Financial Performance - Net loss attributable to common stockholders for Q3 2025 was approximately $6.5 million, a decrease from approximately $12.1 million in Q3 2024, representing a 46% improvement[13] - Revenue for the nine months ended September 30, 2025, was $50,000, compared to $14,000 for the same period in 2024, representing a significant increase[23] - Net loss for the nine months ended September 30, 2025, was $40,669, compared to a net loss of $32,864 for the same period in 2024, reflecting a 23.7% increase in losses[23] - The company reported a comprehensive loss of $40,858 for the nine months ended September 30, 2025, compared to $33,101 in 2024, marking a 23.5% increase[23] Expenses - Research and development expenses for Q3 2025 totaled approximately $4.9 million, down from approximately $10.1 million in Q3 2024, indicating a 52% reduction[13] - General and administrative expenses for Q3 2025 were approximately $2.5 million, slightly up from approximately $2.2 million in Q3 2024[13] - Total operating expenses for the nine months ended September 30, 2025, were $41,959, up from $33,182 in 2024, indicating a 26% increase year-over-year[23] - Stock-based compensation for the nine months ended September 30, 2025, was $6,594, compared to $5,848 in 2024, indicating an increase of 12.8%[27] - The company incurred an impairment of acquired in-process research and development intangible assets amounting to $16,514 for the nine months ended September 30, 2025[27] Cash Position - As of September 30, 2025, the company had cash and cash equivalents of approximately $27.7 million, an increase from $20.9 million as of December 31, 2024[21] - Cash and cash equivalents at the end of the period were $27,734, down from $33,552 at the end of the same period in 2024[27] - Net cash used in operating activities for the nine months ended September 30, 2025, was $19,638, compared to $22,348 in 2024, showing a decrease in cash outflow[27] - The net proceeds from the sale of common stock and warrants for the nine months ended September 30, 2025, were $27,544, slightly down from $27,789 in 2024[27] Shareholder Information - The company had approximately 26.6 million common shares outstanding as of October 30, 2025[13] - The weighted average common shares outstanding for the nine months ended September 30, 2025, was 24,141,613, compared to 19,176,853 in 2024, reflecting a 25.9% increase[23] Clinical Developments - The company is on track to file a Marketing Authorization Application (MAA) for CORDStrom™ in mid-2026, followed by a Biologics License Application (BLA) with the FDA[6] - XPro™ demonstrated a consistent clinical benefit in a predefined population of amyloid-positive early Alzheimer's patients, with an effect size of 0.27 for cognitive decline[6] - The CARE-PC trial met its primary endpoint and 2 of 3 secondary endpoints, showing evidence of NK cell proliferation in vivo in 4 of 6 patients at lower dose levels[6] - The company plans to request an End of Phase 2 meeting with the FDA in Q1 2026[6] - Final data analysis for the INKmune CARE-PC trial is expected to be released in Q4 2026[6]

