INmune Bio Inc

News & Events zu INmune Bio Inc (INMB)

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INMB-News

INMB-Events

10/28 09:28

INmune Bio Enters $4.5M Financing Agreement with Institutional Investor

INmune Bio announced that it has entered into a definitive agreement with a single healthcare-focused, institutional investor for a registered direct offering of an aggregate of 3M shares of common stock and a concurrent private placement of unregistered warrants to purchase up to 3M shares common stock. The gross proceeds to the company from the Offering are expected to be approximately $4.5M, before deducting placement agent fees and other estimated offering expenses. The warrants will have an exercise price of $1.65, will be exercisable six months following their issuance and will expire five and a half years from the issuance date. The closing of the Offering is expected to occur on or about October 29, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from the Offering for working capital purposes and general corporate procedures. A.G.P./Alliance Global Partners is acting as the sole placement agent for the Offering.

10/21 08:00

INmune Bio Submits Final Application for Ebstrocel

INmune Bio announced that it has submitted its final pre-marketing authorization application, or pre-MAA, package to the UK Medicines and Healthcare products Regulatory Agency, or MHRA, for Ebstrocel, its investigational cell therapy for recessive dystrophic epidermolysis bullosa, or RDEB. The company has updated its regulatory submission strategy, as faster-than-expected manufacturing progress supports a full MAA submission in early February 2027, with potential UK approval in mid-2027, subject to MHRA review. Following MHRA feedback on the final pre-MAA package, INmune Bio plans to finalize and submit a complete application in February 2027, replacing the sequential rolling submission previously planned to begin in late 2026. Based on progress in chemistry, manufacturing and controls, or CMC, and discussions with regulatory advisors, the company believes this approach could accelerate potential UK approval by approximately six weeks compared with the previously anticipated timeline. The company anticipates an MHRA response within three to six months after submission, subject to application validation, agency review and any requests for additional information. Submission of the complete package is intended to support assessment of the clinical, manufacturing and quality data together. In parallel, INmune Bio has engaged U.S. regulatory advisors with rare disease expertise to prepare and submit a Type B meeting request to the FDA. Subject to feedback from that meeting, the company plans to submit a Biologics License Application, or BLA, in the second quarter of 2027, seeking traditional or accelerated approval, as appropriate.

10/21 07:30

INmune Bio Enters Services Agreement with Uniphar

INmune Bio announced that it has entered into a master services agreement with Uniphar Durbin Ireland establishing a scalable framework to support international access, distribution and commercialization of Ebstrocel, the company's allogeneic stromal cell therapy for Recessive Dystrophic Epidermolysis Bullosa, or RDEB. INmune Bio initially intends to use the framework to pursue named-patient access in selected European countries and in the Middle East and North Africa, or MENA, subject to applicable law and country-specific statements of work. The relationship may subsequently expand across Europe and other territories by mutual agreement. The company expects named-patient access to be an important component of its international commercialization strategy for Ebstrocel. Where permitted by local law and implemented through statements of work, this pathway may allow physicians to request Ebstrocel for individual eligible patients before local marketing approval or broad commercial availability.

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