Atara Biotherapeutics, Inc.

Good morning, ladies and gentlemen, and welcome to the ATARA Biotherapeutics Q4 and Full Year 2019 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star, then zero on your touchstone telephone. I would now like to turn the conference over to your host, Dr. John Craighead, Vice President of Investor Relations and Corporate Communication of Atara Biotherapeutics. Please go ahead.

Thank you, operator. Good morning, everyone, and welcome to Atara's fourth quarter and full year 2019 conference call. On today's call, we will provide an update of our clinical, operational, and strategic progress. as well as review our upcoming milestones and key objectives Chief Financial Officer, and Joe Newell, Chief Operations Officer, and Dr. A.J. Joshi, Chief Medical Officer. We begin with prepared comments from Pascal and then open the call for your questions. We'd like to remind listeners that during the call, the company's management will be making forward-looking statements. Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and the company's SEC filings. These statements are made as of today's date, and the company undertakes no obligation to update these statements. Now I'd like to turn the call over to ATARA's President and Chief Executive Officer, Pascal Tuchon.

Thank you, John, and thanks to all of you for joining us this morning. 2019 was a year of strategic prioritization and significant advancement of our T-cell immunotherapy programs. I would like to highlight that we've made important progress on our four strategic priorities. We have also extended our cash position into Q2 2021, and we continue to leverage our TAP cell experience to advance our innovative, off-the-shelf T-cell immunotherapy platforms. Building on the significant progress and momentum, let me start by reviewing the recent highlights and anticipated milestones for TAP-Cell. We are currently conducting a phase three clinical trial with TAP-Cell in patients with Epstein-Barr virus, or EEV, associated post-transplant lymphoproliferative disease, or PTLD, in the relapsed refractory setting. ATARA remains on track to initiate the TAP-Cell BLA submission to the FDA in the second half of 2020. We currently have 38 sites in the United States and Australia actively enrolling patients and are preparing to open additional sites in the U.S., Canada, and Europe. Towards this end, we submitted clinical trial application, or CTA, to several European countries in November and December of 2019, which will allow us to open clinical sites in Europe in 2020. We are excited as we recently received CTA approval in the UK, Austria, and Spain. These additional sites are being added to support full enrollment of the Phase III study. However, they are not necessary to meet the number of patients required for the planned Phase III interim analysis. Indeed, as I just mentioned, We continue to be on track to initiate a TAP cell BLA submission for patients with EBV-positive PTLD in the second half of 2020. We plan to hold a pre-BLA meeting with the FDA prior to this submission, during which we will discuss the totality of TAP cell data we and our academic collaborators have generated, including the Phase III HCT and SOT cohorts, MSK Phase II studies, and our expanded access programs. As a reminder, we most recently presented data from this EAP in December 2019 at ASH annual meeting. This data comprised long-term clinical results for 61 patients with diverse EBV-associated disease, including efficacy and safety data for 26 patients with relapsed refractory EBV-positive PTLD, and safety findings for 35 patients with other EBV-associated disease. The data demonstrate that TAP-cell was generally well-federated in all patients participating to this study. Importantly, in a subgroup of 22 patients with EBV-positive PTLD, who would have likely met eligibility criteria for the ongoing TAP-cell Phase III study, the overall response rate for the HCT cohort was 55%, with a two-year estimated overall survival of 79%. For the SOT cohort, of all response rate was 82% and two years estimated of all survival was 81%. We also engage in multiple activities designed to expand access to TAP-Cell for patients in Europe. ATARA recently submitted a Pediatric Investigation Plan or PIP to EMA. Following EMA approval of the PIP, ATARA plans to submit the TAP-Cell EU marketing authorization applications for patients with EBV-positive PTLD in 2021. The clinical data generated to date with our EAP and SPU programs also support the potential of TAP-cell as a transformative therapy in several other EBV-associated disease. In the second half of 2020, we expect to initiate enrollment of a TAP-cell Phase II multigord study, including up to six additional ultra-rare EBV-positive diseases. In addition, we have enrolled the final planned patients in a Phase 1B portion of a Phase 1B2 clinical study of TAP cells in combination with anti-PD-1 therapy in patients with platinum-resistant or recurrent EBV-associated nasopharyngeal carcinoma, NPC. Prior to starting the Phase 2 portion of the study, we will evaluate the initial results of this Phase 1B as well as Relapse Refactory NPC Clinical Landscape. I will now turn to ATA-188 or Allogenic T-Cell Immunotherapy for the treatment of patients with progressive multiple sclerosis. Recall that at ECTRIMS 2019, we reported encouraging early data from a Phase Ia multicenter open-label dose escalation study evaluating the safety and efficacy of ATA-188 Thank you very much. Thank you. Two out of six patients reached clinical improvement at six months. We recently selected the cohort three dose to initiate the randomized double-blind placebo-controlled phase 1B part of this study. Our decision to initiate the phase 1B was based on achieving in cohort three a predetermined criteria of an acceptable safety profile and three out of six patients achieving clinical improvement at six months for more than one clinical study site. Looking ahead, we expect to present updated clinical data at appropriate forms, including