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Edited Transcript of ATRA earnings conference call or presentation 27-Feb-20 1:00pm GMT

·33 min read

Q4 2019 Atara Biotherapeutics Inc Earnings Call SOUTH SAN FRANCISCO Feb 28, 2020 (Thomson StreetEvents) -- Edited Transcript of Atara Biotherapeutics Inc earnings conference call or presentation Thursday, February 27, 2020 at 1:00:00pm GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * John Craighead Atara Biotherapeutics, Inc. - VP of IR & Corporate Communications * Manher Joshi Atara Biotherapeutics, Inc. - Senior VP & Chief Medical Officer * Pascal Touchon Atara Biotherapeutics, Inc. - President, CEO & Director ================================================================================ Conference Call Participants ================================================================================ * Benjamin Jay Burnett Stifel, Nicolaus & Company, Incorporated, Research Division - Associate * John Lawrence Newman Canaccord Genuity Corp., Research Division - Principal & Senior Healthcare Analyst * Matthew Christopher Phipps William Blair & Company L.L.C., Research Division - Senior Research Analyst * Philip M. Nadeau Cowen and Company, LLC, Research Division - MD & Senior Research Analyst * Salim Qader Syed Mizuho Securities USA LLC, Research Division - MD, Senior Biotechnology Analyst of Equity Research & Head of Biotechnology Research * Tessa Thomas Romero JP Morgan Chase & Co, Research Division - Associate ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Good morning, ladies and gentlemen, and welcome to the Atara Biotherapeutics Q4 and Full Year 2019 Financial Results Conference Call. (Operator Instructions). I'd now like to turn the conference over to your host, Dr. John Craighead, Vice President of Investor Relations and Corporate Communications of Atara Biotherapeutics. Please go ahead. -------------------------------------------------------------------------------- John Craighead, Atara Biotherapeutics, Inc. - VP of IR & Corporate Communications [2] -------------------------------------------------------------------------------- Thank you, operator. Good morning everyone, and welcome to Atara's fourth quarter and full year 2019 conference call. On today's call, we will provide an update of our clinical, operational and strategic progress, as well as a review of our upcoming milestones and key objectives for 2020. Earlier this morning, we issued a press release providing an overview of the company's fourth quarter and full year 2019 financial results. This press release and an updated investor presentation are available in the Investor & Media section at atarabio.com. Joining me on today’s call are Dr. Pascal Touchon, President and Chief Executive Officer; Utpal Koppikar, Chief Financial Officer; and Joe Newell, Chief Operations Officer; and Dr. AJ Joshi, Chief Medical Officer. We begin with prepared comments from Pascal and then open 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 Atara's President and Chief Executive Officer, Pascal Touchon. -------------------------------------------------------------------------------- Pascal Touchon, Atara Biotherapeutics, Inc. - President, CEO & Director [3] -------------------------------------------------------------------------------- Thank you, John. And thanks to all of you for joining us this morning. 2019 was a year of strategic prioritization and significant advancement of our T-cell immunotherapy programs. I would like to highlight that we've made important progress on our 4 strategic priorities, we have also extended our cash position into Q2 2021, and we continue to leverage our tab-cel experience to advance our innovative off-the-shelf T-cell immunotherapy platform. Building on this significant progress and momentum, let me start by reviewing the recent highlights and anticipated milestones for tab-cel. We are currently conducting a Phase III clinical trial with tab-cel in patients with Epstein-Barr virus, or EBV associated post-transplant lymphoproliferative disease, or PTLD, in the relapse/refractory setting. Atara remains on track to initiate a tab-cel BLA submission to the FDA in the second half of 2020. We currently have 38 sites in the United States and Australia actively enrolling patients and are preparing to open additional sites in the U.S., Canada and Europe. Toward this end, we submitted clinical trial applications, or CTAs, to several European countries in November and December of 2019, which will allow us to open clinical sites in Europe in 2020. We are excited as we recently received CTA approvals in the U.K., Austria and Spain. These additional sites are being added to support full enrollment of the Phase III study. However, they are not necessary to meet the number of patients required for the planned Phase III interim analysis. Indeed, as I just mentioned, we continue to be on track to initiate a tab-cel BLA submission for patients with EBV positive PTLD in the second half of 2020. We plan to hold a pre-BLA meeting with the FDA, prior to this submission, during which we will discuss the totality of tab-cel data; we, and our academic collaborators have generated; including the Phase III HCT and SOT cohorts, MSK Phase II studies and our expanded access program. As a reminder, we most recently presented data from this EAP in December 2019 at ASH annual meeting. These data comprised long-term clinical results for 61 patients with diverse EBV-associated diseases, including efficacy and safety data for 26 patients with relapsed/refractory EBV positive PTLD and safety findings for 35 patients with other EBV-associated diseases. The data demonstrate that tab-cel was generally well tolerated in all patients participating to this study. Importantly, in a subgroup of 22 patients with EBV positive PTLD, who would have likely met eligibility criteria for the ongoing tab-cel Phase III study, the overall response rate for the HCT