Longeveron says ELPIS II Phase 2b trial of laromestrocel in HLHS misses primary endpoint at 12 months

• Longeveron reported topline results from its ELPIS II Phase 2b trial of laromestrocel in infants with hypoplastic left heart syndrome.
• The study missed its main efficacy goal, raising uncertainty over the program’s near-term regulatory path.
• Safety remained consistent with prior experience, supporting continued analysis of secondary signals that could shape next steps.
• Management plans to take the full dataset to the FDA to assess options for continuing development in HLHS.
• Separately, the company launched a strategic review, citing cost controls and a focus on funding opportunities in longevity and aging-related frailty.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Longeveron Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001213900-26-102611), on September 23, 2026, and is solely responsible for the information contained therein.