Core Insights - INmune Bio Inc. has transitioned from a mid-stage clinical company to a late-stage, registration-directed organization, focusing on harnessing the innate immune system to treat inflammatory diseases [4] - The company is preparing for significant regulatory submissions in 2026 and 2027, with two late-stage assets, CORDStrom™ and XPro™, expected to drive value for patients and shareholders [4] Financial Results - For the year ended December 31, 2025, the net loss attributable to common stockholders was approximately $45.9 million, compared to $42.1 million in 2024 [12] - Research and development expenses were approximately $20.7 million in 2025, down from $33.2 million in 2024, while general and administrative expenses increased to approximately $10.3 million from $9.5 million [12] - The company reported cash and cash equivalents of approximately $24.8 million as of December 31, 2025, an increase from $20.9 million in 2024 [17] CORDStrom™ Platform - CORDStrom™ is on track to file a Marketing Authorization Application (MAA) in the UK by mid-summer 2026, followed by anticipated submissions to the EMA and FDA [5] - The platform is designed to treat recessive dystrophic epidermolysis bullosa (RDEB) and has shown systemic disease-modifying capabilities in clinical trials [5][6] XPro™ Platform - XPro™ is advancing towards an adaptive Phase 2b/3 registrational pathway for early Alzheimer's Disease, with alignment achieved with the FDA [5] - The platform has reported zero cases of ARIA (Amyloid-related imaging abnormalities) across all clinical studies, distinguishing it from other therapies [8] Upcoming Events and Milestones - The company has scheduled a face-to-face meeting with the UK's MHRA in mid-May 2026 as part of its regulatory strategy [11] - INmune Bio's MINDFuL trial data was featured at the AD/PD 2026 conference, highlighting the importance of patient selection in clinical trials [5] Operational Readiness - The company has completed three commercial pilot-scale manufacturing runs at its Stevenage facility, ensuring readiness to supply the market upon regulatory approval [11] - INmune Bio estimates that its current cash position provides a runway through Q1 2027, supporting ongoing operations and clinical development [5]

Core Viewpoint - INmune Bio Inc. will host a conference call on March 30, 2026, to discuss its financial results for the year ended December 31, 2025, and provide a corporate update [1]. Company Overview - INmune Bio Inc. is a clinical-stage biotechnology company focused on developing treatments targeting the innate immune system to combat diseases [3]. - The company has three product platforms: 1. CORDStrom™, a proprietary platform using human umbilical cord-derived mesenchymal stromal/stem cells, which recently completed a trial for recessive dystrophic epidermolysis bullosa 2. XPro™, designed to selectively neutralize soluble TNF, a key driver of inflammation 3. INKmune®, a cell-based medicine aimed at priming natural killer cells to eliminate minimal residual disease in cancer patients [3]. Conference Call Information - The conference call is scheduled for March 30, 2026, at 4:30 PM Eastern Time, with participant dial-in numbers provided for both domestic and international callers [2]. - A live audio webcast will be available, and a replay will be accessible approximately three hours after the call until April 13, 2026 [2].

Core Insights - The article highlights the significance of aligning inflammatory biomarker enrichment with the mechanism of action in Alzheimer's drug development, specifically focusing on INmune Bio's Phase 2 MINDFuL trial of XPro™ [1][2] Group 1: Research and Development - Dr. Malú Gámez Tansey will present the MINDFuL trial results at the AD/PD 2026 conference, emphasizing the role of peripheral inflammation in neurodegenerative diseases [1][2] - The MINDFuL trial enrolled Alzheimer's patients with measurable peripheral inflammation, demonstrating that nearly all efficacy endpoints favored XPro1595 in this subgroup, indicating successful patient identification [3][4] - INmune Bio is advancing to a Phase 2b/3 registrational program for XPro1595, following positive feedback from the FDA, focusing on early Alzheimer's patients enriched for inflammatory biomarkers [5][6] Group 2: Mechanism of Action - XPro™ is a next-generation inhibitor of tumor necrosis factor (TNF) that selectively neutralizes soluble TNF, potentially reducing neuroinflammation and improving cognitive function in patients with neurological diseases [7] - The biomarker enrichment strategy in MINDFuL is compared to precision approaches that have transformed cancer treatment, suggesting a promising direction for Alzheimer's therapy [4] Group 3: Company Overview - INmune Bio Inc. is a clinical-stage biotechnology company focused on developing treatments targeting the innate immune system, with three product platforms: CORDStrom™, XPro™, and INKmune® [8]

Core Viewpoint - INmune Bio Inc. is advancing its clinical development of XPro1595 for early Alzheimer's disease, with a webinar scheduled to discuss the registrational pathway and recent trial results [1][2]. Group 1: Clinical Development - The Phase 2 MINDFuL trial has been completed, and feedback from the FDA supports moving to a registrational study for Alzheimer's patients with inflammation biomarkers [2]. - XPro1595 is a next-generation selective soluble TNF inhibitor aimed at restoring immune homeostasis in the brain without affecting transmembrane TNF or TNF receptors [3][10]. Group 2: Webinar Details - The webinar will cover three main topics: results from the MINDFuL trial, the design of the registrational study, and the strategic roadmap to Phase 3, including global partnership opportunities [3][4][5]. - Featured speakers include Dr. Michael Woodward and Dr. Sharon Cohen, both recognized experts in Alzheimer's disease research [6]. Group 3: Company Overview - INmune Bio Inc. is a clinical-stage biotechnology company focused on developing treatments targeting the innate immune system, with three product platforms: CORDStrom™, XPro™, and INKmune® [11].

