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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, cash runway extension, and advancing clinical programs for HLHS, Alzheimer's disease, and pediatric dilated cardiomyopathy.
Completed full enrollment in pivotal Phase 2b HLHS trial (ELPASO-2/ELPIS II); top-line results expected Q3 2026, with BLA filing targeted for 2027 if successful.
Achieved key regulatory milestones for laromestrocel, including Orphan Drug, Fast Track, Rare Pediatric Disease, and RMAT designations for various indications.
Discontinued Japan frailty trial in 2024 to focus resources on core programs.
Licensing of new stem cell technology and ongoing evaluation of commercial partnerships and M&A opportunities.
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 ended September 30, 2025, was $17.3M, up 45% from $11.9M in 2024, with R&D expenses rising 52% to $9.3M and G&A expenses up 22% to $9.1M.
Gross profit for the nine months was $0.5M, down from $1.4M in 2024.
Cash and cash equivalents as of September 30, 2025, were $9.2M, with working capital of $5.4M.
Accumulated deficit reached $126.9M as of September 30, 2025.
Outlook and guidance
Cash runway extended into late Q1 2026 through operational decisions and recent financing; additional capital required to continue as a going concern.
Top-line results from pivotal HLHS trial expected in Q3 2026, with BLA submission readiness as a key priority for 2027.
Company will seek additional financing through equity, grants, and strategic partnerships; no assurance of future financing at favorable terms.
Anticipates increased spending for BLA-enabling activities and clinical trial advancement.
Substantial doubt exists about the ability to continue as a going concern without new financing.
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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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