cohort was 55%, with a 2-year estimated overall survival of 79%. For the SOT cohort overall response rate was 82% and 2-year estimated overall survival was 81%. We are also engage in multiple activities designed to expand access to tab-cel for patients in Europe. Atara recently submitted a Pediatric Investigation Plan, or PIP, to EMA. Following EMA approval of the PIP, Atara plans to submit a tab-cel EU marketing authorization applications for patient with EBV positive PTLD in 2021. The clinical data generated to date with our EAP and SPU programs also support the potential of tab-cel as a transformative therapy in several other EBV-associated diseases. In the second half of 2020, we expect to initiate enrollment of a tab-cel Phase II multi-cohort study, including up to 6 additional ultra-rare EBV positive diseases. In addition, we have enrolled the final planned patients in the Phase Ib portion of a Phase 1b/2 clinical study of tab-cel in combination with anti-PD-1 therapy in patients with platinum-resistant or recurrent EBV-associated nasopharyngeal carcinoma, NPC. Prior to starting the Phase II portion of the study, we will evaluate the initial results of this Phase Ib, as well as the relapsed/refractory NPC clinical landscape. I will now turn to ATA188, our allogeneic T-cell immunotherapy for the treatment of patients with progressive multiple sclerosis. Recall that at ECTRIMS 2019, we reported encouraging early data from a Phase Ia multicenter, open-label, dose-escalation study evaluating the safety and efficacy of ATA188 in patients with progressive form of MS. Safety results showed that across the full dose cohorts, ATA188 was well-tolerated in patients with progressive MS. We reported at 6 months follow up, in the lowest dose cohort, 1 of 6 patients with clinical improvement using the criteria we defined at ECTRIMS. This improvement was also maintained at 12 months. In Cohort 2, 2 out of 6 patients reached clinical improvement at 6 months. We recently selected the Cohort 3 dose to initiate the randomized, double-blind, placebo-controlled Phase Ib part of this study. Our decision to initiate the Phase Ib was based on achieving, in Cohort 3, a pre-determined criteria of an acceptable safety profile and 3 out of 6 patients achieving clinical improvement at 6 months from more than 1 clinical study site. Looking ahead, we expect to present updated clinical data at appropriate forums, including 6 months follow up for all cohorts in Q2 2020 and 12 months follow up for all cohorts in the second half of 2020. Additionally, we recently re-treated the first patients in the open label extension portion of the Phase Ia study, which is designed to allow patients who complete 1 year in the dose-escalation portion of the study to be re-treated annually using the Cohort 3 dose for up to 4 years. We are also on track to initiate enrollment of a randomized, placebo-controlled Phase Ib ATA188 study in the second or third quarter of 2020. Site activation for this study is in process, and we are expecting an increased number of leading MS centers to participate in the U.S. and Australia. In addition, Atara and leading experts recently published a review article in Trends in Molecular Medicine regarding the mechanistic connection between EBV infection and MS. Now, let’s discuss our EBV CAR-T platforms. At the 2020 Transplantation and Cellular Therapy meeting last week, an academic team presented a clinical study in patients with relapsed/refractory B-cell malignancies treated with an off-the-shelf allogeneic CD19 CAR T made from primary donor or partially HLA matched third-party donor EBV T cells. In this first-in-human study with these EBV CD19 CAR-T cells, investigators observed durable complete responses for 5 out of 6 patients, who received partially HLA matched EBV CD19 CAR-T cells manufactured from third-party donors. No cytokine release syndrome or neurotoxicity above Grade 2, and no dose-limiting toxicities were observed post-infusion, with multiple EBV CD19 CAR-T doses. Also, no confirmed GvHD was observed in patients who received third-party donor EBV CD19 CAR-T cells. Importantly, investigators also observed durable complete response CR with median follow up of 26.9 months for 5 out of 6 patients who received partially HLA matched EBV CD19 CAR-T cells manufactured from third-party donors including 4 out of 4 responses in patients with NHL, 1 out of 1 response in patient with CLL, and 100% survival with NHL and CLL. Findings from this study provide initial clinical proof-of-principle that an EBV T-cell platform has the potential to generate off-the-shelf, allogeneic CAR-T immunotherapies with high and durable responses, low risk of toxicity and rapid delivery to patients. We've continued to make progress in advancing our multiple CAR-T therapeutic candidates. We expect that our collaborators at MSK will submit an IND to the FDA in the second or third quarter of 2020 for ATA2271, an autologous mesothelin targeted CAR-T in patients with advanced mesothelioma. This program incorporates next-generation technologies, including a novel costimulatory domain, 1XX, that may offer greater persistence and more physiologic T-cell signaling as well as a PD-1 dominant negative receptor that is designed to provide intrinsic checkpoint inhibition and unlock the solid tumor microenvironment. Furthermore, we have started preclinical IND enabling studies for ATA3271, an off-the-shelf, allogeneic EBV mesothelin-targeted CAR-T with the same next gen CAR-T technologies as ATA2271. In addition, we have started preclinical IND enabling studies for ATA3219, an EBV CD19-targeted CAR-T that incorporates 1XX. We believe Atara's off-the-shelf, allogeneic EBV CAR-T platform is differentiated and has tremendous potential as an engine for continued innovation leveraging favorable EBV T-cell safety, expansion, trafficking and persistence characteristics. Our dedicated facility in Thousand Oaks has the