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]

Core Insights - INmune Bio Inc. reported its financial results for Q2 2025, highlighting a net loss of approximately $24.5 million, a significant increase from a net loss of about $9.7 million in Q2 2024 [12][30] - The company is focused on developing treatments that utilize the innate immune system, with three main product platforms: XPro™, CORDStrom™, and INKmune® [21] Financial Performance - The net loss attributable to common stockholders for Q2 2025 was approximately $24.5 million, compared to approximately $9.7 million in Q2 2024 [12][30] - Research and development expenses for Q2 2025 totaled approximately $5.8 million, down from approximately $7.1 million in Q2 2024 [12][30] - General and administrative expenses were approximately $2.3 million for Q2 2025, compared to approximately $2.8 million in Q2 2024 [12][30] - As of June 30, 2025, the company had cash and cash equivalents of approximately $33.4 million, an increase from $20.9 million at the end of 2024 [12][25] Product Development Highlights - XPro™ showed favorable trends in the MINDFuL phase 2 trial, particularly in a subset of patients with two or more biomarkers of inflammation [5][4] - CORDStrom™ is in the process of establishing large-scale manufacturing, with plans for MAA and BLA submissions by mid-2026 [10][15] - INKmune® is currently in an open-label Phase I/II trial for metastatic castration-resistant prostate cancer [20][21] Corporate Updates - Dr. RJ Tesi has retired as CEO, with David Moss appointed as the new President & CEO [10] - The company closed a $19 million registered direct offering to support its operations [10] Upcoming Milestones - The company anticipates an end-of-phase 2 meeting regarding the MINDFuL trial with the FDA in Q4 2025 [15] - Additional data from the ongoing phase 2 trial of INKmune® in metastatic castration-resistant prostate cancer is expected to be released [15]

Core Insights - INmune Bio Inc. announced the upcoming release of a video detailing additional findings from the Phase 2 MINDFuL trial evaluating XPro™, a selective soluble TNF inhibitor, following the Alzheimer's Association International Conference (AAIC) in Toronto [1][2] - The video will provide a comprehensive overview of the latest clinical insights shared at the AAIC, focusing on the evaluation of XPro™ within the MINDFuL study design and its significance for patients, clinicians, and investors [2][4] - The MINDFuL trial is a double-blind, Phase 2 proof-of-concept study aimed at assessing XPro™'s potential to slow cognitive decline in early-stage Alzheimer's disease by targeting neuroinflammation [4] Company Overview - INmune Bio Inc. is a publicly traded clinical-stage biotechnology company focused on developing treatments that target the innate immune system to combat diseases [6] - The company has three product platforms: the Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform, the Natural Killer Cell Priming Platform, and the CORDStrom™ platform, each targeting various diseases driven by chronic inflammation and cancer [6] - XPro™ is one of the product candidates in clinical trials aimed at treating Mild Alzheimer's disease, Mild Cognitive Impairment, and treatment-resistant depression [6]

Core Insights - INmune Bio Inc. announced additional analyses from its Phase 2 MINDFuL trial for XPro™, a selective soluble TNF inhibitor, to be presented at the Alzheimer's Association International Conference in Toronto on July 29, 2025 [1] - The MINDFuL trial is a double-blind, Phase 2 proof-of-concept study aimed at evaluating XPro™'s potential to slow cognitive decline in early-stage Alzheimer's disease by targeting neuroinflammation [2] - Although the primary endpoint was not met in the overall modified-intent-to-treat group, significant benefits were observed in a subpopulation with confirmed amyloid-beta pathology and systemic inflammation biomarkers [3] Study Details - The MINDFuL trial enrolled 208 participants with early Alzheimer's disease, requiring at least one biomarker of inflammation [2][6] - Participants received XPro™ or placebo in a 2:1 ratio for 24 weeks, with cognitive changes measured using the Early Mild Alzheimer's Cognitive Composite [2][6] - The trial's findings suggest a potential therapeutic approach for Alzheimer's by targeting inflammation [4] Future Plans - INmune Bio plans to submit a publication of the MINDFuL Phase 2 study results by mid-August [4] - The company is seeking strategic partnerships to expedite the development of XPro™ for Alzheimer's treatment [4] Product Information - XPro™ is designed to inhibit soluble TNF while preserving trans-membrane TNF and TNF receptors, potentially enhancing cognitive function and neuronal communication [7] - INmune Bio focuses on developing treatments that target the innate immune system, with XPro™ being part of its Dominant-Negative Tumor Necrosis Factor product platform [8][9]

