INmune Bio, Inc.

INmune Bio Advances Ebstrocel™ Toward Potential UK Approval in Mid-2027

INmune Bio submitted its final pre-MAA package to the UK MHRA for Ebstrocel (CORDStrom), its cell therapy for recessive dystrophic epidermolysis bullosa, on October 20, 2026. Faster-than-expected manufacturing progress supports a full MAA submission in early February 2027, replacing a sequential rolling submission, with potential UK approval in mid-2027 — about six weeks earlier than previously anticipated. In parallel, the company plans a Q2 2027 U.S. BLA submission, prioritizing FDA ahead of EMA and building on U.S. Orphan Drug and Rare Pediatric Disease designations. Approval is not assured; MHRA response is expected three to six months after submission and the company notes it will need substantial additional funding to reach commercialization.

•11d ago

INmune Bio Establishes Global Commercialization Framework for Ebstrocel™ Through Strategic Agreement with Uniphar

INmune Bio signed a Master Services Agreement with Uniphar to provide international access, distribution and commercialization infrastructure for Ebstrocel, its allogeneic stromal cell therapy for Recessive Dystrophic Epidermolysis Bullosa. Initial focus is named-patient access in selected European and MENA markets, allowing physicians to request the therapy for individual patients before local marketing approval, with scope to expand by mutual agreement. The company frames the deal as a capital-efficient path that avoids building country-by-country capabilities internally, ahead of planned MAA filings with the UK MHRA in 2026 and EU EMA in 2027. No financial terms or revenue commitments were disclosed, and Ebstrocel remains investigational with no regulatory approvals to date.

•11d ago

INmune Bio Inc. and Quantum Computing Inc. Partner to Apply Quantum Optimization and AI to Advance Alzheimer’s Drug Research and Explore New Applications for XPro ™

INmune Bio and Quantum Computing Inc. announced a collaboration applying QCi's Dirac-3S quantum optimization machine with AI to INMB's clinical and biomedical datasets to find new indications and biomarkers for XPro. The Stage 1 engagement is QCi's first commercial customer in pharma/biotech; no financial terms were disclosed. INMB plans to prioritize indications starting with rare diseases where trials are smaller and capital-efficient, and where pediatric approvals may earn a Priority Review Voucher. For INMB this is exploratory optionality on XPro's broader label potential; XPro1595 is already positioned for a Phase 2b/3 registrational program in Alzheimer's with FDA Fast Track designation.

•18d ago

INmune Bio Appoints Sanofi Rare-Disease Executive and Biopharma Business Development Leader to Board

INmune Bio appointed two new directors, R. Duane Clark II and James Sapirstein, adding rare-disease commercial and deal-making depth as it prepares Ebstrocel for potential rare-disease commercialization. Clark currently runs Sanofi's U.S. Rare Diseases business, a multi-billion-dollar unit spanning seven brands. Sapirstein has 40+ years in biopharma business development, led six global product launches, and founded Tobira Therapeutics, later acquired by Allergan in a deal worth up to roughly $1.7 billion including milestones. The board expansion targets market-access and launch planning for Ebstrocel in recessive dystrophic epidermolysis bullosa plus evaluation of licensing and strategic partnerships across the pipeline, which includes CORDStrom (MAA planned for UK MHRA in 2026 and EU EMA in 2027, alongside a planned U.S. BLA) and XPro1595 in early Alzheimer's disease.

•1mo ago

INmune Bio Advances Ebstrocel™ Toward European Marketing Authorization with EMA Regulatory Filings

INmune Bio submitted an Orphan Drug Designation application and a pre-MAA Scientific Advice package to the EMA for Ebstrocel™, supporting a planned EU Marketing Authorization Application in Q1 2027. The filings align with a coordinated global registration strategy, targeting a UK MAA in Q4 2026 and a U.S. BLA in Q1 2027, with potential orphan designation offering 10 years of market exclusivity in Europe. Ebstrocel™ is the first product from the CORDStrom™ platform, being developed as a systemic treatment for recessive dystrophic epidermolysis bullosa (RDEB).