flexibility to produce multiple T cell and CAR-T immunotherapies and integrates preclinical and translational research, process sciences, quality control and regulatory CMC capabilities under one roof. Such close integration enables a rapid development and scale up of robust manufacturing processes to support a potential current and future clinical and commercial demand. The efficiency of our manufacturing platform capabilities has recently been demonstrated with significant improvement in our manufacturing yield with tab-cel. Our commercial stage process is now enabling us to make over 400 doses from a single donor leukapheresis. Over time, we believe our commercial manufacturing process will allow for a cost of goods profile similar to those of biologics. In addition, with our lead program already in Phase III, and T-cell manufacturing commercial validation activities progressing well, we are creating a significant competitive advantage for Atara in off-the-shelf, allogeneic T-cell immunotherapies. Not surprisingly, we are seeing a strong level of interest from potential partners to access our off-the-shelf T-cell platform and we also see opportunities for potential partnerships with the current product portfolio. On the operational front, earlier this month we are pleased to welcome Kristin Yarema as our new Chief Commercial Officer. Dr. Yarema brings extensive hematology, oncology, neuroscience and autoimmune disease commercialization experience to Atara, which are very valuable as the company advances commercialization activities for tab-cel. We also created a Chief Operations Officer role to continue to drive operational excellence across the company program and platform and have appointed Joe Newell, Atara’s current Chief Technical Operations Officer, to this new role. Turning to our financial positions, we extended our cash [runway] into the second quarter of 2021. We ended 2019 with cash, cash equivalents and short-term investments totaling $259.1 million as compared to $282.9 million as of September 30, 2019. Of note, pro forma cash and investments as of December 31, 2019, including ATM and option exercise proceeds from January 2020, was $282.7 million. In closing, the progress we made in 2019 has positioned us well for tremendous success this year, delivering on key milestones for tab-cel, our lead pipeline candidate and further advancing other promising programs through the hard work of all Atara's employees. I’ll now turn the call back to the operator to begin the Q&A portion of the call. Operator? ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- (Operator Instructions). Your first question comes from the line of Phil Nadeau with Cowen and Company. -------------------------------------------------------------------------------- Philip M. Nadeau, Cowen and Company, LLC, Research Division - MD & Senior Research Analyst [2] -------------------------------------------------------------------------------- Just a couple on tab-cel. First, since you're guiding to having a pre-BLA meeting in the second half of this year and starting the filing, even later in the second half this year. It would seem that you've sufficiently enrolled enough patients for the interim analysis. Is that accurate? -------------------------------------------------------------------------------- Pascal Touchon, Atara Biotherapeutics, Inc. - President, CEO & Director [3] -------------------------------------------------------------------------------- We are not making any comment on the enrollment at this stage. And we're confirming our guidance that we plan to initiate filing of the BLA in the second half of 2020 following a pre-BLA meeting with the FDA, where we will present the totality of data. -------------------------------------------------------------------------------- Philip M. Nadeau, Cowen and Company, LLC, Research Division - MD & Senior Research Analyst [4] -------------------------------------------------------------------------------- And what's your most recent thinking on, when you publicly release the data from the interim analysis, is that likely to happen with the filing or would it be some time later? -------------------------------------------------------------------------------- Pascal Touchon, Atara Biotherapeutics, Inc. - President, CEO & Director [5] -------------------------------------------------------------------------------- As we said, we plan to, of course, present this data on the study at an appropriate congress. But we do not intend to do that before the filing. And we want to preserve the integrity of what is an open clinical study, where we will start to initiate the filing with an interim analysis of the data. So, we will certainly discuss with the FDA, during a pre-BLA meeting, what is the best way to be able to communicate this data in due time. But at same time, the initiation of the BLA filing by itself is a material event, so we will indeed communicate publicly that we have initiated the BLA filing. -------------------------------------------------------------------------------- Philip M. Nadeau, Cowen and Company, LLC, Research Division - MD & Senior Research Analyst [6] -------------------------------------------------------------------------------- And last question from me is on the requirements for completing the filing and starting the PDUFA time clock. Do you think you'll be in a position to clarify what those requirements are at the time of the BLA filing -- at the time of the initiation and filing, or will even more in subsequent discussions happen with the FDA once the initial filing is made as to exactly what will be necessary to get the PDUFA time clock started? -------------------------------------------------------------------------------- Pascal Touchon, Atara Biotherapeutics, Inc. - President, CEO & Director [7] -------------------------------------------------------------------------------- When we will communicate about