Atara Biotherapeutics, Inc.

Good afternoon, everyone. Thank you for standing by, and welcome to the Atara Biotherapeutics First Quarter 2021 Financial Results Conference Call. If anyone should require operator assistance during the conference, please press star zero from your telephone keypad. Please be advised that today's call is being recorded. I'd now like to hand the call over to Eric Hallegren, Vice President, Investor Relations and Finance at Atara Biotherapeutics. Please go ahead, sir.

Thank you, Rob. Good afternoon, everyone. and welcome to ATARA's first quarter 2021 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 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. A.J. Joshi, Chief Medical Officer, and Dr. Kristin Yarima, 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 are off to a strong start in 2021, making progress on all three of our strategic priorities, TAP-Cell, ATA-188 in multiple sclerosis, and our next-generation allogeneic CAR-T programs. We are moving ahead to deliver on key milestones this year, including the expected TAP-Cell BLN MAA filings, progress on the ATA program, especially presentation of new clinical and translational data from our Phase I Open Label Expression Study, and first clinical data on our mesothelin CAR-T program in advanced mesothelioma. For TAP-Cell, We are in active discussions with the FDA on the content of CMC Module 3, including methodologies and data to assess comparability between the product use in the pivotal clinical study and the intended commercial product. Supported by our breakthrough therapy designation, we have been having regular dialogue since January with the FDA on the CMC Module 3, and most recently, at teleconference last Friday, where we discussed key aspects of a comparability data package. We believe that we have provided the FDA a robust data package to demonstrate comparability between various process versions of TAP cells, and we are encouraged by the ongoing interactions as we work towards aligning with the FDA. At Arise, a trailblazer for allogenic T cell therapy as a role, and as such, We are paving the way for the first ever allogenic off-the-shelf T-cell therapy for ATARA and for our industry. We understand that doing so will take time, effort, and constructive discussion with regulators, and we are well on our way. Meanwhile, a recent analysis shows that duration of response in our allele study is maturing as anticipated, with a large number of responders followed now for at least six months and a safety profile consistent with previous published data with no new safety signals. As a reminder, we will present data from the Phase III allele study at an appropriate Congress in Q4 2021. In summary, we are making progress to align on comparability with the FDA and are confident we will do so. Pending this alignment, we plan to complete our BLA submission for PTLD in the third quarter of 2021. In the EU, where TAPSEL has prime designation, we have submitted a letter of intent to the European Medicine Agency, or EMA, thereby starting the process of submitting an EU marketing authorization application, or MAA, for TAPSEL in patients with EBV-positive PTLD, which we expect to complete in Q4 2021. In parallel, There has been strong interest from potential partners for commercialization of TAPCELL in Europe and continuous support from physicians and medical experts. We continue to invest in our U.S. commercial readiness activities, mainly disease test education and payer access preparation in anticipation of TAPCELL approval and planned launch in the first half of 2022. We are also building TAPCELL inventory and are on track to reach our goal of over 95% of PTLD patients covered at the time of commercial launch. With regard to our TAP-cell Phase II multicore study in patients with other EBV-driven cancers, we continue to actively open clinical study sites. Evaluation of potential study participants is well underway. The six study populations of which the largest two are EBV-positive AID-LPD and EBV-positive PID-LPD may support meaningful libel expansion beyond PT-LD. Turning to ATA-188, our transformative product candidate for patients with progressive form of multiple sclerosis. We continue to make progress in enrolling the Phase II Randomized Double-Blind Placebo-Controlled Study, or RCT, We are on track to conduct an interim analysis for this study in first half 2022, including efficacy and safety in patients with progressive form 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 perspective for the program and could provide optionality in how we advance development. Meanwhile, momentum continues to build in the community, reinforcing the association between EBV and MS. These contributed to Atera's successful approval of a clinical trial application for the Phase II RCT in Canada in the first quarter of 2021. We also continue to see significant interest from a number of large companies regarding a potential collaboration involving ATA-188. As a reminder, in the second half of 2021, we plan to present long-term, two-year clinical data from the Phase I Open Neighbor Extension, or OLE, as well as translational data from the Phase I study. 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 fully underway with positive alignment with our partner and a successful launch of our joint governance and activities. For APA 2271, our autologous mesothelin CAR-T program, the Phase I clinical study has completed enrollment of the first cohort. First clinical data, is expected to be presented in an appropriate forum in Q4 2021. The off-the-shelf allogenic version of this mesothelin CAR-T program, ATA3271, using PD-1 dominant negative receptor and 1XX-CAR co-stimulatory signaling domain through our EBVT cell platform is currently in IND-enabling studies, work that ATARA is doing. Subsequently, Bayer will submit the IND expected in Q2 or Q3 of 2022 and lead clinical development and commercialization. Turning now to ATA3219 or allogeneic CAR-T for patients with B-cell malignancies, we plan to submit an IND in Q4 2021 or Q1 2022 in line with our strategic goal to develop this asset as best-in-class in B-cell malignancies. Moving to our financials, With regard to our cash position and runway, we ended the first quarter of 2021 with $435 million in cash. With this cash balance and projected revenues from U.S. TapSell sales, we believe we are sufficiently funded into 2023, inclusive of expenses for the BLA filing and U.S. commercial launch of TapSell. As we head into the second quarter of 2021, I've been reflecting how far ATARA has come from this time a year ago. With the pandemic just beginning to gain a foothold in the US back then, we focused on our staff and collaborators' safety in order to continue our mission of bringing transformative therapies to patients. We work closely with clinical study sites and with our manufacturing and logistic partners to ensure patients will continue to access our therapies in our studies. Through the hard work of our ATARA team, We are on path to file our TAPCEL BLA in the third quarter this year and bring this life-saving medicine to patients in need. I will now turn the call over to Jacob. Jacob?