Ladies and gentlemen, thank you for standing by, and welcome to the Autolus Therapeutics first quarter 2022 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one on your telephone. If you require any further assistance, please press star zero. Thank you. I would now like to hand the conference over to our speaker today, Olivia Manser, Director of Investor Relations. Please go ahead, ma'am. Thank you, Ren. Good morning or good afternoon, everyone, and thank you for joining us to take part in today's call on the operational highlights and financial results for the first quarter of 2022. I'm Olivia Manser, Director of Investor Relations, and with me today are Dr. Christian Itin, our Chief Executive Officer, and Dr. Lucinda Crabtree, our Chief Financial Officer. Before we begin, I would like to remind you that during today's call, our discussion will contain forward-looking statements. Please make sure you're familiar with our disclaimer, which is on slide two of the presentation. On slide three, you'll see the agenda for today, which is as follows. Christian will provide an overview of our operational highlights for the first quarter of 2022. Lucinda will then discuss the company's financial results before Christian will conclude with upcoming milestones and any other concluding comments. Finally, of course, we will welcome your questions. Thank you, Olivia, and good morning to you all. Thank you for joining us. It's my pleasure to review our progress for the first quarter of 2022. Please move to slide four. For those of you who are new to Autolus and as a refresher for those who know us well, we're building a fully integrated CAR T company. Building on our broad platform of cell programming technologies, we're generating CAR T products that are tailored to the specific tumor setting. Illustrating this approach are obe-cel, with its focus on physiological engagement of leukemic cells, maximizing potency while improving safety and persistence. AUTO4 or AUTO5, with a unique targeting approach for T-cell lymphomas, and AUTO6NG, a CAR T product candidate building on a clinically validated CAR to GD2 and adding programming modules to render the CAR T cells insensitive to checkpoint and TGFβ inhibition while increasing CAR T-cell persistence. For manufacturing, we're using a common platform and process design principles to generate products that are highly active at persisting in patients. Our current operations for clinical trial supply is working in four shifts, seven days a week, in what we are anticipating to be very close to our commercial manufacturing model. The commercial manufacturing facility designed for 2,000 products per year is under construction in the U.K., about a mile away from our clinical trial manufacturing site, and expected to be ready for GMP supply by middle of 2023. Moving to slide five. We had a successful quarter with obe-cel clearing the pre-planned futility analysis in the FELIX trial and enrollment continuing to plan. In addition to the primary morphological cohort in the FELIX trial, we are expanding the MRD or minimal residual disease cohort to up to 50 patients. In clinical practice, patients get evaluated on a regular basis for recurrence of disease, typically using flow analysis of their bone marrow. Indication of MRD levels or minimal residual disease levels of leukemia triggers treatment of the patients rather than waiting for full-blown relapse before starting treatment. This additional cohort does not impact our planned filing timelines, as the primary data will be based on the data from the morphological cohort. With obtaining RMAT from the FDA, we have received preferred regulatory access for obe-cel in all our key territories, the U.S., E.U., and U.K. In addition, the E.U. granted also orphan drug designation for obe-cel, adding to the same designation we have received previously from the FDA. In the second quarter, we're looking forward to updates at EHA from our evaluation of obe-cel in non-Hodgkin's lymphoma and primary CNS lymphoma, and two oral presentations covering our initial evaluation of the dual targeting AUTO1/22 in children with ALL who are ineligible for Kymriah therapy, and our dose escalation experience for AUTO4 in T-cell lymphoma. In addition, the clinical phase I evaluation for AUTO8 in relapsed refractory multiple myeloma started, and we are on track for AUTO6NG to start a phase I in the second half of the year. Turning to slide six. Here is a snapshot of our operational progress. As indicated, our new manufacturing facility in Stevenage is progressing well. During the quarter, Dr. Lucinda Crabtree was appointed as Chief Financial Officer on the retirement of Andrew Oakley. As we prepare for the potential launch of obe-cel, Brent Rice was promoted to Senior Vice President and