Atara Biotherapeutics, Inc. (ATRA) Q3 2019 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for standing by and welcome to the Atara Biotherapeutics Q3 2019 Financial Results Call. At this time, all participants’ lines are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today’s conference is being recorded. [Operator Instructions] I’d now like to hand the conference over to your speaker today, Dr. John Craighead, Vice President of Investor Relations and Corporate Communications of Atara Biotherapeutics. Please go ahead, sir.

Thank you, operator. Good morning, everyone, and welcome to Atara’s Third Quarter 2019 Conference Call. On today’s call, we plan to discuss our third quarter financial results, as well as recent clinical, operational and strategic progress. Earlier this morning, we issued a press release providing an overview of the company’s third quarter 2019. This press release as well as an updated investor presentation are available in the Investor & Media section at atarabio.com. I’m joined on today’s call by Dr. Pascal Touchon, President and Chief Executive Officer; Utpal Koppikar, Chief Financial 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 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?

Thank you, John, and thank you, everyone, for joining us this morning. Before we begin our discussion on our recent progress, I want to reinforce how proud I am of the advances we’ve made toward our vision of delivering an off-the-shelf allogeneic T-cell immunotherapy to every patient in need at any time. We know that lives depend on us achieving this vision and our team is strongly motivated every day to deliver meaningful results for patients and the company. During today’s call, we’ll provide context surrounding our new strategic priorities, recent clinical and operational progress, and upcoming milestones. First, I would like to update you on Atara’s strategic objective and priority, following the extensive review of technologies, assets, resources and organization that I have conducted during my first month as CEO. Objective moving forward is to become the leading off-the-shelf allogeneic T-cell immunotherapy company, transforming the life of patients with cancer, autoimmune and viral diseases. We are planning to accomplish this objective over the next three years by executing resiliently on four strategic priorities. First and foremost, file and launch tabelecleucel or tab-cel for patients with relapsed/refractory EBV+ PTLD in the U.S. and Europe as well as develop tab-cel for other indications. Second, achieve clinical proof of concept with ATA188 or allogeneic MS-specific EBV T-cell immunotherapy. Third, advance of mesothelin programs with autologous ATA2271 and allogeneic ATA3271. And fourth, develop ATA3219 or allogeneic CD19 therapy to clinical proof of concept in B-cell malignancies. In parallel, we’ll continue to leverage the capabilities and expertise of external partners for autologous CAR T immunotherapy development. Starting with tab-cel, we are very pleased to share exciting long-term outcome data, from a multicenter expanded access program following acceptance of an abstract of presentation at ASH 2019. I would like to ask only to highlight the long-term outcomes in a subgroup of 22 stem cell and 13 organ transplantations with relapsed/refractory EBV+ PTLD treated with tab-cel. We would likely had been eligible for our ongoing Phase III study. These results demonstrates tab-cel was generally well-tolerated with overall response rate of 55% in HCT and 82% in SOT patients. Estimated two-year overall survival lasts 79% for HCT and 81% for SOT. With such large amount of patients and longer duration follow-up, these data are consistent with previous studies showing a well-tolerated safety profile, high response rates and durable overall survival of two years, that to reinforce our clinical development and regulatory strategy for patients with relapsed/refractory EBV+ PTLD. These new data also confirm that tab-cel is potentially the transformative off-the-shelf allogeneic T-cell immunotherapy with compelling value for patient, physician interest in this often deadly ultra-rare cancer. Turning to our pivotal clinical development program for tab-cel, we remain on track to initiate tab-cel BLA submissions for patients with EBV+ PTLD in the second half of 2020. We now have 35 sites available for enrollment in the U.S. and Australia, and plan to continue to open additional sites at transplant centers in the U.S. and Canada over the coming months. We also plan to file a clinical trial application or CTA in several European countries by the end of this year, and to open study sites there next year. Meanwhile, we engage in discussions with the EMA and the outcome of these discussions will determine the timing of the tab-cel EU conditional marketing authorization application for patients with EBV+ PTLD. Our BLA submission guidance takes into account the recruitment constraints inherent in our pivotal study due to the nature of PTLD as an ultra-rare and rapidly progressing disease. Our Phase III study are also only open at about 10% of transplant site in the U.S. And there are a number of