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 Viewpoint - INmune Bio Inc. is set to present top line data from the Phase 2 MINDFuL trial focused on early Alzheimer's Disease during a conference call on June 30, 2025 [1][2]. Group 1: MINDFuL Trial Details - The MINDFuL trial is an international, blinded, randomized Phase 2 study involving patients with early Alzheimer's Disease (AD) who exhibit biomarkers of elevated neuroinflammation [3]. - Participants in the trial must have at least one of four inflammation biomarkers: elevated CRP, HgbA1c, ESR, or ApoE4 allele, and they receive either XPro™ or placebo in a 2:1 ratio for 6 months [3]. - Cognitive endpoints for the trial include EMACC and CDR, with XPro™ administered as a once-a-week subcutaneous injection [3]. Group 2: XPro™ Overview - XPro™ is a next-generation inhibitor of tumor necrosis factor (TNF) that selectively neutralizes soluble TNF without affecting trans-membrane TNF or TNF receptors [4]. - The drug aims to reduce neuroinflammation, potentially benefiting patients with neurological diseases [4]. Group 3: Company Background - INmune Bio Inc. is a publicly traded clinical-stage biotechnology company focused on developing treatments targeting the innate immune system [5]. - The company has three product platforms, including 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][6]. - Other platforms include the Natural Killer Cell Priming Platform and the CORDStrom™ program, which targets chronic inflammation and cancer [5][6].

Pipeline Highlights - XPro: Phase 2 Alzheimer's trial fully enrolled with top-line cognition results expected in June 2025[5], Phase I data showed a 222% increase in Contactin-2 and a 56% decrease in Neurogranin after 12 weeks of treatment[23] - CORDStrom: Completed blinded randomized trial in Recessive Dystrophic Epidermolysis Bullosa (RDEB) with US BLA submission planned for 2026[5], targeting a > $1 billion peak sales opportunity in the US, UK, and EU[50] - INKmune: Phase I dose escalation cohorts complete, with ongoing Phase 2 Metastatic Castrate Resistant Prostate Cancer (mCRPC) data readouts in 2025[5] XPro (Alzheimer's Disease) - TNF inhibitors reduce the risk of developing AD by 60% based on epidemiological studies of over 60 million cases[15] - Phase I results showed dose-dependent reduction of CSF biomarkers of neuroinflammation in AD patients[16] CORDStrom (RDEB) - CORDStrom is potentially the first systemic therapy for RDEB, with itch benefit as a key differentiating factor[50] - Mission EB trial: 30 pediatric patients with RDEB were treated in a double-blind, randomized, placebo-controlled cross-over design clinical trial[52, 56] INKmune (Cancer) - INKmune converts resting NK cells to cancer-killing memory-like NK cells[5, 73]

Analyst’s Disclosure:I/we have a beneficial long position in the shares of INMB either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a partic ...

Core Insights - INmune Bio, Inc. is collaborating with Virginia Commonwealth University to study the effects of Traumatic Brain Injury (TBI) on Alzheimer's disease (AD) and the potential of XPro™ treatment to mitigate these effects [1][2][4] - The study indicates that TBI increases amyloid deposition and neuroinflammation, which are linked to AD progression, and that XPro™ significantly reduces amyloid formation and improves brain function [1][3][4] Group 1: Study Findings - TBI leads to a transient increase in TNFR1, BACE1, and Aβ42 expression in the hippocampus, peaking three days post-injury [3] - Administering XPro™ shortly after TBI inhibits solTNF/TNFR1 activity, preventing elevations in TNFR1, BACE1, Aβ42, and caspase-3 levels [3] - XPro™ treatment reduces intracellular neuronal amyloid accumulation and improves neurological outcomes in treated animals [3][4] Group 2: Implications for Alzheimer's Disease - The findings suggest that targeting TBI-induced solTNF/TNFR1 signaling could mitigate Aβ42 production and neuronal loss, linking TBI and AD [2][4] - XPro™ is positioned as a promising treatment to reduce AD pathology risk following TBI, particularly for the elderly population at risk for dementia [4] Group 3: Company Overview - INmune Bio, Inc. is a clinical-stage biotechnology company focused on developing treatments that target the innate immune system to combat diseases [6][7] - The company has three product platforms, including XPro™, which is in clinical trials for Mild Alzheimer's disease and other conditions [7]

Core Insights - INmune Bio, Inc. (NASDAQ: INMB) reported Q1 2025 business and financial results on May 8th, 2025, surpassing analyst estimates [1] - The company is on track to share results of its ongoing projects, indicating progress in its research and development efforts [1] Financial Performance - The financial results for Q1 2025 showed a positive trend, with the company beating analyst expectations [1] Research and Development - INmune Bio focuses on novel Cell & Gene Therapies (CGT) aimed at addressing various clinical needs, showcasing its commitment to innovation in the biotechnology sector [1]

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]

