Longeveron(US:LGVN) Globenewswire·2025-11-04 21:05Core Viewpoint - Longeveron Inc. is advancing its clinical programs, particularly laromestrocel, with significant progress in treating life-threatening pediatric and chronic conditions, aiming for pivotal trial results in 2026 and potential FDA approval thereafter [2][10]. Development Programs Update - Longeveron's lead investigational product, laromestrocel (Lomecel-B), is being evaluated for multiple indications, including Hypoplastic Left Heart Syndrome (HLHS), Alzheimer's disease, and Pediatric Dilated Cardiomyopathy (DCM) [3][4][5]. - The pivotal Phase 2b clinical trial (ELPIS II) for HLHS is fully enrolled with 40 pediatric patients, and top-line results are expected in Q3 2026 [9][10]. - Laromestrocel has received Orphan Drug, Fast Track, and Rare Pediatric Disease designations from the FDA for HLHS, and RMAT and Fast Track designations for Alzheimer's disease [10][15]. Financial Results Summary - For the nine months ended September 30, 2025, revenues decreased by 53% to $0.8 million compared to $1.8 million in 2024, primarily due to reduced demand for clinical trials and contract manufacturing services [14]. - General and administrative expenses increased by 22% to approximately $9.1 million, while research and development expenses rose by 52% to approximately $9.3 million [14]. - The net loss for the nine months ended September 30, 2025, increased to approximately $17.3 million, up from $11.9 million in the same period in 2024 [14][22]. Corporate Updates - The company appointed Than Powell as Interim CEO and announced key leadership changes, including Dr. Joshua Hare as Executive Chairman [14]. - Longeveron completed a public offering in August 2025, raising approximately $5.0 million, with potential additional proceeds of up to $12.5 million [14]. - The company is seeking strategic collaborations and partnerships to advance laromestrocel in treating Alzheimer's disease [10][14].