the initiation of the BLA filing, we will be hopefully able to give more details on that particular BLA filing, and hence about what is the anticipated time of completion. -------------------------------------------------------------------------------- Operator [8] -------------------------------------------------------------------------------- Your next question comes from the line of John Newman with Canaccord. -------------------------------------------------------------------------------- John Lawrence Newman, Canaccord Genuity Corp., Research Division - Principal & Senior Healthcare Analyst [9] -------------------------------------------------------------------------------- Just curious, it sounds like you have been adding additional trauma sites for tab-cel, just wondering if you have a target number in mind, the total number of sites that you would like to have open and actively involving patients. -------------------------------------------------------------------------------- Pascal Touchon, Atara Biotherapeutics, Inc. - President, CEO & Director [10] -------------------------------------------------------------------------------- Thank you John, for your question. AJ, do you want to take that one? -------------------------------------------------------------------------------- Manher Joshi, Atara Biotherapeutics, Inc. - Senior VP & Chief Medical Officer [11] -------------------------------------------------------------------------------- Sure. So I think, first off, we have, as you know, we have 38 sites open in the U.S. today. And it's important to note that those 38 sites are the number that's necessary to achieve that interim analysis time point so that we can have the initiation of the BLA in the second half of 2020. In terms of Europe, Canada and other sites, I can give you a general sense that in Europe we would run probably up to about 24 sites. -------------------------------------------------------------------------------- John Lawrence Newman, Canaccord Genuity Corp., Research Division - Principal & Senior Healthcare Analyst [12] -------------------------------------------------------------------------------- And then in terms of the data that are coming this year for ATA188 in MS, how should we be thinking about, kind of, the key points on that data? I know that you have sort of a different way of looking at the [SOT] based on deposit. Just curious as to how we should be thinking about the SOT when you give us the data with the 6 and 12 months follow-up there. -------------------------------------------------------------------------------- Manher Joshi, Atara Biotherapeutics, Inc. - Senior VP & Chief Medical Officer [13] -------------------------------------------------------------------------------- Sure. So, in the first half of 2020, we should expect 6 months data on all 4 cohorts and then also 12 months data on the first 3 cohorts. We've talked about the types of analysis that we do in the initial -- the way we described the initial data was really meant as -- for signal seeking and making decisions about the TRAF. And as you know we've achieved our goals in the Phase I study, which is safety and the decision to move forward with the Cohort 3. We do expect to present some additional composite disability measures in that first half 2020 timeframe as well as the second half. -------------------------------------------------------------------------------- Operator [14] -------------------------------------------------------------------------------- Your next question comes from the line of Matt Phipps with William Blair. -------------------------------------------------------------------------------- Matthew Christopher Phipps, William Blair & Company L.L.C., Research Division - Senior Research Analyst [15] -------------------------------------------------------------------------------- First, I guess, a follow-up on Philip's question. So, really the next kind of material disclosure we get on tab-cel then would be the initiation of the rolling submission, is that correct or could there be a material update ahead of that? -------------------------------------------------------------------------------- Pascal Touchon, Atara Biotherapeutics, Inc. - President, CEO & Director [16] -------------------------------------------------------------------------------- So current plan is, as I said, to communicate what we believe will be a material update i.e., the initiation of the BLA filing in the second half of 2020. -------------------------------------------------------------------------------- Matthew Christopher Phipps, William Blair & Company L.L.C., Research Division - Senior Research Analyst [17] -------------------------------------------------------------------------------- And then just 2 other questions on the pipeline, I guess, you mentioned the final patient was enrolled in the nasopharyngeal carcinoma study. Is it possible to see results later this year or is that something for early '21? And then I realize this is an investigator sponsored study, but do you anticipate MSK providing an update on the first gen mesothelin CAR at some point this year? I know they've been enrolling patients beyond mesothelioma as well, so, just curious if you had any discussions with them on their plans there. -------------------------------------------------------------------------------- Pascal Touchon, Atara Biotherapeutics, Inc. - President, CEO & Director [18] -------------------------------------------------------------------------------- Okay. Thank you, Matt. First question, AJ. -------------------------------------------------------------------------------- Manher Joshi, Atara Biotherapeutics, Inc. - Senior VP & Chief Medical Officer [19] -------------------------------------------------------------------------------- Sure. So Matt, regarding the NPC study, the -- we've enrolled -- as you indicated, we enrolled the final patient in the Phase Ib