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EX - 99.1 2 atra - ex991_6.htm EX - 99.1 Exhibit 99.1 Atara Biotherapeutics Announces Second Quarter 2021 Financial Results and Operational Progress Progress with FDA on evaluating tab - cel® product comparability and new robust Phase 3 ALLELE study data Recent positive milestones with EMA provide clear path for EU Marketing Authorization Application submission in November 2021 Important new ATA188 magnetization transfer ratio ( MTR ) imaging biomarker data and updated clinical data to be presented at ECTRIMS in October Company to Host Live Conference Call and Webcast Today at 4:30 p.m. EDT SOUTH SAN FRANCISCO , Calif . , August 9 -- 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 cancer and autoimmune diseases , today reported financial results for the second quarter 2021 , recent business highlights and key catalysts over the next several months . " We are very pleased with the progress achieved across all of our programs and important clinical updates across our full pipeline , which will enable us to deliver on key value drivers through the rest of this year and into 2022 , " said Pascal Touchon , President and Chief Executive Officer of Atara . “ Recent tab - cel® regulatory progress and alignment with both FDA and EMA allow us to continue anticipating approvals in 2022 , while exciting new ATA188 imaging data reinforces our belief in this potentially transformative therapy for patients with multiple sclerosis . " Tabelecleucel ( tab - cel® ) for Post - Transplant Lymphoproliferative Disease ( PTLD ) Atara conducted productive meetings with the U.S. Food and Drug Administration ( FDA ) , gaining clarity on specific next steps required for submission of the Biologics License Application ( BLA ) ○ Alignment on key methodologies for evaluating comparability between Atara product used in the pivotal ALLELE study and the intended commercial product . Atara will provide data on substantially all lots made to date through a Type B CMC meeting to enable FDA to make a final determination on the data package to support comparability FDA decided it cannot make a determination of comparability between material used in non- pivotal and pivotal studies because analytical data is not available and cannot be generated for all lots manufactured at Memorial Sloan Kettering Cancer Center ( MSK ) and used in non - pivotal studies . Consequently , Atara plans to submit clinical data from the pivotal ALLELE study and the non - pivotal studies as separate , non - pooled analyses in the anticipated BLA submission FDA has not requested additional assays or manufacturing lots