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 would now like to hand the call over to Eric Hyllengren, 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 & 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; Joe Newell, Chief Operations Officer; and Dr. AJ Joshi, Chief Medical Officer. We will 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 would 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 health care workers to serve patients, we at Atara would like to honor and thank the health care professionals who are here, especially during this time. This moment in time only reinforces our deep commitment to making a difference in patient's lives. It is with tremendous pride that I acknowledge the commitment and resiliency of our entire Atara team, who has remain 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 have made significant progress in the first quarter of 2020 towards accomplishing our key objectives. Importantly, we remain on track to initiate the BLA submission for tab-cel 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. First, prior to COVID-19 outbreak, as part of our routine supply planning and operational risk management strategies, we had already manufactured significant inventories across tab-cel, ATA188. 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 from our inventory, which is a clear advantage of such off-the-shelf allogeneic EBV T cell. In addition, our teams have been working closely with our clinical site…

[Operator Instructions] And your first question comes from the line of Marc Frahm from Cowen & Company.

Yes. Thanks for the extra clarity kind of around the BLA submission and the interim analysis. But I guess, what is the current plan on when we will see the data that is being generated in Q3? Should we - it would seem that the timing would be amenable to something like an ASH presentation. Should we expect to see that this year? Or is it likely not until 2021?

Thank you, Marc, for your question. As we said previously in previous call, we will discuss with the FDA during the pre-BLA meeting, the totality of that, including this interim analysis. And then we will also discuss with them regarding what will be needed for the completion of the submission as well as the possibility for us to communicate and how to communicate on this interim analysis data. So it all depends on the timing of this pre-BLA meeting. And then, of course, we will communicate with the agreement of the FDA at an appropriate congress after that pre-BLA meeting.

And your next question comes from the line of John Newman from Canaccord.

Thank you for the updates. So Pascal, I just wondered if you could comment a bit about what you expect to see in terms of enrollment from your European sites. You mentioned in your prepared remarks that you have the first site open for enrollment. Just curious if you can talk to us about, perhaps, the number of additional sites you will be looking to open in Europe and sort of what you would expect from enrollment there.

Thank you, John, for your question. AJ, do you want to answer?

Sure. Thanks, John. I think a couple of important points, right, just to reinforce Pascal's point earlier that our focus until now has been the 40 U.S. and Australian sites. And that is driven us to the enrollment points that Pascal have mentioned earlier. In terms of the European sites, we are not really going to specifically talk about the numbers of sites. The main point here is that the European sites are being opened now so that we can complete the study enrollment. And that gives us a much more expeditious path to complete it as rapidly as possible.

And your next question comes from the line of Salim Syed from Mizuho.

Thanks, Pascal, for all the clarity. I guess a few from me on multiple sclerosis on ATA188, if I can. One, can you just - I presume you submitted a late-breaker for EAN, and you are going to find out, at some point, whether that is been accepted or not. If we are going to get the data at EAN, can you tell us how you are - since it is so close now, how are you thinking about displaying that data? Not what the data is, but how are we going to get that data? Is it going to still be lumped like the ECTRIMS data? Or is it going to be more granular? That is the first question. And then the second question I had was just on the clinicaltrials.gov update, which looks like in March of this year you guys upped the trial for the Phase I ATA188 from 72 patients to 97 patients. And I'm wondering why you did that, the implications coming out of that. And then lastly, how much data do you need based on your discussions with the regulators, perhaps, to file early on ATA188, if you show reversal on disability from baseline?

Thank you, Salim. A very detailed question, and thank you, I appreciate that. AJ, do you want to take this question? I will chime in, if needed.

