Boca Raton, FL, Dec. 05, 2025 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (“INmune” or the “Company”), a clinical-stage inflammation and immunology company, announces a recently published overview of future applications and research areas for mesenchymal stromal cell (MSC) therapies, such as INmune’s CORDStrom™ platform. The article, titled, “Fate and Function of Exogenously Administered MSCs: Current Insights and Future Directions,” was published in the peer-reviewed journal Cytotherapy. One of the ...

Core Insights - INmune Bio, Inc. announced new neuroimaging data from its Phase 2 MINDFuL trial of XPro1595 in early Alzheimer's disease patients with elevated neuroinflammation, to be presented at the 18th Clinical Trials on Alzheimer's Disease conference [1][2] Group 1: Clinical Trial Results - The new analyses support XPro1595's mechanism of selectively neutralizing soluble TNF (sTNF), validating the strategy of targeting inflammation-driven Alzheimer's disease, which represents a significant unmet need [2][9] - PerpPD+ MRI imaging analysis indicated a trend towards slowed neurodegeneration progression in patients receiving XPro1595, particularly in those with early Alzheimer's and high inflammatory burden [3][8] - Findings suggest reduced cortical disarray, an imaging hallmark of neurodegeneration, reinforcing previously reported improvements across biological, cognitive, and neuropsychiatric endpoints [4][5] Group 2: Future Developments - Additional MRI analyses from the MINDFuL trial are ongoing and will provide a broader understanding of XPro1595's impact on gray- and white-matter integrity in Alzheimer's patients [7] - The totality of data generated to date positions XPro1595 as a promising first-in-class disease-modifying therapy for Alzheimer's patients with elevated neuroinflammation, a population with limited treatment options [9][10] Group 3: Company Overview - INmune Bio Inc. is a clinical-stage biotechnology company focused on developing treatments targeting innate immune dysfunction to combat diseases [11] - The company's pipeline includes XPro1595, an inhibitor of soluble TNF that aims to restore healthy innate immune function without the immunosuppressive effects of traditional TNF inhibitors [10]

Core Insights - INmune Bio, Inc. is set to present two studies at the 18th Clinical Trials on Alzheimer's Disease conference in San Diego from December 1-4, 2025 [1][2] Presentations - The first presentation will focus on XPro1595, a selective soluble TNF neutralizer, in early Alzheimer's disease with inflammation, showcasing results from the Phase 2 MINDFuL trial [2] - The second presentation will validate the Early Mild Alzheimer's Cognitive Composite (EMACC) through associations with blood-based biomarkers of Alzheimer's disease [2] Company Overview - INmune Bio Inc. is a clinical-stage biotechnology company specializing in treatments targeting immunology and inflammation [3] - The company has three product platforms: - The Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform, which selectively neutralizes soluble TNF [3] - CORDStrom™, a proprietary platform utilizing human umbilical cord-derived mesenchymal stromal cells, which recently completed a trial in recessive dystrophic epidermolysis bullosa [3] - INKmune®, designed to prime natural killer cells to eliminate minimal residual disease in cancer patients, currently in trials for metastatic castration-resistant prostate cancer [3]

Core Viewpoint - INmune Bio, Inc. (INMB) has shown a recent downtrend, losing 11.9% over the past four weeks, but a hammer chart pattern suggests a potential trend reversal as buying interest may be emerging [1][2]. Technical Analysis - The hammer chart pattern indicates a possible bottoming out, with selling pressure likely subsiding, which could lead to a bullish trend for the stock [2][5]. - A hammer pattern forms when there is a small candle body with a long lower wick, signaling that bears may be losing control over the price [4][5]. - This pattern can occur across various timeframes and is utilized by both short-term and long-term investors [5]. Fundamental Analysis - There has been a notable upward trend in earnings estimate revisions for INMB, which is a bullish indicator as it correlates strongly with near-term stock price movements [7]. - The consensus EPS estimate for the current year has increased by 8.2% over the last 30 days, indicating strong agreement among analysts regarding the company's potential for better earnings [8]. - INMB holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [9][10].

Core Points - The article emphasizes the importance of enabling Javascript and cookies in browsers to prevent access issues [1] - It highlights that users with ad-blockers may face restrictions when trying to access content [1] Summary by Categories Technical Requirements - Users are advised to enable Javascript and cookies in their browsers to ensure proper functionality [1] - The presence of ad-blockers can lead to blocked access, necessitating their disabling for content access [1]

Financial Data and Key Metrics Changes - 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 [24] - Research and development expenses totaled approximately $4.9 million for Q3 2025, down from approximately $10.1 million in the same period of 2024 [24] - General and administrative expenses were approximately $2.5 million for Q3 2025, compared to approximately $2.2 million in Q3 2024 [24] - As of September 30, 2025, the company had cash and cash equivalents of approximately $27.7 million, sufficient to fund operations into Q4 2026 [24] Business Line Data and Key Metrics Changes - The Cordstrom program is preparing for submission for marketing approval in the UK and US, with significant improvements noted in patients suffering from recessive dystrophic epidermolysis bullosa (RDEB) [5][10] - The EXPRO platform is focused on treating neuroinflammation in Alzheimer's disease, with a manuscript detailing Phase 2 Mindful trial results submitted for peer-reviewed publication [8][20] - The Incuboom program completed its Phase 2 trial in prostate cancer ahead of schedule, meeting the primary endpoint and two of three secondary endpoints [9][18] Market Data and Key Metrics Changes - The company is optimistic about the regulatory environment, with plans to file a Marketing Authorization Application (MAA) in the UK and a Biologics License Application (BLA) in the US for Cordstrom [10][26] - There is a significant unmet need in the RDEB market, with current treatments being expensive and not widely available through the NHS [60] Company Strategy and Development Direction - The company aims to advance its three drug platforms in parallel to provide strength and opportunity, with a focus on achieving key development milestones [10] - Cordstrom is viewed as a platform opportunity with potential applications in various diseases beyond RDEB, including cancer [8][10] - The EXPRO platform is positioned to address gaps in Alzheimer's treatment, particularly for patients with strong inflammatory profiles [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the next couple of years, expecting to demonstrate the success of their efforts through key development milestones [5] - The company is focused on regulatory alignment and advancing discussions with potential partners to support late-stage clinical development [20] - Management acknowledged the challenges in Alzheimer's drug development but remains confident in EXPRO's potential as a differentiated therapy [22] Other Important Information - The company has relocated to rented CGMP manufacturing space compliant with commercial production as a licensed medicine [16] - The Phase 2 Mindful trial results indicate that longer treatment durations with EXPRO are associated with greater improvements in neuropsychiatric symptoms [21] Q&A Session Summary Question: What are the biggest questions for the end of Phase 2 meeting with the FDA? - Management indicated that questions will focus on EMAC, enrichment biomarkers, and the safety database required for commercialization [32] Question: How are partnership discussions progressing for EXPRO? - Management noted that discussions are ongoing but are waiting for regulatory feedback and more data before aggressive partnering [36] Question: What is the current treatment paradigm for RDEB in the UK? - Management clarified that there is no RDEB-specific treatment available through the NHS, and Cordstrom is expected to fill this gap with a systemic effect [60] Question: What is the cash runway for upcoming milestones? - The current cash position is expected to support operations through Q4 2026, with significant milestones anticipated in early 2026 [67]

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]