Collaboration

Dec 7, 2020

Slides

Ladies and gentlemen, thank you for standing by, and welcome to the Atara Biotherapeutics Conference Call. At this time, all participant lines are in listen only mode. After the speakers' presentation, there will be a question and answer Please be advised that today's conference maybe recorded. I'd now like to hand the conference over to your host today, Mr. Eric Heilengren, Vice President, Investor Relations and Finance at Atara Bio Therapeutics. Please go ahead. Thank you, operator. Good morning, everyone, and welcome to Atara's strategic collaboration conference call. On today's call, members from the Atara executive team will discuss our recently announced strategic collaboration with Bayer as well as recent data presented at the ASH Annual Meeting on our CAR T ATA-three thousand two hundred and nineteen and TAVZAL. We recently issued a joint press release announcing that Atara and Bayer have entered into a strategic collaboration for mesothelin targeted CAR T cell therapies for solid tumors as well as a press release on new data on our assets presented at ASH. These press releases and an updated investor presentation are now available in the Investor and Media section at attarabio.com. Joining me on today's call are Doctor. Pascal Tuchon, President and Chief Executive Officer Doctor. Jacob DuPont, Executive Vice President and Global Head of Research and Development Upal Kopikar, Chief Financial Officer and Joe Newell, Chief Operations Officer. We will begin with prepared comments from Pascal, then open up the call for your questions. We would like to remind listeners that during the call, the company's management will be making forward looking statements. Actual results could differ materially from those stated or implied by our forward looking statements due to risks and uncertainties associated with the company's business. These forward looking statements are qualified in their entirety by the cautionary statements contained in today's press release and the company's SEC filings. These statements are made as of today's date, and the company undertakes no obligation to update these statements. Now I'd like to turn the call over to Pascal. Pascal? Thank you, Eric, and thank you all for joining us this morning. I am very excited to announce that Atara and Bayer have entered into a worldwide strategic collaboration to develop ATARA's novel allogeneic off the shelf mesothelin CAR T program ATA-three thousand two hundred and seventy one and autologous mesothelin CAR T program ATA-two thousand two hundred and seventy one. This agreement recognized ATA's leading technology platform in allogeneic cell therapy and is a fundamental element of Bayer new cell and gene therapy strategy. Our new partner, Bayer, brings significant oncology development and commercialization capabilities in solid tumors as well as an expertise in targeting mesotheli. Partnering with Bayer allows us to accelerate and expand the development of ATA-three thousand two hundred and seventy one, which we believe maximize the possibility to rapidly impact patient and create a significant opportunity for shareholder value. As a reminder, ATA-three thousand two hundred and seventy one is a novel and unique allogeneic mesothelin targeted CAR T with a PD-one dominant negative receptor and the 1XX co stimulatory domain. It has the potential to be 1st in class with an optimized design for solid tumors. By leveraging Bayer's proven track record and clinical development capabilities, the development timeline of ATA-three thousand two hundred and seventy one could be accelerated together with the ability to conduct parallel studies in multiple tumor types such as mesothelioma, non small cell lung cancer and other tumors overexpressing mesotheli. Bayer, with its newly formed cell and gene therapy unit, selected ATARA and our groundbreaking technology as very promising in the field of allogeneic CAR T. Hence, we believe that Bayer's investment in ATA-three thousand two hundred and seventy one provide external validation of Atara's allogeneic EBV CAR T approach and platform, including endorsement of our allogeneic T cell manufacturing process and capabilities. Going forward, Atara will lead IND enabling study and process development for ATA-three thousand two hundred and seventy one and Bayer will be responsible for submitting the IND, which is expected to occur in 2022 and then for subsequent clinical development and commercialization activities. ATARA and Bayer have aligned on preclinical CMC and clinical plans that we believe are leveraging the potential of ATA-three thousand two hundred and seventy one across various solid tumors over expressing mesothelin with significant unmet need and sizable patient population. Under the terms of the agreement, Atara will receive $60,000,000 in cash upon signing and is eligible to receive up to $610,000,000 in development, regulatory and commercial milestone payment plus tier royalties up to low double digit percentage of net sales. As a result, our cash runway is expected to extend to mid-twenty 22. And moving forward, we will be able to allocate even more resources to Atara's other proprietary programs such as tab cel, 8,188, 832-nineteen and a number of early stage CAR T programs in hematological malignancies and solid tumors. At start of the transaction, Atara will also provide translational research and clinical manufacturing services to be reimbursed by Bayer. In addition and for a limited period of time, Bayer has a non exclusive right to negotiate a license for additional ATARACARTI product