Key Highlights

  • AdAlta received an Advance Overseas Finding confirming that key overseas EW-001 work is eligible for the R&D Tax Incentive.
  • The finding covers IND-enabling studies, investigator-initiated clinical trials in China and the purchase of raw materials for manufacturing EW-001.
  • AdAlta anticipates an additional FY26 refund in excess of A$1 million, on top of a first instalment of A$0.23 million already received.
  • A pre-IND meeting with the US FDA is scheduled for 4 November 2026 (AEST).

AdAlta Limited (ASX:1AD), a developer of cellular immunotherapies for solid cancers, announced on 19 October 2026 that it has received an Advance Overseas Finding for research and development carried out overseas on EW-001, formerly BZDS1901. The company also received the first instalment of its FY26 R&D Tax Incentive (RDTI) refund.

What the finding covers

The RDTI is the Australian Government’s main program for encouraging R&D investment, working as a cash refund of a share of eligible R&D spending for smaller companies. As a general rule only R&D carried out in Australia qualifies. An Advance Overseas Finding is a formal decision that specific overseas activities can also be claimed because they are closely linked to a company’s Australian R&D and could not be carried out in Australia.

AdAlta’s finding covers three areas of EW-001 work: the IND-enabling laboratory and safety studies that the US Food and Drug Administration expects before clinical trials under an Investigational New Drug application, investigator-initiated clinical trials of EW-001 run by doctors in China, and raw materials purchased to manufacture EW-001.

Expected refund

AdAlta anticipates an additional RDTI refund in excess of A$1 million for the financial year ended 30 June 2026. This is in addition to the first FY26 instalment of A$0.23 million, which has been received. The company said it will now complete the steps required to claim the additional refund. It described the finding as confirming that China-based work central to its East to West strategy can attract Australian R&D support, which lowers the net cost of developing EW-001.

EW-001 development steps

EW-001 continues to advance. AdAlta’s pre-IND meeting with the US FDA is scheduled for 4 November 2026 (AEST), and the transfer of EW-001 manufacturing to Cell Therapies Pty Ltd in Melbourne is proceeding. The company said the East to West model brings products and early clinical data from cell therapy innovators in China together with Australia’s platform for FDA-standard manufacturing and clinical development, and that future products it brings into the pipeline could benefit from the same support, subject to the same eligibility tests.

About EW-001

EW-001 is described as a novel, first-in-class CAR-T cell therapy for mesothelioma, a rare and rapidly fatal cancer usually linked to asbestos exposure, with possible application in more than ten other cancers. CAR-T therapies are manufactured from a patient’s own immune cells, which are engineered to find and kill cancer. EW-001 targets mesothelin, a protein highly expressed in many cancers, and is also engineered to produce a checkpoint inhibitor protein designed to protect the CAR-T cell from a defensive mechanism used by cancers.

Company details

The announcement was authorised for release by the Board of AdAlta Limited. The company is based in Hawthorn East, Victoria, and described the announcement as part of an update available through its InvestorHub.