Every 8-K that INmune Bio Inc. (INMB) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow INMB and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full INMB filings page.
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. entered into a warrant inducement offer and a warrant amendment with holders of its April 2024 common stock purchase warrants. Holders agreed to exercise 647,112 warrants, representing 50% of their April 2024 Warrants, at a reduced exercise price of $1.40 per share, down from $1.95. INmune Bio expects to receive $905,957 in cash from these exercises. In return, the company extended the maturity date for the remaining 50% of these warrants from June 30, 2026 to December 31, 2027, preserving additional future warrant exercise optionality.
INmune Bio Inc. reported receiving official, accepted meeting minutes from a pre-Marketing Authorization Application Scientific Advice meeting with the UK MHRA for its CORDStrom-derived product Ebstrocel in recessive dystrophic epidermolysis bullosa (RDEB). The minutes document written alignment across all company questions and outline a clear regulatory path for a planned 2026 UK Marketing Authorization Application seeking Conditional Marketing Authorization.
MHRA feedback confirmed the company’s pooled-donor CMC and commercial manufacturing framework, endorsed a focused, literature-supported non-clinical safety strategy, and clarified an evidence approach tailored to ultra-rare RDEB, including openness to Bayesian statistics and patient- and parent-reported outcomes. INmune Bio plans to incorporate endpoint and pediatric population recommendations into a confirmatory Phase 3 program expected to open in 2026, and to use this guidance for future EMA and FDA submissions planned for late 2026 or early 2027.
INmune Bio Inc. reported results from its annual meeting of stockholders. Stockholders approved the Third Amended and Restated 2021 Stock Incentive Plan, increasing the shares of common stock available under the plan from 6,500,000 to 9,158,525, providing more capacity for equity-based awards to directors, officers and employees.
The amended plan also adds an evergreen provision, allowing the share reserve to increase automatically on the first trading day of each calendar year from 2027 through 2031 by the lesser of 10.0% of shares outstanding as of the prior December 31 or a smaller amount set by the board. Stockholders also elected five directors and ratified CBIZ CPAs P.C. as independent auditors for the fiscal year ending December 31, 2026.
INmune Bio Inc. reported new exploratory MRI biomarker results from its MINDFuL Phase 2 trial of XPro™ (XPro1595) in patients with early Alzheimer’s disease. Chi-separation MRI showed a statistically significant treatment effect on white matter myelin in the full modified intent-to-treat population of 200 patients (p=0.0028; d=0.46).
In a biomarker-enriched subgroup of 100 patients with elevated inflammation, the effect strengthened (p=0.0098; d=0.59), supporting the company’s precision-medicine approach and planned Phase 2b/3 registrational program. These data complement prior MINDFuL results, FDA End-of-Phase 2 alignment, FDA Fast Track designation, and a favorable safety profile with no observed ARIA-E or ARIA-H.
INmune Bio Inc. announced that the U.S. Food and Drug Administration has granted Fast Track designation to XPro™ (pegipanermin), its first-in-class selective soluble TNF inhibitor, for treating early Alzheimer’s disease. The designation covers patients with mild cognitive impairment due to Alzheimer’s and mild Alzheimer’s dementia.
Fast Track status is intended for serious diseases with unmet medical needs and can allow more frequent FDA interactions, Rolling Review and other expedited review tools. INmune plans a Phase 2b/3 seamless adaptive registrational program in biologically confirmed early Alzheimer’s patients with inflammatory biomarkers, using EMACC and plasma pTau217 as decision-gating endpoints before moving to clinical outcome measures such as CDR-SB.
INmune Bio Inc. has entered into an amended and restated Material Transfer and License Agreement with its UK subsidiary INmune Bio International and UK charity Anthony Nolan to expand long-term supply of umbilical cord tissue for the CORDStrom™ MSC platform.
Anthony Nolan grants an exclusive, sublicensable license to use, process, test and store donor materials and related products, while INmune Bio and its subsidiary are jointly and severally liable for royalty obligations. Anthony Nolan will receive a 2% royalty on net sales per Product, capped at £5,000,000 annually, plus £400 per umbilical cord tissue for Cell and Gene Therapies Services, with annual CPI-linked fee increases starting January 1, 2027. The agreement runs until terminated under its terms or for ten years from the First Commercial Sale and includes stringent GMP and HTA quality and traceability provisions.
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. reported that stockholders approved a one-time repricing of certain outstanding stock options covering up to 5,511,000 shares under its equity incentive plans. Effective November 18, 2025, the exercise price of these options for eligible employees and directors was reduced to $1.50 per share, matching the Nasdaq closing price that day, while all other option terms remain unchanged.
At the special meeting, 26,585,258 shares were entitled to vote, with 10,193,242 shares represented, establishing a quorum. The option repricing proposal passed with 7,144,433 votes for, 2,926,973 against, and 121,836 abstentions. INmune Bio also announced in a press release that it will deliver two presentations at the 18th Clinical Trials on Alzheimer’s Disease conference in San Diego from December 1–4, 2025.
INmune Bio (INMB) furnished an Investor Presentation under Regulation FD. The company reported via an 8-K that a slide deck intended for periodic presentations was made available as Exhibit 99.1. The disclosure is provided under Item 7.01, which is furnished and not deemed “filed” for purposes of Section 18 of the Exchange Act and is not incorporated by reference.
The filing also lists Exhibit 104 for the cover page interactive data file embedded within the Inline XBRL document.
INmune Bio Inc. filed a current report stating that on October 30, 2025 it announced financial results for the quarter ended September 30, 2025 and provided a business update. The company released these details through a press release, which is attached as Exhibit 99.1.
The report clarifies that the press release and related information are being furnished rather than filed under securities laws, limiting their use for certain legal liability purposes unless specifically incorporated by reference into other regulatory documents.
INmune Bio (INMB) will host a conference call on October 30, 2025 at 4:30 p.m. Eastern Time to discuss results for its third quarter ended September 30, 2025 and provide a corporate update. The company attached a related press release as Exhibit 99.1.
INmune Bio reported that CEO David Moss will participate in a Dermatologic Rare Disease Panel at the Maxim Growth Summit presented by Maxim Group LLC. The event takes place at the Hard Rock Hotel in New York City on October 22–23, 2025.
The company furnished a related press release dated October 14, 2025 as Exhibit 99.1 under Item 8.01.
INmune Bio Inc. reported that it has submitted a scientific manuscript for peer review describing results from its Phase 2 MINDFuL trial in early Alzheimer’s disease with inflammation. The manuscript, titled “XPro1595, a Selective Soluble TNF Neutralizer, in Early Alzheimer’s Disease with Inflammation (ADi): Results from the Phase 2 MINDFuL Trial,” was submitted to npj Dementia, a Nature Portfolio journal. The company furnished a press release about this submission as an exhibit to the report.
INmune Bio (NASDAQ:INMB) filed an 8-K announcing it will host a conference call on June 30, 2025 at 8:00 a.m. ET to present top-line data from its Phase 2 MINDFuL trial in early Alzheimer’s disease.
The filing:
- Attaches the related press release as Exhibit 99.1
- Provides no efficacy or safety figures; full results will be disclosed during the call
- Contains no changes to financial statements or guidance
The scheduling of a data read-out signals analysis completion and sets a near-term catalyst for shareholders, but the document itself does not alter the company’s financial position.