Workflow
Longeveron® Announces Second Quarter 2025 Financial Results and Provides Business Update

Core Viewpoint - Longeveron Inc. is advancing its clinical-stage regenerative medicine programs, particularly focusing on laromestrocel for treating rare pediatric and chronic conditions, with significant developments in clinical trials and regulatory interactions with the FDA [2][8]. Financial Results - Revenues for the six months ended June 30, 2025, were $0.7 million, a decrease of 31% compared to $1.0 million in 2024, primarily due to reduced participant demand for the Bahamas Registry Trial and contract manufacturing services [14]. - General and administrative expenses increased to approximately $5.5 million in 2025, up 28% from $4.3 million in 2024, mainly due to higher personnel costs [14]. - Research and development expenses rose to approximately $5.5 million, a 39% increase from $3.9 million in 2024, driven by increased personnel costs and patent amortization [14]. - The net loss for the six months ended June 30, 2025, was approximately $10.0 million, an increase of 34% from a net loss of $7.5 million in 2024 [14]. Development Programs Update - 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 has achieved full enrollment of 40 pediatric patients, with top-line results expected in Q3 2026 [9]. - The FDA has granted laromestrocel Orphan Drug, Fast Track, and Rare Pediatric Disease designations for HLHS, and a similar pathway is being pursued for Alzheimer's disease [9][11]. Corporate Updates - The company completed a public offering, raising approximately $5.0 million, with potential additional proceeds of up to $12.5 million from short-term warrants [9]. - In July 2025, the FDA approved the IND application for laromestrocel as a potential treatment for pediatric dilated cardiomyopathy, allowing the company to move directly to a pivotal Phase 2 trial [9]. - The company is actively seeking strategic collaborations and partnerships to advance its Alzheimer's disease program and is focused on BLA readiness for HLHS [9][14].