Inmune Bio Inc SEC Filings

INmune Bio Inc. reported a net loss of $5.4 million for the three months ended March 31, 2026, narrower than the $9.7 million loss a year earlier, as research and development spending fell to $3.6 million from $7.6 million after completing its Alzheimer’s Phase 2 trial.

The company had $21.4 million in cash and cash equivalents and used $3.4 million in operating cash during the quarter. Management concluded that these resources are projected to be insufficient to fund operations for one year after the statements are issued, raising substantial doubt about its ability to continue as a going concern.

INmune Bio is a clinical-stage biotech focused on reprogramming the innate immune system, with lead program CORDStrom for recessive dystrophic epidermolysis bullosa. The company is preparing marketing applications in the UK, EU and plans a U.S. BLA targeted for 2026, while also expanding long-term umbilical cord tissue supply through an amended Anthony Nolan agreement.

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. 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. is asking stockholders to approve three items at its virtual annual meeting on June 16, 2026: elect five directors, ratify CBIZ CPAs P.C. as auditor for 2026, and approve an expanded equity incentive plan.

The Third Amended and Restated 2021 Stock Incentive Plan would increase the share reserve by 2,658,525 shares, from 6,500,000 to 9,158,525 shares, and add an evergreen feature allowing annual increases through 2031 of up to 10% of shares outstanding or a smaller amount set by the board. The company notes this equity capacity is intended to support ongoing grants to employees, directors, consultants and advisors but acknowledges potential dilution and anti-takeover effects.

The proxy also reviews 2025 executive pay, including new CEO David Moss and retiring CEO Raymond Tesi, committee structures, governance policies such as clawback and anti-hedging rules, and stock ownership. INmune Bio reported net losses of $46 million in 2025 and $42 million in 2024, while continuing to rely heavily on equity-based compensation.

INmune Bio outlines major pipeline developments and regulatory progress for the year ended December 31, 2025. The company’s lead program, CORDStrom, is an off‑the‑shelf umbilical cord‑derived cell therapy for Recessive Dystrophic Epidermolysis Bullosa, which showed clinically meaningful itch, pain and skin improvements in a 30‑patient MissionEB trial with over 27% sustained itch reduction at six months in severely affected children. INmune licensed the MissionEB data from Great Ormond Street Hospital for an upfront payment of about $0.3 million and faces a potential milestone of up to £6 million (approximately $8.1 million) on first marketing authorization. CORDStrom has received FDA Rare Pediatric Disease and Orphan Drug Designations, keeping it eligible for a Priority Review Voucher if approved by September 30, 2029, and the company plans a pre‑BLA meeting and BLA filing, followed by Marketing Authorization Applications in the United Kingdom and European Union. In Alzheimer’s disease, XPro’s 208‑patient Phase 2 MINDFuL trial did not meet primary or key secondary endpoints in the full analysis set, though a biomarker‑defined subgroup (n=100) showed effect sizes above 0.2 on cognition and neuropsychiatric symptoms; INmune will seek partners and does not plan to independently advance XPro. INKmune, evaluated in small leukemia and metastatic castrate‑resistant prostate cancer studies, generated immune activity signals but will not move further into development for now due to capital constraints. As of March 30, 2026, INmune Bio had 26,585,258 common shares outstanding, and non‑affiliate equity value was approximately $51 million as of June 30, 2025.

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.