RDTI receipt, Advanced Overseas Finding
Released
Released
Announcement PDF
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AdAlta Limited (ASX:1AD) · ABN: 92 120 332 925 · www.adalta.com.au
Suite 1.01, 117 Camberwell Road, Hawthorn East VIC 3123, Australia
ASX Announcement | 19 October 2026
AdAlta Limited (ASX:1AD)
AdAlta secures Advance Overseas Finding for EW-001 and
receives first FY26 R&D Tax Incentive instalment
Finding expected to add more than A$1 million to AdAlta’s FY26 R&D refund
by recognising key EW-001 work conducted overseas
Investment highlights
• AdAlta has received an Advance Overseas Finding confirming that key overseas EW-001 work is
eligible for the Australian Government’s R&D Tax Incentive (“RDTI”).
• The finding covers EW-001 IND-enabling studies, investigator-initiated clinical trials in China and the
purchase of raw materials needed to manufacture EW-001.
• As a result of this positive finding, AdAlta anticipates an additional FY26 RDTI refund in excess of
A$1 million.
• AdAlta has already received a first FY26 RDTI instalment of A$0.23 million for the financial year
ended 30 June 2026.
• The finding confirms that China-based work central to AdAlta’s “East to West” strategy can attract
Australian R&D support, lowering the net cost of developing EW-001.
Melbourne, Australia: AdAlta Limited (ASX:1AD) (“AdAlta” or “the Company”), developer of next
generation cellular immunotherapies for solid cancers, today announced that it has received an Advance
Overseas Finding in respect of research and development (“R&D”) activities conducted overseas for EW-001
(formerly BZDS1901), its lead CAR-T cell therapy for advanced mesothelioma and other mesothelin-
expressing cancers. As a result of this positive finding, AdAlta anticipates an additional Research and
Development Tax Incentive (“RDTI”) refund in excess of A$1 million in respect of the financial year ended 30
June 2026 (“FY26”). This is in addition to the first FY26 RDTI refund instalment of A$0.23 million, which AdAlta
has now received.
The RDTI is the Australian Government’s main program for encouraging companies to invest in R&D. For
smaller companies like AdAlta, it works as a cash refund of a significant share of what they spend on eligible
R&D. As a general rule, only R&D carried out in Australia qualifies. An Advance Overseas Finding is a formal
decision by the Government that specific R&D activities carried out overseas can also be claimed, because
they are closely linked to the company’s R&D in Australia and could not be carried out here. AdAlta’s finding
covers three areas of EW-001 work: the laboratory and safety studies the US Food and Drug Administration
(“FDA”) expects to see before it allows clinical trials under an Investigational New Drug (“IND”) application
(“IND-enabling studies”); the investigator-initiated clinical trials of EW-001 run by doctors in China; and raw
materials purchased to manufacture EW-001.
AdAlta CEO and Managing Director, Dr Tim Oldham said:
“Our East to West strategy brings together the speed and cost advantages of cell therapy innovation in
China with Australia’s world-class clinical and manufacturing capabilities. This finding recognises that certain
work being done on EW-001 in China that cannot be performed in Australia is an integral part of an
Australian R&D program. It means every dollar we invest in bringing EW-001 to patients goes further.”
Next steps and strategic significance
AdAlta will now complete the steps required to claim the additional FY26 refund. Meanwhile, EW-001 continues
to advance, with AdAlta’s pre-IND meeting with the US FDA scheduled for 4 November 2026 (AEST) and
transfer of EW-001 manufacturing to Cell Therapies Pty Ltd in Melbourne proceeding.
For shareholders, the finding matters for two reasons. First, it returns a meaningful share of what AdAlta has
already invested in EW-001. Second, it confirms that the East to West model works the way it was designed:
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products and early clinical data come from leading cell therapy innovators in China, while Australia provides
the platform for FDA-standard manufacturing and clinical development – and Australian R&D support can
extend across both. That lowers the net cost of developing EW-001 and could similarly benefit future products
AdAlta brings into its East to West pipeline, subject to the same eligibility tests.
To view a summary, and engage in discussion about this announcement visit AdAlta’s InvestorHub here:
https://investorhub.adalta.com.au/link/rDv9oy
This ASX announcement has been authorised for release by the Board of AdAlta Limited (ASX:1AD).
