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Jun 30, 2021
Atara Q2 2021 Earnings Report
Atara reported second quarter 2021 financial results and operational progress.
Key Takeaways
Atara Biotherapeutics reported a net loss of $83.8 million, or $0.91 per share, for the second quarter of 2021. The company's cash, cash equivalents, and short-term investments totaled $373.4 million as of June 30, 2021. License and collaboration revenue was $3.9 million for the second quarter 2021.
Progress with FDA on evaluating tab-cel® product comparability and new robust Phase 3 ALLELE study data
Recent positive milestones with EMA provide clear path for EU Marketing Authorization Application submission in November 2021
Important new ATA188 magnetization transfer ratio (MTR) imaging biomarker data and updated clinical data to be presented at ECTRIMS in October
Atara believes that its cash as of June 30, 2021 is sufficient to fund planned operations into 2023
Atara
Atara
Forward Guidance
Atara anticipates approvals in 2022.
Positive Outlook
- Alignment on key methodologies for evaluating comparability between Atara product used in the pivotal ALLELE study and the intended commercial product.
- Atara will provide data on substantially all lots made to date through a Type B CMC meeting to enable FDA to make a final determination on the data package to support comparability
- Top-line data with additional patients confirm a strong objective response rate (ORR) in line with prior results while demonstrating durability. There were no new safety signals, consistent with previously published findings
- Atara expects to complete the BLA submission for tab-cel® in Q1 2022.
- Atara is adapting investment in U.S. commercial readiness toward anticipated approval in H2 2022
Challenges Ahead
- FDA decided it cannot make a determination of comparability between material used in non-pivotal and pivotal studies because analytical data is not available and cannot be generated for all lots manufactured at Memorial Sloan Kettering Cancer Center (MSK) and used in non-pivotal studies.
- Consequently, Atara plans to submit clinical data from the pivotal ALLELE study and the non-pivotal studies as separate, non-pooled analyses in the anticipated BLA submission
- Atara is making progress on enrolling the ATA188 Phase 2 randomized, double-blind, placebo-controlled trial (EMBOLD study) evaluating the efficacy and safety of ATA188 in patients with PMS
- Planned interim analysis in H1 2022 to assess efficacy and safety
- Based on current target, Atara expects to complete enrollment in H1 2022