Earnings Call: Q3 2022

Nov 8, 2022

Afternoon, everyone. Thank you for standing by, and welcome to the Atara Biotherapeutics Third Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. Please be advised that today's call is being recorded. I'd now like to hand the call over to Eric Heilengren, Vice President of Investor Relations and Finance at Atara Biotherapeutics. Please go ahead, sir. Thank you, operator. Good afternoon, everyone, and welcome to Atara's Q3 2022 results conference call. Earlier today, We issued a press release announcing our Q3 financial results and corporate update. This press release and an updated slide deck are available in the Investors and Media section at attarabio.com. On today's call, members from the attara executive team will provide an update on our results, operational progress and strategy, and also review our upcoming key milestones and objectives. Joining me on today's call are Doctor. Pascal Tushon, President and Chief Executive Officer Doctor. Jacob DuPont, Executive Vice President and Global Head of Research and Development to Paul Kopikar, Chief Financial Officer and Doctor. Ajay Joshi, Chief Medical Officer. We will begin with prepared comments from Pascal and Jacob, then open the call up 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 afternoon. We are extremely excited that Tapcel, under the trade name of Advalo, received a CHMP positive opinion for its first indication and is on track to obtain European Commission approval by the end of this year. This will be the first ever approval on allogeneic over the shelf T cell therapy. The EMA was accordingly very pleased to highlight eValu positive opinion in the public release as one of the landmark of the October CHMP meeting. Meanwhile, our commercial partner, Pierre Fabre, is actively preparing for the Advalo launch in Europe in Q1 2023. We eagerly anticipate this launch As we believe Edvalo can deliver a compelling value proposition for patients, payers and European Healthcare Systems, With significant pricing potential in such an ultra rare disease and high double digit Royalty, for our agreement with Perfab, we believe Advalo commercialization will progressively contribute to Atara's revenues and cash runway. I would like now to give an update on our progress with tab cel in the U. S. Following constructive discussions with the FDA, including senior leadership, we recently held a Type A CMC meeting with the review team that culminated in clear guidance and agreement on specific CMC Module 3 requirements for a BLA submission. In addition, a Type B clinical meeting request has been granted and is being scheduled to discuss and potentially align on the clinical data package requirements to prepare for a pre BLA meeting. Following this meeting and possible further interactions with the FDA, we expect to give further guidance in Q1 2023 on progress to a BLS submission. At the ASH conference in December, we will present updated interim analysis relapsedrefractory, EBV plus PTLD, with additional patients and longer follow-up confirming the transformative potential of tab cel. We will also present exciting new data in patients with EBV positive leiomyosarcoma, a type of EBV associated solid tumor. Jacob will provide more details on this data in a moment. Finally, for FabCell, we have started to seek a commercial partner in the U. S. Entering into such a partnership will avoid further investment and could provide additional cash inflows further extend our cash runway. We are confident in a significant business opportunity that TapCel represent in the U. S. With potential for peak sales over $500,000,000 per year across multiple indications. Now on to ATA188, our potentially transformative therapy for those suffering from progressive forms of multiple At the Xtrem's 2022 conference, we presented new MRI biomarker imaging and open label extension clinical data on the Phase 1 study of ATA188 in progressive MS. New biomarker imaging data suggest patients who achieved confirmed disability improvement or CDI demonstrated significantly less brain atrophy over time and increased SYNCHRONY T2 lesions. These data support that brain structural changes, including potential remelination, May underlie durable CDI or confirmed disability improvement associated with ATA188. Also, updated results from the ongoing open label extension with up to 46 months total follow-up In patient achieving CDI demonstrate durability of improvement once achieved. Remarkably, patient with stable disease, meaning no decline in EDSS have maintained such stability for up to 4 years, which would also represent a transformational profile relative to the expected natural course of the disease. As a reminder, based on enrollment at the end of July for Phase 2 AMBOLD study evaluating AT1-eighty eight versus placebo in non active PMS patients, approximately 90 patients Our plan to be included in the readout of the study primary endpoint of confirmed disability improvement by EDSS at 12 months. We expect to communicate the final data readout in October of 2023. All in all, this new XTRIMES data from our Phase 1 study and OLE open label extension together with the 2 landmark studies published This year in Science and Nature and our 2 fast track designations with the FDA further support Our confidence in the possibility for 8,188 to deliver transformational clinical improvement to progressive MS patients. We are truly excited by 8,188 potential