Longeveron Inc.

Longeveron Inc. is a clinical-stage biotechnology company dedicated to developing cellular therapies for aging-related and life-threatening conditions. Headquartered in Miami, Florida, the company's mission is to deliver regenerative medical therapies for unmet medical needs, with a focus on extending healthspan through innovative approaches.

The company's lead investigational product is laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell (MSC) therapy derived from the bone marrow of young, healthy adult donors. This therapy is being developed for several therapeutic areas, including Hypoplastic Left Heart Syndrome (HLHS), Alzheimer's disease, Pediatric Dilated Cardiomyopathy (DCM), and Aging-related Frailty. Laromestrocel is designed to promote tissue repair, organ maintenance, and immune function through pro-vascular, pro-regenerative, and anti-inflammatory mechanisms.

In recent developments, Stephen H. Willard was appointed Chief Executive Officer in February 2026. The company secured approximately $15 million in an initial private placement tranche in March 2026, with potential for an additional $15 million based on milestone achievements. Longeveron anticipates top-line data from its pivotal Phase 2b ELPIS II clinical trial for HLHS in the third quarter of 2026, which, if successful, could support a Biologics License Application (BLA) submission. Its programs have received multiple FDA designations, including Orphan Drug, Fast Track, Rare Pediatric Disease, and Regenerative Medicine Advanced Therapy (RMAT) for HLHS and Alzheimer's disease.