Atara Biotherapeutics, Inc. Q3 FY2021 earnings call

Tab-cel

• Positive top-line data from pivotal Phase 3 ALLELE study in EBV positive PTLD with 50% objective response rate, clear durability, and 89% one-year survival in responders; imminent EU MAA submission and plan for US BLA submission in 2022; commercialization agreement with Pierre Fabre for Europe, Middle East, Africa, etc.

ATA188

• Phase 1 open label extension data in progressive MS shows sustained disability improvement and MTR data suggesting remyelination may drive clinical improvement; interim analysis in H1 2022 to assess efficacy, safety, and biomarkers.

CAR-T Portfolio

• ATA2271 and ATA3271 with Bayer progressing; ATA3219 to submit IND in Q1 2022; new Atara Research Center opened to support product pipeline.

No detailed financial performance with revenue contribution % provided. Focus is on product segments: Tab-cel had positive top-line data from pivotal Phase 3 ALLELE study in EBV positive PTLD; ATA188 showed sustained disability improvement and MTR data in progressive MS; CAR-T portfolio includes ATA2271, ATA3271, and ATA3219 with various progress in development.

Tab-cel

• Imminent EU MAA submission; plan BLA submission in Q2 2022; step-wise progress with FDA on CMC and comparability.

ATA188

• Interim analysis in H1 2022 to assess efficacy, safety, and biomarkers.

CAR-T

• IND filing for ATA3271 in H2 2022; ATA3219 to submit IND in Q1 2022.

Risks

• Regulatory uncertainties in FDA interactions and BLA submissions.
• Clinical trial risks related to interim analysis outcomes for ATA188.
• Potential differences between forward-looking statements and actual results due to various uncertainties.

Q: On ATA188, when disclosing data in H1 2022, will P values be disclosed and is disclosure limited by FDA?

A: AJ Joshi states the interim analysis for the Phase 2 study will involve efficacy, safety, and biomarkers, and they'll communicate publicly after the IA, maintaining study integrity and not disclosing specific P values yet.

Q: Color on CMC regulatory discussions for tab-cel?

A: Pascal mentions providing additional analysis requested by FDA, with step-wise progress towards BLA submission, including aligning on comparability approach with FDA.

Q: On ATA188's MTR data and its predictive value, how confident is it?

A: AJ Joshi explains MTR data in progressive MS shows unique remyelination correlation with disability improvement, which is novel and supports potential biological basis for ATA188's effects.

Q: Status of IND filing for ATA3271?

A: Jakob mentions ATA3271 is on track for IND filing in H2 2022, leveraging next-gen tech and EBV T-cell platform.