as a unique game changer in MS, and we are eager to reach the AMBOLD primary endpoint out in October 2023. Meanwhile, we'll continue to be opportunistic in exploring potential partnering opportunities with biopharma companies that could maximize the value creation potential of AT1-eighty eight. Now, I would like to hand over to Jacob to provide more details on our pipeline portfolio and strategy before I give you an update on our financials. Jacob? Thank you, Pascal. As Pascal mentioned, we are extremely excited about the recent Positive CHMP opinion for Advalo in Europe. We are advancing ever closer to receiving European Commission approval for this first of its kind off the shelf T cell therapy. We also believe that this positive decision which now has treated more than 500 patients with clear evidence of efficacy and safety, the most of any allogeneic cell therapy company to date. We're also encouraged by the steady progress we're making on the U. S. Regulatory front and expect to have more to say in Q1 of next year. Looking ahead to the Upcoming 2022 ASH meeting in December, we will present updated efficacy and safety results of the Phase 3 ALLEAL study in relapsedrefractory EBV positive PTLD, now with additional patients and longer follow-up. The data to be presented that was published in the ASH abstracts last week are consistent with the transformative potential Independent oncologic and radiographic assessment was 51.2% in the sample size of 43 patients. The response rate after HCT was 50% and after SOT was 51.7%. The median time to response was very rapid at 1 month and this urgent response is needed for these patients with such The duration of response was an impressive 23 months And the median overall survival was 18.4 months with patients to responded having longer survival than non responders. These new allele clinical trial data were impactful for the positive CHMP opinion that we just received. Additionally, at ASH, we will present updated efficacy and safety data from 2 single center open label studies and multicenter expanded access program in patients with EBV positive leiomyosarcoma Coma, who have received at least one therapy. Now the clinical benefit rate from tabso was 77.8% with an objective response rate of 22.2 percent in this rare and difficult to treat solid tumor and the estimated median overall survival was 77.4 months. In all these studies, the safety profile of tab cel remains consistent with previously reported data with no new reports of tumor flare reaction, cytokine release syndrome, Transmission of infectious diseases, graft versus host disease or infusion reaction related to treatment. We believe these data continue to support the benefit of tab cel and its potential to transform the lives of thousands of patients each We believe that targeting EBV infected B cells is a validated approach towards finding a transformative treatment for these for this debilitating disease. The recent publications in Nature showed that EBV infected B cells mature into antibodies secreting plasma cells that generate Brain reactive antibodies. In addition, EBV infected B cells can stimulate auto reactive T cells and thus drive chronic inflammation. Taken together, these recent scientific advances support Our excitement around the potential of this therapy. Now as Pascal noted, the new MRI data and updated OLE data presented at Actrims On top of previous Phase 1 data further reinforce our belief in the transformative potential of ATA188. We look forward to the final data readout from the approximately 90 patients who will be included in the primary analysis of the randomized double blinded Placebo Controlled Phase 2 IMBOLD study in October of next year. Now I want to provide an update on our CAR T therapies as well. With respect to ATA-two thousand two hundred and seventy one, which as a reminder Is our autologous mesothelin product candidate being currently developed by our partner Memorial Sloan Kettering Cancer Center and we are pleased to report that the Phase 1 dose escalation clinical study conducted by MSK has resumed enrollment after the voluntary pause earlier this year due to a fatal serious event in one patient. Additionally, for this program, we expect MSK to provide a Phase 1 data update for ATA-two thousand two hundred and seventy one in December of this year at the ESMO IO conference. In addition, we are advancing ATA-three thousand two hundred and nineteen, which is our potentially best in class allogeneic CAR T for B cell malignancies expressing CD19. Now the manufacturing process optimization is progressing to ensure appropriate Scale up while maintaining a unique memory T cell phenotype following completion of process optimization and manufacturing runs in the GMP manufacturing suites of our strategic manufacturing partner, Fujifilm Diosynth Biotechnologies, we now anticipate an IND filing in Q2 of next year. As a reminder, we're using an optimized manufacturing process to ensure enrichment for a memory T cell phenotype, which has shown robust activity in preclinical studies as shown on Slide 55 of our updated investor deck, where ATA-three thousand two hundred and nineteen outperforms an autologous CAR T benchmark on overall survival in a preclinical model. This manufacturing approach is part of the overall optimization of ATA-three thousand 2019 to differentiate it from the existing products and to address the high unmet medical need. Our focus on