Good morning, ladies and gentlemen, and welcome to the Atara Biotherapeutics Q4 and Full Year 2019 Financial Results Conference Call. At this time, all participants’ are in a listen-only mode. Later, we will conduct a question-and-answer session. I would 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.

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 review 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. A.J. Joshi Chief Medical Officer. We begin with prepared comments from Pascal and then open the call for your questions. We'd 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.

Thank you, John and thanks to all of you for joining us this morning. 2019 was a year of strategy prioritization and significant advancement of our T-cell immunotherapy programs. I would like to highlight that we've made important progress on all four 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 anticpated milestones for tab-cel. We are currently conducting a Phase 3 clinical trial with tab-cel in patients with Epstein-Barr virus or EBV associated post-transplant lymphoproliferative disease or PTLD in the relapsed factory setting. Atara remains on track to initiate a tab-cel BLA submissions 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. Towards this end, we submitted clinical trial application of CTA 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 approval in the U.K. Austria and Spain. These additional sites are being added to support full enrolment of the Phase 3 study or whether they are not necessary to meet the number of patients required for the plan phase 3 interim analysis. Indeed, as I just mentioned, we continue to be on track to initiate a tab-cel BLA submissions 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 the submission during which we will discuss the totality of tab-cel data,…

[Operator Instructions] Your first question comes from Phil Nadeau from Cowen & Company. You may ask your question.

Good morning. Thanks for taking my questions, and congrats on the progress. 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 later in the second half this year. It would seem that you've sufficiently enrolled enough patients for the interim analysis, is that accurate?

Thank you, Phil for your question. We are not making any comment on the enrollment at this stage. And we confirming our guidance that we plan to initiate filing of the BLA in the second half of 2020, following pre-BLA meeting with the FDA where we'll present the totality of data.

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 sometime later?

As we said, we plan to of course present these 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 a filing with an interim analysis of the data. So we will certainly discuss with the FDA, doing a pre-BLA meeting what is the best way to be able to communicate these data in due time, but at the same time, the initiation of the BLA filing by itself is a matter or event, so it will indeed communicate publicly that we are initiated the BLA filing.

Great. And last question for 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 filings made as to exactly what will be necessary to get the PDUFA time clock started?

Whether 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.

Got it. Perfect, thanks for taking my questions.

Your next question comes from the line of John Newman with Canaccord. You may ask your question.

Hi guys. Good morning. Thanks for taking my question. Just curious. It sounds like you have been adding additional trial 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 enrolling patients?

Thank you John for your question. A.J, you want to take that one.

Sure. So I think I'm 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 enrol probably up to that 24 sites.

Okay, great. 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 from that data? I know that you have sort of a different way of looking at the efficacy based on a composites. Just curious as to how we should be thinking about the efficacy, wouldn't you give us data with the six and 12 month follow up there?

Sure. So in the first half of 2020, we should expect six month data on all four cohorts, and then also 12 months data on the first three cohorts. The -- we've talked about the types of analysis that we do in the initial, the way we described the initial data was really meant for signal seeking and making decisions about the trial. And as you know, we've achieved our goal in the Phase 1 study, which is safety and the decision to move forward with a cohort 3. We do expect to present some additional, composite disability measures, in that first half 2020 timeframe as well as the second half.

Great. Thank you.

Your next question comes from the line of Matt Phipps with William Blair. You may ask your question.

Good morning. Yes, thanks for taking my questions. First, I guess follow up on Phil'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?

So our current plan is as I say to communicate what we believe will be a material update i.e. the initiation of the BLA filing in the second half of 2020.

Got it. Thanks. And then just two other questions on Pipeline. I guess, you mentioned the final patient was enrolled in the nasopharyngeal carcinoma study. Is it possible we see results later this year, or is that solving for early 2021? 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 mesothelin as well. So just curious, if you've had any discussions with them on their plans there?

Okay. Thank you, Matt. First, question, AJ.

Sure. So Matt, regarding the NPC study, we’ve enrolled as you as you have indicated, we enrolled the final patient in the Phase 1b portion of the study, and our anticipation is we're going to evaluate the results and actually the entire NPC landscape, because as you know that whole treatment landscape has been evolving. So as the results mature, and we assessed the landscape, we’ll then make decisions as to the appropriate forum to present those assessments.

And second question, regarding the first generation mesothelin CAR T. As you said, this is an investigators-initiated study. What we understand is that the investigator is continuing to follow these patients and also including additional patients that study, it is we understand the intent of the investigator at the appropriate stage to communicate further results of that study in Congress. We cannot comment at this date on which one and when exactly that will occur. But that's certainly the plan of the investigator.

