Atara Biotherapeutics, Inc.
Atara Biotherapeutics, Inc. Q1 FY2022 earnings call
May 5, 2022 · fiscal period ended 2022-03
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2022-05-05
Management highlights
- ATA188: Progress with 2 landmark publications, EBV and MS Day, updated Phase I data; on track for Phase II EMBOLD interim analysis in June, plan to communicate IA decisions and rationale in July, discuss with FDA and partnering.
- tab-cel: On track for EU EC approval in Q4 2022, EMA requested additional time but still expect Q4 approval, pre-approval inspections confirmed, comparability data submitted to EMA.
- CAR T programs: ATA2271 had a fatal adverse event but Atara believes not caused by the product, ATA3271 IND filing in Q4, ATA3219 on track to submit IND in Q4 with unique features.
- Operational updates: Hired Chief Technical Officer, sold manufacturing facility to FUJIFILM Diosynth Biotechnologies, cash position $302M as of Q1 2022.
Segment performance
ATA188: Made progress with 2 landmark publications in Nature and Science, conducted EBV and MS Day with updated Phase I data showing majority of patients had EDSS improvement/stability; on track for Phase II EMBOLD interim analysis in June. tab-cel: On track for EU EC approval in Q4 2022, EMA requested additional time but still expect Q4 approval, pre-approval inspections confirmed, comparability data submitted to EMA. CAR T programs: ATA2271 had a fatal adverse event but Atara believes not caused by the product, ATA3271 IND filing in Q4, ATA3219 on track to submit IND in Q4 with unique features. Operational updates: Hired Chief Technical Officer, sold manufacturing facility to FUJIFILM Diosynth Biotechnologies, cash position $302M as of Q1 2022.
Guidance
- ATA188: On track for Phase II EMBOLD interim analysis in June, plan to communicate IA decisions and rationale in July, discuss with FDA and partnering.
- tab-cel: Expect EC approval in Q4 2022, ongoing dialogue with FDA for BLA filing without new Phase III study.
- CAR T programs: ATA3271 IND filing in Q4, ATA3219 IND submission in Q4.
Risks
- ATA188: Uncertainty around IA results and sample size adjustments.
- tab-cel: Uncertainty in FDA BLA review process, potential need for additional studies.
- ATA2271: Pause in enrollment due to fatal adverse event, pending final assessment.
Q&A highlights
Q: Salim Syed asked about ATA188 IA interpretation and if it would be an interpretable readout, A: Pascal Touchon Q: Tessa Romero asked about tab-cel EU approval and ATA188 activities, A: Jakob Dupont and AJ Joshi Q: John Newman asked if clear separation between ATA188 and placebo at interim could be disclosed in Q3 and about 12-month data, A: Pascal Touchon Q: Marc Frahm asked about EMA comparability and tab-cel commercial lots, A: Pascal Touchon Q: Neil Carnahan asked about ATA2271 patient death cause, A: Jakob Dupont Q: Jonathan Miller asked about ATA188 IA stats and tab-cel FDA dialogue, A: AJ Joshi and Jakob Dupont Q: Matt Sykes asked about tab-cel multi-cohort data and ATA2271 Phase I update, A: Jakob Dupont Q: Yigal Nochomovitz asked about ATA188 IA scenarios, A: Pascal Touchon and AJ Joshi Q: Tony Butler asked about communication to clinical sites for ATA188, A: AJ Joshi
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
|---|---|---|---|---|
| EPS | $-21.75 | $-24.50 | +11.2% | — |
| Revenue | $7.3M | $5.8M | +26.4% | — |
Transcript
May 5, 2022Full transcript unavailable for redistribution
The structured summary above covers the available call sections. Full transcript text is not included on this page.
Continue exploring
Prior quarters
This page presents the stored structured earnings-call summary and deterministic earnings calendar values. How this is generated. For informational purposes only; not investment advice.