Inmune Bio, Inc.

Inmune Bio, Inc. announced a warrant inducement offer to holders of its April 2024 Warrants. The offer allows holders to exercise 50% of their warrants at a reduced price of $1.40 per share, down from $1.95. In exchange, the maturity date for the remaining 50% of the warrants will be extended from June 30, 2026, to December 31, 2027. The company expects to receive approximately $905,957 from the exercise of 647,112 warrants.

INmune Bio, Inc. has submitted its CORDStrom™ platform patent application into the U.S. national phase before the USPTO. This move is a key element of the company's global intellectual property strategy for its next-generation mesenchymal stromal cell platform, including Ebstrocel for epidermolysis bullosa. If granted, this foundational patent family is projected to provide exclusive commercial protection extending into at least 2045, following a favorable PCT Written Opinion. The company also plans to pursue corresponding patent protection in other strategic jurisdictions worldwide.

INmune Bio announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved the Pediatric Investigation Plan (PIP) for Ebstrocel™ for Recessive Dystrophic Epidermolysis Bullosa (RDEB). This approval is the first required stage toward a Marketing Authorization Application (MAA) submission in the United Kingdom, aligning with the company's 2026 MAA filing timeline and early 2027 US filing for Accelerated Approval. The MHRA's expedited review, completed in under three months, validates the clinical data package and significantly de-risks the regulatory pathway for Ebstrocel™.

INmune Bio Inc. announced it received official meeting minutes from the UK Medicines & Healthcare products Regulatory Agency (MHRA) regarding its pre-Marketing Authorization Application (pre-MAA) for CORDStrom™ (Ebstrocel™) in Recessive Dystrophic Epidermolysis Bullosa (RDEB). The MHRA provided written alignment across all submitted questions, confirming agreement on CMC, non-clinical, and clinical evidence packages. This provides a clear regulatory path for the company's planned 2026 UK MAA submission, with EU and US submissions to follow.

Inmune Bio, Inc. stockholders approved the Third Amended and Restated 2021 Stock Incentive Plan at their annual meeting on June 16, 2026. The plan increases the shares reserved for awards from 6,500,000 to 9,158,525 and includes an evergreen provision for future automatic increases. Additionally, stockholders elected five directors and ratified CBIZ CPAs P.C. as the independent auditors for fiscal year 2026.

INmune Bio announced positive results from exploratory chi-separation MRI imaging analyses from its Phase 2 MINDFuL clinical trial of XPro™ (XPro1595) in patients with early Alzheimer's disease. The results showed a statistically significant treatment effect on white matter, particularly in patients with elevated inflammation, supporting the company's precision-medicine strategy. The company has also secured FDA alignment on an integrated Phase 2b/3 registrational pathway and received Fast Track designation for XPro™.

Inmune Bio announced positive results from exploratory chi-separation MRI imaging analyses of its XPro™ (XPro1595) Phase 2 MINDFuL clinical trial for early Alzheimer's disease. The trial demonstrated a highly significant treatment effect on myelin in the full mITT population (p=0.0028; d=0.46) and further strengthened in biomarker-enriched patients (p=0.0098; d=0.59). These findings support the company's precision-medicine approach and align with the FDA-aligned Phase 2b/3 registrational program, which recently received Fast Track designation. The company plans to present the complete dataset at AAIC 2026.

INmune Bio Inc. announced the publication of positive results from its Phase 2 MINDFuL trial of XPro™ in Alzheimer’s disease in the peer-reviewed journal NPJ Dementia. The study demonstrated directionally consistent benefits across multiple cognitive, functional, behavioral, and biomarker endpoints in a pre-specified Alzheimer’s Disease with inflammation (ADi) subgroup over 24 weeks, with no observed amyloid-related imaging abnormalities (ARIA). These findings, including effect sizes up to 0.27, support an inflammation-enriched strategy for future studies and strengthen the value of the XPro platform, which also holds FDA Fast Track designation.

INmune Bio Inc. announced that the FDA granted Fast Track designation to XPro™ (pegipanermin), its selective soluble TNF inhibitor, for the treatment of early Alzheimer's disease. This designation covers both mild cognitive impairment due to AD and mild Alzheimer’s disease dementia, recognizing the urgent need for treatments targeting neuroinflammation. The Fast Track status will facilitate development and expedite the review process for XPro™, which aims to alter the trajectory of this devastating disease.

INmune Bio Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to XPro (pegipanermin) for the treatment of early Alzheimer's disease. This designation covers both mild cognitive impairment due to AD and mild Alzheimer dementia, addressing a significant unmet medical need. The company believes XPro has the potential to alter the disease's trajectory by targeting underlying neuroinflammation, and the designation will facilitate development and expedite regulatory review.