For further information, please contact:
AdAlta Limited (ASX:1AD)
Tim Oldham
CEO & Managing Director
P: +61 403 446 665
E: ir@adalta.com.au
About EW-001 (formerly BZDS1901)
EW-001 is a novel, first in class, CAR-T cell therapy designed to treat mesothelioma (a rare but rapidly fatal
cancer usually linked to asbestos exposure) and with possible application in more than ten other cancers.
CAR-T cell therapies are living drugs manufactured from a patient’s own immune cells that are engineered to
be able to find and kill cancer. They offer the potential to provide durable cancer control or cure from a single
treatment. EW-001 targets a protein called mesothelin that is highly expressed in many cancers. EW-001 is
also engineered to produce a protein called a checkpoint inhibitor that is designed to protect the CAR-T cell
from a key defensive mechanism used by cancers.
Patients diagnosed with mesothelioma today are typically treated with surgery if possible and then initial or
first line drug treatments are chemotherapy or immunotherapy. Once a patient has relapsed after initial
therapy, second line treatment options are even more limited and outcomes are much poorer. Current
treatments typically deliver: 1,2
• Tumour shrinkage (Overall Response) in only 40-44% of first line patients and 11-29% of second
and subsequent line patients
• Complete tumour clearance (Complete Response) is rare and seen in less than 3% of first line
patients and almost never in second line patients
• Median survival (at which point 50% of patients will have died) is often only 14-18 months for first
line and 8-10 months for second line treatment, with tumours beginning to grow again typically after
only half that time.
By contrast, EW-001 clinical studies in relapsed or advanced mesothelioma patients (second line and later)
in China have reported:
• Up to 50% Overall Response rate (tumour shrinkage)
• Up to 20% Complete Response rate (complete tumour clearance)
• Two patients achieving Complete Responses have now reached two and one year survival
milestones respectively with no evidence of cancer returning providing evidence of durability of
response
• Median overall survival has not yet been reached in the current generation manufacturing process,
however an earlier generation of EW-001 achieved more than 25 months median survival
These early results suggest EW-001 may offer an exciting potential new treatment option for patients with
few alternatives. EW-001 has not yet received regulatory approval for general commercial launch anywhere
in the world.
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CHECKMATE-743 study (nivolumab + ipilimumab against chemotherapy): S Peters et al, Annals of Oncology, 2022 (33) 488;
https://doi.org/10.1016/j.annonc.2022.01.074
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See for example CONFIRM study (nivolumab against placebo): DA Fennell et al, Lancet Oncol 2021 (22) 1530
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About AdAlta
AdAlta (ASX: 1AD) is a clinical stage biotechnology business addressing the need for effective cellular
immunotherapies for the treatment of solid cancers.
Through its ‘East to West’ strategy, the Company is integrating Asia's prowess in T cell therapy development
with the efficiency and quality of Australia's clinical and manufacturing ecosystem to create a pathway
connecting ‘Eastern’ innovation in cellular immunotherapies with ‘Western’ regulated markets and patients.
AdAlta in-licenses products from Asian originators and invests to establish US FDA regulated manufacturing
and conduct Phase I clinical studies with potential to position each product for on-licensing to larger
biopharmaceutical companies for potential registrational studies and commercialisation.
AdAlta implements a disciplined approach to asset selection focused on highly differentiated T cell therapy
products supported by clinical data in solid cancers. The company adopts a capital efficient business model
delivering a rapid return on investment in each project that is replicable and provides opportunities to scale
across multiple products.
Solid tumours account for 90% of cancers yet remain underserved by current cellular immunotherapies.
AdAlta aims to dominate this high-growth segment. The cellular immunotherapy market is projected to grow
at a compound annual growth rate of 34% to reach US$20.3 billion by 2028.
AdAlta’s other assets include first in class fusion protein, AD-214, that takes a whole new approach to fibrotic
diseases of the lung and kidney, such as the degenerative and fatal Idiopathic Pulmonary Fibrosis and
WD-34, a novel pan-strain inhibitor of malaria, Babesia and Toxoplasma parasites. Following demonstration
of efficacy in multiple animal models of disease and two successful Phase I clinical studies, AD-214 is
available for partnering. WD-34 is seeking grant funding to optimise the molecule format to enable single
dose seasonal prophylaxis.
To learn more, please visit: www.adalta.com.au
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