Longeveron reports Q2 2026 results, keeps September readout for HLHS heart trial

Longeveron said it is expecting topline results in September 2026 from the Phase 2b clinical trial known as ELPIS II, which is evaluating laromestrocel as a potential adjunct therapy for hypoplastic left heart syndrome (HLHS)¹. The trial is run together with the National Heart, Lung, and Blood Institute using funding from the National Institutes of Health¹.

Ahead of that readout, the company disclosed two earlier regulatory and oversight steps. In May, it said the FDA held a Type C meeting in late March 2026 on the ELPIS II trial and the upcoming data readout¹. Also in May, the independent Data Monitoring Committee finished its last scheduled review; the committee conducted a risk-benefit assessment, found no safety concerns, and cleared the study to proceed as designed to completion¹.

For the company's other pipeline programs: the IND for laromestrocel in pediatric dilated cardiomyopathy became effective in July 2025, allowing the company to move directly into a single Phase 2 registrational trial¹, which the company expects to start in 2027, with planning beginning this year¹. In Alzheimer's disease, a July poster at the Alzheimer's Association International Conference presented additional Phase 2a data showing laromestrocel reduced neuroinflammation in patients with mild Alzheimer's disease¹.

On finances, Longeveron reported a net loss of $6.1 million for the quarter, up from $5.0 million a year earlier¹. It held $10.1 million in cash as of June 30, 2026, which it said should fund operations into the fourth quarter of 2026¹ based on its current budget. The company said it intends to pursue additional financing, capital raises, and non-dilutive funding to support its operating plans¹.