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Longeveron (LGVN) investor relations material
Longeveron Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary4 Nov, 2025
Executive summary
Leadership transition with a new interim CEO and board members, focusing on disciplined execution and advancing clinical programs, especially Lomecel-B/laromestrocel for rare pediatric and age-related diseases.
Pipeline includes HLHS, pediatric dilated cardiomyopathy, Alzheimer's disease, and aging-related frailty, with five positive clinical trials and key regulatory milestones including Orphan Drug, Fast Track, Rare Pediatric Disease, and RMAT designations.
Completed full enrollment in pivotal Phase 2b HLHS trial (ELPASO-2/ELPIS II); top-line results expected Q3 2026, with potential BLA filing in 2027 if successful.
FDA granted RMAT and Fast Track designations for laromestrocel in mild Alzheimer's; planning pivotal Phase 2/3 trial, pending partnerships and funding.
Discontinued Japan frailty trial in 2024 to focus resources on core programs.
Financial highlights
Revenue for the nine months ended September 30, 2025, was $0.8M, down 53% from $1.8M in 2024, due to decreased demand in the Bahamas registry trial and contract manufacturing.
Net loss for the nine months increased 45% to $17.3M from $11.9M in 2024, reflecting higher R&D and G&A expenses.
General and administrative expenses rose 22% to $9.1M, and R&D expenses increased 52% to $9.3M, mainly from higher personnel and technology transfer costs.
Gross profit for the nine months was $0.5M, a 60% decrease from $1.4M in 2024.
Cash and equivalents were $9.2M as of September 30, 2025, with working capital of $5.4M.
Outlook and guidance
Cash runway extended into late Q1 2026 through operational discipline and recent financing; additional capital required to continue as a going concern.
Full BLA filing for HLHS now expected in 2027, delayed from late 2026 due to spend optimization in CMC and manufacturing.
Top-line HLHS trial results expected in Q3 2026; BLA submission to follow if data are positive.
Actively seeking additional financing, including up to $10.7M via ATM facility, grants, and partnerships.
Anticipates increased spending for BLA-enabling activities and clinical trial advancement.
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Next Longeveron earnings date
Q4 202527 Feb, 2026
Next Longeveron earnings date
Q4 202527 Feb, 2026
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Frequently asked questions
Longeveron Inc. is a clinical-stage biotechnology company focused on the development of cellular therapies for aging-related and life-threatening conditions. The company’s lead investigational products are based on allogeneic mesenchymal stem cells (MSCs), which aim to promote tissue repair, reduce inflammation, and enhance immune responses. Longeveron’s research targets indications such as aging-related frailty, cardiovascular diseases, and other chronic conditions. The company is headquartered in Miami, Florida, and its shares are listed on the NASDAQ.
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