Hello, ladies and gentlemen, and welcome to the Autolus Therapeutics third quarter 2023 financial results conference call and business update. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to turn the conference over to your host, Julia Wilson. Please go ahead. Thank you. Good morning or good afternoon, everyone, and thank you for joining us to take part in today's call for Autolus's third quarter 2023 financial results and business update. I'm Julia Wilson, Communications Consultant for Autolus. With me today are Dr. Christian Itin, our Chief Executive Officer, and Rob Dolski, our Chief Financial Officer. Before we begin, I would like 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 status of clinical trials and development and/or regulatory timelines for our product candidates and our expectations regarding our cash runway. 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 today's press release and our SEC filings, both available on the investor section of our website. On slide three, you will see the agenda for today's call, which is as follows: Christian will provide an overview of our operational highlights for the third quarter of 2023. Rob will then discuss the company's third quarter 2023 financial results, before Christian will conclude with upcoming milestones and closing remarks. Finally, we will, of course, welcome your questions. Over to you, Christian. Thank you, Julia. Good morning to you all. Thank you for joining us. It's my pleasure to review our progress for the third quarter in 2023. Moving to slide number four. We'll give you here a quick summary of the progress we've made with obe-cel during the third quarter. Key focus has been on preparing the BLA filing, which is on track for a filing by the end of the year. Building on the data we presented at ASCO and EHA early in the year for our pivotal FELIX study in adult patients with relapsed refractory acute lymphoblastic leukemia, we look forward to presenting longer follow-up and subgroup analyses at ASH in December. The ASH abstract embargo has just lifted, and we have an oral presentation giving longer follow-up data from the FELIX study on Saturday, December 9. In addition, we will, in a poster presentation, provide long-term follow-up data from our prior ALLCAR19 study and the FELIX Ib study. On both ALLCAR19 and FELIX Ib, we're approaching up to five years and up to three years of follow-up, respectively. I'd also like to highlight that before the end of the year, we'll be initiating a pediatric phase I study of obe-cel to support our filing with the European Medicines Agency, which is expected to start in the first half, will be filed in the first half of 2024. Critical for the successful outcome of the FELIX study was our robust product delivery platform with high manufacturing success rate, short range delivery time, and high percentage of patients dosed with obe-cel. During the third quarter, we successfully completed the process performance qualification at The Nucleus manufacturing facility set up for commercial supply and are on track to support a biologics license application with the FDA by the end of 2023, and a market authorization application with EMA in the first half of 2024. Importantly, we will be presenting more detail about the obe-cel manufacturing performance also at the ASH meeting in December in a poster presentation. As the program is progressing through the regulatory review, we are actively preparing obe-cel for a potential U.S. launch, with critical activities underway in medical affairs, completion of value dossiers, and onboarding of CAR T centers. Moving to slide five. Here is a quick overview of the pipeline progress during the third quarter. First, we continue to expand the obe-cel opportunity, and we are progressing the development of obe-cel in autoimmune diseases, starting with a phase I dose confirmation study in SLE patients, which we expect to start early in 2024. We held an analyst and investor event last week, where we discussed this in more detail, and a replay of this, presentation can be found on the events section of the Autolus website. In summary, we believe that the excellent clinical profile we've seen for obe-cel will translate well into B-cell mediated autoimmune diseases. The differentiated mechanism of action, regulatory package, clinical validation in ALL, substantial safety database, and commercial manufacturing and delivery base will provide a differentiated opportunity for obe-cel in autoimmune disease. Data presented at ASH last year demonstrated the potentially best-in-class profile of obe-cel, supported by the data observed from the obe-cel extension study in B-cell non-Hodgkin's lymphoma, with continued high levels of clinical activity paired with an encouraging tolerability profile across diffuse large B-cell lymphoma, mantle cell lymphoma, follicular lymphoma, and chronic lymphocytic leukemia. We expect to complete enrollment in the obe-cel extension study by the end of the year and to publish the data in a peer-reviewed journal, as well as update data at the upcoming ASH conference this year as well. Together with Dr. Sara Ghorashian from Great Ormond Street Hospital, we published the phase I experience with AUTO1/22 in pediatric ALL patients in B-ALL. The study showed that patients who were not eligible for commercial CAR T therapy showed a high level of clinical activity and good tolerability, with over 80% of patients achieving a molecular complete remission with no antigen-negative relapses seen, with a median follow-up of up to 8.7 months. Included, also were patients who had relapsed after Kymriah therapy with CD19 negative disease. Our final pipeline updates, continued during the quarter include AUTO8 and AUTO6NG, both in collaboration with UCL. AUTO8 is progressing well in the phase I study in multiple myeloma patients called the MCARTY study, and I'll give you more information shortly on the anticipated study data at ASH. With AUTO6NG, we expect the first patient to be dosed in the neuroblastoma phase I study by the end of the year. Moving to slide six, as well as from there, going straight to slide seven, focusing on obe-cel. As you remember, obe-cel has a unique mechanism of action. What's fundamentally different about our product candidate is that it has an ability to engage physiologically with