Longeveron Reports $6.1 Million Q3 Loss, Requests FDA Meeting on ELPIS II

Longeveron reported a net loss of $6.1 million for the third quarter of 2026 and held $7.2 million in cash and cash equivalents as of September 30, 2026. The Miami-based clinical-stage biotechnology company disclosed the figures in its quarterly results, Stock Titan reported on November 12, 2026.

Longeveron's ELPIS II Results and FDA Request

Longeveron is developing laromestrocel (Lomecel-B), an allogeneic mesenchymal stem cell therapy, across hypoplastic left heart syndrome (HLHS), Alzheimer's disease, pediatric dilated cardiomyopathy and aging-related frailty. In September and October, the company announced topline and updated results from ELPIS II, its Phase 2b trial testing laromestrocel as an adjunct to Stage 2 palliative surgery in 40 infants with HLHS. The trial did not meet its primary efficacy endpoint of change from baseline in right ventricular ejection fraction at Month 12.

On the pre-specified secondary endpoints, laromestrocel was associated with fewer adjudicated clinical and safety events than the standard of care arm. Review of major adverse cardiac events showed statistical significance, with 8 events in the standard of care arm versus 1 in the laromestrocel arm (P=0.043). Longeveron has requested a meeting with the FDA to review the results and determine potential next steps for the HLHS program.

"With ELPIS II results now available, we have requested a meeting with the FDA to determine potential next steps for the HLHS development program," said Stephen H. Willard, Longeveron's chief executive officer. "At the same time, we continue to review potential strategic alternatives for the Company as we explore all opportunities to maximize value for our stockholders."

Longeveron's Strategic Review and Cash Position

Longeveron has retained Lucid Capital Markets as its financial advisor to evaluate strategic and financing alternatives, which may include a strategic partnership or investment, additional financing, a sale or merger, or a business combination. The company said it has not set a definitive timeline for the process and does not intend to disclose further developments unless disclosure is appropriate or required by law. Longeveron also implemented cash conservation measures to contain costs and did not hold a conference call to review the quarter's results.

According to akta.pro company records, Longeveron closed a private placement of up to $30 million in March 2026 led by Coastlands Capital, with participation from Janus Henderson Investors, Logos Capital and Kalehua Capital. The same records show the company's total funding at $69 million.

Longeveron's Path to the Third Quarter

In March 2026, an FDA Type C meeting determined that the trial's current primary endpoint of right ventricle ejection fraction was insufficient to demonstrate efficacy and that the agency would no longer refer to ELPIS II as pivotal, according to akta.pro company records. In August 2026, Longeveron appointed Nirav Jhaveri as chief financial officer, principal financial officer and principal accounting officer, Seeking Alpha reported. In October 2026, Longeveron posted a preprint showing laromestrocel may slow neuroinflammation in Alzheimer's, with the strongest effects in the hippocampus, Longevity.Technology reported.

What Comes Next for Longeveron

Longeveron said it anticipates its existing cash and cash equivalents will fund operating expenses and capital expenditure requirements into the first quarter of 2027, based on its current operating budget, cash flow forecast and cash conservation measures. The company's Investigational New Drug application for laromestrocel in pediatric dilated cardiomyopathy became effective in July 2025 and provides for moving directly to a single Phase 2 registrational clinical trial.