Longeveron Announces Its ELPIS II Study Of Laromestrocel Failed To Meet Primary Efficacy Endpoint Of Change From Baseline In Right Ventricular Ejection Fraction To Treat Infants With Hypoplastic Left Heart Syndrome

Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapy for life-threatening, rare pediatric and chronic aging-related conditions, today announced updated results from ELPIS II following planned additional analysis conducted by the Company and the National Institutes of Health (NIH) funded trial investigators. ELPIS II is the Company’s Phase 2b clinical trial evaluating its investigational stem cell therapy laromestrocel as an adjunct to Stage 2 palliative surgery in 40 infants with hypoplastic left heart syndrome (HLHS).

The ELPIS II trial did not meet the primary efficacy endpoint of change from baseline in right ventricular ejection fraction (RVEF) at Month 12. Based on the secondary endpoints, laromestrocel was associated with fewer adjudicated clinical and safety events than the standard of care (SOC) arm. Additional review of the pre-specified secondary endpoint major adverse cardiac events (MACE) showed statistical significance with 8 events in the SOC arm versus 1 in the laromestrocel treatment arm (P=0.043). Laromestrocel demonstrated a favorable safety and tolerability profile through 12 months, with no treatment-related serious adverse events identified. The Company believes the favorable pre-specified secondary endpoint findings suggest that laromestrocel has the potential to meaningfully improve clinical outcomes of children with HLHS undergoing Stage II surgical palliation. The Company intends to request a meeting with the U.S. Food and Drug Administration (FDA) to review the results to determine potential next steps for the HLHS development program.