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Longeveron (LGVN) investor relations material
Longeveron Q2 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q2 2025 earnings summary13 Aug, 2025
Executive summary
Achieved full enrollment for pivotal phase 2b HLHS trial (ELPIS II), with top-line results expected Q3 2026 and BLA submission targeted for late 2026, pending positive results.
Advanced stem cell pipeline for HLHS, Alzheimer's, and pediatric dilated cardiomyopathy, including FDA IND approval for pediatric DCM and positive regulatory progress for Alzheimer's.
Received FDA Orphan Drug, Fast Track, Rare Pediatric Disease, and RMAT designations for HLHS and Alzheimer's programs.
Discontinued Japan Aging-related Frailty trial to focus resources on core programs.
Ongoing efforts to secure additional financing and strategic partnerships, with substantial doubt about ability to continue as a going concern without new capital.
Financial highlights
Revenue for the first half of 2025 was $0.7M, down 31–32% year-over-year, mainly due to lower demand for clinical trials and contract manufacturing.
Gross profit for the first half of 2025 was $0.4M, a 37% decrease from the prior year.
General and administrative expenses rose 28% to $5.5M; R&D expenses increased 39% to $5.5M, driven by personnel and BLA readiness costs.
Net loss for the first half of 2025 was $10.0M, up 34% year-over-year.
Cash and equivalents stood at $10.2–$10.3M as of June 30, 2025; $5M raised in August public offering, with up to $12.5M more possible from warrants.
Outlook and guidance
Existing cash expected to fund operations into Q1 2026; additional capital required to continue beyond that period.
Operating expenses and capital requirements projected to rise through 2025 and 2026 due to BLA and manufacturing readiness.
BLA filing for HLHS targeted for late 2026, contingent on ELPIS II results; pivotal phase 2 trial for pediatric DCM anticipated to begin in H1 2026, subject to financing.
Seeking partnerships for Alzheimer's program and pursuing non-dilutive funding.
Assess HLHS and DCM market size differences.
HLHS approval impact on DCM regulatory path?
Discuss iPS cell transplant arrhythmia risks.
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Next Longeveron earnings date
Q3 202511 Nov, 2025
Next Longeveron earnings date
Q3 202511 Nov, 2025
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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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