Atara Biotherapeutics, Inc.

Good afternoon, everyone. Thank you for standing by and welcome to the Atara Biotherapeutics second quarter 2021 financial results conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please be advised that today's call is being recorded. I now would like to hand the call over to Eric Heilengrand, Vice President of Investor Relations and Finance at Atara Biotherapeutics. Please go ahead, sir.

Thank you, operator. Good afternoon, everyone, and welcome to Atara's second quarter 2021 results conference call. Earlier today, we issued a press release announcing our second quarter financial results and operational progress. This press release and an updated investor presentation are available in the Investors and Media section at atarabio.com. On today's call, members from the ATARA Executive Team will provide an update on our financial results and operational progress, and also review our upcoming key milestones and objectives. Joining me on today's call are Dr. Pascal Tuchon, President and Chief Executive Officer, Dr. Jacob DuPont, Executive Vice President and Global Head of Research and Development, Upal Kopikar, Chief Financial Officer, Joe Newell, Chief Operations Officer, Dr. Jose Vidal, Head of GMP Quality and Process Sciences, Dr. A.J. Joshi, Chief Medical Officer, and Dr. Kristen Urema, Chief Commercial Officer. We will begin with prepared comments from Pascal and Jacob, then open up the call for your questions. We would 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 Pascal. Pascal?

