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]

Former hedge fund manager Martin Shkreli has issued a stark warning on the near-term trajectory of a biotech startup, just days after it witnessed a surge. What Happened: On Saturday, in a post on X, Shkreli forecasted a potential 90% drop in the shares of biotech startup, Inmune Bio Inc. INMB, a clinical-stage biotechnology company that is focused on using a patient’s immune system to fight cancers.According to Shkreli, there’s a “very good chance $INMB will be at 0.50 on Monday,” a 90.61% drop from its cl ...

Boca Raton, Florida, June 30, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company, today announced that it has closed its registered direct offering, announced on June 27, 2025, (the "Offering") for the purchase and sale of 3,000,000 shares of its common stock at a purchase price of $6.30 per share, priced at-the-market under Nasdaq rules. The gross proceeds from the Offering are approximately $19 million, before deducting placement a ...

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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]

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, eve ...

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]

Core Viewpoint - INmune Bio Inc. has announced a registered direct offering of 3,000,000 shares of its common stock at a price of $6.30 per share, aiming to raise approximately $19 million in gross proceeds for working capital and general corporate purposes [1][2]. Group 1: Offering Details - The offering is expected to close on or about June 30, 2025, pending customary closing conditions [2]. - A.G.P./Alliance Global Partners is acting as the sole placement agent for the offering [2]. - The offering is made under an effective shelf registration statement previously filed with the SEC [3]. Group 2: Company Overview - INmune Bio Inc. is a clinical-stage biotechnology company focused on developing treatments targeting the innate immune system [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].

Core Viewpoint - INmune Bio Inc. is set to present top line data from the Phase 2 MINDFuL trial focused on early Alzheimer's Disease during a conference call on June 30, 2025 [1][2]. Group 1: MINDFuL Trial Details - The MINDFuL trial is an international, blinded, randomized Phase 2 study involving patients with early Alzheimer's Disease (AD) who exhibit biomarkers of elevated neuroinflammation [3]. - Participants in the trial must have at least one of four inflammation biomarkers: elevated CRP, HgbA1c, ESR, or ApoE4 allele, and they receive either XPro™ or placebo in a 2:1 ratio for 6 months [3]. - Cognitive endpoints for the trial include EMACC and CDR, with XPro™ administered as a once-a-week subcutaneous injection [3]. Group 2: XPro™ Overview - XPro™ is a next-generation inhibitor of tumor necrosis factor (TNF) that selectively neutralizes soluble TNF without affecting trans-membrane TNF or TNF receptors [4]. - The drug aims to reduce neuroinflammation, potentially benefiting patients with neurological diseases [4]. Group 3: Company Background - INmune Bio Inc. is a publicly traded clinical-stage biotechnology company focused on developing treatments targeting the innate immune system [5]. - The company has three product platforms, including 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][6]. - Other platforms include the Natural Killer Cell Priming Platform and the CORDStrom™ program, which targets chronic inflammation and cancer [5][6].

Pipeline Highlights - XPro: Phase 2 Alzheimer's trial fully enrolled with top-line cognition results expected in June 2025[5], Phase I data showed a 222% increase in Contactin-2 and a 56% decrease in Neurogranin after 12 weeks of treatment[23] - CORDStrom: Completed blinded randomized trial in Recessive Dystrophic Epidermolysis Bullosa (RDEB) with US BLA submission planned for 2026[5], targeting a > $1 billion peak sales opportunity in the US, UK, and EU[50] - INKmune: Phase I dose escalation cohorts complete, with ongoing Phase 2 Metastatic Castrate Resistant Prostate Cancer (mCRPC) data readouts in 2025[5] XPro (Alzheimer's Disease) - TNF inhibitors reduce the risk of developing AD by 60% based on epidemiological studies of over 60 million cases[15] - Phase I results showed dose-dependent reduction of CSF biomarkers of neuroinflammation in AD patients[16] CORDStrom (RDEB) - CORDStrom is potentially the first systemic therapy for RDEB, with itch benefit as a key differentiating factor[50] - Mission EB trial: 30 pediatric patients with RDEB were treated in a double-blind, randomized, placebo-controlled cross-over design clinical trial[52, 56] INKmune (Cancer) - INKmune converts resting NK cells to cancer-killing memory-like NK cells[5, 73]