공시 • May 16
INmune Bio Inc. Publishes Phase 2 MINDFuL Trial Results in NPJ Dementia, Advancing the XPro Platform INmune Bio Inc. 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 e4 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. 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. 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. 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. New Risk • May 15
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$9.6m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Market cap is less than US$100m (US$44.7m market cap). 공시 • May 01
INmune Bio Inc. to Report Q1, 2026 Results on May 07, 2026 INmune Bio Inc. announced that they will report Q1, 2026 results on May 07, 2026 공시 • Apr 24
INmune Bio Inc., Annual General Meeting, Jun 16, 2026 INmune Bio Inc., Annual General Meeting, Jun 16, 2026. 공시 • Apr 16
Inmune Bio Inc. Announces New Preclinical Data At Aacr 2026 Demonstrating Inb03 (Xpro1595) Overcomes Resistance and Reduces Metastases in Her2-Positive Breast Cancer Models INmune Bio Inc. announces new preclinical data for INB03 (XPro1595 for oncology). The data will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2026 in San Diego on April 17-22. The poster, titled, “Soluble TNF blockade overcomes tyrosine kinase inhibitors resistance in HER2-positive breast cancer,” details how INB03 (“XPro™”), a first-in-class dominant-negative soluble TNF (sTNF) inhibitor, significantly enhances the anti-tumor activity of the tyrosine kinase inhibitors (TKIs) lapatinib and tucatinib while reducing metastatic spread to the brain, lungs, and liver in HER2-positive breast cancer models. It was authored by collaborators from the Instituto de Biología y Medicina Experimental (IBYME-CONICET) in Buenos Aires, Argentina. Overcoming Resistance in Vitro: The combination of INB03 (10 µg/mL) with either lapatinib (1 µM) or tucatinib (10 µM) produced statistically superior inhibition of cell proliferation and migration in both HER2+ JIMT-1 and brain-metastatic JIMT-1 Br3-luc cell lines compared to TKIs alone (p < 0.05 to p < 0.0001). Enhanced Tumor Control In Vivo: In female nude mice bearing JIMT-1 or JIMT-1 Br3-luc tumors, INB03 + TKI combinations markedly slowed tumor growth compared to TKIs alone. Reduction of Metastatic Spread: The addition of INB03 significantly reduced the incidence of metastases to brain, lung, and liver (quantified by ex-vivo IVIS luminescence imaging). Notably, it further enhanced tucatinib’s effect on lung metastases (p < 0.05 to p < 0.0001). Mechanism of Action: These results support prior research showing that selective sTNF neutralization with INB03 down-regulates MUC4, a protein that shields the HER2 molecule and prevents therapies from binding effectively. 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 this section of INmune Bio’s website. New Risk • Mar 31
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$24m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$24m free cash flow). Revenue is less than US$1m (US$50k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$11m net loss in 3 years). Shareholders have been diluted in the past year (16% increase in shares outstanding). Market cap is less than US$100m (US$30.3m market cap). 
