INmune Bio Inc.'s SEC filings document the disclosure record of a Nasdaq-listed Nevada biotechnology company developing innate-immune therapies. Its filings identify common stock traded under INMB and cover material-event reports, Regulation FD presentations, shareholder letters, clinical and regulatory updates, operating and financial results, and capital-structure disclosures.
Recent 8-K filings include disclosures tied to product-platform communications and a material definitive agreement involving INmune Bio International and Anthony Nolan for the CORDStrom platform. Proxy materials cover shareholder voting and governance matters, while the company’s formal disclosures frame recurring risks and development-stage issues associated with biotechnology research, regulatory pathways, collaborations and financing.
INmune Bio Inc. furnished an investor presentation describing its late-stage pipeline and regulatory plans. The slide deck highlights CORDStrom, a systemic cell therapy for recessive dystrophic epidermolysis bullosa (RDEB), which showed improvements in itch, pain, skin scores, gastrointestinal symptoms and quality of life in a randomized, double-blind, placebo-controlled Phase III Mission EB trial.
The company outlines anticipated annual reimbursement for CORDStrom of about $700,000 per patient and a potential total addressable market above $1.4 billion, along with Orphan Drug and Rare Pediatric Disease designations and planned MAA and BLA submissions. The presentation also details XPro1595 for “Alzheimer’s disease with inflammation,” summarizing Phase 2 MINDFuL data with clinically meaningful effect sizes on cognition, imaging and neuropsychiatric endpoints, a differentiated safety profile with no ARIA, and an FDA-aligned adaptive Phase 2b/3 design using CDR-SB as the primary endpoint.
INmune Bio Inc. filed an 8-K to highlight a press release about an upcoming webinar on the registrational pathway for its drug candidate XPro1595 (XPro™) in early Alzheimer’s disease. The webinar will be held on February 27, 2026 at 9:30 a.m. ET and will cover Phase 2 MINDFuL trial results, related FDA End-of-Phase 2 discussions, and the planned registrational study design in a biomarker-enriched Alzheimer’s population.
The company states it has received alignment after its End-of-Phase 2 meeting with the FDA that supports advancing XPro™ to a registrational study in patients with Alzheimer’s disease with biomarkers of inflammation. Key opinion leaders Dr. Michael Woodward and Dr. Sharon Cohen, both MINDFuL trial investigators, will present and discuss the clinical data and the strategy toward Phase 3 development and potential global partnership opportunities.
INmune Bio Inc. filed an update noting it will host a webinar on February 26, 2026 at 1:00 p.m. ET to present new clinical data on CORDStrom for treating recessive dystrophic epidermolysis bullosa (RDEB). Clinical investigators from the MissionEB Phase III trial will share real-world experience and highlight systemic disease-modifying results.
The press release also describes CORDStrom as a patent-pending, off-the-shelf cell therapy made from pooled human umbilical cord-derived mesenchymal stromal cells, designed for scalable, consistent manufacturing. INmune Bio is a clinical-stage biotechnology company with three platforms: CORDStrom, XPro for inflammatory conditions, and INKmune for cancer.
INmune Bio Inc. reports two major regulatory milestones for its pipeline. The company has submitted a pre-submission package to the UK Medicines and Healthcare Products Regulatory Agency for CORDStrom™, a cell therapy being developed as a potential first systemic treatment for recessive dystrophic epidermolysis bullosa. This step is intended to streamline a future Marketing Authorization Application targeted for mid-summer 2026, with potential EU and U.S. submissions in Q4 2026. CORDStrom already holds U.S. Orphan Drug and Rare Pediatric Disease designations and may benefit from the recently reauthorized FDA Rare Pediatric Disease Priority Review Voucher program, which runs through September 30, 2029.