candidates, if ATARAC decides to add license fees. Just to be clear, tab cel and 8188 are not part of this consideration. Before opening for questions on this exciting deal, I'd like to provide a brief update on our key data presentation at the American Society of Hematology 2020 Annual Meeting. Today, we are presenting preclinical data for ATA-three thousand two hundred and nineteen, our allogeneic CAR T, targeting CD19 in B cell malignancies. This program also utilized the 1XX co stimulatory technology. The data presented at ASH showed potent anti tumor activity both in vitro and in vivo with long term allogeneic CAR T persistence and no evidence of allotoxicity in vivo. We are encouraged by these results as they support our plans to develop a potential best in class allogeneic CAR T for B cell malignancies with high and durable responses in patients. We anticipate submission of an IND for ATA-three thousand two hundred and nineteen in 2021. Additionally, we are presenting several data sets related to tab cel, including the first ever presentation of clinical data on patients with life threatening complications associated with EBV varenia. This heterogeneous group of patients, including some with hemophagocytic lymphoistheocytosis or HLH, a condition with poor prognosis for which treatment options are limited, 80% of patients in the EAP-two zero one study with persistent IVV viremia were responders and 50% of the patients in EAP-nine zero one with IVV viremia and HLH were responders. The overall survival OS rate at 1 year in patients with EBV viremia treated in the EAP-two zero one study was 100% for a median follow-up of 14.6 months. We are also presenting data on the substantial cost burden of PTLD, defining important aspect of the significant value that the transformative treatment such as FabCell could provide to PTSD patients and healthcare systems. I'll now turn the call back to operator to begin the Q and A portion of the call. Operator? Our first question comes from John Newman with Canaccord. Your line is now open. Hi, guys. Good morning and congratulations on a very nice agreement here. It's very good. Pascal, I just had a question regarding the agreement. I'm wondering if the agreement allows Bayer to run future clinical studies for the autologous 2,271 product. I see in the press release that you'll be responsible for the ongoing Phase I study. I'm just wondering if it's fair to say that Bayer is prioritizing the allogeneic product at this point? Yes. It's fair to say that the collaboration of Bayer and Aptara are prioritizing the allogeneic product ATA-three thousand two hundred and seventy one because we believe that's the one that could rapidly develop significant value for patients and our shareholders. At the same time, however, we are considering this Phase I study with our collaborators at Memorial for ATA-two thousand two hundred and seventy one. And I would say that I will tell that at this stage priority is 3,271. But of course, if we with Bayer see a significant positive data coming from the autologous version of the product, certainly we will discuss and Bayer has a possibility to continue the development of the autologous version. So priority is the allogeneic, but we are continuing the development of the autologous. Great. Thank you. Our next question comes from Salim Syed with Mizuho. Your line is now open. Great. Thanks for the question, guys. And I'll add my congrats to the deal. Just a couple from me. Pascal, just one housekeeping on the milestones. Can you just give us the breakout between development, regulatory and then also commercial, so 2 buckets or 3 buckets, however you want to do it. And then just on the rationale here, for metho, I understand, but the other CAR Ts here, can you just like maybe outline for us how you're thinking about partnering those CAR Ts as well? I know Bayer has a non exclusive right here for a limited period of time. What sort of time period are we talking about? And is it your preference to partner those out? Or would you like to retain those in house? Thank you. Thank you, Salim for your question, Dave. So answering the first question, we are not disclosing at this stage a particular detail or the different milestone. Let's just say that this is a very classical type of deal with milestone related to progress in development in regulatory and of course then commercial milestone. But at this stage, we are not disclosing any detail there. Coming now to the second question. So as you know, Atara is developing a large number of proprietary assets. In fact, all our assets are proprietary assets at this stage. It is the first one that we are partnering out with someone, which we believe can accelerate and expand the development of these particular assets, I mean Bayer. Now we are developing a number of CAR T, one of them allogeneic CAR T, one of them is advanced. It should go to IND in 2021, that's ATA-three thousand two hundred and nineteen for which we are presenting today at harsh, very exciting preclinical data there that confirms our intent and possibility to become potentially a best in class in B cell malignancies. That is the most advanced one. We have done a number of CAR T that we are progressing at earlier stage with our collaborators at Moffitt Cancer Center and at Memorial Sloan Kettering. So that's our portfolio of proprietary assets in the CAR T space. Now what the agreement is saying is that due to the very high level of interest of Bayer in this alloCAR T technology and platform that we have, there is a possibility for us if we decide and that's our