Atara Biotherapeutics, Inc.

Good day, ladies and gentlemen, and welcome to ATERRA Biotherapeutics Quarter 3, 2021 Financial Results Conference Call. All lines have been placed on a listen-only mode, and the floor will be open for questions and comments following the presentation. If you should require assistance throughout the conference, please press star zero on your telephone keypad to reach a live operator. At this time, it is my pleasure to turn the floor over to your host, Eric Hallgren, VP, Investor Relations and Finance. Sir, the floor is yours.

Thank you, operator. Good morning, everyone, and welcome to ATARA's third quarter 2021 results conference call. Earlier today, we issued a press release announcing our third quarter financial results and operational progress. This press release and an updated corporate slide deck 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, Dr. A.J. Joshi, Chief Medical Officer, and Dr. Kristin 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 morning. We continue to make meaningful progress across our three strategic priorities, DAP cell 8188 in multiple sclerosis, and our next-generation allogeneic CAR-T programs. Today, we announce for the first time positive top-line data from a pivotal phase III allele study for TAP cell in EBV-positive PTLD, which includes new analysis, additional patients, and extended follow-up. These data confirm a strong objective response rate of 50%. with clear durability of response and overall survival of 89% at one year in responders, while still demonstrating a well-tolerated safety profile in line with prior results. These data will be the basis for the imminent MAA submission in the EU and our planned BLA submission in the U.S. next year for patients with EBV-positive PTLD. We are very excited to submit in the next few days our filing for approval in Europe. And with our recently granted accelerated assessment, we anticipate a decision regarding EU TAPCEL approval in the second half of 2022. Additionally, in October, we were extremely pleased to announce our exclusive commercialization agreement with Pierre Fabre for TabCell in Europe, Middle East, Africa, and other select emerging markets for EBV-positive cancers. We believe this partnership reinforces the commercial opportunity for TabCell in these markets and maximizes the strategic and financial value of this potentially transformative therapy. On the U.S. regulatory front for TabCell, we continue to make stepwise progress for Type B meetings with the FDA. In particular, we have aligned with the FDA on comparability approach, including the statistical methodology. Based on new requests from the CMC review team, following our recent interactions, we will provide the agency additional analysis of CMC data we have already submitted. We plan to have further interactions with the FDA in Q1 2022, to resolve the outstanding items and expect to complete the BLA submission for TAP-Cell in Q2 2022. Concurrently, we continue to work on pursuing the development of TAP-Cell in additional EBV patient population with a primary focus on immunodeficiency-associated lymphoproliferative disease, IALPDs. is continuing at site in the Label Expansion Multicore Study, which is evaluating six patient populations, including four within IALPDs and two in other ABV-driven disease in the U.S. and EU. The Multicore Study data is expected in 2023, and we believe this could be a meaningful label expansion opportunity. Turning to ATA-188, or Potentially Transformative Therapy, for Patients with Progressive Multiple Sclerosis. Last month, we presented at ECTRIMS updated Phase I Open Level Extension, or OLE, data in patients with progressive MS, treated with ATA-188 for up to 39 months. As a reminder, the natural history of patients with progressive MS is continuous disability progression. The OLE data we presented demonstrate that patients have achieved sustained disability improvement, or SDI, at a higher rate and longer duration that would be expected based on this natural history. The majority of SDI seen in the data presented is driven by sustained EDSS improvement, which is a primary endpoint in our Phase II randomized control of the so-called EMBOLD study. Additionally, we presented magnetization transfer ratio, MTR data, and imaging biomarker considered to reflect the state of myelination in the central nervous system. The statistically significant increase in MTR parallels the EDSS improvement observed and provides evidence that re-myelination may be the driver for clinical improvement. These potential biological basis for clinically significant EDSS improvement observed with 80188 continues to build awareness and interest in the transformative potential of 80188 in the medical community and with potential partners. As a reminder, in the first half of 2022, We will conduct an interim analysis, or IA, to assess efficacy and safety. And we plan to disclose our decision regarding the next steps for the program and our rationale for this decision based on data from the IA while still maintaining the integrity of the study. We believe this IA will be an important milestone for the company, investors, and potential strategic partners. With regard to our CAR-T portfolio, our mesothelin product candidates, ATA2271 and ATA3271, partnered with Bayer, are progressing well. Our collaborators at Memorial Sloan Kettering will present preclinical, clinical and translational data from the lowest dose cohorts of the open-label, single-arm Phase I clinical study of ATA2271 and autologous CAR-T therapy targeting mesothelin through a mini-oral presentation at ESMO-IO in December 21. Meanwhile, we continue to make progress on IND-enabling studies for ATA3271 and off-the-shelf allogeneic CAR-T therapy targeting mesothelin using next-generation PD-1 dominant negative receptors and 1XXCAR co-stimulatory signaling domain technologies for which we anticipate an IND filing in the second half of 2022. Additionally, we plan to present new preclinical data confirming potential benefits in solid tumors for ATA3271 at CIDC in November. Turning to ATA3219 or allogeneic CD19 targeted CAR-T for patients with B-cell malignancies. We expect to submit an IND in Q1 2022. ATA3219 leverages our next-generation 1XX CAR cost-imminatory signaling domain, an allogeneic EBV T-cell platform, and is a potential best-in-class therapy that does not require TCR or HLA gene editing, which we believe is a key differentiator of our platforms. To further support our differentiated allogeneic artery platform, we have invested in new capabilities to support our product pipeline and further drive innovation by opening our new ATARA Research Center, or ARC, in Fathanox to house our translational and preclinical science, process science, and analytical development teams. Our talented team at this new facility will support our product pipeline and further drive innovation by leveraging our unique and differentiated allogenic cell therapy platform. Moving now to our financials. With regard to our cash position and runway, we ended the third quarter of 2021 with $357 million in cash. This includes $46 million for the sales of shares of common stock for our ATM facility. We believe we are sufficiently funded in the second quarter of 2023 with risk cash and the 45 million upon payment received in the Pierre Fabre commercialization agreement. As we head into the final months of 2021, I'm a part of the ATARA staff and partners for steady progress in improving the lives of patients with serious disease. We are very close to filing the MAA in the EU for TAP-Cell, the first ever application for an allogeneic T-cell therapy in the world. and our progress in 18188 clinical studies could bring a truly transformational therapy to MS patients. We look forward to providing more updates to you in the coming weeks. I will now turn the call over to Jacob. Jacob?