Separately, INmune Bio received official minutes from an End-of-Phase 2 meeting with the U.S. Food and Drug Administration confirming regulatory alignment on an integrated Phase 2b/3 registration-intent strategy for XPro1595 in early Alzheimer’s disease. The design uses a nine‑month Phase 2b segment informed by cognitive and biomarker endpoints (EMACC and plasma p‑tau‑217), followed by a Phase 3 segment that will use CDR-SB as the sole primary efficacy endpoint. The company is incorporating FDA feedback into the final protocol for this precision-medicine, enrichment-led program.
INmune Bio Inc. filed a current report to note that it issued a press release on January 27, 2026 announcing a shareholder letter. The letter is intended to provide shareholders with updates on the company’s prior and future operations.
The press release is included as Exhibit 99.1 and, along with the related disclosure, is being furnished under Regulation FD rather than filed. As a result, this information is not subject to certain liability provisions of the federal securities laws and will not be incorporated into other Securities Act or Exchange Act filings unless specifically referenced.
Inmune Bio, Inc. (INMB) reported a stock option repricing for a director effective as of November 18, 2025. Stockholders approved a one-time adjustment that reduced the exercise price of certain outstanding stock options granted under the company’s 2017, 2019 and 2021 stock incentive plans to $1.50 per share, matching the closing price of Inmune Bio’s common stock on The Nasdaq Capital Market on that date. The filing shows multiple stock option awards where higher exercise prices were replaced by new options at $1.50, while all other terms, including vesting schedules and expiration dates, remain unchanged and continue to depend on the director’s ongoing service.
Inmune Bio, Inc. (INMB) reported that its Chief Executive Officer and director had multiple outstanding stock option awards repriced on November 18, 2025. Stockholders approved a one-time repricing of certain options granted under the company’s 2017, 2019, and Second Amended and Restated 2021 Stock Incentive Plans, reducing the exercise price of each affected option to $1.50, which was the company’s Nasdaq closing share price on the repricing date. For example, one stock option covering 400,000 shares originally exercisable at $7.80 was adjusted to a $1.50 exercise price. The filing states that all other terms of these repriced options, including vesting schedules and terms, remain unchanged, and exercisability continues to depend on the CEO’s ongoing service.
Inmune Bio (INMB) reported a Form 4 filing for its Chief Scientific Officer, Mark William Lowdell, reflecting a one-time repricing of certain outstanding stock options. Effective as of November 18, 2025, stockholders approved reducing the exercise price of these options granted under the 2017, 2019 and Second Amended and Restated 2021 Stock Incentive Plans to $1.50, equal to the Nasdaq Capital Market closing price of the company’s common stock on that date. The table shows multiple existing stock option grants being adjusted from higher exercise prices to $1.50 while keeping the same share amounts and expiration dates. All other terms, including vesting and option terms, remain in full force and effect, so the change mainly affects the price at which these options can be exercised.
Inmune Bio, Inc. (INMB) reported a one-time repricing of certain outstanding stock options for a company director effective November 18, 2025. The stockholders approved reducing the exercise price of these existing options to $1.50 per share, which matches the closing price of Inmune Bio’s common stock on The Nasdaq Capital Market on that date. Multiple previously granted stock options with higher exercise prices, covering blocks such as 108,000, 35,000, 32,500 and other share amounts, were cancelled and replaced with new options for the same number of underlying common shares at the new $1.50 exercise price. All other terms of the repriced options, including vesting schedules and expiration dates under the company’s 2017, 2019 and 2021 stock incentive plans, remain unchanged.
Inmune Bio, Inc. (INMB) director reprices stock options following shareholder approval. On November 18, 2025, the company’s stockholders approved a one-time repricing of certain outstanding stock options granted under Inmune Bio’s 2017, 2019 and 2021 stock incentive plans. The repricing reduced the per-share exercise price of each affected option to $1.50, which was the closing price of Inmune Bio common stock on The Nasdaq Capital Market on the repricing date. The table shows prior options with exercise prices such as $7.80, $3.91, $24.82, $17.49, and others being replaced with new options at $1.50 for the same share amounts, including grants of 108,000 and 35,000 shares. All other terms of these options, including vesting schedules and expiration dates, remain unchanged and continue to depend on the director’s ongoing service.