Sure. So thanks, Salim. I think - yes, so we have submitted to EAN for a late breaker, and we are waiting for decision as everyone else is, quite frankly, for the late breakers. And in terms of the question on how we are going to be presenting there, we are certainly going to be giving more detailed information. Because as the data has matured, we are able to, now, actually provide that level of detail. And to kind of reinforce the notion, one of the biggest questions we continue to be asked is what were the - what do the disability assessments look like? And we will be providing detail on those, both by composite scales as well as by individual disability scales. In terms of the patient enrollment numbers, part of what we - what we are doing here is we have set up the design of that study to allow us to have various elements of adaptive design, so that if we see any elements of clinical signal or biological signals in the course of that study, we are able to adapt the design and essentially target it towards potentially more meaningful statistical outcomes. So it is really an element of flexibility that you are seeing there as opposed to a specific need or driver that says we need to add more patients. It is meant to allow us the flexibility so that we can power the study along a variety of different measures, depending on how the cohort 4 data look, as well as how some of the blinded information looks like in the RCTs. And I guess the third question that you had was in terms of, if we were to see reversal of disability, then does that give us some kind of accelerated pathway? I'm not going to comment on a specific - whether reverse or a specific end point at this point. What I would say is that if there is - if we are able to show an efficacy signal that would be a transformational product profile when you prove it out in later studies, then I do think that creates significant opportunity for various conversations with FDA on some form of accelerated pathway. But all of that obviously has to be proven out a bit more in a randomized setting to be able to say that there might be any kind of accelerated pathway there. But certainly, a transformational - potentially transformational profile would give us that opportunity.

Thank you, AJ. And it is really what is important for us, Salim, is really to aim at a transformative treatment of MS. And that is what we would like to bring to further development of that product in line with the need, the medical need that is immense in that population. Because as you know, no treatment today is really able to reverse decline or they are just delaying the decline. I mean talking about treatment approved in progressive MS. So there is really an unmet medical need, and we really aim at addressing that unmet medical need.

And your next question comes from the line of Yigal Nochomovitz from Citigroup.

Yes. Can you just explain a little bit more what exactly is going to happen at [Technical Difficulty] that you set for, what would be a success from analysis? So understanding of what you need

Yigal, we have some challenge to hear you, but I guess you have questions about the interim analysis in Q3 2020 and what will be considered a success. Isn't it?

Yes. [Technical Difficulty] you have outlined that needs to beat to be comfortable with...

Okay. I think I understand the question. Thank you. AJ, do you want to answer? And then, Yigal, you will tell us whether it is answering your question because we still have some difficulty to hear you clearly.

Yes. I'm going to just take a crack at it, Yigal, and see if it ticks the point. I think the - as is the case in most ultra-rare conditions, the totality of data is what is most relevant here. We are not going to be specifically talking about exact numbers that are necessary for hitting an interim analysis. I think the key point here is that when you have the Phase III data and the totality of information that we have described here, it is that package that will drive the FDA view on things. And if you think about an ultra-rare condition, the package of information we have here is fairly significant when you look at totality of information. So I think that is the main factor is how does that entire view look, of course, incorporating these major elements of the Phase III enrollment in study. Did that answer the question?

I guess I was looking for numbers. You probably don't want to give numbers. I just wanted - I was hoping to get a sense as to more detail. But I understand you are not in a position to talk about that. To understand that the additional patients in the study, so those patients I mean, they are obviously not in interim. They are going to be - since that data will be submitted later, presumably for approval when you get that data from these additional patients for the site you started in [Technical Difficulty]

Yes. I guess - it is still very difficult to hear you, Yigal. I guess your question is what is the objective of the patient - the additional patient to complete the enrollment of the study and how do we plan to discuss these with regulatory authorities. Is that right?

Yes. Can you hear me better now? Is that better?

Yes. Much, much better now. Yes. AJ, do you want to answer that question?

Yes. So typically when - if we were to - when you do an analysis like this, you - I think I got your question correctly, were those additional data that get generated after this analysis are information that you are definitely going to provide to the regulators. And oftentimes, in a situation like this, and I'm not going to predict which way things go, but there wouldn't necessarily be a prerequisite, for example, for moving forward. Most of the time, those are things that, say, the data that you provided at the time of the pre-BLA discussion, are the basis for the decision that they make to say, yes, let's - you can move forward with your BLA filings. Any data that you generate related to the Phase II program, they are always going to want to see when you finish generating those. But they will not be necessary for that decision that happened that is made at the timing of the pre-BLA meeting.

