INmune Bio Inc. develops clinical-stage immunology and biotechnology treatments designed to target the innate immune system in disease. Company news commonly centers on three platforms: CORDStrom, a pooled allogeneic human umbilical cord-derived mesenchymal stromal/stem cell platform; XPro, a dominant-negative TNF platform intended to selectively neutralize soluble TNF; and INKmune, a cell-based medicine designed to prime natural killer cells against residual cancer.
Recurring updates include clinical and preclinical data, regulatory pathway discussions, manufacturing and collaboration agreements, conference presentations, shareholder communications, and quarterly or annual financial results. Coverage also reflects program areas such as recessive dystrophic epidermolysis bullosa, early Alzheimer’s disease, neuroinflammation, inflammatory disease and oncology.
INmune Bio (INMB) submitted its final UK pre-application package for Ebstrocel to the MHRA on October 20, 2026. The investigational cell therapy targets recessive dystrophic epidermolysis bullosa (RDEB). The company targets a complete marketing application in early February 2027, replacing a rolling submission previously planned to start in late 2026.
INmune Bio believes faster manufacturing progress supports a revised approach that could advance potential UK approval by approximately six weeks to mid-2027, subject to MHRA review. It expects a response within three to six months after submission, subject to validation, review and additional information requests. A U.S. biologics license application is planned for Q2 2027, subject to feedback from a planned FDA Type B meeting; the company is prioritizing the FDA application ahead of an EMA submission.
INmune Bio (NASDAQ: INMB) signed a Master Services Agreement with Uniphar Durbin Ireland to support international access and commercialization of Ebstrocel.
The investigational cell therapy is being developed for recessive dystrophic epidermolysis bullosa (RDEB). INmune Bio initially plans named-patient access, allowing physician requests for individual eligible patients, in selected European countries and the Middle East and North Africa, subject to local law and country-specific statements of work. This pathway may permit access before local marketing approval. Broader distribution depends on securing regulatory approvals, pricing and reimbursement in individual countries; territorial expansion requires mutual agreement. INmune Bio believes using Uniphar’s existing infrastructure offers a capital-efficient alternative to building country-by-country capabilities.
INmune Bio (INMB) and Quantum Computing (QUBT) announced a collaboration to explore potential new applications for INmune Bio's investigational Alzheimer's treatment XPro. The work combines INmune Bio's preclinical research and data from four clinical trials with QCi's Dirac-3S quantum optimization machine, artificial intelligence and conventional analytics. The companies intend to identify treatment-response biomarkers and prioritize potential disease indications, with INmune Bio initially focusing on rare diseases.
The Stage 1 engagement marks QCi's first commercial customer in pharmaceutical and biotechnology markets; the agreement includes options for additional work. The companies plan to compare quantum optimization with conventional statistical and machine-learning methods to test where it adds value. They also aim to establish a repeatable discovery process for additional datasets and potential indications.
INmune Bio (INMB) will attend the 2026 Maxim Growth Summit from October 12 to 14 at The Hard Rock Hotel NYC. The company will hold one-on-one meetings with institutional investors and engage with Maxim research analysts. CEO David Moss will present on the Immunology & Inflammation Therapies Panel on October 14 at 10:30 a.m. Portions of the summit will also be streamed online.
INmune Bio (INMB) appointed R. Duane Clark II and James Sapirstein to its Board of Directors to bolster rare-disease commercialization and business-development capabilities as Ebstrocel™ advances toward potential launch.
Clark is General Manager, U.S. Rare Diseases at Sanofi, leading a multi‑billion‑dollar portfolio of seven brands with full profit-and-loss responsibility and extensive experience in market access, launches and M&A integration. Sapirstein brings more than 40 years of biopharma leadership, including six global product launches, founding Tobira Therapeutics and guiding it into a potential $1.7 billion Allergan transaction, and broad transaction, licensing and restructuring experience.
INmune Bio is advancing two late-stage platforms: CORDStrom™, which has shown successful clinical readouts in recessive dystrophic epidermolysis bullosa (RDEB) and is moving toward MAA filings with the UK MHRA in 2026 and EU EMA in 2027 plus a planned U.S. BLA; and XPro1595™, which has FDA Fast Track designation and End-of-Phase 2 regulatory alignment supporting an integrated Phase 2b/3 seamless adaptive registrational program in early Alzheimer’s disease with neuroinflammation.
