Longeveron(US:LGVN)2025-08-13 20:00Clinical Pipeline & Regulatory Pathway - Longeveron has positive initial results in 5 clinical trials across 3 indications and a well-established safety profile[62] - The company has a clear regulatory pathway to Biologics License Application (BLA) with positive FDA Type C meeting for HLHS and an ongoing pivotal trial[62] - For Alzheimer's Disease (AD), there was a positive FDA Type B meeting with a planned single, pivotal Phase 2/3 clinical trial[62] - Longeveron has 5 important FDA designations including Orphan Drug, Fast Track & Rare Pediatric Disease for HLHS, and Regenerative Medicine Advanced Therapy (RMAT) & Fast Track for AD[62] Market Opportunity - The company is targeting large U S markets including Hypoplastic Left Heart Syndrome (HLHS) with a market of approximately $1 billion[6, 62] - Alzheimer's Disease (AD) has a market of approximately $5+ billion[6, 62] - Aging-related Frailty has a market of approximately $4+ billion[6, 62] Laromestrocel (Lomecel-B) - Laromestrocel is being developed as a cellular therapy for life-threatening and chronic aging-related conditions[1, 7] - Laromestrocel is an allogeneic (donor-derived) mesenchymal stem cell (MSC) therapy isolated from bone marrow of healthy young adults[9] - In Alzheimer's Disease, brain MRI results from the CLEAR MIND Phase 2a trial demonstrated a 49% reduction in brain volume loss and improvement in cerebral blood flow[50] - In Aging-related Frailty, a completed U S Phase 2b study (N=143) showed a statistically significant increase in the 6-minute walk test (6MWT) in multiple laromestrocel treatment groups 9 months after a single infusion compared to placebo[56] Financial Status - As of June 30, 2025, the company had approximately $103 million in cash and cash equivalents[57] - As of June 30, 2025, there were approximately 151 million shares of common stock outstanding, plus approximately 68 million shares of common stock exercisable under outstanding warrants[58]