Atara Biotherapeutics, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the ATARA Biotherapeutics First Quarter 2020 Financial Results Conference Call. Please be advised that today's call is being recorded. I'd now like to hand the call over to Eric Hallengren, Vice President of Investor Relations and Finance at ATARA Biotherapeutics. Please go ahead, sir.

Thank you, Elaine. Good afternoon, everyone, and welcome to ATARA's first quarter 2020 conference call. On today's call, we will provide an update of our operational and strategic progress, review our upcoming key milestones and objectives for 2020, and discuss the potential impacts of the COVID-19 pandemic on our current and planned activities. Earlier today, we issued a press release providing an overview of the company's first 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 Duchamp, President and Chief Executive Officer, Upal Kopikar, Chief Financial Officer, Joel Newell, Chief Operations Officer, and Dr. A.J. Joshi, Chief Medical Officer. We will begin with prepared comments from Pascal. 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 thanks to all of you for joining us this afternoon. Let me open today's call by acknowledging the environment we are currently in. This global pandemic has impacted many lives across the globe, and our hearts go out to everyone who has been directly affected. Sharing the same vision as our frontline healthcare workers to serve patients, we at ATARA would like to honor and thank the healthcare professionals who are here, especially during this time. This moment in time only reinforces our deep commitment to making a difference in patient lives. It is with tremendous pride that I acknowledge the commitment and resiliency of our entire ATARA team who has remained focused on our mission to serve patients and implemented industry-leading practices to ensure safety while mitigating the impact of COVID-19 on our business. We've made significant progress in the first quarter of 2020 toward accomplishing our key objectives. Importantly, We remain on track to initiate the BLA submission for TAF cell in the second half of 2020 and to present key data from the Phase Ia study of ATA188 in patients with progressive multiple sclerosis in the second quarter. I want to take a moment to provide a brief update on the operational adjustments that we have made in response to the pandemic. Prior to COVID-19 outbreak, as part of our routine supply planning and operational risk management strategies, we have already manufactured significant inventories across TAPCEL, 8188, and our other programs, including process intermediates and the required starting materials needed to maintain long-term product supply. Consequently, we continue to deliver product to patients for more inventory which is a clear advantage of such off-the-shelf allogeneic EDVT cells. In addition, our teams have been working closely with our clinical staff to ensure the safety of site staff and patients and to preserve data integrity and access to treatment as appropriate. Where needed, they have established remote study visits, leveraged telemedicine, on healthcare and other methods to ensure continuity of care for patients and to preserve key endpoint data. We are closely monitoring the evolving COVID-19 pandemic and continue to assess its potential impact on our business and operations, including the timing and execution of clinical and preclinical studies. Regardless of the current pandemic, Atara Biotherapeutics remains a pioneer in allogenic T-cell immunotherapy. With our lead program in Phase III clinical development, we are the most advanced allogenic T-cell immunotherapy company, and we intend to rapidly deliver off-the-shelf treatments to patients with high and met medical needs. Our platform leverages the unique biology of EBV T-cells and has the capability to treat a wide range of EBV-associated disease or other severe disease, including solid tumors, and hematological cancers for incorporation of engineered CARs or TCRs. A key step toward achieving this mission is initiating the BLS submission for TAD cells in EDV-positive PTLD, which remains on track for the second half of 2020. We are very pleased to have enrolled a sufficient number of patients in our Phase 3 study to perform an interim analysis in Q3 2020 after the appropriate follow-up. We then plan to request a pre-VLA meeting with FDA to discuss the totality of data from the TAF cell program, including the MSKCC Phase 2 studies and ATARA's Expanded Access Program and single patient use. If the totality of clinical data are considered compelling enough by the FDA, we will initiate a BLA submission for TAP-cell. With respect to site activity and patient enrollment for the ongoing Phase III TAP-cell study, most of the 40 active clinical sites in the US and Australia are available for enrollment. And we are continuing to prepare to open additional sites in the US, Canada, and Europe. As previously discussed, We submitted clinical trial applications or CTAs to several European countries in November and December 2019 to enable the opening of European clinical sites in 2020. In addition to the previously reported approvals in the UK, Austria and Spain, I am very pleased to report that a CTA in France was recently approved and that we have just activated our first European site in Spain. As I've noted before, these additional sites are being added to support full enrollment of the Phase III study and not an interim analysis for which we have already enrolled a sufficient number of patients. With respect to TAP-cell regulatory exceding in Europe, in Q1 2020, we submitted a Pediatric Investigator Plan, or PIP, to the EMA as per their usual requirements. Following EMA approval of the PIP, we intend to submit a tap-sell EU marketing authorization application for patients with UPV-positive PTLD in 2021. We continue to see strong tap-sell investigator, physician, and patient interest even during this COVID-19 pandemic. And for cases in which patients are not able to enroll, in the EBV-positive PTLD Phase III clinical study, we are providing TAP-cell to patients in need under our EAP and also SPU. Additionally, a growing body of data suggests that TAP-cell may provide clinical benefit in additional EBV-positive disease, and we are advancing clinical studies to further evaluate its potential. Towards this end, We continue to expect to initiate enrollment in the second half of 2020 in a TAP-cell Phase II multi-core study that will include up to six additional ultra-rare EBV-positive patient populations. I will now turn to ATA-188, or allogenic T-cell immunotherapy, for the treatment of patients with multiple sclerosis. We previously reported encouraging early data at EXTREMES 2019, from a Phase I multicenter