Longeveron® Announces First Quarter 2025 Financial Results and Provides Business Update

Core Viewpoint - Longeveron Inc. is making significant progress in the development of its stem cell therapy, laromestrocel, with a focus on advancing clinical trials for Hypoplastic Left Heart Syndrome (HLHS) and Alzheimer's disease, while preparing for potential regulatory submissions in the coming years [2][8]. Financial Results Summary - Revenues for Q1 2025 were $0.4 million, a decrease of 30% from $0.5 million in Q1 2024, primarily due to reduced participant demand for the Bahamas Registry Trial [9]. - Clinical trial revenue from the Bahamas Registry Trial decreased by 50% to $0.3 million in Q1 2025 from $0.5 million in Q1 2024 [9]. - Contract manufacturing revenue increased by approximately 270% to $0.1 million in Q1 2025 from $33,000 in Q1 2024 [9]. - General and administrative expenses rose by 34% to approximately $2.9 million in Q1 2025 compared to $2.2 million in Q1 2024 [9]. - Research and development expenses increased by 13% to approximately $2.5 million in Q1 2025 from $2.2 million in Q1 2024 [9]. - Net loss for Q1 2025 was approximately $5.0 million, an increase of 23% from $4.0 million in Q1 2024 [16]. Development Programs Update - The pivotal Phase 2b clinical trial (ELPIS II) for laromestrocel in HLHS has reached approximately 95% enrollment and is expected to complete enrollment in Q2 2025 [8][9]. - A potential Biologics License Application (BLA) submission for HLHS is anticipated in 2026, contingent on the success of ELPIS II [9]. - Results from the Phase 2a clinical trial (CLEAR MIND) for Alzheimer's disease were published in Nature Medicine, supporting further clinical development [9]. - The FDA has granted laromestrocel multiple designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease for HLHS, and RMAT and Fast Track for Alzheimer's disease [11]. Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines, with laromestrocel (Lomecel-B™) as its lead investigational product [11]. - The company is pursuing treatments for HLHS, Alzheimer's disease, and aging-related frailty, leveraging the therapeutic potential of its allogeneic mesenchymal stem cell therapy [11].