Longeveron provides corporate update, 2023 strategic priorities

Longeveron provided a corporate update highlighting the Company’s strategic priorities and anticipated milestones for 2023. 2023 Pipeline Updates and Anticipated Milestones: Hypoplastic Left Heart Syndrome: 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. 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, 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(TM) 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 and Juntendo University Hospital and the clinical sites have been activated and patients are being screened for participation. After consultation with the United States Food and Drug Administration, 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. Alzheimer’s Disease: In November 2022, Longeveron announced the completion of enrollment in a Phase 2a trial of Lomecel-B in patients with mild Alzheimer’s Disease. Longeveron expects to release topline data from the Phase 2a trial in early 2024. The Phase 2a trial is a clinical trial of Lomecel-B designed to evaluate the safety of single and multiple infusions of two different dose levels compared to placebo in patients with mild AD.