Core Insights - INmune Bio, Inc. has submitted a manuscript detailing the results of its Phase 2 MINDFuL trial for XPro1595, a selective soluble TNF neutralizer, in early Alzheimer's disease with inflammation [1][2] - The trial did not meet its primary endpoint in the overall population, but showed promising results in a prespecified subgroup with amyloid pathology and high inflammatory burden [2][3] - The company anticipates regulatory feedback from the FDA in the first quarter of 2026 regarding the trial results [3] Company Overview - INmune Bio is a clinical-stage biotechnology company focused on developing treatments that target the innate immune system [5] - The company has three product platforms: DN-TNF, CORDStrom™, and INKmune®, each targeting different diseases and mechanisms [5] Product Insights - XPro1595 is a next-generation TNF inhibitor that selectively neutralizes soluble TNF without affecting trans-membrane TNF or TNF receptors, potentially reducing neuroinflammation in neurological diseases [4][6] - The trial results indicate that XPro1595 may benefit a specific subset of Alzheimer's patients, supporting its development as a precision medicine approach [6] Safety Profile - XPro1595 demonstrated a favorable safety profile, with no amyloid-related imaging abnormalities (ARIA) observed, distinguishing it from other treatments [6]

Core Insights - INmune Bio Inc. reported its financial results for Q2 2025, highlighting a net loss of approximately $24.5 million, a significant increase from a net loss of about $9.7 million in Q2 2024 [12][30] - The company is focused on developing treatments that utilize the innate immune system, with three main product platforms: XPro™, CORDStrom™, and INKmune® [21] Financial Performance - The net loss attributable to common stockholders for Q2 2025 was approximately $24.5 million, compared to approximately $9.7 million in Q2 2024 [12][30] - Research and development expenses for Q2 2025 totaled approximately $5.8 million, down from approximately $7.1 million in Q2 2024 [12][30] - General and administrative expenses were approximately $2.3 million for Q2 2025, compared to approximately $2.8 million in Q2 2024 [12][30] - As of June 30, 2025, the company had cash and cash equivalents of approximately $33.4 million, an increase from $20.9 million at the end of 2024 [12][25] Product Development Highlights - XPro™ showed favorable trends in the MINDFuL phase 2 trial, particularly in a subset of patients with two or more biomarkers of inflammation [5][4] - CORDStrom™ is in the process of establishing large-scale manufacturing, with plans for MAA and BLA submissions by mid-2026 [10][15] - INKmune® is currently in an open-label Phase I/II trial for metastatic castration-resistant prostate cancer [20][21] Corporate Updates - Dr. RJ Tesi has retired as CEO, with David Moss appointed as the new President & CEO [10] - The company closed a $19 million registered direct offering to support its operations [10] Upcoming Milestones - The company anticipates an end-of-phase 2 meeting regarding the MINDFuL trial with the FDA in Q4 2025 [15] - Additional data from the ongoing phase 2 trial of INKmune® in metastatic castration-resistant prostate cancer is expected to be released [15]

Core Viewpoint - INmune Bio Inc. will host a conference call on August 7, 2025, to discuss its financial results for the quarter ended June 30, 2025, and provide a corporate update [1]. Company Overview - INmune Bio Inc. is a clinical-stage biotechnology company focused on developing treatments targeting the innate immune system to combat diseases [3]. - The company has three product platforms: - The Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform aims to neutralize soluble TNF, which is linked to various diseases, with candidates in clinical development for Alzheimer's disease and other indications [3]. - The Natural Killer Cell Priming Platform includes INKmune®, which is designed to enhance NK cell activity against minimal residual disease in cancer patients, currently in trials for metastatic castration-resistant prostate cancer [3]. - The CORDStrom™ platform utilizes pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs) and has recently completed a trial for recessive dystrophic epidermolysis bullosa [3]. - The company employs a precision medicine approach for diseases associated with chronic inflammation and cancer [3]. Conference Call Information - The conference call is scheduled for August 7, 2025, at 4:30 PM Eastern Time, with participant dial-in numbers provided for both domestic and international callers [2]. - A live audio webcast will be available, and a transcript will be released approximately 24 hours after the call [2]. Contact Information - The company contact for inquiries includes David Moss, Chief Financial Officer, and Daniel Carlson, Head of Investor Relations, with provided phone numbers and email addresses [6].

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 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].

