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. (INMB) submitted the final pre-Marketing Authorisation Application (pre-MAA) package for investigational Ebstrocel to the UK MHRA on October 21, 2026. After MHRA feedback, it plans a complete UK MAA in February 2027, replacing a rolling submission previously planned for late 2026. The company says the revised approach could advance potential UK approval by approximately six weeks; potential approval in mid-2027 remains subject to MHRA review, and it anticipates a response within 3 to 6 months after submission, subject to validation, review and requests for information.
It also entered a Master Services Agreement with Uniphar Durbin Ireland Limited for international access, distribution and commercialization. Initial plans focus on named-patient access in selected European countries and the Middle East and North Africa, subject to applicable law and country-specific statements of work; expansion requires mutual agreement. For the U.S., INmune Bio has engaged advisors to prepare and submit an FDA Type B meeting request and plans a BLA in Q2 2027, subject to FDA feedback. Ebstrocel remains investigational and has not been approved by FDA, MHRA, EMA or another regulatory authority.
The October 2026 investor presentation also describes an adaptive Phase 2b/3 XPro1595 design, naming CDR-SB as the sole Phase 3 primary endpoint. It says its summary of FDA alignment reflects the company’s interpretation of FDA feedback.
Inmune Bio, Inc. director Ronnie Duane Clark received an initial award of options covering 100,000 common shares on September 15, 2026, under the Third Amended and Restated 2021 Stock Incentive Plan. The options have a $2.33-per-share exercise price and vest in 36 equal monthly installments over three years, beginning one month after grant; full vesting occurs on the third anniversary. They expire September 14, 2036. No Rule 10b5-1 plan is reported.
Inmune Bio, Inc. (INMB) reported that director James Sapirstein received a grant of 100,000 stock options on September 15, 2026 as compensation for his service on the board of directors. The options have an exercise price of $2.33 per share and are exercisable for 100,000 shares of common stock.
The award was granted under Inmune Bio, Inc.'s Third Amended and Restated 2021 Stock Incentive Plan and vests in 36 equal monthly installments over three years, beginning one month after the grant date, becoming fully vested on the third anniversary of the grant. Following this award, Sapirstein holds stock options for 100,000 shares, with the options scheduled to expire on September 14, 2036. No Rule 10b5-1 trading plan is reported.
Inmune Bio, Inc. (INMB) has a new Form 3 on file identifying James Sapirstein as a director and reporting person with respect to the company’s equity securities. The filing, as summarized here, does not list any specific share or derivative holdings or any reportable transactions.
INmune Bio, Inc. (INMB) reported that its Board of Directors increased its size to seven members and appointed R. Duane Clark II and James Sapirstein as independent directors, effective September 8, 2026, with terms lasting until the next annual election and until successors are elected and qualified.
Both will also serve on the Nominating and Corporate Governance Committee and bring more than 40 years each of global pharma and biopharma experience in rare diseases, commercialization, business development, licensing and capital formation, supporting preparation for potential commercialization of Ebstrocel and broader strategic partnering.
Each new director is expected to receive an option to purchase 100,000 shares of common stock vesting over 36 months, plus an annual cash retainer of $50,000 and reimbursement of related expenses, under the company’s existing director compensation framework and indemnification arrangements.
INmune Bio Inc. reports that it remains a clinical-stage company with no product revenue and a net loss of $6.7 million for the six months ended June 30, 2026, a significant improvement from a $34.2 million loss a year earlier, largely due to lower Alzheimer’s program spend and the absence of a prior-year $16.5 million impairment.
Cash and cash equivalents were $18.4 million at June 30, 2026, down from $24.8 million, with $6.6 million used in operating activities in the first half. Management states that existing cash and projected operating needs create substantial doubt about the company’s ability to continue as a going concern for one year after issuance.
The lead program is CORDStrom for recessive dystrophic epidermolysis bullosa, which has completed a pivotal randomized cross-over trial. The company plans to file a Marketing Authorization Application in the UK by late 2026, an EU filing in early 2027, then a BLA with the FDA. INmune Bio also highlights $4.4 million in R&D tax rebates received in the first half and continued access to a $65 million at-the-market equity facility, of which only a small portion has been used.
INmune Bio Inc. reported that on July 30, 2026 it received a research and development cash rebate from Australia of approximately $4.2 million. This payment follows an additional approximately $0.4 million R&D rebate from the United Kingdom during June 2026, for combined rebates of about $4.6 million.
The company states that, after adjusting second-quarter operating cash flows to exclude the UK rebate received during the quarter, the combined rebate proceeds exceeded its net cash used in operating activities for that period. Management describes these rebates as non-dilutive cash that strengthens the balance sheet, extends the cash runway, and supports advancing CORDStrom™ (Ebstrocel™) toward regulatory filings, alongside other late-stage innate immune system programs.
Inmune Bio, Inc. director Juda Scott exercised common stock purchase warrants in a cash transaction, acquiring 14,801 shares of Common Stock at $1.40 per share. This exercise stems from an April 2024 warrant inducement agreement with the company.
Following the transaction, Scott directly owns 86,404 shares of Common Stock. Under the same inducement letter, the maturity date of the remaining 50% of Scott’s April 2024 warrants that were not exercised was extended from June 30, 2026 to December 31, 2027, providing a longer exercise window for those warrants.
INmune Bio, Inc. Chief Scientific Officer Mark William Lowdell exercised common stock purchase warrants to acquire 7,211 shares of Common Stock at an exercise price of $1.40 per share. This increased his directly held stake to 1,518,017 Common shares.
The exercise was part of a warrant inducement arrangement tied to April 2024 Warrants. Lowdell agreed to exercise 50% of his April 2024 Warrants for cash, while the company extended the maturity date of the remaining 50% of those warrants from June 30, 2026 to December 31, 2027.