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]

Core Insights - INmune Bio Inc. has partnered with the Cell and Gene Therapy Catapult to establish large-scale manufacturing for its cell therapy platforms, enhancing its production capabilities for commercial readiness [1][3] Company Overview - INmune Bio is a clinical-stage biotechnology company focused on harnessing the innate immune system to treat diseases such as Alzheimer's, prostate cancer, and recessive dystrophic epidermolysis bullosa (RDEB) [2][8] - The company has a diversified portfolio with active trials in the UK, Europe, Australia, Canada, and the US, addressing significant unmet medical needs [2] Collaboration Details - The partnership with CGT Catapult will leverage its expertise at the Stevenage Manufacturing Innovation Centre, initially focusing on scaling production of CORDStrom™, a therapy for RDEB [3][4] - CORDStrom™ has shown promise in a Phase 2 trial, reducing pain and itch while potentially improving skin integrity and disease activity, with an estimated 4,000 children in the US, UK, and EU who could benefit [3] Future Plans - Following CORDStrom™, INmune Bio plans to transition production of INKmune®, its NK-priming cell medicine for solid tumors, to the same facility, supporting ongoing trials in the US and UK [4] - This collaboration is expected to accelerate the company's path to commercialization by providing efficient, scalable manufacturing while maintaining operational control [4] Industry Context - The Cell and Gene Therapy Catapult aims to advance the cell and gene therapy industry, creating collaborations to overcome challenges and support the development of life-changing therapies [6]

Core Insights - INmune Bio, Inc. is presenting data from the MINDFuL Phase II trial at the International Conference on Alzheimer's and Parkinson's Diseases, focusing on early Alzheimer's disease (AD) and inflammation biomarkers [1][5] - The trial enrolled 208 patients, with 44% diagnosed with Mild Cognitive Impairment (MCI) and 56% with mild AD, averaging 72 years of age [2] - The primary endpoint is the change in cognitive scores measured by the Early and Mild Alzheimer's Cognitive Composite (EMACC), which is designed for sensitivity in early AD trials [3] Patient Demographics and Trial Design - The enrolled patients met criteria for inflammation biomarkers, including hsCRP > 1.5 mg/L, ESR > 10 mm/hr, HbA1c > 6.0%, or at least one APOE ε4 allele [2] - Patients were randomized in a 2:1 ratio to receive XPro™ (1.0 mg/kg) or placebo weekly for 23 weeks [2] - The screen failure rate was 72%, primarily due to disease severity as measured by the MMSE [4] Preliminary Findings - Preliminary analyses indicate a well-characterized cohort with 69.2% being APOE ε4 carriers and 64.4% meeting criteria for multiple enrichment biomarkers [5] - Secondary endpoints include CDR-SB, E-Cog, ADL, and Neuropsychiatric Inventory (NPI), along with blood biomarker and neuroimaging outcomes [5] - Topline results from the MINDFuL trial are expected to be reported in June 2025 [6] Company Overview - INmune Bio is a clinical-stage biotechnology company focused on treatments targeting the innate immune system, with three product platforms including DN-TNF, NK Cell Priming, and CORDStrom™ [7] - The company is developing therapies for Mild Alzheimer's disease, Mild Cognitive Impairment, and treatment-resistant depression [7]