decision to partner out one of his CAR T, we will then as part of the agreement discuss and negotiate in a non exclusive way with Bayer the possibility for them to become the partner on one of these Carty. But again, it's only if we decide to do so, when we decide of course it and it's a non exclusive right to negotiate. Does it answer your question? Yes, sort of. And I guess the other I mean is it your preference to partner these out? I mean is there rationale here that it's non diluted financing or is it just the acceleration or both? No. At this stage, we want to create value with these assets. They are early stage asset. And 3,219, we believe it's important to show some clinical data hopefully demonstrating the positive for that asset to become a best in class in the B cell maintenances field. So our intent is not to partner at this stage. We want to continue to progress with our own resources into clinical development and for the earlier stage asset into IND enabling study and clinical development. So we are not intending to partner at this stage. Our next question comes from the line of Michael DeFiori with Evercore ISI. Your line is now open. Hi, guys. Thanks so much for taking my question and congrats on a very good deal. Just have one clarifying question. Maybe I missed it. But with regards to the, I guess, non exclusive option today, I'm just trying to get a sense of how much flexibility Atara has. I realize that since it is non exclusive, Atara retains some optionality on these later CAR T technologies. But just if you could elaborate, if possible, on how much flexibility Atara has in this regard, that would be helpful. Thank you. Thank you for your question. We have a lot of flexibility. In fact, what's happening there is that, first of all, it is at Atara discretion to decide, of course, to partner or not to partner any CAR T program that we have. Say, take 80, 3,290. If we decide by the time we get clinical data that it's a great potential best in class in that class, but we want to commercialize by ourselves and we don't want to partner. That's our choice. That's our strategic choice. So this is full freedom of strategic choice for the decision to partner. Now if we decide to partner, we will discuss with Bayer's company including Bayer and that's what we call a non exclusive right. And I think it makes sense for us to have that possibility to discuss with Bayer because we believe that they are a great partner and we're going to work efficiently with them to develop our mesothelin CAR T program as fast as possible. So to us, it was extremely logical to be able to discuss with them if we decide to partner another type of CAR T program at certain stage. Does this answer your question? Yes. Thank you very much. Our next question comes from Ben Burnett with Stifel. Your line is now open. Hey, thanks very much and congrats on the partnership. I actually wanted to ask you a question regarding ATA-three thousand two hundred and nineteen and the preclinical data that was described in the press release and coming out of the meeting. Basically, can you just talk about how you characterize persistence in vivo? And I guess, how does that translate to what you expect for persistence and patients? Any color on that would be super helpful. Thank you. Thank you, Ben, for the question. Jacob, do you want to take that one? Yes, certainly, Pascal. And thank you, Ben. Yes, so we as we presented here at ASH, the first public presentation of the 3,219 preclinical data, which is our allogeneic CD19 specific CAR. And we showed in vivo and in vitro data and persistence was really assessed according to the presence of these T cells in the mice over the passage of time. So we were able to see with the 1XX co stimulatory domain that's built into the 3,219 cells that we do see long persistence of these T cells in the animals as we assess them over time. And obviously, this comes with excellent efficacy and we also see really no evidence of allo reactivity, which portends well for the safety profile as we move towards the IND filing in 2021 next year. And I would add, Ben, that this is really in line with what we've seen from the academic construct, which was using the different cost inventory domain. The data that were presented at TCT meetings in February this year. You may remember this clinical data on 6 patients treated with an allogeneic EBV CD19 CAR T made by Memorial Circuitry. And in these six patients with advanced B cell malignancies, the response rate, the CR rate, complete remission rate was 83 over 83%, 83.6%. And these patients were followed for a very long time. In fact, the longest follow-up ever of allogeneic CD19 CAR T inpatient. And the median follow-up was 26.9 months, so more than 2 years, and the patients were still responders at the time. So we have this initial proof of principle for that academic construct that building a CD19 CAR onto an ABVD cell, an allogeneic ABVD cell is indeed leading to high level of response and durable response with a very long follow-up. So what we see right now in the animal models in the preclinical data of ATA-three thousand two hundred and nineteen is very much aligned from what Memorial has seen in the clinical study that they conducted. Okay. That's very helpful. And if I could just ask one follow-up question. Just can you talk about your plan on how you approach or how you plan on approaching lymphodepletion in clinical studies with 3,219? And I guess, is this a variable that you would focus on in terms of optimizing? And is there a scenario where you think maybe you won't need chemo