The US Food and Drug Administration (FDA) has accepted our request for a pre-IND meeting on EW-001, our lead CAR-T cell therapy for advanced mesothelioma and other mesothelin-expressing cancers. It will be AdAlta’s first significant engagement with the world’s most experienced regulator of cell therapies, and a key milestone for the second half of calendar 2026. The meeting will be held on 3 November 2026

A pre-IND meeting is a formal opportunity to put our development plan in front of FDA reviewers and get their feedback before we commit to the most expensive parts of that plan. It is not something a company can simply ask for: the FDA first requires a detailed briefing document setting out what the product is, how it is made and tested, what is already known about its safety and effectiveness, and exactly what we plan to do next.

Being in a position to prepare that document and support the positions advocated for is the real achievement here, and it took three separate bodies of work coming together: the transfer and review of hundreds of documents from our co-development partner Shanghai Cell Therapy Group (SHcell); a draft Phase 1 clinical trial protocol developed with our clinical advisory board, drawn from Australia’s leading CAR-T and mesothelioma treatment centres; and manufacturing technology transfer and process optimisation work with our contract manufacturer, Cell Therapies Pty Ltd.

FDA feedback will provide important input into manufacturing technology transfer and optimisation, the remaining IND-enabling non-clinical studies, and Phase 1 clinical trial design. Aligning with FDA expectations now, rather than after a formal submission, reduces the risk of delays and additional product development work later, helps ensure our protocol design meets current safety and efficiency expectations, and supports EW-001’s attractiveness to future partners.