Financial Data and Key Metrics Changes - INmune Bio raised $29.9 million from the sale of common stock and warrants in 2024, issuing a total of 4,145,978 shares and warrants for 3,898,852 shares [37][38] - The net loss attributable to common stockholders for the year ended December 31, 2024, was approximately $42.1 million, compared to approximately $30 million for 2023 [40] - Research and development expenses totaled approximately $33.2 million for 2024, up from approximately $20.3 million in 2023 [40] - Cash and cash equivalents at December 31, 2024, were approximately $20.9 million, with an additional $5.4 million raised since year-end [41] Business Line Data and Key Metrics Changes - The ADO2 trial for Alzheimer's disease is expected to announce top-line data in less than 100 days, focusing on neuroinflammation as a primary driver of the disease [8][14] - The INmune platform has pivoted to target solid tumors, with ongoing trials for castrate-resistant metastatic prostate cancer [17][18] - CORDStrom, a new therapeutic platform, is positioned to address systemic disease modification for RDEB, differentiating itself from local wound management therapies [22][24] Market Data and Key Metrics Changes - The ADO2 trial enrolled 208 patients across eight countries, with a focus on those with neuroinflammation driving their Alzheimer's disease [15] - The CaRe PC trial for prostate cancer is progressing, with completion of dosing in the Phase 1 part and ongoing Phase 2 dosing expected to complete by 2025 [18][43] Company Strategy and Development Direction - INmune Bio aims to challenge the amyloid-centric paradigm of Alzheimer's treatment by focusing on neuroinflammation [14][33] - The company is committed to advancing its three therapeutic platforms, with a focus on achieving regulatory milestones and potential commercialization [36][45] - The management emphasizes a precision medicine approach in clinical trials, particularly in the ADO2 trial [10][29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming results from the ADO2 trial, viewing it as a potential catalyst for a paradigm shift in Alzheimer's treatment [34][35] - The company believes that addressing neuroinflammation could have broader implications for various CNS diseases [35] - Management highlighted the importance of safety in treating elderly patients with Alzheimer's, noting no significant adverse events reported thus far [31] Other Important Information - The company plans to file a BLA for CORDStrom in the first quarter of 2026, which would mark its first market therapeutic [44][112] - Management is focused on ensuring the quality of regulatory submissions to facilitate successful approvals [113] Q&A Session Summary Question: Is the 12-month open label trial for RDEB required for filing? - Management indicated that they believe the current data is adequate for a BLA submission, but the FDA will ultimately decide [50][51] Question: Will EMACC and CDR results be released at the same time? - Management confirmed that both EMACC and CDR results will be available at the time of data release [56][60] Question: Are there any dropouts in the EXPAREL Phase 2 trial? - Management reported that dropouts are within expected ranges, primarily due to typical issues associated with elderly patients [86] Question: How does the company plan to commercialize CORDStrom? - Management aims to move towards commercialization independently but may seek a partner closer to the launch [93] Question: Will the BLA for CORDStrom be filed in the UK and US? - Management confirmed that they expect to have all necessary data ready for filing in both regions by early 2026 [101][102]

Financial Performance - The company reported a net loss attributable to common stockholders of approximately $42.1 million for the year ended December 31, 2024, compared to a loss of approximately $30.0 million in 2023[9]. - Total revenue for 2024 was $14,000, a decrease of 91% compared to $155,000 in 2023[22]. - Operating expenses increased to $42,649,000 in 2024, up 42.6% from $29,896,000 in 2023[22]. - Net loss for 2024 was $42,082,000, compared to a net loss of $30,008,000 in 2023, representing a 40.4% increase in losses[22]. - Cash and cash equivalents decreased to $20,922,000 in 2024 from $35,848,000 in 2023, a decline of 41.7%[20]. - Total assets decreased to $39,562,000 in 2024 from $57,001,000 in 2023, a reduction of 30.5%[20]. - Total liabilities decreased to $7,465,000 in 2024 from $18,862,000 in 2023, a decline of 60.5%[20]. - Net cash used in operating activities was $33,361,000 in 2024, significantly higher than $11,980,000 in 2023[24]. - Net proceeds from the sale of common stock and warrants amounted to $27,789,000 in 2024, compared to $775,000 in 2023[24]. Research and Development - Research and development expenses totaled approximately $33.2 million for the year ended December 31, 2024, up from approximately $20.3 million in 2023[9]. - Research and development expenses rose to $33,166,000 in 2024, an increase of 63.6% from $20,273,000 in 2023[22]. - The company completed enrollment for its Phase 2 trial (AD02 trial) with 208 patients, exceeding the target of 201 patients, focusing on Early Alzheimer's Disease[2]. - Interim analyses of the AD02 trial showed a significant correlation (p<0.001) between baseline scores on the EMACC cognitive measure and the Clinical Dementia Rating-Sum of Boxes (CDR-SB)[2]. - The company plans to initiate a 12-month open label study for CORDStrom™ therapy, including all patients from the MissionEB study[5]. Regulatory and Market Developments - CORDStrom™ received Rare Pediatric Disease Designation and Orphan Drug Designation from the FDA for the treatment of epidermolysis bullosa[5]. - The company anticipates filing a Biologics License Application (BLA) for CORDStrom™ in 2025 or early 2026, which could be eligible for a Priority Review Voucher if approved by September 2026[9]. - The company joined the Russell 3000® Index effective July 1, 2024, following the annual reconstitution[9]. Shareholder Information - The company executed securities purchase agreements for total gross proceeds of approximately $27.5 million, issuing about 3.9 million warrants to purchase common stock[9]. - The weighted average number of common shares outstanding increased to 19,944,304 in 2024 from 17,980,791 in 2023, a growth of 10.9%[22].

