BOCA RATON, Fla., March 30, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a late-stage biotechnology company focused on inflammation and immunology, today announces its financial results for the year ended December 31, 2025 and provides a business update.
Recent Corporate Highlights
CORDStrom Platform:
- The CORDStrom program in recessive dystrophic epidermolysis bullosa (RDEB) is on target to file an MAA submission in the UK mid-summer, followed shortly thereafter by anticipated EMA and FDA regulatory submissions.
- Hosted KOL led webinar focused on the latest results from the MissionEB Phase III clinical trial highlighting the systemic disease-modifying capabilities of CORDStrom in patients with RDEB.
- Announced the publishing of an overview of future applications and research areas for mesenchymal stromal cell (MSC) therapies in the peer-reviewed journal Cytotherapy-
XPro Platform:
- Reported new Phase 2 imaging data at the 18th Clinical Trials on Alzheimer's Disease conference (CTAD), in San Diego, CA. Additional brain imaging analyses are ongoing and expected to be reported in the near future.
- Announced FDA alignment to advance to an adaptive Phase 2b/3 registrational pathway with XPro in early Alzheimer's Disease.
- Hosted expert-led webinar on XPro registrational study strategy for early Alzheimer's Disease, with the discussion focused on results of the Phase 2 MINDFuL trial and alignment with the FDA following the End-of-Phase 2 meeting.
- INmune's MINDFuL trial was featured in a plenary presentation at the AD/PD 2026 conference as a successful example of how aligning patient selection with mechanism of action identifies the patients most likely to respond.
INKmune® Platform:
- Met primary and two of three secondary endpoints in CARE-PC trial
- Continued evaluation of clinical data from the INKmune® CARE-PC trial in metastatic castration-resistant prostate cancer.
- Ongoing analysis of immune activation and tumor response endpoints to inform future development strategy.
Corporate:
- Received Australian R&D rebate of $5.2m AUD ($3.6 million USD) during January 2026.
- Company estimates that cash on hand provides runway through Q1 of 2027.
- During 2025, the Company sold 4,304,707 shares of common stock in exchange for net cash proceeds of $27.5 million.
- Continued alignment of capital allocation with clinical development priorities.
Upcoming Events and Milestones:
- The Marketing Authorization Application (MAA) for CORDStrom is scheduled for submission to the UK's MHRA in mid-summer, followed directly by an EMA filing.
- CORDStrom Biologics License Application (BLA) submission to the FDA expected in Q4 2026.
"Reflecting on the progress of 2025 and the momentum of early 2026, it is clear that INmune Bio has reached a defining inflection point," said David Moss, CEO of INmune Bio. "We have transitioned from a mid-stage clinical company into a late-stage, registration-directed organization. Our mission to harness the innate immune system to treat diseases of inflammation has never been more tangible or more urgent. Looking ahead through 2026 and 2027, our strategy is anchored by two late-stage assets that represent significant value for both patients and shareholders: CORDStrom and XPro."
CORDStrom: A Clear Path to Commercialization
CORDStrom, our mesenchymal stromal cell platform for Recessive Dystrophic Epidermolysis Bullosa, is our most immediate commercial catalyst.
- 2026 Regulatory Milestones: In February, we formally submitted our pre-submission package to the UK's MHRA. A face-to-face meeting with the MHRA is scheduled for mid-May. We remain on track to file our first Marketing Authorization Application (MAA) in the UK by mid-summer 2026, followed by EU and U.S. (BLA) filings in Q4.
- Operational Readiness: We have successfully completed three commercial pilot-scale manufacturing runs at our Stevenage facility, meeting all release criteria. This ensures we are ready to supply the market upon approval.
- Financial Strategy: With the recent reauthorization of the Rare Pediatric Disease Priority Review Voucher (PRV) program through 2029, CORDStrom offers a dual-value proposition: a life-changing therapy for "butterfly children" and a high-value PRV that can be monetized to non-dilutively fund our long-term operations.
XPro: Redefining the Alzheimer's Paradigm
The landscape of Alzheimer's disease (AD) is shifting toward precision medicine, and INmune Bio is at the forefront.
- 2026 Focus: Following our successful End-of-Phase 2 meeting with the FDA in February, we have achieved alignment on an integrated Phase 2b/3 registrational pathway. Unlike traditional "all-comer" trials, our program uses a biomarker-enriched design, targeting patients with neuroinflammation. This "precision" approach, validated by our MINDFuL trial data featured at the AD/PD 2026 Plenary, significantly de-risks our path forward.
