Financial Condition - As of December 31, 2024, the company had cash and cash equivalents of $19.2 million, which is expected to fund operations into Q4 2025 based on current forecasts[191]. - The company has accumulated a deficit of approximately $109.6 million as of December 31, 2024, up from $85.0 million in 2023, indicating ongoing financial losses[194]. - The company anticipates significant increases in operating expenses and capital expenditures in 2025 due to ramped-up activities related to Biologics License Application (BLA) enabling activities[195]. - The company expects to incur additional losses in the future, with operating expenses likely to increase as it conducts more preclinical studies and clinical trials[190]. - The company has ongoing challenges with liquidity and access to capital, which could impact its ability to fund operations and clinical programs[190]. - The company’s ability to continue as a going concern is dependent on its available cash and successful management of its operating requirements[198]. - The company has been funded in part by government and non-profit association grants, which are not guaranteed sources of future funding[199]. - The company anticipates that its current cash resources will be insufficient to fund operations beyond Q4 2025, necessitating additional funding[356]. Regulatory Challenges - The company faces significant risks related to the transition from research to commercial activities, which may require substantial additional capital[167]. - There are no FDA-approved allogeneic, cell-based therapies for Aging-related Frailty or other conditions the company is studying, complicating potential regulatory approval[172]. - The FDA has indicated that the concept of "Frailty" will require additional clinical data and discussion before marketing authorization can be obtained[173]. - The lengthy and uncertain process of obtaining regulatory approvals for product candidates may hinder the company's ability to generate sufficient revenues[245]. - Delays in clinical trials or regulatory approvals could shorten exclusive commercialization periods, allowing competitors to enter the market earlier[243]. - The complexity of obtaining regulatory approval for mesenchymal stem cells may result in longer timelines compared to conventional drugs, impacting commercialization efforts[246]. - Regulatory approvals for product candidates may be subject to limitations and require costly post-marketing testing, including Phase 4 clinical trials[258]. - The FDA has historically been stringent with Alzheimer's disease drug approvals, with only two drugs, Aduhelm® and Leqembi™, receiving accelerated approval, both requiring confirmatory trials[251]. - The company has not had success in developing therapeutics for Alzheimer's disease, despite significant investment from the biopharmaceutical industry[252]. - The acceptance of clinical trial data by regulatory authorities such as the U.S. FDA and Japanese PMDA is uncertain, which could impact the commercialization of product candidates[310]. - Changes in regulations and future legislation could prevent or delay regulatory approval of product candidates, affecting profitability[325]. Competition and Market Risks - The company is facing increased competition in the cell therapy field from both established companies and academic institutions, which may have greater resources[186][187]. - If the company's product candidates are approved, potential competitors may seek to introduce biosimilar products using abbreviated approval pathways[223]. - The biotechnology industry is highly competitive, and the company's success depends on its ability to respond to rapid technological changes and attract skilled personnel[222]. - The company may face challenges in protecting its proprietary rights, as competitors could independently develop similar technologies[225]. - The company may need to obtain licenses from third parties to advance research or commercialization, and failure to do so could significantly harm its business[218]. Intellectual Property Risks - The company has pending patent applications related to MSC technology, but these may not issue or may issue with narrower claims, potentially allowing competitors to develop similar products[206]. - The company faces risks regarding the assignment of patents from third parties, which could affect its control over patented technology and its ability to commercialize products[208]. - The extensive time required for product development may lead to patent expirations before commercialization, reducing competitive advantages[209]. - The Leahy-Smith America Invents Act transitioned the U.S. to a "first inventor to file" system, increasing the risk of third parties obtaining patents for inventions made independently[228]. - The U.S. patent law changes