Core Insights - Longeveron Inc. has received FDA approval for its IND application for laromestrocel, a stem cell therapy aimed at treating pediatric dilated cardiomyopathy (DCM) [2][4] - The approval allows the company to proceed directly to a Phase 2 pivotal registration clinical trial, anticipated to begin in the first half of 2026 [8] Company Overview - Longeveron is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs, with laromestrocel being its lead investigational product [6] - Laromestrocel is derived from mesenchymal stem cells (MSCs) and has multiple potential mechanisms of action, including anti-inflammatory and pro-vascular regenerative responses [3][6] Disease Context - DCM is the most common form of cardiomyopathy in children, with 50-60% of pediatric cardiomyopathy cases diagnosed as dilated [5] - Nearly 40% of children diagnosed with DCM may require a heart transplant or may die within two years of diagnosis, highlighting the urgent need for effective treatments [3][8] Clinical Development - The IND approval marks a significant milestone in pediatric cardiovascular treatment, as current therapies primarily manage symptoms rather than address underlying causes [4] - The development program for laromestrocel reinforces Longeveron's commitment to innovative stem cell therapies for rare diseases, particularly in the cardiovascular space [3][4] Market Potential - Pediatric cardiomyopathies affect at least 100,000 children globally, indicating a substantial market opportunity for effective treatment options [8] - The innovative approach of using stem cells to repair damaged heart tissue could represent a groundbreaking development in treating cardiovascular diseases in children [4]

Core Insights - Longeveron Inc. has appointed Than Powell as Chief Business Officer to lead its business strategy and international efforts, particularly in Alzheimer's disease and hypoplastic left heart syndrome (HLHS) programs [1][2][4] - The company has recently completed enrollment for its pivotal Phase 2 trial of laromestorcel for HLHS, with top-line data expected in approximately 13 months, which could support the first Biological License Application (BLA) submission [2][6] Company Overview - Longeveron is a clinical stage biotechnology company focused on developing regenerative medicines for life-threatening and chronic aging-related conditions [6] - The lead investigational product, laromestrocel (Lomecel-B™), is an allogeneic mesenchymal stem cell therapy derived from young, healthy adult donors, with potential applications across various disease areas [6] - The company is pursuing three pipeline indications: HLHS, Alzheimer's disease, and aging-related frailty, and has received multiple FDA designations for its programs [6] Leadership Background - Than Powell brings over 25 years of experience in the pharmaceutical and biotech industries, having held leadership roles at organizations such as GSK and Eli Lilly [4][5] - Prior to joining Longeveron, Powell led Corporate Development & Strategy for Surescripts, culminating in the company's acquisition by TPG [4]

Nataliya Agafonova Nataliya Agafonova, M.D., Chief Medical Officer, Longeveron Top-line trial results are anticipated in the third quarter of 2026, after the final follow-up at 12-monthsLaromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated in 2026, if ELPIS II results are positiveU.S. FDA has awarded laromestrocel HLHS program Rare Pediatric Disease designation, Orphan drug designation, and Fast track designationLaromestrocel HLHS program addres ...

MIAMI, June 09, 2025 (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 Wa’el Hashad, CEO, will present at the H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference, taking place June 16-17, 2025. Details for the Company’s corporate presentation: Pre-recorded presentation available on-demand Monday, June 16, at 7:00 a.m. ETLonge ...

Core Viewpoint - Longeveron Inc. is actively pursuing partnerships for its Alzheimer's disease program, which has shown promising results in clinical trials, particularly with its lead candidate, laromestrocel [2][5]. Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs, with laromestrocel as its lead investigational product [7]. - Laromestrocel is an allogeneic mesenchymal stem cell therapy derived from the bone marrow of young, healthy adult donors, with potential applications across various disease areas [7]. Clinical Trial Results - The Phase 2a clinical trial (CLEAR MIND) demonstrated that laromestrocel treated patients experienced an overall slowing or prevention of disease worsening compared to placebo, achieving primary safety and secondary efficacy endpoints [3][4]. - Statistically significant improvements were observed in pre-specified clinical and biomarker endpoints for specific laromestrocel groups compared to placebo [3]. Regulatory Designations - The FDA has granted laromestrocel both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the treatment of mild Alzheimer's disease, facilitating greater access to FDA interactions during its development [5]. - Laromestrocel is noted as the first cellular therapeutic candidate to receive FDA RMAT designation for Alzheimer's disease [5]. Upcoming Events - Longeveron will participate in the BIO International Convention from June 16-19, 2025, to explore potential partnerships and strategic opportunities for its Alzheimer's disease program [1][2].

Longeveron (LGVN) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Company Participants Derek Cole - PresidentJoshua Hare - Co-Founder, Chief Science Officer & ChairmanWa'el Hashad - CEO & DirectorNataliya Agafonova - Chief Medical OfficerDevin Blass - SVP & CTOLisa Locklear - CFO & TreasurerRaghuram Selvaraju - Managing Director, Healthcare Equity Research Conference Call Participants Boobalan Pachaiyappan - Managing Director, Senior Research AnalystMichael Okunewitch - Senior Biotechnology Analyst Operator ...

Longeveron (LGVN) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Speaker0 a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Derek Cole of Investor Relations Advisory Solutions. Thank you. You may begin. Speaker1 Thank you, operator. Good afternoon, everyone, and thank you for joining us today to review Longgevron's twenty twenty five first quarter financial results and business update. After The U. S. Markets closed today, we issued a press release with financial r ...

Investor Presentation Nasdaq (LGVN) │ May 2025 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 act ...

Wa'el Hashad Wa'el Hashad, CEO, Longeveron Pivotal Phase 2b clinical trial (ELPIS II) evaluating laromestrocel in HLHS, a rare pediatric disease and orphan-designated indication, has reached approximately 95% enrollment and is expected to complete enrollment in the second quarter of 2025Laromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated in 2026, if ELPIS II is successfulResults from the Phase 2a clinical trial (CLEAR MIND) evaluating laromest ...

MIAMI, May 02, 2025 (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 report first quarter 2025 financial results and provide a business update on Thursday, May 8, 2025 after the U.S. financial markets close. The Company will host a conference call and webcast the same day at 4:30 p.m. ET. Conference Call and Webcast Details: ...