy is a progressive disorder with no current cure, often leading to heart transplantation No approved treatments for aging-related frailty, a syndrome affecting older individuals that impairs human Healthspan, and is characterized by weakness, low physical activity, slowed motor performance, exhaustion, and unintentional weight loss Laromestrocel, a mesenchymal stem cell therapy, has delivered positive initial results across two clinical trials in aging-related frailty MIAMI, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapy for life-threatening, rare pediatric and chronic aging-related conditions, today announced that the Canadian Intellectual Property Office (CIPO) has granted a patent covering administration of laromestrocel (LOMECEL-B®), the Company’s proprietary mesenchymal stem cells (MSCs), for the treatment of patients with symptoms of aging-related frailty and also for the treatment of non-ischemic dilated cardiomyopathy (NIDCM). Canadian Patent No. 3043594, entitled “Method of Using Human Mesenchymal Stem Cells to Effect Cellular and Humoral Immunity,” provides Longeveron with patent rights in Canada through 2037. Aging-related frailty is a syndrome of multisystem physiological dysregulation occurring in older individuals which diminishes human healthspan. The symptoms of aging-related frailty include weakness, low physical activity, slowed motor performance, exhaustion, and unintentional weight loss. Many studies show a direct correlation between aging-related frailty and inflammation. Inflammaging has received considerable attention because it proposes a link between immune changes and a number of diseases and conditions (such as aging-related frailty) common in old age. Longeveron has previously conducted Phase 1 and 2 studies in aging-related frailty designed to show improvements in the six-minute walk test and physical functioning for its lead MSC drug, laromestrocel. Non-ischemic dilated cardiomyopathy (NIDCM) is a condition where the heart muscle becomes weakened and enlarged, negatively affecting its ability to pump blood effectively. NIDCM is a progressive disorder with no current cure, often leading to heart transplantation. In vivo administration of isolated MSCs has been shown to favorably alter several immunologic markers typically elevated in chronic inflammation. Restoration of immune competence has clinical relevance in patients who are of higher risk for co-morbid infectious disease. About laromestrocel (LOMECEL-B®) Laromestrocel is a living cell product made from specialized cells isolated from the bone marrow of young healthy adult donors. These specialized cells, known as mesenchymal stem cells (MSCs), are essential to our endogenous biological repair mechanism. MSCs have been shown to perform a number of complex functions in the body, including the formation of new tissue. They also have been shown to respond to sites of injury or disease and secrete bioactive factors that are immunomodulatory and regenerative. We believe that laromestrocel may have multiple potential mechanisms of action that may lead to anti-inflammatory, pro-vascular regenerative responses, and therefore may have broad application for a range of rare and aging related diseases. About Longeveron Inc. Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is laromestrocel (LOMECEL-B®), an allogeneic mesenchymal stem cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Laromestrocel has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, and Pediatric Dilated Cardiomyopathy (DCM). Laromestrocel development programs have received five distinct and important FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program - Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram. Forward-Looking Statements Certain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve known and unknown risks, uncertainties, and other important factors that could cause actual results, performance, or achievements to differ materially from those anticipated, expressed, or implied by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expects,” “intend,” “looks to,” “may,” “on condition,” “plan,” “potential,” “predict,” “preliminary,” “project,” “see,” “should,” “target,” “will,” “would,” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, our cash position and need to raise additional capital, the difficulties we may face in obtaining access to capital, and the dilutive impact it may have on our investors; our financial performance, and ability to continue as a going concern; the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials, and the reporting of data from those studies and trials; the size of the market opportunity for certain of our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting; our ability to scale production and commercialize the product candidate for certain indications; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates in the U.S. and other jurisdictions; our plans relating to the further development of our product candidates, including additional disease states or indications we may pursue; our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and our ability to attract and retain such personnel; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing. Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on February 28, 2025, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The Company operates in highly competitive and rapidly changing environment; therefore, new factors may arise, and it is not possible for the Company’s management to predict all such factors that may arise nor assess the impact of such factors or the extent to which any individual factor or combination thereof, may cause results to differ materially from those contained in any forward-looking statements. The forward-looking statements contained in this press release are made as of the date of this press release based on information available as of the date of this press release, are inherently uncertain, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Investor and Media Contact: Derek Cole Investor Relations Advisory Solutions derek.cole@iradvisory.com