competing, although less advanced, clinical trials. Since July, we have upgraded the way we are addressing these constraints. And importantly, we believe these development constraints should have limited impact on the tab-cel business case for PTLD. Indeed, the value to individual patients will be high with such a potentially transformative T-cell immunotherapy. Also tab-cel could be delivered within three days of order to any center to an appropriate patient’s need. And if tab-cel becomes the first approved treatment for PTSD, it will likely be supported by patients and physicians based on proven efficacy and safety. The potential U.S. market sites where we serve tab-cel indication is several 100 patients per year. Taken together with the potential tab-cel opportunity in Europe, we believe there is a strong and profitable business case for Atara to commercialize that sale in the relapsed/refractory EBV+ PTLD in these geographies. We’re also advancing studies in potential additional indication for tab-cel. We continue to enroll patients in our Phase I/II clinical study of tab-cel in combination with anti-PD-1 therapy in patients with platinum-resistant or recurrent EBV-associated NPC. We also expect to start enrollment in the Phase II multi-cohort study targeting other EBV+ cancer in the second half of 2020 to continue expanding the value proposition of tab-cel. Overall, these value studies show the potential opportunity for tab-cel as an ultra-rare disease pipeline in a product. Now turning to our second corporate priority, ATA188. We reported encouraging data taken since September in patients living with progressive MS. Recently we reviewed the six months follow-up data for cohort 3 dose. Based on this data, we are pleased to share that we have selected this cohort 3 dose to initiate the Phase Ib portion of the study. The decision to initiate the Phase Ib was based on achieving in cohort 3 our pre-determined criteria of a continued well-tolerated safety profile and at least 50% of patients experiencing clinical improvement based on the multi-scale assessment defined at ECTRIMS with improving patient coming from more than one clinical study site. Recognizing these are early data and incorporating input from external experts, we believe these results merit the acceleration of ATA188 development for progressive MS patients who have limited treatment options and in whom continuous decline is expected. In addition, enrolment in the fourth and final client Phase I dose escalation cohort is complete. Six months data from cohort 4 will be mature in April 2020. We plan to present then all cohort data in detail at an appropriate congress in 2020. Following such encouraging ATA188 results and in line with our strategic focus on allogeneic T-cell therapy, we have decided not to move forward with the Phase II study for ATA190 or autologous product in MS. This decision will allow us to focus our resources on ATA188 to ensure efficient study execution as well as reduced autologous operating complexity and associated manufacturing cost. We’ll continue to evaluate strategic options for ATA190. Our first strategic priority is around the mesothelin CAR T programs, ATA2271 and ATA3271. ATA2271 is an autologous CAR T for mesothelin-associated solid tumors for which an IND is planned in 2020. ATA2271 will enter the clinic first, while we work to advance development of ATA3271, our allogeneic mesothelin-targeted CAR T, leveraging our EBV T cell platform. Both of these programs have great potential due to the incorporation of a novel 1XX co-stimulatory domain and a PD-1 dominant negative receptor. Finally, Atara’s first strategic priority is ATA3219 or internal allogeneic CD19 CAR T. This asset is currently in preclinical study and will later evolve to IND with the goal to demonstrate clinical proof-of-concept for our EBV CAR T cell platform. Here we intend to show that allogeneic EBV CAR Ts are safe, expand in vivo traffic to more sites and persist efficiency to obtain high response rate and durability of responses. Turning to a few operational updates. Facility commissioning and qualification activities to support clinical development at our operations and manufacturing facility ATOM are complete. Commercial production qualification activities are progressing well and aligned with our commercial strategy. Additionally, and will be expected by a new CEO, Operations, maximizing at a rather operational efficiency, I am now in a process of adapting my leadership team to a new strategic priority. This effort includes active searches for a new Global Head of Research and Development, a Head of Commercial and a General Counsel. Before opening the call to – for the questions, I would like to comment on our third quarter 2019 financial results. We ended the quarter with cash balance of $282.9 million, reflecting proceeds from a recent secondary follow-on financing. We continue to expect to have cash to fund and growing operations in 2021. I would like now to turn the call back over to the operator, so we can go ahead and take your questions. Operator?

[Operator Instructions] And our first question comes from Anupam Rama from JPMorgan. Your line is now open.

