On March 30, 2026 INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a late-stage biotechnology company focused on inflammation and immunology, reported its financial results for the year ended December 31, 2025 and provides a business update.

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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:
View Source;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.

(Press release, INmune Bio, MAR 30, 2026, View Source [SID1234664051])