INmune Bio Inc. (NASDAQ:INMB) (the "Company"), a late-stage biotechnology company focused on inflammation and immunology, today announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved the Pediatric Investigation Plan (PIP) for Ebstrocel™ for the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB).

The approval of the PIP is the first required stage toward a Marketing Authorization Application (MAA) submission in the United Kingdom. This regulatory milestone remains strictly aligned with the Company’s established timetable for an MAA filing in 2026 and a US filing for Accelerated Approval in early 2027.

"We submitted the PIP for Ebstrocel expecting a ten-month review cycle, but requested an accelerated review based on the critical unmet need in RDEB," said Dr. Mark Lowdell, Chief Scientific Officer of INmune Bio. "The MHRA’s turnaround in under three months represents a clear endorsement of the clinical data package. Their constructive advice on minor adjustments to the phase 3 open-label trial protocol has already been integrated. This allows us to maintain our twin-track regulatory strategy: filing for conditional marketing authorization this year to enable early market access, while running the open-label registration trial in 2027 to satisfy post-marketing commitments for full marketing authorization."

In the UK, EU, and U.S., all medicinal products seeking marketing approval must include an agreed-upon plan for pediatric delivery. The Ebstrocel™ PIP submission establishes the scientific justification for treating children with RDEB, characterized not merely as a skin condition but as a devastating systemic disease. The submission highlighted Ebstrocel’s potential to address the most debilitating symptoms reported by the patient community, specifically chronic wounds, intractable itch, and severe pain, which are the primary drivers of poor quality of life. With approximately 300 children affected by RDEB in the United Kingdom, part of a broader epidermolysis bullosa (EB) community of at least 5,000 individuals supported by DEBRA UK, this approval addresses a critical unmet medical need in a well-defined patient population facing substantial care burdens. The MHRA raised no objections to the clinical data or the claims presented in the submission.

"Securing PIP approval ahead of schedule, together with the MHRA's written alignment across our CMC, non-clinical and clinical strategy, represents a significant regulatory de-risking milestone for Ebstrocel™ and the broader CORDStrom™ platform," said David Moss, CEO of INmune Bio. "Importantly, the MHRA has now reviewed and provided guidance across the key elements required for our planned 2026 Marketing Authorization Application, substantially reducing regulatory uncertainty as we move toward submission. The accepted meeting minutes from our face-to-face Scientific Advice meeting provide a clear roadmap for Conditional Marketing Authorization and establishes alignment on the evidence package, manufacturing transition strategy, and confirmatory trial design needed to support review. With these milestones achieved, we believe Ebstrocel is now positioned on a well-defined path to potential approval, bringing us closer to delivering the first systemic therapy designed to address the underlying disease burden of RDEB while creating a significant value inflection opportunity for shareholders as we move from late-stage development toward potential commercialization."

The Company is now focused on its final preparations for the MAA submission and completing the final commercial manufacturing steps necessary for Ebstrocel™ authorization.