Atara Biotherapeutics, Inc.

Good day, ladies and gentlemen, and welcome to the ATARA Biotherapeutics Second Quarter 2019 Financial Results Conference Call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session. Instruction will follow at that time. If anyone should require assistance at any time, please press stars and zero on your touchtone telephone. I will now like to turn the conference over to your host, Dr. John Chapman. Thank you, Operator.

Good morning, everyone, and welcome to the Atara second quarter 2019 financial results and corporate update conference call. Earlier this morning, we issued a press release providing an overview of the company's second quarter 2019 financial results and recent operational progress. This press release, as well as an updated investor presentation, are available in the investor and media section of atarabio.com. I'm joined on the call today by Dr. Pascal Tuchon, President and Chief Executive Officer, Upal Kopikar, Chief Financial Officer, Dr. Chris Hack, Chief Scientific Officer, and Dr. A.J. Joshi, Chief Medical Officer. We'll begin with prepared comments from Pascal, and then open the call for your questions. I'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 the 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 would like to turn the call over to ATARA's President and Chief Executive Officer, Pascal Tuchon. Pascal?

Thank you, John, and thank you everyone for joining us this morning. Today is my first conference call as the Chief Executive Officer of ATARA Biotherapeutics. It has only been a few weeks since I joined ATARA in late June, but I have already been impressed by the expertise and commitment of our teams In developing T-cell immunotherapies to transform the lives of patients with serious diseases. Indeed, I am confident that we are now in a strong position to execute on our commitment and create value for patients, physicians, and shareholders across all TAP cells, multiple sclerosis, and next-generation CAR-T programs. What I would like to do today is first provide a brief overview on my background and tell you why I am so excited about Atara's potential. I joined from Novartis, where I served as Global Head Cell and Gene and member of the Oncology Executive Committee. In this role, my responsibilities included the regulatory approval, pricing and reimbursement, and global launch of Chimaia, the first-ever CAR-T approved globally in two indications. I was also leading Novartis' global CAR-T strategy, clinical development, manufacturing and technical operations, and the financial performance of the Oncology Cell and Gene activities. Prior to that role, I was Global Health Strategy, Business Development and Licensing Oncology at Novartis, and beforehand Executive Vice President at Servier, where I initiated the partnership with Selectis and Pfizer on allogeneic CAR T. I believe my experience makes me uniquely suited to carry out ATARA's mission to transform the lives of patients with serious diseases. Having worked over the last five years in the field of autologous CAR T, as well as first-generation gene-edited allogeneic CAR-T, I believe cell therapy is the next therapeutic frontier in oncology and immunology following its transformative impact on patients with B-cell malignancies. What excites me most about ATARA is that its T-cell immunotherapy platform could have several important advantages over both autologous CAR-T therapies and gene-edited allogeneic CAR-T therapies. Indeed, for allogeneic T-cell therapies, may be immunoprivileged. They are obtained from healthy donors and do not require HLA edits, hence maintaining proliferation and persistence advantages. As they are matched for each patient from our inventory and available to patients within days, the treatment is more similar to prescribing and administering a biologic than the complex process of today's autologous CAR-T cell therapies. or Epstein-Barr virus or EBV-specific platform can lead to therapies directed at EBV-associated diseases like TAF cell and ATA-188 as well as allogeneic cardiotherapies. Our platform is already in clinical development for EBV-associated post-transplant lymphoproliferative disease or PTLD and other EBV-associated diseases including nasopharyngeal carcinoma and multiple sclerosis. We are also developing next-generation CAR-T immunotherapies for both solid tumors and hematological cancer. Our main priority here is our mesothelin-targeted next-generation CAR-T candidate with initially ATA2271, an autologous version, to rapidly achieve clinical proof of concept, followed by the allogenic version. With our unique innovative platform and our own state-of-the-art manufacturing facility, ATOM, We are creating a leadership position in T-cell immunotherapy, developing truly transformative therapies for durable treatment effects, and I feel fortunate to lead such an innovative company. I would like now to discuss our strategic priorities in greater detail, starting with TAP-cell. As recently announced, based on discussions with the FDA, we now plan to initiate, first in the U.S., a TAP-cell regulatory submission for relapsed refractory EBV-positive PTLD. during the second half of 2020. We are also in active discussions with the EMA to align on regulatory requirements and determine tap-cell submission timing in Europe. The FDA has agreed to combine our two ongoing tap-cell clinical studies into a single study called Allel. Both bone marrow and solid organ transplant patients are included, with target enrollment of 33 patients in each cohort. The primary endpoint remains objective response rate. We also plan to conduct an interim analysis prior to initiating VLA submission. Now, let's discuss the disease burden and market characteristics of this aggressive, often deadly cancer, affecting a limited but meaningful