Okay. But that is - the first submission for the BLA, that will be - I mean is it understood that that is going to be a conditional to - on further data? Or is this going to be a full approval? Or you don't know yet?

I think that is a review issue. That is going to be part of the discussion with FDA at the pre-BLA meeting. But I wouldn't say priori, I would say that this is going to be conditional.

It would not. Okay. Got it. And then.

Not a priori.

Not a priori, conditional. Okay. And then I just have a question on MS. So we have talked to some of the experts in the United States, when we talk to one fellow at Cleveland Clinic who's one of its KOLs in EBV biology and, well, in MS. And he was saying that his view is that the EBV hypothesis is quite strong in relapsed/refractory disease, but not as clear in [Technical Difficulty]

Okay. We lost you again. But I guess you wanted to say in PMS. So probably your question is that on the EBV expert you mentioned - in the EBV hypothesis is - in MS, is stronger in relapse-remitting than it is in progressive. AJ, do you want to take that, and I will chime in?

Sure. The hypothesis, and I would love to maybe have some conversations because these are always good dialogue. But for that particular individual, the EBV hypothesis actually does not differentiate between whether it is relapsing-remitting or progressive MS. And to give you a little perspective, we had a recent advisory board with all our top advisers. And these are very well-established individuals within the MS space. And very consistently, there is no reason why it should impact one space versus the other. Their comment is, hey, if we start seeing something in PMS, you should be looking at all of them. And that has always been the plan. So there is not really been a differentiation. The hypothesis is MS. It is not just PMS. There should be really no difference between those two spaces in terms of EBV being a major element of the pathogenesis of the MS process.

And clearly, the reason we went into progressive MS, as I said earlier on, is because of the immense unmet medical need that exists there. And if we can show safety in this early study safety and a potential clinical efficacy signal that represent - would represent a transformational product profile in PMS, we will then go, of course, not only to pursue that in PMS, but also in other type of MS.

And your next question comes from the line of Ben Burnett from Stifel.

This is [Kellie Breza] (Ph) on for Ben Burnett. My first question is just pertaining to tab-cel. And I know that you guys are looking to do a Phase II multi-cohort study that includes up to 6 additional ultra-rare EBV+ patients. I was wondering if you could provide any additional color pertaining to like disease severity, patient population size relative to PTLD.

Yes. I think clearly, this study that we are doing is intending to expand the tab-cel label beyond second line PTLD and to address a serious unmet need in patients with EBV+ disease. This study is planned with up to 6 additional cohorts, creating the possibility for additional indication or even potentially to discuss a broader mechanistic label. And this is based on experience that we have both ourselves at Atara with our EAP and single patient use as well as our collaborators at Memorial in earlier study, that we have some clinical data in this type of patients. So we are building upon this clinical data to move forward in this multi-cohort study. Each of these cohorts represents ultra-rare conditions. But collectively, they represent a potentially addressable EBV population - EBV+ population several times greater than the size of the second line EBV+ PTLD. And there are different type of disease that we are exploring there of patient population, some are related to immunodeficiency lymphoproliferative disorders like primary immunodeficiency LPD and also acquired immunodeficiency LPD. We are also going to explore LMS, leiomyosarcoma, for which we had presented data in the past, as well as first-line EBV+ PTLD for patients where current first-line treatment are inappropriate and first or second line, CNS-PTLD. So as you can see, a range of different type of patient population. And altogether, these are representing a significant commercial potential, if we are successful and a population that is several times greater than the size of the second line EBV+ PTLD, which is the first indication that we are pursuing.

Great. And then if I can have one more question. I had a question regarding ATA2271. What is gating for the mesothelioma IND? And are there any plans to develop this in additional solid tumors outside of mesothelioma?

Thank you for your question. So as we said, there will be the presentation of some preclinical data from the IND-enabling studies, that will have been accepted as the late-breaking poster at AACR, and the abstract will be released on May 15. And these are part of the package that we need our collaborators, who are going to - at MSK, we are going to submit that IND needs to submit the IND. All the data and all the studies have been done now. So it is just more of moving into the preparation of the submission. And that is why we are confident that this IND submission should be able to be done in Q2 or Q3 2020. Now in terms of this first study, it will be addressing advanced mesothelioma. But we have the plan to go in other type of solid tumors, where you have high expression of mesothelin, in particular, ovarian cancer and pancreatic cancer.