Product Development and Clinical Trials - The company aims to develop and commercialize product candidates targeting diseases related to inflammation and immunology, with a primary focus on Alzheimer's Disease (AD) and recessive dystrophic epidermolysis bullosa (RDEB) [102]. - XPro for AD has completed Phase I and Phase II trials, with the Phase II trial involving 208 patients and top-line data expected in June 2025 [103][109]. - In the Phase II trial, the modified intent-to-treat (mITT) population did not meet primary and key secondary endpoints, with no decline observed in the placebo group [109][112]. - The enriched subgroup of patients, defined as amyloid positive with a higher burden of inflammation, showed a beneficial effect of XPro on cognitive measures, with an effect size of 0.27 for the Early and Mild Alzheimer's Cognitive Composite (EMACC) [115][120]. - XPro demonstrated a significant reduction in neuroinflammation biomarkers, including a 91% reduction in Visinin-like protein-1 and an 84% reduction in Neurofilament light [106]. - The Phase II study was a multicenter, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of XPro1595 in early AD patients with inflammatory biomarkers [108]. - The company believes that neutralizing soluble TNF (sTNF) is crucial for treating neuroinflammation and immune dysfunction in AD [104]. - The company is focused on leveraging its DN-TNF platform to treat selected neurodegenerative diseases without immunosuppression [106]. - The Phase I trial of XPro was partially funded by a Part-the-Clouds Award from the Alzheimer's Association, indicating external validation of the research [106]. - The Phase 2 results suggest XPro may benefit a subgroup of Alzheimer's patients with biomarker-defined neuroinflammation, regardless of comorbidities or ApoE4 status [127]. Product Applications and Regulatory Designations - The company plans to submit a Marketing Authorization Application (MAA) in the UK and a Biologics License Application (BLA) with the FDA in the US for CORDStrom in 2026 [103]. - CORDStrom platform utilizes proprietary techniques to produce off-the-shelf, allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells (HucMSCs) for treating complex inflammatory diseases [128]. - Approximately 2,000 individuals in the US, UK, and EU suffer from RDEB, representing a significant unmet medical need [130]. - CORDStrom demonstrated a sustained reduction of over 27% in itch severity at 6 months for patients with severe disease activity [132]. - The FDA granted Rare Pediatric Disease Designation (RPDD) to CORDStrom on December 13, 2024, making it eligible for a Priority Review Voucher [137]. - The FDA also granted Orphan Drug Designation (ODD) to CORDStrom on January 6, 2025, providing benefits such as tax credits and market exclusivity [138]. - The Company plans to submit a Biologics License Application (BLA) for CORDStrom this year, with submissions to the EU and UK planned for 2026 [139]. Financial Performance - The company reported a net loss of $40.7 million for the nine months ended September 30, 2025, compared to a net loss of $32.9 million for the same period in 2024 [165]. - Research and development expenses were approximately $18.3 million for the nine months ended September 30, 2025, down from $25.8 million in the same period in 2024, primarily due to a $9.5 million reduction in Alzheimer's clinical program expenses [160]. - The company recognized revenue of $50,000 during the nine months ended September 30, 2025, compared to $14,000 in the same period in 2024 [158]. - Total operating expenses for the nine months ended September 30, 2025, were $41.96 million, an increase of $8.78 million from $33.18 million in 2024 [158]. - The company incurred a significant impairment of $16.5 million related to acquired in-process research and development intangible assets due to the failure of the Phase 2 clinical trial for the Alzheimer's drug candidate [162]. - Cash and cash equivalents as of September 30, 2025, were $27.7 million, up from $20.9 million as of December 31, 2024 [142]. - The company expects to continue incurring significant losses and increasing operating expenses as it advances its product candidates through clinical development [151]. - General and administrative expenses were approximately $7.1 million for the nine months ended September 30, 2025, compared to $7.4 million in the same period in 2024 [161]. - The company recorded $1.24 million of other income during the nine months ended September 30, 2025, compared to $304,000 in the same period in 2024 [163]. Financing and Cash Flow - The company plans to finance its operations through equity and debt financing, as well as potential collaborations and government funding [143]. - The Company sold 1,304,707 shares of common stock at an average price of $8.01, generating gross proceeds of approximately $10.4 million under the ATM offering during the nine months ending September 30, 2025 [166]. - In June 2025, the Company sold 3,000,000 shares of common stock in a registered direct offering for gross proceeds of $18.9 million, with net proceeds of approximately $17.4 million [166]. - Cash and cash equivalents at the end of the period were $27.7 million, with total current assets of $30.7 million, projected to be insufficient to sustain operations for one year following the issuance of financial statements [169]. - Operating activities used approximately $19.6 million of cash during the nine months ended September 30, 2025, primarily due to a loss of $40.7 million [174]. - The Company incurred $0.9 million in equipment acquisitions for its CORDStrom clinical program during the nine months ended September 30, 2025 [176]. - Financing activities generated $27.5 million during the nine months ended September 30, 2025, compared to $20.3 million in the same period of 2024 [173]. - The Company reported a net cash outflow from operating activities of $22.3 million for the nine months ended September 30, 2024 [175]. - The Company has significant research and development expenses in Australia and the United Kingdom, with foreign currency fluctuations potentially impacting financial results [168]. - The Company anticipates financing operations through public or private equity sales, debt financing, or other capital sources due to ongoing net losses and negative cash flows [169]. - The Company has raised concerns regarding its ability to continue as a going concern within one year after the issuance of its financial statements due to recurring net losses [169].

Core Insights - INmune Bio Inc. reported its financial results for Q3 2025, highlighting advancements in its clinical programs and a significant reduction in net loss compared to the previous year [1][10]. Financial Performance - The net loss attributable to common stockholders for Q3 2025 was approximately $6.5 million, a decrease from approximately $12.1 million in Q3 2024 [10]. - Research and development expenses totaled approximately $4.9 million for Q3 2025, down from approximately $10.1 million in Q3 2024 [10]. - General and administrative expenses were approximately $2.5 million for Q3 2025, compared to approximately $2.2 million in Q3 2024 [10]. - As of September 30, 2025, the company had cash and cash equivalents of approximately $27.7 million [10]. Product Development Highlights - The CORDStrom™ platform successfully completed its first two commercial pilot-scale manufacturing runs, with plans to file a Marketing Authorization Application (MAA) in mid-2026 for recessive dystrophic epidermolysis bullosa (RDEB) [5]. - XPro™, a selective soluble TNF neutralizer, showed promising results in a Phase 2 trial for early Alzheimer's disease, demonstrating cognitive benefits and a favorable safety profile [5][11]. - The INKmune® platform is currently in a Phase I/II trial for metastatic castration-resistant prostate cancer, with data expected to be released in Q4 2025 [12][10]. Corporate Updates - Dr. RJ Tesi retired, and David Moss was appointed as the new President & CEO [10]. - Cory Ellspermann was appointed as CFO, and Kelly Ganjei was named Chairman of the board of directors [10]. - The company plans to present additional data on CORDStrom™ and imaging data from the Phase 2 MINDFuL trial in Q4 2025 [10].

