Atara Biotherapeutics reported a net loss of $93.3 million for Q4 2021, with cash, cash equivalents, and short-term investments totaling $371.1 million as of December 31, 2021. The company is progressing its pipeline, including tab-cel and ATA188, but faces regulatory challenges with the FDA regarding tab-cel's BLA submission in the U.S.
Atara's EMA filing for tab-cel is progressing as planned, with anticipated EU approval in Q4 2022 under Accelerated Assessment.
ATA188 was granted FDA Fast Track designation in both non-active PPMS and non-active SPMS, with Phase 2 EMBOLD study interim analysis planned for Q2 2022.
Atara entered a long-term strategic manufacturing partnership with Fujifilm, receiving an upfront cash payment of USD 100 million.
Further engagement and alignment are required with the FDA to determine the path forward for a BLA submission in the U.S. for tab-cel.
Atara believes that its cash as of December 31, 2021, together with the anticipated $100.0 million payable to Atara upon closing of the strategic transaction with FDB, will be sufficient to fund the Company’s planned operations into the fourth quarter of 2023
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