Longeveron Inc. announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to Lomecel-B for the treatment of mild Alzheimer?s Disease. Lomecel-B is a proprietary, scalable, allogeneic cellular investigational therapy being evaluated across multiple indications, including Alzheimer?s Disease (Phase 2a completed), Aging-related Frailty (Phase 2b completed) and hypoplastic left heart syndrome (HLHS) (Phase 2b on-going). To the Company's knowledge based on publicly available information, Lomecel-B is the first cellular therapeutic candidate to receive RMAT designation for Alzheimer?s Disease.

Longeveron previously announced top-line results for the CLEAR MIND Phase 2a clinical trial on October 5, 2023, and reported additional clinical data and imaging biomarker results on December 20, 2023. Full study results for CLEAR MIND will be reported in a Featured Research Oral Presentation at the 2024 Alzheimer?s Association International Conference (AAIC) on July 28, 2024. Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the drug development and review processes for promising pipeline regenerative medicine products, including cell therapies.

A regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug or therapy has the potential to address unmet medical needs for such disease or condition. Similar to Breakthrough Therapy designation, RMAT designation provides the benefits of intensive FDA guidance on efficient drug development, including the ability for early interactions with FDA to discuss surrogate or intermediate endpoints, potential ways to support accelerated approval and satisfy post-approval requirements, and potential priority review of the biologics license application (BLA) if Priority Review designation is granted following BLA submission.

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Longeveron Inc. Announces U.S. FDA Grants Lomecel-B Regenerative Medicine Advanced Therapy Designation for the Treatment of Mild Alzheimer's Disease -...

Longeveron announced that the U.S. FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Lomecel-B for treating mild Alzheimers Disease. This makes Lomecel-B the first cellular therapeutic candidate to receive RMAT for Alzheimers. The therapy is being evaluated in multiple conditions, including Alzheimers (Phase 2a completed), Aging-related Frailty (Phase 2b completed), and Hypoplastic Left Heart Syndrome (HLHS) (Phase 2b ongoing). The CLEAR MIND Phase 2a trial indicated that Lomecel-B slowed/prevented disease progression compared to placebo, meeting safety and efficacy endpoints. Full results will be presented in July 2024. RMAT designation aims to expedite the drug development process and offers benefits like FDA guidance and potential priority review.

Positive

Receiving the RMAT designation is a significant advancement in Longeveron's journey, especially since Lomecel-B appears to be the first cellular therapeutic candidate to obtain such recognition for treating Alzheimer's Disease. The RMAT status, akin to the Breakthrough Therapy designation, implies that preliminary clinical data is promising enough to warrant expedited review processes. This designation potentially translates into a faster path to market, provided subsequent trials reinforce the positive outcomes observed in the Phase 2a.

Primarily, the designation underscores early indicators of efficacy. The Phase 2a trial demonstrated the slowing or prevention of disease progression, which is quite notable given the limited therapeutic options currently available for Alzheimer's. If these results hold true in further phases, it could revolutionize treatment paradigms.

For investors, the RMAT designation should be seen as a validation of both the science behind Lomecel-B and the strategic decisions of Longeveron. However, it's essential to remember that while the RMAT can speed up the process, it doesn't guarantee final FDA approval. Therefore, keeping an eye on upcoming clinical results, especially from the CLEAR MIND study, is crucial.

The financial landscape of Longeveron could witness substantial shifts due to the RMAT designation for Lomecel-B. Market sentiment often reacts positively to such regulatory advancements, potentially driving up stock prices in the short term. The RMAT designation also enhances the company's profile, making it more attractive to potential investors and partners who are interested in regenerative medicine and neurodegenerative diseases.

In the long run, successful commercialization of Lomecel-B for Alzheimer's could position Longeveron as a leader in a high-demand yet underserved market. With Alzheimer's Drug sales expected to continue growing due to the aging population, the financial implications of successfully bringing an approved treatment to market could be immense.