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 [26] - Research and development expenses totaled approximately $7.6 million for Q1 2025, down from approximately $8.7 million in Q1 2024 [26] - General and administrative expenses remained stable at approximately $2.3 million for both Q1 2025 and Q1 2024 [26] - As of March 31, 2025, the company had cash and cash equivalents of approximately $19.3 million, which is expected to fund operations through Q3 2025 [27] Business Line Data and Key Metrics Changes - The company is preparing to report top-line results from the MINDFUL phase two trial in early Alzheimer's disease, expected in mid to late June 2025 [6][27] - The market opportunity for EXPAREL in early Alzheimer's disease has increased to nearly 70% of early AD patients, up from the previously estimated 40% [7][8] - The safety profile of EXPAREL remains excellent, with no reports of adverse events in the ongoing 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 is focused on targeting neuroinflammation in Alzheimer's disease, positioning itself as a leader in this area [81][82] - Plans for the Kordstrom program include filing a Biologics License Application (BLA) in 2026 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB) [17][24] - The company aims to transition manufacturing processes to optimize production for both Kordstrom and Inkmune, ensuring cost-effectiveness and regulatory compliance [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming MINDFUL trial results, believing they will significantly impact the treatment landscape for early Alzheimer's disease [16][81] - The company is optimistic about the regulatory environment for rare disease treatments, particularly following recent FDA comments [18][24] Other Important Information - The company has successfully transitioned its drug supply logistics for Inkmune to a US-based contractor, Cryoport, to ensure trial completion [21] - The company is also preparing for an IND submission for Kordstrom in the US, with manufacturing of a new batch of products using US-approved cord donors starting soon [73] Q&A Session Summary Question: Can you walk us through the next steps for the program assuming a positive readout in June? - Management indicated that they would defer specific timelines until after the FDA meeting, aiming to move quickly to open sites and enroll patients [32][33] Question: Can you comment on the FDA review team for your program? - Management believes that the FDA has remained on track and that the review team is stable, although they cannot predict future outcomes [36] Question: How do you think investors will react if EMAC hits but CDR is equivocal? - Management emphasized that EMAC is the primary driver for cognitive changes, and they expect correlations with CDR, which is a more blunt instrument [46][49] Question: Are APOE4 patients inherently inflammatory? - Management confirmed that APOE4 carriers tend to have earlier onset and faster progression of Alzheimer's disease, indicating a link to inflammation [62] Question: Are you still on track to initiate the twelve-month open-label trial for Cordstrom mid this year? - Management confirmed they are following FDA guidance and expect to submit an IND late this year, with plans for a follow-on trial in the US [73][74]

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 [26] - Research and development expenses totaled approximately $7.6 million for Q1 2025, down from approximately $8.7 million in Q1 2024 [26] - General and administrative expenses remained stable at approximately $2.3 million for both Q1 2025 and Q1 2024 [26] - As of March 31, 2025, the company had cash and cash equivalents of approximately $19.3 million, which is expected to fund operations through Q3 2025 [27] Business Line Data and Key Metrics Changes - The company is preparing to report top-line results from the MINDFUL phase two trial in early Alzheimer's disease, expected in mid to late June 2025 [6][16] - The market opportunity for EXPAREL in early Alzheimer's disease has increased to nearly 70% of early AD patients, up from the previously estimated 40% [7][8] - The safety profile of EXPAREL remains excellent, with no adverse events reported in the ongoing 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 tau 217 levels, is expected to enhance the therapeutic response measurement in patients [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 [83][84] - The upcoming BLA filing for Cordstrom in 2026 is part of the company's strategy to address rare diseases, specifically recessive dystrophic epidermolysis bullosa (RDEB) [17][24] - The company is transitioning its manufacturing processes to optimize production for both Inkmune and Cordstrom, ensuring cost-effective scalability [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming MINDFUL trial results, which are anticipated to significantly impact the treatment landscape for early Alzheimer's disease [16][84] - The company is closely monitoring FDA developments and believes that the regulatory environment remains favorable for drug development [36] Other Important Information - The company raised approximately $2.1 million from the sale of common stock after the end of the quarter [27] - The company is also planning to initiate a phase two trial of EXPAREL in patients with treatment-resistant depression once NIH funding is secured [28] Q&A Session Summary Question: Can you walk us through 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 [32] Question: Can you comment on the turnover at the FDA and the review team for your program? - Management believes that the FDA remains on track and that the review team is stable [36] Question: How do you think investors will react if EMAC hits but CDR is equivocal? - Management emphasized that EMAC is the primary driver for cognitive changes and that they expect correlations with CDR [46][50] Question: What is the expected reduction in CDR for a trial of this size? - Management expressed confidence in their power calculations based on previous trials and the quality of their patient population [62][70] Question: Are you still on track to initiate the twelve-month open-label trial for Cordstrom? - Management confirmed that they are following FDA guidance and expect to submit an IND later this year [74]

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]