Great, guys. Thanks for taking the questions and congrats on all the progress. In the past, we’ve talked about in PPMS the need to follow patients long term to truly kind of understand the emerging clinical profile of ATA188. What are you seeing at the six-month time point in cohort 3 dose that’s really giving you the confidence to move forward here given the 12-month, 18-month time points are not available?

Thank you, Anupam, for your question. I will start and maybe AJ will chime in there. So clearly, we are predetermined criteria for moving forward to the Phase Ib. These Phase Ia study, as you know, is built as a one-year study with different time points for assessment of the clinical evaluation of the patients there. So we have reached that particular situation with cohort 3 dose having data at six months. That shows that not only we have this well accepted safety profile, but we have also this clinical improvement in at least 50% of the patient coming for more than one site. And when we have this results in hands, we believe these results merit acceleration of our decision to move for the Ib, while we of course pursuing the Ia and we will add more mature data on these different course, particularly cohort 4 for which we don’t have yet this six months data. AJ, do you want to comment on that?

Sure. Anupam, just recalling the criteria that we used, we specifically set those criteria up to try to find early signals because your point, it does take a longer time frame to really have some of those – some of the EDSS and other style endpoints. So again, this approach specifically looked for early signals. Now based on the approach, when we talk about 50% having clinical improvement, the bar was relatively high, because there were seven different scales we used and we required an improvement on two separate scales at consecutive time points. So that means we measured at three months and six months, those are our time points. You’d have to have improvement on two scales at each of those time points for the patient. And yes, when we discussed that with the [indiscernible], they thought that was a relatively high bar for us to hit. And then we also said, you know what, it’s an open label study, we want to make sure that these improvements are happening at more than one site. So these – the 50% target that we hit was 50% improvers plus it was at two different sites. So the intent was to set a high bar using this kind of early signal detection. And that’s what gives us the confidence because it was a high bar and we did have that early detection.

Yes. And as we say, there will be additional details to be shown at appropriate 2020 Congress in 2020.

Great. Thanks so much and congrats on all the progress. Thank you.

Thank you.

Thank you. [Operator Instructions] And our next question comes from John Newman from Canaccord. Your line is now open.

Hi, thanks for taking my question. This is Chris on the phone for John. So I just wanted to ask if we could get any additional color on the enrollment. And you’ve also mentioned opening more clinical sites in Canada and the U.S. Just wondering what that timeline would look like and how many sites you guys are thinking about?

Thank you for the question, Chris. In terms of enrollment, the enrollment is progressing as planned to be aligned with our guidance for initiating the BLA submission in second half of 2020. As we mentioned earlier on, part of the challenge in recruiting more patients in this study is the need to expand a number of sites because today we are only about 10% of transplant sites in the U.S. So this is done two way. In the U.S., we are continuously increasing the number of sites. This takes the necessary time for these sites to be open and running. And then we’ve obtained in July, the approval from the Canadian authority to start opening site in Canada, and that’s why we are now moving into Canada. We had already opened five in the past in Australia. And then the next stage will really be Europe where we’re going to file a CTA in several European countries by the end of the year to be able to open site next year, once the usual process of redo of the CTA have gone through in these specific countries.

Got it. Thank you very much.

You’re welcome.

Thank you. And our next question comes from Salim Syed from Mizuho Securities. Your line is now open.

Hey, guys. Thanks very much for taking my questions. Congrats on the progress. Just a couple for me. So when you were thinking about cohort 3 and making a decision to either move cohort 3 forward or waiting for cohort 4, was there a reason why you decided not to wait for cohort 4 here specifically, theoretically or without actual data? And then also just on the ATA190. When you say you’re not developing it at this time and you’re evaluating strategic options, can you give us a little more color? Does that mean you’re planning to sell the product? Or are you holding on to it? Do you no longer think that it’s part of – it can address a different part of the commercial market?

Thanks, Salim, for your good questions. Maybe AJ, you can start with the first one, I will take the second one.

