Longeveron Reports 82% Revenue Decline in Q3 2025, Net Loss Increases

Longeveron Inc. reported a significant decline in financial performance for the third quarter of 2025, with total revenues of $137,000, a decrease of 82% compared to $773,000 in the same period of 2024. The company's clinical trial revenue fell to $94,000 from $210,000, while contract manufacturing revenue dropped sharply to $43,000 from $600,000. This decline is attributed to reduced demand for contract manufacturing services, particularly under the Secretome Agreement, which has seen a substantial decrease in activity. The gross profit for the quarter was approximately $125,000, down from $682,000 in the prior year.

For the nine months ending September 30, 2025, Longeveron reported total revenues of $834,000, a 53% decrease from $1.79 million in the same period of 2024. The company incurred a net loss of $17.3 million for the nine months, compared to a loss of $11.9 million in the previous year. This increase in net loss is primarily due to higher operating expenses, which rose to $18.4 million from $13.6 million, driven by increased research and development costs as the company prepares for potential regulatory submissions.

In terms of operational developments, Longeveron has been focusing on advancing its lead investigational product candidate, laromestrocel, which is currently in clinical trials for conditions such as Hypoplastic Left Heart Syndrome (HLHS) and Alzheimer’s disease. The company has completed five U.S. clinical studies and is actively conducting the ELPIS II Phase 2b trial for HLHS, which has reached full enrollment. The FDA has granted laromestrocel several designations, including Rare Pediatric Disease and Fast Track, indicating the potential for expedited review and approval.

As of September 30, 2025, Longeveron had cash and cash equivalents of $9.2 million, a decrease from $19.2 million at the end of 2024. The company anticipates that its current cash reserves will fund operations into the first quarter of 2026. However, it has expressed substantial doubt about its ability to continue as a going concern without additional financing. Longeveron has initiated capital-raising efforts, including a public offering that generated approximately $5 million in August 2025 and an At-The-Market offering agreement allowing for the sale of up to $10.7 million in shares.

Looking ahead, Longeveron plans to continue its focus on advancing laromestrocel through clinical trials and regulatory pathways, with a potential Biologics License Application (BLA) filing anticipated in 2027 if the ongoing trials yield positive results. The company is also exploring additional financing options to support its operational and developmental goals, emphasizing the need for strategic partnerships and collaborations to enhance its product pipeline and market presence.