Longeveron(US:LGVN)2025-05-08 21:26Company Overview - Longeveron is a regenerative medicine company focused on cellular therapies for life-threatening and chronic aging-related conditions[1] - The company's lead product is Laromestrocel (Lomecel-B), an allogeneic mesenchymal stem cell (MSC) therapy derived from healthy young adult bone marrow[9] - Longeveron is targeting large U S markets with significant unmet medical needs, including Hypoplastic Left Heart Syndrome (HLHS), Alzheimer's Disease (AD), and Aging-related Frailty (AF)[6] Clinical Pipeline and Regulatory Pathway - The company has positive initial results from 5 clinical trials across 3 indications and a well-established safety profile[6] - Laromestrocel has received 5 important FDA designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease for HLHS, and Regenerative Medicine Advanced Therapy (RMAT) and Fast Track for AD[6] - A positive FDA Type C meeting for HLHS and an ongoing pivotal trial suggest a clear regulatory pathway to Biologics License Application (BLA)[6] - A positive FDA Type B meeting for AD and a planned single, pivotal Phase 2/3 clinical trial also indicate a potential BLA pathway[6] Market Opportunity - The U S market potential for HLHS is approximately $1 billion, for AD it is over $5 billion, and for Aging-related Frailty it is over $4 billion[6] - Alzheimer's Disease (AD) affects 6.9 million people in the U S [12] - Aging-related Frailty affects 8.1 million people in the U S [12] Financial Status - As of March 31, 2025, Longeveron had $14.3 million in cash and cash equivalents[57] - As of May 1, 2025, there were approximately 15.0 million shares of common stock outstanding, with approximately 6.8 million shares exercisable under outstanding warrants[58]