preconditioning? Thank you for the question. Jacob, do you want to take that one as well? Yes, absolutely. So in terms of the clinical trial, we are obviously working towards the IND filing, as I mentioned, which will be submitted to the FDA next year. And when we think about lymphodepletion, we would be planning for standard lymphodepletion with cytoxine and fludarabine as well. But that being said, with this study, we do want to obviously also assess the possibility potentially for decreasing the lymphodepletion over time because of again the 1XX format and some of the potential for persistence as well. But at this point in time, our idea is to proceed with standard side flu lymphodepletion in that study. And I will add that. Clearly, we don't need to add this kind of very aggressive long term lymphodepation to adding to CyFlu like an anti CD52 monoclonal. We don't need that because we have this unique natural state of this EBVT cell that are carrying the CAR. And in fact, we have this partial HLA matching that we believe is helping also the persistence of the cell. So we know already that there is no need for this very heavy long term nephrotic patient that some other are following. Right. Okay. Thank you. I appreciate it. That's helpful. Our next question comes from Phil Nadeau with Cowen and Company. Your line is now open. Good morning. Congratulations on the deal. A few questions from us. First on 30 twonineteen, now that you've had the pre IND meeting with the FDA, what remains to be completed before you can file the IND and begin the clinical studies? Yes. Thank you for your question. So Jacob may want to chime in, but basically what's needed is really to work now on the CMC part and finalize the different batches as well as to fine tune a few of the additional studies there. But everything is on track and we don't expect significant issue at this stage from that point of view. Jacob or Joe, do you want to add anything? Yes. I think, Pascal, full agreement there. We're very much on track, very collaborative pre IND meeting with the FDA as described. And Joe, any other comments on the manufacturing side? Jacob, you characterized it beautifully. We're on track. Manufacturing is going well. Great. And then second question on 3,219. Some of your potential competitors are looking at retreatment strategies in the CD19 ATLAS space. Any thoughts on the need for retreatment with 3,219? Or do you think a single administration of the cells will be sufficient? Yes. Thank you for the question. Maybe I'll start before asking Chetan to chime in. In saying that we know already that there are 2 possibilities that are offered by our technology. 1 is multi dosing. The other one is retreatment, okay? So whether it's retreat if retreatment is defined as the need to treat a patient that is not responding to the first treatment and that is something that is possible with our technology and we have significant experience as you know with tab cel or with 8018 there in patients there. If this is about multi dosing, there is some experience from the Memorial Clinical data that I was mentioning where on these 6 patients, they were treated with 1 to 3 dose. The median was 2. And that's a possibility to do multiple dosing there. So that's possible. Now whether it would be required, really the first thing that I would tell, we believe that the persistence of the sales and the ability for them to expand and really eradicate the tumor cells will be the key to see whether there is a need to do several dosing or whether there is the possibility to do retreatment if the patients are not responding to the first treatment. Jacob, anything to add? Yes. I agree with that, Pascal. I do think the key word here is flexibility. So obviously with the profile of the 3,219 cells, we do see between the EBV T cell back bone and then also the 1XX co stimulatory domain that we think we have the potential for having a best in class behavior for an allogeneic T cell. So perhaps single administration is going to be sufficient. But there's also potentially flexibility for multiple or retreatment, I should say. And so this will be a data driven decision when we actually generate the data in the clinic. But we think there's a chance that single administration could be potent and in and of itself, but again, there could also be the potential for retreatment if Specifically for 2,271, I guess I'm still a little unclear. Specifically for 2,271, I guess I'm still a little unclear how that's handled in the current collaboration. Just for argument's sake, if you move forward with 2,271 instead of 3,271, are the economics the same? And at what point would Bayer start to run the trials for 2,271? Thank you for your question. So we start the collaboration, in fact, with work with Bayer, but it's ATARA leading the 2,271 collaboration for the first in human clinical study with Memorial. By the way, the first patient has been enrolled in that study, and that's very exciting. That's great news. And so that's at our working with Memorial, but of course in collaboration with Bayer as well there. Now we will have data and we said in the past that we should start to see some data from this autologous program in the clinic in the second half of twenty twenty one. So second half of twenty twenty one, we start to see data and we'll see how the data are playing out there. Now depending on the data, there is a possibility for Bayer in that deal to then take over and develop further 2,271. Again, the priority is 3,271. And why is it a priority? Because if you think about it, the IND is coming in 2022. So