Agency Feedback Provides Regulatory Clarity on Enrichment Strategy and Confirms CDR-SB as Sole Primary Endpoint for Registrational Development Boca Raton, FL, Feb. 12, 2026 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (“INmune Bio” or the “Company”), a late-stage biotechnology company focused on inflammation and immunology, today announced that it received the official minutes from its End-of-Phase 2 (Type B) meeting with the U.S. Food and Drug Administration (FDA). The minutes confirm regulatory a ...

INmune Bio (INMB) has formally submitted its pre-submission package for CORDStrom with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency. This early engagement step is designed to solicit targeted scientific, regulatory, and procedural feedback, streamlining the full Marketing Authorization Application process and potentially shortening time to market for what could become the first systemic therapy for this devastating “butterfly skin” disease. INmune Bio has completed three commerc ...

Core Insights - INmune Bio Inc. has submitted a pre-submission package for CORDStrom™ to the UK Medicines and Healthcare Products Regulatory Agency (MHRA), aiming to expedite the approval process for a potential systemic therapy for recessive dystrophic epidermolysis bullosa (RDEB) [1][3] - CORDStrom is being developed as a disease-modifying treatment for RDEB, a rare genetic disorder affecting approximately 1 in 1 million births globally, with no approved systemic therapies currently available [2][5] - The company has completed three commercial pilot-scale manufacturing runs, confirming readiness for commercial supply and plans to file a full Marketing Authorization Application (MAA) with MHRA by mid-summer 2026 [3][4] Regulatory and Legislative Context - CORDStrom has received Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) designation in the U.S., which are significant due to the recent reauthorization of the FDA's Rare Pediatric Disease Priority Review Voucher (PRV) program through September 30, 2029 [4][5] - The reauthorization of the PRV program strengthens incentives for developing therapies for rare pediatric diseases, potentially benefiting INmune Bio as it prepares for a Biologics License Application (BLA) submission later this year [5] Product and Technology Overview - CORDStrom™ is a patent-pending cell medicine utilizing pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs), designed for injection or infusion to treat complex inflammatory and autoimmune diseases [7] - The platform allows for the creation of indication-specific products that can be optimized for various therapeutic characteristics, addressing severe unmet needs in RDEB patients [7][8]

Core Insights - INmune Bio, Inc. has made significant progress in 2025, focusing on developing therapies for neuroinflammatory and immunologic diseases, particularly through its programs XPro™ for Alzheimer's disease and CORDStrom™ for Recessive Dystrophic Epidermolysis Bullosa (RDEB) [1][10] CORDStrom™ Program - CORDStrom™, an allogeneic umbilical cord-derived mesenchymal stromal cell therapy for RDEB, achieved substantial progress in 2025, including successful completion of three commercial pilot-scale runs in preparation for regulatory filings [2] - The company plans to submit a Marketing Authorization Application (MAA) to the UK's Medicines and Healthcare products Regulatory Agency (MHRA) by mid-summer 2026, followed by a Biologics License Application (BLA) to the U.S. FDA towards the end of 2026 [2][3] XPro™ Program - XPro™ demonstrated potential as a differentiated therapy for Alzheimer's disease, with a Phase 2 study (MINDFuL) revealing meaningful signals in a predefined subpopulation of amyloid-positive early AD patients [4][6] - In this subpopulation, XPro™ showed an effect size of 0.27 on the EMACC cognitive scale after 6 months, which compares favorably to the effect sizes of approved anti-amyloid therapies [6][7] - The results support XPro's proposed mechanism of action, which involves selectively inhibiting soluble TNF to reduce neuroinflammation while preserving beneficial TNF signaling [8] Financial Position - As of September 30, 2025, INmune Bio had approximately $27.7 million in cash and cash equivalents, positioning the company well for continued execution and enabling it to achieve key milestones through year-end 2026 [9]

