Longeveron® Co-Founder and Chief Science Officer Dr. Joshua Hare Interviewed on NPR's BioTech Nation Discussing Potential Breakthrough Stem Cell Therapy for Hypoplastic Left Heart Syndrome (HLHS), a Rare Pediatric Congenital Heart Defect

Core Insights - Longeveron Inc. is advancing its clinical-stage cellular therapy, laromestrocel, aimed at treating hypoplastic left heart syndrome (HLHS), a severe congenital heart defect [1][2][4] - The pivotal Phase 2b clinical trial, ELPIS II, has completed enrollment, with top-line results expected in Q3 2026 [2][7] - Laromestrocel has shown promising results in previous trials, achieving 100% transplant-free survival up to five years of age compared to a historical mortality rate of approximately 20% [4] Company Overview - Longeveron Inc. focuses on developing regenerative medicines for unmet medical needs, with laromestrocel as its lead investigational product [5] - The company is pursuing multiple indications, including HLHS, Alzheimer's disease, Pediatric Dilated Cardiomyopathy (DCM), and Aging-related Frailty [5] - Laromestrocel has received several FDA designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease designations for HLHS, and RMAT designation for Alzheimer's disease [5] Clinical Trial Details - ELPIS II is a pivotal trial conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) and supported by NIH grants [4] - The trial aims to evaluate laromestrocel's efficacy as an adjunct treatment for HLHS, a rare pediatric disease [7] - The FDA has confirmed that successful results from ELPIS II could lead to a Biologics License Application (BLA) submission for full approval [4]