Longeveron (LGVN) Investor presentation summary

Platform and pipeline

• Mid-clinical-stage focus on medicinal signaling cells (MSCs) for rare diseases and aging-related conditions; Lomecel-B uses allogeneic cells from bone marrow of healthy young adults.

• Clinical programs span hypoplastic left heart syndrome (HLHS), Alzheimer's disease (AD) and aging-related frailty; prior studies reached Phase 2a in AD and Phase 2b in frailty.

• Lomecel-B is described as pro-vascular, pro-regenerative and anti-inflammatory, with proposed tissue repair, migration to damage sites and off-the-shelf administration.

• On-site GMP production, recent equity offerings, significant insider ownership and no debt were highlighted.

Hypoplastic left heart syndrome

• HLHS affects ~1,000 U.S. babies annually; care involves three staged surgeries, and estimated survival to adolescence is 50%–60%.

• ELPIS II is a randomized, blinded Phase 2b study enrolling 38 patients, comparing standard care with Lomecel-B injected during Stage II surgery; primary endpoint is change in right-ventricle ejection fraction at 12 months.

• In the Phase 1 ELPIS I cohort, all 10 treated patients were alive without transplant up to 5 years after Stage II surgery; a historical comparison reported 80% 5-year transplant-free survival.

• ELPIS II is enrolling at leading pediatric centers with support from the National Heart, Lung, and Blood Institute.

Alzheimer's disease

• CLEAR MIND Phase 2a met its prespecified secondary CADS composite endpoint versus placebo (P < 0.1); hippocampal volume and ADS-QOL components were significant at P < 0.05.

• Lomecel-B showed a positive benefit-risk profile, with no AD-related imaging abnormalities, hypersensitivity, infusion reactions, infusion interruptions or deaths reported.

• Study findings suggested potential to limit disease worsening and support cognition, caregiver-assessed quality of life, brain-volume measures and cerebral blood flow; results support further development in mild AD.