INmune Bio(INMB) - 2025 Q2 - Quarterly Results

Second Quarter 2025 Business Update Overview of Q2 2025 progress for DN-TNF, CORDStrom, and INKmune platforms, corporate updates, and upcoming milestones DN-TNF Platform Highlights (XPro™) 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] - 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] - 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] CORDStrom™ Platform Highlights 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] - 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] - 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] INKmune™ Platform Highlights 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] - 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] - 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] Corporate Highlights 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] - Other management changes include the appointment of Cory Ellspermann as Interim CFO and Kelly Ganjei as Chairman of the Board[12] - The company closed a $19 million registered direct offering[12] Upcoming Events and Milestones 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] - 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] - Additional data from the RDEB trial and the INKmune™ phase 2 trial in prostate cancer are expected in the fourth quarter[12] Financial Results This section presents the company's Q2 2025 financial performance, including balance sheets, statements of operations, and cash flows Second Quarter 2025 Financial Summary 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] - As of June 30, 2025, the Company had cash and cash equivalents of approximately $33.4 million[12] Condensed Consolidated Balance Sheets 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 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 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 This section provides an overview of INmune Bio Inc. and its three core therapeutic platforms: XPro™, CORDStrom™, and INKmune® About XPro™ 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] - The therapeutic goal of XPro™ is to decrease neuroinflammation in patients with neurologic diseases to improve cognitive function and restore neuronal communication[15] About CORDStrom™ 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] - The platform is designed to create high-quality, batch-to-batch consistent, and scalable cGMP manufactured products at a low cost[16] - 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] About INKmune® 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] - The treatment is patient-friendly, requiring no pre-medication or additional cytokine therapy, and is delivered via a simple intravenous infusion[19] - INKmune® is tumor agnostic and is currently being tested in an open-label Phase I/II trial in metastatic castration-resistant prostate cancer[19] About INmune Bio Inc. 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] - The company has three main product platforms: DN-TNF (XPro™), Natural Killer Cell Priming (INKmune®), and CORDStrom™ (allogeneic hucMSCs)[20] Additional Information This section covers Q2 2025 earnings call details and a standard forward-looking statements disclaimer for risks and unapproved product candidates Earnings Call Information 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] - Details for participation, including dial-in numbers, a conference ID (INMUNE), and a webcast link, were provided[14] - A replay of the call was made available for two weeks following the event[14] Forward Looking Statements 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] - 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] - 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]