INmune Bio Inc. Announces First Quarter 2026 Results and Provides Business Update
BOCA RATON, Fla., May 07, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ:INMB) (the "Company"), a clinical-stage 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 March 31, 2026 and provides a business update.
Q1 2026 Recent Highlights:
CORDStrom™ Platform:
- Completed a pre-submission package with the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA). 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.
- Signed an amended and restated Material Transfer and License Agreement with Anthony Nolan. This expanded strategic collaboration secures the long-term, reliable supply of high-quality umbilical cord tissue from their world-class cord blood bank to fuel our CORDStrom™ platform.
- 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.
DN-TNF Platform:
XPro™:
- 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.
INB03:
- Announced New Preclinical Data at AACR 2026 Demonstrating INB03 (XPro1595) Overcomes Resistance and Reduces Metastases in HER2-Positive Breast Cancer Models.
- Ongoing analysis of immune activation and tumor response endpoints to inform future development strategy.
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.
- Additional imaging analyses from the MINDFuL trial with XPro™ in early Alzheimer's Disease is expected to be reported in the near future.
Financial Results for the First Quarter Ended March 31, 2026:
- Net loss attributable to common stockholders for the quarter ended March 31, 2026 was approximately $5.4 million, compared to approximately $9.7 million during the quarter ended March 31, 2025.
- Research and development expenses totaled approximately $3.6 million for the quarter ended March 31, 2026, compared to approximately $7.6 million during the quarter ended March 31, 2025.
- General and administrative expenses were approximately $2.2 million for the quarter ended March 31, 2026, compared to approximately $2.3 million during the quarter ended March 31, 2025.
- As of May 7, 2026, 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 First Quarter Conference Call when reaching the operator.
Date: May 7th, 2026
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-800- 1-800-717-1738 or (international): +1-646-307-1865
Conference ID: INMUNE
An audio webcast of the call can be accessed by clicking here or using this link:
https://viavid.webcasts.com/starthere.jsp?ei=1761180&tp_key=01afd3034a
A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through May 21st, 2026 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering pin no. 1143455.
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.
David Moss
Co-founder and Chief Executive Officer
(858) 964-3720
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. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share amounts) (Unaudited) | ||||||||
| March 31, 2026 | December 31, 2025 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 21,358 | $ | 24,751 | ||||
| Research and development tax credit receivable | 479 | 4,284 | ||||||
| Other tax receivable | 291 | 257 | ||||||
| Prepaid expenses and other current assets | 694 | 595 | ||||||
| TOTAL CURRENT ASSETS | 22,822 | 29,887 | ||||||
| Equipment, net | 903 | 955 | ||||||
| Operating lease – right of use asset | 1,410 | 914 | ||||||
| Other assets | 683 | 595 | ||||||
| TOTAL ASSETS | $ | 25,818 | $ | 32,351 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued liabilities | $ | 4,659 | $ | 7,768 | ||||
| Accounts payable and accrued liabilities – related parties | 25 | 25 | ||||||
| Operating lease, current liabilities | 704 | 623 | ||||||
| TOTAL CURRENT LIABILITIES | 5,388 | 8,416 | ||||||
| Long-term operating lease liability | 806 | 411 | ||||||
| TOTAL LIABILITIES | 6,194 | 8,827 | ||||||
| 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 shares issued and outstanding | 27 | 27 | ||||||
| Additional paid-in capital | 234,768 | 233,271 | ||||||
| Accumulated other comprehensive loss | (727 | ) | (737 | ) | ||||
| Accumulated deficit | (214,444 | ) | (209,037 | ) | ||||
| TOTAL STOCKHOLDERS' EQUITY | 19,624 | 23,524 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 25,818 | $ | 32,351 | ||||
| INMUNE BIO INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share amounts) (Unaudited) | ||||||||
| For the Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| REVENUE | $ | - | $ | 50 | ||||
| OPERATING EXPENSES | ||||||||
| General and administrative | 2,171 | 2,316 | ||||||
| Research and development | 3,641 | 7,639 | ||||||
| Total operating expenses | 5,812 | 9,955 | ||||||
| LOSS FROM OPERATIONS | (5,812 | ) | (9,905 | ) | ||||
| OTHER INCOME, NET | 405 | 166 | ||||||
| NET LOSS | $ | (5,407 | ) | $ | (9,739 | ) | ||
| Net loss per common share – basic and diluted | $ | (0.20 | ) | $ | (0.43 | ) | ||
| Weighted average common shares outstanding – basic and diluted | 26,585,258 | 22,496,191 | ||||||
| COMPREHENSIVE LOSS | ||||||||
| Net loss | $ | (5,407 | ) | $ | (9,739 | ) | ||
| Other comprehensive income (loss) – foreign currency translation | 10 | (35 | ) | |||||
| Total comprehensive loss | $ | (5,397 | ) | $ | (9,774 | ) | ||
| INMUNE BIO INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands) (Unaudited) | ||||||||
| For the Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | (5,407 | ) | $ | (9,739 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 1,497 | 2,076 | ||||||
| Gain on settlement of accounts payable | (91 | ) | - | |||||
| Depreciation expense | 52 | - | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Research and development tax credit receivable | 3,805 | (102 | ) | |||||
| Other tax receivable | (34 | ) | 95 | |||||
| Prepaid expenses | (99 | ) | 124 | |||||
| Other assets | (88 | ) | 30 | |||||
| Accounts payable and accrued liabilities | (3,018 | ) | 659 | |||||
| Accounts payable and accrued liabilities – related parties | - | 78 | ||||||
| Deferred liabilities | - | (37 | ) | |||||
| Operating lease liabilities | (20 | ) | (8 | ) | ||||
| Net cash used in operating activities | (3,403 | ) | (6,824 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Sale of common stock for cash | - | 5,273 | ||||||
| Exercise of warrants for cash | - | 1 | ||||||
| Net cash provided by financing activities | - | 5,274 | ||||||
| Impact on cash from foreign currency translation | 10 | (35 | ) | |||||
| NET DECREASE IN CASH AND CASH EQUIVALENTS | (3,393 | ) | (1,585 | ) | ||||
| CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 24,751 | 20,922 | ||||||
| CASH AND CASH EQUIVALENTS AT END OF PERIOD | $ | 21,358 | $ | 19,337 | ||||
| SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: | ||||||||
| Cash paid for income taxes | $ | - | $ | - | ||||
| Cash paid for interest expense | $ | - | $ | - | ||||
| SUPPLEMENTAL NONCASH INVESTING AND FINANCING ACTIVITIES | ||||||||
| Right of use assets obtained in exchange for lease obligations | $ | 587 | $ | - | ||||
