Atara Biotherapeutics, Inc.

Good afternoon, everyone. Thank you for standing by and welcome to the Atara Biotherapeutics fourth quarter and full year 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 today's conference, please press star zero on your telephone keypad. Please be advised that today's call is being recorded. I'd now like to hand the call over to Mr. Eric Heilengren, 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 fourth quarter and full year 2021 results conference call. Earlier today, we issued a press release announcing our fourth quarter and full year financial results and operational progress. This press release and an updated 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. 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. In the fourth quarter and in 2021, ATARA made important progress across three strategic priorities, TAP-Cell, 8188 in multiple sclerosis, and our next generation allogeneic CAR T programs. I would like to start off with TAP-Cell and provide an update on the MAA review in Europe and our plan for BLA submission in the US. First, some background. on tap-cell CMC development and comparability. As you know, over the last few years, we had to make minor changes in terms of manufacturing process between the pivotal study and intended commercial product to scale up and comply with CGMP. In order to file for regulatory approval for FDE and EMA, we have performed comprehensive studies showing analytical comparability. between the pivotal study and commercial manufacturing process versions. These comparability analyses included all 74 available product laws manufactured by ATARA and covered 21 key attributes for potency, purity, and alloreactivity. For each key attribute, there is some inherent variability even with a well-controlled and robust manufacturing process, as seen already with all approved cell therapies. In the absence of specific guidance for such a first-in-class allogeneic cell therapy, we have determined an acceptable range of variability for the values of key attributes based on the extensive and favorable clinical efficacy and safety data for TAP cells. We then applied a specific and well-established statistical methodology to demonstrate comparability between process versions for each key attribute. Minor differences on a few specific attributes were justified according to ICH guidelines in demonstrating the absence of clinical impact based on a significant and consistent clinical experience across process versions. Following our analytical comparability studies, we believe that tap-sell, pivotal, and commercial product versions are indeed comparable. This comparability data were discussed in a pre-submission meeting with EMA and submitted as part of our MAA filing in November 2021. The review and the accelerated assessment is progressing as planned. following receipt of EMA Day 80 Critical Assessment Report with an anticipated approval in Q4 2022. Pre-launch preparations are progressing well in collaboration with our partner Pierre Fabre. In the U.S., we conducted very recently a Type B CMC meeting in late February with the FDA. to discuss and potentially align on the topic of comparability of pivotal clinical trial to commercial product. As previously noted, we believe this alignment will facilitate a BLS submission by the end of Q2 2022 as planned. Preliminary meeting responses and discussion did not result in alignment and unexpectedly, the FDA has initially recommended ATARA conduct a clinical study with the commercial product, as they do not agree that comparability has been demonstrated. ATARA has responded with additional questions to FDA in order to clarify the FDA view, and has suggested several alternative approaches to progress to a BLS submission, given the unique nature of TAP cells having BTD status with the potential to address an urgent unmet medical need in an ultra-rare disease for patients with limited life expectancy and no approved therapy. As additional background, we also filed an IND amendment in Q4 2021 with the FDA in order to use commercial products for clinical trials. so that we can cover patients with appropriate HLA match using our existing inventory of commercial products instead of needing to manufacture new lots of clinical material for the ongoing studies. Following submission and review of this IND amendment by the FDA, we have started treating patients in Q4 2021 with commercial TAP cell product in our clinical trials and the expanded access program. This means that we are already gathering clinical data with a commercial product, and we will be able to provide such data to the FDA. Additional interaction with the agency are therefore expected, including receipt of the final Type B CMC meeting minutes. However, as a result of such preliminary feedback received from the FDA, ATARA does not currently expect to file a BLA for TAPCEL in Q2 2022. While disappointed by the FDA's unexpected preliminary response on comparability, we will continue to engage with determination and confidence with the FDA on potential pathways to a BLA submission for TAPCEL, and we plan to provide a further update during our next quarterly call. Why are we confident? TapCell is a first-in-class breakthrough therapy-designated product that addresses urgent unmet needs, as patients in secondary PTLD have no approved therapies and a very limited median life expectancy of just a few weeks to a few months. TapCell is also a particularly unique case, as its development over many years has led to the need for minor changes in the manufacturing processes to achieve GMP compliance and scale-up. However, TAP-Cell clinical experience of over 300 patients, including more than 180 with EBV-positive PTLD, establishes, we believe, very clearly, a safe and effective range of key product attributes values, enabling determination of acceptable commercial product specifications. We are pioneers in cell therapy, And TAP-Cell has the potential to be the first of its kind, which may require a unique approach to approval similar to what was achieved by Otologous