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Longeveron (LGVN) 10-K Filings

LGVN NASDAQ

Here are the 10-K annual reports from Longeveron Inc. (LGVN) in our archive since June 2025, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.

A 10-K covers the audited annual report, with the full financial statements, so if you follow LGVN and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full LGVN filings page.

Rhea-AI Summary

Longeveron Inc. is a clinical-stage biotech focused on regenerative cell therapies built around its lead product, laromestrocel (Lomecel‑B), an allogeneic bone‑marrow–derived mesenchymal stem cell therapy. The company is developing laromestrocel for four indications: Hypoplastic Left Heart Syndrome (HLHS), mild Alzheimer’s disease, pediatric dilated cardiomyopathy, and aging‑related frailty.

For HLHS, laromestrocel has Rare Pediatric Disease, Orphan Drug, and Fast Track designations, and the pivotal Phase 2b ELPIS II trial is fully enrolled with top‑line data expected in the third quarter of 2026. For mild Alzheimer’s, a Phase 2a trial (CLEAR MIND) showed a favorable safety profile and signals of efficacy, leading to RMAT and Fast Track designations and FDA alignment on a planned pivotal seamless Phase 2/3 design, with the possibility of a BLA based on positive interim data.

The company operates a cGMP facility in Miami for early‑phase supply but plans to use a contract development and manufacturing organization for potential commercial production, and it has built an extensive global patent and trademark portfolio around laromestrocel and its manufacturing and potency assays.