Atara Biotherapeutics, Inc. (NASDAQ:ATRA) Files An 8-K Other Events
Item 8.01
On May 30, 2019, Atara Biotherapeutics, Inc. (Atara or the Company) announced that Utpal Koppikar, the Companys Chief Financial Officer, will participate in the Jefferies 2019 Healthcare Conference on June 5, 2019 and the Goldman Sachs 40th Annual Global Healthcare Conference on June 13, 2019. Live audio webcasts of the presentations will be available by visiting the Investor Events and Presentations section of atarabio.com. Archived replays will be available on the Companys website for approximately 14 days following the live webcasts.
As part of the presentations, Atara intends to provide an update related to the Companys ongoing discussions with the U.S. Food and Drug Administration (the FDA) regarding the development of tab-cel®. Based on preliminary feedback from the FDA, the Company plans to combine two ongoing tab-cel® Phase 3 clinical studies (MATCH and ALLELE) which were originally designed for enrollment of around 100 total Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) patients into a single tab-cel® Phase 3 protocol (ALLELE). The planned amended ALLELE protocol consists of a hematopoietic cell transplants (HCT) cohort with approximately 33 EBV+ PTLD patients who have failed rituximab as well as a single solid organ transplants (SOT) cohort of approximately 33 EBV+ PTLD patients who have failed rituximab with both chemotherapy and non-chemotherapy prior treatment experience. The Company does not expect to change the primary endpoint for the two cohorts of the combined study.
Forward-Looking Statements
This current report contains forward-looking statements, including, without limitation, statements relating to the potential combination of Ataras tab-cel® Phase 3 studies and the related protocol and endpoint. These forward-looking statements are based upon Ataras current expectations. Because such statements deal with future events and are based on Atara Biotherapeutics current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara Biotherapeutics could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including those discussed in Atara Biotherapeutics filings with the Securities and Exchange Commission, including in the Risk Factors and Managements Discussion and Analysis of Financial Condition and Results of Operations sections of the Companys most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings and in the documents incorporated by reference therein. Except as otherwise required by law, Atara Biotherapeutics disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.