Longeveron's ELPIS II Phase 2b misses primary endpoint; strategic review initiated

Longeveron Inc.

ELPIS II missed primary endpoint: RVEF change from baseline -0.7 pp (95% CI -7.3 to 5.9, p=0.8336) in ITT.
Exploratory: no deaths in laromestrocel arm vs 1 control at 12 months; transplant-free survival 1 vs 2 events.
MACE ~31% fewer (12 vs 19 events) but not statistically significant; no new safety signals across 644 patients.
Company to explore all options to maximize shareholder value, engaging an investment bank and cost containment.
Longevity/frailty: Phase 2b data published in Cell Stem Cell Feb 2026; $1M XPRIZE Milestone 2 Award, up to $81M grand prize.

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