Longeveron (LGVN) Investor presentation summary

Strategy and platform

• Laromestrocel (Lomecel B) is an allogeneic mesenchymal stem cell therapy derived from healthy young-adult bone marrow, culture-expanded and frozen in doses for use.

• Development programs cover HLHS, Alzheimer's disease, pediatric dilated cardiomyopathy and aging-related frailty.

• Initial positive results reported across five clinical trials in three indications, with an established safety profile.

• Proposed mechanisms include pro-vascular, anti-inflammatory and anti-fibrotic effects, plus stimulation of intrinsic repair.

• Stated U.S. market estimates: HLHS ~$1B, Alzheimer's disease ~$5B+ and aging-related frailty ~$4B+.

HLHS

• In ELPIS I, all 10 patients had transplant-free survival up to five years after Stage II surgery; the matched SVR population had a 5-year Kaplan-Meier estimate of 83.1% (95% CI 77.4%-89.3%).

• ELPIS II is a randomized Phase 2b pivotal study; enrollment completed in June 2025, with top-line data anticipated in Q3 2026.

• ELPIS II evaluates change in right-ventricular ejection fraction, 12-month survival and hospitalization length; laromestrocel is injected during Stage II surgery.

• Following an August 2024 Type C meeting, FDA deemed ELPIS II pivotal and acceptable as a BLA basis if positive; FDA alignment covered endpoints, CMC and potency assay plans.

• FDA designations for HLHS include Orphan Drug, Fast Track and Rare Pediatric Disease.

Alzheimer's disease

• CLEAR MIND Phase 2a results showed statistically significant improvements on selected clinical and biomarker endpoints; MRI showed 49% less brain-volume loss and improved cerebral blood flow.

• The trial reported no hypersensitivity, infusion-related reactions or amyloid-related imaging abnormalities; results were published in Nature Medicine in March 2025.

• A positive March 2025 FDA Type B meeting supported a planned single pivotal Phase 2/3 trial; an adaptive interim analysis could enable an earlier BLA if positive.

• Trial initiation is anticipated in 2H 2026, contingent on non-dilutive funding and/or partnering support; FDA granted RMAT and Fast Track designations.