AdAlta Ltd Achieves BZDS1901 Milestone, Secures Clinical Data and Materials
Key points
- AdAlta paid $1M milestone to Shanghai Cell Therapy Group for BZDS1901 CAR-T therapy
- Payment provides access to additional clinical data and secures manufacturing materials
- AdAlta is preparing for FDA engagement and anticipates first Australian manufacturing runs
Full summary
AdAlta Limited (ASX:1AD) has made a US$1 million milestone payment to Shanghai Cell Therapy Group Co Ltd in respect of five additional advanced mesothelioma patients treated with BZDS1901 CAR-T cell therapy in China. The payment was funded in part from the Company's recent A$2.5 million placement. With this payment, AdAlta has fully complied with its initial financing obligations under the Development and Collaboration Agreement, securing its rights to continue developing BZDS1901 for markets outside Greater China. This milestone payment provides AdAlta with access to additional clinical results from investigator-initiated trials of BZDS1901 in China, including detailed safety data tables required for US FDA regulatory submissions, and detailed manufacturing results that will support technology transfer. The payment also secures supply of critical proprietary materials essential to manufacturing BZDS1901. Technology transfer of BZDS1901 manufacturing continues, with first Australian manufacturing runs expected in the second half of calendar 2026. AdAlta is also preparing for a pre-IND meeting with the US FDA, anticipated in the second half of calendar 2026.
Guidance
First Australian manufacturing runs expected in the second half of 2026
Outlook
AdAlta is preparing for FDA engagement and anticipates first Australian manufacturing runs in the second half of 2026.
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