Longeveron initiated a process of exploring options to maximize shareholder value after a stem cell therapy to treat a heart condition in children failed to meet its primary endpoint in a Phase 2b trial.
The clinical-stage biotechnology company said Wednesday that laromestrocel did not meet the endpoint of improvement in right ventricular ejection fraction at month 12 for infants with hypoplastic left heart syndrome.
"The Company has initiated a process of optimizing cost containment and will explore all options with the goal of maximizing shareholder value," Longeveron said, adding that it plans to engage an investment bank as a strategic adviser and has begun implementing cash conservation measures.
The company said it continues to analyze exploratory clinical endpoints from the trial, including the result of zero deaths among patients who received the therapy compared to one death in the control group. It plans to meet with the Food and Drug Administration to determine a potential path forward for the HLHS indication.
Longeveron also plans to pursue funding sources and revenue opportunities for the drug in longevity and aging-related frailty based on results from a separate clinical trial.
Trading of Longeveron shares was halted due to pending news shortly before the company's announcement.
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