memory T cell phenotype for ATA-three thousand two hundred and nineteen product candidate is supported by recent preclinical and clinical presentations of autologous CAR T therapy. Upcoming clinical data at this year's ASH meeting of an autologous CD19 CAR T therapy show that CAR T phenotype with more stemness is associated with improved response rate and durability of response. Additionally, clinical data from another ASH 2022 abstract with the autologous CD19 CAR T containing the new 1XX co stimulatory domain invented by Doctor. Michel Sadlin is associated with favorable response rates, durability and safety. As a reminder, the 1XX co stimulatory domain that we have licensed from MSK is incorporated into the ATA-three thousand two hundred and nineteen construct. We are particularly excited to bring ATA-three thousand two hundred and nineteen to the clinic since this allogeneic CD19 CAR T has several key These include the safety of the EBV CAR T cells, potential best in class efficacy, persistence and off the shelf accessibility and the ATA-three thousand two hundred and nineteen program does not require TCR or HLA in editing. Before I turn the call back to Pascal, I would like to extend my gratitude to the Atara staff, Our collaborators and the patients involved in our studies, together we hope to bring to patients in need of allogeneic T cell therapy, some with curative potential. Pascal? Thanks, Jacob. Now on to our financials. In September 2022, we announced an additional near term milestone payment under an updated tab cel commercialization agreement with Pierre Fabre. Under this agreement, Atara will receive an additional $30,000,000 upon EC approval and subsequent filing of the MAA transfer to PSR. For the Q3 of 2022, with regard to our cash position and runway, we ended This Q3 with approximately €265,000,000 in cash. We believe that this cash balance, Together with potential cash inflows from Pierre Fabry and the expected reduction in future operating cash burn will be sufficient to fund the company planned operations into Q1 of 2024. Following our recent restructuring that is now fully implemented, we are on track to reduce our operating cash burn in 2023 and beyond according to plan. I would like to conclude by extending my sincere gratitude to all Atara staff for patients in need. Thank you all for what you have done. I will now turn the call over to the operator for the Q and A part of the call. Operator? Thank you. We will now be conducting a question and answer session. Thank you. Our first question is from Salim Syed with Mizuho Group. Please proceed with your question. Great. Good afternoon, guys. Thanks for the color and the question. I guess a couple from me on tab cel. So Pascal, curious if you plan on providing any sort of guidance on The EU tab cel revenues at any point in 'twenty three, maybe the first part of 'twenty three, or what format would that take place and also maybe some of the logistical hurdles that you plan on having for having the first Allo T cell product in Europe? And then also just on the U. S. Side, just curious what the gating factors are around finalizing discussions for potential partnership for U. S. Commercialization. Thank you. Thank you, Salim. So regarding Europe, we are not planning at this stage to give any guidance on revenues coming from Europe. Of course, at the time of the launch, which, as I said, is planned for Q1 'twenty three We received the approval and we transferred that to Pfab. We will have more to say about pricing, which is a very important Starting point in any type of launch. At this stage, we have aligned with TFAB and we understand what is their pricing strategy, Which we think is very relevant and fully aligned with the idea to price according to the value brought to patients, physicians, Society and the Healthcare System, but it's too early to make any comment on pricing. We will be able to do so after the product or the time the product is being launched in Q1 'twenty three. Now we will, at the time, give more details if needed on that launch. But Regarding what you call logistical hurdles, we don't see that many on our side in a sense that this is really like a biologic launch. It is of course cell therapy, but it is allogeneic cell therapy, off the shelf cell therapy, which is basically having the ability to deliver product to the institutions or the physicians where the patient is being treated within just a few days from an inventory of product that has already been made. So there is, of course, some aspect of logistics that we have already tested time and time again since we started now a couple of years ago to do clinical trials in Europe As well as Expanded Access Program. So we've treated across Europe in most of the key countries a number of patients. So we are Used to that type of logistic and the ability to deliver within a few days to the patients in need of treatment and we have transferred that knowledge, That know how to PFABRASE. So we're very confident that they will be able to handle that very efficiently. Now on the U. S. Partnering front, As I said, we have started to seek for a partner. I think to be able sorry, to finalize And execute on the partnership, it's not only a question about finding the right type of partner and negotiating the right type of value split and financials. It's also to be clear about the timing of the BLS submission and the approval for the product to prepare for the