•2mo ago

INmune Bio Inc. Announces Second Quarter 2026 Results and Highlights Regulatory, Manufacturing and Clinical Progress

INmune Bio reported a Q2 net loss of $1.3 million, a significant improvement from the prior year's $24.5 million loss, largely due to a $4.2 million Australian R&D tax rebate recognized during the quarter. Operationally, the company secured FDA Fast Track designation for XPro in early Alzheimer's disease and reported statistically significant MRI biomarker data, while Ebstrocel achieved MHRA alignment and commercial manufacturing milestones for its RDEB program. The company ended the quarter with $18.4 million in cash and plans to submit a UK MAA for Ebstrocel in late 2026, followed by a US BLA and an EU MAA in early 2027.

•2mo ago

INmune Bio Receives R&D Rebates of Approximately $4.6 Million

INmune Bio received approximately $4.6 million in non-dilutive R&D cash rebates, comprising $4.2 million from Australia and $0.4 million from the United Kingdom. These proceeds exceeded the company's second-quarter operating cash burn, strengthening its balance sheet and extending its cash runway as it advances CORDStrom toward regulatory filings. Management highlighted that the funding supports upcoming regulatory and clinical milestones without the need for additional equity issuance.

•3mo ago

INmune Bio Establishes Scientific Advisory Board to Support Late-Stage Development and Expansion of CORDStrom™ Platform

INmune Bio formed a Scientific Advisory Board chaired by CSO Mark Lowdell to support the late-stage development of Ebstrocel for RDEB and guide expansion of the CORDStrom platform. The board includes four international experts in MSC biology, rare pediatric skin disease and osteoarthritis who will advise on regulatory strategy, Phase 3 trial design and manufacturing. The CORDStrom platform is advancing toward regulatory submissions with a UK MAA planned for 2026, an EU EMA filing in 2027 and a US BLA targeted for early 2027.

•3mo ago

INmune Bio Completes Commercial Manufacturing Milestone Supporting Planned Global Registration Filings for CORDStrom™ Platform

INmune Bio achieved a key operational milestone by processing its first commercial-ready umbilical cord tissue at the Cell and Gene Therapy Catapult facility in the UK. The successful transfer of the mesenchymal stromal cell isolation process allows the company to generate master cell banks for Ebstrocel, supporting a planned Phase 3 confirmation trial. Management noted that this commercial-ready infrastructure satisfies MHRA, EMA, and FDA standards, positioning the company for upcoming regulatory filings in the US, EU, and UK.

•3mo ago

INmune Bio’s XPro1595 Prevents Brain-Injury-Induced Alzheimer's Pathology, Memory Loss, and Pain in New Peer-Reviewed Preclinical Study

INmune Bio announced the publication of a peer-reviewed preclinical study in the Journal of Neurotrauma showing that its lead candidate XPro1595 prevented Alzheimer's pathology and memory loss in a TBI mouse model. The Department of Defense–funded study found that neutralizing soluble TNF with XPro1595 stopped the rise in amyloid beta and improved cognitive outcomes after injury. Management noted the data reinforces the company's approach of selectively targeting soluble TNF to treat neuroinflammation in neurodegenerative diseases.

•3mo ago

INmune Bio to Present Positive Phase 2 Imaging Data for XPro in Early Alzheimer’s Disease at AAIC

INmune Bio reported positive Phase 2 imaging data for XPro1595 in early Alzheimer’s disease, showing statistically significant treatment-related changes in white matter myelin integrity at Week 24 (p < 0.01). The data, to be presented at the AAIC 2026 conference, also showed concordant effects in cortical gray matter microstructure using independent MRI methods, supporting the drug’s engagement with relevant biology. These results reinforce the company’s strategy of using biomarker enrichment and support the progression of XPro1595 into an integrated Phase 2b/3 seamless adaptive registrational program.

•3mo ago

INmune Bio Advances CORDStrom™ Platform Patent Application in the U.S. Following Favorable International Written Opinion

INmune Bio advanced its CORDStrom platform patent application into the U.S. national phase after receiving a favorable Written Opinion during the international phase. The patent application seeks protection for composition-of-matter and methods of treatment for Ebstrocel and next-generation modalities, with exclusivity potentially extending to 2045. The company continues to pursue corresponding patent protection in the UK, Europe, and other strategic jurisdictions to support global commercialization efforts.

