Boca Raton, FL, Sept. 29, 2025 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB), a clinical-stage inflammation and immunology company, today announces the submission of a manuscript detailing the results of its Phase 2 MINDFuL trial. The manuscript, titled, “XPro1595, a Selective Soluble TNF Neutralizer, in Early Alzheimer’s Disease with Inflammation (ADi): Results from the Phase 2 MINDFuL Trial,” has been submitted for peer review to npj Dementia, a Nature Portfolio journal. The detailed manuscript prov ...

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]

[Second Quarter 2025 Business Update](index=1&type=section&id=Second%20Quarter%202025%20Business%20Update) Overview of Q2 2025 progress for DN-TNF, CORDStrom, and INKmune platforms, corporate updates, and upcoming milestones [DN-TNF Platform Highlights (XPro™)](index=1&type=section&id=DN-TNF%20Platform%20Highlights%20(XPro%E2%84%A2)) The MINDFuL Phase 2 trial for Alzheimer's disease missed its primary cognitive endpoints in the broader patient group, but showed a positive impact in an inflammatory biomarker subgroup - The top-line data from the MINDFuL phase 2 trial, involving 208 patients with MCI and early Alzheimer's, missed its primary cognitive endpoints in the 200 modified mITT patients[5](index=5&type=chunk) - XPro™ showed a **positive impact** on the primary cognitive endpoint EMACC in a pre-defined 'enriched population' subset of 100 patients (50%) who had two or more biomarkers of inflammation[5](index=5&type=chunk) - While underpowered for statistical significance in the enriched population, Cohen's d effect sizes were used to evaluate meaningfulness, showing consistent favorable trends for XPro™ over placebo, with effect sizes approaching the **0.2 threshold for clinical relevance**[4](index=4&type=chunk) [CORDStrom™ Platform Highlights](index=2&type=section&id=CORDStrom%20Platform) The CORDStrom™ platform achieved significant progress with a favorable international patent opinion and a strategic manufacturing partnership, with RDEB trial data expected in Q4 2025 - Received a **favorable written opinion** from the USPTO on all claims in the international patent application for CORDStrom™[8](index=8&type=chunk) - Partnered with the Cell and Gene Therapy Catapult (CGT Catapult) to establish **large-scale manufacturing** in preparation for MAA and BLA submissions in 2026[8](index=8&type=chunk) - The complete clinical database from the CORDStrom trial in Recessive Dystrophic Epidermolysis Bullosa (RDEB) is being analyzed by an independent firm, with data anticipated in **Q4**[8](index=8&type=chunk) [INKmune™ Platform Highlights](index=2&type=section&id=INKmune%E2%84%A2%20Platform) The CARE-PC Phase I/II trial met secondary endpoints, demonstrating NK cell activation and proliferation, and has closed recruitment after gathering sufficient data for future trial design - In the CARE-PC trial, early analysis confirmed that the secondary endpoints of **NK activation and NK cell proliferation in vivo** had been met[8](index=8&type=chunk) - It was determined that patients with **low NK cell function responded better to treatment**, which will allow for patient screening in future trials to select for likely responders[8](index=8&type=chunk) - The CARE-PC trial has been closed to further recruitment, as it has provided all necessary data to design a future randomized trial, with follow-up expected to be complete by the end of **Q4 2025**[12](index=12&type=chunk) [Corporate Highlights](index=3&type=section&id=Corporate) The company experienced significant leadership changes, including a new President & CEO, Interim CFO, and Chairman, while strengthening its balance sheet with a $19 million direct offering - Dr. RJ Tesi retired as CEO, and **David Moss was appointed President & CEO** and to the Board of Directors[12](index=12&type=chunk) - Other management changes include the appointment of Cory Ellspermann as Interim CFO and Kelly Ganjei as Chairman of the Board[12](index=12&type=chunk) - The company closed a **$19 million registered direct offering**[12](index=12&type=chunk) [Upcoming Events and Milestones](index=3&type=section&id=Upcoming%20Events%20and%20Milestones) INmune Bio anticipates an end-of-phase 2 FDA meeting for MINDFuL in Q4 2025, remains on track for CORDStrom MAA/BLA filing by mid-2026, and expects additional RDEB and INKmune™ trial data in Q4 - An end-of-phase 2 meeting with the FDA regarding the MINDFuL trial is expected to take place in the **fourth quarter**[12](index=12&type=chunk) - The Company remains on track to file a Marketing Authorization Application (MAA) in the UK and a Biologic