Atara Biotherapeutics(US:ATRA)2020-02-27 20:03Financial Data and Key Metrics Changes - Atara Biotherapeutics ended 2019 with cash, cash equivalents, and short-term investments totaling $259.1 million, down from $282.9 million as of September 30, 2019 [21] - Proforma cash and investments as of December 31, 2019, including ATM and option exercise proceeds from January 2020, was $282.7 million [21] Business Line Data and Key Metrics Changes - The company is conducting a Phase 3 clinical trial with tab-cel for patients with EBV-associated PTLD, with 38 sites actively enrolling patients in the U.S. and Australia [8][9] - The overall response rate for the HCT cohort in the tab-cel study was 55%, with a two-year estimated overall survival of 79% [11] - For the SOT cohort, the overall response rate was 82%, and the two-year estimated overall survival was 81% [11] Market Data and Key Metrics Changes - The potential indication for tab-cel in relapsed refractory PTLD is considered an ultra-rare disease, with several hundred patients in the U.S. and a similar number in Europe [55] - The company anticipates that the multi-cohort study planned for the second half of 2020 could lead to up to six additional indications, increasing the treatable population by at least a factor of four [55] Company Strategy and Development Direction - Atara is focused on advancing its T-cell immunotherapy programs, particularly the tab-cel platform, and has extended its cash runway into Q2 2021 [8][21] - The company aims to leverage its manufacturing capabilities to create a competitive advantage in off-the-shelf, allogeneic T-cell immunotherapy [20][72] - Atara is also exploring partnerships to access its off-the-shelf T-cell platform and other product portfolios [20][73] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made in 2019 and the positioning for success in 2020, particularly regarding key milestones for tab-cel [22] - The company is optimistic about the potential of its innovative therapies and the interest from potential partners [20][73] Other Important Information - Atara has appointed Kristin Yarema as the new Chief Commercial Officer, bringing extensive experience in hematology, oncology, and autoimmune disease commercialization [20] - The company is on track to initiate enrollment for a randomized, placebo-controlled Phase 1b study of ATA188 in the second or third quarter of 2020 [16] Q&A Session Summary Question: Update on tab-cel enrollment and interim analysis - Management confirmed that they are not commenting on enrollment at this stage but reiterated plans to initiate BLA filing in the second half of 2020 following a pre-BLA meeting with the FDA [25][26] Question: Target number of trial sites for tab-cel - Currently, there are 38 sites open in the U.S., and the company anticipates enrolling up to 24 sites in Europe [33] Question: Data release timeline for ATA188 - Six-month data for all cohorts is expected in the first half of 2020, with 12-month data for the first three cohorts anticipated in the second half of 2020 [35] Question: Timing for results from the nasopharyngeal carcinoma study - The final patient has been enrolled, and results will be evaluated as the landscape matures [40] Question: Market size for EBV+ relapsed refractory PTLD - The company estimates several hundred patients in the U.S. and Europe could benefit from tab-cel, with plans for additional indications to increase the treatable population [55]