- 2027 Horizon: Our Phase 2b/3 program is built to bridge the gap between early cognitive signals (EMACC) and late-stage functional outcomes (CDR-SB). The Phase 2b stage evaluates co-primary endpoints at nine months and serves as a clearly powered go or no-go before we commit to the full Phase 3 registrational portion of the trial. If EMACC and/or pTau-217 readout successfully in the Phase 2b portion of the trial, it advances seamlessly into the registrational stage Phase 3 with CDR-SB at eighteen months (the same primary endpoint used to approve lecanemab and donanemab). The scientific basis for this design is well established: cognitive changes (EMACC) precede and predict functional decline (CDR-SB), which means early cognitive signals at nine months support confidence in functional outcomes at eighteen. We believe this program represents a compelling partnership opportunity, while remaining a viable path for independent development following CORDStrom approval, assuming favorable capital conditions.
Notably, XPro has reported zero cases of ARIA across all clinical studies to date, a critical differentiator in a treatment landscape where ARIA remains a significant limitation of approved therapies.
"From a capital perspective, we remain committed to capital efficiency," said Mr. Moss. "Our strategy is built on hitting clear, data-driven milestones that allow us to maximize shareholder value while minimizing unnecessary burn. We are focused on maintaining the lean, execution-oriented culture that has brought us to this stage."
"2026 is the year of filings and preparation; 2027 will be the year of pivotal execution and potential launch. We thank you for your continued trust and partnership as we work to transform the treatment of inflammatory disease."
Financial Results for the Year Ended December 31, 2025
- Net loss attributable to common stockholders for the year ending December 31, 2025 was approximately $45.9 million, compared to approximately $42.1 million during the year ended December 31, 2024.
- Research and development expenses totaled approximately $20.7 million for the year ended December 31, 2025, compared to approximately $33.2 million during the year ended December 31, 2024.
- General and administrative expenses were approximately $10.3 million for the year ended December 31, 2025, compared to approximately $9.5 million during the year ended December 31, 2024.
- Impairment of acquired in-process research and development intangibles assets was $16.5 million during the year ended December 31, 2025, compared to $0 during the year ended December 31, 2024.
- As of December 31, 2025, the Company had cash and cash equivalents of approximately $24.8 million.
- As of December 31, 2025, the Company had approximately 26.6 million common shares outstanding.
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 Fourth Quarter and Full Year Ended December 31, 2025 Conference Call when reaching an operator.
Date: March 30th, 2026
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-800-343-4136
Participant Dial-in (international): +1-203-518-9843
Conference ID: INMUNE
A live audio webcast of the call can be accessed using this link or clicking here:
https://viavid.webcasts.com/starthere.jsp?ei=1748958&tp_key=96ca7c85d7
A replay will be available approximately 3 hours after the call through April 13, 2026 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 11160807.
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 and autoimmune 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 affordably and with repeatable specification. Pooling allows tuning of different CORDStrom products with different effector functions dependent upon selected donor characteristics. 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, visit our website at www.inmunebio.com.
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: (1) CORDStrom, 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; (2) XPro, a Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform designed to selectively neutralize soluble TNF, a key driver of inflammation and innate immune dysfunction; and (3) INKmune®, a cell-based medicine designed to prime a patient's natural killer cells to eliminate minimal residual disease in patients with cancer. To learn more, please visit www.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 trial results, timing of key milestones, future plans or expectations, 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), the UK MHRA or any regulatory body and there cannot be any assurance that they will be approved by the FDA, the UK MHRA 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 Moss
Chief Executive Officer
(561) 710-0512
info@inmunebio.com
Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com
The following tables summarize our results of operations for the periods indicated:
| INMUNE BIO INC. CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share amounts) | ||||||||
