Hello, ladies and gentlemen, and welcome to the Autolus Therapeutics conference call. As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Olivia Manser. Please go ahead. Thanks, LaTonya, and good morning or good afternoon, everyone, and thanks so much for joining us on today's call. With me today are Dr. Christian Itin, our Chief Executive Officer, Rob Dolski, our Chief Financial Officer, and Chris Vann, our Chief Operating Officer. So, on slide two, as usual, I just want to remind you that during today's call, we will make statements related to our business that are forward-looking under federal securities laws and the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These may include, but are not limited to, statements regarding the expected clinical benefit and safety profile of Aucatzyl, the expected timing of the commercial launch of Aucatzyl, Autolus's manufacturing sales and marketing plans for Aucatzyl, including potential refinements at the Nucleus, the market potential for Aucatzyl, and the status of clinical trials and development and/or regulatory timelines for our other product candidates. These statements are subject to a variety of risks and uncertainties that could cause actual results to differ materially from expectations and reflect our views only as of today. We assume no obligation to update any such forward-looking statements. For a discussion of the material risks and uncertainties that could affect our actual results, please refer to the risks identified in Friday's press release and our SEC filings, both available on the investor section of our website. I will now hand you over to Christian to share the news. Over to you, Christian. Thanks, Olivia, and thank you, everyone, for joining us. Friday late afternoon, EST, we received approval from the U.S. FDA to market our lead product, obe-cel, or obecabtagene autoleucel, which will be marketed in the US under the brand name Aucatzyl. Aucatzyl is indicated for the treatment of adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia. It's the first CAR-T therapy approved by the FDA with no requirement for a risk evaluation and mitigation strategy or REMS program. It's the first and currently only approved CD19 CAR-T with a fast off rate, and it's the first and currently only approved CAR-T therapy with a customized tumor-burden-targeted dosing. The full prescribing information can be found from the link included in the press release issued last Friday. This is a defining moment for Autolus as a company, but even more important, it gives patients in the U.S. with relapsed or refractory ALL an additional treatment option. Moving to slide four. As you are aware, CAR-T therapies come with a boxed warning, so please be aware of the important safety information in conjunction with the efficacy we're going to talk about in the subsequent slides. For full prescribing information, please see the link at the bottom of the press release. Slide five. Aucatzyl was approved by the FDA based on the results from the FELIX phase 1b/2 clinical trial. This was an open-label, multicenter, multinational single-arm study and is the largest CAR-T cell therapy study conducted in adult relapsed refractory B-ALL patients to date. In this trial, we had three treatment arms. Patients with morphological disease with more than 5% tumor burden in the bone marrow were the largest cohort and were the efficacy evaluable cohort for the FDA approval. The two other cohorts included patients with minimal residual disease or with extramedullary disease. Here is a short recap of the results of the FELIX studies as presented at ASCO 2023, ASH 2023, and ASCO 2024. We saw a high overall response rate, encouraging event-free survival and overall survival, and favorable tolerability with low levels of high-grade CRS and ICANS. Across all cohorts, 40% of responders were in ongoing remission without subsequent therapy as of February 2024, and the survival outcome suggests the potential of a long-term plateau. As you may remember, the FELIX study was conducted during the COVID-19 pandemic, which added a number of complexities logistically, but also directly impacting our decisions about how to conduct the trial in this highly immunocompromised patient population. Importantly, physicians could use standard bridging therapy, including high-dose chemotherapy and inotuzumab, to manage the patients between enrollment and lymphodepletion. Moving to slide number six. Of the 112 apheresed patients with morphological disease at inclusion, 11 patients died prior to dosing despite standard bridging therapy, and seven additional patients discontinued prior to infusion. Deaths prior to dosing and a high median age of 51 years for all patients enrolled in the trial highlight the real-world nature of this advanced study population. With 94 of the 112 apheresed patients dosed, product delivery was robust, with only six patients being excluded from our efficacy analysis due to receiving product that was out of specification. Due to the standard bridging therapy allowed in the trial, 23 patients, or 24% of the 94 patients dosed, had bone marrow blasts below 5% at the