However, investors should exercise caution. The road to commercialization is fraught with regulatory and developmental hurdles. While the RMAT designation is a positive step, it's just one part of a longer journey. Upcoming clinical data and FDA interactions will provide more definitive indicators of commercial viability.

While my primary focus is oncology, the implications of Lomecel-B's RMAT designation can be understood from a broader biomedical perspective. The RMAT designation emphasizes the therapy's potential to meet unmet medical needs in Alzheimer's Disease, which is a huge medical challenge with significant overlap in the methodologies used in cancer and regenerative medicine research.

The promising early data showing a slowing of disease progression aligns with what we aim for in oncologydisease modification. From a clinical standpoint, this kind of designation is awarded when early clinical trials show significant promise, which in this case, indicates Lomecel-B might have a substantial impact on disease management.

Given the complexity of Alzheimers and the limited treatment options, any therapy that can demonstrate efficacy in the early stages is worth serious attention. However, it's important for investors to recognize that medical breakthroughs undergo rigorous scrutiny and require consistent, replicable results across larger patient populations before they can be deemed effective and safe for widespread use.

- Lomecel-Bappears to be the first cellular therapeutic candidate to receive RMAT designation for Alzheimers Disease

MIAMI, July 10, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for certain life-threatening and chronic aging-related conditions, today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to Lomecel-Bfor the treatment of mild Alzheimers Disease. Lomecel-Bis a proprietary, scalable, allogeneic cellular investigational therapy being evaluated across multiple indications, including Alzheimers Disease (Phase 2a completed), Aging-related Frailty (Phase 2b completed) and hypoplastic left heart syndrome (HLHS) (Phase 2b on-going). To the Company's knowledge based on publicly available information, Lomecel-Bis the first cellular therapeutic candidate to receive RMAT designation for Alzheimers Disease.

The RMAT designation is an important milestone for Longeveron and the Lomecel-Bprogram that recognizes the potential of our cellular therapy to have a positive impact on patients afflicted with this devastating disease, said Joshua Hare, Co-founder, Chief Science Officer and Chairman of the Board at Longeveron. Alzheimers Disease is a neurodegenerative disorder that leads to progressive memory loss and death and currently has very limited therapeutic options. In the CLEAR MIND Phase 2a clinical trial, Lomecel-Bdemonstrated an overall slowing/prevention of disease worsening compared to placebo. The trial achieved the primary safety and secondary efficacy endpoints and showed statistically significant improvements in pre-specified clinical and biomarker endpoints in specific Lomecel-B groups compared to placebo.

Longeveron previously announced top-line results for the CLEAR MIND Phase 2a clinical trial on October 5, 2023, and reported additional clinical data and imaging biomarker results on December 20, 2023. Full study results for CLEAR MIND will be reported in a Featured Research Oral Presentation at the 2024 Alzheimers Association International Conference (AAIC) on July 28, 2024.

We are thrilled to receive the RMAT designation for Lomecel-Bfor the treatment of mild Alzheimers Disease and we look forward to meeting with the FDA to discuss the path forward and the development plans for Alzheimers Disease in the very near future, said Nataliya Agafonova, M.D., Chief Medical Officer at Longeveron.

The RMAT designation is the fourth special regulatory designation received by Longeveron for Lomecel-B. The Lomecel-BHLHS program has received three separate and distinct FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation.

We are happy to receive this important RMAT designation as it continues to validate the work we have done so far and allows us to have the important dialogue with the FDA to advance our work and potentially bring this investigational therapeutic option to the many patients suffering from Alzheimers Disease, said Wael Hashad, Chief Executive Officer and Board Member at Longeveron.

Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the drug development and review processes for promising pipeline regenerative medicine products, including cell therapies. A regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug or therapy has the potential to address unmet medical needs for such disease or condition. Similar to Breakthrough Therapy designation, RMAT designation provides the benefits of intensive FDA guidance on efficient drug development, including the ability for early interactions with FDA to discuss surrogate or intermediate endpoints, potential ways to support accelerated approval and satisfy post-approval requirements, and potential priority review of the biologics license application (BLA) if Priority Review designation is granted following BLA submission.

