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EX - 99.1 2 atra - ex991_69.htm EX - 99.1 Exhibit 99.1 Atara Biotherapeutics Announces First Quarter 2021 Financial Results and Operational Progress Conference Call and Webcast Today at 4:30 p.m. EDT SOUTH SAN FRANCISCO , Calif . , May 4 -- Atara Biotherapeutics , Inc. ( Nasdaq : ATRA ) , a pioneer in T - cell immunotherapy , leveraging its novel allogeneic EBV T - cell platform to develop transformative therapies for patients with serious diseases including solid tumors , hematologic cancers and autoimmune diseases , today reported financial results for the first quarter 2021 , recent business highlights and key catalysts over the next 18 months . " Atara is off to a strong start in 2021 , advancing all three strategic priorities to deliver on key value drivers , " said Pascal Touchon , President and Chief Executive Officer of Atara . “ We look forward to several milestones in 2021 , including the expected tab - cel® BLA and MAA filings , progress on the ATA188 program - especially the presentation of clinical and translational data from the Phase 1 OLE study , and the first clinical data on our mesothelin CAR T franchise . " Tabelecleucel ( tab - cel® ) for Post - Transplant Lymphoproliferative Disease ( PTLD ) • Atara is in active discussions with the FDA and progressing toward alignment on the content of CMC Module 3 , including methodologies to assess comparability between the product used in the pivotal ALLELE study and the intended commercial product A recent analysis shows that duration of response ( DOR ) in its ALLELE study is maturing as anticipated with a larger number of responders followed for at least six months and a safety profile consistent with previously published data with no new safety signals Atara is working toward completing a BLA submission in Q3 2021 pending alignment with the FDA The Company has submitted a letter of intent to the European Medicines Agency ( EMA ) , starting the process for a submission of an EU Marketing Authorization Application ( MAA ) for tab - cel® in patients with EBV + PTLD expected in Q4 2021 Atara has data at two medical congresses from a combined long - term overall survival ( OS ) analysis from three clinical studies of tab - cel® demonstrating that patients with EBV + PTLD , following both HCT ( hematopoietic cell transplantation ) and SOT ( solid organ transplant ) , that is relapsed or refractory ( R / R ) to initial treatment , derived similar OS benefit greater than 80 percent at two years whether they achieved complete or partial response ( CR or PR ) with tab - celⓇ Data from the Phase 3 ALLELE study will be presented at an appropriate congress in Q4 2021 The Company is continuing to invest in U.S. commercial readiness activities in anticipation of tab - cel® approval and planned launch in H1 2022. In addition , Atara is in discussions with potential partners for the commercialization of tab - cel® in Europe Tab - cel® Potential Additional Indications Atara is actively opening sites in the Phase 2 multi - cohort study for patients with other EBV - driven cancers ATA188 for Progressive Forms of Multiple Sclerosis ( MS ) Atara continues to make progress enrolling the ATA188 Phase 2 randomized , double - blind , placebo- controlled trial ( RCT ) evaluating the efficacy and safety of ATA188 in patients with progressive forms of MS ( PMS )