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. ...

Medical review of Phase 1 cohorts demonstrated no safety issuesData to be presented at the 10th Annual Innate Killer Summit, March 3-5 BOCA RATON, Fla, Feb. 12, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology and inflammation company, continues to advance its Natural Killer (NK) cell therapy, INKmune™, in a Phase I/II trial (the “CaRe PC” trial) for men with metastatic castration-resistant prostate cancer (mCRPC). The Company is pleased to announce compl ...

Summary of INmune Bio (INMB) Earnings Conference Call Company Overview - **Company**: INmune Bio (INMB) - **Event**: Earnings Conference Call - **Date**: February 11, 2025 Key Points Industry and Product Focus - The call primarily discusses the clinical development of **KORSTORM**, a unique mesenchymal stem stromal cell product (MSC) aimed at treating **Refractory Dystopic Etymolysis Bullosa (RDEB)**, a rare inherited blistering disorder characterized by skin blisters from minor trauma [2][3] Clinical Study Insights - **KORSTORM** is currently in pivotal studies for RDEB, which is a debilitating multisystem disorder [4] - The clinical trial results indicate that the product has shown potential in addressing the severe itch associated with the condition, which significantly impacts patients' quality of life [9][25] - The FDA has provided clear indications that the endpoints proposed for the Biologics License Application (BLA) submission are meaningful and suitable [11][19] Data and Statistical Analysis - The small patient population in the Phase II study (30 patients) makes it challenging to derive statistically significant P values, leading to questions about the statistical validity of the results [12] - No complete wound closure rates were reported from the cohort, as the scoring system used did not yield such results [14] Regulatory and Future Plans - The FDA did not express concerns regarding the number of patients studied but emphasized the need for a randomized controlled trial [19] - There are no other clinical trials currently planned or underway for KORSTORM, although a precursor trial has been completed and is awaiting publication [22] Unmet Medical Need - The call highlighted the severe unmet need for effective treatments for RDEB, with INmune Bio positioning KORSTORM as the only planned systemic treatment for affected children [25] Additional Considerations - The potential for using KORSTORM in conjunction with CRISPR technology was mentioned, indicating ongoing exploration of treatment synergies [16] - The impact of itch as a side effect of the condition was discussed, emphasizing its significance in the overall treatment strategy [16] Conclusion - INmune Bio is focused on addressing a critical unmet need in the treatment of RDEB with KORSTORM, supported by ongoing clinical studies and regulatory engagement. The company aims to advance its product towards market approval while navigating the complexities of clinical data and regulatory requirements.

The Company reports results of a double-blinded, randomized, placebo-controlled study, known as "MissionEB," investigating CORDStrom for treatment of RDEB in pediatric patients, which evidence a favorable benefit-risk profile in support of the intended applications for marketing authorization. CORDStrom, developed by INmune Bio is a patent pending, off the shelf, advanced mesenchymal stromal cell (MSC) platform developed to treat complex inflammatory diseases that has significant clinical development advant ...

First patient treated in Phase II portion of clinical trial in metastatic prostate cancer at the West Los Angeles Veterans Administration Hospital Boca Raton, Florida, Jan. 28, 2025 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, has an ongoing Phase I/II trial in men with metastatic castration-resistant prostate cancer (mCRPC). The Comp ...

Vivo Empowers Clinical Development Teams to Accelerate Decision-making and Analyses in Clinical Trials for Improved Outcomes HOUSTON and BOCA RATON, Fla., Dec. 04, 2024 (GLOBE NEWSWIRE) -- OmniScience and INmune Bio (NASDAQ: INMB) today announced a pioneering partnership to revolutionize operations for INmune Bio’s global Phase 2 Alzheimer’s disease (AD) clinical trial (the “AD02 trial”) using OmniScience’s flagship product, Vivo, an industry-first, genAI-powered control tower designed specifically for cent ...

Financial Performance - Net loss attributable to common stockholders for Q3 2024 was approximately $12.1 million, compared to $8.6 million in Q3 2023, representing an increase of 40.7%[17] - Total revenue for the nine months ended September 30, 2024, was $30,000, compared to $43,000 for the same period in 2023, representing a decrease of 30.23%[29] - Net loss for the nine months ended September 30, 2024, was $32,864, compared to a net loss of $21,600 for the same period in 2023, reflecting an increase of 52.00%[31] - The company reported a net cash used in operating activities of $22,348 for the nine months ended September 30, 2024, compared to $8,579 for the same period in 2023, an increase of 160.00%[31] Research and Development - Research and development expenses totaled approximately $10.1 million for Q3 2024, up from approximately $6.0 million in Q3 2023, indicating a year-over-year increase of 68.3%[17] - Research and development expenses for the nine months ended September 30, 2024, were $25,813, up from $14,266 in the same period of 2023, marking an increase of 81.00%[29] - The Phase 2 Alzheimer's trial (AD02) has completed enrollment with a target of 201 patients, with interim analysis showing a highly significant correlation (p<0.001) between EMACC and CDR-SB[2][3] - INKmune™ demonstrated excellent safety and increased NK-Cell activity in the Phase I/II trial for metastatic Castration-Resistant Prostate Cancer, with 2 of 3 patients showing increased circulating activated NK cells[7] - The CaRe PC trial has recently dosed the first patient in the highest dose cohort, with the intermediate and high dose cohorts being 3 and 5 times the initial dose[9] - Top-line data from the Phase 2 Alzheimer's trial is expected in Q2 2025, with a Phase II trial of XPro™ in Treatment-Resistant Depression set to initiate in 2H 2024[14] - The company received a $2.5 million research and development rebate from Australia in July 2024[13] Cash and Equity - As of September 30, 2024, the company had cash and cash equivalents of approximately $33.6 million[18] - Cash and cash equivalents at the end of the period were $35,848, down from $52,153 at the end of the same period in 2023, indicating a decrease of 31.36%[31] - The company executed securities purchase agreements for gross proceeds of approximately $13.0 million[13] - The company had total liabilities of $14,107 as of September 30, 2024, down from $18,862 at the end of 2023, a decrease of 25.51%[28] - Total stockholders' equity increased to $38,675 as of September 30, 2024, from $37,340 at the end of 2023, reflecting an increase of 3.59%[28] - As of October 31, 2024, the company had approximately 22.2 million common shares outstanding[18] - The weighted average common shares outstanding for the nine months ended September 30, 2024, were 19,176,853, compared to 17,966,990 for the same period in 2023, an increase of 6.71%[29] - The company reported net proceeds from the sale of common stock and warrants of $27,789 for the nine months ended September 30, 2024, compared to $775 for the same period in 2023, a significant increase[31] Operating Expenses - Operating expenses for the nine months ended September 30, 2024, totaled $33,182, an increase of 54.38% from $21,489 in the same period of 2023[29]