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$(TM)$ Platform:
-- The CORDStrom(TM) 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(TM) 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(TM) 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(TM) in early Alzheimer's Disease.
-- Hosted expert-led webinar on XPro(TM) 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$(R)$ Platform:
-- Met primary and two of three secondary endpoints in CARE-PC trial
-- Continued evaluation of clinical data from the INKmune(R) 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(TM) is scheduled for submission to the UK's MHRA in mid-summer, followed directly by an EMA filing. -- CORDStrom(TM) 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(TM) and XPro(TM)."
CORDStrom(TM): A Clear Path to Commercialization
CORDStrom(TM), 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(TM)
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(TM): 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(TM) 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(TM)
CORDStrom(TM) 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(TM) 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(TM) 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(TM) 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(TM)
XPro(TM) 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(TM) 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(TM)
INKmune(TM) 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(TM) treatment converts the patient's own NK cells into mlNK cells. In patients, INKmune(TM) 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(TM) is a patient friendly drug treatment that does not require pre-medication, conditioning or additional cytokine therapy to be given to the patients. INKmune(TM) is easily transported, stored and delivered to the patient by a simple intravenous infusion as an out-patient. INKmune(TM) 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(TM) 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(TM), 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(TM), 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(R), 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(TM), XPro1595(TM) (XPro(TM), pegipanermin), and INKmune(R)(TM) 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, December 31,
2025 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 $ -
(END) Dow Jones Newswires
March 30, 2026 16:00 ET (20:00 GMT)
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