INmune Bio Inc.

What they do

INmune Bio is developing a pipeline of product candidates designed to reprogram the innate immune system to address diseases driven by chronic inflammation and immune dysfunction. Its lead program is CORDStrom, a pooled human umbilical cord-derived mesenchymal stromal cell platform being developed for Recessive Dystrophic Epidermolysis Bullosa (RDEB), for which it has completed a pivotal blinded, randomized cross-over trial. It also has two other clinical-stage platforms: XPro1595, a soluble TNF-neutralizing protein therapeutic for neuroinflammation, and INKmune, an NK cell-priming platform for cancer.

Revenue drivers

• CORDStrom for RDEB — Lead program and primary focus; no commercial revenue yet, with the company transitioning toward regulatory submission after completing a pivotal trial.
• XPro1595 — A next-generation protein therapeutic targeting neuroinflammation by selectively neutralizing soluble TNF; has completed Phase I and Phase II trials in Alzheimer's Disease but is not currently planned for independent late-stage development.
• INKmune — A natural killer cell-priming platform for cancer, nearing completion of an open-label Phase II trial in metastatic castrate-resistant prostate cancer (mCRPC).
• Grant and collaboration funding — Historically supported development, including CORDStrom's initial development at INKmune manufacturing facilities using United Kingdom academic grant funding, and the MissionEB study primarily funded by a grant.

Recent performance

Inmune Bio has never been profitable and reported a net loss of $45.9 million for the year ended December 31, 2025, compared to a $42.1 million net loss for 2024. For the six months ended June 30, 2026, the company reported a net loss of $6.7 million. Cash and cash equivalents were $24.8 million at December 31, 2025 and $18.4 million at June 30, 2026. Revenue remains minimal, with annual revenue of $50,000 in 2025 and $14,000 in 2024.

Strategy

The company's primary focus is CORDStrom for RDEB, and based on pivotal trial data it is transitioning toward regulatory submission and commercialization. It intends to file a Marketing Authorization Application in the United Kingdom by the end of Q3 or early Q4 of 2026, in the European Union in early 2027, and a Biologics License Application with the FDA. For XPro1595, the company intends to pursue strategic partnership opportunities rather than independently advancing it into later-stage development. INKmune is nearing completion of an open-label Phase II trial in mCRPC. The company expects to finance operations through equity or debt financings, government funding, collaborations, strategic alliances, divestment of non-core assets, or licensing arrangements.

Risks

• Going concern — Recurring net losses and negative cash flows raise substantial doubt about the company's ability to continue as a going concern within one year.
• Dependence on CORDStrom — The company is substantially dependent on the success of CORDStrom, and it may never obtain regulatory approval.
• Clinical development uncertainty — Clinical drug development is lengthy, expensive, and inherently uncertain, and product candidates may never receive regulatory approval.
• Competition — The company faces intense competition in the markets targeted by its product candidates, with many competitors having substantially greater resources.

Outlook

Management intends to file a Marketing Authorization Application in the United Kingdom by the end of Q3 or early Q4 of 2026 and in the European Union in early 2027, followed by a Biologics License Application with the FDA. XPro1595 is expected to be advanced through strategic partnership rather than independent later-stage development. The company expects to continue incurring significant losses for the foreseeable future and will need to raise additional capital to fund operations.