INmune Bio to Detail XPro1595 Registrational Strategy in Upcoming Alzheimer's Webinar
MWN-AI** Summary
INmune Bio Inc. (NASDAQ: INMB), a late-stage biotechnology company specializing in inflammation and immunology, is set to host a pivotal webinar on February 27, 2026, at 9:30 a.m. ET. The focus will be on the registrational strategy for its investigational drug, XPro1595 (“XPro™”), aimed at treating early Alzheimer's disease. Following the successful completion of the Phase 2 MINDFuL trial and a constructive End-Of-Phase 2 meeting with the FDA, INmune has laid out a pathway toward advancing XPro™ into a registrational study targeting Alzheimer’s patients exhibiting biomarkers of inflammation.
The webinar will address three critical areas. First, it will present results from the MINDFuL trial, highlighting significant biological and clinical findings that influenced the recent discussions with the FDA. Second, the company will share the design of the forthcoming registrational study and detailed feedback from the FDA that supports its strategic approach. Finally, there will be a forward-looking discussion about the roadmap to Phase 3 trials, which includes plans to establish global partnerships aimed at maximizing XPro™'s clinical and commercial prospects.
Notably, the webinar will feature presentations from esteemed clinical experts like Dr. Michael Woodward from Austin Health and Dr. Sharon Cohen of the Toronto Memory Program, both of whom played pivotal roles in the MINDFuL trial and are recognized leaders in Alzheimer’s research.
XPro™ is a next-generation soluble TNF inhibitor that aims to reduce neuroinflammation and potentially enhance cognitive function in Alzheimer's patients. As the company moves forward, it seeks to address critical market needs in Alzheimer's treatment, reinforcing its commitment to developing innovative therapies targeting innate immune dysfunction. Interested participants can register for the webinar via the provided link.
MWN-AI** Analysis
As an analyst focusing on the biotechnology sector, I find INmune Bio Inc. (NASDAQ: INMB) to be particularly noteworthy as it gears up for its upcoming webinar on February 27, 2026. The spotlight will be on the registrational strategy for XPro1595 (XPro™), a selective TNF inhibitor aimed at treating early Alzheimer’s disease, a condition that presents a considerable unmet medical need.
Following promising results from the Phase 2 MINDFuL trial, INmune has received favorable guidance from the FDA, signaling readiness to move forward with a registrational study. This aligns well with the growing recognition of the importance of targeting neuroinflammation in Alzheimer’s treatment. Investors should note that XPro’s unique mechanism—neutralizing soluble TNF without affecting transmembrane TNF—may position it as a valuable therapeutic option in managing Alzheimer’s disease characterized by inflammatory biomarkers.
The webinar promises to provide critical insights into the regulatory pathway, study design, and potential strategic partnerships to maximize XPro™’s clinical and commercial reach. Given the recent validation from the FDA and the expertise of the presenters, Dr. Michael Woodward and Dr. Sharon Cohen, it is likely that this event will bolster confidence among stakeholders and attract investor interest.
For investors considering a position in INmune Bio, the key indicators to monitor will be the outcomes of the registrational studies and FDA interactions moving forward. A strong partnership approach, especially in a market facing increasing regulatory scrutiny, could further enhance the company’s long-term prospects. I recommend keeping an eye on post-webinar market reactions and any forthcoming updates on clinical milestones, as these could serve as significant price catalysts in an otherwise volatile biotech environment.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
Boca Raton, FL, Feb. 23, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (“INmune” or the “Company”), a late-stage biotechnology company focused on inflammation and immunology, will host a webinar focused on the registrational pathway of XPro1595 (“XPro™”) for the treatment of early Alzheimer’s disease on February 27, 2026 at 9:30 a.m. ET.
Post the completion of the Phase 2 MINDFuL trial, along with feedback from the FDA in a recent End-Of-Phase 2 meeting, the Company has received alignment supporting advancement to a registrational study in patients with Alzheimer’s Disease with biomarkers of Inflammation.
Webinar Focus: From Phase 2 Results to Phase 3 Readiness
XPro™ is a next-generation, selective soluble TNF inhibitor designed to selectively neutralize soluble TNF (sTNF) and restore immune homeostasis in the brain, without affecting transmembrane TNF (tmTNF) or TNF receptors.
The webinar will be organized around three core topics:
1. MINDFuL Trial Results and Path to the FDA End-of-Phase 2 Meeting A detailed presentation of MINDFuL Phase 2 trial results, including key biological and clinical findings, and how those results informed the Company's End-of-Phase 2 meeting with the FDA. Discussion will highlight the impact of the enrichment strategy and the biomarker data that shaped the FDA dialogue.
2. Registrational Study Design and FDA Feedback An overview of, and rationale for, the registrational study design and the specific FDA feedback received that supports advancement of XPro™ in a biomarker enriched population.
3. Path to Phase 3 and Maximizing XPro™'s Potential Through Global Partnership A forward-looking discussion on the strategic roadmap to Phase 3, including the Company's approach to securing a global partnership to maximize the clinical and commercial potential of XPro™ and accelerate its development for patients with Alzheimer's Disease with Inflammation worldwide.