Sure. So it’s a good question, Salim. I think, the pre – when we had our predetermined criteria for go, no-go, as I mentioned earlier, it was a relatively high bar. To some extent, actually, some of our top leaders didn’t think we’d hit that. They thought we’d be kind of in a middle zone. And we hit it pretty nice with cohort 3. And the decision was that, you know what, the cohort 3 dose looks good. And because there’s such a high unmet need here for these patients because remember, this is a baseline decline population and we should expect decline everywhere, right. And the measures that we use should pick those things up. And even despite that concept, we have those three patients have clinical improvement. So it made sense to move forward with a cohort 3 dose. But we’ve also left ourselves some optionality because as we get the data in, the six-month data will mature for the cohort 4 dose in the April timeframe. As we get those data in, if we’re seeing a signal that suggests we need to actually take a look at cohort 4, we’ve already set up a plan to adapt our protocol to allow for that dose to be evaluated as well. So for us, we feel like we have a good dose now. We may have a better dose and relieve ourselves at options to go for both, but no sense in holding back and given the high unmet medical need here.

And your second question, Salim, I mean, clearly with these two offsets, ATA190 and ATA188, they were about at the same stage of development. I wouldn’t even say that ATA188 was a bit more advanced being in these program of 1a followed by 1b. We were ready to start a Phase II for ATA190 as we had explained in the past. But having these encouraging results, we say let’s focus on the allogeneic T-cell therapy there because clearly for this side of disease, a chronic disease where we’re going to bring for the first time ever we believe a T-cell therapy, allogeneic offers significant advantages compared with autologous there. And we don’t see what autologous could bring right now in terms of advantages. But we also want to focus our resources on delivering rapidly some clear proof of concept from the Phase Ib in a double-blind randomized placebo-controlled way. So we will keep the 190 in our portfolio and review specific options. There are other ideas that we are considering right now. But we want really to focus and to execute resiliently on this development because the Phase Ib is truly the key element of value creation for the company and for patients once we have these results. And the more we can accelerate based on proper achievement of predetermined criteria and with the support of excellent expert, the better for the patient and for the company.

Great. Thanks so much guys.

Is that fine?

Yes, that’s perfect. Thanks so much, Pascal. Thanks so much, guys.

Thank you. And our next question comes from Phil Nadeau from Cowen and Company. Your line is now open.

Good morning. Thanks for taking my questions. A few on tab-cel. I guess first a follow-up to an earlier question. You mentioned that you’re in 10% of U.S. centers now. I guess the question is, why is it just 10% of U.S. centers? Trials have been open for I think close to two years. So what has been the hold up in getting more sites on board in the U.S.?

I think, AJ, do you want to answer that?

Yes. I think, when you – I wouldn’t necessarily call it a hold up. Where we’re at, we are kind of focused in on the centers that we feel like are going to be the best geographically suited and the ones that are seeing – going to be seeing the most patients. Then we have a kind of a secondary structure that for the centers where we’re not in. We actually hired a fairly decently sized medical science liaison team to reach out to those additional centers where if there are patients being found at those centers, we have to refer them in to those top – those the 35 or so that we have now. So, it’s – there’s really never an intent to – there’s an over 300 transplant centers in that country. There’s not an intent to be a 300 transplant centers. It’s really to try to zone in and optimize the centers that we’re at now. Doesn’t mean, we’re not going to continue. We are continuing to add centers, but we really never try to get to whatever, 200 centers there. The goal would be to be at the top centers to refer patients in when they’re found from the other centers. And then of course, the geographic expansion through Canada and Europe will be the next key part of it.

And I would add I feel that since July, we have also eyed additional MSL to continue to increase awareness and interaction with HCP at transplant centers. And we are also starting to use artificial intelligence technology to evaluate claims data to identify potential patients suitable for enrollment. So we have upgraded our efforts there. So it’s not only the number of centers, it’s all the efforts we have done and accelerated since July to be able to record in line with our guidance.

Then second is on the U.S. filing guidance. You mentioned a filing will be initiated in the second half of 2020. What modules will be filed first? And do you have a sensor or some guidance for when the filing will be completed?

So as we said last time, this filing will be based – this initiation of filing will be based on an interim analysis that has been pre-specified in our protocol. So that’s why we’re mentioning these word of initiation of the BLA filing there. And at this stage, there is some very specific requests from the FDA in terms of follow up of the patients. And I think we shared that with you last time that the FDA is asking for a six months follow-up following response. So response usually is being identified at two months after the first infusion. So two months plus six months, about eight months of follow-up from the last patient being enrolled there. So that’s an important aspect to take into account. Our guidance has been clear that we will be able to initiate this BLA filing in the second half of 2020 based on the one hand on the interim analysis for a part of the total population. On the other hand, of course, on all the CMC and other aspect that is needed for the filing. And this is on track on schedule. There is absolutely no issue there. It’s really the limiting factor for the timing. It’s really the recruitment and enrollment of patient and achieving of pre-determined pre-specified number of patients for the interim analysis there.