launch. So there is some ability to run-in parallel the process of finding the right commercial partner that could maximize the value of tab cel in the U. S, which We believe it's very significant, while we are also progressing with the FDA in terms of fine tuning the exact timing of the BLA submission And in some ways derisking that BLE submission with all these activities of interactions and meeting that we have with the FDA. Does Thank you. Our next question is from John Newman with Canaccord. Please proceed with your question. Hi there, team. Thanks for taking my question. Just curious if you could comment a little bit more regarding The number of patients that you currently have treated with the commercial formulation for tab cel and also How much follow-up time you might have there? Just kind of curious as to how the patient distribution looks across Commercial product versus the clinical study material. Thanks. Thank you, John. Jacob, do you want to take that one? Sure, Pascal. And John, thanks for the question. So as you know, we filed this IND amendment last year to put the intended commercial material into the clinic and then we had good discussions with the FDA and they're certainly interested to see the clinical data for these patients treated with the intended commercial material. So that's going well. We are not going to Comment at the present time on the number of patients that we've treated and the amount of follow-up. But I will say and We mentioned this previously, but we've had constructive dialogues with the FDA about a possible path forward to BLA submission without the need for new clinical trial and that we could use these commercially commercial processed treated tab cel patients. And again, the FDA was supportive of not conducting a new clinical trial, and we've previously announced that. And again, we are proceeding ahead and we're treating patients in the clinic. But At this point, we're not going to give specifics as to how many patients have been treated with the commercial material or the duration of follow-up at this point. Pascal? Yes. No, nothing to add on my side. I mean, in terms of duration of follow-up, the typical one that has been done with the FDA in the past Was to have response and to have the patient followed for 6 months following response. But at this stage, we are not going to comment about what the exact requirements regarding this population of patients with the commercial product. Suffice to say that things are posing well and we are treating new patients in different setting with the commercial And also do you just curious if you've discussed with the agency or perhaps You've thought about utilizing patients in the future or currently in the multi cohort study, if those Patients were to receive the commercial product, might that Satisfy FDA's request as well as perhaps give the opportunity to potentially broaden the label a bit. Yes. Maybe I start and Jacob you might want to chime in. I mean there are 2 aspects. One is from a safety database point of view for the intended commercial product, Any type of use of that product in terms of indication, in terms of setting, be it in the pivotal study, the allele study or be it in Expanded access program or even single patient use, all that is, of course, not only useful, but required for safety assessment and that will be useful there. From an efficacy point of view, as you can imagine, the FDA is looking more at the specific indication we are pursuing with the future potential BLA filing. So that's where we will need to focus on the efficacy data in that specific indication. Jacob, anything to add? Yes, I think that's well summarized, Pascal. But I do think the spirit is right. We are treating patients in a variety of settings with the intended commercial material and all of this is certainly going to be informative for the FDA as that they would ultimately make a risk benefit assessment for these patients treated with tab cel. Okay, great. Thank you. Thank you. Our next question is from Tessa Romero with JPMorgan. Please proceed with your question. Hey, guys. This is Taylor on for Tess. Thanks for taking the question. So we were just Curious, what is the size and the scope of the data that will be presented on ATA-two thousand two hundred and seventy one at ESMO next month? And In particular, will we get more details on the fatal SAE that was reported earlier this year? And what factors led to the MSK Case study resuming. Jacob, do you want to take that one? Yes, absolutely. So The intended target and the presentation will be made to the ESMO IO conference here coming up before the end of the year and certainly clinical data will be presented there. Now because of the hold on enrollment, There will be patients presented here up to that first patient in the 3rd dose escalation cohort. So there We anticipate and again the presenting author is still putting together the slide presentation, but we fully expect there's going to be Safety data presented, there's going to be some degree of PK data, potentially also Some information on this particular patient, there was an extensive workup as we've previously detailed, including an autopsy for that patient and that type of translational work will also be part of the presentation We suspect and in terms of the factors that were assessed by the FDA that where the FDA was in agreement that enrollment should start once again, included the information on