the target cell. What this allows us is to actually have a product that can rapidly bind the target cell, which delivers specificity paired with a fast off rate for rapid disengagement from the target cell once the kill has been delivered. This unique engagement drives maximal activity while minimizing toxicity, and is at the heart of the differentiated clinical profile we are observing for obe-cel and ALL, and we believe provides a great platform for future indication expansions in oncology and autoimmune diseases. Moving to slide eight. On this slide, you can see a summary of the FELIX data we presented at ASCO/ EHA earlier this year. What we've characterized to date and what we continue to hear from KOLs as we share the FELIX data, is that we enrolled a study, and studied a patient population, our FELIX trial, that is highly representative of a real-world clinical setting. Remember, we did this study during the pandemic, obviously, where patient flow was very challenging, particularly, given the challenges with access to centers, and a lot of patients only being moved to centers, when there was an absolute need for them to actually move to the next therapy. FELIX patients were refractory to multiple lines of therapy, including stem cell transplants, presented with high disease burden, with median bone marrow blast of 50% at screening, and extramedullary disease was present in 19% of the patients. Despite this challenging population with high disease burden, lots of risk features, overall older than was studied in prior programs, obe-cel delivered complete responses in 76% of patients, and of those responders, 97% actually had deep MRD negative responses. The tolerability is remarkable. Obe-cel had 3% high-grade CRS, as well as patients with ICANS Grade Three, ICANS in the range of 7%. So both of these numbers are very low compared to any other trial conducted in this type of indication, and also obviously allows for a very good level of control of these patients. Most of these events, particularly the high-grade ICANS, occurred in patients that had more than 75% tumor burden at lymphodepletion. And as you know, we're providing longer-term follow-up from this study, as well as further subgroup analyses at the ASH meeting. Regarding the manufacturing process, irrespective of disease burden and adverse prognostic factors, the manufacturing was robust and reliable. The majority of patients for whom leukapheresis was received achieved and a released product with a median vein to delivery time of 21 days. 84% of the enrolled patients were also dosed. CAR T cell engraftment and persistence look consistent with our prior observations in the ALL CAR19 study, where we showed that all patients with long-term outcome had also long-term persistent CAR T cells. Moving to slide number nine. As I've mentioned, the ASH abstracts were released this morning and are available online via the ASH conference platform, and we just would like to briefly highlight the presentations at the conference. We have had four abstracts accepted, two oral presentations, and two poster presentations. In an oral presentation on Saturday afternoon, December 9, Professor Claire Roddie will present the pooled safety and efficacy, as well as longer follow-up data from the FELIX study, including subgroup analysis, in addition. Data from all patients treated in the FELIX study continued to demonstrate high rates of overall responses, CRS and CRis, and a very favorable safety profile. Additionally, data suggests better outcomes in a subgroup of patients with low leukemia burden at screening and lymphodepletion. Data presentation will be based on a median follow-up of approximately 15 months versus nine months at ASCO earlier this year, and we look forward to sharing more details, obviously, at the actual presentation. Secondly, the poster presentation will look in addition at data from a pooled analysis of relapsed refractory adult ALL patients that were treated in the ALLCAR19 study, as well as the FELIX phase Ib study. So this was the precursor, the running part of the study before we conducted the pivotal study. After a median follow-up of more than three years, between those two studies, we approximately have 30% of patients that remain in remission without subsequent transplant or other anti-leukemia therapy, indicating that we have a proportion of patients that are likely to experience a long-term benefit. When we then look into the CLL and NHL cohorts of the ALLCAR19 extension study, we have there more than two years of follow-up at this point in time. The study also shows durable responses and a low incidence of serious infections, as well as a very good overall safety profile, which gives us, I think, a very strong rationale for moving over time into these additional disease settings. Continuing on with the obe-cel abstracts, we'll also be presenting data on our manufacturing capabilities in a poster presentation. Data gathered in the FELIX study successfully demonstrated the robust operability of obe-cel manufacturing. All apheresis starting materials were successfully processed despite the multitude of constraints posed by the COVID-19 pandemic, and many patients that had very high levels of leukocytes and cancer cells, frankly, collected in the leukapheresis. Further optimization improvements were made during the start-up of the study and increased reliability, consistency, and precision of the manufacturing process, as well as improved analytics helped to minimize turnaround time and supported development of obviously The Nucleus as well as our new obe-cel manufacturing facility. Shifting gears to our dual BCMA, CD19 targeting CAR T program, AUTO8, for multiple myeloma. In an oral presentation, we'll be sharing preliminary data from the ongoing phase I MCARTY study at ASH. All patients treated achieved a response, and doses were well tolerated with no ICANS or CRS larger than Grade Three, with a median follow-up of 4.5 months at the time of the abstract. With that, we're transitioning to slide number 11, and we're looking at the preparation for commercial launch of obe-cel. As you can see on slide number 11, we are well on track with the activities as we have laid out. Key, obviously, is getting the manufacturing supply all set up, and that's obviously has progressed very well. I'll