Longeveron completes enrollment in HLHS pediatric heart trial

MIAMI - Longeveron Inc. (NASDAQ:LGVN), a clinical-stage biotechnology company with a market capitalization of $17.3 million and currently trading near its 52-week low, has completed enrollment for its Phase 2b clinical trial evaluating laromestrocel as a potential treatment for Hypoplastic Left Heart Syndrome (HLHS), a rare pediatric heart condition. According to InvestingPro analysis, the company maintains strong liquidity with a current ratio of 5.6x, though it faces challenges with rapid cash burn.

The trial, known as ELPIS II, enrolled 40 pediatric patients across twelve children’s treatment institutions. Top-line results are expected in the third quarter of 2026 following the final 12-month follow-up. While the company shows promise in its clinical development, InvestingPro data reveals significant financial metrics that matter - discover more with our comprehensive Pro Research Report, available for over 1,400 US stocks.

HLHS is a congenital birth defect where the left ventricle is severely underdeveloped or missing, requiring a three-stage heart reconstruction surgery over the first five years of life. Despite current treatments, only 50% of infants survive to adolescence due to right ventricular failure.

The U.S. Food and Drug Administration has granted laromestrocel Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation for HLHS treatment.

"Completion of enrollment in this pivotal trial is an important step on the pathway to a potential additional treatment for HLHS," said Nataliya Agafonova, Chief Medical Officer of Longeveron.

ELPIS II builds on results from the ELPIS I trial, where children experienced 100% transplant-free survival up to five years after receiving laromestrocel during surgery, compared to approximately 20% mortality in historical control data.

The FDA confirmed in October 2024 that ELPIS II is pivotal and, if positive, acceptable for Biological License Application submission for full traditional approval. Longeveron anticipates submitting the application in 2026 if trial results are positive.

The information in this article is based on a company press release statement. Despite trading below its InvestingPro Fair Value, investors should note that analysts anticipate a sales decline in the current year, with the company not yet achieving profitability over the last twelve months.

In other recent news, Longeveron LLC reported its first-quarter 2025 earnings, showing a notable decline in revenue and an increased net loss. The company’s revenue fell by 30% compared to the same quarter in 2024, dropping to $400,000. This decrease was mainly due to reduced clinical trial revenues, though contract manufacturing revenues saw a slight increase. The net loss for the quarter rose to $5 million from $4 million the previous year. Despite these financial challenges, Longeveron remains focused on advancing its clinical trials and exploring market opportunities. The company plans to complete enrollment for its ELPIS-two Phase 2b trial for Hypoplastic Left Heart Syndrome (HLHS) by the second quarter of 2025. Additionally, Longeveron aims to submit a Biologics License Application for HLHS in 2026 and is seeking partnerships for its Alzheimer’s program. The company has also received positive feedback from the FDA regarding its regulatory pathway for potential approval of its stem cell therapy.

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