AdCella milestones and regulatory progress

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Stock Adalta Ltd (1AD.ASX)
Release Time 21 Jan 2026, 8:51 a.m.
Price Sensitive Yes
 AdCella milestones and regulatory progress
Key Points
  • New US FDA requirements support AdCella's manufacturing scalability and automation strategy
  • AdCella has made a first payment of US$0.5 million (A$0.75 million) due to Shanghai Cell Therapy Group ('SHcell')
  • AdAlta Group receives additional $0.15 million Research and Development Tax Incentive refund
Full Summary

AdAlta Limited (ASX:1AD), developer of next generation cell and protein therapeutic products, believes that new US Food and Drug Administration ('FDA') requirements for manufacturing of cell and gene therapy products aligns with, and further enables, AdCella's 'East to West' cellular immunotherapy strategy. AdCella has now made the first milestone payment due under the recently executed development collaboration agreement for BZDS1901 with Shanghai Cell therapy Group ('SHcell') and the group has now received an additional $0.15 million Research and Development Tax Incentive ('RDTI') refund in respect of BZDS1901. The new FDA guidance on manufacturing requirements for cell and gene therapies is expected to provide greater flexibility to introduce continuous process improvement over time and reduce the cost and time to transition from Phase 1 to Phase 2 studies, enhancing the commercial viability and partnerability of AdCella's pipeline. AdAlta's CEO, Dr Tim Oldham, stated that demonstrating scalability and portability of cellular immunotherapy manufacturing processes is critical to support commercial viability and requires continuous adoption of new technologies. The first milestone payment of US$0.5 million (~A$0.75 million) to SHcell was made using funds invested by AdAlta Ltd, and the additional $0.15 million RDTI refund was paid following a favourable Advance Overseas Finding in respect of certain offshore research expenses for CAR-T cell therapy products in the Company's 'East to West' cellular immunotherapy pipeline.