Quarterly Appendix 4C and Activities Report
Summary
June Quarter 2026 highlights
• Initial investment in EW-001 completed: a further US$1 million (A$1.39 million) milestone payment to Shanghai Cell Therapy Group (“SHcell”) secured AdAlta’s rights to continue development of EW-001 (formerly BZDS1901) CAR-T therapy for markets outside Greater China.
• Milestone unlocked additional clinical data and secured the proprietary materials needed to manufacture EW-001 in Australia
• Technology transfer to Cell Therapies continues, with first Australian manufacturing runs expected in the second half of calendar 2026.
• Preparing for a pre-IND meeting with the US FDA, anticipated in the second half of calendar 2026.
• Strong external validation: the world’s first approval of a solid-tumour CAR-T therapy (in China) confirmed the potential of CAR-T in solid cancers and of AdAlta’s “East to West” strategy.
• A$2.5 million placement completed to fund the milestone payment and operations.
• Stepping up AI capability through a strategic collaboration with Oktopi, complementing AdAlta’s in-house Claude-based screening agent (“EMU”) to sharpen asset selection and development decisions (post period end).
Commenting on the quarter, AdAlta CEO and Managing Director, Dr Tim Oldham said:
“This was a quarter of disciplined execution. By completing our initial financial commitment to EW-001 we have secured our rights to a genuinely exciting CAR-T therapy for patients with few options, unlocked valuable new clinical data, and locked in the materials we need to make EW-001 here in Australia. We are now firmly focused on the milestones that most influence near term value – building Australian manufacturing and engaging with the US FDA. The first ever approval of a solid-tumour CAR-T therapy during the quarter is powerful proof that the science behind our strategy works, and the recognition of our model by peers and the addition of new AI tools give us real momentum as we look to add further assets.”
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