time of lymphodepletion and were excluded from efficacy analysis by the FDA. Slide seven. Of the 65 patients analyzed for efficacy by the FDA, 33 patients, or 51%, achieved a complete response at any time as their best response, and an additional eight patients, or 12%, had a best response of complete remission with incomplete recovery, CRi, at any time. ORR, combining CR and CRi, was 63%. Median duration of response was 14.1 months for all responses. With this challenging patient population, Aucatzyl confirmed the favorable safety profile seen in prior clinical studies. High-grade CRS, grade 3 or higher, was in 3% of the patients, and high-grade ICANS, grade 3 or higher, in 7% of patients. Moving to slide number eight. As an illustration of the impact of bridging therapy on bone marrow blasts at lymphodepletion, I would like to go back to a presentation of the FELIX data at ASH 2023. On this slide, I would like to highlight that even patients receiving intense bridging therapy can reach more than 75% bone marrow blasts prior to lymphodepletion and could reach. On the other hand, you would also have patients that would have very high tumor burden of 75% at inclusion that after bridging therapy could reach less than 5% bone marrow blasts at lymphodepletion following therapy. Considering this range of outcome, treating physicians need flexibility on how to manage real-world patients. Limiting bridging options or discouraging bridging would require physicians to look for patients with slow-progressing relapse to manage them. None of that was an option during the pandemic and would also have limited the value of the study outcome as physicians could not recognize their normal patients in such a study. Slide number nine. As shown at ASH 2023, patients with less than 5% marrow blasts at lymphodepletion had a more favorable event-free survival rate, with our data indicating an EFS plateau for this group forming at around 65%. Also visible on this chart are patients with more than 75% bone marrow blasts at lymphodepletion, showing an almost immediate decline in EFS. I'm now handing over to Chris Vann, our Chief Operating Officer, to highlight our launch readiness. Chris, over to you. Chris, you may be on mute. Please stand by. Your conference will resume momentarily. Please stand by. Your conference will resume momentarily. My screen saver shut me off, so thank you, Christian. Slide 10. I'm pleased to report that we've completed all of the pre-launch activities, and we're primed to launch Aucatzyl in the US. The most critical factors underpinning a successful launch are the authorization of treatment centers, product awareness and differentiation, robust and reliable supply, and the ongoing support for centers and patients through our Autolus Assist service to ensure they receive an exceptional experience each and every time. Having now received the approval in the US market, we will move forward to complete the final steps of the onboarding of treatment centers. This includes conducting final training according to the approved label and switching on the business systems such as patient scheduling, Cardinal Health infrastructure, and support services for patients and providers. In parallel, treatment centers will also need to complete their own specific center requirements, such as formal apheresis and updating ordering sets. This process typically takes them 2 to 12 weeks to complete. We are ready to authorize 30 centers over the course of the upcoming weeks, which means we're on target, and we estimate that this will cover around 60% of the target population. Over the course of next year, we will increase this number to about 60 centers to reach approximately 90% of the patients. Reliable and robust supply is a critical element underpinning any successful CAR-T launch, and it's particularly important in the relapsed refractory setting where patients may progress rapidly. Our supply chain has been tested under the most difficult circumstances as we rolled out pivotal FELIX study during the peak of the COVID pandemic. The Nucleus, our dedicated state-of-the-art commercial manufacturing facility, and our experienced product delivery team are ready to go, and we've been targeting an initial vein-to-vein delivery time of 16 days with potential for improvements in the future. In order to ensure the requisite high levels of service engagement and center engagement service and support, we have built a US team that is very knowledgeable and experienced. Indeed, each member of our team has been engaged in at least one prior cell and gene therapy launch and, in many cases, multiple launches. To service the needs of the customers, we work in pods, which are dedicated, collaborative, cross-functional teams covering all aspects needed to serve the needs of the treatment centers, but listening to the centers, we've also simplified interactions for them from a hospital perspective by establishing a single point of contact to coordinate these activities. The list price of Aucatzyl is $525,000. Our pricing strategy is focused on delivering value while achieving broad access. We believe this pricing reflects