License Application (BLA) for CORDStrom in RDEB by **mid-2026**[12](index=12&type=chunk) - Additional data from the RDEB trial and the INKmune™ phase 2 trial in prostate cancer are expected in the **fourth quarter**[12](index=12&type=chunk) [Financial Results](index=3&type=section&id=Financial%20Results) This section presents the company's Q2 2025 financial performance, including balance sheets, statements of operations, and cash flows [Second Quarter 2025 Financial Summary](index=3&type=section&id=Financial%20Results%20for%20the%20Second%20Quarter%20Ended%20June%2030,%202025) For Q2 2025, INmune Bio reported a net loss of $24.5 million, significantly higher than Q2 2024, primarily due to a $16.5 million intangible asset impairment, ending the quarter with $33.4 million in cash | Financial Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | **Net Loss** | $24.5 million | $9.7 million | Increased | | **R&D Expenses** | $5.9 million | $7.1 million | Decreased | | **G&A Expenses** | $2.3 million | $2.8 million | Decreased | | **Impairment Charge** | $16.5 million | $0 | Increased | - The significant increase in net loss was primarily due to a **$16.5 million impairment** of acquired in-process research and development intangible assets[12](index=12&type=chunk) - As of June 30, 2025, the Company had cash and cash equivalents of approximately **$33.4 million**[12](index=12&type=chunk) [Condensed Consolidated Balance Sheets](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) As of June 30, 2025, total assets decreased to $38.1 million due to intangible asset impairment, while cash and cash equivalents increased to $33.4 million, and total liabilities rose to $9.4 million | Balance Sheet Item | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | **Cash and cash equivalents** | $33,374 | $20,922 | | **Total Current Assets** | $35,760 | $22,662 | | **Acquired in-process R&D intangible assets** | $0 | $16,514 | | **Total Assets** | $38,145 | $39,562 | | **Total Liabilities** | $9,366 | $7,465 | | **Total Stockholders' Equity** | $28,779 | $32,097 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20LOSS) For Q2 2025, the company reported a net loss of $24.5 million, or ($1.05) per share, largely driven by a $16.5 million impairment charge on acquired R&D assets, despite reduced operating expenses | Statement of Operations | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | | :--- | :--- | :--- | | **General and administrative** | $2,253 | $2,812 | | **Research and development** | $5,881 | $7,053 | | **Impairment of acquired in-process R&D** | $16,514 | $0 | | **Loss from Operations** | ($24,648) | ($9,865) | | **Net Loss** | ($24,535) | ($9,746) | | **Net loss per common share** | ($1.05) | ($0.50) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) For the first six months of 2025, net cash used in operating activities was $14.2 million, offset by $27.5 million from financing activities, resulting in a period-end cash balance of $33.4 million | Cash Flow Item | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :--- | :--- | :--- | | **Net cash used in operating activities** | ($14,188) | ($15,362) | | **Net cash used in investing activities** | ($706) | $0 | | **Net cash provided by financing activities** | $27,545 | $10,497 | | **Net increase (decrease) in cash** | $12,452 | ($4,779) | | **Cash and cash equivalents at end of period** | $33,374 | $31,069 | [Company and Platform Overview](index=4&type=section&id=Company%20and%20Platform%20Overview) This section provides an overview of INmune Bio Inc. and its three core therapeutic platforms: XPro™, CORDStrom™, and INKmune® [About XPro™](index=4&type=section&id=About%20XPro%E2%84%A2) XPro™ is a next-generation TNF inhibitor designed to selectively neutralize soluble TNF (sTNF) to decrease neuroinflammation and improve cognitive function in neurologic diseases - XPro™ is a next-generation TNF inhibitor that neutralizes **soluble TNF (sTNF)** without affecting trans-membrane TNF (tmTNF) or TNF receptors[15](index=15&type=chunk) - The therapeutic goal of XPro™ is to decrease neuroinflammation in patients with neurologic diseases to improve cognitive function and restore neuronal communication[15](index=15&type=chunk) [About CORDStrom™](index=4&type=section&id=About%20CORDStrom%E2%84%A2) CORDStrom™ is a patent-pending, off-the-shelf cell therapy platform utilizing allogeneic human umbilical cord-derived mesenchymal stromal cells for scalable, cost-effective treatment of inflammatory diseases - CORDStrom™ is an allogeneic, **off-the-shelf cell medicine** made from pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs)[16](index=16&type=chunk) - The