INB-03

In the Phase 2 MINDFuL trial of XPro ™ in patients with early Alzheimer’s Disease (AD) with biomarkers of inflammation, the modified intent-to-treat (mITT) population (n=200) did not meet the primary cognitive endpoint (EMACC), however in a predefined population of amyloid-positive early AD patients with two or more biomarkers of inflammation (n=100), a benefit of XPro ™ treatment over placebo was observed in cognitive, behavioral and biological endpoints. Treatment with XPro ™ was well-tolerated and safe, even in the high risk ApoE4+/+ patient group, and ARIA-E or ARIA-H was not observed in any patients. The most common adverse events (AE) were injection site reactions. Additional analyses will be presented at Alzheimer’s Association International Conference (AAIC) in Toronto, Canada (July 27-31, 2025) and the Company will submit for Breakthrough Therapy designation with the FDA. Conference call today at 8AM ET, details below. BOCA RATON, FL, USA I June 30, 2025 I INmune Bio Inc. (NASDAQ: INMB), today announced results from its Phase 2 MINDFuL trial (NCT05318976) evaluating XPro™, a selective soluble TNF inhibitor, in early AD with biomarkers of inflammation. Despite showing no effects in the modified intent-to-treat population (mITT, n=200), predefined analyses demonstrated a cognitive benefit for XPro™ over placebo on the primary endpoint EMACC, a behavioral benefit on the Neuropsychiatric Inventory, and a biological benefit on pTau217 in early Alzheimer’s patients with two or more biomarkers of inflammation at baseline (n=100), marking a key milestone in the development of XPro™ for Early AD. The MINDFuL trial, a double-blind, placebo-controlled study, enrolled 208 participants with early-stage AD to assess XPro™’s potential in slowing cognitive decline by tackling neuroinflammation. Patients with at least one of four inflammatory biomarkers (elevated CRP, ESR, HbA1c, or at least one ApoE4 allele) were randomized 2:1 (XPro™:placebo) and treated over 24 weeks. The primary endpoint was change in cognition over 6 months on the Early Mild Alzheimer’s Cognitive Composite (EMACC), a cognitive assessment designed specifically to measure change in early AD patients. While the primary endpoint was not met in the mITT group, key changes in clinical measures of cognition, behavior, and an AD-related biomarker demonstrated a benefit in a subpopulation of patients treated with XPro™ over patients treated with placebo. These results identify a clear population of AD patients for which XPro™ might have therapeutic benefit. Key Findings in the Amyloid positive Early AD participants with two or more biomarkers of inflammation (N=100): “These results highlight the potential of XPro™,” stated RJ Tesi, MD, CEO of INmune Bio. “Our findings indicate that XPro™ may offer benefits to Alzheimer’s patients across all age groups, regardless of comorbidities, additional medications, or ApoE4 status. This evidence lays the foundation for advancing XPro™ as a promising treatment option for Alzheimer’s disease.” CJ Barnum, PhD, VP of CNS Drug Development, added, “By targeting neuroinflammation, a key driver of Alzheimer’s disease progression, XPro™ offers a novel mechanism to potentially slow disease progression and cognitive symptoms for persons living with Alzheimer’s disease and inflammation. The continued development of this therapeutic, whether as a standalone treatment or in combination with other therapies, holds promise in addressing this critical and growing unmet medical need.” Additional analyses are underway and will be presented at AAIC in Toronto, Canada (July 27-31, 2025). Expert Commentary on Use of Effect Size in Clinical Trials “In early-phase Alzheimer’s disease trials, absolute effect sizes of 0.2 or greater are considered preliminary evidence of potential therapeutic efficacy and are informative for signal detection in early phase studies when sample sizes are small and the unknowns of a novel mechanism are significant,” said Dr. Judith Jaeger, a leading expert in cognitive assessment and consultant to INmune Bio on this trial. “When a therapy consistently meets the 0.2 benchmark across multiple parameters (clinical and biological), confidence in the validity of the observed effects increases, indicating a therapy is worth advancing.” Next Steps INmune Bio will present additional analyses from the MINDFuL trial at AAIC® in Toronto, Canada (July 27-31, 2025). Based on the totality of the data, the company intends to: MINDFuL Results Call Information: To participate in this event, dial approximately at least 10 minutes before the beginning of the call or use the webcast link below. Please ask for the INmune Bio MINDFuL Conference Call when reaching the operator. Date: June 30, 2025 Time: 8:00 AM Eastern Time Participant Dial-in: +1-800-267-6316 Participant Dial-in (international): +1-203-518-9783 Conference ID: INMUNE NOTE: THIS CONFERENCE ID WILL BE REQUIRED FOR ENTRY To join by webcast link please click here or copy and past the link below into your browser: A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through July 30, 2025 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering pin no. 11159260. Acknowledgements INmune Bio wishes to extend their gratitude to the participants, caregivers, trial site staff, vendors, and any others who supported the efforts of this proof-of-concept phase 2 clinical trial. About MINDFuL (NCT05318976) The MINDFuL trial is an international, blinded, randomized Phase 2 trial in patients with Early AD with biomarkers of elevated neuroinflammation. Early AD includes patients with MCI (mild cognitive impairment) and mild AD. Patients must have at least one of four biomarkers of inflammation – elevated CRP, HgbA1c, ESR or ApoE4 allele.  