AdCella and SHcell hold first JDC meeting

• Potential to accelerate manufacturing transfer to Australia by up to six months
• Two stage US FDA engagement strategy before clinical trial application
• Updated clinical results from China Investigator Initiated Trials pending

AdAlta Limited (ASX:1AD), developer of next generation cell and protein therapeutic products, advises that its subsidiary, AdCella Pty Ltd ('AdCella') has completed the inaugural Joint Development Committee ('JDC') meeting with Shanghai Cell Therapy Group Co Ltd ('SHcell') for its first-in-class CAR-T therapy, BZDS1901. BZDS1901 will initially be tested as a treatment for advanced mesothelioma patients (relapsed after first treatment) for whom there are limited clinical options today. The meeting marks the transition of the collaboration from planning into joint execution and identified opportunities to accelerate development timelines and reduce regulatory risk. Key outcomes from the JDC meeting include: manufacturing technology transfer to Australia may be accelerated by up to six months, bringing forward a key development milestone and reducing clinical timeline risk; earlier Australian manufacturing enables more effective regulatory engagement; US FDA engagement now planned across two meetings before clinical trial ('IND') application to improve certainty and reduce regulatory risk; SHcell's new plasmid manufacturing facility is in advanced construction, supporting supply of critical starting materials for Australian clinical trials; China Investigator Initiated Trial ('IIT') extension Cohort 1 dosing completed (five mesothelioma patients) with updated results to be announced when available; and clinical trial strategy improvement opportunities have been identified for both the extension Cohort 2 of the China IIT study, and the planned Phase 1 clinical trial in Australia. The flexibility of the collaboration agreement to accommodate manufacturing and regulatory changes and AdCella's current resourcing schedule was also confirmed.