About Longeveron Inc.

Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Companys lead investigational product is Lomecel-B, an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B 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), Alzheimers Disease, and Aging-related Frailty. The Lomecel-BHLHS program has received three separate and distinct FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation. For more information, visit http://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 managements current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as believe, expects, may, looks to, will, should, plan, intend, on condition, target, see, potential, estimates, preliminary, or anticipates or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects and include, but are not limited to, the potential for Lomecel-Bto be an effective treatment for Alzheimers Disease or achieve U.S. FDA approval as a Regenerative Medicine Advanced Therapy (RMAT). 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, market and other conditions, our limited operating history and lack of products approved for commercial sale; adverse global conditions, including macroeconomic uncertainty; inability to raise additional capital necessary to continue as a going concern; our history of losses and inability to achieve profitability going forward; the absence of FDA-approved allogeneic, cell-based therapies for Aging-related Frailty, Alzheimers Disease, or other aging-related conditions, or for HLHS or other cardiac-related indications; ethical and other concerns surrounding the use of stem cell therapy or human tissue; our exposure to product liability claims arising from the use of our product candidates or future products in individuals, for which we may not be able to obtain adequate product liability insurance; the adequacy of our trade secret and patent position to protect our product candidates and their uses: others could compete against us more directly, which could harm our business and have a material adverse effect on our business, financial condition, and results of operations; if certain license agreements are terminated, our ability to continue clinical trials and commercially market products could be adversely affected; the inability to protect the confidentiality of our proprietary information, trade secrets, and know-how; third-party claims of intellectual property infringement may prevent or delay our product development efforts; intellectual property rights do not necessarily address all potential threats to our competitive advantage; the inability to successfully develop and commercialize our product candidates and obtain the necessary regulatory approvals; we cannot market and sell our product candidates in the U.S. or in other countries if we fail to obtain the necessary regulatory approvals; final marketing approval of our product candidates by the FDA or other regulatory authorities for commercial use may be delayed, limited, or denied, any of which could adversely affect our ability to generate operating revenues; we may not be able to secure and maintain research institutions to conduct our clinical trials; ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations; if we receive regulatory approval of Lomecel-B or any of our other product candidates, we will be subject to ongoing regulatory requirements and continued regulatory review, which may result in significant additional expense; being subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our therapeutic candidates; reliance on third parties to conduct certain aspects of our preclinical studies and clinical trials; interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data; the volatility of price of our Class A common stock; we could lose our listing on the Nasdaq Capital Market; provisions in our certificate of incorporation and bylaws and Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the market price of our Class A common stock; we have never commercialized a product candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators; and in order to successfully implement our plans and strategies, we will need to grow our organization, and we may experience difficulties in managing this growth. Further information relating to factors that may impact the Companys results and forward-looking statements are disclosed in the Companys filings with the Securities and Exchange Commission, including Longeverons Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on February 27, 2024, as amended by the Annual Report on Form 10-K/A filed March 11, 2024, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The forward-looking statements contained in this press release are made as of the date of this press release, 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 Contact: Derek Cole Investor Relations Advisory Solutions derek.cole@iradvisory.com

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Lomecel-B is a proprietary, scalable, allogeneic cellular investigational therapy developed by Longeveron for treating conditions like mild Alzheimers Disease.

The RMAT designation expedites the development and review process of Lomecel-B, providing benefits like FDA guidance and potential priority review, indicating its potential to address unmet medical needs in Alzheimers Disease.

The CLEAR MIND Phase 2a trial showed that Lomecel-B slowed/prevented the worsening of Alzheimers Disease compared to placebo, achieving primary safety and secondary efficacy endpoints.

Lomecel-B demonstrated in clinical trials the ability to slow or prevent the progression of Alzheimers Disease, suggesting it could be a viable therapeutic option for patients.

The full results of the CLEAR MIND Phase 2a trial will be presented at the Alzheimer's Association International Conference (AAIC) on July 28, 2024.