platform is designed to create high-quality, batch-to-batch consistent, and **scalable cGMP manufactured products at a low cost**[16](index=16&type=chunk) - While the first product is indication-agnostic, the platform allows for the creation of indication-specific products optimized for anti-inflammatory, immunomodulatory, or wound healing characteristics[17](index=17&type=chunk) [About INKmune®](index=4&type=section&id=About%20INKmune%C2%AE) INKmune® is a novel, tumor-agnostic immunotherapy that primes a patient's resting NK cells into highly active, tumor-killing memory-like NK cells, administered via simple IV infusion - INKmune® is a pharmaceutical-grade cell line that primes a patient's resting NK cells, converting them into tumor-killing **memory-like NK cells (mlNK cells)**[18](index=18&type=chunk) - The treatment is patient-friendly, requiring no pre-medication or additional cytokine therapy, and is delivered via a **simple intravenous infusion**[19](index=19&type=chunk) - INKmune® is tumor agnostic and is currently being tested in an open-label Phase I/II trial in metastatic castration-resistant prostate cancer[19](index=19&type=chunk) [About INmune Bio Inc.](index=5&type=section&id=About%20INmune%20Bio%20Inc.) INmune Bio is a clinical-stage biotechnology company focused on developing treatments that target the innate immune system across three distinct product platforms: DN-TNF, Natural Killer Cell Priming, and CORDStrom™ - INmune Bio is a clinical-stage biotechnology company that develops treatments targeting the **innate immune system** to fight disease[20](index=20&type=chunk) - The company has three main product platforms: DN-TNF (XPro™), Natural Killer Cell Priming (INKmune®), and CORDStrom™ (allogeneic hucMSCs)[20](index=20&type=chunk) [Additional Information](index=4&type=section&id=Additional%20Information) This section covers Q2 2025 earnings call details and a standard forward-looking statements disclaimer for risks and unapproved product candidates [Earnings Call Information](index=4&type=section&id=Earnings%20Call%20Information) The company held its Q2 2025 earnings conference call on August 7, 2025, providing dial-in details and a webcast link, with a replay available for two weeks - The conference call to discuss Q2 2025 results was scheduled for **August 7, 2025, at 4:30 PM Eastern Time**[14](index=14&type=chunk) - Details for participation, including dial-in numbers, a conference ID (**INMUNE**), and a webcast link, were provided[14](index=14&type=chunk) - A replay of the call was made available for **two weeks** following the event[14](index=14&type=chunk) [Forward Looking Statements](index=5&type=section&id=Forward%20Looking%20Statements) This section serves as a standard safe harbor statement, cautioning that the press release contains forward-looking statements subject to significant risks and uncertainties, with no product candidates yet approved by regulatory bodies - The press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties[21](index=21&type=chunk) - It explicitly states that its product candidates, including CORDstrom™, XPro™, and INKmune®, are in clinical trials and **have not been approved by the FDA or any regulatory body**[21](index=21&type=chunk) - Key risks include the ability to produce more drug for trials, the need for substantial additional funding, and uncertainties related to research, development, and regulatory approval[21](index=21&type=chunk)

PART I – FINANCIAL INFORMATION [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The company reports a net loss of $34.2 million, driven by a $16.5 million asset impairment, and issues a going concern warning [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets declined due to a $16.5 million impairment of an intangible research and development asset Balance Sheet Highlights | Balance Sheet Items (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $33,374 | $20,922 | | Acquired in-process R&D intangible assets | $0 | $16,514 | | Total Assets | $37,684 | $39,562 | | **Liabilities & Equity** | | | | Total Liabilities | $8,817 | $7,465 | | Accumulated deficit | $(197,301) | $(163,104) | | Total Stockholders' Equity | $28,867 | $32,097 | - Total assets decreased primarily due to the full impairment of acquired in-process research and development intangible assets, which were valued at **$16.5 million** at the end of 2024 and written down to zero[10](index=10&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss significantly increased for the three and six-month periods due to a one-time $16.5 million impairment charge Three-Month