number of allogenic stem cells and solid organ transplant patients. There are no approved therapies for PTLD, and this disease This proportionately affects younger patients with a median age of under 40 compared to about 65 for all lymphomas. Unfortunately, the expected survival after failure of the standard first-line therapy of rituximab with or without chemotherapy is between 3 to 12 months in a case of SOT. In HCT, survival after rituximab failure is about 1 month. In the U.S., We estimate that there are several hundreds patients with EBV-positive PTLD who have failed rituximab with or without chemo. This is a typical ultra rare disease with significant unmet medical need. Given the severe disease burden of this condition, we believe TAP-Cell has the opportunity to deliver a compelling value proposition to patients and health systems. First off, TAP-Cell has demonstrated in both Phase II and EAP studies that it has a high and durable treatment effect with objective response rates between 50% and 83% and overall survival in responders at two years of over 80% in both HCT and SOT. Secondly, in these studies, we have observed few treatment-related serious adverse events for TAP cell in PTLD patients with no observed cytokine release syndrome or treatment-related mortalities. In addition, TAP-Cell has a low administration burden with no pretreatment required, a brief IV push administration, and only two-hour post-administration monitoring in clinical trials. Additionally, our off-the-shelf T-Cell order, match, and supply management system is designed to deliver the treatment within three days. Beyond the significant business case in PTLD, we're excited about the potential of TAP-Cell as and ultra-rare disease pipeline in a product. TAP cell is in ongoing phase 2 clinical development for patients with platinum pre-treated metastatic nasopharyngeal carcinoma in combination with pembrolizumab. This is an EBV-associated cancer with limited overall survival and therapeutic options. Incidence is high in East Asia, but even in the US and Europe, there are hundreds of patients in need of better therapeutic options. Our third tap-cell opportunity is based on a multi-corrode phase 2 study that we expect to start in the second half of 2020. We plan to enroll patients having other EBV-related cancers with poor prognosis and for which we have some clinical experience from previous studies. This study could support potential registrational opportunities. Hence, the same product may progressively treat more and more patients in multiple Ultra Rare Severe Disease. Turning now to MS program. We are also leveraging here our innovative platform in developing the first EBV-specific T-cell immunotherapy in autoimmune disease. Our of-the-shelf allogenic ATA-188 program for multiple sclerosis is ongoing Phase I clinical study for patients with progressive MS. In late June, we presented the initial safety data of the first three cohorts for ATA188 at the 5th Congress of the European Academy of Neurology. We saw no dose-limiting toxicity and no treatment-related, treatment-emergent adverse event at grade 3 or higher. We are dosing the fourth and final planned cohort now and expect to enroll a total of 24 to 30 patients in the study. VB safety results also add to the overall profile of our allogenic T-cell platform with favorable tolerability in non-immunocompromised MS patients as well as immunocompromised PTLD patients. Although designed to evaluate safety and tolerability in order to determine a recommended Phase II dose, the study also includes clinical efficacy secondary endpoint, including a number of established measures of physical, neurological, and cognitive functions. We expect to report initial results on some of these clinical secondary endpoint at ECTRIMS in September, as well as additional safety results. On the basis of the Phase Ia data, we plan to proceed into the randomized placebo-controlled portion of the study. In parallel, we plan to initiate a randomized Phase II study of ATA190, an autologous version of ATA188, during the second half of this year, to compare the efficacy and safety profile of these two EBV-specific cell therapies. Last but not least, I would like to provide a brief overview of our next-gen CAR-T portfolio. We had a number of recent presentations at both AACR and ASCO earlier this year. What was most exciting for us were the two presentations by our MSK collaborators on a Phase I clinical study with a mesothelin-targeted CAR-T immunotherapy in patients with advanced mesothelioma. Mesothelin is highly expressed on cells in aggressive solutumus, including mesothelioma triple negative breast cancer, ovarian, pancreatic, and non-small cell lung cancers, as well as mesothelioma. In the latest ASCO presentation, a subset of 16 patients with malignant mesothelioma followed for a minimum of three months and receiving MSK mesocarty together with anti-PD-1 and nephrodepleting chemotherapy showed a 12-month overall survival rate of 80% and an objective response rate of 63%. We viewed these data as highly encouraging and have prioritized our mesothelin-targeted next-generation CAR T program, ATA 2271, with a plan in collaboration with MSK to submit an IND for this program in 2020. Before opening the call to your questions, I would like to comment on a recent public offering. In July, we completed an underwritten public offering of $150 million for the issuance of 6.9 million shares of common stock and 2.9 million pre-funded warrants. The successful offerings transcend financial positions and funds plan operation into 2021 for key milestones next year, including initiating the TAFSA BLA submission and next-generation mesothelin party IND. I would like now to turn the call back over to the operator so we can go ahead and take your questions. Operator?