Atara Biotherapeutics(US:ATRA)2021-05-05 12:54Financial Data and Key Metrics Changes - Atara ended Q1 2021 with $435 million in cash, which is expected to fund operations into 2023, including expenses for the BLA filing and U.S. commercial launch of tab-cel [15][16] - The company reported approximately $3.6 million in revenue from the Bayer collaboration during Q1 2021, with expectations of similar revenue in future quarters due to deferred revenue of around $70 million on the balance sheet [68] Business Line Data and Key Metrics Changes - Progress on tab-cel includes active discussions with the FDA regarding comparability data, with plans to complete the BLA submission for PTLD in Q3 2021 [10][16] - The ATA188 program for multiple sclerosis is on track for an interim analysis in the first half of 2022, with ongoing enrollment in the Phase 2 randomized controlled trial [12][20] - The mesothelin CAR T programs, ATA2271 and ATA3271, are advancing with positive collaboration with Bayer, and initial clinical data is expected to be presented in Q4 2021 [13][22] Market Data and Key Metrics Changes - The company is preparing for the commercial launch of tab-cel in the U.S. in the first half of 2022, with a focus on disease state education and payer access preparation [11] - There is strong interest from potential partners for the commercialization of tab-cel in Europe, with a letter of intent submitted to the EMA for MAA submission [10][11] Company Strategy and Development Direction - Atara is focused on three strategic priorities: tab-cel, ATA188 for multiple sclerosis, and next-generation allogeneic CAR T programs [7] - The company aims to establish itself as a leader in allogeneic T-cell therapy, with ongoing efforts to align with regulatory bodies and prepare for commercial launches [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing discussions with the FDA regarding comparability data for tab-cel, which is crucial for the BLA submission [16][41] - The company is optimistic about the potential of ATA188 to be a game-changer in the field of multiple sclerosis, with plans to engage potential partners for further development [51][75] Other Important Information - The British Society of Hematology has updated guidelines recommending the use of EBV-specific immunotherapy for relapsed refractory PTLD, highlighting the relevance of tab-cel [19] - Atara's CAR T programs are distinguished by their use of an allogeneic EBV T-cell platform, which aims to improve efficacy and durability of response [22][23] Q&A Session Summary Question: Regarding the tab-cel filing and patient data - Management confirmed that the number of patients enrolled in the ALLELE study is sufficient for the BLA filing, with ongoing work on comparability data [30][31] Question: On ATA188's interim analysis and FDA discussions - The interim analysis will inform potential adjustments to the study design, with alignment on patient populations being crucial for future pivotal studies [35][38] Question: Timeline for tab-cel multi-cohort study and initial data - Enrollment in the multi-cohort study has been impacted by COVID-19, but recent site activations are expected to accelerate patient enrollment [43] Question: Expectations for mesothelin CAR T data presentation - Initial data from the mesothelin CAR T program will include safety data and tumor assessments, with a focus on response rates and persistence [46][47] Question: Resource allocation for tab-cel, ATA188, and CAR T programs - The company plans to partner for the European launch of tab-cel while self-launching in the U.S., with significant investments in ATA188 and CAR T programs [72][75]