Operations | Metric (in thousands, except per share) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development | $5,804 | $7,053 | | Impairment of acquired in-process R&D | $16,514 | $0 | | **Net Loss** | **$(24,458)** | **$(9,746)** | | Net loss per common share | $(1.05) | $(0.50) | Six-Month Operations | Metric (in thousands, except per share) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development | $13,443 | $15,746 | | Impairment of acquired in-process R&D | $16,514 | $0 | | **Net Loss** | **$(34,197)** | **$(20,771)** | | Net loss per common share | $(1.49) | $(1.11) | - The significant increase in net loss for both the three and six-month periods ended June 30, 2025, was primarily driven by a one-time **impairment charge of $16.5 million** related to the XPro Alzheimer's drug candidate[12](index=12&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash position improved due to $27.5 million in financing activities, which offset cash used in operations Cash Flow Summary | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(14,199) | $(15,362) | | Net cash used in investing activities | $(706) | $0 | | Net cash provided by financing activities | $27,545 | $10,497 | | **Net increase (decrease) in cash** | **$12,452** | **$(4,779)** | | **Cash at end of period** | **$33,374** | **$31,069** | - The company's cash position improved significantly due to **$27.5 million in net proceeds** from the sale of common stock and warrants, which more than offset the $14.2 million cash used in operations[23](index=23&type=chunk) [Notes to the Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Key disclosures include a going concern warning, a $16.5 million asset impairment, recent financing, and CEO retirement - **Going Concern:** The company has incurred significant losses (**$34.2M net loss** for the six months) and projects insufficient liquidity to sustain operations for one year, raising substantial doubt about its ability to continue as a going concern[27](index=27&type=chunk) - **Intangible Asset Impairment:** The company recorded a **$16.5 million impairment charge** for its Alzheimer's drug candidate, XPro, after its Phase 2 clinical trial failed to meet the primary endpoint[48](index=48&type=chunk)[65](index=65&type=chunk) - **Financing Activities:** In June 2025, the company raised gross proceeds of **$18.9 million** from a registered direct offering and approximately **$10.1 million** in net proceeds through its ATM program in the first half of 2025[85](index=85&type=chunk)[89](index=89&type=chunk) - **Subsequent Event:** On August 4, 2025, President and CEO Dr. Raymond J. Tesi announced his intention to retire, and a separation agreement was executed[99](index=99&type=chunk)[100](index=100&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company discusses clinical trial results, a major asset impairment, and its precarious liquidity position despite recent financing [Business Overview and Clinical Development](index=22&type=section&id=Business%20Overview%20and%20Clinical%20Development) The Alzheimer's drug XPro missed its primary endpoint, but a subgroup showed promise, while other pipeline programs advance - **XPro (Alzheimer's):** The Phase 2 MINDFuL trial for XPro in early AD **did not meet its primary and key secondary endpoints** in the modified intent-to-treat (mITT) population (n=200)[111](index=111&type=chunk) - **XPro Subgroup Analysis:** A prespecified subgroup of patients with a higher inflammation burden (n=100) showed a promising signal, with an **effect size of 0.27** on the primary endpoint, exceeding the company's threshold of 0.2[114](index=114&type=chunk)[117](index=117&type=chunk) - **CORDStrom (RDEB):** The MissionEB study showed CORDStrom was well-tolerated and demonstrated beneficial effects, **significantly reducing itch scores** in patients[136](index=136&type=chunk)[139](index=139&type=chunk) - **CORDStrom Regulatory Status:** The FDA has granted CORDStrom **Rare Pediatric Disease Designation (RPDD)** and **Orphan Drug Designation (ODD)**, with a Biologics License Application (BLA) anticipated in the first half of 2026[105](index=105&type=chunk)[141](index=141&type=chunk)[142](index=142&type=chunk) - **INKmune (Cancer):** The INKmune program is in a Phase II trial for metastatic castrate resistant prostate cancer, with enrollment expected to be complete in Q4 2025[144](index=144&type=chunk)[145](index=145&type=chunk) [Results of Operations](index=35&type=section&id=Results%20of%20Operations) Net loss widened significantly due to a $16.5 million impairment charge, partially offset by lower R&D expenses Three-Month Operations