Featured Clinical Experts
The webinar will feature a presentation of MINDFuL trial results by Dr. Michael Woodward, Associate Professor at the Memory Clinic at Austin Health (Australia), and an expert clinical discussion by Dr. Sharon Cohen, MD, FRCPC, Medical Director at the Toronto Memory Program (Canada). Both physicians served as site investigators in the MINDFuL trial and are internationally recognized as Key Opinion Leaders in Alzheimer's disease research.
Registration Details
To register for the webinar on February 26, 2026, at 9:30 a.m. ET, click here or copy and paste the link below:
About Dr. Woodward
Associate Professor Michael Woodward is Head of Aged Care Research and the Memory Clinic at Austin Health in Melbourne, Victoria. He is a specialist in geriatric medicine with major interests in the treatment of Alzheimer’s disease (AD) and other dementias. He is Principal Investigator for numerous research trials of new therapies for AD and related disorders. He is immediate Past President of the AC4R – now called Dementia Trials Australia, that brings together researchers into therapeutic agents for dementia. He is also a member of the Board of the Dementia Alzheimer Research Foundation, which annually administers over $10 million of dementia research funding. He is one of now 3 Honorary Medical Advisors for Dementia Australia.
Michael Woodward’s publication record includes over 140 original research and review articles. He is a Fellow of the Australian Association of Gerontology (AAG), the Australian and New Zealand Society for Geriatric Medicine, the Australian Wound Management Association (AWMA- now Wounds Australia) and of the Royal Australasian College of Physicians (RACP) and has long served each of these professional bodies, including being President of AWMA and AAG (Vic) and chairing the Committee for Physician Training that oversaw the training of all RACP trainees. He is currently Chair of the Accreditation Committee of the Adult Division of the RACP, accrediting training and training sites for Basic Physician Training and sits on the Adult Division Education Committee of that College.
About Dr. Sharon Cohen
Dr. Cohen is a behavioral neurologist known for her excellence in patient care, teaching, and clinical research. She completed her neurology residency and behavioral neurology fellowship at the University of Toronto. She is the Medical Director and site Principal Investigator (PI) of Toronto Memory Program, a community-based medical facility that she established in 1996 for the purpose of enhancing diagnosis, care, and therapeutic options for individuals with or at risk of Alzheimer’s disease and related disorders. Under her guidance, Toronto Memory Program’s multidisciplinary team has grown to a staff of 60 individuals. Its memory clinic and research site are among the most active in Canada. Dr. Cohen has over 30 years of experience in clinical research and has been a site PI for over 180 pharmacological trials. Her site has been credited as a “go to” center for Alzheimer’s disease trials and has been awarded for superior performance and quality in clinical research. Dr. Cohen represents Canada on international advisory boards and steering committees and is a consultant to a wide range of stakeholders in dementia including government organizations and patient advocacy groups. She is a frequent lecturer and contributes to media events including those on medical ethics. She is known for her advocacy of individuals with neurodegenerative diseases.
About XPro™
XPro™ is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro™ could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication, visit our website at www.inmunebio.com.
About INmune Bio Inc.
INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has three product platforms: (1) CORDStrom™, a proprietary pooled, allogeneic, human umbilical cord-derived mesenchymal Stromal/Stem cell (hucMSCs) platform that recently completed a blinded randomized trial in recessive dystrophic epidermolysis bullosa; (2) XPro™, a Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform designed to selectively neutralize soluble TNF, a key driver of inflammation and innate immune dysfunction; and (3) INKmune®, a cell-based medicine designed to prime a patient’s natural killer cells to eliminate minimal residual disease in patients with cancer. To learn more, please visit www.inmunebio.com.
Forward Looking Statements
Clinical trials are in early stages, and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, including trial results, timing of key milestones, future plans or expectations, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. 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™, XPro1595™ (XPro™, 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 produce more drug 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
Chief Executive Officer
(561) 710-0512
info@inmunebio.com
Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com
Daniel Carlson
FAQ**
How might the advancements in XPro™ by INmune Bio Inc. (NASDAQ: INMB) impact the treatment landscape for early Alzheimer's disease, particularly considering the results from the Phase 2 MINDFuL trial?
What specific FDA feedback did INmune Bio Inc. (NASDAQ: INMB) receive during the End-of-Phase 2 meeting that supports the enrollment of a biomarker-enriched population for the registrational study of XPro™?
Can you elaborate on the strategic roadmap that INmune Bio Inc. (NASDAQ: INMB) intends to follow to facilitate a Phase 3 clinical trial for XPro™, and how do global partnerships play a role in this strategy?
What are the potential challenges and risks that INmune Bio Inc. (NASDAQ: INMB) faces as it transitions from Phase 2 results to the Phase 3 readiness of XPro™, especially regarding regulatory approval and funding for future trials?
**MWN-AI FAQ is based on asking OpenAI questions about INmune Bio Inc. (NASDAQ: INMB).
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