Patients receive either XPro™ or placebo (2:1 ratio) for 6 months. The cognitive endpoints are EMACC and CDR. XPro™ is given as a once-a-week subcutaneous injection.  For more information on the MINDFuL clinical trial please visit www.clinicaltrials.gov or www.inmunebio.com About Judith Jaeger, PhD Judith Jaeger, PhD, is the principal developer of the EMACC. Judith Jaeger PhD is founder and President of CognitionMetrics, a prominent neurocognition consulting firm. Dr. Jaeger is an internationally recognized expert in designing cognitive function testing programs to use in clinical trials with more than two decades’ experience. About EMACC The EMACC is a validated cognitive composite derived from six standardized neuropsychological tests, empirically developed to provide optimal for sensitivity to decline in early AD. Unlike traditional clinical rating scales, EMACC minimizes variance from informant demographics, providing an objective measure of cognitive performance with no floor or ceiling effects. About XPro™ XPro™ is an advanced tumor necrosis factor (TNF) inhibitor that targets soluble TNF (sTNF) while preserving trans-membrane TNF (tmTNF) and TNF receptors. By reducing neuroinflammation, XPro™ may offer significant benefits for patients with neurologic disorders, potentially enhancing cognitive function and supporting neuronal communication. 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: the Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. DN-TNF product candidates are in clinical trials to determine if they can treat Mild Alzheimer’s disease, Mild Cognitive Impairment and treatment-resistant depression (XPro™). The Natural Killer Cell Priming Platform includes INKmune® developed to prime a patient’s NK cells to eliminate minimal residual disease in patients with cancer and is currently in trials in metastatic castration-resistance prostate cancer. The third program, CORDStrom™, is a proprietary allogeneic, pooled, human umbilical cord-derived mesenchymal Stromal/Stem cell (hucMSCs) platform that recently completed a blinded randomized trial in recessive dystrophic epidermolysis bullosa. INmune Bio’s product platforms utilize a precision medicine approach for diseases driven by chronic inflammation and cancer. SOURCE: INmune Bio

INmune Bio ended March with $19.3 million and closed a $19 million financing this week. \n A phase 2 study of INmune Bio’s TNF inhibitor in Alzheimer’s disease has missed its primary endpoint, wiping 60% off the biotech share price.As INmune CEO Raymond Tesi, M.D., said on an earnings call last month, the company designed the phase 2 trial to show “what happens in Alzheimer\'s disease when you properly target neuroinflammation?” The answer, assuming INmune properly targeted neuroinflammation, appears to be “not much,” at least in the overall population.After six months of treatment, patients on INmune’s XPro drug candidate did no better than their peers on placebo on the EMACC measure of cognition in early Alzheimer’s. The result meant the trial missed its primary endpoint. The study also missed its secondary endpoints, Tesi said on a call with analysts Monday. INmune’s press release lacks data on how XPro performed in the 200-patient modified intent-to-treat population. Instead, the biotech dug into how the drug candidate fared in a predefined population of 100 amyloid-positive early Alzheimer’s patients with two or more biomarkers of inflammation. The biotech reported a clinical benefit of XPro over placebo on EMACC and the secondary endpoint neuropsychiatric inventory in the subpopulation. INmune also linked XPro to a change in the biomarker pTau217 in the 100 patients. Effect sizes exceeded the 0.2 that Judith Jaeger, Ph.D,, a consultant to INmune on the trial, said in a statement is considered preliminary evidence of potential efficacy in early-phase trials. “When a therapy consistently meets the 0.2 benchmark across multiple parameters (clinical and biological), confidence in the validity of the observed effects increases, indicating a therapy is worth advancing,” Jaeger said.The question of who will pay to advance XPro remains unanswered. Tesi told analysts that “XPro appears to be effective in an easily defined and commercially relevant patient population with early Alzheimer\'s disease and we see a path forward.” But the CEO also recognized “there is work to be done and that work will require financial resources.”INmune ended March with $19.3 million and closed a $19 million financing this week. Investors showed little enthusiasm for XPro after seeing the data, sending INmune shares down 59% to $2.17 in premarket trading. Needing financial support, Tesi said the biotech plans to explore partnering opportunities as it prepares to present additional analyses of the data and talk to the FDA.