Atara Biotherapeutics(ATRA) - 2022 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q3 2022, Atara Biotherapeutics ended with approximately $265 million in cash, which is expected to fund operations into Q1 2024 [20] - The company anticipates a reduction in future operating cash burn following a recent restructuring [20] Business Line Data and Key Metrics Changes - The tab-cel therapy, under the trade name Ebvallo, received a positive opinion from the CHMP for its first indication, with a launch planned in Europe for Q1 2023 [5][6] - The overall response rate for the Phase 3 ALLELE study in EBV-positive PTLD was reported at 51.2%, with a median overall survival of 18.4 months [13][62] Market Data and Key Metrics Changes - The company is preparing for the launch of Ebvallo in Europe, which is expected to have significant pricing potential in an ultra-rare disease market [6] - The U.S. market for tab-cel is projected to have peak sales potential over $500 million per year across multiple indications [8][71] Company Strategy and Development Direction - Atara is seeking a commercial partner in the U.S. to avoid further investment and to extend its cash runway while maximizing the value of tab-cel [8][57] - The company is focused on leveraging its clinical data and regulatory discussions to facilitate a BLA submission without the need for new clinical trials [67] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the transformative potential of tab-cel and ATA188, particularly in addressing significant unmet medical needs in their respective markets [5][15] - The company is optimistic about the upcoming data readout from the Phase 2 EMBOLD study for ATA188, expected in October 2023, which could serve as a significant value inflection point [71] Other Important Information - Atara has treated over 400 patients with tab-cel in clinical settings, which is expected to support the BLA submission process [68] - The company has received fast track designations from the FDA for both tab-cel and ATA188, indicating regulatory support for their development [10] Q&A Session Summary Question: Guidance on EU tab-cel revenues and logistical hurdles - Management is not planning to provide revenue guidance for Europe at this stage but will discuss pricing at the time of launch [24] - Logistical hurdles are minimal as the company has experience in delivering allogeneic cell therapies efficiently [25] Question: Number of patients treated with commercial formulation for tab-cel - Management did not disclose specific numbers but confirmed constructive dialogues with the FDA regarding the clinical data from patients treated with commercial material [31] Question: Data presentation at ESMO for ATA2271 - Safety and PK data will be presented, including details on the fatal SAE that led to the pause in enrollment [40] Question: Clinical data package requirements for tab-cel - The upcoming Type B meeting with the FDA will discuss clinical data package requirements, with a focus on leveraging existing clinical experience [66] Question: Strategic rationale for U.S. partnership - A partnership is seen as beneficial to avoid commercialization costs and to leverage existing commercial structures in the U.S. [57]