Core Points - INmune Bio Inc. will host a conference call on October 30, 2025, at 4:30 PM ET to discuss its third-quarter results and provide a corporate update [1][2] - The company is a clinical-stage biotechnology firm focused on developing treatments targeting the innate immune system [3] Company Overview - INmune Bio Inc. is publicly traded on NASDAQ under the ticker INMB [3] - The company has three product platforms: - The Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform, which neutralizes soluble TNF to address immune dysfunction [3] - CORDStrom™, a proprietary platform using human umbilical cord-derived mesenchymal stromal/stem cells, which recently completed a trial for recessive dystrophic epidermolysis bullosa [3] - INKmune®, designed to enhance natural killer cells to target minimal residual disease in cancer patients, currently in trials for metastatic castration-resistant prostate cancer [3]

Core Insights - INmune Bio, Inc. is participating in the Dermatologic Rare Disease Panel at the Maxim Growth Summit on October 22-23, 2025, where CEO David Moss will discuss the company's CORDStrom™ platform for treating Recessive Dystrophic Epidermolysis Bullosa (RDEB) [1][2] 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: - Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform, which neutralizes soluble TNF to address immune dysfunction [3] - CORDStrom™, a proprietary platform using human umbilical cord-derived mesenchymal Stromal/Stem cells, which has completed a blinded randomized trial for RDEB [3] - INKmune®, designed to enhance natural killer cells to eliminate minimal residual disease in cancer patients, currently in trials for metastatic castration-resistant prostate cancer [3] Event Details - The Maxim Growth Summit will be held at the Hard Rock Hotel in New York City, with David Moss available for one-on-one meetings throughout the conference [1][2]

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. has successfully completed its first full-scale pilot commercial manufacturing run of CORDStrom™, a therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB), marking a significant step towards regulatory submissions and commercialization [1][2][3] Group 1: Product Development - CORDStrom™ is designed to meet the severe unmet needs of RDEB patients, addressing issues such as skin fragility, blistering, and chronic wounds [2] - The therapy has shown promising results in the Phase 2 Mission EB trial, with improvements in itch, pain, wound scores, and quality of life [2] - The successful manufacturing run confirms the scalability and consistency of CORDStrom™ production, ensuring a high-quality, GMP-compliant product [2] Group 2: Regulatory and Commercialization Plans - The company is on track to file a Marketing Authorization Application (MAA) in the UK in the first half of 2026, followed by a Biologics License Application (BLA) in the US [1][3] - The completion of the pilot run is seen as a pivotal moment in the journey to market, reinforcing confidence in delivering a reliable supply chain for global commercialization [3] Group 3: Company Background - INmune Bio Inc. is a clinical-stage company focused on developing treatments that target the innate immune system, with three product platforms including CORDStrom™ [5][6] - The company collaborates with the Cell and Gene Therapy Catapult to enhance its manufacturing capabilities and accelerate its path to commercial production [3][7]

Core Viewpoint - INmune Bio, Inc. (INMB) has experienced a significant decline of 23.8% over the past four weeks, but it is now positioned for a potential trend reversal as it is in oversold territory, supported by analysts predicting better earnings than previously expected [1] Group 1: Technical Indicators - The Relative Strength Index (RSI) is a momentum oscillator that indicates whether a stock is oversold, with readings below 30 typically signaling this condition [2] - INMB's current RSI reading is 27.46, suggesting that the heavy selling pressure may be exhausting itself and a trend reversal could be imminent [5] Group 2: Fundamental Indicators - There is a strong consensus among sell-side analysts that earnings estimates for INMB have increased by 15.7% over the last 30 days, indicating a potential for price appreciation [6] - INMB holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the stock's potential turnaround [7]