spend a little bit on the next slide on that as well. Remember, what we designed the facility for is for a capacity that will allow us to actually address and support 2/3 of the total market in the U.S. and Europe in for relapsed/refractory ALL patients. So we have an initial capacity set for 2,000 batches a year. The full capacity of the facility actually exceeds that level. Secondly, obviously, we're working towards the filing of the BLA. The target is to get the filing in before year-end, and we're on track of delivering that important milestone for the program and the company. We then also will, as we go through the early part of next year, obviously, we'll go through a set of inspections of the facility. We will certainly have one from the MHRA, which we expect in the early part of next year, as well as in the context of a BLA review, obviously, additional inspections that are expected during that process. The filing for an EU registration is expected in the first half of next year, and is also conducted under a PRIME designation, similar to the RMAT designation that we have with the FDA. From a commercial perspective, there's been a significant amount of activities this year, particularly in the medical affairs side, where we obviously are very active sharing the data, running medical education, et cetera. The second key area that we're working on is really working through the value proposition for the program and the value doses. So that's a key set of activity, that we're well on track with and, and exactly where we expect it to be at this point in time. And third, obviously, we have started, the onboarding of clinical centers, for obe-cel, which is a process, as we had indicated in the past, it typically takes somewhere between about, between probably nine and probably 15 months, depending on the center, to actually get, fully onboarded and, and, and registered. When we look into next year, obviously, we'll start to build up towards U.S. launch preparation, and that obviously will be one of the key activities that we're really gonna get seriously focused on in terms of build-up, as we're after we have filed the BLA and we're in the review process of the application. So with that, we're going to slide number 12, and this is a brief overview of The Nucleus facility. As you remember, this is a very compact facility, quite unusual in its design. Has a total square footage of 70,000 sq ft. It's a four-story building, industrial height, and in order to actually get it, get this building off the ground and operationally ready in a very, very short period of time, we have taken on an approach that built on or it was based on a high degree of off-site building of the facility. In fact, we had about 70% of the facility built off-site, moved to the actual construction site, and they're actually assembled. By doing, taking this approach and then also taking an unusual start-up approach, in order to get the facility up and running and qualified, we're actually able to go from November 8, 2021, with the groundbreaking, in less than two years, or actually, to the full qualification of the facility, which is complete at this point in time. And obviously, if we look at the timing for the BLA filing, we've been just around a little bit above probably two years of time to go from groundbreaking to a full package that is submittable in its complete form. So that's an exceptionally fast process that we're able to run through. Had a lot to do with the innovation that we're applying to both the design as well as the build up. The design was not just, you know, chosen for the reason of actually it being fast and be able to actually set up this facility in probably less than half the time than anyone actually had done it in the space so far. But also because it gives us an ability to replicate the facility with increased demand elsewhere, and also be able to do that with relatively short timelines from decision-making to operational activity. That is going to be important because there's a big impact on the risk profile of investments and the timing of investments. What you then see on the right-hand side is the actual inside of the initial operating suite. This is a suite that's designed to deliver about 700 products a year. What you see here is the facility, this suite, actually, in full, at full activity level during the capacity challenge. The manufacturing process, as you remember, is highly, is highly automated, and that gives us an ability to really run a relatively large number of products in parallel within the same environment. And in fact, what you see here is, in fact, a picture that comes from the actual capacity challenge, where we pushed the output of that particular clean room to its limits. And obviously, with the key objective to be able to demonstrate sustained control throughout that level of pressure and be able to deliver high-quality products during this period. A key aspect, actually, also of data that goes into a BLA filing as well. When we look beyond the ALL opportunity and moving to slide 14, what you see summarized on slide 14 is basically the evolution of the obe-cel program as we see it currently. First of all, as you've seen, obviously, obe-cel with its anchor indication in ALL gives us a very unique product with an exceptional level of activity, combined with a remarkable level of safety. And that creates a unique opportunity, not only for the development of the product in patients with acute lymphoblastic leukemia, but also, obviously, for indication sets in non-Hodgkin lymphoma, as well as in autoimmune disease. So that's the core opportunity we see with obe-cel, and obviously, we're active on all those fronts with the program. When we think about sort of the next steps of the program and building on the unique features of the CD19 CAR That's utilized in obe-cel, we developed, obviously, two next stage products. One is AUTO1/22, that I mentioned before, where we published the data in B-ALL from our phase I initial clinical trial, which is a dual targeting approach with the aim to minimize the risk of patients relapsing with CD19 negative disease, which is one of the major drivers for relapse in acute lymphoblastic leukemia, both in children as well as in adult patients. This product obviously gives us sort of a next leg up. It builds