it's not too distant from the first clinical data with 2,271. So one way to really accelerate the development of 3,271 is really to leverage the information, the data, the know how that we as collaboration we get from a clinical study of 2,271 to be able to further accelerate 3,271 clinical development. Now again, both product, both assets, 2,271 and 3,271 are part of the deal. And moving forward, the data will be the key to decide what we do. But clearly, the emphasis on that deal and collaboration is on the allogeneic EBV mesothelin CAR T because we believe that will offer much more flexibility and benefit for patients. And also, as you know very well, we are moving forward with new manufacturing technologies, new manufacturing process into bioreactor and the possibility to have a low cost of goods manufactured for this type of allogeneic EBV CAR Ts. And we believe with our partner buyer that is also something very important to consider moving forward to develop a successful and profitable product. That's great. And then just the last question is on the timing of the collaboration. I'm curious why now? Why do you think this is the time to maximize the value for shareholders? It does seem like there's a decent number of milestones for 2,271 and 3,271 over the next 12 to 18 months. So why now? And why not wait to get some data and maybe a bit more progress on 3,271? Yes. We think that it was the right time to do a deal now for two good reasons. One is that with a partner like Bayer, we can accelerate and expand our development of 3,271 because this particular allogeneic PPV CAR T could really address several type of tumors from mesothelioma to non small cell lung cancer and then to a number of other tumors that are also overexpressing mesotheliene like ovarian cancer, pancreatic cancer. So if you think about the broad type of tumors that could benefit from that type of product, having the possibility to do a parallel type of development is very important because then you can really accelerate and broaden the possibility to create value there. So the idea to go fast and to go broad was really what was behind the deal with a partner like Valeo that not only is very enthusiastic, is very committed, but we agreed with them on the development plan there. And it's a very exciting development plan that really is maximizing the value of the asset there. Now the second aspect is that from a resource point of view and the allocation of resource at Atara and financial and other resources, we believe it was important to partner some asset at this stage because that allows us to then dedicate a lot of our resources to other proprietary programs, especially tab cel 8,188 where we are waiting now for the response from the FDA by the end of the year on the randomized controlled trial. We're very excited about this program. We have also to accelerate the development of ATA-three thousand two hundred and nineteen and this early stage CAR T program that we were mentioning earlier on. So these two aspects, one is how can we maximize the value of that asset, make sure that we have very large potential ahead of us if we go fast and we go in parallel in multiple development and then at the same time having the possibility to allocate a resource in a way that could allow us to develop to the true potential tab cel 8,188 and other allogeneic parties. That's very helpful. Thank you for taking my questions and congratulations again on the deal. Thanks Phil. Appreciate it. Our next question comes from Matt Phipps with William Blair. Your line is now open. Good morning. Thanks and congrats obviously. But kind of following up on Phil's question there, I mean it seems like this trial just started with the 2,271. I guess how much data was available from that for the deal? It seems like if you could have gotten some real proof of concept with that, the deal could have been more attractive for you all. So just again with the timing for doing it now and I guess specifically was there data available for the deal negotiations? Yes. No, no data was available apart of course from the IND package, but no data related to the clinical results because as I said, the first patient has just been on November. So it's nothing to do with that. I mean, certainly, the IND package and the fact that the FDA are clear that IND, all that played a role in the deal and was discussed with Bayer there, but not any clinical data on 2,071. Now again, one thing that is very important to keep in mind that as any biotech company, you could wait for all your property program to come to different type of value inflection point. Here in that particular case, we thought that the best way to create value for our shareholders and for patients was to accelerate this program right now, right here, not to wait a year, a year and a half to have data and then to consider partnering that particular asset or that bunch of asset. Going fast now is the best way to be competitive and other programs that are targeting mesothelin, but also to be able to, as I say, run-in parallel several development for ATA-three thousand two hundred and seventy one, I mean, several clinical studies and development across different tumor sites, that requires significant investment, not only to go to the IND, but then also to move forward, build the inventory to do various clinical studies and so on and so forth. So from that point of view, we thought that the best way to create value is to accelerate and expand the value potential of this asset in doing a deal right now with a partner that is very committed, very knowledgeable