INmune Bio completes pilot commercial manufacturing of CORDStrom for RDEB treatment.

• INmune Bio completes first full-scale pilot commercial run of CORDStrom™. • CORDStrom™ is an off-the-shelf, allogeneic, umbilical cord tissue-derived MSC therapy. • Treats Recessive Dystrophic Epidermolysis Bullosa (RDEB). • Milestone achieved at Cell and Gene Therapy Catapult's Manufacturing Innovation Centre. • Keeps the Company on track for filing a Marketing Authorization Application (MAA) in the UK in H1 2026 and a Biologics License Application (BLA) in the US.

INmune Bio Inc. (NASDAQ: INMB), a clinical-stage immunology company, has successfully completed its first full-scale pilot commercial manufacturing run of CORDStrom™, an off-the-shelf, allogeneic, umbilical cord tissue-derived mesenchymal stromal cell (MSC) therapy. The milestone was achieved at the Cell and Gene Therapy Catapult's Manufacturing Innovation Centre in Stevenage, United Kingdom, and marks a significant step toward regulatory submissions for the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB).

CORDStrom™ is designed to address the severe unmet needs of RDEB patients, a condition characterized by extreme fragility of the skin and internal linings, leading to widespread blistering, chronic wounds, scarring, and increased skin cancer risk. The therapy has shown promising results in the Phase 2 Mission EB trial, demonstrating improvements in itch, pain, wound scores, and quality of life.

The successful manufacturing run confirms the scalability and consistency of CORDStrom™ production, utilizing a proprietary process to ensure high-quality, GMP-compliant products. This achievement aligns with INmune Bio's aggressive regulatory timeline, keeping the company on track to file a Marketing Authorization Application (MAA) in the UK during the first half of 2026, followed by a Biologics License Application (BLA) in the US.

Ben Weil, Head of UK Operations at INmune Bio, stated, "This achievement at a commercial-ready UK facility is a testament to our team's dedication, operational excellence, and strength of the collaboration with the Cell and Gene Therapy Catapult. It is a milestone which ensures we remain aligned with our aggressive regulatory timeline."

Dr. Mark Lowdell, Chief Scientific Officer of INmune Bio, added, "The completion of this first commercial pilot run is a pivotal moment in our journey to bring CORDStrom™ to market. Building on the positive safety and efficacy data from the Phase 2 trial, this manufacturing success reinforces our confidence in delivering a reliable supply chain for global commercialization. We're excited to advance toward MAA and BLA submissions in 2026, with the goal of providing hope to families affected by this devastating disease."

Matthew Durdy, Chief Executive at the Cell and Gene Therapy Catapult, said, "The successful completion of this first pilot run is a major accomplishment for INmune Bio as it looks to accelerate its path to commercial manufacturing. This initial run has provided valuable learnings on how to refine and scale-up the manufacturing, and we are committed to supporting INmune Bio on its ambition to ensure the potentially life-changing benefits of CORDStrom™ reach patients with RDEB."

INmune Bio continues to prioritize efficient execution across its pipeline, including ongoing preparations for regulatory interactions to support CORDStrom™'s launch.