Financial Data and Key Metrics Changes - The net loss attributable to common stockholders for Q2 2025 was approximately $24.5 million, compared to approximately $9.7 million for the same period in 2024, indicating a significant increase in losses [33] - Research and development expenses totaled approximately $5.8 million for Q2 2025, down from approximately $7.1 million in Q2 2024 [33] - General and administrative expenses were approximately $2.3 million for Q2 2025, compared to approximately $2.8 million for the same period in 2024 [33] - The impairment of acquired in-process research and development intangible assets was $16.5 million, compared to zero during the same period in 2024 [34] - As of June 30, 2025, the company had cash and cash equivalents of approximately $33.4 million, which is expected to fund operations into 2026 [34] Business Line Data and Key Metrics Changes - The phase two MINDFUL trial for EXPAREL confirmed that Alzheimer's patients with two or more biomarkers of inflammation are optimal candidates, with an estimated 40% to 60% of all Alzheimer's cases fitting this profile [7][8] - In the key subgroup of patients with high inflammation, the trial observed an effect size of 0.27 on the primary endpoint EMAC and 0.23 on a key secondary behavioral endpoint, the neuropsychiatric inventory [15][16] - The company has decided not to pursue treatment-resistant depression at this time and is reevaluating opportunities for EXPAREL beyond Alzheimer's disease [10][11] Market Data and Key Metrics Changes - The company anticipates filing for approval of Cordstrom in both the UK and US by mid-2026, with expectations that it will qualify for a Priority Review Voucher if approved in the US [12] - The company is exploring shorter pathways to market for EXPAREL, including opportunities in rare diseases to maximize impact and accelerate patient access [9] Company Strategy and Development Direction - The company is focused on securing strategic partnerships to advance the EXPAREL program, which requires substantial investment in manufacturing and clinical trials [8][9] - The company aims to prepare for an end of phase two meeting with the FDA to align on the design of the phase three trial for EXPAREL [21] - The company is committed to exploring strategic partnerships to fuel growth and complete trials, while also ensuring the development of Cordstrom and INKmune [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of EXPAREL as a first-in-class drug for Alzheimer's disease, emphasizing its unique approach to addressing neuroinflammation [7][8] - The management highlighted the importance of the recent phase two trial results and the potential for strategic partnerships to support the program's advancement [22] - Management acknowledged the challenges of the current operating environment but remains optimistic about the company's robust pipeline and potential value creation [36] Other Important Information - The company plans to publish the trial results in a peer-reviewed journal and prepare a briefing book for the FDA meeting, expected to occur before the end of the year [35] - The company is actively exploring additional indications for Cordstrom beyond recessive dystrophic epidermolysis bullosa [12][26] Q&A Session Summary Question: Confirmation of end of Phase two meeting date with FDA - The specific meeting date has not been set yet, and the briefing book is being prepared [41] Question: Atmosphere at AAIC and feedback from thought leaders - Feedback was positive, with strong interest in the neuropsychiatric inventory and the absence of amyloid-related imaging abnormalities [42][44] Question: Strategic partnerships for EXPAREL - A partnership is not expected until after the end of phase two meeting with the FDA, as partners will want to see the publication and FDA feedback first [46][48] Question: Insights from ongoing statistical analysis for Cordstrom - The statistical analysis plan is expected to yield improved data for submission, and the open-label trial is planned for early 2027 [70][72]

XPro Program for Alzheimer's Disease - XPro1595 is designed to selectively inhibit soluble TNF to treat neurologic disease, with Phase 1b study demonstrating safety and dose-dependent reduction in inflammatory cytokines in cerebrospinal fluid (CSF)[34] - A Phase 2 study of XPro1595 in early Alzheimer's patients with biomarkers of inflammation used an enriched population (n=100) with amyloid and ≥ 2 biomarkers of inflammation, showing a beneficial signal across multiple measures[42, 57] - In the Safety Analysis Set (SAF) population (n=206) for the Phase 2 study, 51% were female, and 95.1% were white[39] - In the mITT population (n=200), 75% were Amyloid-beta (Aβ) positive[39] - The most common Treatment Emergent Adverse Event (TEAE) in the XPro1595 group was Injection Site Reaction (ISR), occurring in 52.5% of patients[54] - The company plans to validate the enriched population in a fully powered trial and anticipates an end-of-Phase 2 meeting with the FDA in Q4 2025[56, 59] CORDStrom Program for RDEB - CORDStrom is an investigational disease-modifying treatment for recessive dystrophic epidermolysis bullosa (RDEB), a rare genetic disease affecting an estimated 4000 people in the US, UK, and EU, representing a > $1B peak sales opportunity[64] - A Phase 2 trial of CORDStrom in 30 pediatric patients with RDEB showed beneficial effects with respect to Itch Man Scale, iscorEB clinician score, skin score, and QOL, with no CORDStrom-related serious adverse events reported[66] - The company plans to compile and file a BLA in the US & MAA in UK/EU in 1H 2026[77] INKmune Program for Cancer - INKmune is an off-the-shelf NK cell therapy candidate designed to convert patient's resting NK cells into cancer-killing memory-like NK cells[78] - An INKmune® mCRPC Phase I/II Trial is ongoing, with safety endpoints met and evidence of in-vivo NK cell activation and regression of some tumor lesions by PSMA-PET[80]