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Longeveron Announces U.S. FDA Grants Lomecel-B Regenerative Medicine Advanced Therapy (RMAT) Designation for the Treatment of Mild Alzheimers Disease...

SALT LAKE CITY, July 9, 2024 /PRNewswire/ --DiscGenics, Inc., a privately held, late-stage clinical, biopharmaceutical company developing allogeneic, cell-based, regenerative therapies for musculoskeletal degeneration, today announced publication of results in the International Journal of Spine Surgery from the combined Phase I/Phase II, first-in-human clinical study of an allogeneic disc progenitor cell therapy (IDCT or rebonuputemcel) for painful lumbar degenerative disc disease (DDD).

The study met the primary safety and efficacy endpoints, showing that a single intradiscal injection of high-dose IDCT (9,000,000 cells/mL) safely increases disc volume and produces statistically significant, clinically meaningful improvements in back pain, disability, and quality of life out to 2 years post-injection in patients with lumbar disc degeneration.

"The results from this study demonstrate IDCT's potential to safely and effectively reduce pain associated with DDD while also producing a regenerative effect within the degenerating disc. MRI image analysis of disc volume indicated the potential to halt and possibly reverse the progression of the disease," said Matthew F. Gornet, M.D., lead author, Board Certified Spine Surgeon at The Orthopedic Center of St. Louis, and top enroller in the IDCT study. "I have been a practicing spine surgeon for more than 30 years and been involved in over 35 FDA clinical trials, and the patient outcomes from this study are very promising."

In the FDA-allowed, prospective, randomized, double-blinded, vehicle- and placebo-controlled,multicenter study, 60 patients with symptomatic, single-level lumbar DDD were randomized to receive single intradiscal injections of either low-dose cells (n= 20), high-dose cells (n= 20), vehicle alone (n= 10), or placebo (n= 10). The primary endpoint was mean visual analog scale (VAS) pain improvement >30% at 52 weeks. Disability and quality of life were evaluated via Oswestry Disability Index (ODI) and EQ-5D, respectively. Disc volume was radiologically assessed. Adverse events (AEs), regardless of whether they were related to treatment, were reported. Patients were assessed at baseline and at 4, 12, 26, 52, 78, and 104 weeks post treatment.

At Week 52, the primary study period, the high-dose group had a mean VAS percentage decrease from baseline (62.8%, P= 0.0005), achieving the endpoint of back pain improvement >30%; the mean change was also significantly greater than the minimal clinically important difference (MCID) of a 20-point decrease (42.8,P= 0.001). This clinical improvement was maintained at Week 104. In addition, the high-dose group had clinically meaningful, statistically significant improvements in ODI and EQ-5D by 12 weeks. Clinical improvement was sustained at 26 weeks, 52 weeks, 78 weeks, and 104 weeks following a single intradiscal injection. Only the high-dose group had a significant change in disc volume, with mean increases of 249.0 mm3(P= 0.028) at 52 weeks and 402.1 mm3(P= 0.028) at 104 weeks. Overall, a minority of patients (18.3%) reported AEs that were severe, with the highest percentage being reported in the placebo group. During the course of the trial, 6.7% of patients experienced serious AEs, all occurring in the vehicle (n= 1) or placebo (n= 3) groups, none were treatment related.

"Since the inception ofDiscGenics, we have seen consistent evidence of safety and the regenerative potential of the unique disc cell population in IDCT to address disc degeneration," said Kevin T. Foley, MD, Chief Medical Officer of DiscGenics and Chairman of Semmes-Murphey Neurologic & Spine Institute. "Our early basic science studies, our demonstrated ability to safely use human cells in 14 different pre-clinical animal studies conducted in the U.S.and Japan, and recently, data from our first-in-human safety and patient-reported outcomes published in this IJSS manuscript, all support the notion that this cell has the potential to safely regenerate the intervertebral disc from the inside-out."

DDD is a chronic and progressive condition where the intervertebral disc breaks down and causes pain and disability. It accounts for nearly 40% of chronic low back pain cases in the U.S., a serious medical condition that affects 12-30% of U.S. adults at a given time and is estimated to cost the U.S. healthcare system over $100 billion each year, creating a considerable burden on the economy and individual patients.

