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 ...

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].

Financial Data and Key Metrics Changes - The net loss attributable to common stockholders for Q1 2025 was approximately $9.7 million, compared to approximately $11 million for the same period in 2024, indicating an improvement [27] - Research and development expenses totaled approximately $7.6 million for Q1 2025, down from approximately $8.7 million in Q1 2024 [27] - General and administrative expenses remained stable at approximately $2.3 million for both Q1 2025 and Q1 2024 [27] - As of March 31, 2025, the company had cash and cash equivalents of approximately $19.3 million, sufficient to fund operations through Q3 2025 [28] Business Line Data and Key Metrics Changes - The company is preparing to report top-line results from the MINDFUL trial, a Phase 2 trial in early Alzheimer's disease, expected in mid to late June 2025 [5][16] - The market opportunity for EXPAREL in early Alzheimer's disease patients has increased to nearly 70%, up from the previously estimated 40% [6][8] - The safety profile of EXPAREL remains strong, with no reports of adverse events in the MINDFUL trial [9] Market Data and Key Metrics Changes - The approval of mecanumab in the EU and UK excludes patients with two copies of the APOE4 gene, creating an unmet need for EXPAREL therapy in this subgroup [10][11] - The evolving biomarker landscape in Alzheimer's disease, particularly the significance of p-tau217, is expected to enhance the company's market position [12] Company Strategy and Development Direction - The company aims to position itself as a leader in targeting immune dysfunction that drives neuroinflammation in Alzheimer's disease [81][82] - Plans to file a Biologics License Application (BLA) for Cordstrom in 2026, with ongoing development for Inkmune in prostate cancer [17][29] - The company is focused on transitioning manufacturing processes to meet regulatory requirements and maximize production efficiency [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in reporting results that could change the care of patients with early Alzheimer's disease, highlighting substantial share ownership by management as alignment with investor interests [16][80] - The company anticipates an end-of-Phase 2 meeting with the FDA in Q4 2026 to discuss the design of a Phase 3 trial [29] Other Important Information - The company has successfully transitioned its drug supply logistics for Inkmune to a US contractor, ensuring readiness for trial completion [21] - The FDA has indicated a willingness to expedite the approval process for rare disease treatments, which bodes well for Cordstrom [18] Q&A Session Summary Question: What are the next steps for the program assuming a positive readout in June? - Management indicated that they would defer specific timelines until after the results and discussions with the FDA [35] Question: Can you comment on the turnover at the FDA and the receptivity at the ADPD conference? - Management believes the FDA remains on track and noted positive feedback from the ADPD conference regarding their approach to measuring cognition [39][44] Question: How many APOE homozygous patients are in the trial? - The trial includes approximately 9% of APOE homozygous patients, which is consistent with other studies [53] Question: What is the expected reduction in CDR for the trial? - Management expressed confidence in their power calculations based on previous studies, suggesting they are well-positioned to achieve statistically significant results [62] Question: Are you still on track to initiate the open-label trial for Cordstrom? - The company is following FDA guidance and expects to submit an IND later this year, with plans for a follow-on trial in the US [73]

Conference Call Today at 4:30pm ETBOCA RATON, Fla., May 08, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage biotechnology company targeting inflammation and immunology through the innate immune system, today announces its financial results for the quarter ended March 31, 2025 and provides a business update. Q1 2025 and Recent Corporate Highlights DN-TNF Platform Highlights (XPro™): Top-line results from the MINDFuL phase 2 trial in Alzheimer’s expected in the secon ...

INmune Bio (INMB) Q4 2024 Earnings Call March 27, 2025 04:30 PM ET Company Participants David Moss - Chief Financial OfficerRaymond Tesi - CEO & ChairmanGeorge Farmer - Managing DirectorMark Lowdell - Chief Scientific Officer & Chief Manufacturing OfficerCJ Barnum - Head of NeuroscienceDenis Reznik - Senior Equity Research AssociateElemer Piros - Senior Managing Director Conference Call Participants Thomas Shrader - Equity Research AnalystJames Molloy - Managing Director, Senior Biotechnology & Specialty Ph ...