the clinical evidence and benefit we have observed to date, as well as the differentiated, sorry, as well as the differentiated safety profile, which delivers meaningful economic benefits to the healthcare system. Next slide, please. Slide 11. Today, we're also launching Autolus Assist, our corporate customer service and support program. This will offer a comprehensive and competitive set of services from the outset for patients, carers, and treatment centers. I'll now hand back to Christian. All right, moving to, thank you, Chris. Moving to slide number 12, I would like to take a minute to recognize and thank the remarkable team that came up with obe-cel and has been with the program through its entire development. This is a group of highly dedicated physician scientists who bridge from medical practice, caring for patients, all the way over to molecular design and manufacturing. Aucatzyl is Martin Pule's brainchild. Martin is the CSO and founder of Autolus and continues his academic lab and project at UCL. Leila, Ann, and Gordon did the initial characterization of the CAR and Sara Ghorashian, together with Persis Amrolia, around the first clinical study in pediatric patients at GOSH called CARPALL. The study showed for the first time that the design premise is translated into the desired clinical profile, and the results were published in 2019 in Nature Medicine. Based on this initial clinical experience, Karl Peggs and Claire Roddie set up the ALLCAR19 study and reproduced the experience with obe-cel in adult patients. The results were published in the Journal of Clinical Oncology in 2021. Claire then also drove the multinational pivotal FELIX study and has been presenting key outcomes of the study over the last 18 months. The collaboration with our colleagues at UCL has been very productive across a range of product candidates, and we're looking forward to continued success. Slide 14. Slide 13. And finally, the most important slide before we take questions. I would like to thank our patients and their caregivers for participating in our clinical studies, the physicians and nurses who cared for them, regulators, our partners, and our entire team and shareholders at Autolus. We're very proud of today's milestone and could not have achieved it without this collaborative effort. With that, I'd like to thank you again for joining us today, and I would like to open the call for Q&A. Over to you, LaTonya. Certainly. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster, and one moment for our first question. Our first question will be coming from Asthika Goonewardene of Truist. Your line is open. Hi, good morning, everyone. I want to offer you my heartfelt congratulations on achieving this milestone. It's remarkable. So congrats to everyone, the team, the Autolus guys. Well done. A couple of quick questions, if I may. So Christian, first off, on not having the REMS requirement, obviously that looks like a differentiated feature on the label, but can you quantify how much time that shaves off on the onboarding process? And then maybe to Chris, on the 30 centers that are primed for activation, what proportion of those will be ready to enroll patients by the end of 2024? I know that's pushing a hard deadline there, but what proportion would be operational and recruiting patients by the end of 2024? And then I have a quick follow-up. All right, well, first of all, thanks a lot. Really appreciate your comment, Asthika, so first question related to the REMS. Also, the REMS is basically a reporting obligation that the centers have, so there is an element that goes into the training and the process you have to set up, but I think the more relevant aspect actually is that it's an ongoing requirement. It's an ongoing obligation for the centers over a long period of time, and that is actually where the real challenge, I think, is from a center perspective, that it's not just the onboarding time, which is an element to consider here, but it's the fact it is a long-term, over-years commitment that the centers have to enter into, and that is actually not having to do that is very beneficial because a lot of the data actually gets collected already under other headers, frankly. There was a lot of duplication of work for many of the centers to report on. So it's a big, I think, relief, I think, for centers to be able to simplify the approach there. And so that's where we see actually the biggest opportunity. And then I would say with regards to the questions around the 30 centers that we're getting ready and the time and where we think we're going to be by the end of the year, and I'll hand over to Chris. Yeah. So firstly, we expect to have the majority of them to go live within around 12 weeks. But as you will actually appreciate, we picked an interesting time of the year to go out because there's a number of holidays, congresses, and other things. So the intention is to have the majority of those centers operating for most of next year, whether that's by the 31st of December or very early into January, that would be the intention. And then we're already working with the next wave of centers. And