on the unique properties on the CD19 targeting, utilizing the same CD19 CAR as obe-cel does, but actually adds a highly potent CD22 CAR That was designed to recognize cells that express very low levels of CD22 on their surface, which is one of the known escape mechanisms for CD22. So this is the next generation program for obe-cel, which is really designed for oncology indications, as sort of the primary area of opportunity. The second program, AUTO8, I mentioned before, we're gonna be presenting an oral presentation on the initial phase I data that we generated together with our colleagues at UCL. This program again builds on the CD19 CAR from obe-cel, and it adds a highly potent BCMA CAR. In this case as well, optimized for recognizing very low levels of BCMA on the surface of target cells. This is a known challenge with BCMA targeting, is that you do have t hat the target is selective, but the target is often expressed at copy numbers that are maybe as low as 10 or 20 molecules on the cell surface for multiple myeloma cells. And as you can imagine, that creates somewhat of a challenge to actually efficiently recognizing these cells and making sure you can really get at all the cells and not just the higher level expressing multiple myeloma or plasma cells. So this program, obviously, is again, as with AUTO1/22, a dual targeting program, and so that starts opening up opportunities that could go both on the oncology as well as the autoimmune side. Depending on the development of the data, we'll make decisions in which direction we think we're gonna be taking this program. Moving to slide 15, this is just a slide that we have shown last week and explained and sort of walked through in more detail. Fundamentally, we believe we're in a very good position with our program. Given that we do obviously have a substantial amount of clinical validation, we have a large data set and an incredibly difficult to treat patient population, where we show a sort of a best-in-class benefit risk ratio for sure across across this indication, but also a highly attractive profile in the non-Hodgkin's lymphoma settings as well. This gives us a lot of confidence around the product. What you need to do is you need to, obviously, in these autoimmune diseases, make a very deep cut into the B-cell compartment. This is what we've demonstrated, obviously, and in all of these patients, where we can demonstrate and show that indeed, these patients do experience B-cell aplasia. But I think much more stringently, we can demonstrate that we also get the patients that have leukemia into a MRD negative state, which gives us a much higher level of resolution and a much more stringent measure of removal of all CD19-positive cells in these patients. So it gives us a strong amount of information about the quality of the clinical activity that we can see in these patients, and obviously, combined with an exceptional safety profile. Safety matters a lot in autoimmune disease. It's more important actually than in oncology. And one of the advantages that we have with obe-cel is that we always have a substantial safety database now that we have generated in the development leading up to the, you know, imminent filing for patients with ALL. Now, this safety data becomes important, particularly when you think about the opportunity that we have seen from the work that was done by Georg Schett and Andreas Mackensen in inducing deep responses in SLE patients. In fact, by now actually have shown that indeed, those responses are sustainable at least for a year to two years, which is the observation time that's currently in available for those initial patients treated with their own CD19 CAR T therapy, which they manufactured on the academic side. Now, this level of activity creates, obviously an interesting opportunity with regards to the development path you can take in SLE, which is a much more aggressive, much more compact development path, as you would normally have seen with the standard add-on trial designs that have been used for the various monoclonal antibodies that have developed for the space, which tend to do sort of a limited, or can show a limited improvement over the standard of care, and obviously require very large patient numbers to demonstrate the effect as a consequence of it. Here we believe that if those, if that level of activity can actually be confirmed, that was originally seen in the ALLCAR19 study, that you would be able to actually run the relatively compact studies that you would then actually have to supplement with safety information from other studies, to actually discharge the safety risks for the product. We believe this puts us in a very strong position because obviously, we do have a substantial amount of data from our current development. We also, obviously, do have a very significant level of de-risking from a manufacturing perspective, from a regulatory perspective, as well as from a commercial perspective. I think one point I want to just highlight is that we believe it's going to be important in this indication to also have an ability to deliver product with a good, cost of goods, as we think that the range of prices that ultimately will be realized will be similar, but may not exceed what we're seeing on the oncology side. Clearly, that requires you to actually have attractive cost of goods to actually maintain profitability across these indications. That's gonna be very difficult to actually generate if you had to, for example, utilize a CDMO on the way there. This is a few considerations here for why we think we're exceptionally well positioned. Obviously, we're gonna be starting with the dose confirmation study early next year. With data from that study, we'll then discuss the pivotal study designs and take it from there. But we believe that this is obviously with all the work that we've done, and enabling work and infrastructure pieces we have in place, puts obe-cel in a very, very strong position. Moving to slide number 16, this is just a quick overview in terms of so the competitive environment, where we have either companies that have significant presence in the CAR T field, but have changed the manufacturing process to a point where the product, as far as we can tell, will not be comparable to what they have used in the past in the oncology setting. At