"The significant and durable results from this study demonstrate the incredible potential ofIDCT to change the paradigm of care for patients with DDD, a condition with limited treatment options," said Flagg Flanagan, Chief Executive Officer and Chairman of the Board for DiscGenics." We are excited by the momentum the publication of these study results offers, as we expect to initiate Phase III clinical study of this novel therapy in the U.S. imminently."

AboutIDCT

IDCT (injectable disc cell therapy, orrebonuputemcel) is a standalone, single-injection biologic treatment designed to halt progression of symptomatic lumbar disc degeneration and regenerate the disc from the inside out. The active ingredient (Drug Substance) in IDCT is a live, manufactured progenitor cell population derived from donated adult human intervertebral disc tissue. These cells are enriched and expanded into Discogenic Cells through a multistep manufacturing process in a highly controlled environment under current good manufacturing practices (cGMP) that results in significant proliferation and phenotypic changes to the cells. At the completion of the manufacturing process, the Discogenic Cells are subjected to extensive testing prior to use, including identity, purity, potency, and safety evaluations. The Discogenic Cells are then mixed with a viscous Sodium Hyaluronate Solution and excipients to generate IDCT, the Final Drug Product. IDCT is cryopreserved and maintained as individual "off-the-shelf" doses for administration viapercutaneous injection into the intervertebral disc in an outpatient setting. IDCT has been granted regenerative medicine advanced therapy (RMAT)and Fast Trackdesignations by the U.S. Food and Drug Administration.

Disclaimer:IDCT is an investigational product that is under development by DiscGenics and has not been approved by the FDA or any other regulatory agency for human use.

AboutDiscGenics

DiscGenics is a privately held, late-stage clinical biopharmaceutical company developingallogeneic, cell-based regenerative therapies for musculoskeletal degeneration. It's lead product candidate, IDCT (injectable disc cell therapy, or rebonuputemcel), is a standalone, single-injection biologic treatment designed to halt progression of lumbar disc degeneration and regenerate the disc from the inside out. DiscGenics is also developing a follow-on allogeneic cell platform to enable new musculoskeletal indications. To further development of these unique therapies, and to maintain control over compliance, cost, and production timelines, DiscGenics has built and validated an in-house scalable, allogeneic cell manufacturing process and cGMP facility at its headquarters in Salt Lake City, Utah. For more information, visitdiscgenics.com.

SOURCE DISCGENICS, INC.

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DiscGenics Announces the International Journal of Spine Surgery Has Published Results from an FDA-Approved Study of an Allogeneic Disc Progenitor Cell...

MIAMI, July 09, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, including hypoplastic left heart syndrome (HLHS) and Alzheimers disease, today announced that Neha Motwani, a senior healthcare investment banker, has been elected to the Longeveron Board of Directors at the Companys recent Annual Meeting of Stockholders.

I am delighted to welcome Neha, with her tremendous healthcare industry experience, to the Board of Directors, said Joshua Hare, Co-founder, Chief Science Officer and Chairman of the Board at Longeveron. Her extensive knowledge of biopharma company operations, financing and capital markets will bring significant value to Longeveron as we continue to advance Lomecel-B, our proprietary, scalable, allogeneic cellular therapy. With five positive clinical trials across three indications, we believe Lomecel-Bhas the potential to be an important therapy for some of the most difficult diseases and conditions associated with aging.

Neha Motwani has over 25 years of healthcare investment banking experience, most recently serving as Managing Director, Healthcare Investment Banking at William Blair. She previously held investment banking roles of increasing responsibility with Truist Securities, Oppenheimer and Company, Stifel Financial and Cowen and Company, where, collectively, she completed transactions raising approximately $7.0 billion. Ms. Motwani earned her B.A. in political science from Columbia University.

I am delighted to join the Board of Directors of Longeveron at this exciting phase of the Companys clinical development, said Ms. Motwani. I look forward to working with this talented team to continue their mission to advance their novel cellular therapy, Lomecel-Bfor the potential treatment of HLHS, a rare and devastating congenital heart condition, and diseases of the aging.

