Full Press Release Details
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 business update.
Q32025and Recent CorporateHighlights
CORDStrom™ Platform:
DN-TNF Platform Highlights (XPro™):
INKmune® Platform:
Corporate:
Upcoming Events and Milestones:
FinancialResultsforthe Third Quarter Ended September 30, 2025:
Earnings Call Information
To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio Second Quarter Conference Call when reaching an operator.
Date: October 30, 2025Time: 4:30 PM Eastern TimeParticipant Dial-in: 1-800-225-9448Participant Dial-in (international): 1-203-518-9708Conference ID: INMUNE
A live audio webcast of the call can be accessed using this link:https://viavid.webcasts.com/starthere.jsp?ei=1733354&tp_key=a3c75da53b
A replay will be available approximately 3 hours after the call through November 13, 2025 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 11159914.
About CORDStrom™
CORDStrom™ is a patent-pending cell medicine comprising aseptic, allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs) in suspension for injection or infusion. The CORDStrom™ platform leverages, among other things, proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled hucMSCs as medicines to treat complex inflammatory diseases. CORDStrom™ products are designed to provide high-quality, off-the-shelf, batch-to-batch consistent, scalable, cGMP manufactured, potent cellular medicines that can be produced at low cost and with repeatable specification independent of donor characteristics.
Initially developed at the INKmune® manufacturing facilities utilizing UK academic grant funding, CORDStrom™ is an MSC product platform that shows promise as a first systemic therapy for potentially treating RDEB and many other debilitating conditions. While the first generation CORDStrom™ product is agnostic to disease indication, the platform enables creation of indication-specific products, which can be tuned for optimization of anti-inflammatory, immunomodulatory, wound healing, and other characteristics.
About XPro™
XPro™ is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro™ could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visitthissection of INmune Bio’s website.
About INKmune™
INKmune™ is a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals to convert the cancer patient’s resting NK cells into tumor killing memory-like NK cells (mlNK cells). INKmune™ treatment converts the patient’s own NK cells into mlNK cells. In patients, INKmune™ primed tumor killing NK cells have persisted for more than 100 days. These cells function in the hypoxic TME because due to upregulated nutrient receptors and mitochondrial survival proteins.
INKmune™ is a patient friendly drug treatment that does not require pre-medication, conditioning or additional cytokine therapy to be given to the patients. INKmune™ is easily transported, stored and delivered to the patient by a simple intravenous infusion as an out-patient. INKmune™ is tumor agnostic; it can be used to treat many types of NK-resistant tumors including leukemia, lymphoma, myeloma, lung, ovarian, breast, renal and nasopharyngeal cancer. INKmune™ is treating patients in an open label Phase I/II trial in metastatic castration-resistant prostate cancer in the US this year.
About INmune Bio Inc.
INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has three product platforms: the Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. The second program, CORDStrom™, is a proprietary pooled, allogeneic, human umbilical cord-derived mesenchymal Stromal/Stem cell (hucMSCs) platform that recently completed a blinded randomized trial in recessive dystrophic epidermolysis bullosa. The third program, INKmune®, is designed to prime a patient’s natural killer cells to eliminate minimal residual disease in patients with cancer and is currently in a trial in metastatic castration-resistance prostate cancer. To learn more, please visitwww.inmunebio.com.
Forward Looking Statements
Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, including the results of the Phase 2 MINDFuL trial, the timing of key milestones, future plans or expectations for the treatment of XPro™, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to several risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements because of these risks and uncertainties. CORDstrom™, XPro1595 (XPro™, pegipanermin), and INKmune®™ have either finished clinical trials, are still in clinical trials or are preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA) or any regulatory body and there cannot be any assurance that they will be approved by the FDA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements to reflect any event or circumstance that may arise after the date of this release.
