Longeveron Inc. provided a corporate update highlighting the Company's strategic priorities and anticipated milestones for 2023. Hypoplastic Left Heart Syndrome (HLHS): The ELPIS II trial continues to enroll at 7 clinical sites. ELPIS II is a Phase 2a clinical trial intended to evaluate the safety and efficacy of intramyocardial injection of Lomecel-B™ in infants with HLHS who are undergoing Stage II reconstructive cardiac surgery.

Lomecel-B™ for HLHS has received Fast Track, Rare Pediatric Disease, and Orphan Drug Designations from the U.S. Food and Drug Administration (FDA). Longeveron expects to publish the full data from the Phase 1 ELPIS I trial in a peer-reviewed publication in 1Q23. Top-line data from ELPIS I were previously announced in 2021.

Aging-Related Frailty:Longeveron expects to enroll the first patient in the Company's Phase 2 clinical trial of Lomecel-B™ for Aging-Related Frailty in Japan. The Phase 2 clinical trial is a 3-arm, parallel design, randomized (1:1:1), placebo-controlled, double-blind single-infusion study of two different dose levels of Lomecel- B™. The primary objective of the study is to evaluate the safety of Lomecel-B™ as a treatment for Aging-Related Frailty.

The trial is expected to enroll 45 patients. The Phase 2 trial is being conducted in partnership with the National Center for Geriatrics & Gerontology (NCGG; Nagoya) and Juntendo University Hospital (Tokyo) and the clinical sites have been activated and patients are being screened for participation. After consultation with the United States Food and Drug Administration (FDA), Longeveron may advance a parallel program in the United States.

In the near-term, Longeveron is focusing its Aging-Related Frailty resources on clinical development in Japan.