Core Insights - INmune Bio, Inc. has published an overview of future applications and research areas for mesenchymal stromal cell (MSC) therapies, particularly focusing on its CORDStrom™ platform, in the journal Cytotherapy [1][2] Group 1: Research and Development - The article reviews current knowledge and identifies critical gaps in MSC therapies to enhance their development, including topics like systemic delivery and in vivo persistence [2] - CORDStrom™ is initially being developed for recessive dystrophic epidermolysis bullosa (RDEB), with plans to file a Biologics License Application (BLA) and Marketing Authorization Application (MAA) in 2026 [3] - The publication provides important scientific background for the future development of the CORDStrom™ platform, which may significantly impact various indications such as inflammation and wound healing [3] Group 2: CORDStrom™ Platform - CORDStrom™ is a patent-pending cell medicine made from aseptic, allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs) designed for injection or infusion [4] - The platform utilizes proprietary techniques for screening, pooling, and expanding hucMSCs, aiming to create consistent, scalable, and affordable cellular medicines for complex diseases [4] - CORDStrom™ products are designed to be indication-specific, optimizing characteristics for anti-inflammatory and immunomodulatory effects [4] Group 3: Company Overview - INmune Bio Inc. is a publicly traded clinical-stage biotechnology company focused on developing treatments targeting innate immune dysfunction [5] - The company's pipeline includes CORDStrom™, DN-TNF Platform (XPro™/XPro1595) for neuroinflammatory conditions, and INKMune™ for cancer treatment [7]

Core Insights - INmune Bio, Inc. announced new neuroimaging data from its Phase 2 MINDFuL trial of XPro1595 in early Alzheimer's disease patients with elevated neuroinflammation, to be presented at the 18th Clinical Trials on Alzheimer's Disease conference [1][2] Group 1: Clinical Trial Results - The new analyses support XPro1595's mechanism of selectively neutralizing soluble TNF (sTNF), validating the strategy of targeting inflammation-driven Alzheimer's disease, which represents a significant unmet need [2][9] - PerpPD+ MRI imaging analysis indicated a trend towards slowed neurodegeneration progression in patients receiving XPro1595, particularly in those with early Alzheimer's and high inflammatory burden [3][8] - Findings suggest reduced cortical disarray, an imaging hallmark of neurodegeneration, reinforcing previously reported improvements across biological, cognitive, and neuropsychiatric endpoints [4][5] Group 2: Future Developments - Additional MRI analyses from the MINDFuL trial are ongoing and will provide a broader understanding of XPro1595's impact on gray- and white-matter integrity in Alzheimer's patients [7] - The totality of data generated to date positions XPro1595 as a promising first-in-class disease-modifying therapy for Alzheimer's patients with elevated neuroinflammation, a population with limited treatment options [9][10] Group 3: Company Overview - INmune Bio Inc. is a clinical-stage biotechnology company focused on developing treatments targeting innate immune dysfunction to combat diseases [11] - The company's pipeline includes XPro1595, an inhibitor of soluble TNF that aims to restore healthy innate immune function without the immunosuppressive effects of traditional TNF inhibitors [10]

Core Insights - INmune Bio, Inc. is set to present two studies at the 18th Clinical Trials on Alzheimer's Disease conference in San Diego from December 1-4, 2025 [1][2] Presentations - The first presentation will focus on XPro1595, a selective soluble TNF neutralizer, in early Alzheimer's disease with inflammation, showcasing results from the Phase 2 MINDFuL trial [2] - The second presentation will validate the Early Mild Alzheimer's Cognitive Composite (EMACC) through associations with blood-based biomarkers of Alzheimer's disease [2] Company Overview - INmune Bio Inc. is a clinical-stage biotechnology company specializing in treatments targeting immunology and inflammation [3] - The company has three product platforms: - The Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform, which selectively neutralizes soluble TNF [3] - CORDStrom™, a proprietary platform utilizing human umbilical cord-derived mesenchymal stromal cells, which recently completed a trial in recessive dystrophic epidermolysis bullosa [3] - INKmune®, designed to prime natural killer cells to eliminate minimal residual disease in cancer patients, currently in trials for metastatic castration-resistant prostate cancer [3]