•4mo ago

INmune Bio Inc. Achieves MHRA Approval of PIP for CORDStrom™

INmune Bio secured MHRA approval for the Pediatric Investigation Plan for Ebstrocel, validating its clinical data package for RDEB treatment. The accelerated review, completed in under three months, keeps the company on track for a UK Marketing Authorization Application in 2026 and a US filing in early 2027. Management highlighted the milestone as a significant regulatory de-risking event that aligns the evidence package and manufacturing strategy for potential commercialization.

•4mo ago

INmune Bio Receives MHRA Written Alignment Supporting Planned 2026 UK Conditional Marketing Authorization Application for CORDStrom™ in RDEB

INmune Bio received written alignment from the UK MHRA confirming agreement on CMC, non-clinical, and clinical strategies, paving the way for a planned 2026 Conditional Marketing Authorization Application for CORDStrom™ in RDEB. The agency validated the company's capital-efficient non-clinical safety package and recognized MissionEB Phase 2 data as showing clinically meaningful symptomatic benefits, specifically in pain and pruritus. However, MHRA noted the study did not demonstrate durable wound closure, suggesting the product be positioned as chronic or intermittent supportive therapy rather than a curative wound closure treatment.

•4mo ago

INmune Bio Reports Statistically Significant Treatment Effect on Advanced White Matter MRI Biomarker in Phase 2 MINDFuL Alzheimer's Trial

INmune Bio reported statistically significant treatment effects on white matter MRI biomarkers in its Phase 2 MINDFuL Alzheimer's trial for XPro1595. The full intent-to-treat population (n=200) showed a p-value of 0.0028 and a medium effect size (d=0.46), while the inflammation-enriched subgroup (n=100) showed a stronger effect (p=0.0098, d=0.59). These results validate the drug's mechanism of action and support the company's FDA-aligned Phase 2b/3 registrational strategy, which has already secured Fast Track designation and End-of-Phase 2 meeting alignment.

•4mo ago

INmune Bio Publishes Phase 2 MINDFuL Trial Results in NPJ Dementia, Advancing the XPro™ Platform

INmune Bio published Phase 2 MINDFuL trial results for XPro in Alzheimer’s disease in the journal NPJ Dementia. In a pre-specified subgroup of 100 patients with amyloid positivity and inflammation biomarkers, XPro showed directional improvements across cognitive, functional, and biomarker endpoints over 24 weeks. No amyloid-related imaging abnormalities (ARIA) were observed, and the company cites these findings as the foundation for a future Phase 3 program using a biomarker-enriched strategy.

•5mo ago

INmune Bio Inc. Announces First Quarter 2026 Results and Provides Business Update

INmune Bio reported Q1 2026 financial results with a net loss of $5.4 million, a significant improvement from the $9.7 million loss in the prior year period, driven largely by lower R&D expenses of $3.6 million compared to $7.6 million. The company achieved key regulatory milestones, completing a pre-submission package for CORDStrom™ with the UK MHRA and securing FDA alignment to advance XPro™ into an adaptive Phase 2b/3 registrational pathway for early Alzheimer's Disease. Management expects to file a Marketing Authorization Application for CORDStrom™ in the UK mid-summer, followed by submissions to the EMA and FDA, with a BLA submission expected in Q4 2026.

•5mo ago

INmune Bio and Anthony Nolan Announce Strategic Expansion of CORDStrom™ MSC Platform Collaboration to Target RDEB, Oncology, and Inflammatory Diseases

INmune Bio expanded its collaboration with Anthony Nolan to secure a long-term supply of umbilical cord tissue for its CORDStrom platform. The amended agreement supports development in RDEB, oncology via CORDStrom-TRAIL, and inflammatory diseases like osteoarthritis and SLE. CEO David Moss emphasized that this partnership solves MSC consistency challenges and enables consistent, high-potency treatments for new indications.

•5mo ago

Biotech Leaders Launch National Alliance to Define the Future of American Innovation

INmune Bio CEO David Moss announced the company as a founding member of the American Biotech Innovation Alliance (ABIA), a coalition of 21 biotech firms. The alliance aims to develop a national innovation roadmap addressing regulatory policy, capital formation, and workforce development to sustain U.S. leadership. ABIA distinguishes itself from traditional trade groups by focusing on strategic alignment through small-group convening rather than broad advocacy.

•5mo ago