and is going really to support this program moving forward in collaboration with Atara. Okay. Thanks, Pascal. And then what is owed to MSK now? Does Bayer take responsibility for any royalties paid to MSK or is that has to come from you all? We are not disclosing any particular aspect of that. I mean the specifics of the deal and what we put on the 8 ks. And of course, there will be the redacted version of the agreement next year in our filings there. But at this stage, we're not disclosing anything. Suffice to say that we believe that this deal is creating significant value for Atara, and that's very exciting to be able, as I say, not only to have the possibility to accelerate and expand the program, but also to have resources that we can dedicate to and particularly financial resources that we can dedicate to all the proprietary programs to advance rapidly. Okay. Thanks, Pascal. And then one question, if I may, on 3,219, just bigger picture question. Based on kind of what we've seen from both autologous and other allogeneic programs, where specifically the allogeneic having persistence problems, How do you think about this for 3,219, particularly going into maybe the leukemias versus the lymphomas? Some data with the autologous program showing that persistence might be more important actually in the leukemias than the lymphomas. Does that influence your thinking for 3/2/19 as far as where to initially try it out? Okay. Thank you for your question. We certainly are aimed at B cell malignancies in general. So lymphoma leukemia with that program, we don't have any focus on only one type of dermatological maintenance is the increased B sales debt. Now this being said, we believe that persistence of the sales and what I will call functional persistence, which we believe is very important, is key in both disease. And the idea is that when you think about the best in class in the lymphoma, it's a mix of higher response rate than what is existing today, better safety than what is existing today and longer durability of response that is what is existing today. Because if you look at the kinetics of response in the autologous setting right now, you have this initial peak in response, but then with time this is progressively decreasing. Then you have a plateau, which is probably around the 40%, 50% CERs and long term there. But that means 50% to 60% of the patients are not benefited. So there is a significant unmet medical need right there from that point of view. And of course, safety is still an area where there is a need to progress compared to the current approved total loops. So all these aspects are very important in FY 'nineteen. We believe that the way we've constructed AT30 to 19 with 1XX as a costimulatory domain, which is helping that functional persistence and we have this clinical data from 30 to 90 9. And by the way, also from 30 to 71 showing these functional persistence that are just sitting longer and then not exhausted, they are able to continuously address the antigen challenge there is important. Now leukemia, it's right that the persistence of the cells seems to be even more important there, but we believe that this is will be an additional element of creating value for ATA30 to 20 19 moving forward. Our next question comes from Anupam Rama with JPMorgan. Your line is now open. Hi, guys. Thanks so much for taking the question and congrats on the buyer collaboration. Just a quick question on the collaboration. It seems like for a time period here Bayer will have the potential to negotiate additional licensees for CAR T programs. What is that time period? And I guess this is nonexclusive. So should we be taking that as you got strategically open to additional partnerships outside of FAIR as well? How should we be thinking about that? Thanks so much. Thank you, Anupam, for your question. So here, clearly, first, is Atara's decision. So we decide in the future whether we want to partner or not some other CAR T programs. Take ATF-twenty 19, which is the most advanced, okay? If we decide in the next 2 to 3 years to develop that program, we will go to discuss with different companies, including Bayer, And to us, it makes sense to if we decide to partner that program, to connect with value as well. And that would be a competitive process to extract as much value as possible for our shareholders there. But again, it's our decision. If we decide not to partner over the next few years this program, we just continue as a proprietary program and continue to create value internally for our shareholders and we might decide to commercialize by ourselves or to get a partner at a later stage for commercialization and not for development. I mean there are many options. So we have the flexibility in our option. And I think that's what is very important in that type of deal. I think buyer interest in other CAR P, I believe, is something linked with the keen interest that they have in cellular therapy in oncology and in our technology. So that's I see that as a tribute stage to the amazing work that's been done by my team in R and D, in manufacturing and technical operation and process science. So that's good. That's great. We were not ready to partner anything else at this stage because we think we have to first create value and then decide whether we want to partner or not some of these assets at a later stage. Does it answer your question, Anytime? Yes. Thanks so much. Okay. You're welcome. Our next question comes from Salveen Richter with Goldman Sachs. Your line is now open. Thanks for taking the question. This is Andrea on for