CAR-T. Further collaboration with the FDA could allow us to align on a reasonable path to submission and approval so as to allow U.S. patients in serious need to access this potentially life-saving therapy. I know from personal experience that bringing a transformative therapeutic innovation to patients is not always straightforward, but I feel confident that we will find a constructive way to get TAP-Cell filed and approved in the U.S. Now moving to the rest of our pipeline. It is important first to mention that we believe the current comparability regulatory topic on TAP-Cell is specific to this product development. Indeed, this unique situation with TAP-Cell does not apply to 80188 or our Allogeneic RT programs. It is also worth noting that as a result of our CMC development history and regulatory interactions with TAPCEL, we have already incorporated several learnings and have adjusted our approach going forward to optimize success with regulatory agencies for other pipeline products and our platform. Turning now to 80188, our Allogeneic MS program. Momentum continues to build for this potentially game-changing product within both the medical and investor community. Recently, two separate non-marked publications in Science and Nature presented what we believe is compelling new epidemiologic evidence that EBV is the leading cause of MS and mechanistic evidence showing how EBV infection can initiate and propagate the autoimmune attack on the brain in MS. As a result of the excitement generated by these publications, we are seeing increasing interest from patients, MS experts, and potential partners. Further, building on this increase in momentum, we are also pleased to announce that we will be hosting an ATARA EBV and MS Day with investors and analysts in late March, prior to conducting the interim analysis in Q2 of this year. The ATARA EBV and MS Day will cover all aspects of the causal association between MS and EBV, the rationale of addressing this disease as its root cause through precision therapy like 80188, and current data and development plans for 80188. We hope this event will continue to further build excitement and understanding around the potential of our approach to create significant value for patients, for ATARA, and for shareholders prior to conducting the IA in Q2. As we communicated in January, FDA granted fast-track designations in both non-active SPMS and non-active PPMS populations. And we are continuing to make good progress with enrolling the Phase II randomized double-blind placebo control and BOLD study, evaluating the efficacy and safety of 8188 in patients with progressive MS with patient number 80 expected to be enrolled soon after the planned interim analysis. With respect to the interim analysis for the 80 on 88 and both studies, we are on track to conduct the IA in Q2 of this year so as to optimize the likelihood of success in phase two and to confirm our development strategy going forward. After the IA is conducted, we plan to communicate our decision on next step for the program including rationale for adapting or not the study sample size. We also plan to continue our productive dialogue with the FDA following the IA. And first, we will likely communicate our decision on next steps for the program before we formally discuss the IA data with the FDA. Our planned discussions with the FDA following the IA will include next steps on the development pathway and potentially other accelerated pathway applications such as RMAT. We will communicate any relevant update as appropriate following these discussions. Additionally, we continue to have strong interest from large pharma companies on potential partnering opportunities with ATO and ATA, and we will continue those discussions following the IA. Our main strategy is focused upon ATO and ATA, but it also includes developing an EBV vaccine, leveraging our unique knowledge of the link between EBV and autoimmune disease like MS. To this end, we are pleased to announce that preclinical work is progressing on ATARA's very own EBV vaccine. For some time, we've been collaborating with our vaccine expert, QIMR, with encouraging preclinical studies, and we are currently advancing into IND enabling studies. We will have more to say about this program at our upcoming ATARA EBV and MS Day. Last month, we were also pleased to announce our strategic partnership with Fujifilm Biotech Technologies to acquire our atom manufacturing facility in Fasanox for 100 million euros, which is on track for an anticipated close in April. As part of the transaction, we will enter into a long-term supply agreement with Fuji, which will provide ATARA with access to expert cell therapy manufacturing staff, flexible capacity, and specific capability to support our pipeline. Additionally, we expect to benefit from reduced operating expenses going forward over time. Importantly, after the close of the deal, we retain a talented technical operation team, including process science, quality assurance, and supply chain logistics. And we'll also continue to invest in our research, product design, manufacturing and asset development, for early stage and scale-up phases. We are excited to work closely with Fuji going forward. I would like also to highlight that any possible delays in TAPCEL US approval will not impact this partnership, as we built in the necessary flexibility in terms of our supply needs. Moving now to our financials, with regard to our cash position and runway, we ended the fourth quarter of 2021 with $371 million in cash. This includes $48 million from the sale of shares of common stock for our ATM facility in the quarter and a $45 million upfront payment received in a Pierre Fabre commercialization agreement. We believe cash, as of December 31, 2021, together with the anticipated $100 million payable to Atara upon closing of the strategic transaction with Fuji, will be sufficient to fund the company plan operation into the fourth quarter of 2023. I will now turn the call over to Jacob to give you more details on ATA-188 development and all CAR-T programs. Jacob?