AdAlta (ASX:1AD) has raised $2.5 million from sophisticated investors to accelerate development of its lead CAR T therapy, BZDS1901, and to progress manufacturing and regulatory milestones in Australia and the United States.
The placement, announced on 4 May 2026, will fund pre-IND engagement with the US Food and Drug Administration and support the first technology transfer work order with Cell Therapies to establish local manufacturing reliability and scalability.
The company said clinical data from studies in China have shown multiple tumour responses in heavily pretreated advanced mesothelioma patients, including two complete tumour clearances and one patient remaining alive 22 months after treatment with no reported recurrence.
AdAlta said the proceeds will enable two critical next steps before trials in Australia. The first is formal engagement with regulators to obtain pre-IND guidance and to evaluate expedited pathways, and the second is the transfer of manufacturing to Australia.
The company frames its strategy around an 'East to West' platform that licenses Asian innovation and bridges it to other regulatory and manufacturing ecosystems. The company argues that this model is increasingly valuable amid changing US policy on the acceptability of clinical data generated in certain countries.
The placement will issue approximately 625 million new shares at $0.004 each, together with attaching options exercisable at $0.01, subject in part to shareholder approval at an Extraordinary General Meeting anticipated in early June.
CEO and Managing Director Tim Oldham highlighted the clinical promise and the manufacturing step in a quoted statement saying, "Clinical results showing multiple patients responding to BZDS1901, including difficult to achieve complete tumour clearance in some patients and one patient still alive 22 months after treatment with no reported tumour recurrence, continue to support the extraordinary potential of this product to offer new hope to advanced mesothelioma patients. With the signing of our first technology transfer Work Order with Cell Therapies, we are poised to address the second heavily scrutinised element of CAR T cell therapy manufacturing reliability and scalability. This financing enables us to advance BZDS1901 through value-enhancing manufacturing and regulatory milestones. We are grateful to our leading shareholders for their continued support."