open-label dose escalation study evaluating the safety and efficacy of ATA-188 in patients with progressive form of MS. We are looking forward to presenting in the second quarter of 2020, in an appropriate form, the six-month results for the dose escalating cohort 1 to 4, and very importantly, the 12-month results for the cohort 1 to 3. We plan to present data on clinical measures and, in particular, assessment of disability. We also expect to present 12-month cohort 4 data in the second half of 2020 when such data are available. We are still retreating patients in the open-label extension of the Phase 1a study in an appropriate setting given the constraints of the COVID-19 pandemic. and as determined by the treating physician and patients. As previously announced, we have temporarily paused the screening and enrollment of patients in the Phase 1b Randomized Placebo Control Study to ensure that the participating clinical sites can focus on meeting the needs of patients with COVID-19 and to protect the safety of study participants, investigators and staff. These pause will also help preserve the study and data integrity as there are numerous assessments that require a specific clinical setting and we want to have confidence that the clinical environment will allow these assessments to be conducted at the time period specified in the protocol. Based on our current assessment and information from the clinical sites, we expect this post to be limited and therefore to initiate enrollment in this study in the second or third quarter of 2020. Throughout the first quarter of 2020, we also continue to make progress in advancing our CAR-T pipeline. We expect that our collaborators at Memorial Sloan Kettering will submit an IND application to the FDA in the second or third quarter of 2020 for our next-generation mesothelin-targeted autologous CAR-T immunotherapy, ATA2271 ATA2271 is designed to improve efficacy, persistence, and durability of response using novel 1XX-CAR co-stimulatory domain and cell-intrinsic checkpoint inhibition technology with a PD-1 dominant negative receptor. Preclinical data from ATA2271 IND enabling studies have been accepted as a late-breaking e-poster at the AACR virtual annual meeting in June, and the abstract will be released on May 15. We also expect that MSK will present additional clinical data for the academic first-generation program in the second half of this year. We have also initiated preclinical IND enabling studies, for off-the-shelf allogenic mesothelin-targeted CAR-T, aka 3271, as well as for aka 3219, or CD19-targeted CAR-T. Both of these programs utilize our next-generation CAR-T technologies and eBVT cell platform. ATA 3219, in particular, is supported by the initial proof of principles from an academic of the shelf allogeneic EBV CD19 CAR T clinical study presented at the 2020 DCT meetings, which to date show the longest duration of response for an allogeneic CD19 CAR T with 26.9 months median follow-up. As we advance multiple innovative programs and generate a growing body of promising clinical data We are increasingly confident that our eBVT cell platform and technologies are strongly positioned to provide patients with meaningful clinical benefit and create tremendous value for shareholders. eBVT cells offer numerous advantages as the basis of our allogenic platform. They are potent cell killers that specifically target disease cells, are safe, traffic to the site of disease, expand, and persist in patients. Beyond the therapeutic potential of our platform, we also have a robust and scalable manufacturing capability that is nearing commercial readiness. We are on track to complete commercial validation this year and have the ability to rapidly deliver products from inventory to patients in the US, Europe, and Australia in three days or less. We continue to innovate at our manufacturing facility in Southern California. Over time, We expect to further increase manufacturing yields to bring ATARA off-the-shelf allogenic T-cell therapy cost-of-goods manufactured in range with those of traditional biologics. In addition to the significant progress we achieve in the first quarter in our clinical, preclinical, and manufacturing activities, we also continue to attract highly talented individuals to the ATARA team. I am confident in the leadership team we are building out including Ron Renaud, who has been appointed as our new non-executive board chair, and Ammar Murugan, who has named senior vice president and general counsel. We are making tremendous progress on hiring a new head of R&D and currently expect to make this announcement in the very near future. We are on track to achieve our key 2020 objectives, and I strongly believe that we have the team, the technology, and the passion to succeed in our mission of innovating with transformative immunotherapies that have the potential to improve outcomes for patients with serious disease. Now turning to our financial results. We ended the first quarter of 2020 with $214.6 million in cash, cash equivalents and short-term investment. This is a decrease of $44.5 million from the prior quarter, and Reflect Cash used from operating activities of 67 million offset by net proceeds from our at-the-market facility or ATM of 23.1 million. We believe our cash, cash equivalent and short-term investment as of March 31, 2020 are sufficient to fund planned operations into the second quarter of 2021. In summary, Despite operating in these unique and changing times, we remain committed to our mission and believe that we'll be able to continue advancing our programs in the months ahead. I believe that this experience will only strengthen our resolve and commitment to our company and the patients we seek to serve. I know that many of you are experiencing disruption in your own professional and personal lives, and I truly appreciate your time today. I also want to take this opportunity to thank our staff and our clinical collaborators for continuing to support our trials as they face their own challenges in caring for patients in an unprecedented environment. Also, I want to ensure the patients currently participating or interested in participating in our studies that we remain committed to their safety and are positioned to continue dosing in our ongoing studies as they and their physicians deem appropriate. We understand that the pandemic is another significant obstacle in what is already a tremendously challenging patient journey. And we are doing everything in our power to minimize its impact on how we move forward. I hope that everyone on the call today is staying safe and healthy, and I look forward to sharing our progress with you in the weeks and months ahead. I now turn the call back to the operator to begin the Q&A portion of the call. Operator?