So when will a PDUFA date be decide – be given to you by the FDA? Will it be upon the initiation of the filing or do you have to get that six-month follow-up data in first?

This is truly a review process because as expected, we will go to a pre-BLA meeting with the FDA and discuss with them how they see our data so far and what is the best possible way to move forward for these patients. I would like to say that the FDA has been very constructive in our discussions so far. So we are very optimistic there that we will find the best possible way to bring this transformative therapy to U.S. patient if indeed the results are at the level we believe they could be.

And one last question for me. Just on the EU, can you give us an update on the issues that you continue to discuss with the regulators and any guidance for when you see a clarity from the EMA? And what will be necessary for a European filing?

Yes. We are not going to give a guidance on timing. I would say, we are really discussing with them. We as you know, in the PRIME system in the EU, which is a system that for transformative therapies levels, also some interactive dialogue with a PRIME repertoire that is designated by the EMA. And this dialogue is a constructive dialogue and the importance there is to agree specifically on the SOT because that’s where we have challenged following alignment with the FDA that produce protocol in terms of joining the two quality into one. And we want to make sure that this type of change is fully supported by the EMA for the PRIME system of interaction with EMA. So, we will inform you when we make progress there and when we have a clear view on when we believe we can file in Europe for conditional approval.

Perfect. Thanks for taking my questions.

Thank you. And our next question comes from Tony Butler from Roth Capital. Your line is now open.

Thank you very much. AJ, you made reference to – in 188 to an earlier question that early signals gave you confidence to move forward in the Phase Ib portion of the study. What I’m about to ask you is more theoretical and clearly not known. But the question is question is, do you have – do those early signals tell you something about the duration that a patient may see on therapy? And second, with that stated, do you think that EDSS actually that – as the patient progresses on study, that their EDSS scores actually improve beyond that initial signal? So the question is more about what happens in the future if you have a view? And then my second question if I may. Pascal, could you maybe provide us with some of the criteria you think about when you’re looking at ahead of R&D? And how you might think about those criteria when you want to hire that person?

Sure, so if you might imagine getting into the future is always going to be a little bit difficult. Certainly, when you – maybe just to give you an overall perspective because when you think about clinical improvement, this is what we’re really talking about now. There is very few – people have not really thought about clinical improvement MS. There’s very few companies, very few products and programs that ever looked at that. So the ones that have looked at it have anticipated that yes, over time, you would see some kinds of improvements in a variety of disability measures. So when they looked, they haven’t looked just at EDSS, they’ve looked at a variety of disability measures. Sometimes separately, sometimes as composites. So as you – if you think about, okay, we would look at our product in a similar fashion, if you are looking for improvement, you would look for something like that. So maybe that’s the best way I can answer it. Obviously, we’re going to have 12 months data that’s going to continue to mature over time. So we’ll be presenting that style of 12 months data in 2020. So we’ll have a cleaner view on it. So we won’t be just guessing into the future. But that’s the best I can do in terms of expectation. I hope that answer the question.

I appreciate it...

One other point actually, sorry, I would like to say, sorry, Pascal is that we are – for the Phase Ia portion of the study, we are continuing an open label extension. So we will be having annual dosing. In that, we will also get some additional long-term information on this entire group of Phase Ia 24 patients.

