Miami biotech Longeveron taps Lucid to explore strategic options
The company’s review may include a business combination, following Phase 2b results that missed the trial’s primary endpoint.
Key Takeaways
- •Longeveron retained Lucid Capital Markets on Oct. 28 to advise on strategic alternatives.
- •The ELPIS II Phase 2b trial missed its primary endpoint; a secondary MACE result favored laromestrocel.
- •The Miami company plans to ask the FDA to discuss next steps for the HLHS program.
Longeveron Inc. has hired Lucid Capital Markets to advise it as it explores strategic alternatives, including a potential business combination, the Miami biotechnology company said in an Oct. 28 announcement. The review puts a possible transaction on the table, but the company has announced no deal.
Longeveron is based at 1951 NW Seventh Avenue, Suite 520, in Miami, according to its Oct. 26 filing with the U.S. Securities and Exchange Commission. The company develops cell therapies for rare pediatric conditions and chronic aging-related conditions.
The strategic review follows new results from ELPIS II, a Phase 2b study of laromestrocel as an addition to Stage 2 palliative surgery for infants with hypoplastic left heart syndrome, or HLHS. The trial enrolled 40 infants.
The study did not meet its primary efficacy endpoint: change from baseline in right ventricular ejection fraction at 12 months. In an additional analysis, the company reported eight major adverse cardiac events in the standard-care group and one in the laromestrocel group, a statistically significant difference on that prespecified secondary endpoint (P=0.043).
The company said the updated results followed planned additional analysis by Longeveron and NIH-funded trial investigators. Its release also reported fewer adjudicated clinical and safety events in the laromestrocel group and no treatment-related serious adverse events identified through 12 months.
The findings point in different directions. The primary measure did not show the improvement the trial was designed to detect, while the reported secondary finding may inform further development. The results do not establish that laromestrocel is effective for HLHS or that regulators will approve it.
Longeveron said it intends to request a meeting with the FDA to review the findings and discuss possible next steps for the HLHS program.
