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 - INmune Bio (NASDAQ: INMB) has been part of the "Bio Boom" speculative portfolio since September 2023, with no changes made to its position despite the company's progress [2] Group 1 - The company has not seen any adjustments in its investment thesis since its inclusion in the portfolio [2] - The leader of the investing group Compounding Healthcare focuses on innovative companies developing breakthrough therapies and pharmaceuticals [2] Group 2 - The analyst holds a beneficial long position in INMB shares, indicating confidence in the company's potential [3]

Core Viewpoint - Former hedge fund manager Martin Shkreli has warned of a potential 90% drop in shares of Inmune Bio Inc., a biotech startup focused on using the immune system to combat cancers, following a recent surge in its stock price [1][2]. Group 1: Stock Performance and Predictions - Shkreli predicts that Inmune Bio's stock could fall to $0.50, representing a 90.61% decline from its closing price of $5.33 on the previous Friday [2]. - The company's shares had recently surged by 44% due to investor enthusiasm surrounding its neuroinflammation candidate, XPro1595, which targets Alzheimer's disease and other central nervous system disorders [2]. Group 2: Critique of Inmune Bio - Shkreli has expressed concerns regarding the lack of robust Phase 1 trial data and the absence of peer-reviewed publications supporting the efficacy of the candidate [4]. - He criticized the study design for not including a placebo arm, which complicates the assessment of whether observed improvements are due to the drug or a placebo effect [4]. - BMF Reports, an activist short-seller, has echoed Shkreli's concerns, highlighting flawed science, questionable trial designs, and accounting improprieties, including payments to "ghost consultants" [5]. Group 3: Market Reaction - Following Shkreli's warning, Inmune Bio's shares fell by 15.13% on Friday and continued to decline by 16.32% in after-hours trading [7].

Core Viewpoint - INmune Bio Inc. has successfully closed a registered direct offering of 3,000,000 shares at a price of $6.30 per share, generating approximately $19 million in gross proceeds for working capital and general corporate purposes [1][2]. Group 1: Offering Details - The offering was priced at-the-market under Nasdaq rules and was announced on June 27, 2025 [1]. - The gross proceeds from the offering are approximately $19 million, before deducting placement agent fees and other estimated offering expenses [2]. - A.G.P./Alliance Global Partners acted as the sole placement agent for the offering [2]. Group 2: Company Overview - INmune Bio Inc. is a clinical-stage biotechnology company focused on developing treatments targeting the innate immune system to combat diseases [5]. - The company has three product platforms: - The Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform, which is in clinical trials for Mild Alzheimer's disease, Mild Cognitive Impairment, and treatment-resistant depression [5]. - The Natural Killer Cell Priming Platform, which includes INKmune® for cancer treatment, currently in trials for metastatic castration-resistant prostate cancer [5]. - The CORDStrom™ platform, which recently completed a trial for recessive dystrophic epidermolysis bullosa [5].

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive focuses on sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Core Insights - INmune Bio Inc. is experiencing a significant decline in stock price, trading down 59% at $2.14, with a session volume of 23.2 million shares compared to an average of 1.45 million shares [1][5] - The company announced results from its Phase 2 MINDFuL trial for XPro, a selective soluble TNF inhibitor aimed at early Alzheimer's Disease, which showed cognitive benefits in a specific subpopulation despite not meeting the primary endpoint in the modified intent-to-treat population [2][4] Trial Results - The MINDFuL trial enrolled 208 participants, with the primary endpoint being the change in cognition over 6 months measured by the Early Mild Alzheimer's Cognitive Composite (EMACC) [3] - Although the primary endpoint was not met in the mITT group, significant benefits were observed in a subpopulation of patients with two or more biomarkers of inflammation [4] - Key findings indicated a cognitive benefit for XPro over placebo on the primary endpoint EMACC (effect size: 0.27) and a behavioral benefit on the Neuropsychiatric Inventory (effect size: -0.24) [5] Future Plans - The company plans to file for Breakthrough Therapy Designation with the FDA and schedule an End-of-Phase 2 meeting in Q4 2025 to discuss the path for a pivotal trial to support XPro's approval in early Alzheimer's Disease [5] - INmune Bio announced a registered direct offering of 3 million shares at $6.30 per share, aiming for approximately $19 million in gross proceeds to be used for working capital and general corporate purposes [4][5]

Summary of Immune Bio's Mindful Phase Two Topline Data Conference Call Company and Industry - **Company**: Immune Bio - **Industry**: Alzheimer's Disease Treatment Key Points and Arguments Trial Overview - The MINDFUL trial is a double-blind, placebo-controlled Phase II trial evaluating Xpro for early Alzheimer's disease in patients with biomarkers of inflammation [6][14] - The trial included a modified intent to treat population of 200 patients, with a focus on a biologically defined group of 150 patients with early Alzheimer's disease confirmed by amyloid positivity and at least one biomarker of inflammation [10][11] Results and Efficacy - Xpro was found to be safe for early Alzheimer's patients and showed potential effectiveness in a defined patient population [6][12] - The primary endpoint was not met in the overall modified intent to treat population, but a consistent benefit was observed in the subgroup of patients with two or more biomarkers of inflammation [11][20] - The effect size for the primary endpoint (EMAC) was 0.27, indicating a meaningful benefit in cognition for the targeted patient group [19][20] - Positive effects were also noted on secondary endpoints related to behavior and disease-relevant biomarkers in the blood, including p tau 217 [11][19] Safety Profile - Xpro demonstrated a favorable safety profile with no deaths and no cases of ARIA (Amyloid-Related Imaging Abnormalities) reported [17][22] - The most common adverse event was injection site reactions, occurring in 80% of patients receiving Xpro, but these were manageable and did not lead to significant complications [25][28] Future Development Plans - Immune Bio plans to explore partnership opportunities and prepare for an end-of-phase two meeting with the FDA to discuss regulatory pathways and potential breakthrough designation [7][85] - The company aims to confirm EMAC as a primary cognitive endpoint with the FDA, which could facilitate a more efficient Phase III trial design [48][79] Market Implications - The trial results suggest a potential path forward for Xpro as a best-in-class therapy for early Alzheimer's disease, particularly in patients with neuroinflammation [14][28] - Immune Bio is committed to advancing Xpro's development and addressing the needs of Alzheimer's patients and their caregivers [82][85] Additional Important Content - The trial faced challenges with patient screening, leading to the exclusion of 50 patients who were not confirmed to have Alzheimer's disease [52][68] - The company emphasized the importance of biomarkers in understanding disease progression and treatment efficacy, noting that p tau 217 is gaining recognition as a significant prognostic indicator [44][70] - Immune Bio acknowledged the need for effective therapies for Alzheimer's, highlighting the trial's contribution to understanding neuroinflammation's role in the disease [28][82]

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 - The article emphasizes the importance of understanding the science behind biotech investments to avoid pitfalls in the industry [1] Group 1 - The author has a PhD in biochemistry and extensive experience analyzing clinical trials and biotech companies [1] - The mission is to educate investors on the scientific aspects of biotech businesses [1]