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Mar 31, 2021
Atara Q1 2021 Earnings Report
Atara reported financial results for the first quarter of 2021 and provided recent business highlights.
Key Takeaways
Atara Biotherapeutics reported a net loss of $78.3 million, or $0.86 per share, for the first quarter of 2021. The company's cash, cash equivalents, and short-term investments totaled $435.2 million as of March 31, 2021. License and collaboration revenue was $3.6 million for the quarter, stemming from the Bayer Collaboration Agreements.
Atara is progressing toward alignment with the FDA on the content of CMC Module 3 for tab-cel®.
BLA submission for tab-cel® is expected in Q3 2021, and MAA submission in EU is expected in Q4 2021.
Enrollment is progressing in the ATA188 Phase 2 trial for progressive forms of MS, with an interim analysis planned for H1 2022.
The global strategic collaboration with Bayer, including ATA2271 and ATA3271, is progressing well with successful launch of joint governance and activities.
Atara
Atara
Forward Guidance
Atara believes that its cash as of March 31, 2021 together with projected revenue from U.S. tab-cel® sales is sufficient to fund its operations into 2023.
Positive Outlook
- Completing a BLA submission in Q3 2021 pending alignment with the FDA.
- Submitting an EU Marketing Authorization Application (MAA) for tab-cel® in patients with EBV+ PTLD expected in Q4 2021.
- Presenting data from the Phase 3 ALLELE study at an appropriate congress in Q4 2021.
- Presenting long-term two-year clinical data from the Phase 1 open-label extension (OLE) and translational data from the Phase 1 study in H2 2021.
- Submitting an IND for ATA3219 in Q4 2021 / Q1 2022.
Challenges Ahead
- The costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success
- The ongoing COVID-19 pandemic, which may significantly impact Atara's business, research, clinical development plans and operations
- COVID-19 may impact Atara's ability to access capital
- COVID-19 may impact the value of Atara's common stock
- The sufficiency of Atara’s cash resources and need for additional capital