Thanks guys for taking my questions.

[Operator Instructions] Your next question comes from the line of Salim Syed with Mizuho Securities. You may ask your question.

Hey guys. Thanks so much for taking my questions, and thanks for all of the color as usual. Just a few for me on the multiple sclerosis program. AJ, did I hear you correctly in saying that we're going to be getting 12-month data either at AAN and EAN for the Cohort 3.

So in terms of 12-month data in the first half of 2020, absolutely we would be getting 12-month data through cohorts 1, 2, 3.

Okay, for all six patients in that cohort.

Yes.

Okay. 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-month data for investors to really diligence the ATA188 efficacy profile or will six months data be enough? You know when we're going into AAN and EAN and where you represent the data, will that be enough of a time duration to diligence this data set?

I think when you -- when you take a look at certainly in all MS studies, you'll like to see some duration of response. So like anything else, 12 months is better than six months. When we talk about the ultimate proof-of-concept, that certainly is going to come at the one year end point to the Phase 1b randomized portion, but certainly the 12-month data off of this portion of the study would provide good additional support I think.

Okay. And lastly from me, on the re-dosing from multiple sclerosis, are you guys expecting upon re-dosing -- the one year time point and the two year time point further improvement in disability or some sort of plateauing?

To say, 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 and that is already a major win in progressive MS. So that should be our baseline that we work off of.

Okay. Excellent. Thanks so much.

Your next question comes from the line of Ben Burnett with Stifel. You may ask your question.

Oh hi. Thanks for taking my question. 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 what -- and to what extent you think this could be done in an outpatient setting?

Thank you for your questions. 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 lympho depleting regimen for ATA3219. This is something that we plan to study, in/or first in-human study. Or whether what we are going to do is to work with MSK on this particular set of data that they had 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 for first in-human study with ATA3219.

Okay perfect. And then just one more question on ATA2271. What's gating further mesothelioma. IND submission and are there any plans to develop this in addition in solid tumors outside of mesothelioma?

So thank you. There is no particular gating, it’s just the time needed to put together all the data. Things up on site progressing well and of course there will be the time then to submit that IND as we say it will be done by our collaborators at MSK in the second or third quarter of 2010. Now the first in-human will be, the innovative construct of CAR T is going to be an 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 over expressing mesothelin and particularly so, ovarian cancer and pancreatic cancer.

Okay. Perfect. Those are all my questions. Thank you.

Your next question comes from the line of Anupam Rama with JPMorgan. You may ask your question.

Hi guys. Good morning. 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 initial EBV+ relapsed refractory PTLD indication in the U.S. And then maybe ex-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 patients globally? Thanks so much.

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 relapsed refractory PTLD is around – is a neutral 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 and the holding the multi-cohort study with up to six type of ultra-rare disease that could lead to up to six additional indications there that are going to increase the size, we believe by atleast a factor of four of the population that could be treated efficiently by tab-cel. In terms of the commercial organization that is needed there, with this being an ultra-rare disease, and having no other treatment post to-date for that disease, we believe that the commercial organization that will be needed to make sure that patients can access tab-cel is of limited size. It will be typical often ultra-rare disease type of commercial organization.

Okay, great. Thank you so much for taking the questions.

Your next question comes from the line of Maury Raycroft with Jefferies. You may ask your question.

Hi. Good morning. This is [Indiscernible] for Maury. So the MSK data looked quite promising specially and overall survival aspects. But how confident are you that the non-standard conditioning lympho-depletion contributed to the survival benefit?

So again, this study is, we believe clinical proof-of-principle that the EBV based CD 19 CAR T allogeneic off-the-shelf, as the six 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 all altogether, the comprehensive nature of these data are a key clinical proof-of-principle that allogeneic off the shelf CD 19 EBV CAR T are again safe and effective. And we are particularly encouraged by the long term durability of the response. If you think about five out of six patient with CR and this CR being durable with in fact survival following the follow up of 26.9 months survival of 100% in the patient with NHL and CLL these are very encouraging data about the effect of these allogeneic off-the-shelf EBV CD CAR T.

Thank you. And have you considered like what conditioning rates you meant, and the variables you are going to do in your Atara run study and which ones you should focus on?

