Longeveron Starts Strategic Review After ELPIS II Trial Misses Primary Endpoint

Longeveron Inc. (Nasdaq: LGVN) said it is reviewing strategic options, including a possible sale or merger, and has asked the U.S. Food and Drug Administration for a meeting on its heart-disease program, according to an 8-K filed Thursday, Nov. 12, 2026. The filing furnishes a press release with third-quarter results and a business update.

Trial result behind the review

The ELPIS II Phase 2b trial tested laromestrocel as an add-on to palliative surgery in 40 infants with hypoplastic left heart syndrome. The trial did not meet its primary efficacy endpoint, the change from baseline in right ventricular ejection fraction at Month 12. On a pre-specified secondary endpoint, major adverse cardiac events, the release reports 8 events in the standard-of-care arm versus 1 in the laromestrocel arm, with a P value of 0.043. The company has requested a meeting with the FDA to determine potential next steps for the program.

Strategic review and cash position

The company said it is evaluating a range of options, which may include a strategic partnership or investment, additional financing, a sale or merger, or a business combination. It has retained Lucid Capital Markets, LLC as financial advisor. The company has not set a timeline and said it does not intend to disclose further developments unless appropriate or required by law.

Cash and cash equivalents were $7.2 million at Sept. 30, compared with $10.1 million at June 30. The company said that cash should fund operations and capital expenditures into the first quarter of 2027. Total liabilities were $7.3 million against total assets of $12.0 million. Before the filing, the market value was about $94.7 million, based on 31.9 million shares as of Aug. 6 and the $2.97 close on Nov. 12.

Third-quarter results

Total revenue was $115,000 in the quarter, compared with $137,000 a year earlier. Loss from operations was $7.2 million, compared with $7.3 million. Other income of $1.1 million included a $1.0 million Milestone 2 Award from the XPRIZE Healthspan competition. The net loss was $6.1 million, compared with $7.2 million, a decrease of $1.1 million, or 15%. Basic and diluted net loss per share was $1.91, compared with $3.93, figures the filing presents after a 1-for-10 reverse stock split that took effect Aug. 26.

What the company said comes next

The company said it will not hold a conference call on the third-quarter results while the strategic review continues. The filing does not say when the FDA meeting will take place or what terms any transaction would involve. An earlier 8-K filed Nov. 5 reported that director Ursula Ungaro resigned from the board and all committees, citing personal health reasons.