that point, you do lose the ability to actually utilize the safety information that you generated on the oncology side, and you need to actually generate more clinical data to discharge the safety risk. There's also, obviously, investment required to sort of adjust manufacturing, et cetera, to the new manufacturing process, which we do not have to do. And then obviously, we have additional new programs coming in, which lack clinical data as well as infrastructure, which obviously will require very substantial investments to be in a competitive place going forward. And it'll be interesting to see over time what potential allogeneic approaches might do. At this point, obviously, there's still a lack of data, and obviously needs to be built frankly across the board in terms of capability. So with that, I'll move on to just a quick update on the pipeline. We touched on most of the programs. What I briefly want to just highlight is that we're in the process of writing up the clinical experience with AUTO4, which we expect to publish in a peer review journal, as well as with regards to AUTO6NG, our neuroblastoma program, where we expect to dose our first patient during the quarter, the fourth quarter now as well. A program we're excited about, as we're sort of included in that program, quite a range of cell programming technology we've developed over the last few years, and they're now basically bringing together in this indication, solid tumor indication. So with that, I'd like to actually hand over to Rob, and we're moving to slide number 19. Thanks, Christian, and good morning or afternoon to everyone. It's my pleasure to review our financial results for the third quarter, ended September 30, 2023. Our cash and cash equivalents at September 30 totaled $256.4 million, as compared to $382.4 million in December 31, 2022. Total operating expenses net for the three months ended September 30, were $47.8 million, as compared to $43.5 million for the same period in 2022. Our research and development expenses decreased by $0.4 million- $37.2 million for the three months ended September 30th, compared to the same period in 2022. This was primarily due to decreases in clinical trial and supply costs related to our obe-cel clinical program, and these were partially offset by increases in operating costs related to our new manufacturing facility, as well as salaries and employee-related costs driven by increased headcount. On the G&A side, general and administrative expenses increased by $2.4 million- $10.6 million for the three months ended September 30, compared to the same period in 2022. This increase was primarily due to salaries and other employee-related costs, driven by an increase in general administrative headcount, supporting the overall business growth, primarily related to pre-commercialization activities. Our net loss attributable to ordinary shareholders was $45.8 million for the three months ended September 30th, 2023, compared to $42.8 million for the same period in 2022. Autolus estimates that our current cash and cash equivalents on hand and anticipated future milestone payment from Blackstone will extend the company's cash runway into 2025. Just as a reminder, in our projections, we do anticipate an R&D tax refund from the U.K. HMRC in Q4 of this year, and would anticipate being eligible for a tax refund in a similar fashion next year as well. I'll now hand back to Christian to wrap up with a brief outlook on expected milestones. Christian? Thank you, Rob. And so we're moving to slide 21. This is a quick summary of kind of the planned news flow, and as you can see, there's a lot of activity coming up towards the end of the year and into the early part of next year. As mentioned before, big item of focus and clearly where most of the organization is working towards is get the BLA filing in before the end of the year. We obviously talked about the obe-cel FELIX data update, as well as the updates around ALLCAR19 and the FELIX Ib study, which gives us longer term information. And I think a very nice proxy for in terms of what to expect in terms of longer term outcome from the larger pivotal FELIX study. We're then obviously will have the update on AUTO8, which is a program that is shaping up very nicely and I think will give us sort of a first interesting look at the profile of that program. And then, as mentioned just before, the start of the AUTO6NG phase I trial in children with neuroblastoma, which we expect to actually get the first child in before the year end. Importantly, as we go into early next year, we expect to get the phase I up and running, and the first patient in, in the early part of next year, treating patients with autoimmune disease, particularly focused obviously here is SLE in this initial study. The study is designed to confirm the dose, and with that, then be able to have a basis for the regulatory discussions around the pivotal study design. Then as indicated also in the earlier part of next year, we're expecting to get the filing in, in Europe, the MAA application with the European agency as well. So a lot of activity in the upcoming month. I think a lot of very significant value steps for the company. I think we're very well set up, and we have a fantastic team, also on the now building up on the commercial side, that I think will put us in a very strong position to get to the next steps once we're through the actual interactions on the regulatory side. So a lot of good stuff ahead of us. Really looking forward to seeing many of you probably at ASH, and happy to take questions now. Thank you. At this time, we will conduct a question and answer session. As a reminder, to ask a question, you'll need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our Our first question comes from the line of Matthew Phipps of William Blair. Your line is now open. Hi, thanks for taking my questions and all the updates. I guess first on ASH, will the, the obe-cel FELIX update, do, do you think you'll have sufficient follow-up to really show EFS curves at ASH? And then for AUTO8, another six evaluable patients, were those just from the BCMA alone CAR in cohort one, or were there some of those with cohort two that had the CD19 as well? And I guess maybe how many patients do you expect from cohort two at ASH? Yeah, very good questions. Thanks for