so we have CDAs in place with a considerable number of additional centers that we're bringing along as well. And it's also fair to say that there's a group of centers who obviously are ready to go and particularly already have patients that are in need of therapy. So that obviously will have a positive impact on the startup time. Got it. Okay. And then an interesting part of Aucatzyl's emerging profile is that it has durable benefit and it doesn't make actual sense to use it as a bridge to transplant, which is quite differentiating versus a lot of the other CAR-Ts used in leukemia. Is there an opportunity to get this differentiating feature into the label, or is this something that your MSLs will have to communicate? I think one of the key things is there's sort of, obviously, there's the label, which is defined and is what it is at this point in time. Obviously, we're expecting to publish our results from the study in the not-too-distant future. And we obviously shared a lot of the information at the various congresses. And I think that is sort of where the initial, I think, analysis will come from. And I think the initial communication will come from that, obviously, can also be carried by our medical affairs team. And what we're certainly going to do also as we look forward into the upcoming ASH conference is we're also looking at factors that are driving outcomes. And that's going to be, I think, one of the key themes that we continue to work on. I think that will be very important and helpful for physicians to make treatment decisions around exactly those questions. Great. Thanks, guys. Congrats again. Thanks, Asthika. Appreciate it. Thank you. One moment for our next question. Our next question will be coming from James Shin of Deutsche Bank. Your line is open. Good morning, guys. Well done on getting Aucatzyl across the line. Just had a couple of questions on the logistics for Aucatzyl. Do you have a timeline for when you will get the reimbursement code? And what are the next steps to get an NTAP for Aucatzyl? And then it's sort of. And then I have one follow-up. And I'll let you answer those two questions first. Okay, Chris. Yeah. So obviously, you need two codes. The first thing is we actually have the code, the ICD-10 code. We already have that. The second is for the product itself. You will need eventually a C or a Q code, but we actually can use a temporary code for now. So there's nothing from that perspective that's holding us up. You will note that we actually submitted an NTAP application in October. And if it's successful, then we would actually expect that to be applied from October 2025. Wonderful. So all said and done, is this still mostly a 2025 launch? I think, given the number of patients that are actually, we're launching very much today. But given that there are a couple of lag times in terms of both getting the center on board and identifying patients, getting them freeze-treated, we'll see the majority of the value obviously realized with a lag. So that will come in 2025. It may come slightly earlier than that, again, around the turn of the year for the first patients, we'll see. But the principal value will be noted in 2025. Also, of course, the standard requirements for revenue recognition. So that also comes in approximately 90 days after the patients have been treated. So that's wider for lag time and realizing the value of the full value of the product. Understood. Thank you, guys. Congratulations. Thanks, James. One moment for our next question. Our next question will come from Kelly Shi of Jefferies. Your line is open, Kelly. Congrats on achieving a big success. And thank you for taking my questions. My first question is, so when we think about a commercial strategy, what would be the key product features that a physician's community most appreciate when compared to Tecartus's experience in adult ALL? Is more on the tolerability, especially the neurotoxicity, or actually the reduced needs of following transplant in a significant portion of patients? Also have a follow-up. Thank you. Yeah. Thanks for joining, Kelly. I think this is a really good question, and I think it goes back to sort of the fundamental properties of the product. The first thing that you can appreciate and you'll actually see is experienceable is obviously the safety profile of the product because that's immediate. You treat the patient. You have an immediate amount of work, challenge, focus to sort of manage the patient through the initial phase of the therapy, and that is obviously immediately experienceable, and that's interesting because it is something that also drives to a large extent the workload and the challenges that the physicians are facing with the patient. The second question is then with regards to duration of response or subsequent steps, and that obviously will take time to build because obviously, you remember that our product has a remarkable level of persistence in these patients. So we actually have an ability to obviously see the product in these patients for long periods of time. I think the longest out, we probably were getting close to five years in some