Salveen. Maybe as a first one, if you could speak on what we could expect from the regulatory update from ATA188? And then just remind us on the 12 month catalyst path? Thanks so much. Yes. Okay. Jacob, do you want to take the 8,188 questions, please? Yes. Certainly, Pascal. So Andrea, thanks for the question. So as you know, with the ATA188 program, we have patients. So what we did in the fall is we submitted a data package to the FDA along with the randomized controlled trial protocol. And we asked the agency a series of questions. Number 1, in terms of the protocol, what about the patient population, the primary endpoint and the timing of the primary endpoint. And we expect to get feedback from the agency in the short term and I'll describe the timing of that in a moment. Then we also asked them about the randomized controlled trial, if that could actually be part of a registration intent package with another Phase 3 study conceivably. Our base case currently is that we would do this randomized controlled trial and then follow that with 2 Phase 3 studies in progressive MS, but we want to be opportunistic and see if the agency is open to letting us use this current randomized controlled trial as part of a registrational package. And then the final series of questions was really related to expedited development of the ATA188 program, namely pathways such as breakthrough therapy designation RMAT or fast track designation. So we asked the agency whether or not the data in the package that we submitted was sufficient for us to proceed to apply for some of these designations. And if not, if they could give us guidance on what else they would like to see. So we do expect to receive feedback from the agency here between now and the end of the year, and we do intend to communicate the outcome of that feedback by the early part of next year. And regarding the cash situation, Elton? Okay. So maybe I'll answer for that. So as you know, at the end of September, we had EUR 3.27 million of cash. And this particular deal is really helping us now with the cash at signing to extend our cash runway into mid-twenty 22. Does this answer your question, Doug? Hello? Yes, I can hear you, Pascal. This is Jacob. Our next question comes from Jonathan Miller with Evercore ISI. Your line is now open. Hi, guys. Thanks for squeezing me in here. I guess we've had a lot of questions on the other programs. I'd love to ask one on tab cel. You had some expanded access data in AID and PD, LPDs at ASH. How good should we think of this ASH data as a proxy for behavior in these indications in the multi cohort study? Is this the sort of response rate and behavior you expect to see as we move forward in that indication? Or is there some reason to think that those populations would be different? Thanks. Yes. No, thank you for your question, John. I mean, before handing over to Jacob, clarification that we have, as you know, 6 cohorts in our medical study that we have initiated recently. And now we have shown PDCA data in most, if not all of course, the most recent being what we're presenting at ASH on people with life threatening situation of EBV viremia there with this high level of response there. So Jacob, do you want to comment on the response rate per cohort that we've seen so far in previous clinical data and what's our expectations for the MERTICAL study? Yes, absolutely. So thank you for the question. So at the ASH meeting, which is currently ongoing, we did present data from our expanded access and Phase 2 experience of tab cel and the academic one as well. And then and we did describe that for this population of patients that have severe EBV viremia that we do see response rates depending on the study on the order of 50% to 80%, which is obviously a very high response rates and we also see overall survival at 1 year of 100% with a median follow-up of 14.6 months. So this is obviously quite strong and profound data. So if you look now at the 6 populations that are included in the multi cohort study, whether it's the PID, LPD, AID, LPD, the CNS PTLD, the frontline PTLD patients or the leiomyosarcoma patients and now most recently the EBV viremia patients, we have now publicly disclosed historical data from our clinical experience of tab cel in all six populations. And I think it's fair to say that we are seeing response rates and durability of response across all of those 6 populations that are meaningful, where these are patients with really no significant treatment options. And we are seeing high response rates and durability that we believe are meaningful here for these patients. So that's obviously why we are also initiating the multi cohort study. The study is open and enrolling and we're seeking that first patient enrolled before the end of the year. And we do think that this multi cohort study does allow us to expand the reach of tab cel in terms of treating patient populations. Obviously, PTLD is where we're attempting to get our regulatory approval first. And again, we feel quite confident on that based on the interim analysis of the pivotal study, as well as the interactions that we've had with the Food and Drug Administration and EMA for that matter. But the multi cohort study really does represent a significant opportunity to expand the reach of tab cel and to help more patients and certainly enhance the commercial opportunity. Sure. Thanks. And that concludes today's question and answer session. Ladies and gentlemen, thank you for participating in today's conference. This concludes the program and you may now disconnect. Everyone have a great day.