Longeveron Inc (NASDAQ:LGVN) shares fell 59.58% to $2.70 in after-hours trading Wednesday after the company announced topline results from its Phase 2b ELPIS II clinical trial evaluating laromestrocel as a potential treatment for hypoplastic left heart syndrome.
Longeveron is a clinical-stage biotechnology company developing cellular therapies for life-threatening, rare pediatric and chronic aging-related conditions.
Trial Results
The company announced that the ELPIS II trial did not meet its primary efficacy endpoint of change from baseline in right ventricular ejection fraction at Month 12. In the intent-to-treat population, the least-squares mean difference between treatment groups was negative 0.7 percentage points, with a p-value of 0.8336.
The trial included 40 infants with hypoplastic left heart syndrome. Exploratory results showed no deaths over 12 months among patients who received laromestrocel, compared with one death in the control group. The laromestrocel arm also had one transplant-free survival event among 17 patients, compared with two among 21 patients in the standard-of-care arm.
Adjudicated major adverse cardiovascular events were approximately 31% fewer in the laromestrocel arm, with 12 events compared with 19 in the untreated arm. However, the negative binomial analysis was not statistically significant.
FDA Path Forward
Longeveron said it is conducting additional analyses of the complete dataset and plans to discuss the results with the U.S. Food and Drug Administration to determine potential next steps for the HLHS development program.
CEO Stephen H. Willard said the company would work with its advisors to evaluate all options to maximize shareholder value.
The company also announced a process to review all options, including engaging an investment bank as a strategic advisor and implementing cash-conservation measures.
Trading Metrics
Longeveron has a market capitalization of $21.30 million.
The stock has a 52-week high of $12.30 and a 52-week low of $4.75.
Longeveron shares are down 11.05% over the past year.
Benzinga’s Edge Stock Rankings show a negative price trend across the short-, medium- and long-term time frames.
Price Action: In the regular session, the stock fell 2.62% to close at $6.68, according to Benzinga Pro data.
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