That’s exactly the point I wanted to add on. On the Ia, we’ll continue when – we’ll continue to inform us and physician and experts about the durability of response there. So now turning to your second question there. I think clearly we have the – I have in mind and we have in mind the ideal profile. And that’s what we are looking for is to try to be as close as possible from that ideal profile. By that I mean, a clear scientist physician, ideally an MD Ph. D. is knowledgeable about cell therapy, was being a clinician in oncology, ideally a transplanter as well. We also have developed product, particularly in oncology, to the finish post in terms of getting FDA approval and EMA approval. And someone who has worked in both large company and biotech company and has been a true leader in bringing projects forward and excellent execution and operational execution there in bringing product forwards to the finish line. So that’s really what we have in mind. It’s – I’ve been starting to meet with potential candidates. And there is a lot of excitement for these type of individuals in the sense that the scientific basis of our platform, the technology that we have at our disposal now for the various collaboration, the way we have developed these technologies, but also the quality of the team is amazing et cetera. And that’s something that we would like to insist upon that we are benefiting and I am benefiting myself from what I will call a very strong bench of experienced leaders, with our CMO Head of Clinical Development, AJ Joshi, who is with us today. We have our Head of Regulatory Affairs, Renu Vaish and our Head of Preclinical and Translational Research, Blake Aftab. So very strong batch, very capable leaders, very knowledgeable and experienced people there that are supporting the value development. We also benefit from direct support to our pipeline and technologies, not only from Chris Haqq, our Former CSO, who is continuing in an advisory role with the company, but with key academy experts in the field: Michel Sadelain and Prasad Adusumilli, Richard O’Reilly from MSK on all different programs there, Marco Davila from Moffitt, Rajiv Khanna from QIMR. So we are really strongly supported by these experts who are taking active part in our discussion related to our science and technology. And we add to that also some key advisors, especially in MS where we are working with key expert of the field, not only from Australia, but from U.S. and more and more from Europe as well. I hope I answered your question.

Yes, sir. You did. Thank you, Pascal.

Thank you. And our next question comes from Salveen Richter from Goldman Sachs. Your line is now open.

Good morning. Thanks for taking my questions. Two from me. I guess, Pascal, one is a strategic question here. As you look to creating your CAR T – your allogeneic CAR-T pipeline, just a question as to why you would go into the CD19 space just given the crowded nature there versus maybe going after some other targets apart from mesothelin? And then a second question just following up on what Phil said, what gives you the confidence just given that you have only 10% of transplant sites in the U.S. open for the EBV program that you can hit this second half 2020 BLA submission?

Thank you for your question. So let’s start with the first one. There is one slide in our new investors deck that I recommend you maybe to have a look to Slide 40, 4-0. And that’s trying to explain how we see the different assets for the different CAR T that we have right now. We have clearly a need to accelerate the clinical stage development of ATA2271 or mesothelin autologous CAR T. And, as you know, we are also actively developing at a preclinical stage our allogeneic version of the mesothelin CAR-T ATA3271. Now the reason we are pursuing the development of a CD19 allogeneic EBV based CAR-T ATA3219 is really because we can go there faster to get to the clinical stage where we can compare what we will get there with currently approved product in that space, which are autologous, and also some clinical result that starts to appear with some other allogeneic type of platform there. We strongly believe that our EBV based allogeneic T-cell as CAR T could lead to not only a very safe and well tolerated way to treat these patients, but the level of expansion, trafficking and persistence that is needed to have a significant level of response and durable response there. Persistence is one of the key aspect I believe there. And I think that has been one of the challenge of many of the allogeneic type of platform. We have data, as you know, for more that cell experience that shows that the cells of the system and in different type of patients, and are persisting long enough to our few other remission there. We would like to show the same with the CD19 construct and that we believe will be the definite proof of concept, and not only we have a suitable platform for allogeneic CAR T, but we have a better platform for allogeneic CAR T than any other platform that exist right now. So again, that’s why we think in that program, it’s really to have proof of concept that will support all of our other effort in terms of allogeneic CAR T, and ability to do so in a rapid way and to do so in the particular type of disease, B-cell malignancies, where the existing data from autologous and some other early data from other allogeneic platform will help us to be able to compare the type of results we get. And hopefully, as we believe, to show how we could be superior to other approaches there. I hope I answered your question on that one. And on the number of site, as we said, we are in about 10% of the site, but as you can imagine from what we’ve said, the increased number of site in the U.S., in Canada, then later on Europe, all of these will play a significant role in terms of enrolling and recruiting new patients in that pivotal study. We are, of course, benefiting here from the work that has been done. So the guidance we’re giving about the second half of 2020 is based on the reasonable on the whole month’s rate in line with what we’re seeing right now. So that’s something is important. It’s a reasonable estimate in terms of what we’re seeing right now. Any increase in the number of site is going to help us to continue the work to be able to be in line with our guidance, which is our objective. We want to be able to execute as expected and we need to deliver as expected what we would like to do for patients and for our shareholders.

Thank you.

Thank you. And our next question comes from Ben Burnett from Stifel. Your line is now open.