portion of the study, and our anticipation is, we're going to evaluate the results and act to the entire NPC landscape, because as you know that whole treatment landscape has been evolving. So, as the results mature and we assess to the landscape, we'll then make decisions as to the appropriate forum to present those assessments. -------------------------------------------------------------------------------- Pascal Touchon, Atara Biotherapeutics, Inc. - President, CEO & Director [20] -------------------------------------------------------------------------------- And second question. Regarding the first innovation mesothelin CAR-T, as you said this is an investigator's initiated study. What we understand is that the investigator is continuing to follow-up these patients and are also including additional patients in that study. It is -- we understand the intent of the investigator at the appropriate stage to communicate further results of that study in a congress. We cannot comment at this stage on which one, when exactly that will occur but that's certainly the plan of the investigator. -------------------------------------------------------------------------------- Operator [21] -------------------------------------------------------------------------------- (Operator Instructions) Your next question comes from the line of Salim Syed with Mizuho Securities. -------------------------------------------------------------------------------- Salim Qader Syed, Mizuho Securities USA LLC, Research Division - MD, Senior Biotechnology Analyst of Equity Research & Head of Biotechnology Research [22] -------------------------------------------------------------------------------- Just a few from me on the multiple sclerosis program. AJ, did I hear you correctly in saying that we're going to be getting 12 months data either at AAN or EAN for the Cohort 3? -------------------------------------------------------------------------------- Manher Joshi, Atara Biotherapeutics, Inc. - Senior VP & Chief Medical Officer [23] -------------------------------------------------------------------------------- So, in terms of 12 months data in the first half of 2020, absolutely, we would be getting 12 months Cohorts 1 through 3. -------------------------------------------------------------------------------- Salim Qader Syed, Mizuho Securities USA LLC, Research Division - MD, Senior Biotechnology Analyst of Equity Research & Head of Biotechnology Research [24] -------------------------------------------------------------------------------- Okay. For all 6 patients in that cohort? -------------------------------------------------------------------------------- Manher Joshi, Atara Biotherapeutics, Inc. - Senior VP & Chief Medical Officer [25] -------------------------------------------------------------------------------- Yes. -------------------------------------------------------------------------------- Salim Qader Syed, Mizuho Securities USA LLC, Research Division - MD, Senior Biotechnology Analyst of Equity Research & Head of Biotechnology Research [26] -------------------------------------------------------------------------------- So, when we're thinking about ATA188, I know this was something that came up at ECTRIMS last year. Are you guys still thinking here that the -- that we're going to need 12 months data for investors to really diligence the ATA188 efficacy profile or will 6 months data be enough, when we're going into AAN and EAN, where we present the data, will that be enough of a time duration to diligence this data set? -------------------------------------------------------------------------------- Manher Joshi, Atara Biotherapeutics, Inc. - Senior VP & Chief Medical Officer [27] -------------------------------------------------------------------------------- Yes, I think when you take a look at, certainly in all MS studies, you'd like to see some duration of response. So like anything else, 12 months is better than 6 months. When we talk about the ultimate proof of concept that certainly is going to come at the 1-year endpoint of the Phase Ib randomized portion but certainly the 12 months data off of this portion of the study would provide good additional support, I think. -------------------------------------------------------------------------------- Salim Qader Syed, Mizuho Securities USA LLC, Research Division - MD, Senior Biotechnology Analyst of Equity Research & Head of Biotechnology Research [28] -------------------------------------------------------------------------------- And lastly for me, on the re-dosing for multiple sclerosis, are you guys expecting upon re-dosing that -- the 1-year time point and the 2-year time point, further improvement in disability or some sort of plateauing? -------------------------------------------------------------------------------- Manher Joshi, Atara Biotherapeutics, Inc. - Senior VP & Chief Medical Officer [29] -------------------------------------------------------------------------------- Okay. We don't really have data to suggest one way or the other, obviously, we'd love it if we have further improvement. But I think the most important thing is, whatever improvement we achieve, if you're able to maintain that, that is already a major win in progress of MS, so that should be our baseline that we work off of. -------------------------------------------------------------------------------- Operator [30] -------------------------------------------------------------------------------- Your next question comes from the line of Ben Burnett with Stifel. -------------------------------------------------------------------------------- Benjamin Jay Burnett, Stifel, Nicolaus & Company, Incorporated, Research Division - Associate [31] -------------------------------------------------------------------------------- So, this is a question regarding CAR-T. So, how has the Memorial Sloan Kettering study impacted your thinking on lympho