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 Insights - INmune Bio Inc. is a clinical-stage biotechnology company focused on inflammation and immunology through the innate immune system [1][2] - The company will present at the 2025 RBC Capital Markets Global Healthcare Conference on May 20-21, 2025 [1][2] Company Overview - INmune Bio Inc. is publicly traded on NASDAQ under the ticker INMB [2] - The company has three main product platforms: - Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform, targeting Mild Alzheimer's disease, Mild Cognitive Impairment, and treatment-resistant depression [2] - Natural Killer Cell Priming Platform, featuring INKmune®, aimed at treating metastatic castration-resistant prostate cancer [2] - CORDStrom™, a proprietary platform using human umbilical cord-derived mesenchymal Stromal/Stem cells, recently completed trials for recessive dystrophic epidermolysis bullosa [2] - The company employs a precision medicine approach for diseases associated with chronic inflammation and cancer [2]

Core Insights - INmune Bio Inc. reported its financial results for Q1 2025, highlighting a net loss of approximately $9.7 million, an improvement from a loss of $11.0 million in Q1 2024 [6][11][21] - The company is advancing its clinical programs, including the MINDFuL phase 2 trial for Alzheimer's and plans to submit a Biologics License Application (BLA) for CORDStrom targeting Recessive Dystrophic Epidermolysis Bullosa (RDEB) [6][14] Financial Results - For the quarter ended March 31, 2025, the company reported revenue of $50,000, compared to $14,000 in the same period of 2024 [21] - Research and development expenses were approximately $7.6 million, down from $8.7 million in Q1 2024 [6][21] - General and administrative expenses remained stable at approximately $2.3 million [11][21] - As of March 31, 2025, cash and cash equivalents totaled approximately $19.3 million, a decrease from $20.9 million at the end of 2024 [11][18] Clinical Developments - Top-line results from the MINDFuL phase 2 trial in Alzheimer's are expected in the second half of June 2025 [6] - The company plans to file a BLA for CORDStrom in early 2026 [6] - The INKmune Phase II trial has been expanded to include veterans with prostate cancer [6] Product Platforms - The XPro™ platform is a next-generation TNF inhibitor currently in clinical trials, targeting neuroinflammation [8][14] - CORDStrom™ is a cell medicine platform utilizing pooled human umbilical cord-derived mesenchymal stromal cells, aimed at treating complex inflammatory diseases [9][10] - INKmune® is designed to prime a patient's NK cells for cancer treatment, currently in trials for metastatic castration-resistant prostate cancer [12][14]

Company Overview - INmune Bio Inc. is a clinical-stage biotechnology company focused on developing treatments targeting the innate immune system to combat diseases, particularly Alzheimer's Disease [3] - The company operates three product platforms: Dominant-Negative Tumor Necrosis Factor (DN-TNF), Natural Killer Cell Priming Platform, and CORDStrom™ [3] - DN-TNF product candidates are in clinical trials for Mild Alzheimer's disease, Mild Cognitive Impairment, and treatment-resistant depression [3] - INKmune® is designed to prime NK cells to eliminate minimal residual disease in cancer patients and is currently in trials for metastatic castration-resistant prostate cancer [3] - CORDStrom™ is a proprietary platform that recently completed a trial in recessive dystrophic epidermolysis bullosa [3] Upcoming Events - The company will host a conference call on May 8th, 2025, at 4:30 PM EDT to discuss the results for the quarter ended March 31, 2025, and provide a corporate update [1][2] - Participants can join the call by dialing in 5 to 10 minutes before the start time [2] Financial Information - The company is publicly traded on NASDAQ under the ticker INMB [3]

Core Insights - INmune Bio Inc. has achieved a significant intellectual property milestone with its CORDStrom™ product, a next-generation mesenchymal stromal cell (MSC) therapy targeting inflammation and immunology [1][4] - The United States Patent and Trademark Office (USPTO) has issued a favorable written opinion on INmune Bio's international patent application, confirming the novelty and industrial applicability of all claims [2] - CORDStrom™ is designed to provide consistent therapeutic performance across various inflammatory and degenerative diseases, utilizing pooled, culture-expanded human umbilical cord-derived MSCs [3][6] Intellectual Property Developments - The favorable opinion from the USPTO confirms that all claims in the patent application possess novelty, inventive step, and industrial applicability, which are essential for patentability [2] - The patent application, once granted, will provide IP exclusivity for the CORDStrom product platform until at least 2045, with potential extensions [4] - INmune Bio plans to expedite the U.S. national application process through the Patent Prosecution Highway (PPH) program [4] Product and Clinical Development - CORDStrom™ represents an advancement in cell therapy, offering batch-to-batch consistency and tunability for multiple disease indications [4][7] - Recent Phase 2 trial data indicated that CORDStrom™ reduced pain and itch, with early signs of improved skin integrity and disease activity, marking a pivotal step for the MSC platform [5] - The CORDStrom™ platform is designed to create off-the-shelf, allogeneic MSCs that can be produced at low cost and with consistent specifications, independent of donor characteristics [6] Company Overview - INmune Bio Inc. is a clinical-stage biotechnology company focused on developing treatments that target the innate immune system [8] - The company has three product platforms, including the DN-TNF platform for treating diseases like Alzheimer's and the Natural Killer Cell Priming Platform [8] - CORDStrom™ is positioned as a first systemic therapy for conditions like recessive dystrophic epidermolysis bullosa (RDEB) and can be tailored for specific indications [7]