may increase uncertainties and costs related to patent application prosecution and enforcement, potentially adversely affecting the company's competitive position[230]. - Patent terms in the U.S. generally last 20 years from the earliest filing date, which may not provide sufficient protection against competition if patents expire before product commercialization[233]. - Patent term extensions of up to five years may be available, but failure to obtain these extensions could lead to reduced revenue as competitors may launch products post-expiration[234]. - The company may face challenges in protecting intellectual property rights globally due to varying enforcement levels and legal complexities in foreign jurisdictions[236]. - Compulsory licensing laws in many countries could force the company to grant licenses to third parties, impairing its competitive position[238]. - Non-compliance with procedural requirements could lead to the loss of patent rights, significantly impacting the company's business and financial condition[240]. Operational Risks - The company relies on a limited supply of bone marrow donors, which may impact its ability to produce sufficient quantities of product candidates for clinical trials[178]. - Future government regulations or health concerns may further reduce the number of available bone marrow donors, limiting production capabilities[179]. - The company’s processing and storage facility is located in a hurricane-prone area, posing risks to its operations and product candidates[183]. - Ethical concerns surrounding stem cell therapy may negatively affect public perception and regulatory approval of the company’s products[184]. - The company relies on research institutions for clinical trials, which may lead to increased costs and delays if agreements are not reached or maintained[254]. - The reliance on third parties for clinical trials and manufacturing poses risks, including potential delays and increased costs if these parties fail to meet obligations[273][280]. - Future dependence on third-party manufacturers may expose the company to supply shortages and price fluctuations, potentially harming its operations[285]. - Risks associated with third-party suppliers include supply interruptions, compliance failures, and delays in product shipments, which could adversely affect the company's ability to meet clinical trial demands[286][287]. Legislative and Healthcare Environment - Legislative changes, such as the Budget Control Act, have resulted in Medicare payment reductions of 2% per fiscal year since April 2013, impacting revenue[262]. - Increasing governmental efforts to cap healthcare costs may limit coverage and reimbursement for newly approved products[263]. - The Inflation Reduction Act of 2022 allows CMS to negotiate prices for certain high-cost drugs under Medicare Part B and Part D, starting with ten drugs in 2026 and increasing to 20 drugs by 2029[272]. - Medicare beneficiaries' annual out-of-pocket drug expenses are capped at $2,000 under the Inflation Reduction Act[272]. - Legislative changes may lead to reductions in Medicare and other healthcare funding, impacting the prices for product candidates and their prescription frequency[268]. - The trend towards managed healthcare and cost containment initiatives is expected to exert pricing pressures on future approved products[268]. - The FDA has been directed to clarify the approval framework for generic drugs, which may affect competition in the pharmaceutical market[266]. - State legislatures are implementing regulations to control pharmaceutical pricing, which may include price constraints and access restrictions[267]. - The evolving legislative landscape in healthcare reform may materially impact revenue prospects and operational stability[269]. - Increased scrutiny over drug pricing practices has resulted in Congressional inquiries and proposed legislation aimed at enhancing transparency and reforming reimbursement methodologies[330]. - The company anticipates that future healthcare reforms may impose more rigorous coverage criteria and downward pressure on product pricing, impacting revenue generation and profitability[331]. Stock and Market Risks - Class A common stock closing bid price as of February 18, 2025, was $1.58[364]. - Nasdaq's minimum bid price requirement is $1.00 per share[364]. - Company executed a reverse stock split on March 26, 2024[364]. - If closing bid price drops below $1.00 before March 26, 2025, immediate delisting proceedings will commence[364]. - Loss of Nasdaq listing would significantly reduce liquidity and adversely affect stock value[364]. - The company is at risk of delisting if share price does not meet requirements[364]. - Current market conditions may impact the ability to maintain share price above the minimum requirement[364].

Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs [3] - The company's lead investigational product is Lomecel-B™, an allogeneic medicinal signaling cell therapy derived from the bone marrow of young, healthy adult donors [3] - Lomecel-B™ has multiple potential mechanisms of action, including pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair effects, with applications across various disease areas [3] Pipeline and FDA Designations - Longeveron is pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease, and aging-related frailty [3] - The HLHS program has received three important FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation [3] - The Alzheimer's disease program has received two significant FDA designations: Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation [3] Upcoming Financial Results - Longeveron will report its full-year 2024 financial results and provide a business update on February 28, 2025, after U.S. financial markets close [1] - A conference call and webcast will be held on the same day at 4:30 p.m. ET [1][2]

Core Viewpoint - Longeveron Inc. has received approval from the WHO for the non-proprietary name "laromestrocel" for its cellular therapy Lomecel-B™, marking a significant milestone in its development and potential commercialization [1][2][6]. Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs, with its lead product being Lomecel-B™, an allogeneic medicinal signaling cell therapy derived from the bone marrow of young, healthy adult donors [4][6]. - The company is pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease, and aging-related frailty [4]. Product Details - Lomecel-B™ is a proprietary, scalable cellular therapy being evaluated for Alzheimer's disease and HLHS, a rare pediatric disease [1][6]. - The therapy utilizes medicinal signaling cells (MSCs) that play a crucial role in the body's repair mechanisms, potentially offering anti-inflammatory and regenerative benefits across various diseases [3][4]. Regulatory Designations - Lomecel-B™ has received multiple FDA designations: Regenerative Medicine Advanced Therapy (RMAT) and Fast Track for mild Alzheimer's disease, and Orphan Drug, Fast Track, and Rare Pediatric Disease designations for HLHS [2][4].

Wa'el Hashad Wa'el Hashad, CEO, Longeveron Cellular therapy Lomecel-B™ has been granted an International Non-proprietary Name (INN) of “laromestrocel” on the INN List issued by the World Health Organization (WHO)Lomecel-B™ is a proprietary, scalable, allogeneic cellular therapy being evaluated in Alzheimer’s disease and hypoplastic left heart syndrome (HLHS), a rare pediatric disease and orphan indicationLomecel-B™ first cellular therapeutic candidate to receive U.S. FDA Regenerative Medicine Advanced T ...

Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs [3] - The company's lead investigational product is Lomecel-B™, an allogeneic medicinal signaling cell therapy derived from the bone marrow of young, healthy adult donors [3] - Lomecel-B™ has multiple potential mechanisms of action, including pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair effects, with applications across various disease areas [3] Pipeline and FDA Designations - Longeveron is pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease, and aging-related frailty [3] - The HLHS program has received three important FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation [3] - The Alzheimer's disease program has received two FDA designations: Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation [3] Upcoming Events - Longeveron will participate in the Emerging Growth Virtual Conference on February 18-19, 2025, with a presentation scheduled for February 19, 2025, from 3:10 to 3:20 p.m. ET [1] - The webcast for the conference presentation will be accessible on the company's website, with a replay available for 180 days post-conference [1]

MIAMI, Dec. 02, 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 it will participate in the Emerging Growth Virtual Conference taking place December 4-5, 2024. Details for the Company’s presentation: Date:December 5, 2024Time:12:00 – 12:30 p.m. ET   The webcast for this conference presentation may be accessed at the “Events and Pre ...

Findings offer potential mechanistic and clinical insights in the development of cellular therapy LomecelB™ for mild Alzheimer's disease (AD) Lomecel-B™ capacity to inhibit MMP14 correlates with improved clinical and biomarker outcomes in mild AD Immunomodulatory and pro-vascular effects of Lomecel-B™ in mild AD potentially driven by ability to exert MMP14 inhibition which may protect TIE2 receptor integrity in human AD patients MIAMI, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clin ...

Oral presentation highlights findings that patients treated with Lomecel-BTM in ELPIS I, in an openlabel follow-on study, experienced 5-year survival after stage 2 Glenn surgery of 100% with none requiring heart transplant; this compared to the largest data set from the Single Ventricle Reconstruction Trial which showed 83% survival, with a 5.2% heart transplantation rate ELPIS I met its primary endpoint of safety through 1-year post-treatment, with 100% survival rate, 100% transplant-free and patients main ...

MIAMI, Oct. 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, today announced that its submission entitled "Long-term Transplant-free Survival Is Improved In Hypoplastic Left Heart Syndrome With Cell-based Therapy" has been selected for oral presentation at the Congenital Heart Surgeons' Society (CHSS) 51st Annual Meeting to be held October 27-28, 2 ...

MIAMI, Oct. 02, 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 it will participate in the 3rd Annual ROTH Healthcare Opportunities Conference taking place October 9, 2024 in New York City, including Wa'el Hashad, Chief Executive Officer, speaking on the panel "Emerging Frontiers in Neuroscience" and investor 1x1 meetings. The Lon ...