of our prior studies and we're now approaching three-plus years in the FELIX study. So we know we have long-term persistence. What we also do know, and this is one of the key things that we certainly will be reporting on as well at ASH, is that depth of response matters as well. And I think between those two parameters and in early indicators for sort of a waning of the activity of the CAR-T cell, which is B-cell recovery, gives you actually a set of tools that actually allow you to make informed decisions. And that will actually build over time. But in terms of the initial, I think, initial experience, it's really driven by the safety profile because that's sort of the biggest challenge that I think in any CAR-T therapies, the physicians have to deal with as they sort of manage the patients at their centers. Thank you. Super helpful. And also regarding the product release criteria, what kind of a difference do you expect in commercial settings compared to, let's say, for a clinical trial? And also when we think about implementing the split dosing protocol in the commercial settings, do we expect a different impact on CRS compared to one-dose cell therapy? Thank you. Yeah. One of the, I think, important things is that the way that the specifications are informed is really by the clinical data and the experience you had in your trial. So it's that experience in terms of what was the specification of the products that we had and the actual outcomes that we had on the manufacturing in the clinical trial. And then that actually then defines then the specs that are being chosen. Now, what we do know is that the specifications that we managed to reach and the outcome that we managed to reach in the clinical trial matches very nicely with the specifications that are now actually part of the product, of the approved product. So we don't expect any significant change based on that because, frankly, the goalposts haven't moved in a significant way. They're pretty much where they need to be. They were slightly tighter, but they were tighter because our actual data was tighter than the specifications we had used for the clinical study. But that's sort of, I think, that part of the answer. I think the second one was around the dosing. Obviously, we infuse in two steps. We have a first dose that is guided by the tumor burden that the patient has. And that obviously, that first dose really defines where the patient is dosed. So from a commercial perspective, that's the dosing. And then obviously, depending on the condition the patient is in, after about 10 days, there's a decision to be made by the physician whether to dose the second dose or not. And as you remember from the FELIX study, almost all patients receive both doses. Only in cases where you have an elevated level of adverse events in the patients, you would actually withhold the second dose. But it gives the physician an added level of control. And I think that is important, is putting the physicians in control of the therapy. And that is exactly what it allows you to do. Maybe just to add two very important points. Just reinforce what Christian's saying. The doctors are actually viewing very favorably the control that they have in order to help them manage the profile of the product, particularly with regard to adverse events. And the second thing is that it is one treatment given in a divided dose. So the billing actually happens on the first dose, which actually keeps it relatively straightforward. There's a nominal billing for the second dose, but the actual patients are considered to receive a treatment when they get the first dose. Congrats again to all those teams. Thanks, Kelly. Much appreciated. One moment for our next question. Our next question will be coming from Matthew Phipps of William Blair. Your line is open. Hi, Christian. Let me offer my congrats to you and the team as well. It's a great milestone for the company, obviously. Just curious on the kind of timing of expansion, both from centers and capacity. I know a couple of months ago, you all entered into an initial agreement with the Nucleus facility to start building out a clean room. Just wondering on the timing to get to that operational. Does that correspond with getting to 60 centers by the end of next year? And then separately, or I guess related, but is there any gating from the FDA or regulatory on kind of just initial slots available? Thank you. So the facility actually is not limiting us in terms of the ramp that we can run in terms of the actual launch ramp. I think what is important is that the facility has earmarked for the adult ALL population three large clean rooms that are all dedicated for this manufacturing process. And what we're going to do is we're going to obviously add and activate the second and the third clean room as the demand actually kicks up. The rooms are identical in setup, and that allows us to actually have a very simplified and much more condensed startup procedure and getting those onto the license for the facility. And with that, we can take that point and time it appropriately to make sure that we're sort of well ahead of the