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EX - 99.1 2 atra - ex991_6.htm EX - 99.1 Exhibit 99.1 Atara Biotherapeutics Announces Third Quarter 2021 Financial Results and Operational Progress Positive Pivotal Phase 3 ALLELE Data Reinforcing the Transformative Potential of Tab - cel® to be Highlighted as Oral Presentation at Upcoming American Society of Hematology Meeting Significant Tab - cel® Regulatory Progress with Imminent EU MAA Submission and Additional Clarity on FDA Requirements for BLA Submission Planned for Q2 2022 ATA188 Data Demonstrates Durable , Clinically Meaningful Disability Improvement and Possible Remyelination in Patients with Progressive Multiple Sclerosis Company to Host Live Conference Call and Webcast Today at 8:30 a.m. EDT SOUTH SAN FRANCISCO , Calif . , November 4 -- Atara Biotherapeutics , Inc. ( Nasdaq : ATRA ) , a leader in T - cell immunotherapy , leveraging its novel allogeneic Epstein - Barr virus ( EBV ) T - cell platform to develop transformative therapies for patients with cancer and autoimmune diseases , today reported financial results for the third quarter 2021 , recent business highlights and key catalysts over the next several months . " Atara continues to make meaningful progress across our strategic priorities and with positive data from our pivotal Phase 3 ALLELE study and imminent EU regulatory submission , we are now at an inflection point as we work to deliver tab - celⓇ® , a potentially transformative first - in - kind therapy , to patients in need , ” said Pascal Touchon , President and Chief Executive Officer of Atara . “ We are equally encouraged by new data confirming our conviction for ATA188 as the first investigational therapy to reverse disability in progressive multiple sclerosis , and upcoming milestones related to our potentially best - in - class CART portfolio that does not require TCR or HLA gene editing . ” Tabelecleucel ( tab - cel® ) for Post - Transplant Lymphoproliferative Disease ( PTLD ) • First presentation of new positive data from the pivotal Phase 3 ALLELE study , reinforcing the transformative potential of tab - cel , has been accepted as an oral session at the 63rd American Society of Hematology ( ASH ) Annual Meeting in December 2021 Top - line data with additional patients and extended follow up confirm a strong objective response rate ( ORR ) and a safety profile in line with prior results , demonstrate durability of response , and will support the imminent EU Marketing Authorization Application ( MAA ) submission 0 An ORR , as measured by independent oncologic response adjudication ( IORA ) assessment , of 50 % ( 19/38 , 95 % CI : 33.4 , 66.6 ) was observed , with an ORR of 50 % ( 12/24 , 95 % CI : 29.1 , 70.9 ) in PTLD following SOT and 50 % ( 7/14 , CI : 23.0 , 77.0 ) in PTLD following HCT , with a best overall response of Complete Response ( CR ; n = 5 , SOT ; n = 5 , HCT ) or Partial Response ( PR ; n = 7 , SOT ; n = 2 , HCT ) Overall , the median time to response ( TTR ) was 1.1 months ( 0.7-4.7 ) . Of 19 responders , 11 had a duration of response ( DOR ) lasting more than six months and median DOR has not been reached yet The one - year survival rate was 61.1 % overall ( 57.4 % for SOT , and 66.8 % for HCT ) . Those who responded had a longer survival compared to the non - responders , with a median