depletion? And whether or not this needs to be done? And to what extent you think this could be done in the out-patient setting? -------------------------------------------------------------------------------- Pascal Touchon, Atara Biotherapeutics, Inc. - President, CEO & Director [32] -------------------------------------------------------------------------------- Thank you for your question. And I think, as you know this study that was presented last week is an academic study in 10 patients and that study has gone for some time with different type of lympho depleting regimen using these patients. So, we do not think we can draw a conclusion right now on what will be possible, if any, at least for depletion regimen for ATA3219. This is something that we plan to study in our first-in-human study. However, what we're going to do is to work with MSK on this particular sets of data that they have, and more particularly on samples that they have, of blood marrow and blood to be able to better understand the expansion and persistence of the EBV CAR-T CD19 T-cells in these patients and see whether there is any relationship whatsoever with the lympho depleting regimen that they've had. So, that will be informative for us as we design the protocol off of first-in-human study with ATA3219. -------------------------------------------------------------------------------- Benjamin Jay Burnett, Stifel, Nicolaus & Company, Incorporated, Research Division - Associate [33] -------------------------------------------------------------------------------- And then just 1 more question on ATA2271. What's gating for the mesothelioma IND submission and are there any plans to develop this in addition in solid tumors outside of mesothelioma? -------------------------------------------------------------------------------- Pascal Touchon, Atara Biotherapeutics, Inc. - President, CEO & Director [34] -------------------------------------------------------------------------------- So, thank you. There is no particular gating, it's just the time we need to put together all the data, things have on site focusing well. And of course, it will be the time then to submit that IND. As we stated it will be done by our collaborators at MSK in the second or third quarter of 2020. Now, the first-in-human with this very innovative construct of CAR-T is going to be in advanced mesothelioma. But we are already discussing with investigators about the possibility to use this construct, this new CAR-T in other type of solid tumors that are overexpressing mesothelin and particularly so, ovarian cancer and pancreatic cancer. -------------------------------------------------------------------------------- Operator [35] -------------------------------------------------------------------------------- Your next question comes from the line of Anupam Rama with JP Morgan. -------------------------------------------------------------------------------- Tessa Thomas Romero, JP Morgan Chase & Co, Research Division - Associate [36] -------------------------------------------------------------------------------- This is Tessa on the call today for Anupam. Thank you for taking the questions here. Perhaps I could ask about your most up-to-date thoughts on the market size for the NHL EBV positive relapsed refractory PTLD indication in the U.S. and then maybe at U.S. as well in key geographies. And then, how are you thinking about sort of the size and scope of sales infrastructure to sort of address these -- the patients, globally. -------------------------------------------------------------------------------- Pascal Touchon, Atara Biotherapeutics, Inc. - President, CEO & Director [37] -------------------------------------------------------------------------------- Thank you very much for your question. So, as we already indicated, we believe that in the U.S., the setting of our studies that could lead to a potential indication in relapse refractory PTLD is around -- it's an ultra-rare disease, which means that we believe there are several hundred patients in the U.S. that could benefit potentially from tab-cel. We believe also that a similar number exists in Europe. And also a similar type of number exists in the rest of the world beyond the United States and Europe. So, this is an ultra-rare indication, this is our first indication for tab-cel that we hope will be followed by several other indication. As we confirmed today, we're going to start in the second half of 2020 enrolling a multi-cohort study, with up to 6 types of ultra-rare disease that could lead up to 6 additional indications there, that are going to increase the size, we believe, by at least a factor of 4 of the population that could be treated efficiently by tab-cel. In terms of the commercial organization that is needed there, we -- this being an ultra-rare disease and having no other treatment approved today for the disease. We believe that the commercial organization that will be needed to make sure the patient can access tab-cel is of limited size. And so will be typical often ultra-rare disease type of commercial organization. -------------------------------------------------------------------------------- Operator [38] -------------------------------------------------------------------------------- Your next question comes from the line of Maury Raycroft with Jefferies. -------------------------------------------------------------------------------- Unidentified Analyst, [39] -------------------------------------------------------------------------------- This is [Faiti Ram] for Maury. So the MSK data looked quite promising especially on the overall survival aspects. But how confident are you that the non-standard conditioning lympho-depletion contributed to the survival benefit? -------------------------------------------------------------------------------- Pascal Touchon, Atara Biotherapeutics, Inc. - President, CEO & Director [40] -------------------------------------------------------------------------------- So again, this study is, we believe, a clinical proof-of-principle that the EBV based CD19 CAR-T allogenic off-the-shelf as the 6 patients, where the cells were coming from third-party donors are demonstrating, is feasible, is safe and is effective. Now, there are a limited number of patients, we recognize that, as well as, different type of disease. But altogether, the comprehensive nature of this data are a clear clinical proof-of-principle that a allogenic off-the-shelf CD19 EBV CAR-T are again, safe and effective. And we are particularly encouraged by the long-term durability of the response. If you think that 5 out of 6 patient with CR and this CR being durable with in fact survival following the follow-up of 26.9 months survival of 100% in a patient with NHL and CLL, these are very encouraging data about the effect of these allogenic off-the-shelf EBV CD19 CAR-Ts. -------------------------------------------------------------------------------- Unidentified Analyst, [41] -------------------------------------------------------------------------------- And have you considered, like what conditioning regimen and variables you're going to do in your ATA run study and which ones you should focus on? -------------------------------------------------------------------------------- Pascal Touchon, Atara Biotherapeutics, Inc. - President, CEO & Director [42] -------------------------------------------------------------------------------- First of all, what we're doing to go into the clinic is a different product. This is ATA3219, which is also based on EBV T cells, but using Atara on process and especially using a new costimulatory domain 1XX, which is there to bring increase -- potentially increase persistence of the cells and less exertion of the T cells. So that's a different product. But of course, we will be informed in our first-in-human study protocol and follow up, by the experience that this academic team has obtained with this construct, which is again a different product from ATA3219. But that's why we say that this is a clinical proof-of-principle, but ATA3219 is really the product we are supporting the development of, we have started, as we said, technical IND enabling studies for that product to bring it to the clinic as soon as possible, and to be able to prove the concept of our EBV T cell CAR-T platform and the ability to treat patients safely, effectively with an off-the-shelf treatment that could be available within days to patients. -------------------------------------------------------------------------------- Operator [43] -------------------------------------------------------------------------------- Your next question comes from the line of Tony Butler with Roth Capital. -------------------------------------------------------------------------------- Unidentified Analyst, [44] -------------------------------------------------------------------------------- This is [Tash] dialing in for Tony here. Just a quick question on 3219, in continuation of your latest comment. Based on the learnings from the TCT Congress data. Do you have any specific plan as to what kind of population that you will be targeting with say CLL, NHL versus ALL? -------------------------------------------------------------------------------- Pascal Touchon, Atara Biotherapeutics, Inc. - President, CEO & Director [45] -------------------------------------------------------------------------------- We are not communicating, at this stage, what will be the protocol and the type of patients we'd address in our first-in-human but we'll do so at the appropriate time. Clearly, we believe that there is a medical need today that still exist in the population of NHL patient, CLL patient, ALL patients, we will have ourselves to decide at the time we enter the clinic where we want to focus. But we believe that ATA3219 has the potential to bring significant benefit to patients. -------------------------------------------------------------------------------- Operator [46] -------------------------------------------------------------------------------- Your next question comes from the line of Yigal Nochomovitz with Citi. -------------------------------------------------------------------------------- Unidentified Analyst, [47] -------------------------------------------------------------------------------- Hi, this is [Samantha] for Yigal. Thanks for taking our questions. I wanted to sort of build on a prior question on the EBV CAR-T study presented at TCT. Can you talk about any other differences outside of the 1XX stimulatory domain that [ATA319] will have versus the CAR-T season out study. And with these differences between the 2 products, which should we think about the read through in terms of the data that was presented there, and the differences you think might show up in your clinical program? -------------------------------------------------------------------------------- Pascal Touchon, Atara Biotherapeutics, Inc. - President, CEO & Director [48] -------------------------------------------------------------------------------- So a few things, first of all, what we are doing with ATA3219 is to develop a product, through a proper manufacturing process and development phase. So, this will not be an academic type of study, it will be Atara study developing that particular product. And the differences that we anticipate at this time is mainly the difference in a co-stimulatory domain as well as in the manufacturing process to have a product that not only allows us to prove in the clinic, potentially safety, efficacy and persistence and durability there. But also this is helping to build a platform of alloCAR-T. As you know, ATA3219 is just one of the allogenic EBV based CAR-T that we are developing, and advancing that would -- pre IND enabling studies, IND first-in-human is going to help us to continue to progress with our