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]

Exhibit 99.1 CORDStrom™ Platform INKmune® Platform: 2 ● Reported results of a double-blinded, randomized, placebo-controlled, cross-over study, known as "MissionEB," investigating CORDStrom™ for treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) in pediatric patients, which evidenced a favorable benefit-risk profile. ● FDA granted CORDStrom™ a Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) for treatment of epidermolysis bullosa (EB). ● Data from the MissionEB trial s ...

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 ...

Core Insights - INmune Bio Inc. reported its financial results for the year ended December 31, 2024, and provided a business update, highlighting advancements in its clinical programs and financial performance [1][9]. Financial Performance - The net loss attributable to common stockholders for 2024 was approximately $42.1 million, compared to a loss of approximately $30.0 million in 2023 [9][25]. - Research and development expenses totaled approximately $33.2 million for 2024, up from approximately $20.3 million in 2023 [9][25]. - General and administrative expenses were approximately $9.5 million for 2024, slightly down from approximately $9.6 million in 2023 [9][25]. - The company had cash and cash equivalents of approximately $20.9 million as of December 31, 2024 [9][25]. Clinical Developments - The company completed enrollment for its Phase 2 trial (AD02 trial) focused on Early Alzheimer's Disease, exceeding the target enrollment with 208 patients [4]. - Interim analyses of the AD02 trial data 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) [4]. - The EMACC measure demonstrated high reliability with a correlation of 0.93 between screening and first study visit scores [4]. - CORDStrom™ received FDA's Rare Pediatric Disease Designation and Orphan Drug Designation for treating epidermolysis bullosa [4][7]. Product Platforms - XPro™ is a next-generation TNF inhibitor in clinical trials, targeting neuroinflammation to potentially improve cognitive function in neurological diseases [11]. - CORDStrom™ is a cell medicine platform utilizing human umbilical cord-derived mesenchymal stromal cells, showing promise for treating complex inflammatory diseases [14][15]. - INKmune® is designed to prime a patient's NK cells for cancer treatment, currently in a Phase I/II trial for metastatic castration-resistant prostate cancer [16][17]. Upcoming Milestones - Top-line cognitive results from the AD02 trial are expected in June 2025 [13]. - A Phase II trial of XPro™ for Treatment-Resistant Depression will begin enrollment soon [13]. - The company anticipates filing a Biologics License Application (BLA) for CORDStrom™ in 2025 or early 2026 [13].

Boca Raton, Florida, March 24, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company, today announced that it will host a conference call on Thursday, March 27, 2025, at 4:30pm EDT to discuss results for its quarter ended December 31, 2024, and to provide a corporate update. Conference Call Information To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio Third Q ...

INmune Bio (NASDAQ: INMB ) has recently announced that it will be seeking approval of CORDStrom for the treatment of recessive dystrophic epidermolysis bullosa [RDEB] after favorable investigator-initiated trial results. CORDStrom was out of focus of investors. The FDA recentlyI am a long-term investor focused on growth markets, AI and biotech opportunities in my more volatile portfolio. I try to look for undervalued and under-the-radar stocks with serious potential and good scientific or other background. ...