AdAlta Advances CAR-T Therapy with East-to-West Strategy and Australian Manufacturing Transfer

Breakthrough Responses in Mesothelioma with BZDS1901

AdAlta Limited (ASX:1AD) has unveiled early clinical results for its lead CAR-T therapy candidate, BZDS1901, that are turning heads in the notoriously difficult-to-treat mesothelioma space. The therapy, developed in collaboration with Shanghai Cell Therapy Group Co Ltd (SHcell), has demonstrated multiple tumour responses, including two rare complete tumour clearances in advanced, treatment-resistant patients. Remarkably, one patient remains tumour-free 22 months post-treatment, a significant milestone given the dismal 8–10 month median survival typical in this disease.

These outcomes suggest BZDS1901 may outperform existing second-line treatments, which typically achieve tumour shrinkage in only 11–29% of patients and rarely complete responses. The therapy’s 50% overall response rate and 20% complete response rate in early Chinese trials position it as a potential game-changer in a market forecast to reach US$12.2 billion by 2034. AdAlta stands to receive 60% of any commercial proceeds following Phase 1 completion, highlighting the program’s strategic value.

Strategic Manufacturing Shift to Australia

Manufacturing is the linchpin for CAR-T therapies, which require patient-specific cell engineering. AdAlta has signed its first Work Order with Cell Therapies Pty Ltd (CTPL) to transfer BZDS1901 manufacturing from China to Australia, a move critical to supporting upcoming Australian clinical trials and ensuring regulatory compliance for Western markets. This transfer not only reduces supply chain risks but also enhances the therapy’s appeal to global pharmaceutical partners.

Further strengthening this effort, AdAlta has entered a Memorandum of Understanding with CTPL and Oribiotech to deploy Oribiotech’s IRO automated manufacturing platform across Australia and Asia Pacific. The IRO system promises 10–50 times higher throughput, 30–50% cost reductions, and faster manufacturing cycles, potentially transforming production scalability for BZDS1901 and other cell therapies. This initiative aligns with AdAlta’s ambition to build a next-generation cell therapy platform capable of meeting global demand efficiently.

The importance of this manufacturing shift is underscored by the fact that BZDS1901’s current process already boasts a short two-day manufacturing cycle, significantly faster than the typical nine days for many CAR-T products. The Australian manufacturing transfer and automation partnership are therefore expected to further reduce costs and timelines, enhancing the therapy’s commercial prospects. This development follows AdAlta’s recent Australian manufacturing transfer signed and the MoU with Oribiotech and CTPL to deploy automated platforms.

Capital Raise and Financial Position

To fuel these ambitions, AdAlta raised $1.2 million through a private placement at $0.005 per share, issuing 240 million shares along with attaching options exercisable at $0.01. The funds are earmarked to accelerate the East-to-West strategy, advance transaction opportunities, bolster intellectual property, and maintain working capital. The company also received a $0.15 million R&D tax incentive refund during the quarter.

Despite these inflows, operating cash outflows were $1.93 million for the quarter, inclusive of a $1.46 million payment to SHcell. The cash balance stood at $0.83 million as of 31 March 2026, down from $1.58 million the previous quarter. Operating costs were tightly managed, with a reduction in underlying cash operating expenses excluding the SHcell payment. AdAlta is actively pursuing further capital raising options and financing facilities to extend its runway, acknowledging that without the SHcell payment and discretionary board fees, available funding would cover approximately 2.8 quarters.

Board Changes and Pipeline Progress

Governance updates included the appointment of Fadi Diab as a Non-executive Director in March 2026, while Dr David Fuller retired post period-end in April. Beyond BZDS1901, AdAlta is seeking partners for its i-body® fibrosis asset AD-214, with growing interest in kidney fibrosis, and progressing its anti-malarial program WD-34 through grants and potential spinout structures.

AdAlta’s CEO Tim Oldham emphasised the company’s focus on translating Asian cell therapy innovations for Western markets, leveraging Australian manufacturing and clinical expertise to unlock value. The early clinical data and manufacturing advances position AdAlta at an intriguing inflection point in the CAR-T therapy landscape.