INmune Bio (INMB) will present at the H.C. Wainwright 28th Annual Global Investment Conference in New York, with an on-demand presentation available starting September 11, 2026, at 7:00 a.m. ET.
Chief Executive Officer David Moss will host one-on-one meetings with institutional investors and deliver a live presentation on Monday, September 14 at 10:30 a.m. ET. The company highlights two late-stage platforms: CORDStrom™, which is moving to regulatory filing phases with an MAA planned for the UK MHRA in 2026 and EU EMA in 2027 plus a planned U.S. BLA; and XPro1595™, which has FDA Fast Track designation and is positioned for an integrated Phase 2b/3 seamless adaptive registrational program in neuroinflammation-enriched early Alzheimer’s disease.
INmune Bio (NASDAQ: INMB) has submitted two key regulatory packages to the European Medicines Agency for its investigational therapy Ebstrocel™ in recessive dystrophic epidermolysis bullosa (RDEB): an application for Orphan Drug Designation and a pre-MAA Scientific Advice package.
According to INmune Bio, these filings are intended to support a planned EU Marketing Authorization Application (MAA) in Q1 2027, as part of a coordinated global strategy that also targets a UK MAA in Q4 2026 and a U.S. BLA in Q1 2027. If orphan designation is granted and maintained through approval, the RDEB indication could access development incentives and potentially 10 years of EU market exclusivity, subject to applicable requirements. Ebstrocel is the first disease-specific product from the company’s CORDStrom™ pooled, allogeneic umbilical cord-derived mesenchymal stromal cell platform, which is designed to deliver scalable, off-the-shelf therapies.
INmune Bio (NASDAQ: INMB) reported second quarter 2026 net loss attributable to common stockholders of approximately $1.3 million, versus $24.5 million a year earlier, with the prior period including a $16.5 million in-process R&D impairment. Research and development expenses were a $0.8 million benefit, compared with $5.8 million expense, mainly from Australian R&D tax rebates, while general and administrative costs were stable at $2.3 million. As of June 30, 2026, cash and cash equivalents were $18.4 million.
INmune Bio highlighted regulatory and clinical progress: commercial-ready Ebstrocel™ manufacturing in the UK, MHRA alignment and PIP approval ahead of a planned UK MAA by late Q3/early Q4 2026, and preparations for a Phase 3 RDEB trial. For XPro™, the company reported statistically significant MRI biomarker effects in the Phase 2 MINDFuL trial, publication in NPJ Dementia, expanded imaging data, and FDA Fast Track designation for early Alzheimer’s disease, supporting a planned registrational Phase 2b/3 program.
INmune Bio (NASDAQ: INMB) reported receiving a research and development cash rebate of approximately $4.2 million from Australia on July 30, 2026, in addition to about $0.4 million from the United Kingdom in June, for total rebates of roughly $4.6 million.
According to INmune Bio, after adjusting second-quarter operating cash flows to exclude the $0.4 million UK rebate, the combined rebate proceeds exceeded net cash used in operating activities for the quarter. The company said the non-dilutive funding strengthens its balance sheet and extends its cash runway as it advances its late-stage platforms CORDStrom™ (Ebstrocel™) toward regulatory filings and XPro1595™ toward an integrated Phase 2b/3 program in early Alzheimer’s disease.
INmune Bio (NASDAQ: INMB) will report second quarter 2026 results and provide a corporate update on a conference call and webcast on Thursday, August 6, 2026 at 4:30 p.m. Eastern Time. Investors can join via U.S. dial-in 1-800-717-1738 or international +1-646-307-1865 using Conference ID “INMUNE,” or through a live audio webcast.
A replay will be available through September 21, 2026. INmune Bio is a late-stage biotechnology company advancing two platforms: CORDStrom, moving toward MAA and BLA regulatory filings after RDEB readouts, and XPro1595, which holds FDA Fast Track designation and is planned for an integrated Phase 2b/3 program in early Alzheimer’s disease.