That patient who was treated on the clinical trial, who had very refractory mesothelioma and a lot of Other comorbid illnesses and that where the protocol amendment was created by The investigators at Memorial Sloan Kettering, they submitted it to the FDA. And again, the FDA was accepting of the workup of that patient, The data provided and the proposed amendment as well that really led to the FDA agreement that enrollment could start once again for that particular trial. Okay. And are you able to provide any more details on the protocol amendment that was accepted? Yes. So in terms of the protocol amendment, some of the Details were that the study would be started once again. Now, what was agreed was that the study treatment of the patients would resume at the dose at the Cohort 2 dose. So there would be a return to the 2nd cohort that had already been cleared and treat a couple of more patients at that dose 3x106 CAR T cells per kilogram. So we'll see information from a couple of more patients treated there. And there is also a little bit of amendment of the eligibility criteria here where as I mentioned, this was quite a confounded Patient who'd received a lot of different treatment, including checkpoint inhibitors, COVID vaccines and so forth. So there was A requirement that there was a bit longer of a washout of checkpoint inhibitor therapy before the patient was treated On the clinical trial with the CAR T therapy, I would say those were the predominant changes that were made. Okay, great. Thank you so much. Absolutely. Thank you. Our next question is from Phil Nadeau with Cowen and Company. Please proceed with your question. Good afternoon. Thanks for taking our questions. A few clarifying questions. First, on your guidance about meeting with the FDA, Are we correct that the next meeting is a Type B meeting and that's simply to prepare for the pre BLA meeting? The pre BLA meeting will happen at some time After the Type B meeting? Yes, that's okay. So the pre BLA meeting will be after the Type B and The Type B is really to align discuss and align on the number of patients and the duration of follow-up that he wants to see in the clinical data package That will allow then to move to the pre BLA meeting. Got it. And the update in Q1 of next year, that's after the Type B meeting, presumably not after the pre BLA meeting? Yes. At this stage, what we're talking about, the meeting that is being scheduled as we speak, it is a Type B meeting. Got it. Okay. And do you have a sense of how long it's going to take for you to complete the CMC Module 3 Based on the requirements that have been agreed upon with the FDA or is that dependent upon the outcomes of the Type B meeting with how many patients of clinical data you're going to need? No, it is independent from the clinical meeting. I mean, we have now very clear view about what's needed for the BLA filing, what type of information And so on. Nothing surprising here. So it's aligned with our expectations. So we are not giving any guidance for the time, but that's a reasonable time frame in line with our expectations regarding that CMC part. So we think that the now the main Next item to clarify before we can give a guidance on the timing of the BDA filing is really the clinical part. TMC is very clear. And do you think the clinical parts gating or is that likely to be gating for the filing? We cannot comment on whether it's going to be gating If we have that meeting with the FDA, because that's really the key aspect to discuss with them is about how many patients, for how long and how do we relate to the other type of patients and so on. Got it. Okay. Then last question from us, just on The partnership in the U. S, can you talk a little bit more about the strategic rationale for signing a partner at this point in development? It sounds like Again, close to the U. S. Filing, we wouldn't imagine the commercial spend is too large for a disease like PTLD. So can talk a little bit more about why you think a partnership would be wise? Yes. I think we believe that there is a Clear business case for tab cel in the U. S. In its first indication and followed by additional indication as part of the label expansion that we are already planning, as you know, for The Multicore study in particular. So the business case is very clear. As you know, we've had done significant level of work to prepare for that Future launch in terms of pricing reimbursement to discuss with peers. We know the price level that will be an acceptable one in that We have already achieved a very unique situation of having The product, in fact, into the DRG 18, that will be implemented next year. So payers, Reimbursement, all that has been well prepared. We've also well prepared the mapping of all the centers where we believe the focus Of key account management and medical affairs work should be really at the launch time. So all that is ready. And it's true that The launch of a product like that in an ultra rare disease with significant unmet medical need, no competition And very clearly identified patients as post transplant patients now are all being tested for EBV and When there is lymphoma in this patient, it's really clearly linked with an EBV positive PTLD in most of the cases. Physicians are aware about that. So the awareness of physicians is going to be the key at the time of the launch and this is progressing as we For example, the new data we'll present at ASH in a couple