And your next question comes from the line of Tony Butler from Roth Capital.

Really thre very brief questions. Number one is when you think about the 188 Ia study, they are - in the open-label portion, there is retreatment. And I'm curious if, potentially, there will be some retreatment data that will also be presented at EAN. That is question one, and I will finish the other two very quickly, if I may. The second is with respect to the Ib study of 188. I think currently, you have nine sites open. Because you have paused the Ib study, will you then decide to create a greater number of sites in order to speed up that enrollment opportunity? And then finally, on the CAR programs on 7119, your programs, do you think - or is it a goal to file INDs for those in this calendar year? Or is that more a 2021 event?

Thank you, Tony. AJ, do you want to take the first two questions? I will take the last one.

Sure. So with respect to the Ia long-term extension patients, just a quick reminder, we chose the dose for that long-term extension based on the cohort three data. So if you recall, once we achieve the pre-specified end points of the Phase Ia to move into the RCT, we did that based on the Phase III cohort dose. So that became the dose that we used for the open-label extension. So it may - so because of that, we have treated several patients actually, and we have begun to treat them in the open-label extension. But they are not far enough along to present at the EAN. So we will ultimately present those data, but they are not going to be available for the EAN discussion. And in terms of your question on adding additional sites to try to catch up on the RCT, the good news for us is although we paused the actual enrollment, we were able to continue the pre-screening activities. So we do have several patients lined up for those for that study once we are able to resume full enrollment activities. So I don't really anticipate needing to - sorry, yes?

We lost you. So if you can start, you are explaining that what is happening in the current time where we paused, but we are still active in preparing the site. I guess that is what you wanted to say.

Yes. So sorry about the connection issue. Yes. So we have remained active in - essentially prescreening patients for the studies. So that we have actually got several patients lined up so that the moment we resume enrollment activities, we can put them through the full screening process. Because of that, I don't really anticipate needing to add additional sites. And where we are now is we do expect to resume enrollment activity soon in that study. Specifically, the approach is going to be that, as you might imagine with COVID-19, there is center-by-center variability. We have had really close relationships with the sites. So what we are going to do is, on a site-by-site basis, to expeditiously get them started up again. We have just got a checklist that ensures that the sites have the capability to do all the assessments that are necessary, that they have the staff, facilities and equipment all available. And as long as we are able to meet that checklist, we are going to be able to resume enrollment at those sites. So again, I anticipate that happening very soon because of that. And the patients we are [Technical Difficulty]

Team, as you know, we have started the IND-enabling study and we are making steady progress towards bringing this exciting asset into the clinic. We are not communicating right now the timing of such IND filing, and we will communicate the timing at [Technical Difficulty]

And your next question comes from the line of Maury Raycroft from Jefferies.

This is [Brice] (Ph) on for Maury. I guess a couple of quick questions. For the IND-enabling studies on the ATA2271, do you expect to include like nonhuman primates later? Or if you can provide some more perspective into what to expect.

I think his line is disconnected, and he's dialing back in now, one moment [Technical Difficulty]

This is AJ Joshi. Sorry for the technical issues. I think I've just been able to get back in. Eric are you on?

It looks like they have him, and about to put him in.

Okay. I was going to say maybe what we can do is, moderator, do you know where we got lost? Was it in the middle of my response on the MS, so I can continue that while we wait for others to join back in?

