Atara Biotherapeutics(ATRA) - 2020 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Atara Biotherapeutics ended Q4 2020 with $500.7 million in cash, cash equivalents, and short-term investments, which includes proceeds from the Bayer collaboration and December 2020 financing [17][18][19] - The company believes it is sufficiently funded into 2023, covering expenses for the BLA filing and U.S. commercial launch of Tab-cel [17][18] Business Line Data and Key Metrics Changes - For Tab-cel, Atara is on track to complete a rolling BLA submission for EBV positive PTLD in Q3 2021, with significant progress in manufacturing and clinical studies [8][10][19] - The Phase 2 multi-cohort study for Tab-cel is accelerating, with six study populations identified for potential label expansion [10][12] - ATA188 for multiple sclerosis is progressing well, with an interim analysis planned for the first half of 2022 [13][21] Market Data and Key Metrics Changes - The company is focusing on the U.S. market for Tab-cel, with plans for a targeted commercialization approach consistent with rare disease models [11][12] - In the EU, Atara plans to submit a marketing authorization application for Tab-cel in EBV+ PTLD in Q4 2021 [12] Company Strategy and Development Direction - Atara is advancing its three strategic priorities: Tab-cel, ATA188, and next-generation CAR T programs, with a focus on leveraging its allogeneic EBV T cell platform [7][15][19] - The company is seeking partnerships for the commercialization of Tab-cel outside the U.S., particularly in Europe [12][70] Management's Comments on Operating Environment and Future Outlook - Management expressed gratitude for the team's efforts during the COVID-19 pandemic and highlighted significant milestones achieved in 2020 [17][18] - The company remains optimistic about the potential of its therapies, particularly in addressing unmet medical needs in rare diseases and multiple sclerosis [11][21] Other Important Information - Atara's CAR T programs are based on innovative technologies aimed at improving efficacy and durability of response [15][27] - The company is actively engaging with the FDA to ensure alignment on the BLA submission process and regulatory pathways [19][76] Q&A Session Summary Question: Inquiry about Tab-cel rolling BLA submission - Management confirmed productive discussions with the FDA regarding the rolling BLA submission and the comparability of historical data [33][35] Question: Update on Mesothelin CAR T program - Management stated that updates from the academic program at Memorial Sloan Kettering are not available as it is separate from Atara's partnership with Bayer [41][38] Question: Scenarios for ATA188 interim analysis - Management discussed potential outcomes from the interim analysis, emphasizing the importance of FDA alignment on the study's design and endpoints [41][44][55] Question: Change of primary endpoint for ATA188 - Management reassured that the change to EDSS as the primary endpoint does not diminish confidence in the program, as most improvements were already driven by EDSS [50][51] Question: Commercial readiness for Tab-cel launch - Management outlined a rare disease commercialization model with a limited number of specialized staff and a focus on early identification of patients [64][66] Question: Partnerships for ex-U.S. commercialization - Management confirmed ongoing discussions with potential partners in Europe, focusing on those with existing infrastructure in rare diseases and oncology [70][71]