About Longeveron Inc.

Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Companys lead investigational product is Lomecel-B, an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B 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), Alzheimers disease, and Aging-related Frailty. The Lomecel-BHLHS program has received three distinct and important FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation. For more information, visit http://www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram.

Investor Contact: Derek Cole Investor Relations Advisory Solutions derek.cole@iradvisory.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/00f0eb5c-76f5-49b1-9994-ee363513547b

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Neha Motwani Elected to Longeveron Board of Directors - GlobeNewswire

MIAMI, July 08, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that Roger Hajjar, MD, Director of the Gene and Cell Therapy Institute at Mass General Brigham, has been elected to the Longeveron Board of Directors. Dr. Hajjar is an internationally recognized scientist whose cardiac gene therapy discoveries have spurred clinical trials for heart failure, whose methodologies for cardiac-directed gene transfer are currently utilized by investigators around the world, and who was appointed as the inaugural director of the Gene and Cell Therapy Institute. Dr. Hajjar was elected at the Companys recent Annual Meeting of Stockholders.

I am delighted to welcome Roger, and his tremendous experience as a scientist, academic, and operational executive, to the Board of Directors, said Joshua Hare, Co-founder, Chief Science Officer and Chairman of the Board at Longeveron. His thought leadership in gene and cell therapy will bring significant value to Longeveron as we continue to advance Lomecel-B, our proprietary, scalable, allogeneic cellular therapy being evaluated in multiple indications. I look forward to collaborating with him to advance these important therapeutic development programs.

I am excited to join the Longeveron Board at this important time, both for the Company and in the history of gene therapy, said Dr. Hajjar. Gene and cell therapy is revolutionizing patient care with the potential to cure diseases or halt their progression. The Lomecel-Bdata generated to date in HLHS and Alzheimers disease support broad potential for this novel cellular therapy as a regenerative medical therapy across multiple indications and position the Company to potentially profoundly impact affected patients lives for the better.

Dr. Hajjars addition to the Board is part of the planned Board refreshment process at Longeveron, with a focus on bringing in new, relevant, experienced leaders over time to add to the knowledge base and experience provided by current and departing Board members.

Dr. Hajjar is an internationally renowned scientific leader in the field of cardiac gene therapy. His laboratory had validated a number of cardiac targets that led to the initiation and completion under his guidance of First-in-Human gene therapy trials in patients with heart failure. He has initiated multiple clinical trials in gene therapy for a variety of cardiovascular diseases.

He has authored over 500 publications and has received numerous awards for his achievements in the field of cardiac gene therapy. Dr. Hajjar received his Bachelor of Science in Biomedical Engineering from Johns Hopkins University and his Doctor of Medicine from Harvard Medical School and the Harvard-MIT Division of Health Sciences & Technology. He completed his training in internal medicine, cardiology, heart failure/cardiac transplantation, and research fellowships at Massachusetts General Hospital in Boston where he then directed the Cardiology Laboratory of Integrative Physiology and Imaging. From 2007 to 2018, Dr. Hajjar was the Director of the Cardiovascular Research Center, and the Arthur & Janet C. Ross Professor of Medicine at Mount Sinai School of Medicine in New York. From 2019 to 2022, Dr. Hajjar was involved in the creation of a number of gene therapy companies at Flagship Pioneering, Cambridge, MA and he was the head of R&D at Ring Therapeutics.

About Longeveron Inc.

Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Companys lead investigational product is Lomecel-B, an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B 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), Alzheimers disease, and Aging-related Frailty. The Lomecel-BHLHS program has received three distinct and important FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation. For more information, visit http://www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram.

Investor Contact: Derek Cole Investor Relations Advisory Solutions derek.cole@iradvisory.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0ff5c44e-e63d-4909-b8b8-6d71186087ec

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Gene Therapy Pioneer Roger Hajjar, MD, Elected to Longeveron Board of Directors - GlobeNewswire