Longeveron® Announces Full-Year 2024 Financial Results and Provides Business Update

Core Viewpoint - Longeveron Inc. reported significant advancements in its clinical programs and financial results for 2024, highlighting the potential of its cellular therapy candidate, Lomecel-B™, in treating Hypoplastic Left Heart Syndrome (HLHS) and mild Alzheimer's disease, with multiple key milestones anticipated in the coming year [2][8]. Financial Results - Total revenue for 2024 increased by 237% year-over-year to $2.4 million, driven by contract manufacturing services and increased demand for the Bahamas Registry Trial [8][19]. - Clinical trial revenue rose to$1.4 million in 2024 from $0.7 million in 2023, marking a 110$1.9 million, a 752% increase compared to $0.2 million in 2023 [8][19]. - General and administrative expenses decreased by 16$10.3 million in 2024, while research and development expenses decreased by 10% to approximately $8.1 million [8][19]. - The net loss for 2024 decreased to approximately$16.0 million from $21.4 million in 2023, representing a 25% reduction [8][16][19]. Development Programs - Lomecel-B™, the company's investigational cellular therapy, is being evaluated for HLHS and mild Alzheimer's disease, with over 90% enrollment achieved in the pivotal Phase 2b clinical trial (ELPIS II) for HLHS [2][8][9]. - The FDA has granted Lomecel-B™ several designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease for HLHS, and Regenerative Medicine Advanced Therapy (RMAT) and Fast Track for Alzheimer's disease [8][11]. - The WHO approved "laromestrocel" as the non-proprietary name for Lomecel-B™ in February 2025 [3][8]. Future Outlook - The company anticipates completing enrollment in the ELPIS II trial by the second quarter of 2025 and plans to submit a Biological License Application (BLA) for HLHS in 2026, contingent on trial success [2][8]. - A meeting with the FDA is expected in late Q1 2025 to discuss the development pathway for Lomecel-B™ in mild Alzheimer's disease [8][9].