Core Insights - The Phase 2 MINDFuL trial of XPro™ in early Alzheimer's Disease (AD) patients with inflammation biomarkers did not meet the primary cognitive endpoint in the modified intent-to-treat (mITT) population, but showed cognitive, behavioral, and biological benefits in a predefined subgroup of amyloid-positive patients with two or more inflammation biomarkers [1][3][4] Group 1: Trial Results - The MINDFuL trial enrolled 208 participants with early-stage AD, assessing XPro™'s potential to slow cognitive decline by targeting neuroinflammation [4] - In the predefined subgroup of amyloid-positive early AD patients with two or more inflammation biomarkers (n=100), XPro™ demonstrated a cognitive benefit on the primary endpoint EMACC (effect size: 0.27) and a behavioral benefit on the Neuropsychiatric Inventory (effect size: -0.24) [7] - A biological benefit was observed in blood levels of pTau217 (effect size: -0.20), indicating a positive impact on AD pathology [7] Group 2: Safety and Tolerability - XPro™ treatment was well-tolerated and safe, with no occurrences of ARIA-E or ARIA-H reported [2][7] - The most common adverse events were injection site reactions, occurring in 80% of the XPro™ group compared to less than 20% in the placebo group [7] - There were no deaths or drug-related hospitalizations during the trial, indicating a favorable safety profile [7] Group 3: Future Plans - The company plans to submit for Breakthrough Therapy designation with the FDA and will present additional analyses at the Alzheimer's Association International Conference (AAIC) in July 2025 [2][10] - The company aims to engage regulatory authorities in the UK, EU, and other regions to define the path for a pivotal trial to support XPro™ approval in early AD [14]

Core Insights - INmune Bio Inc. reported its financial results for Q1 2025, highlighting a net loss of approximately $9.7 million, an improvement from a loss of $11.0 million in Q1 2024 [6][11][21] - The company is advancing its clinical programs, including the MINDFuL phase 2 trial for Alzheimer's and plans to submit a Biologics License Application (BLA) for CORDStrom targeting Recessive Dystrophic Epidermolysis Bullosa (RDEB) [6][14] Financial Results - For the quarter ended March 31, 2025, the company reported revenue of $50,000, compared to $14,000 in the same period of 2024 [21] - Research and development expenses were approximately $7.6 million, down from $8.7 million in Q1 2024 [6][21] - General and administrative expenses remained stable at approximately $2.3 million [11][21] - As of March 31, 2025, cash and cash equivalents totaled approximately $19.3 million, a decrease from $20.9 million at the end of 2024 [11][18] Clinical Developments - Top-line results from the MINDFuL phase 2 trial in Alzheimer's are expected in the second half of June 2025 [6] - The company plans to file a BLA for CORDStrom in early 2026 [6] - The INKmune Phase II trial has been expanded to include veterans with prostate cancer [6] Product Platforms - The XPro™ platform is a next-generation TNF inhibitor currently in clinical trials, targeting neuroinflammation [8][14] - CORDStrom™ is a cell medicine platform utilizing pooled human umbilical cord-derived mesenchymal stromal cells, aimed at treating complex inflammatory diseases [9][10] - INKmune® is designed to prime a patient's NK cells for cancer treatment, currently in trials for metastatic castration-resistant prostate cancer [12][14]

MINDFuL Phase II Blinded, Randomized, Placebo-Controlled Data Anticipated June 2025 Poster #294: ALZHEIMER'S DISEASE (AD) AND IMMUNE DYSFUNCTION: BASELINE DEMOGRAPHICS AND DISEASE CHARACTERISTICS FROM A PHASE-2 STUDY OF XPRO1595 IN EARLY AD Topline results of the MINDFuL trial will be reported in June 2025. 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. INm ...