Atara Biotherapeutics, Inc.

Ladies and gentlemen, thank you for standing by, and welcome to the ATARA Biotherapeutics Q3 2019 Financial Results Call. At this time, all participants' lines are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star and then 0. I'd now like to hand the conference over to your speaker today, Dr. John Craighead, Vice President of Investor Relations and Corporate Communications of Atara Biotherapeutics. Please go ahead, sir.

Thank you, operator. Good morning, everyone, and welcome to Atara's third quarter 2019 conference call. On today's call, we plan to discuss our third quarter financial results as well as recent clinical, operational, and strategic progress. Earlier this morning, we issued a press release providing an overview of the company's third quarter 2019. This press release, as well as an updated investor presentation, are available in the investor and media section of Vitarabio.com. I'm joined on today's call by Dr. Pascal Tuchon, President and Chief Executive Officer, Upal Kopikar, Chief Financial Officer, and Dr. A.J. Joshi, Chief Medical Officer. We will begin with prepared comments from Pascal and then open the call for your questions. We'd like to remind listeners that 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 ATAR's President and Chief Executive Officer, Pascal Tuchon. Pascal?

Thank you, John, and thank you, everyone, for joining us this morning. Before we begin our discussion on our recent progress, I want to reinforce how proud I am of the advances we've made toward a vision of delivering an off-the-shelf allogeneic T-cell immunotherapy to every patient in need at any time. We know that life depends on us achieving this vision, and our team is strongly motivated every day to deliver meaningful results for patients and the company. During today's call, we'll provide context surrounding our new strategic priorities, recent clinical and operational progress, and upcoming milestones. First, I would like to update you on ATARA's strategic objective and priority following the extensive review of technologies, assets, resources, and organization that I have conducted during my first month as CEO. Objective moving forward is to become the leading of the shared allogenic T-cell immunotherapy company, transforming the lives of patients with cancer, autoimmune, and viral diseases. We are planning to accomplish this objective over the next three years by executing resolutely on four strategic priorities. First and foremost, file and launch tab-le-clos-cells, or tab-cells, for patients with relapsed refractory EBV-positive PTLD in the U.S. and Europe, as well as develop tab-cells for other indications. Second, achieve clinical proof of concept with ATA-188 or allogeneic MS-specific EBVT cell immunotherapy. Third, advance on mesothelin programs with autologous ATA2271 and allogeneic ATA3271. And fourth, develop ATA3219 or allogeneic CD19 CAR-T to clinical proof of concept in B-cell malignancies. In parallel, we'll continue to leverage the capabilities and expertise of external partners for autologous CAR-T immunotherapy development. Starting with TAP-Cell, we are very pleased to share exciting long-term outcome data from our multicenter expanded access program following acceptance of an abstract for presentation at ASH 2019. I would like particularly to highlight the long-term outcomes in a subgroup of 22 stem cells and solid organ transplant patients with relapsed refractory EDV-positive PT-LB treated with TAP cells who would likely have been eligible for ongoing Phase III studies. These results demonstrate TAP cells was generally well-tolerated with overall response rate of 55% in HCT and 82% in SOT patients. Estimated two-year-old survival was 79% for HCT and 81% for SOT. With such a larger number of patients and longer duration follow-up, these data are consistent with previous studies showing a well-tolerated safety profile, high response rates, and durable overall survival at two years. They do reinforce our clinical development and regulatory strategy for patients with relapsed refractory EBV-positive PTLD. These new data also confirm that TAP-Cell is potentially the transformative off-the-shelf allogenic T-cell immunotherapy with compelling value for patients, physicians, and payers in this often deadly ultra-aware cancer. Turning to our Pivotal Clinical Development Program for TAP-Cell, We remain on track to initiate a TAP-cell VLA submission for patients with EBV-positive PTLD in the second half of 2020. We now have 35 sites available for enrollment in the U.S. and Australia and plan to continue to open additional sites at transplant centers in the U.S. and Canada over the coming months. We also plan to file a clinical trial application, or CTA, in several European countries by the end of this year, and to open study sites there next year. Meanwhile, we engage in discussions with the EMA, and the outcome of these discussions will determine the timing of the TAPCEL EU conditional marketing authorization application for patients with EBV-positive PTLB. Our BLA submission guidance takes into account the recruitment constraints inherent in our pivotal study due to the nature of PTLD as an ultra-rare and rapidly