Thank you, Eric, and thank you all for joining us this afternoon. We have completed a strong first half of 2021 and are making good progress on all three of our strategic priorities, TAP-Cell, ATA-188 in multiple sclerosis, and our next-generation allogeneic CAR-T programs. Supported by our breakthrough therapy designation, we have been having regular dialogue since January with the FDA. We recently conducted productive meetings with the review team at the FDA and gained alignment, clarity, and actionable next steps in order to submit the TAP-Cell BLA. First, we gained alignment with the FDA on the key methodology for evaluating comparability between TAP-Cell clinical and commercial products. In addition, the FDA asked for and we will provide to them data on substantially all TAP cell lots made to date by ATARA. We believe this should clear the way for the FDA to make a determination at an upcoming Type B CMC meeting regarding our expanded data package supporting comparability between the product used in the pivotal clinical study and the intended commercial product. Next, the FDA decided It cannot make a determination of comparability between the non-pivotal product and the pivotal clinical study product. Hence, clinical data from the historical non-pivotal study will not be pooled with the pivotal allele study data. Rather, we intend to present these data in parallel as part of the BLA submission. Importantly, at this time, The FDA has made no new request of ATARA to conduct additional clinical studies, develop new assays, or conduct new manufacturing of lots. We are confident that we will have a robust data package to demonstrate comparability to the FDA between pivotal and commercial process versions of TAP cells, and we are encouraged by the ongoing interactions as we work towards finalizing of CMC module 3 for the DLA submission. Turning to the pivotal allele study, we have recently successfully completed the analysis of the Q2 data cut previously requested by the FDA. Top line data shows strong objective response rate in line with prior results and a consistent safety profile with no new safety signals. In addition, we now have new robust durability data as well. These data from a pivotal study are impressive. for such an ultra-rare and iron-methanate conditions like relapsed refractory PTLD where patients have no treatment options. The latest data cut will be discussed with the FDA for the Type B clinical meeting and is what we plan to use as the basis of both the BLA and the MAA submissions. As a reminder, we continue to plan to present these phase III allele data at an appropriate congress in Q4 2021. Looking ahead, we now have clarity around the required next steps for resolution and submission of the BLA for TAP cells. Although this has taken some time, as ATARA is a trailblazer for allogenic cell therapy in the world and is paving the way for this first-ever allogenic, off-the-shelf T-cell therapy to reach regulatory findings, we now expect to complete the BLA submission for TAP cells in Q1 2022. Our investment in U.S. commercial readiness activities have been shifted to this new timing, gating or spending versus what was previously anticipated, as we now plan for TAP cell approval and U.S. launch in the second half of 2022. As we continue to prepare for commercial launch, I am very pleased to announce that cell therapy and oncology commercialization veteran Amit Malik was appointed to the Board of Directors. Amit brings to ATARA's board a wealth of experience with U.S. payers, access, and reimbursement strategies, and launches of innovative oncology therapy, including CAR T's. Now turning to Europe, where we're also making excellent progress. We recently had successful pre-submission, as well as co-rapporteur and rapporteur meeting with EMA, and cleared all compliance checks. So we can now move forward to submit the EU market authorization application, for patients with EBV-positive PTLD in November of 2021. In parallel, there is a strong level of interest from ex-US partners, and our partnering discussions are progressing very well, in line with our expectations to secure a partner for Europe by Q4 2021. Meanwhile, we are also actively enrolling patients in our TAP-cell Phase II multicore study in other EBV-driven cancers. The six study populations, of which the largest two are EBV-positive AID-LPD and EBV-positive PID-LPD, may support meaningful label expansion beyond second-line PTLD. Turning now to 8E188, our transformative product candidate for patients with multiple sclerosis. I'm very excited to announce that important new data will be presented in October at ECTRIMS. These will include new magnetization transfer ratio imaging data, an imaging biomarker linked with myelination, in addition to the two-year clinical data update from the Phase Ia open-label extension study. We are excited to present this new data, and Jacob will have more to say in a moment. Meanwhile, we continue to make progress in enrolling the Phase II randomized double-blind placebo-controlled study, or NBOLD study. We are on track. to conduct an interim analysis of this study in the first half of 2022, including efficacy and safety in patients with progressive forms of MS. Following this interim analysis, we expect to have further discussion with the FDA regarding potential study adjustment for pivotal intent. These are important discussions from both regulatory and strategic perspectives for the program and could provide optionality on how we advance development. Momentum, meanwhile, continues to build in the community, reinforcing the association between EBV, Epstein-Barr virus, and MS, and the transformative potential of 8188 for MS patients. This was confirmed by a recent survey amongst top US neurologists. We also continue to see significant interest from a number of large companies regarding a potential collaboration involving 8188, as we truly have a unique asset. the only investigational therapy in a randomized controlled trial in progressive MS with disability improvement as the primary endpoint. Moving to our CAR-T portfolio and first our mesothelin franchise program, ATA 2271 and ATA 3271, these mesothelin-targeted CAR-T products are benefiting from our global strategic collaboration with Bayer, which is off to a strong start. For ATA2271, our autologous mesothelin CAR-T program, we expect to present the first update on Phase I data for patients with advanced mesothelioma in Q4 2021. The off-the-shelf, allogeneic version of this mesothelin CAR-T program, ATA3271, using a PD-1 dominant negative receptor and 1XX CAR co-simulatory signaling domain built on our EBV T-cell platform, is currently in IND-enabling studies and is progressing well. We expect Bayer to submit an IND in the second half of 2022 and subsequently lead clinical development and commercialization activities. Turning to ATA3219 or allogenic CD19 targeted CAR-T for patients with B-cell malignancies, we plan to submit an IND in Q1 2022 in line with our strategic goal to develop this asset as best-in-class for B-cell malignancies. Moving to our financials, with regard to our cash positions and runway, our cash burn in Q2 was $61.8 million, and we ended the second quarter of 2021 with $373.4 million in cash. With this cash balance and our updated and well-controlled plan-expand profile, we believe we are sufficiently funded into 2023. As we turn ahead into the third quarter of 2021, I am delighted to see how far ATARA has come from this time a year ago. Each and every one of our staff has delivered on our goal of saving and improving lives of patients with serious disease. On a daily basis, we partner closely with clinical study sites, with our manufacturing and logistics partners, and our collaborators, in order to ensure patients could continue to access our therapies. With the hard work of the ATARA team, We are on a clear path to file our TAB-CEL regulatory submissions and bring this life-saving medicine to patients in need. I will now turn the call over to Jacob. Jacob?