Longeveron said its Phase 2b ELPIS II trial of laromestrocel in infants with hypoplastic left heart syndrome did not meet its primary efficacy endpoint. The least-squares mean difference in change from baseline in right ventricular ejection fraction at Month 12 was negative 0.7 percentage points, with a p-value of 0.8336. Exploratory results showed no deaths among laromestrocel recipients over 12 months versus one in the standard-of-care group, while transplant-free survival events occurred in one of 17 treated patients and two of 21 controls. Major adverse cardiovascular events were approximately 31% lower with laromestrocel, although the negative binomial analysis was not statistically significant. Shares fell 59.58% to $2.70 after hours after closing down 2.62% at $6.68. Longeveron is conducting additional analyses, plans to discuss the findings with the U.S. Food and Drug Administration, and has begun a strategic review that includes hiring an investment bank and conserving cash.