joining, Matt. So first question is, are we expecting to update or present event-free survival data? And the answer is yes, on the FELIX study. And then with regards to the AUTO8 program, what Matt was referring to is that we started the phase I clinical study, dosing patients with the BCMA CAR alone to establish the base profile for the BCMA CAR, and then actually, after that was initially established, added also the CD19 CAR component to the product. And we're actually gonna have data from both patients with BCMA only, as well as with both CARs present. And we're at a point where we're probably gonna be in the range of about 10 patients, maybe slightly above that. If I could ask just one other one on the autoimmune side again. Can you remind me, I can't remember if this was discussed, last week, but is there a safety kind of DLT period, like, in between patients for the initial, like, you have to wait a month before you can treat a subsequent patient or anything like that? We would expect that there is a gap between probably the initial patients, and then as soon as you actually have initial data, you can then actually enroll at that level. Obviously, we do have quite a number, quite a good level of data at this level of dose, across particularly the ALL population. So there's a lot of safety data already in place, so we should be able to enroll relatively quickly. Great, thanks for taking my questions. Thanks, Matt. One moment for our next question. Our next question comes from the line of Dev Prasad of Jefferies. Your line is now open. Hi, thank you for taking our question. This is Dev, on for Kelly, at Jefferies. So I have a quick question on SLE. How do you think about the cell persistence, that can have an impact on efficacy and safety, in contrast to, to the oncology indications that we have seen so far? Hi, Dev. Very good question. And so as we, as mentioned before, what you're looking to sort of achieve is a very deep cut into the compartment to remove both so that the autoreactive precursor cells and memory cells, as well as the autoreactive plasma cells. Deep cut is what you need, given that this is a cell-based therapy that will take some time to be effective and complete. You will need a certain level of persistence to be able to do that. What we've seen and what I think is very encouraging is that the program in Erlangen showed very nicely that they did get a very deep response. They got, obviously, a good transition in terms of translation from a clinical efficacy perspective. When you look at the persistence of the CAR T cells, you see that the CAR T cells are pretty much around for about six months. After that, you do start to see the B-cell compartment regenerate. You see the maturation of B cells from the various subtypes, antibody subtypes perspective. But what you do not see is actually recurrence of alloreactivity. So there is a certain amount of persistence that clearly will be important. What we do see is that our product and, in fact, the product that was used in Erlangen in pediatric ALL patients, has quite very similar behavior in terms of persistence. Also, in their hands, they did see, do see that they have children with long-term persistence. We're talking two years, at least the current experience. And that's quite similar to what we have seen with obe-cel. And so we think actually that the profile should match very nicely. Thank you for taking our question. Thank you. One moment for our next question. Our next question comes from the line of Gil Blum of Needham & Company. Your line is now open. Good morning, and good afternoon, and thanks for taking our questions. A couple of items from us. First of all, for AUTO8, it looks like the data is really interesting, but, you know, it's a super crowded market, and there's a lot of assets going into it. What do you think is gonna be a key differentiator, maybe on the angle of safety? So first of all, thanks, Gil, for joining. A very interesting question, and I think one that we sort of see actually quite a bit of an evolution in the field as well. So in order for what we're designed the product for is to be able to get, on the one hand, deep responses. So we want to actually see that indeed we can get to very low levels of disease burden in these patients. And obviously, you can measure in multiple myeloma, similar to ALL, you can measure minimal residual disease levels, and that gives you one parameter, I think, that we're clearly very interested in looking at and pursuing. The second aspect was one, was a bit of a conundrum, I think from a, in the field, in the sense that what, what we're seeing with regards to cell, dynamics, CAR T cell dynamics in multiple myeloma patients, is that, the CAR T cells tend to actually not persist well. And so one of the things we wanted to achieve is see that indeed we can actually get, a longer term persistence, with the CD19 CAR component, with the basic rationale that you do have, obviously, new CD19 positive cells being formed that can actually help drive, a certain level of baseline activation and maintain that for the CAR T cells. The other aspect, the third aspect, I think, goes, actually links quite nicely with the, conversation we just had on, the autoimmune side, which is that, there is at a early stage of the plasma cell compartment is CD19 positive, and certainly it's been sort of postulated, for probably more than 25 years, then, that, the driver cells from multiple myeloma might in fact have a CD19, a CD19 expression. So what it also will allow us to do, the combination, is to obviously get into that part of the compartment, and, may actually also help us get at some of the driver cells. And so that's sort of the three hypotheses. In terms of the data, what we're looking for, is we want to see a high level of responses, in these patients. We want to see whether these responses get deep over time, usually depending on what you need to score for, can take a bit of time to develop fully. And secondly, we want to see the cellular dynamics of the product in the patients as a consequence of adding the CD19 component to the product. So those are probably the key things, and I think once we have that data in, and you know, with a reasonable number of patients stacking it. I think that's then the time for us to sort of think about the approach