Comparison | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $5,804 | $7,053 | $(1,249) | | General and administrative | $2,253 | $2,812 | $(559) | | Impairment of intangible assets | $16,514 | $0 | $16,514 | | **Net Loss** | **$(24,458)** | **$(9,746)** | **$(14,712)** | Six-Month Operations Comparison | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $13,443 | $15,746 | $(2,303) | | General and administrative | $4,569 | $5,150 | $(581) | | Impairment of intangible assets | $16,514 | $0 | $16,514 | | **Net Loss** | **$(34,197)** | **$(20,771)** | **$(13,426)** | - The decrease in R&D spending for the six-month period was mainly due to incurring **$3.0 million less** in expenses for the Alzheimer's clinical program as the trial was completed in 2025[165](index=165&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds $33.4 million in cash but faces substantial doubt about its ability to continue as a going concern - **Cash Position:** As of June 30, 2025, the company had cash and cash equivalents of **$33.4 million**[170](index=170&type=chunk) - **Going Concern Warning:** Recurring net losses and negative cash flows from operations raised **substantial doubt** about the company's ability to continue as a going concern, with cash projected to be insufficient for the next year[174](index=174&type=chunk) - **Recent Financing:** During the first six months of 2025, the company raised approximately **$10.4M (gross)** from its ATM program and **$18.9M (gross)** from a registered direct offering[171](index=171&type=chunk) Cash Flow Activity | Cash Flow Summary (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(14,199) | $(15,362) | | Net cash provided by financing activities | $27,545 | $10,497 | [Quantitative and Qualitative Disclosures About Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exempt from providing this information as a 'smaller reporting company' - The company is a 'smaller reporting company' and is **exempt from providing these disclosures** under Item 305(e) of Regulation S-K[186](index=186&type=chunk) [Controls and Procedures](index=40&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal financial reporting controls were effective - Management, including the Principal Executive Officer and Interim Chief Financial Officer, concluded that **disclosure controls and procedures were effective** as of June 30, 2025[188](index=188&type=chunk) - There were **no material changes** in the company's internal control over financial reporting during the quarter[190](index=190&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=41&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no material legal proceedings but discloses an ongoing $1.6 million dispute with a vendor - The company is **not currently party to any material pending legal proceedings**[193](index=193&type=chunk) - An ongoing dispute exists with a vendor over invoices totaling approximately **$1.6 million**, though the company has only recorded an estimated obligation of $0.2 million[97](index=97&type=chunk) [Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) This section is not required as the company qualifies as a smaller reporting company - **Not required** for smaller reporting companies[194](index=194&type=chunk) [Other Information](index=41&type=section&id=Item%205.%20Other%20Information) This section details significant leadership changes, including the retirement of the CEO and appointment of a successor - **CEO Retirement:** Dr. Raymond J. Tesi retired as President, CEO, and Chairman, effective August 12, 2025[198](index=198&type=chunk) - **New CEO Appointment:** David J. Moss, previously CFO, was appointed as the new President and CEO[205](index=205&type=chunk) - **New Chairman:** J. Kelly Ganjei, an existing board member, was appointed as Chairman of the Board[204](index=204&type=chunk) - **Interim CFO:** Cory Ellspermann, previously Controller and VP of Finance, was appointed as Interim CFO[209](index=209&type=chunk) [Exhibits](index=44&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the report, including key employment and severance agreements - Lists exhibits filed with the report, including the **severance agreement for Dr. Tesi** and the **employment agreement for Cory Ellspermann**[216](index=216&type=chunk)