First of all, what are we are going to bring to the clinic is a different product. This is ATA3219 which is also based on EBITDA sales, but using Atara on process, and especially using a new co-stimulatory domain 1XX, which is there to bring, increase, potentially increased persistence of the sales, and less exertion of the T-cells. So that's a different product, but of course we'll be informed in our first in-human study protocol and follow it by the experience that the academic team has obtained with these constructs, 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 say preclinical IND enabling studies for that product to bring into the clinic as soon as possible, and to be able to prove the concept of EBV T-cell CAR T platform and the ability to treat patients safely, effectively with off-the-shelf treatment that could be available within days to patients.

Thank you.

Your next question comes from the line of Tony Butler with ROTH Capital. You may ask your question.

Hey, good morning. This is Tosh on 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 would say a CLL NHL versus ALL?

We are not communicating at this stage what will be the protocol and the type of patients; we laid to rest in or first in-human. But we do so at the appropriate time. Clearly, we believe that there is a medical need today that still exist in the population of an 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.

Thank you, that helps.

Your next question comes from the line of Yigal Nochomovitz with Citi. You may ask your question.

Hi, this is Samantha on for Yigal. Thank you for taking our questions. I wanted to sort of build on a prior question on the EVB 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 used in that study, and with these differences between the two 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?

So a few things. First of all, what are we doing with ATA3219 is to develop a product, through a proper manufacturing process and development phase. So this would 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 co-stimulatory domain as well as in the manufacturing process to have a product that not only allows us to put in a clinic, potentially safety, efficacy and persistence and durability there, but also this is helping to build a platform of CAR T. As you know ATA3219 is just one of the allogeneic 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 product. So two 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 pre-clinical studies, these particular co-stimulatory domain are 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 benefits. And at the same time, the fact that we built a robust manufacturing process allowing us not only to make allogeneic CD 19 CAR T based on EBV T-cell but all the type of allogeneic CAR T based on EBV T-cells will be something very important there. And there were some particular details in the presentation of the academic team last week, just to give you an example, the level of CAR T cells conviction that he had at 20.5% is something that we believe can and is to be improved by a manufacturing process as well as the yield, the possibility to make significant number of doses from one Leukopak. As you know recently we have announced that we with tab-cel which is at the beginning, the same type of process where we offer sales for [Indiscernible] we select and activate these cells. We are not able to make four hundred doses from one Leukopak. So this type of efficiency of our manufacturing process is what we want to see in the manufacturing of ATA3219 and the pre-clinical stage we are 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.

Got it. Thank you for all the detail, very helpful. That sort of leads into my other question. When we think about your CAR T pipeline long term, should we anticipate using the EBV CAR T platform that you mentioned you're building out here, and you had a comment about partnering potential? Is this platform that you're thinking about, versus say like a partnership with MSK for the ATA2271?

Thank you for your question. So clearly, our current pipeline in CAR T in terms of strategic priorities is having to allogeneic CAR T based on the EBV T-cell. ATA3219 that is in preclinical IND enabling study, and ATA3271 the mesothelin targeted allogeneic CAR T that is also in pre-clinical IND enabling studies. So these are the two that are the most advanced. We have also activities we have collaboratored 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 develop first by these academy collaborators as autologous CAR T and once we are moving into a full development, we are going to as usual develop an allogeneic version based on the EBV T-cells. What we’ve built is a tool allogeneic CAR T platform based on the EBV T-cells. And this is allogeneic CAR T platform that benefit from the work we've done on tab-cel as well as the work we're doing on ATA181. But there is a clear co-relation between these. We have the most advanced allogeneic T-cell immunotherapy with tab-cel as it is now in Phase 3 and we don't know any others that is in Phase 3 at this stage right now. We have a robust manufacturing process there. We're going to leverage that, and that's what we do every day, our team is doing everything in our manufacturing unit, leveraging that experience to make a robust and efficient process for allogeneic CAR T platform based on the EBV T-cells. Regarding your question on partnering. As we said, we have a 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 T, and the same time we also open the discussion on partnering other assets of our pipeline.

Got it. Thanks very much for taking the question.

I'm showing no further question at this time. I would now like to turn the conference back to this call to Pascal Touchon.

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'm very pleased to have had the opportunity to review our recent accomplishments and discuss our upcoming milestone for 2020. We have a great deal of momentum coming into 2020, and I look forward to updating you on our continued progress in the months ahead. We aim at transforming the lives of many patients in need, across value – disease. And this is possible only from the contribution of many individuals to whom we are very thankful, including all 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.

Ladies and gentlemen, this concludes today's conference. Thank you for your participation, and have a wonderful day. You may all disconnect.