Boca Raton, FL, Nov. 18, 2025 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB), a clinical-stage inflammation and immunology company, today announces two presentations at the upcoming 18th Clinical Trials on Alzheimer’s Disease conference (CTAD), in San Diego, CA on December 1-4, 2025. Presentations: Title:XPro1595, a Selective Soluble TNF Neutralizer, in Early Alzheimer’s Disease with Inflammation (ADi): Results from the Phase 2 MINDFuL Trial Date:Monday, December 1, until Tuesday December 2, 2025 Tim ...

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].

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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]

Exhibit 99.1 INmune Bio Inc. Announces Third Quarter 2025 Results and Provides Business Update Company to Host Conference Call Today, October 30, at 4:30pm ET BOCA RATON, Fla., Oct. 30, 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, today announces its financial results for the quarter ended September 30, 2025 and provides a busine ...

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]