Core Insights - INmune Bio Inc. reported its financial results for Q2 2025, highlighting a net loss of approximately $24.5 million, a significant increase from a net loss of about $9.7 million in Q2 2024 [12][30] - The company is focused on developing treatments that utilize the innate immune system, with three main product platforms: XPro™, CORDStrom™, and INKmune® [21] Financial Performance - The net loss attributable to common stockholders for Q2 2025 was approximately $24.5 million, compared to approximately $9.7 million in Q2 2024 [12][30] - Research and development expenses for Q2 2025 totaled approximately $5.8 million, down from approximately $7.1 million in Q2 2024 [12][30] - General and administrative expenses were approximately $2.3 million for Q2 2025, compared to approximately $2.8 million in Q2 2024 [12][30] - As of June 30, 2025, the company had cash and cash equivalents of approximately $33.4 million, an increase from $20.9 million at the end of 2024 [12][25] Product Development Highlights - XPro™ showed favorable trends in the MINDFuL phase 2 trial, particularly in a subset of patients with two or more biomarkers of inflammation [5][4] - CORDStrom™ is in the process of establishing large-scale manufacturing, with plans for MAA and BLA submissions by mid-2026 [10][15] - INKmune® is currently in an open-label Phase I/II trial for metastatic castration-resistant prostate cancer [20][21] Corporate Updates - Dr. RJ Tesi has retired as CEO, with David Moss appointed as the new President & CEO [10] - The company closed a $19 million registered direct offering to support its operations [10] Upcoming Milestones - The company anticipates an end-of-phase 2 meeting regarding the MINDFuL trial with the FDA in Q4 2025 [15] - Additional data from the ongoing phase 2 trial of INKmune® in metastatic castration-resistant prostate cancer is expected to be released [15]

Core Insights - INmune Bio Inc. has successfully completed its Phase I/II trial of INKmune™ for men with metastatic castration-resistant prostate cancer (mCRPC), meeting both primary and secondary endpoints, and is now closed to further enrollment [1][2] - INKmune™ demonstrated an excellent safety profile across all three dose levels, with significant improvements in NK cell activation biomarkers observed in patients with low NK cell activation [2][3] - The company plans to advance the INKmune™ program by designing a randomized Phase 2b trial targeting patients with less severe disease to better measure the drug's effects and potential clinical benefits [3] Product Overview - INKmune™ is a pharmaceutical-grade, replication-incompetent human tumor cell line that primes resting NK cells to become tumor-killing memory-like NK cells, with effects persisting for over 100 days [4] - The treatment is patient-friendly, requiring no pre-medication or additional cytokine therapy, and can be administered via simple intravenous infusion as an outpatient procedure [5] - INKmune™ is tumor agnostic, applicable to various NK-resistant tumors, including leukemia, lymphoma, myeloma, and several solid tumors [5] Company Background - INmune Bio Inc. is a publicly traded clinical-stage biotechnology company focused on developing treatments that target the innate immune system to combat diseases [6] - The company has three product platforms: DN-TNF for chronic inflammation and cognitive disorders, Natural Killer Cell Priming Platform including INKmune™, and CORDStrom™ for regenerative medicine [6]

Core Viewpoint - INmune Bio Inc. will host a conference call on August 7, 2025, to discuss its financial results for the quarter ended June 30, 2025, and provide a corporate update [1]. 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: - The Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform aims to neutralize soluble TNF, which is linked to various diseases, with candidates in clinical development for Alzheimer's disease and other indications [3]. - The Natural Killer Cell Priming Platform includes INKmune®, which is designed to enhance NK cell activity against minimal residual disease in cancer patients, currently in trials for metastatic castration-resistant prostate cancer [3]. - The CORDStrom™ platform utilizes pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs) and has recently completed a trial for recessive dystrophic epidermolysis bullosa [3]. - The company employs a precision medicine approach for diseases associated with chronic inflammation and cancer [3]. Conference Call Information - The conference call is scheduled for August 7, 2025, at 4:30 PM Eastern Time, with participant dial-in numbers provided for both domestic and international callers [2]. - A live audio webcast will be available, and a transcript will be released approximately 24 hours after the call [2]. Contact Information - The company contact for inquiries includes David Moss, Chief Financial Officer, and Daniel Carlson, Head of Investor Relations, with provided phone numbers and email addresses [6].