of weeks, no, a bit more than a couple of weeks, a few weeks, It's going to be very important again to stimulate that awareness of physicians about the ability of a treatment like tab cel to transform the life of these patients We have significant data in terms of efficacy and safety. So all that preparation of the launch has been done by Atara and we continue to make sure that there is the proper communication of scientific data that are very convincing, we believe. Now this being said, Implementing a launch will still require an investment to create the full commercial and medical team and to be able then to handle the launch before you start to have some profit breakeven and then profitability. Typical situation Even though we believe that the penetration of that population could be relatively happy due to the unmet medical need and the lack of competition. So we think that from a corporate strategy point of view, it is better to rely on the partner that has already a structure, their commercial structure in the U. S. That they could leverage with that launch. And the advantage for us at the corporation level will be to avoid to have to further Invest from a commercialization point of view and therefore to allocate some resources to that commercialization and then we can also get some cash inflows Based on that partnership, as we've proven, when we signed that deal for Europe with a €45,000,000 upfront, and as you know, the U. S. Is a much larger market than Europe for several aspects in that particular disease area. So we are confident that we have the possibility here the opportunity To avoid allocating resource to commercialization, to get some cash inflows that will help us to extend our cash runway and also to continue or a creational value for especially the allogeneic CAR T programs that we are developing. Does it answer your question? Yes, that's very helpful. Thanks for taking our questions. You're welcome. Thank you. Our next question is from Ben Burnett with Stifel. Please proceed with your question. Hi. This is Kelly Breza on for Ben Burnett. Thanks for taking our questions. I just had a quick question about the Phase 3 allele update that's slated for ASH. I was just curious if you guys could give us an idea of how many patients They're going to be at this update as opposed to the previous update that we had received, I think actually maybe a couple of years ago on this program. And then, maybe how many of these new patients that are in this update, how many of these patients are also new to the FDA? Thank you. Okay. Maybe I start and Jacob you can share me. Just to clarify one point, the last update we gave on NALID was in Just a year ago, it was ASH 2021. So it was not a couple of years ago, it was just a year ago. And now this new update is based on the abstract that was released last week. So maybe Jacob you can comment on the number of patients. And what I will say regarding the regulatory aspect, sorry, That is that we're extremely important in getting the European positive opinion at the CHMP level because that's repaired of the submitted data. Jacob? Yes, absolutely. So just to give a little granularity and this is also captured in our press release from today. But when you look at it in the Phase 3 allele study, obviously, in relapsedrefractory EBBB positive PTLD patients, We're now presenting data from a total of 43 patients that are evaluable here. And as I mentioned in my Initiating remarks, we do have that overall response rate of 51.2% response rate and of those, 14 of those patients had been post HCT. So again, we and the response rate here was 50%, So 7 out of those 14 patients were responders. And then if you look particularly at the SOT patients, We had 29 patients and 15 of those patients were responders for an overall response rate of 51.7 Percent response rate, which again is a remarkably high response rate in this Particular population of patients that have a very high unmet need. And as Pascal mentioned, these data From the ALLEAL study, we're really the crown jewel in the MAA filing that led to the positive CHMP opinion just a few weeks ago. And then obviously, we had median overall survival data of 18.4 months, which again is Quite remarkable when you consider that for these patients post SOT or HCT, you're looking at a median overall survival of somewhere We have 0.7 months and 4 months median survival. So again, these are really pretty remarkable data. Sure. Thank you. Our next question is from John Miller with Evercore. Please proceed with your question. Hi. This is Jessica Hui on for John. A couple of questions for me. First on tab cel, could you just give a little bit more Color on this new meeting planned with the FDA to discuss clinical data. So you just said now that a new Phase 3 may not necessarily be required for BLA submission. But what are the range of possibilities for clinical data package requirements for CapTel? And then also, How much could you expect to extend cash runway with a potential U. S. Commercialization partner? And then lastly, just a question Are there any updates on potential large pharma partnership interest? Thank you very much. Thank you. Jacob, do you want to take the first one? I'll take the next 2. Yes, sure. Absolutely. So, and just To sort of summarize the status with the FDA, so we have had these constructive conversations with the FDA Between Atara senior management, as well within FDA and Pascal mentioned