Atara Biotherapeutics, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the ATARA Biotherapeutics Q3 2020 Financial Results Call. At this time, all participants 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. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Eric Heilengren, VP of Investor Relations and Finance of ATARA Therapeutics. Thank you, please go ahead, sir.

Thank you, operator. Good afternoon, everyone, and welcome to ATARA's third quarter 2020 conference call. 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. Earlier today, we issued a press release announcing our third quarter 2020 financial results and operational progress. This press release and an updated investor presentation are available in the Investor and Media section at atarabio.com. 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. A.J. Joshi, Chief Medical Officer, and Kristen Urema, Chief Commercial Officer. We will begin with prepared comments from Pascal and Jacob, and 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. During the third quarter of 2020, we continued to make excellent progress in delivering on our strategic priorities and advancing our three areas of focus, tap sales, AT188 in multiple sclerosis, and our emerging CAR-T portfolio. We are on track to finish the year strong, meeting each external milestone set to date, while progressing on a mission to bring transformative T-cell immunotherapies to patients with serious diseases. I would like to thank very much the ATARA staff who have worked so hard to deliver on expectations despite the COVID-19 pandemic. Very significantly, we completed an interim analysis for the TAP cell pivotal 302 study or allele study in the third quarter, achieving a 50% objective response rate by independent oncologic and radiographic review. objective response rate is consistent with previously published investigator-assessed data. And the TAP cell safety profile in allele is also consistent with previously published data with no new safety signals. Following these encouraging pivotal interim analysis data for TAP cell in EBV-positive PTLD and very productive interactions with regulatory authorities We are now preparing for TAPCEL regulatory submissions and then potential approval and launch. We were particularly pleased to gain clarity on the regulatory package with FDA. Notably, that we can initiate a rolling submission and that we can complete the BLA filing with the allele study currently enrolled patients with at least six months of follow-up for durability of response. We plan to initiate the rolling BLA submission of TAP-Cell for EBV-positive PTLD by the end of 2020, and we expect to finalize the BLA submission in Q3 2021. We are also on track to submit an EU marketing authorization application for patients with EBV-positive PTLD in the second half of 2021. Jacob will give you more details about these regulatory updates in a moment. Meanwhile, we are near completion of testing the manufacturing lots that support a commercial validation of a scaled-up process, and we're investing in building the commercial inventory needed for launch. We believe that TabCell has the potential to transform the treatment of EBV-positive PTLD and offers a compelling value proposition for patients and the healthcare system. Indeed, EBV-positive PTLD is an aggressive, often deadly cancer with no approved therapy. The median survival for HCT and SLT patients with PTLD, who are relapsing or refractory after first-line therapy, is only two to three months. With TAP cell, the survival rate has been shown in prior studies to be over 80% at two years among responders with few treatment-related serious adverse events. In addition, we have been able to deliver TAP cells to U.S. clinical trial patients within three days from our inventory and with relatively low burden of administration on the patients and treatment centers. In terms of potential labor expansion for TAP cell, We initiated the TAP-cell Phase II multicore study in Q3 2020 with the goal of expanding the potential label in PTLD and closely related EBV-driven cancers. I would like to specifically highlight TAP-cell potential in additional immunodeficiency-associated lymphoproliferative disease beyond PTLD, given the high unmet medical need for a significant number of such immunocompromised patients. and our new positive clinical data for TAP cell presented at ESMO. I would like now to transition to our multiple sclerosis program, ATA-188. We are very excited about the potential for ATA-188 to become a transformative therapy for MS patients, bringing clinical benefit not achieved so far with existing therapies. As a reminder, Data presented at the joint ACTRiMS-HECTRiMS meeting held in September 2020 showed that patients with progressive MS who achieved sustained disability improvement, or SDI, with ATA-188 therapy at any time point maintained it at all future time points. And a higher proportion of patients showed SDI with increasing dose. We will continue to present additional data from our Open Naval Extension periodically over the next 12 months, with the next readout of such additional data at the European Charcot Foundation 28th Annual Meeting to be held as of November 15, 2020. Additionally, we are increasing our investment to support 8188 in translational research, manufacturing process improvements, and clinical development. In particular, we are advancing as rapidly as possible the enrollment of patients in the double-blind randomized placebo-controlled trial, which aims at confirming the transformative impact of this new therapy in MS. Switching now to CAR-T, we believe that we have an exciting portfolio of innovative and differentiated CAR-T programs. These programs are based on our eBVT cell platform, and our ability to leverage new technologies like 1XX and PD1 DNR to improve efficacy, persistence, and durability of response, and addressing limitations of autologous and other allogeneic CAR T. Jacob will detail in a moment the progress we are making in developing these exciting and competitive programs. With regard to our cache position and runway, we ended the third CAR T of 2020 with $327.2 million in cash, cash equivalent, and short-term investment, which we believe are sufficient to fund planned operations into 2022. ATARA's unique allogeneic EVVT cell platform has the ability to deliver off-the-shelf therapeutics with potentially transformative efficacy and safety profiles, and to produce them at scale meeting the needs of large patient populations. We believe strongly that this differentiates us from our peers. As we are rapidly progressing on creating value across our three strategic priorities, I'd like to conclude by expressing sincere thanks to the patients, caregivers, collaborators, and staff at ATARA. We are all committed to delivering on our corporate goals and creating shareholder value. I will now turn the call over to Jacob.