Company Contact:
David MossChief Executive Officer(561) 710-0512info@inmunebio.com
Daniel CarlsonHead of Investor Relations(415) 509-4590dcarlson@inmunebio.com
The following tables summarize our results of operations for the periods indicated:
| INMUNE BIO INC. | |||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS(In thousands, except share and per share amounts)(Unaudited) | |||||||
| September 30,2025 | December 31,2024 | ||||||
| ASSETS | |||||||
| CURRENT ASSETS | |||||||
| Cash and cash equivalents | $ | 27,734 | $ | 20,922 | |||
| Research and development tax credit receivable | 1,704 | 1,181 | |||||
| Other tax receivable | 760 | 228 | |||||
| Prepaid expenses and other current assets | 472 | 331 | |||||
| TOTAL CURRENT ASSETS | 30,670 | 22,662 | |||||
| Equipment, net | 878 | - | |||||
| Operating lease – right of use asset | 1,064 | 307 | |||||
| Other assets | 746 | 79 | |||||
| Acquired in-process research and development intangible assets | - | 16,514 | |||||
| TOTAL ASSETS | $ | 33,358 | $ | 39,562 | |||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
| CURRENT LIABILITIES | |||||||
| Accounts payable and accrued liabilities | $ | 6,875 | $ | 6,539 | |||
| Accounts payable and accrued liabilities – related parties | 25 | 25 | |||||
| Deferred liabilities | - | 517 | |||||
| Operating lease, current liabilities | 457 | 140 | |||||
| TOTAL CURRENT LIABILITIES | 7,357 | 7,221 | |||||
| Long-term operating lease liabilities | 623 | 244 | |||||
| TOTAL LIABILITIES | 7,980 | 7,465 | |||||
| COMMITMENTS AND CONTINGENCIES | |||||||
| STOCKHOLDERS’ EQUITY | |||||||
| Preferred stock, $0.001 par value, 10,000,000 shares authorized, 0 shares issued and outstanding | - | - | |||||
| Common stock, $0.001 par value, 200,000,000 shares authorized, 26,585,258 and 22,280,451 shares issued and outstanding, respectively | 27 | 22 | |||||
| Additional paid-in capital | 229,888 | 195,754 | |||||
| Accumulated other comprehensive loss | (764 | ) | (575 | ) | |||
| Accumulated deficit | (203,773 | ) | (163,104 | ) | |||
| TOTAL STOCKHOLDERS’ EQUITY | 25,378 | 32,097 | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 33,358 | $ | 39,562 | |||
| INMUNE BIO INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(In thousands, except share and per share amounts)(Unaudited) | |||||||||||||||
| For the Three MonthsEndedSeptember 30, | For the Nine MonthsEndedSeptember 30, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| REVENUE | $ | - | $ | - | $ | 50 | $ | 14 | |||||||
| OPERATING EXPENSES | |||||||||||||||
| General and administrative | 2,546 | 2,219 | 7,115 | 7,369 | |||||||||||
| Research and development | 4,887 | 10,067 | 18,330 | 25,813 | |||||||||||
| Impairment of acquired in-process research and development intangible assets | - | - | 16,514 | - | |||||||||||
| Total operating expenses | 7,433 | 12,286 | 41,959 | 33,182 | |||||||||||
| LOSS FROM OPERATIONS | (7,433 | ) | (12,286 | ) | (41,909 | ) | (33,168 | ) | |||||||
| OTHER INCOME, NET | 961 | 193 | 1,240 | 304 | |||||||||||
| NET LOSS | $ | (6,472 | ) | $ | (12,093 | ) | $ | (40,669 | ) | $ | (32,864 | ) | |||
| Net loss per common share – basic and diluted | $ | (0.24 | ) | $ | (0.60 | ) | $ | (1.68 | ) | $ | (1.71 | ) | |||
| Weighted average common shares outstanding – basic and diluted | 26,585,258 | 20,185,676 | 24,141,613 | 19,176,853 | |||||||||||
| COMPREHENSIVE LOSS | |||||||||||||||
| Net loss | $ | (6,472 | ) | $ | (12,093 | ) | $ | (40,669 | ) | $ | (32,864 | ) | |||
| Other comprehensive loss – foreign currency translation | (1 | ) | (323 | ) | (189 | ) | (237 | ) | |||||||
| Total comprehensive loss | $ | (6,473 | ) | $ | (12,416 | ) | $ | (40,858 | ) | $ | (33,101 | ) | |||
| INMUNE BIO INC.CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(In thousands)(Unaudited) | |||||||
| For the Nine MonthsEndedSeptember 30, | |||||||
| 2025 | 2024 | ||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | |||||||
| Net loss | $ | (40,669 | ) | $ | (32,864 | ) | |
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
| Stock-based compensation | 6,594 | 5,848 | |||||
| Accretion of debt discount | - | 73 | |||||
| Gain on settlement of accounts payable | (626 | ) | - | ||||
| Depreciation expense | 28 | - | |||||
| Impairment of acquired in-process research and development intangible assets | 16,514 | - | |||||
| Changes in operating assets and liabilities: | |||||||
| Research and development tax credit receivable | (523 | ) | 796 | ||||
| Other tax receivable | (532 | ) | 226 | ||||
| Prepaid expenses | (141 | ) | 646 | ||||
| Prepaid expenses – related party | - | 127 | |||||
| Other assets | (667 | ) | 49 | ||||
| Accounts payable and accrued liabilities | 962 | 2,689 | |||||
| Accounts payable and accrued liabilities – related parties | - | 20 | |||||
| Deferred liabilities | (517 | ) | 60 | ||||
| Operating lease liabilities | (61 | ) | (18 | ) | |||
| Net cash used in operating activities | (19,638 | ) | (22,348 | ) | |||
| CASH FLOWS FROM INVESTING ACTIVITIES | |||||||
| Purchase of equipment | (899 | ) | - | ||||
| Net cash used in investing activities | (899 | ) | - | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | |||||||
| Net proceeds from sale of common stock and warrants | 27,544 | 27,789 | |||||
| Exercise of warrants for cash | 1 | - | |||||
| Repayments of debt | - | (7,500 | ) | ||||
| Net cash provided by financing activities | 27,545 | 20,289 | |||||
| Impact on cash from foreign currency translation | (196 | ) | (237 | ) | |||
| NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 6,812 | (2,296 | ) | ||||
| CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 20,922 | 35,848 | |||||
| CASH AND CASH EQUIVALENTS AT END OF PERIOD | $ | 27,734 | $ | 33,552 | |||
| SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: | |||||||
| Cash paid for income taxes | $ | - | $ | - | |||
| Cash paid for interest expense | $ | - | $ | 661 | |||
| SUPPLEMENTAL DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | |||||||
| Right of use assets obtained in exchange for lease obligations | $ | 702 | $ | - | |||