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Quarterly Appendix 4C and Activities Report
EW-001, our armoured CAR-T product for mesothelioma and other solid cancers is on the threshold of its first US FDA advice and first Australian manufacturing runs, headlining the September 2026 Quarter.
Quarter highlights
· US FDA pre-IND meeting granted for EW-001, scheduled for 4 November 2026 (AEST) representing the program’s first formal US regulatory advice.
· First Australian manufacturing runs of EW-001 on track for the second half of 2026.
· EW-001 evidence keeps building: first complete responder passed two years without cancer recurrence, and EW-001 was approved for special access in China’s Hainan province.
· Manufacturing automation strategy validated by Oribiotech’s 10-year, up to US$120 million commercial agreement for the IRO® platform AdAlta has chosen for future products.
· Shanghai representative office opened, giving AdAlta the ability to engage local staff and contractors to represent and promote the Company in China.
· Non-dilutive funding: A$0.23 million R&D Tax Incentive refund received, with further inflows of more than A$1 million expected in the December quarter.
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