Atara Biotherapeutics(US:ATRA)2021-01-20 20:26Tab-cel® Program - Atara expects to complete the Biologics License Application (BLA) rolling submission for Tab-cel® for patients with EBV+ PTLD in Q3 2021[21, 23, 24] - The company anticipates potential U S approval of BLA for Tab-cel® for patients with EBV+ PTLD in H1 2022[12, 24] - Phase 3 study interim analysis showed a 50% objective response rate (ORR) by Independent Oncologic and Radiographic Assessment (IORA) across HCT and SOT cohorts for Tab-cel®[36] - Phase 2 overall survival at 2 years in responders is 83% and EAP overall survival at 2 years for all patients is 79%[33] ATA188 Program - Atara plans to conduct a formal interim analysis in H1 2022, including efficacy and safety, for ATA188 Phase 2 randomized, double-blind, placebo-controlled study in patients with progressive forms of MS[24, 76] - The company plans to complete enrollment of Phase 2 randomized, double-blind, placebo-controlled study in patients with progressive forms of MS in H1 2022[24] - Phase 1a data in Progressive MS showed 50% sustained disability improvement (SDI) in Cohorts 3 – 4 at 15 Months[64] - The potential annual US revenue opportunity in PMS is ~$3.5B+[83] CAR T Program - Atara will receive $60 million in cash upon signing and is eligible to receive up to $610 million in development, regulatory, and commercial milestone payments, plus tiered royalties up to low double-digit percentage of net sales from Bayer collaboration[87] - The company expects to submit next-generation off-the-shelf, mesothelin-targeted allogeneic CAR T IND for patients with advanced mesothelioma in Q2 2022 / Q3 2022[21, 24] Financial Status - As of September 30, 2020, Atara had $327.2 million in cash, cash equivalents, and short-term investments[25] - Proforma cash, cash equivalents, and short-term investments as of Sept 30, 2020 is $544.2 million, including Bayer collaboration upfront and Dec 7, 2020 follow on offering[25]