Core Viewpoint - INmune Bio, Inc. (INMB) has shown a recent downtrend, losing 11.9% over the past four weeks, but a hammer chart pattern suggests a potential trend reversal as buying interest may be emerging [1][2]. Technical Analysis - The hammer chart pattern indicates a possible bottoming out, with selling pressure likely subsiding, which could lead to a bullish trend for the stock [2][5]. - A hammer pattern forms when there is a small candle body with a long lower wick, signaling that bears may be losing control over the price [4][5]. - This pattern can occur across various timeframes and is utilized by both short-term and long-term investors [5]. Fundamental Analysis - There has been a notable upward trend in earnings estimate revisions for INMB, which is a bullish indicator as it correlates strongly with near-term stock price movements [7]. - The consensus EPS estimate for the current year has increased by 8.2% over the last 30 days, indicating strong agreement among analysts regarding the company's potential for better earnings [8]. - INMB holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [9][10].

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Financial Data and Key Metrics Changes - The net loss attributable to common stockholders for Q3 2025 was approximately $6.5 million, a decrease from approximately $12.1 million in Q3 2024 [24] - Research and development expenses totaled approximately $4.9 million for Q3 2025, down from approximately $10.1 million in the same period of 2024 [24] - General and administrative expenses were approximately $2.5 million for Q3 2025, compared to approximately $2.2 million in Q3 2024 [24] - As of September 30, 2025, the company had cash and cash equivalents of approximately $27.7 million, sufficient to fund operations into Q4 2026 [24] Business Line Data and Key Metrics Changes - The Cordstrom program is preparing for submission for marketing approval in the UK and US, with significant improvements noted in patients suffering from recessive dystrophic epidermolysis bullosa (RDEB) [5][10] - The EXPRO platform is focused on treating neuroinflammation in Alzheimer's disease, with a manuscript detailing Phase 2 Mindful trial results submitted for peer-reviewed publication [8][20] - The Incuboom program completed its Phase 2 trial in prostate cancer ahead of schedule, meeting the primary endpoint and two of three secondary endpoints [9][18] Market Data and Key Metrics Changes - The company is optimistic about the regulatory environment, with plans to file a Marketing Authorization Application (MAA) in the UK and a Biologics License Application (BLA) in the US for Cordstrom [10][26] - There is a significant unmet need in the RDEB market, with current treatments being expensive and not widely available through the NHS [60] Company Strategy and Development Direction - The company aims to advance its three drug platforms in parallel to provide strength and opportunity, with a focus on achieving key development milestones [10] - Cordstrom is viewed as a platform opportunity with potential applications in various diseases beyond RDEB, including cancer [8][10] - The EXPRO platform is positioned to address gaps in Alzheimer's treatment, particularly for patients with strong inflammatory profiles [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the next couple of years, expecting to demonstrate the success of their efforts through key development milestones [5] - The company is focused on regulatory alignment and advancing discussions with potential partners to support late-stage clinical development [20] - Management acknowledged the challenges in Alzheimer's drug development but remains confident in EXPRO's potential as a differentiated therapy [22] Other Important Information - The company has relocated to rented CGMP manufacturing space compliant with commercial production as a licensed medicine [16] - The Phase 2 Mindful trial results indicate that longer treatment durations with EXPRO are associated with greater improvements in neuropsychiatric symptoms [21] Q&A Session Summary Question: What are the biggest questions for the end of Phase 2 meeting with the FDA? - Management indicated that questions will focus on EMAC, enrichment biomarkers, and the safety database required for commercialization [32] Question: How are partnership discussions progressing for EXPRO? - Management noted that discussions are ongoing but are waiting for regulatory feedback and more data before aggressive partnering [36] Question: What is the current treatment paradigm for RDEB in the UK? - Management clarified that there is no RDEB-specific treatment available through the NHS, and Cordstrom is expected to fill this gap with a systemic effect [60] Question: What is the cash runway for upcoming milestones? - The current cash position is expected to support operations through Q4 2026, with significant milestones anticipated in early 2026 [67]