progressing disease. Our phase three studies are also only open at about 10% of transplant sites in the U.S., and there are a number of competing, although less advanced, clinical trials. Since July, we have upgraded the way we are addressing these constraints, and importantly, We believe these development constraints should have limited impact on the TAP-cell business case for PTLD. Indeed, the value to individual patients will be high with such a potentially transformative T-cell immunotherapy. Also, TAP-cell could be delivered within three days of order to any center to an appropriate patient's needs. And if TAP-cell becomes the first approved treatment for PTLD, It would likely be supported by patients and physicians based on proven efficacy and safety. The potential U.S. market size for this first TAP cell indication is several hundred patients per year. Taken together with a potential TAP cell opportunity in Europe, we believe there is a strong and profitable business case for ATARA to commercialize TAP cells in the VLABS refractory BV-positive PTLD in this geography. We're also advancing studies in potential additional indication for TAP cells. We continue to enroll patients in our Phase I-II clinical study of TAP cells in combination with anti-PD-1 therapy in patients with platinum-resistant or recurrent EBV-associated NTC. We also expect to start enrollment in a Phase II multi-core study targeting other EBV-positive cancer of 2020. to continue expanding the value proposition of TAP-Cell. Overall, these value studies show the potential opportunity for TAP-Cell as an ultra-aware disease pipeline in a product. Now, turning to our third on-campus priority, HE188. We reported encouraging data at extremes in September in patients living with progressive NS. We reviewed the six-month follow-up data of our cohort-free dose. Based on this data, we are pleased to share that we have selected this cohort-free dose to initiate the Phase 1b portion of the study. The decision to initiate the Phase 1b was based on achieving in cohort-free or predetermined criteria of a continued well-tolerated safety profile and at least 50% of patients experiencing clinical improvement based on the multi-scale assessment defined at x-rays, with improving patients coming from more than one clinical study site. Recognizing these are early data and incorporating input from external experts, we believe these results merit the acceleration of ATA-188 development for progressive MS patients who have limited treatment options and in whom continuous decline is expected. In addition, enrollment in a fourth and final plane phase one dose escalation cohort is complete. Six months' data from cohort four will be mature in April 2020. We plan to present then all cohort data in detail at an appropriate congress in 2020. Following such encouraging ATA188 results and in line with our strategic focus on allogenic T cell therapy, We have decided not to move forward with a Phase II study for ATA 190 or autologous product in MS. This decision will allow us to focus our resources on ATA 188 to ensure efficient study execution as well as reduce autologous operating complexity and associated manufacturing cost. We'll continue to evaluate strategic options for ATA 190. Our first strategic priority is around the mesothelin CAR-T programs, ATA 2271 and ATA 3271. ATA 2271 is an autologous CAR-T for mesothelin-associated solid tumors for which an IND is planned in 2020. ATA 2271 will enter the clinic first while we work to advance development of ATA 3271, or allogenic mesothelin-targeted CAR-T. Leveraging or EDVT Cell Platform. Both of these programs have great potential due to the incorporation of a novel 1XX co-stimulatory domain and a PD-1 dominant negative receptor. Finally, Atara's fourth strategic priority is ATA3219 or Internal Allogenic CD19 CAR-T. This asset is currently in preclinical study and will later be brought to IND with the goal to demonstrate clinical proof of concept for our EBV CAR-T cell platform. Here we intend to show that allogenic EBV CAR-Ts are safe, expand in vivo, traffic to tumor sites, and persist sufficiently to obtain high response rate and durability of responses. Turning to a few operational updates, Facility commissioning and qualification activities to support clinical development at our operations and manufacturing facility ATOM are complete. Commercial production qualification activities are progressing well and aligned with our commercial strategy. Additionally, and as would be expected by a new CEO focused on maximizing Ataraz operational efficiency, I am now in the process of adapting my leadership team to our new strategic priorities. This effort includes active searches for a new global head of research and development, a head of commercial, and a general counsel. Before opening the call to questions, I would like to comment on our first quarter 2019 financial results. We ended the quarter with cash balance of $282.9 million, reflecting proceeds from our recent secondary follow-on financing. We continue to expect to have cash to fund ongoing operations in 2021. I would like now to turn the call back over to the operator so we can go ahead and take your questions. Operator?