actual building demand. So we're not limited with that. So the suite is as is. We can run up to, give or take, 700 or so products that are the expected capacity of that suite, which gives us a lot of flexibility. So that, I think, is sort of, I think, addressing that part. With With regards to the centers, I think what we do with the 30 centers out of the gate, we indicated that allows us to actually address about 60% of the patients in the U.S. So that's a very significant amount of the population from the start, very different from pretty much any other launch that has been done in the space. And then we're obviously going to move, as we're going through the course of the year, we'll move through the 60 centers to get us to about 90% overall. So that obviously is a process that will continue. The onboarding process for all these 60 centers is actually running. So it's not like we're kind of making a decision sometime down the line to actually get going on that. This is actually ongoing. But obviously, the second 30 are slightly staggered in terms of by the time point they're going to be finished for the onboarding process. So we think we're going to be. We're not going to be limited on the manufacturing side. And I think we're going to have a very strong start in a large number of the centers that are relevant for these patients. But at the same time, it's a manageable number of centers that allows us to actually make sure we have very robust delivery to those centers, very good experiences, and then actually really ramp from there. Yeah. Maybe just to reinforce that the supply is not what would actually alter our plans to actually roll out in the centers. The most important thing with the centers, and it's been seen with previous launches, is once you establish a center, you want to get it into routine use of your product before you move on because you actually want to be pulling the patients through the centers and then expanding. That way, you can actually cope with any of the issues that any individual center faces in the onboarding process and as they get to know your product, so the speed with which we actually will expand will be largely determined on the pull-through and the preparedness of the next 60 centers, and some of them are quite a way forward in their preparation. One quick follow-up, if I can. I guess, what are your expectations or target for out-of-spec product, at least maybe over the next year or so? Yeah. I would say that's we had 6% within the FELIX study. We expect to be in that range in terms of out-of-specs. That's our current expectation. Great. Thank you. And congrats again. Thanks a lot. Thank you. One moment for our next question, which will be coming from Gil Blum of Needham & Company. Your line is open. Good morning and good afternoon. And allow me to also add my congratulations. It's a major milestone for the company. So maybe a specific question here on the label. So both your product and Tecartus, the labels, they focus on patients with greater than 5% blast and morphological disease. I'm just wondering kind of what's going on in the real-world setting as it relates to use of Tecartus, especially given the new published data and the outcomes are actually a lot better for patients with lower disease. Thanks. Thanks a lot, Gil. And really appreciate you joining. I think what we've learned in the field over the last probably 20 years is that you would like to, if you have a chance, we'd like to actually treat a patient with as low tumor burden as possible. And we've seen consistently through a whole sequence of studies in the field over the last 20 years that when you do that, that your ability to generate long-term outcome improves substantially. And that's been consistently shown for blinatumomab or Blincito. It's been shown for Kymriah. It's been shown now for Tecartus. It certainly is also visible in the FELIX study when you look at the impact we're seeing. And this is actually that and there's sort of two measures here. One is the amount of tumor burden at the inclusion of a therapy or at the start of a therapy versus then the separate additional check that the agency did, which is, well, what was your tumor burden, not only at inclusion, but also before the lymphodepletion, before you actually started the dosing of your therapy, so those are two steps that were actually introduced, which obviously are not something you can actually control, that second step in particular, because you make a decision for treatment at the time of inclusion, and then you have to manage the patient to the best of your ability, and then you dose, and then you see the outcome, but in general, you're absolutely right. You would like to go to the lowest level of tumor burden possible for therapy and for treatment, and in the end, it's a statistical problem. It's just a question of what are the number of leukemic cells that are floating around in that patient. And based on the number of those cells, there's a certain probability you get all of them, and then you got the long-term outcome, or you only get most of them, and then you actually have only a transient outcome. So