FDA Grants Longeveron Type C Meeting At March End To Prepare For Anticipated Q3 Data Readout Of ELPIS II, Pivotal Phase 2 Clinical Trial Evaluating Laromestrocel For HLHS Treatment

• ELPIS II top-line trial results are anticipated in the third quarter of 2026
• Laromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated if ELPIS II results are positive
• U.S. FDA has awarded laromestrocel HLHS program Rare Pediatric Disease designation, Orphan Drug designation, and Fast Track designation
• Laromestrocel HLHS program has the potential to address an unmet medical need with significant U.S. market opportunities
• Even with current standard of care surgeries, only 50% of infants survive to adolescence due to right ventricular failure
   

MIAMI, Jan. 26, 2026 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ:LGVN), a clinical stage biotechnology company developing cellular therapy for life-threatening, rare pediatric and chronic aging-related conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted Longeveron a Type C meeting at the end of March to prepare for the anticipated third quarter data readout of ELPIS II, the pivotal Phase 2 clinical trial evaluating the Company's proprietary stem cell therapy, laromestrocel (LOMECEL-B®), as a potential treatment for Hypoplastic Left Heart Syndrome (HLHS), a rare pediatric and orphan-designated disease. The primary purpose of the meeting is to gain alignment on the clinical efficacy data endpoints and statistical analysis plan (SAP) to support a Biologics Licensing Application (BLA).

The Company expects to provide a regulatory update after the receipt of the official meeting minutes.

ELPIS II is a Phase 2b clinical trial evaluating laromestrocel as a potential adjunct therapy for HLHS. The clinical trial enrolled 40 pediatric patients at twelve premiere infant and children's treatment institutions across the country. ELPIS II is being conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) through grants from the National Institutes of Health (NIH).