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 ...

Financial Data and Key Metrics Changes - The net loss attributable to common stockholders for the year ended December 31, 2024, was approximately $42.1 million, compared to approximately $30 million for 2023, indicating a significant increase in losses [41] - Research and development expenses totaled approximately $33.2 million for the year ended December 31, 2024, compared with approximately $20.3 million for 2023, reflecting a substantial increase in investment in R&D [41] - General and administrative expenses were approximately $9.5 million for the year ended December 31, 2024, compared with approximately $9.6 million for 2023, showing a slight decrease [41] - As of December 31, 2024, the company had cash and cash equivalents of approximately $20.9 million, with an additional $5.4 million raised since year-end through the use of the ATM [42] Business Line Data and Key Metrics Changes - The ADO2 trial for Alzheimer's disease enrolled 208 patients across eight countries, with nearly 800 patients screened, indicating a rigorous patient selection process [15][16] - The CARE-PC trial using IncMUNE for treating metastatic prostate cancer has made steady progress, with completion of dosing in the Phase 1 dose escalation part and ongoing dosing in the Phase 2 part [18] Market Data and Key Metrics Changes - The company has pivoted to solid tumors with the INCMUNE platform, believing that future opportunities are greater in this area compared to hematologic diseases [17] Company Strategy and Development Direction - The company aims to challenge the traditional amyloid-centric paradigm of Alzheimer's disease treatment by focusing on neuroinflammation as a primary driver [14][35] - The addition of Cordstrom has introduced a third therapeutic platform, which is expected to accelerate the timeline to becoming a commercial entity [37] - The company plans to file a Biologics License Application (BLA) for Cordstrom in the first quarter of next year, marking a significant milestone towards revenue generation [45] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming results from the ADO2 trial, viewing it as a potential catalyst for a paradigm shift in Alzheimer's treatment [35][36] - The company is focused on achieving primary clinical objectives while remaining cost-prudent, with expectations of sufficient cash to fund operations through Q3 2025 [42][43] Other Important Information - The company has received orphan drug status and rare pediatric disease designation for Cordstrom, differentiating it from other therapies by providing a systemic disease-modifying approach [22] Q&A Session Summary Question: Is the 12-month open-label trial required for filing? - Management indicated that they have access to all clinical data from the current trial and believe it will be adequate for a BLA submission [51] Question: Will the EMAC and CDR results be staggered? - Both EMAC and CDR results will be released simultaneously when the data becomes public [56][57] Question: Are there any dropouts in the Phase II trial? - Dropouts are less than expected, primarily due to typical elderly-related issues rather than drug efficacy or safety concerns [76] Question: How does the company plan to commercialize Cordstrom? - The company aims to move forward independently but may seek a partner for distribution and marketing as they approach commercialization [82][83] Question: Will the BLA for Cordstrom be filed in the UK and US? - The company expects to have all necessary data ready for filing in the first quarter of 2025, with ongoing preparations for both markets [90][91]

FORM 10-K ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: December 31, 2024 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission file number: 001-38793 INMUNE BIO INC. (Exact name of registrant as specified in its charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Nevada 47-5205835 (State or other jurisdiction of inco ...