Atara Biotherapeutics(US:ATRA)2019-11-09 00:56Financial Data and Key Metrics Changes - The company ended Q3 2019 with a cash balance of $282.9 million, reflecting proceeds from a recent secondary follow-on financing, and expects to have sufficient cash to fund operations through 2021 [19]. Business Line Data and Key Metrics Changes - Tab-cel demonstrated an overall response rate of 55% in hematopoietic cell transplant (HCT) patients and 82% in solid organ transplant (SOT) patients, with estimated two-year overall survival rates of 79% for HCT and 81% for SOT [10][11]. - The company is on track to initiate Biologics License Application (BLA) submissions for tab-cel in the second half of 2020, with 35 sites available for enrollment in the U.S. and Australia [11][12]. Market Data and Key Metrics Changes - The potential U.S. market for tab-cel in relapsed/refractory EBV+ PTLD is estimated to be several hundred patients per year, with additional opportunities in Europe [14]. Company Strategy and Development Direction - The strategic objective is to become the leading off-the-shelf allogeneic T-cell immunotherapy company, focusing on four priorities: filing and launching tab-cel, achieving clinical proof of concept with ATA188, advancing mesothelin programs, and developing ATA3219 for B-cell malignancies [8][9]. - The company plans to leverage external partners for autologous CAR T immunotherapy development while focusing on allogeneic therapies [9]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term outcomes of tab-cel, emphasizing its potential as a transformative therapy for patients with relapsed/refractory EBV+ PTLD [10][11]. - The company is actively engaging with the European Medicines Agency (EMA) to determine the timing of the tab-cel EU conditional marketing authorization application [12]. Other Important Information - The company has completed facility commissioning and qualification activities to support clinical development at its operations and manufacturing facility [19]. - The management team is adapting to new strategic priorities, including searches for key leadership positions [19]. Q&A Session Summary Question: What gives confidence to move forward with ATA188 based on six-month data? - Management highlighted that cohort 3 met predetermined criteria with a well-tolerated safety profile and clinical improvement in at least 50% of patients, justifying the decision to proceed [22][23][24]. Question: What is the timeline for opening more clinical sites in Canada and the U.S.? - Enrollment is progressing as planned, with efforts to increase the number of sites in the U.S. and Canada, and a CTA filing in Europe is expected by the end of the year [27][28]. Question: Why is only 10% of U.S. centers involved in the trials? - The focus is on optimizing top centers that are geographically suited and seeing the most patients, rather than opening all available centers [37][38]. Question: What is the strategy for the CD19 allogeneic CAR-T program? - The company aims to demonstrate that its EBV-based allogeneic CAR-T can provide a safe and effective treatment option, with a focus on rapid clinical development [59][60]. Question: How many patients have been treated in the expanded access program for tab-cel? - While specific numbers were not disclosed, management indicated that data from the expanded access program will inform future studies and updates will be provided at future congresses [75].