Successful Commercial Launch of AUCATZYL
The commercial launch of AUCATZYL in the U.S. is progressing well, with 33 centers authorized as of March 19, covering approximately 60% of the target patient population. The company expects to have 60 centers by year-end, potentially covering the majority of U.S. patients.
U.S. Approval and Positive Label for obe-cel
Obe-cel was approved in the U.S. on November 8, slightly ahead of schedule, with a favorable label for relapsed refractory ALL in adult patients and without a REMS program, indicating a strong foundation for commercial use.
Strong Financial Position
Added $600 million to the balance sheet through collaboration with BioNTech and public financing, resulting in a cash position of $588 million at year-end 2024, compared to $239 million at the end of 2023.
Positive Clinical Data
Published clinical results in the New England Journal of Medicine, showing high clinical activity and an attractive safety profile of obe-cel, with low levels of high-grade CRS and ICANS.
Strategic Milestone Payments
Received $30 million milestone payment from Blackstone following FDA approval, demonstrating financial support and collaboration success.