Great. Thanks so much. Congrats on the progress. I have a question about the tab-cel expanded access program. I guess specifically the stem cell transplant group that you reported on yesterday. I think the ORR it was reported yesterday was 55%, which is a bit lower than a previous analysis of 80%. Obviously, there are more patients. But I was wondering if there’s any notable differences between the new –the six new patients that enrolled into the EAP and were included in this analysis versus the original, I think, five just in terms of disease severity or baseline characteristics?

Thank you, Ben, for your question. AJ, you want to take that one?

Yes, I wouldn’t say that there is a significant difference. As you see in the abstract, the HCT patients in general did have kind of an intermediate to high risk. A higher proportion of them were intermediate to high risk relative to the SOT group. So they were generally a bit sicker patients, but honestly, it’s a small number of patients. So I wouldn’t – at least from our read, I wouldn’t over read that. I think the key point for us has been that these data are pretty consistent with almost everything we’ve presented. We’ve generally had a 50 to eight – little bit over 80% ORR across all of the different study populations we’ve reported on. So for me, it’s still a fairly consistent deal.

And I think the – also the ability of responding, something that is very important. The fact that we have the 79% to 81% – by the way, on a full population there is extremely encouraging there in terms of overall survival on two years.

Great. That’s helpful. Okay. And then if I could just ask one more, maybe just a follow up on Salveen’s question. Could you just maybe articulate a little bit more on the strategy with regards to the mesothelin assets? The 2271 as a tall, I guess. So I guess is there a plan shift away from this asset at some point to focus on 3271?

Thank you for your question. Here we are, as we said, our priority is on both assets. We want to go to the clinic with 2271. We believe it’s going to offer superiority potentially to the first generation due to the integration of this 1XX co-stimulatory domain which is going to have an impact we believe from preclinical data, from initial data on persistence, and more a physiologic way of addressing the target there for the activation of the T-cell of the CAR T. And I think also the PD-1 DNR with its intrinsic ability to address the immunosuppressive environment that the CAR T is encountering in these type of disease there. So we’re very confident on this autologous CAR T going to the clinic next year. And the idea is to pursue that. So, we start with first in human, clarifying the dose and moving into hopefully proof of concept. And then if we could accelerate to a pivotal study, we will do so. So that’s really our aim is to accelerate not only moving to the clinic, but ideally moving through a product that could be approved there. Now the allogeneic version is beyond in terms of time for good reasons. And we are pursuing that and accelerating that because ultimately, we believe that adding an allogeneic CAR T that is able to offer a clinical same efficacy and safety and some significant advantages in terms of the delivery to patient within three days for more inventory, as well, as of course, cost of goods will be significant in terms of what we can achieve in that particular space. But clearly, ATA2271 is a priority for us to move as fast as possible to the clinic through proof of concept and ideally to some type of people on study.

Got it. That’s helpful. Okay, thanks and congrats again on the progress.

Thank you.

Thank you. And our next question comes from Maury Raycroft from Jefferies. Your line is now open.

Hi, everyone, good morning and thanks for taking my questions. So, I just had a question on the early access and single patient use program for tab-cel. Just wondering if you could provide an update on how many patients you treated with tab-cel in those programs? And then are you acquiring specific data from these patients? And do you plan on providing an update on those patients at some point? Or could you provide a general update on the patients now?

Sure. So in terms of kind of the total number of patients across all groups, we’re probably not going to be giving exact numbers there. What I will tell you though is a couple of different things about this, for example, this 201 expanded access program. So you talked about are we going to be providing data on some of the other patients? Yes, so at a future congress, we do plan on talking about some of the other populations that we’re seeing. I think the important thing to understand off of the 201 data that’s not PTLD patients that we’ve got is that those are data that we’ve utilized to plan for our multi-cohort study, the 205 study that we have talked about because it’s the information that we’ve got gained in that 201 study. That’s actually given us the necessary requirements to figure out how we want to do the 205. So the data that we’ve gotten is useful, and we will be presenting that at some future point.

Great. Thanks for taking my questions.

Thank you. And that concludes our question-and-answer session for today. I’d like to turn the conference back to Pascal Touchon for closing remarks.

Thank you, everyone on the call today. It’s been a great pleasure talking with you. We look forward to finishing the year very strong. And hope to see many of you in Orlando at ASH. Have a very nice day. Bye.

Ladies and gentlemen, this concludes today’s conference call. Thank you for participating and you may now disconnect.