Longeveron Inc. announced new long-term follow-up data from the Company's ELPIS I trial of Lomecel-BTM for patients with hypoplastic left heart syndrome (HLHS). The data showed that 100% of the 10 patients who participated in the ELPIS I trial survived and remained heart transplant-free for up to 5 years of age after receiving Lomecel-BTM during their Stage 2 surgery. To-date All 10 patients enrolled in the study have been monitored for at least 3.5 years after treatment with Lomecel-BTM.

All patients are more than 4 years of age, with 2 being 5 years of age, and additional long-term follow-up is ongoing in the ELPIS I participants. Historical results have shown that children with HLHS have approximately 20% mortality by 5 years. In addition, about three years after the Stage 2 surgery, most of these patients undergo the third palliative surgery, which is the last of the standard sequence of surgeries that comprises the current standard of care for HLHS.

To-date, 5 of 5 of the eligible patients from the ELPIS I trial have already undergone this third surgery. The ELPIS I trial was open-label, Phase 1b study designed to evaluate the safety of Lomecel-BTM in patients with HLHS. Patients underwent the Glenn Procedure (an open heart surgery) at approximately 4-5 months of age.

The results from the ELPIS I trial, which were previously reported, showed that the study met its primary safety endpoint, and that all patients were alive, transplant-free, and maintained their expected rate of growth one year after treatment. Longeveron is currently enrolling patients at 7 sites in the ELPIS II trial, a 38-patient, randomized (1:1) blinded, controlled Phase 2a clinical trial designed to evaluate the safety and efficacy of intramyocardial injection of Lomecel-BTM in infants with HLHS undergoing the Glenn Procedure. Lomecel-BTM for HLHS has received Fast Track, Rare Pediatric Disease, and Orphan Drug Designations from the U.S. Food and Drug Administration (FDA).