Joshua Hare Joshua Hare, MD, FACC, FAHA, Co-Founder, Chief Science Officer and Chairman, Longeveron Longeveron has licensed issued US Patent 12,168,028 B2, entitled “Methods for obtaining cardiomyogenic precursor cells” from the University of MiamiNew patent protects a method to derive GHRH-Receptor+ cardiomyogenic cells from pluripotent stem cells (PSCs)New technology substantially advances Longeveron’s repertoire of stem cell therapy technologiesOpportunity to expand pipeline in cardiovascular, rare a ...

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]

Core Insights - Longeveron Inc. has completed full enrollment of the Phase 2b clinical trial (ELPIS II) for laromestrocel, targeting Hypoplastic Left Heart Syndrome (HLHS) [1][2] - The trial aims to evaluate laromestrocel as a potential adjunct treatment for HLHS, with top-line results expected in Q3 2026 [1][5] - Laromestrocel has received multiple FDA designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease designations, indicating its potential significance in addressing unmet medical needs [4][5] Company Overview - Longeveron is a clinical stage biotechnology company focused on developing regenerative medicines, with laromestrocel as its lead investigational product [9] - The company is pursuing treatments for HLHS, Alzheimer's disease, and aging-related frailty, with laromestrocel being an allogeneic mesenchymal stem cell therapy [9] Clinical Trial Details - ELPIS II enrolled 40 pediatric patients across twelve leading treatment institutions, with primary endpoints including survival at 12 months and changes in right ventricular ejection fraction [2][3] - The trial builds on the success of ELPIS I, which reported 100% transplant-free survival at five years for patients treated with laromestrocel [3][6] Market Potential - The U.S. market potential for laromestrocel in treating HLHS is estimated to be up to $1 billion, highlighting the significant unmet medical need in this area [5] - If successful, the company could be eligible for a Priority Review Voucher (PRV), which can expedite the review process for future drug applications [7] Regulatory Status - The FDA has confirmed that ELPIS II is a pivotal trial, and positive results could lead to a Biological License Application (BLA) submission for full approval [4][5] - The Rare Pediatric Disease PRV program is currently facing uncertainty, but recent legislative efforts may extend its availability [7]

Financial Data and Key Metrics Changes - The company held its fourth annual meeting of stockholders on June 13, 2025, with a quorum established based on the voting shares represented [8][9] - The financial statements for the year ending December 31, 2024, were certified by independent auditors CBIZ, and the annual report was made available to stockholders [5][14] Business Line Data and Key Metrics Changes - The meeting included proposals for the election of a director and amendments to the incentive award plan, indicating ongoing corporate governance and compensation strategies [9][11] Market Data and Key Metrics Changes - No specific market data or key metrics were discussed during the meeting, focusing instead on internal governance matters [9][11] Company Strategy and Development Direction and Industry Competition - The company is focused on enhancing its incentive award plan by increasing the number of shares available for issuance, which may indicate a strategy to attract and retain talent [11][14] Management's Comments on Operating Environment and Future Outlook - Management did not provide specific comments on the operating environment or future outlook during this meeting, as the focus was primarily on procedural matters and voting [9][15] Other Important Information - The results of the voting on the proposals will be reported on Form 8-K to be filed with the SEC within four business days of the meeting [14] Q&A Session Summary - No questions were raised during the meeting regarding the proposals, indicating either satisfaction with the agenda or a lack of engagement from stockholders [11][15]

Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs [2] - The company's lead investigational product is laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell therapy derived from the bone marrow of young, healthy adult donors [2] - Laromestrocel has multiple potential mechanisms of action, including pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair effects, with applications across various disease areas [2] Pipeline and FDA Designations - Longeveron is pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease, and aging-related frailty [2] - The HLHS program has received three important FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation [2] - The Alzheimer's disease program has received two FDA designations: Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation [2] Upcoming Events - Wa'el Hashad, CEO of Longeveron, will present at the H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference on June 16-17, 2025 [1] - The conference presentation will be accessible via a webcast, with a replay available on the company's website for 90 days following the event [1]

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].

Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing cellular therapies for life-threatening and chronic aging-related conditions [6] - The company's lead investigational product is laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell therapy derived from the bone marrow of young, healthy adult donors [6] - Laromestrocel has potential applications across various disease areas, including hypoplastic left heart syndrome (HLHS), Alzheimer's disease, and aging-related frailty [6] Recent Developments - Longeveron has been selected as a Semi-Finalist Team in the XPRIZE Healthspan competition, receiving a $250,000 Milestone 1 Award [1][2] - The XPRIZE Healthspan competition is a 7-year, $101 million global initiative aimed at revolutionizing the approach to human aging [4] - The competition evaluates teams based on their scientific merit and the feasibility of their therapeutic approaches to restore or preserve functions lost to age-related degradation [2][4] Clinical Trials and FDA Designations - Laromestrocel has shown positive initial results in five clinical trials across three indications: Alzheimer's Disease, aging-related frailty, and HLHS [2] - The development programs for laromestrocel have received five significant U.S. FDA designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease designations for HLHS, and Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for Alzheimer's Disease [2][6] Competition Goals - The XPRIZE Healthspan competition aims to develop therapeutics that can restore muscle, cognitive, and immune function by at least 10 years, with an ambitious goal of extending healthy life by 20 years [2][4] - The competition's top 100 teams were selected from over 600 applicants across 58 countries, with the potential for a grand prize of between $61 million and $81 million for the winning team [2][4]

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 ...