| December 31, 2025 | December 31, 2024 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | - | 24,751 | - | 20,922 | ||||
| Research and development tax credit receivable | 4,284 | 1,181 | ||||||
| Other tax receivable | 257 | 228 | ||||||
| Prepaid expenses and other current assets | 595 | 331 | ||||||
| TOTAL CURRENT ASSETS | 29,887 | 22,662 | ||||||
| Equipment, net | 955 | - | ||||||
| Operating lease - right of use asset | 914 | 307 | ||||||
| Other assets | 595 | 79 | ||||||
| Acquired in-process research and development intangible assets | - | 16,514 | ||||||
| TOTAL ASSETS | - | 32,351 | - | 39,562 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued liabilities | - | 7,768 | - | 6,539 | ||||
| Accounts payable and accrued liabilities - related parties | 25 | 25 | ||||||
| Deferred liabilities | - | 517 | ||||||
| Operating lease, current liability | 623 | 140 | ||||||
| TOTAL CURRENT LIABILITIES | 8,416 | 7,221 | ||||||
| Long-term operating lease liability | 411 | 244 | ||||||
| TOTAL LIABILITIES | 8,827 | 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 | 233,271 | 195,754 | ||||||
| Accumulated other comprehensive loss | (737 | - | (575 | - | ||||
| Accumulated deficit | (209,037 | - | (163,104 | - | ||||
| TOTAL STOCKHOLDERS' EQUITY | 23,524 | 32,097 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | - | 32,351 | - | 39,562 | ||||
| INMUNE BIO INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS FOR THE YEARS ENDED DECEMBER 31, 2025 AND 2024 - In thousands, except share and per share amounts) | ||||||||
| 2025 | 2024 | |||||||
| REVENUE | - | 50 | - | 14 | ||||
| OPERATING EXPENSES | ||||||||
| General and administrative | 10,260 | 9,483 | ||||||
| Research and development | 20,659 | 33,166 | ||||||
| Impairment of acquired in-process research and development intangible assets | 16,514 | - | ||||||
| Total operating expenses | 47,433 | 42,649 | ||||||
| LOSS FROM OPERATIONS | (47,383 | - | (42,635 | - | ||||
| OTHER INCOME, NET | 1,450 | 553 | ||||||
| NET LOSS | - | (45,933 | - | - | (42,082 | - | ||
| Net loss per common share - basic and diluted | - | (1.86 | - | - | (2.11 | - | ||
| Weighted average number of common shares outstanding - basic and diluted | 24,757,545 | 19,944,304 | ||||||
| COMPREHENSIVE LOSS | ||||||||
| Net loss | - | (45,933 | - | - | (42,082 | - | ||
| Other comprehensive income (loss) - foreign currency translation | (162 | - | 224 | |||||
| Total comprehensive loss | - | (46,095 | - | - | (41,858 | - | ||
| INMUNE BIO INC. CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED DECEMBER 31, 2025 AND 2024 (In thousands) | ||||||||
| 2025 | 2024 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | - | (45,933 | - | - | (42,082 | - | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 9,910 | 7,605 | ||||||
| Accretion of debt discount | - | 79 | ||||||
| Gain on settlement of accounts payable | (626 | - | - | |||||
| Depreciation expense | 84 | - | ||||||
| Impairment of acquired in-process research and development intangible assets | 16,514 | - | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Research and development tax credit receivable | (3,103 | - | 724 | |||||
| Other tax receivable | (29 | - | 309 | |||||
| Prepaid expenses and other current assets | (264 | - | 1,179 | |||||
| Prepaid expenses - related party | - | 142 | ||||||
| Other assets | (516 | - | 52 | |||||
| Accounts payable and accrued liabilities | 1,855 | (1,362 | - | |||||
| Accounts payable and accrued liabilities - related parties | - | (10 | - | |||||
| Deferred liabilities | (517 | - | 28 | |||||
| Operating lease liability | 43 | (25 | - | |||||
| Net cash used in operating activities | (22,582 | - | (33,361 | - | ||||
| CASH FROM INVESTING ACTIVITIES | ||||||||
| Purchase of fixed assets | (1,042 | - | - | |||||
| Net cash used in investing activities | (1,042 | - | - | |||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Net proceeds from sale of common stock and warrants | 27,544 | 27,789 | ||||||
| Cash proceeds for amendment of warrants | 67 | - | ||||||
| Exercise of warrants for cash | 1 | - | ||||||
| Repayment of debt | - | (10,000 | - | |||||
| Net proceeds from the exercise of stock options | - | 422 | ||||||
| Net cash provided by financing activities | 27,612 | 18,211 | ||||||
| Impact on cash from foreign currency translation | (159 | - | 224 | |||||
| NET INCREASE (DECREASE) IN CASH | 3,829 | (14,926 | - | |||||
| CASH AT BEGINNING OF YEAR | 20,922 | 35,848 | ||||||
| CASH AT END OF YEAR | - | 24,751 | - | 20,922 | ||||
| SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: | ||||||||
| Cash paid for income taxes | - | - | - | - | ||||
| Cash paid for interest expense | - | - | - | 1,690 | ||||
| SUPPLEMENTAL NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||||||||
| Right of use assets obtained in exchange for lease obligations | - | 702 | - | - | ||||