that would be suitable for the development for the program going forward. But you know, in terms of the hurdle for development, clearly you need to have an exceptional profile of the product to develop that in multiple myeloma. So that's sort of where we are and our current thinking is. Makes sense. I do wanna go back to a point that you made during the SLE event. Why does the company believe that, you know, other commercial stage CAR T's would need to maybe redo their production and do more clinical studies in order to move into SLE, despite the fact that they already have commercial stage assets? That's a really good question, and I think, what we're seeing with, with two programs, that are being moved forward, is that the companies decided to massively change their manufacturing. So in one case, it's moving from a manual, very lengthy manufacturing process to, a highly automated, probably two-day process. That's a massive change in terms of the actual manufacturing process. It will lead to, frankly, different products, and particularly if you go to this very early, stage of a short manufacturing process around the, the additional issue that, at that point in time, the CAR, the CARs, the chimeric antigen receptors, are not yet expressed properly on the surface. And with that, the cells are not yet functional, biologically functional, from a potency perspective or an ability to kill other cells perspective. So it creates clearly a very, very different type of product, different set of product properties. And with that, you have a new product. And that means that you have to obviously redo or generate new clinical safety data, et cetera, build that database. And from a commercial manufacturing base, it's a fundamentally different setup from the manual setup, which requires, as an example, you know, high-grade clean room environment, versus the semi or the automated platform as we use it, where you basically go to a low-grade clean room environment. So it's a very different environment to be optimal. The way you have the flows in the facility and be optimal for that from a cost perspective, looks different, and we would expect it will require pretty significant investments to actually change or build new manufacturing facilities to sort of accommodate this very different manufacturing process. The second company in the space also has made very significant changes, calls the product differently as well in terms of its coding. And we do not believe that the product will be comparable, and there's also gonna be certainly some level of adjustment that will have to be made to the commercial manufacturing infrastructure to sort of adjust to the new process and frankly, be effective with it, efficient with it. So those are probably some of the key considerations. What they obviously do have is the base set of systems for commercialization, for cell orchestration and so on. That's obviously straight usable and can be straight applied. So there is clearly an advantage there of you know, being able to rely on that as we will rely on the systems we're setting up now for ALL. All right. Thanks for taking our questions. Thanks a lot, Gil. One moment for our next question. Our next question comes from the line of Yanan Zhu of Wells Fargo. Your line is now open. Hi, thanks. Thanks for taking our questions. I have a couple for the SLE and a couple for FELIX. Perhaps let's start with the SLE. I was wondering, Christian, you were talking about the benefit of, you know, of having—o ne of the benefits of having the same product as your other soon-to-be commercial product is that you may be discharged of some of the safety database size requirements in your new indication. I was just wondering, is that something that you have had some preliminary agreement with the agencies on? Or is that your general expectation? Also, I was wondering if you have any thoughts on Novartis's YTB323 abstract at ACR. Any comment on their dose level, early efficacy, and also early safety, and how does that have any implication for your confidence for obe-cel in SLE? I'll ask the FELIX question afterwards. Thanks. Okay. Well, thanks, Yanan, for joining. Really good question. So first off, on the safety, obviously, this is based on sort of the regulatory guidance you have in terms of the general size of safety databases that you have to discharge, you know, the respective level of risk. And that's actually consistent when you look at the various indications and the way you can actually use information gained in one indication applied to another, for as long as you're working with the same product. So this is not specific guidance. This is the general guidance that you have in this, in terms of safety requirements and discharging safety risks. The second aspect, or second part of the question was related to the abstract from Novartis program, which I think looks good. I think it's very encouraging because, overall, it looks like they were able to replicate the data from the Erlangen team. I think that's great news. I think for the approaches that we're working on, and particularly also for the approach we're working on. In terms of the dose, the dose is relatively low, and that is actually, I think, quite consistent with our own experience, where we have been able to obviously show in adult patients, we can go as low as 10 million cells, and we get high degrees of activity and responses. So we know that the cells are active at that level, and they're operating at a somewhat lower level that was used in the ALL trial. But again, it's a different product that they're using. So, there's going to be some differences, and it may also be guided to some extent for, you know, needing some safety data at the respective dose levels. So, I think overall, I think very encouraging, and I think good news because we start to get, I think, a clear view that the data can be replicated that the human ALL trial has generated. And I think that's frankly good news for everyone in the field. Great. Great. So on FELIX and the ASH abstract, ASH update, I was wondering, is the data cutoff for the abstract, which we are seeing now, would that be the same as the actual presentation? And also, you know, I think we noted the median DOR is now stated as not reached. I thought, I think that back at ASCO, there was a median DOR. So