this. But again, the feedback that we got here over the summer was, which was really a Ursula, I would say, some of the feedback that we got back in February is that there could be a possible path to BLA submission without the need for new Clinical trial. If we were to use the commercial intended commercial process version of tab cel. And obviously, we did, as I mentioned, put this particular product version into the clinic at the latter part of last So we're gaining real clinical experience. So what we propose to the agency, which again they are The product as well in the pivotal study, but as we also discussed from other sources as well. So The other really impactful meeting that we had with the FDA quite recently was a Type A CMC meeting and Pascal mentioned this as well. But this culminated and this is very important in clear guidance From the FDA that we have agreement on the specific CMC Module 3 requirements for the potential BLA submission. So Again, we feel as if we have really cleared through the CMC hurdle, which has been a major source of discussion over the last couple of years. Now we also mentioned that we have an upcoming clinical Type B meeting and this was actually suggested by FDA leadership that we actually have this clinical meeting to discuss and potentially align on the clinical data package requirements, leading up to the pre BLA meeting. So we are actively preparing those arguments. Again, we are going to leverage patients treated with the clinical material, but We certainly have a very large clinical experience and we've discussed the fact that we've treated over 400 patients with tab cel in the clinic. And again, this is going to be approved in Europe very shortly. And we have close to 200 patients with PTLD treated as well. So we think that that clinical experience is quite impactful. So again, We are preparing this argument between the intended commercial treated patients as well as our very robust other clinical experience, where again this is going to be quite an interesting Type B clinical meeting coming up where we hope to gain agreement with the FDA on that, the contents of that clinical package. Pascal, anything to further add? No, I think that's clear on that. So to your Two questions, Jessica. On the cash runway extension, we're not going to comment on that. We are starting this discussion with potential partners. Maybe what I could say that we had a very successful process in Europe with, I think we received 6 term sheet at a time on the product and which was The best partner with the $45,000,000 upfront for Europe, plus a few emerging markets, as well as all the Milestone, both regulatory and sales, plus very significant double digit royalty. So we managed to have a very good Partner, but also a very good deal for the company. So when you think about the U. S, we'll, of course, try to replicate this type of And we think there is, as you can imagine, a much larger business opportunity in the U. S. Than it is in Europe. And I'll let To decide how large it is compared with yours, but it is very significant. And we mentioned that particular number of over $500,000,000 of peak sales in our views regarding the business opportunity to U. S. So that's going to be, we hope, significant, in line with the value and of the product in its 1st indication and follow-up indications. Now this being said, we've also said last time that our intent in terms of cash The end sorry, the Q4 of 'twenty four the end of 'twenty four and the reason is to have 1 year of cash at some stage beyond the readout of Ambor, which is a very significant potential value inflection point for the company in October of 'twenty three. So that's our intent. We are into Q1, 'twenty four now, but we still have a number of activities that we can manage To support the funding of the company, we have already cash beyond the onboard readout, which is important to notice and it's Q1 'twenty four, We believe we'll have opportunities to go much further than that. Now on 198 partnering, we are not giving any particular update. We just To reiterate what we say that we are, of course, discussing with various companies, but the most important is that is If we were to consider partnering before the onboard readout, it will have to be of a very significant value and value We recognize value as well as potential value split in the future because we want to make sure that our shareholders benefit from The potential value inflection point depending on the readout of onboard in October 2023. Thank you very much. Thank you. Thank you. Our next question is from Salveen Richter with Goldman Sachs. Please proceed with your question. Hi. Thanks for taking the question. This is Mason on for Salveen. On 188, what might give you confidence that 1 year could be sufficient for the Phase 2 data there? Thank you. Yes. A. J, do you want to take that one? Sure. Thanks for the question. The conference for 1 year being sufficient really drives from the Phase 1 data that we saw where When you look for the disability improvers, so the confirmed disability improvers by EDSS, almost all of them improved within that 1st 12 month timeframe. As you know, we are the study is a 2 year study, so we are following patients beyond that 1 year time point. But because Really the large majority of improvements occurred in that 1st 12 month timeframe. We have confidence that that will be a good endpoint for the IMbOLD readout. Okay. Thank you.