six months follow-up for all cohorts in Q2 2020, and 12 months follow-up for all cohorts in the second half of 2020. Additionally, we recently re-treated the first patients in the open-label extension portion of the Phase 1 study. which is designed to allow patients who complete one year in a dose escalation portion of the study to be retreated annually using the cord-free dose for up to four years. We are also on track to initiate enrollment of a randomized placebo-controlled Phase 1b-88-188 study in the second or third quarter of 2020. Site activation for this study is in process, and we are expecting an increased number of leading MS centers to participate in the US and Australia. In addition, Atara and leading experts recently published a review article in Trends in Molecular Medicine regarding the mechanistic connection between EBV infection and MS. Now, let's discuss our EBV CAR T platforms. At the 2020 Transplantation and Cellular Therapy meeting last week, an academic team presented a clinical study in patients with relapsed refractory B-cell malignancies treated with an off-the-shelf allogeneic CD19 CAR-T made from primary donor or partially HLA-matched third-party donor EBVT cells. In this first inhuman study with these EBV CD19 CAR-T cells, investigators observed durable complete responses for five out of six patients who received partially HLA-matched EBV CD19 CAR-T cells manufactured from third-party donors. No cytokine release syndromes or neurotoxicity above grade two, and no dose-limiting toxicities were observed post-infusion with multiple EBV CD19 CAR T doses. Also, no confirmed GVHD was observed in patients who received third-party donor EBV CD19 CAR T cells. Importantly, investigators also observed durable complete response, CR, with median follow-up of 26.9 months for five out of six patients who received partially HLA-matched EBV CD19 CAR-T cells manufactured from third-party donors, including four out of four responses in patients with NHL, one out of one response in patients with CLL, and 100% survival with NHL and CLL. Findings from this study provide initial clinical proof of principle that an EBVT cell platform has the potential to generate off-the-shelf allogeneic CAR T immunotherapies with high and durable responses, low risk of toxicity, and rapid delivery to patients. We continue to make progress in advancing our multiple CAR T therapeutic candidates. We expect that our collaborators at MSK will submit an IND to the FDA in the second or third quarter of 2020 for ATA2271, an autologous mesothelin-targeted CAR-T in patients with advanced mesothelioma. This program incorporates next-generation technologies, including a novel co-stimulatory domain, 1XX, that may offer greater persistence and more physiologic T-cell signaling, as well as a PD-1 dominant negative receptor that is designed to provide intrinsic checkpoint inhibition and unlock the solid tumor microenvironment. Furthermore, we have started preclinical IND enabling studies for ATA3271 and off-the-shelf allogenic EBV mesothelin-targeted CAR-T with the same next-gen CAR-T technologies as ATA2271. In addition, we have started preclinical IND enabling studies for ATA3219 and EBV CD19-targeted CAR-T that incorporates 1XX. We believe ATARA's off-the-shelf allogeneic EBV CAR-T platform is differentiated and has tremendous potential as an engine for continued innovation, leveraging favorable EVV T-cell safety, expansion, trafficking and persistence characteristics. Our dedicated facility in Phasanox has the flexibility to produce multiple T-cell and CAR-T immunotherapies and integrates preclinical and translational research, process science, quality control, and regulatory CMC capabilities under one roof. Such close integration enables a rapid development and scale-up of robust manufacturing processes to support a potential current and future clinical and commercial demand. The efficiency for manufacturing platform capabilities has recently been demonstrated with significant improvement in our manufacturing yield with TabCell. Our commercial stage process is now enabling us to make over 400 doses from a single donor, Luca Ferezes. Over time, we believe our commercial manufacturing process will allow for a cost-of-goods profile similar to those of Biologics. In addition, With our lead program already in Phase 3 and T-cell manufacturing commercial validation activities progressing well, we are creating a significant competitive advantage for ATARA in off-the-shelf allogenic T-cell immunotherapies. Not surprisingly, we are seeing a strong level of interest from potential partners to access our off-the-shelf T-cell platform, and we also see opportunities for potential partnership with the current product portfolio. On the operational front, earlier this month, we are pleased to welcome Christine Yarema as the new Chief Commercial Officer. Dr. Yarema brings extensive hematology, oncology, neuroscience, and autoimmune disease commercialization experience to ATARA, which are very valuable as the company advances commercialization activities for TAP-Cell. We also created a Chief Operations Officer role to continue to drive operational excellence across the company program and platform, and have appointed June Newell, ATARA current Chief Technical Operations Officer, to this new role. Turning to our financial positions, we extended our cash runway into the second quarter of 2021. We ended 2019 with cash, cash equivalent, and short-term investment totaling $259.1 million, as compared to 282.9 million as of September 30, 2019. Of note, pro forma cash and investments as of December 31, 2019, including ATM and option exercise proceeds from January 2020, was 282.7 million. In closing, the progress we made in 2019 has positioned us well for tremendous success this year, delivering on key milestones for TAPCEL, our lead pipeline candidate, and further advancing other promising programs for the hard work of all ATARAS employees. I now turn the call back to the operator to begin the Q&A portion of the call. Operator?