it feels like the curve has probably fluctuated around the median and was bumped up somewhat with newer patient and longer additional patient or longer follow-up. I was just wondering if that's the right understanding, and also if you can comment on how much it was bumped up, that would be super helpful. Thank you, Christian. Yeah. So, in terms of the data cut, obviously, the data cut that we're gonna have at the ASH meeting will give us about the six months additional view on the patients. I did indicate that the median follow-up at ASH was nine months. We expect the median follow-up at ASCO was 9 months, and we expect the median follow-up for ASH to be at around 15 months. So it is a—it's a substantial data cut, and it's also different from the abstract, the data cut that went into the abstract. I think one of the things that we're pointing out in the context of the ASCO data, the ASCO presentation, was that the fact that the time-dependent measures clearly were not mature by any stretch of the imagination. We have most of the patients still in the very early part of the curves when we presented at ASCO, which means that there's still a significant amount of variability that we had in the curve. We're seeing, obviously, some of that play out, and you know, usually it's one patient up or down that can move the curve, particularly if you're focused on the median, and that's almost arbitrary. So you need to, you know, clearly, we're gonna have more follow-up, six additional months of follow-up, that obviously will give us more stability into the curve. But clearly, the compared to where we were at at ASCO was predominantly driven by the fact that most of the data were still very early. Great. Very helpful. Thank you, Christian. All right. Thank you very much. One moment for our next question. Our next question comes from the line of Asthika Goonewardene of Truist. Your line is now open. Hi, this is Karina for Asthika. Congrats on the progress. I had a question on a few questions on AUTO8. So what kind of data can we expect at ASH? Will this have, like, baseline characteristics and percentage of patients with EMD and other high-risk prognostic factors? And I think you said it's gonna be eight patients worth of data at ASH. Can you just confirm that? So the data, obviously, this is a phase I study, so yes, you know, we'll obviously have a review of the patients that were included, the state they're in, condition they're in. And we'll also give a full characterization of those data, of those patients on the treatment. Overall, we think we're probably gonna be in the range of 10+ patients, as mentioned, as mentioned before, so this is still, as I indicated, a phase I study. Okay. And will there be enough follow-up for six months, nine month PFS? No, that's—w ell, there's some follow-up, but I think we need more patients and more follow-up to sort of be firm around those types of information. Okay. Thank you. Thank you, Karina. One moment for our next question. Our next question comes from the line of Simon Baker of Redburn Atlantic. Your line is now open. Thank you for taking my questions, two, if I may, please. Firstly, on SLE, as you say, you have an advantage over most, if not all, competitors in the space in terms of the size of the safety database and the suitability of the manufacturing process. I just wonder if you could give us some idea of how much in terms of time that advantage is. Or alternatively, and I suspect you probably won't, but some idea on when we should think about pivotal trial starting and potential commercialization, should it be successful. And then secondly, on the manufacturing capacity and The Nucleus, could you give us an idea of the validated capacity here and now at Nucleus? I know it's a modular facility that can be expanded, but some idea of where, what the capacity is at the moment would be very handy. Thanks so much. All right. Well, thanks, Simon. Thanks for joining. On the SLE side, the question was, when do we expect a pivotal trial to be run? Obviously, that's slightly premature, but the basic notion is that we're planning the dose confirmation during the course of next year. With that data, we'll then approach the regulators, which would sort of point to the following year as the start point and the starting point for a pivotal study. I think it is too early to point to kind of what the duration of a pivotal trial would be in the absence of having an agreement on the trial design with the agency. So that's probably too early. With regards to the capacity question at The Nucleus, so the facility is basically, it's a modular set up as indicated. It has, for the initial set up for ALL, three clean rooms, each one of those scaled for 700 products a year. And we're obviously gonna be launching out of the first clean room, so that gives us an immediate 700 capacity. And then obviously, we'll bring online the second and the third clean room, 'cause it doesn't make sense to operate clean rooms that are not being utilized from a capacity perspective yet. But the facility is fully built and obviously validated. But in terms of the actual ramp and how you run that, is that you make sure that you have the right level of capacity at the right point in time. But the important thing is here, is we have no limitation to actually ramp ahead of demand here. And I think that sets us apart from all the other launches that we've seen over the last three years. Great. Thanks so much. Thank you, Simon. This concludes our question and answer session. I would now like to turn it back to Christian Itin for closing remarks. Well, first of all, thanks all for joining. Looking forward, obviously, to seeing you at ASH with the additional data updates. For those of you who happen to be in London middle of November, we're having a visit at the actual manufacturing facility. So if either on the analyst or investor side, there is interest to visit the facility, please contact Susan Leland to join us for that visit. But you might find it interesting and helpful to sort of understand what the reality looks like on the CAR T therapy side, and what you need to have in place to be able to launch. So with that, I'd like to thank you all for joining. Appreciate your time, and speak to you soon. Thank you. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.