Here are the 10-K annual reports from Ernexa Therapeutics Inc. (ERNA) 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 ERNA 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 ERNA filings page.
Ernexa Therapeutics Inc. files its 2025 Annual Report describing a preclinical-stage synthetic allogeneic iMSC platform focused on cancer and autoimmune diseases. Lead candidate ERNA-101 for platinum‑resistant ovarian cancer showed preclinical tumor growth reduction and survival benefit and followed a successful FDA pre‑IND meeting.
The company plans IND‑enabling work and an IND filing in 2026, targeting a Phase I investigator‑sponsored trial in the second half of 2026, and is advancing ERNA‑201 for autoimmune disorders. Ernexa relies heavily on an exclusive license with Factor Bioscience covering 13 patent families and 33 granted patents as of March 12, 2026.
The filing highlights substantial capital needs and states current cash is insufficient to fund operations for 12 months after the financial statement issuance date, raising going concern risk. Stockholders’ equity was about $2.4 million at December 31, 2025, and a February 10, 2026 public offering generated roughly $9.5 million in net proceeds, lifting equity above Nasdaq’s $2.5 million threshold. As of March 12, 2026, Ernexa had 29,154,431 common shares outstanding and reported non‑affiliate market value of about $17.5 million as of June 30, 2025.
The report warns of possible Nasdaq delisting if the bid price remains below $1.00 following a recent reverse split, intense competition in cell therapy and ovarian cancer, complex manufacturing and regulatory pathways for iPSC‑derived products, and heavy dependence on the Factor license and outsourced manufacturing relationships.