Laromestrocel (lomecel-B) - (ELPIS II)

Sept. 16, 2026: Longeveron Inc. (NASDAQ: LGVN) reported topline Phase 2b ELPIS II results for laromestrocel in 40 infants with hypoplastic left heart syndrome (HLHS) given as an adjunct to Stage 2 palliative surgery. The trial missed its primary endpoint: change from baseline in right ventricular ejection fraction at 12 months, with an ITT least-squares mean difference of -0.7 percentage points versus control (95% CI: -7.3 to 5.9; p=0.8336).

Exploratory as-treated outcomes included no deaths over 12 months in the laromestrocel arm versus one in control; transplant-free survival follow-up to up to 5 years showed one event in 17 treated patients versus two in 21 controls; hospitalization burden was similar; and adjudicated MACE were about 31% lower (12 vs. 19 events), but not statistically significant. A sponsor-defined hierarchical composite endpoint of all-cause mortality and inpatient hospitalization duration was also not statistically significant in ITT.

Safety was described as consistent with prior studies, with no new safety signals and no TEAEs or serious TEAEs deemed treatment-related. The company plans additional analyses and discussions with FDA on next steps for HLHS. Separately, it said it is pursuing cost containment, engaging a strategic advisor to review options to maximize shareholder value, and seeking funding for laromestrocel in aging-related frailty, where prior Phase 2b results were published in Cell Stem Cell in February 2026.