Atara Biotherapeutics, Inc.
Atara Biotherapeutics, Inc. Q2 FY2022 earnings call
August 8, 2022 · fiscal period ended 2022-06
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2022-08-08
Management highlights
- The company announced a 20% staff reduction and a over 20% reduction in annual cash burn to focus on R&D. 2. Prioritized R&D activities on three core priorities: clinical development of ATA188 for progressive multiple sclerosis, EU and potential U.S. regulatory filings for tab-cel and seeking a commercial partner, and Q4 2022 IND filing for ATA3219. 3. Completed interim analysis of ATA188 Phase 2 EMBOLD study with no sample size adjustment, expecting data readout in October 2023. 4. Tab-cel made progress with FDA recommending path to BLA submission without new trial, CMS assigning to DRG-18, passed EU pre-approval inspection, and anticipates European Commission approval in Q4 2022. 5. Terminated Bayer collaboration for mesothelin-directed CAR T therapies, paused ATA3271 IND, and advancing ATA3219 with plan to submit IND in Q4 2022. 6. Partnerships with FUJIFILM Diosynth Biotechnologies and Pierre Fabre are ongoing.
Segment performance
For the second quarter of 2022, Atara reported license and collaboration revenue of $51.6 million, primarily from deferred revenue recognition due to the termination of the Bayer collaboration agreements. A net gain of $18.9 million was also reported, including a gain on the sale of the ATOM facility of $50.2 million. The company ended the second quarter with approximately $331 million in cash. It is expected that the actions taken to reduce cash burn will extend the cash runway into Q1 of 2024.
Guidance
- Cash runway extended to Q1 2024 due to cash burn reduction. 2. Expect to communicate final data readout of ATA188 Phase 2 study in October 2023. 3. Tab-cel has potential BLA submission path without new trial, seeking commercial partner in U.S. 4. Anticipate Q4 2022 IND filing for ATA3219. 5. European Commission approval for tab-cel expected in Q4 2022.
Risks
- Uncertainties around regulatory approvals for tab-cel and ATA188. 2. Clinical trial outcomes may not meet expectations. 3. Challenges in partnering negotiations for tab-cel.
Q&A highlights
Q: Could you confirm if the executive team saw the IA data for ATA188 and if it factored into the decision to continue the study?
A: Following the IDSMC recommendation and having seen the top line data, the decision to continue the study was based on that and the IDSMC recommendation.
Q: On tab-cel, what's the scenario for BLA submission path?
A: Constructive discussions with FDA recommend path to BLA without new trial, with planned interactions to align on BLA content.
Q: About ATA3219 clinical design, what patient population?
A: Focus on medical needs like durability of clinical response in lymphoma and patients relapsing after previous CD19 therapy.
Key numbers
Reported versus consensus
Earnings calendar feed
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Transcript
August 8, 2022Full transcript unavailable for redistribution
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