I think it might be - AJ, I think it was when I was starting to answer on ATA3219. So maybe you can start there. Can I start operator? Operator, can I start? Are we on line? Everyone. I'm very, very sorry. I really apologize for this technical issue. So I'm going to go back to the questions from Tony on 3219. As I said, at this stage, we are working actively on the IND-enabling studies, but we are not going to say when is that going to be filed. We will do that at the appropriate time. However, I would like to say that this program, we believe, is very exciting because this field of CD19 CAR T is well-known in terms of the level of safety and efficacy achieved by autologous CAR T at this stage. And we believe that we, in going as fast as we can in the clinic, we can really deliver a proof-of-concept of our platform in terms of its ability to deliver safe and effective allo CAR-T. But at the same time, if due to the specificity of allo platform, particularly. So the EBV T cell and 1XX has a unique co-stimulatory domain that impact on the persistence and efficacy of the T-cells having less exhaustion of the T-cells, this might lead to superior activity in patients. And in that case, of course, that will create a very significant value for that product. Does it answer your question, Tony?

[indiscernible] from Jefferies.

This is [Brice] on for Maury. So the first question is for the ATA2271 program. Are you going to have nonhuman primates data included there as well that you are going to present?

For ATA2271, the mesothelin autologous CAR T, that is the one you are asking about?

Yes.

Okay. So the IND-enabling studies are mostly in vitro and in vivo studies that are needed as well, of course, CMC package that is needed for the FDA to review through the IND process. So the data that will be presented are related to in vivo preclinical studies. And I'm not going to give any more detail at this stage as the add part is going to be released very soon.

Okay. That is fine. For the MSK data previously, the off-the-shelf EBV CD19 data, so it lacked many specifics on the CAR-T expansion persistence area. So did you get a chance to evaluate the peripheral and the marrow samples from the 10 patients?

So this is, as you know, an academic study. And the data they presented at the TCT meetings with - by the way, on the 6 patients that were treated with this third-party donor cells modified with CD19 CAR, have been quite clear in terms not only of the level of response with 5 out of 6 in CR, but the durability of response for a median follow-up of 26.9 months, so the longest ever for an allo CAR T. Now we don't have a - need MSK data at this stage on the kinetics of the cells. These are the type of data analysis that hopefully they will be able to do in the future based on the samples they have. But we don't have these data available at this stage.

Okay. That is fine. The other question is for the ATA188. Can you recap the redosing plan strategy and insight about how the redosing is going?

Yes. Thank you for your question. AJ, do you want to answer this one?

Sure. So the redosing plan is when patients come due for redosing, that is essentially we have left a relatively open window, but it is after the 12-months' time point, so it usually hit anywhere between 12 and - I think we leave a window of about 12-months to 24-months because that allows some of the earlier cohort patients to be re-treated. But the goal was to re-treat as close to that 12-month time frame as we can. And it is basically 1-cycle treatment at that point. So it would be day one, day eight, day 15, you get doses of ATA188. And the goal is going to be that we are going to continue annual treatments on these patients all the way through to five years of follow-up from the initial study entry.

And your next question - and your last question is from Salveen Richter from Goldman Sachs.

This is Andrea on for Salveen. Maybe just one question on tab-cel. As you have seen an increasing number of clinical sites come online, particularly in Europe, has this provided any additional insights into the potential market size opportunity?

Thank you for your question. As you know, we are working on opening new sites in Europe in various countries. And we do so once we have obtained, of course, the CTA approval. And this has been obtained in four countries right now, the U.K., Austria, Spain and France. So we are working in these four countries on active opening and activating sites. And as we said earlier on, we have just activated the first European site in Spain very recently. So things are progressing there, but I guess your question is about the medical need and the patient population. And when we discussed with European experts, they clearly told us that there is a medical need. They have patients that don't have options for treatment today. And they are very eager to get access to tab-cel. So we see that in terms of the clinical trials, but also we plan to open, as we have done in Australia and the U.S. in parallel to our clinical trials, a compassionate use program, which is a different system at the EAP, but similar in different European countries, which is to be able to address the need of patients that, for whatever reason, cannot be enrolled in the study. So we clearly see a strong demand there from these sites in terms of having access to tab-cel and we are getting ready to be able to deliver tab-cel to them either through the clinical pivotal study or for compassionate use, because they have many patients waiting for transformative treatment for their very severe and rapidly progressing disease. No further question?

That concludes our question and answer session for today. Thank you for joining the Atara Biotherapeutics First Quarter 2020 Financial Results Conference Call. You may now disconnect your line.