Inmune Bio, Inc. SEC Filings

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.

Inmune Bio, Inc. Chief Executive Officer David J. Moss exercised common stock purchase warrants to acquire 9,014 shares of Common Stock at an exercise price of $1.40 per share in cash. Following this transaction, he directly holds 1,294,883 shares of Common Stock. Under a related warrant inducement offer letter, the remaining 50% of his April 2024 Warrants that were not exercised now have their maturity date extended to December 31, 2027.

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. 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.