platform. We've made significant progress about it. And we're going to leverage that progress. So, 2 key differences will be 1XX and the manufacturing process. And we believe that in particular, 1XX is going to bring some significant potential advantage. In preclinical studies, this particular co-stimulatory domain as shown, that is indeed inducing less exertion of the T cells and more persistence, so that's something that is certainly going to bring some potential benefit. And at the same time, the fact that we built a robust manufacturing process, allowing us not only to make allogenic CD19 CAR-T based on the EBV T cells, but other type of allogenic CAR-T based on EBV T cells will be something very important, there. And there was some particular details in the presentation of the academic team last week. Just to give you an example, the level of CAR-T cells [transfixion] that they had at 20.5% is something that we believe can and is to be improved by our manufacturing process as well as the yield, the possibility to make significant number of doses from 1 Leukopak. As you know recently we've announced that with tab-cel, which is at the beginning the same type of process, where we harvest cells from healthy donors, we select and activate these cells. We are now able to make 400 doses from 1 Leukopak. So this type of efficiency of our manufacturing process is what we want to see in the manufacturing of ATA3219. And the preclinical stage we are at right now is indicative that we are on the right track in terms of making not only rapidly bringing the product to the clinic but also making, manufacturing this product in a very efficient way. -------------------------------------------------------------------------------- Unidentified Analyst, [49] -------------------------------------------------------------------------------- That sort of leads into my other question. When we think about your CAR-T pipeline long-term, should we anticipate you using the EBV CAR-T apart from that you mentioned you're building out here and you had a comment about partnering potential. Is it this platform that you're thinking about versus say like this partnership with MSK for the ATA2271? -------------------------------------------------------------------------------- Pascal Touchon, Atara Biotherapeutics, Inc. - President, CEO & Director [50] -------------------------------------------------------------------------------- Thank you for your question. So, clearly our current pipeline in CAR-T in terms of strategic priority is having 2 allogeneic CAR-T based on EBV T-cells, ATA3219, that is in preclinical IND enabling study; and ATA3271, the mesothelin targeted allogeneic CAR-T that is also in preclinical IND enabling study. So these are the two that are the most advanced. We have also activities with our collaborators at Memorial Sloan Kettering as well as at Moffitt Cancer Center in Tampa, where at the earlier stage we have some exciting type of CAR-T that are being developed and these are developed first by these academic collaborators as autologous CAR-T. And once we are moving into full development, we're going to, as usual, develop an allogeneic version based on EBV T-cells. What we've built is a tool allogeneic CAR-T platform based on this EBV T-cells. And this is an allogeneic CAR-T platform that benefit from the work we've done on tab-cel, as well as the work we're doing on ATA188. So there is a clear correlation between these. We have the most advanced allogeneic T-cell immunotherapy with tab-cel, as it is now in Phase III and we don't know any other that is in Phase III at this stage right now. We have a robust manufacturing process there, we're going to leverage that and that's what we're doing everyday -- our team is doing everyday in our manufacturing unit, leveraging that experience to make robust and efficient process for allogeneic CAR-T based on EBV T-cells. Getting your question on partnering, as we said, we have a very advanced platform for allogeneic CAR-T. So that's why there is strong interest regarding the possibility to partner with -- around this platform, to be able to develop, create, develop and make allogeneic CAR-The, and at the same time we also open to discussion on partnering other assets of our pipeline. -------------------------------------------------------------------------------- Operator [51] -------------------------------------------------------------------------------- And I am showing no further question at this time. I would now like to turn the conference back to Pascal Touchon. -------------------------------------------------------------------------------- Pascal Touchon, Atara Biotherapeutics, Inc. - President, CEO & Director [52] -------------------------------------------------------------------------------- Thank you very much, Operator. So, thank you very much for being there today for our conference. Clearly, we are making significant progress. This is an exciting time for all of us at Atara. And I am very pleased to have had the opportunity to review recent accomplishments and discuss our upcoming milestones for 2020. We have a great deal of momentum coming in 2020 and I look forward to updating you on our continuous progress in the months ahead. We aim at transforming the lives of many patients in need across various serious disease and this is possible only from the contribution of many individuals to whom we are very thankful, including our shareholders, our committed employees, our clinical investigators, our academic collaborators, and of course all the patients that are participating in our studies. Thank you very much. -------------------------------------------------------------------------------- Operator [53] -------------------------------------------------------------------------------- Ladies and gentlemen, this concludes today's conference. Thank you for your participation and have a wonderful day. You may all disconnect.