very straightforward, and I think it carries through every data point that we know over the last 20 years, both in the pediatric and the adult side. And that's clearly where you see from a real-world perspective, that's what all of the physicians are certainly going to move towards and make sure they can identify the patients early. This is also the drive towards much more sensitive methodologies to actually identify the cells, either by NGS, by flow, by PCR, which all are driving in the same direction of trying to pick up the disease early in relapse. Thank you for all that now, Christian. And we haven't forgotten the MRD positive cohort that you included in your study. So on a different topic, any information you can provide on gross to net at this point? I'm sorry. You kind of broke off there for a moment. I was asking if you can provide any information on gross to net? Gross to net. Rob, are you on? Yep. Thank you. Thanks for the question. Not at this point. I think it's a little bit too early to comment on the gross to net, and certainly would expect that that's something we'll track and update as launch progresses next year. I think, broadly speaking, obviously, it's highly dependent on the patient mix, how that evolves over time, and we would expect largely to be in line with other CAR-T cell therapies. Thank you, and again, congratulations. Thanks a lot, Gil. One moment for our next question. Our next question will be coming from Sebastiaan van der Schoot of Kempen. Your line is open, Sebastian. Hi, team. Congratulations on achieving this amazing milestone. Really exciting and well-deserved. I was wondering on the ordering and reimbursement process, could you provide some insight into what measures you have taken to facilitate adoption of Aucatzyl in these treatment centers? And I was also wondering whether you could provide some insight into the current market share of the existing CAR-T in this setting. Yeah. So what I can so let's deal with the reimbursement piece first. For Aucatzyl, we have a comprehensive pharmacoeconomic data set and models to actually support the pricing. To build on the previous question, 60% of the use of CAR-T in the ALL market is actually in the private or commercial sector. 40% is in areas such as Medicare, which is slightly higher, by the way, than DLBCL for the commercial proportion. Regarding market share, it's a little bit tricky to estimate specifically the market share because, as you're aware, Tecartus is used in two indications. And also, we're in a situation as well where there is clearly some Kymriah leakage even up to the age of patients who are 40 years old. We've seen cases. But we estimate that there is somewhere in the region of 300 patients treated with CAR-T in ALL out of a potential population of around 1,500. That's our estimate. But it is very much an estimate because we don't get direct information on Tecartus in ALL as opposed to in mantle cell. Great. That is really helpful. Thank you. Yeah. I think, yeah. One moment for our next question. Our next question will be coming from Yanan Zhu of Wells Fargo. Your line is open. Great. Thanks for taking our questions and congrats on the approval. I was wondering, in terms of the price, can you talk about whether this is at premium or in line with Tecartus? It feels like it's a little bit at premium, but if you can talk about that, that would be great. And what do you expect the initial insurance approval time for the patients might be? And I have a follow-up. Thanks. Yeah, so I think two things. Firstly, it is a price premium. It's around 11% higher than Tecartus. The second thing is that I envisage that the majority of the early usage will require single-case agreements. And that's very much dependent on the group that the hospital is working with to get that. But in this case, given that it's a relapsed refractory disease, I'm sure that they will be very motivated to give that approval as fast as possible. Got it. Super helpful. If you could also talk about what launch metrics you might be talking about in January or at the earnings time, understanding that revenue probably won't come in until later. But what early launch metrics would you be reporting to help us get a sense of the initial uptake? And could you also comment on your expectations for those initial uptake? Thanks. Thanks, Yanan. I think this is one for you, Rob. Yeah. Hi, Yanan. Thanks for the question. Yeah. I think next year, one of the most important things and one of the activities, obviously, that we're focused on is the onboarding of centers. And so that'll be something that we will track and certainly make available as we go through the year. To your other point, it's probably early to talk in terms of specific sales and guidance on that front, so the large focus will be on the center. Got it. Got it. Would you be talking about apheresis? Currently, right now, I don't think there would be plans to get to that level in some of the reporting. Again, I think we would focus on the center and possibly things like repeat usage in a center, but really focused on the uptake on the center onboarding front. Got