Core Insights - INmune Bio Inc. is hosting a webinar on February 26, 2026, to discuss CORDStrom for treating recessive dystrophic epidermolysis bullosa (RDEB) and present new data from the MissionEB clinical study [1][2] Group 1: CORDStrom Overview - 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, allowing for the creation of off-the-shelf medicines for complex inflammatory and autoimmune diseases [4] - CORDStrom™ products aim to provide consistent, scalable, and affordable cellular medicines with optimized characteristics for various indications [4] Group 2: Clinical Trial Insights - The upcoming webinar will highlight the systemic disease-modifying capabilities of CORDStrom™ in RDEB patients, contrasting it with current standard-of-care options that focus on topical treatments [2] - Key clinical benchmarks to be discussed include improvements in the EBDASI (EB Disease Activity and Scarring Index), nutritional and weight gain data in pediatric patients, reductions in pain and itch, and enhancements in quality of life [6] - Principal investigators, including Dr. Anna Martinez and Prof. Mark Lowdell, will provide insights from the MissionEB study, emphasizing the systemic nature of RDEB and the scientific rationale for using CORDStrom™ [6][3] Group 3: Company Background - INmune Bio Inc. is a clinical-stage biotechnology company focused on developing treatments targeting the innate immune system, with three product platforms: CORDStrom™, XPro™, and INKmune® [7] - The company is publicly traded on NASDAQ under the ticker INMB and is dedicated to advancing therapies for various diseases [7]

Core Insights - The FDA has provided regulatory clarity on INmune Bio's integrated Phase 2b/3 clinical development strategy for XPro1595 in early Alzheimer's Disease, confirming CDR-SB as the sole primary endpoint for registrational development [1][2][5] FDA Alignment Highlights - The FDA's feedback validates the enrichment-led design and primary endpoint, supporting the scientific and clinical strategy of the company [2][5] - The Phase 2b study will include approximately 300 participants over a nine-month evaluation period, utilizing the Early Mild Alzheimer's Cognitive Composite (EMACC) and plasma p-tau-217 as key measures [4][5] - CDR-SB will serve as the sole primary efficacy endpoint for the Phase 3 segment, aligning with its established role in Alzheimer's therapies [5][6] Integrated Phase 2b/3 Framework - The FDA indicated no objection to the integrated Phase 2b/3 design under a single master protocol, with the full program expected to enroll around 1,000 participants [5] - The Phase 3 portion will evaluate XPro1595 over an 18-month period [5] - An exploratory cohort of non-enriched early Alzheimer's patients will be included to assess broader effects, comprising approximately 20% of total enrollment [5] XPro™ Overview - XPro™ is a next-generation TNF inhibitor that selectively neutralizes soluble TNF, potentially reducing neuroinflammation and improving cognitive function in neurological diseases [8] Company Background - INmune Bio Inc. is a late-stage clinical biotechnology company focused on developing treatments targeting the innate immune system, with three product platforms including XPro™ [9]

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. 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 Points - INmune Bio Inc. will host a conference call on October 30, 2025, at 4:30 PM ET to discuss its third-quarter results and provide a corporate update [1][2] - The company is a clinical-stage biotechnology firm focused on developing treatments targeting the innate immune system [3] Company Overview - INmune Bio Inc. is publicly traded on NASDAQ under the ticker INMB [3] - The company has three product platforms: - The Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform, which neutralizes soluble TNF to address immune dysfunction [3] - CORDStrom™, a proprietary platform using human umbilical cord-derived mesenchymal stromal/stem cells, which recently completed a trial for recessive dystrophic epidermolysis bullosa [3] - INKmune®, designed to enhance natural killer cells to target minimal residual disease in cancer patients, currently in trials for metastatic castration-resistant prostate cancer [3]

Core Insights - INmune Bio, Inc. has submitted a manuscript detailing the results of its Phase 2 MINDFuL trial for XPro1595, a selective soluble TNF neutralizer, in early Alzheimer's disease with inflammation [1][2] - The trial did not meet its primary endpoint in the overall population, but showed promising results in a prespecified subgroup with amyloid pathology and high inflammatory burden [2][3] - The company anticipates regulatory feedback from the FDA in the first quarter of 2026 regarding the trial results [3] Company Overview - INmune Bio is a clinical-stage biotechnology company focused on developing treatments that target the innate immune system [5] - The company has three product platforms: DN-TNF, CORDStrom™, and INKmune®, each targeting different diseases and mechanisms [5] Product Insights - XPro1595 is a next-generation TNF inhibitor that selectively neutralizes soluble TNF without affecting trans-membrane TNF or TNF receptors, potentially reducing neuroinflammation in neurological diseases [4][6] - The trial results indicate that XPro1595 may benefit a specific subset of Alzheimer's patients, supporting its development as a precision medicine approach [6] Safety Profile - XPro1595 demonstrated a favorable safety profile, with no amyloid-related imaging abnormalities (ARIA) observed, distinguishing it from other treatments [6]