Atara Biotherapeutics, Inc.

Good afternoon, everyone. Thank you for standing by and welcome to the Altara Biotherapeutics first quarter 2022 financial results conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone to 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'd now like to hand the call over to Eric Halligren, Vice President of Investor Relations and Finance at Atara Biotherapeutics. Please proceed, sir.

Thank you, Operator. Good afternoon, everyone, and welcome to Atara's first quarter 2022 results conference call. Earlier today, we issued a press release announcing our first quarter 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. I would like to start with ATA-188. or potentially transformative therapy for multiple sclerosis, where in the first quarter, we have made good progress and momentum continues to build around this exciting program. This recent momentum was marked by two landmark publications in Nature and Science, which continue to drive significant interest and awareness of EBV as the leading cause and trigger of MS in the medical, scientific, and investment community. In addition, we conducted a successful EBV and MS Day in March, where we covered the MS disease landscape, the history of 8188, an overview of EBV as a cause of MS, and very importantly, updated phase one and open level extension data. highlighting that a majority of patients have demonstrated either confirmed EDSS improvement or stability in up to 42 months follow-up. These events clearly establish 8188 as a unique opportunity for value creation, with its potential to transform patients' lives and the treatment paradigm in MS. Jacob will have more to say in a moment. Looking ahead, we are pleased to announce that we are on track to conduct the interim analysis of the Phase II EMBOL study in June. As a reminder, the goals of conducting the IA are, first, to decide whether we should increase the sample size or not in order to achieve the target conditional power by the end of the study. Second, it will be used to inform Phase III timing design, planning, and investment. And lastly, it will inform broader development plans, including phase two studies in potential new indications. Ultimately, the interim analysis data will allow us to accelerate and expand 81-88 development, starting phase three preparation, discussing further development steps with FDA, and finding the right partner for value creation. Once we analyze the data and decide on sample size and timing for study completion, we plan to communicate both our decisions and the rationale behind our decision in July of this year. We then plan to discuss with the FDA the IEA data and next steps for potential development pathways and the 8188 fast track designations for both non-active primary progressive MS and non-active secondary progressive MS. In parallel, we intend to accelerate our partnering discussion with biopharma companies that are progressing very well so far. Turning now to TAP-Cell, I would like to provide an update on our MAA in the EU and our continuing dialogue with FDA in the US. First, we are on track. and continue to expect a decision regarding CLABSEL European Commission approval in the fourth quarter of this year. As part of our ongoing dialogue with the European Medicine Agency, EMA recently requested additional time to review our answers to their day 120 list of questions, which results in adding an additional 30 days to the review process. We believe the answers we are preparing for the EMA will sufficiently address their questions. As a result of their need for additional time, EMA transitioned TAPCEL to a standard assessment review timeline. However, even after this transition to standard assessment, we continue to anticipate EC approval in Q4 of this year. Looking ahead, a key step in the regulatory review is conducting pre-approval inspections with EMA. And we are pleased to say that the dates for the pre-approval inspection have recently been confirmed. We are making good progress and are looking forward to completing this inspection with EMA soon. In addition, as we previously have noted, comparability data have been submitted to EMA for EMA filing. We have now received the EMA Day 120 Critical Assessment Report, and EMA has considered The comparability data between clinical and commercial manufacturing process versions are sufficient to demonstrate comparability. We are pleased with our progress and look forward to further dialogue with EMA. On the U.S. regulatory front, we are actively discussing proposals to enable a potential filing of the BLA without conducting a new Phase III study. Our proposal leveraged tap-cell status as a BTD product, addressing an ultra-rare and urgent medical need, as patients in second-line PTLD have no approved therapies and a very limited median life expectancy of just a few weeks to a few months. We have made several proposals to the FDA. First, to use only commercial lots that meet a range of specifications coming from our clinically used lots. Our extensive clinical data in more than 190 patients with EBV-positive PTLD clearly establish, we believe, a safe and effective range of values for key product attributes, enabling determination of acceptable commercial product specifications. We propose to use the clinical data being generated with a commercial product in current studies as a way to support the filing without an additional phase three study. Lastly, we propose an appropriate monitoring of patients in a post-marketing setting. The FDA is reviewing our proposals and we expect to provide further clarity on a potential BLA pathway in the next few months. I continue to feel confident that we will find a constructive way to get TAP sales filed and approved in the U.S. Moving to operational and financial updates. Last month, we welcomed Charlene Barnard to ATARA as Chief Technical Officer, overseeing process science, process development, quality, manufacturing, and supply. We also successfully completed the sale of a manufacturing facility to Fujifilm Dioxin Biotechnologies or FDB for 100 million upfront and began a partnership with FDB for access to flexible capacity to manufacture clinical and commercial stage allogeneic T-cell therapy. The partnership is going very well and the transaction is expected to reduce ATARA plant operating expenses over the multi-year partnership period. With regard to our cash position and runway, we ended the first quarter of 2022 with approximately $302 million in cash. We believe cash as of March 31st, 2022, plus the $100 million received from the closing of the strategic transaction with FDB in April, 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 OCAPI programs. Jacob?