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

Boca Raton, FL, May 15, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB), a clinical-stage biotechnology company developing therapies that target innate immune dysfunction, today announced that results from its Phase 2 MINDFuL trial in Alzheimer’s disease have been published in the peer-reviewed journal NPJ Dementia. The study evaluated the safety, biomarker engagement, and clinical efficacy of XPro™ (XPro1595, pegipanermin) in patients with mild Alzheimer’s disease characterized by biomarkers of inflammation. In a pre-specified analysis of the protocol-defined Alzheimer’s Disease with inflammation (ADi) subgroup, XPro™ showed directionally consistent benefit across cognitive, global, functional, behavioral, and biomarker endpoints over 24 weeks, with no amyloid-related imaging abnormalities (ARIA) observed.

The publication, titled “XPro1595 in Early Alzheimer’s Disease with Inflammation: Results from the Phase 2 MINDFuL Trial,” discusses how XPro™ demonstrated consistent positive trends in a pre-specified enriched subpopulation (n=100) with amyloid-beta positivity and two or more inflammation biomarkers (hsCRP, ESR, HbA1c, or APOE ε4 allele). The paper further highlights the effect sizes (Cohen’s d) up to 0.27 across cognitive (EMACC, International Shopping List Test), Patient-Reported Outcomes (Goal Attainment), behavioral (Neuropsychiatric Inventory), and biomarker endpoints (pTau217 and GFAP), directionally consistent with an XPro™ treatment effect. These findings support prioritization of the enriched population in future studies to optimize detection of treatment effects.

CJ Barnum, PhD, Vice President of Neuroscience at INmune Bio, said, “MINDFuL is the first peer-reviewed trial to prospectively identify Alzheimer’s patients by both amyloid pathology and a biomarker-defined inflammatory signature. In this pre-specified subgroup, we observed directional improvements across cognitive, global, functional, behavioral, and biomarker endpoints, with no ARIA. The cross-domain consistency tracks with the underlying biology and represents the type of signal a Phase 2 trial is designed to identify, forming the foundation of a Phase 3 program.”

David Moss, CEO of INmune Bio, said, “The publication of the Phase 2 results from MINDFuL in NPJ Dementia, together with the FDA Fast Track designation, strengthens the value of the XPro platform. The trial also supports a biomarker-enriched (inflammation-enriched) strategy designed to improve future trial design and enhance the potential for clinical success, while reinforcing the broader potential of selective sTNF neutralization across inflammation-driven diseases.”

The full paper is available on the NPJ Dementia website or by clicking here.

For more information about the MINDFuL trial or for additional details about INmune Bio’s ongoing programs, please visit www.inmunebio.com.

About XPro™

XPro™ is a next-generation, dominant-negative protein biologic that acts as a selective inhibitor of soluble tumor necrosis factor (sTNF). Unlike non-selective TNF inhibitors, XPro™ neutralizes the pathological driver — sTNF signaling through TNFR1 — while preserving transmembrane TNF (tmTNF) and its homeostatic signaling through TNFR2, which is essential for normal immune function, cellular repair, and host defense. By targeting innate immune dysfunction rather than broadly suppressing immune function, XPro™ is designed to selectively restore immune balance in the central nervous system.

About INmune Bio Inc.

INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company building therapeutics around the innate immune system. The company’s lead platform, Dominant-Negative Tumor Necrosis Factor (DN-TNF), is designed to selectively neutralize soluble TNF — a driver of innate immune dysfunction implicated across a range of inflammation-driven diseases. XPro™ (pegipanermin), the lead DN-TNF candidate, is in clinical development in Alzheimer’s disease with inflammation (ADi), with FDA Fast Track designation, and in treatment-resistant depression. INmune Bio’s two additional platforms — INKmune®, a natural killer cell priming platform in clinical development for metastatic castration-resistant prostate cancer, and CORDStrom™, an allogeneic human umbilical cord-derived mesenchymal stromal/stem cell (hucMSCs) platform that recently completed a blinded randomized trial in recessive dystrophic epidermolysis bullosa — extend the company’s precision immunology focus. To learn more, please visit www.inmunebio.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These include any statements related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, timing of key milestones, future plans or expectations, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates. Any forward-looking statements contained herein are based on current expectations but are subject to several risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements because of these risks and uncertainties. CORDStrom™, XPro™ (XPro1595, pegipanermin), and INKmune® have either finished clinical trials, are still in clinical trials or are preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA), the UK MHRA or any regulatory body and there cannot be any assurance that they will be approved by the FDA, the UK MHRA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to manufacture sufficient drug supply for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements to reflect any event or circumstance that may arise after the date of this release.

INmune Bio Contacts:

David Moss
Co-founder and Chief Executive Officer
(858) 964-3720
info@inmunebio.com

Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com

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