it. Got it. Thank you. Thanks for the color and congrats again. Thanks, Yanan. And one moment for our next question. Our next question will be coming from Simon Baker of Redburn Atlantic. Your line is open. Thank you for taking my questions and congratulations. Not only a great day for Autolus, but a great day for U.K. biotech. Two questions, if I may. Just going back to insurance coverage, I just wonder if you could talk. You have talked around this, but just if you could give us a little bit more on one specific issue of the evolution of insurance coverage in terms of access and moving from single-patient authorization, what we should think of in terms of timeline there. And then secondly, a question on the REMS program. I wonder if you could give us some practical examples of the implications for both you and prescribers of not having to have a REMS program. Thanks so much. Yeah. So maybe let's talk about the obvious. We want to move away from individual case agreements. And so we've talked to all of the large commercial payers in the U.S. We've also, by the way, talked to the top 10 providers of insurance in each of the centers where we've been present. It's, again, too early to guide specifically on how fast we will move to covered agreements, but probably by the end of next year, we'll certainly be in the majority of cases that we will actually be covered by that. And then we can give some more metrics as we now go and specifically talk to the centers. The second one is the REMS aspect. And there are two elements to that. The first is in the onboarding, we don't need to train for it because we don't have one. And that reduces the burden both for the centers and ourselves because, of course, our team can therefore be more efficient when they're onboarding the centers. The second one is on an ongoing basis. It's a real pain, frankly, for the centers to have to do additional reporting on the patients to fulfill the REMS requirements. Remember as well, a lot of that reporting requirement can be duplicative with other reporting that they're doing to things like the registries, the bone marrow transplant registries, and other things. So it's quite a considerable additional burden because they're actually doing a lot of extra administration. So to take it away is a great thing in terms of reducing the ongoing burden to the centers in reporting. Great. Thanks so much. Thanks a lot, Simon. Appreciate it. Yeah, and one moment for our next question. Our next question will be coming from Jacob Mekhael of KBC Securities. Your line is open, Jacob. Hi, there. And thanks for taking my question. And congrats on this big day. Really good to see this news. I had a question. You mentioned earlier that you expect there are 300 patients that are on CAR-T treatment at the moment. Do you have any idea what proportion of those do you expect to switch to Aucatzyl in the first year? And perhaps a follow-up on that, how do you plan to approach the group of physicians that have not yet prescribed CAR-T for their ALL patients? Yeah. Very good question, Jacob. Obviously, as Chris pointed out, the number that he quoted is an estimate. We don't know for sure whether that's the exact number, but it's somewhere in that ballpark. We'll see, obviously, as we go through the course of the year, and probably we'll have a good feel for where we're going to come out, I think, as we sort of get probably through the second and third quarter next year on where we end up. And I think at that point, we'd be happy to sort of give you a better sense on how we think we can actually penetrate that particular patient population. What's helpful, as before, is that there is obviously the positive safety profile for the product is very quickly experienceable for the physicians. And I think that certainly will be helpful in sort of creating a positive momentum around the product. So that is kind of probably the key aspect there in terms of the patient population. All right. Thank you. Thank you. I would now like to turn the conference back to Christian for closing remarks. Thank you very much, LaTonya. First of all, thanks all for joining today. I would like to briefly remind you of the upcoming ASH presentations. The FELIX study is actually a very rich data set and continues to provide important information in shaping our understanding of the use of obe-cel to treat adult relapsed refractory B-ALL patients. So we're presenting additional data at ASH that suggests deep molecular remission may predict better outcome. We will also show the impact of bridging therapy and outcomes, highlight the cost associated with managing CRS and ICANS, and how we could use hematotoxicity scores to help identify patients who are more likely to benefit from treatment with obe-cel. So that's actually what we're planning ahead for the ASH meeting. Thanks a lot for joining in today. With that, we'd like to close today's call. For those of you available, obviously, we have the earnings call tomorrow at the same time. Thank you very much. This concludes today's conference call. Thank you for participating. 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