Chief Commercial Officer. As well as clinical progress, we continue to innovate with our cell programming platform, and earlier this week, Autolus announced the online publication of three abstracts submitted to the American Society of Gene & Cell Therapy, ASGCT, to be held May 16 to May 19 in Washington, D.C. The three abstracts focus on Autolus' modular approach to CAR T-cell programming. The abstracts involve, first, enhancing CAR T-cell persistence using a constitutively active cytokine receptor. Second, engineering of CAR T-cells to express a Fas-CD40 protein to increase its persistence and antitumor activity. Three, developing a minocycline-mediated protein displacement platform to make cell therapies on-demand tunable with a commercially available and safe small molecule in a dose-dependent and reversible manner. Slide seven, we're jumping over and go directly to slide number eight. The focus is here on obe-cel. Just to remind you, obe-cel has a unique mechanism of action built on a highly specific engagement of CD19, coupled with a fast release from CD19 once the kill of the leukemic cell has been initiated. This fast engagement is based on the fast off-rate of the CAT binder and drives three key properties of obe-cel, very high clinical activity paired with minimal toxicity and excellent persistence. Moving to slide nine. There still remains a very high unmet medical need for adult ALL patients, with approximately 3,000 patients reaching the relapsed refractory stage of the disease that are residing in the U.S. and in the E.U. While frontline high dose combination chemotherapy enables about 90% of the adult patients to achieve complete remissions, only about 30%-40% will achieve long-term remissions. Once patients are relapsed, they have a median overall survival of less than a year. Blincyto has become the standard of care for relapsed and refractory patients. However, most patients progress rapidly. More recently, Tecartus has been approved, showing a higher level of clinical activity, but also a significant increase in toxicity. When we look at slide number 10, this slide summarizes the key data we have shown to date for obe-cel in ALL, which suggests that obe-cel could be potentially a transformational therapy for adult patients with ALL. In the initial FELIX phase I-B data presented at ASH at the end of last year, obe-cel showed a favorable safety and efficacy profile consistent with the data we have collected prior in the older CAR19 study in the same patient population. We saw a high overall response rate and the duration of response from the older CAR19 study remained highly encouraging, with morphological event-free survival for obe-cel of 46% at 24 months with a median follow-up of 29.3 months, and patients approaching up to 42 months of durability. We continue to see sustained obe-cel persistence in those patients as well. To remind you, obe-cel has been granted Orphan Drug Designation by the FDA for ALL, PRIME designation by EMA, ILAP designation by MHRA, and most recently, RMAT designation by the FDA, and as well as Orphan Drug Designation by EMA as well. Moving to slide 11. We're conducting the FELIX study with 100 patients in a morphologic cohort, treating those patients at sites in the U.S., U.K., and in Spain. We expect to be fully enrolled as we go through the course of this year, and as mentioned, expect to have initial data starting in the second half of this year, with full data in the first half of next year. Switching gears and moving to slide number 13. Obe-cel's unique profile means it could be applicable to a broad range of B-cell malignancies. We are evaluating the product outside of ALL in non-Hodgkin's B-cell lymphomas, including the typical follicular DLBCL mantle cell and CLL indications, and expect multiple clinical readouts during the course of 2022. The first clinical updates will be in June at EHA, where we have readouts from a phase I study and extension of the old CAR study in the non-Hodgkin's indications, as well as from a separate study, the so-called CAROUSEL study, in patients with primary CNS lymphoma. On slide 14, on the right-hand table, we provide a quick summary of the basic experience that we have to date with obe-cel in pediatric ALL patients in the so-called FELIX study. The fundamental finding was that we have excellent activity without high-grade cytokine release syndrome, but we did see about half of the patients relapse due to antigen loss of CD19. That is why we went back and built on this favorable profile of obe-cel that we have seen in kids, adding a highly potent CD22 CAR to create a product called AUTO1/22. We will have an oral presentation at EHA of the phase I data for AUTO1/22 in pediatric ALL patients that were ineligible for Kymriah therapy. Moving to slide 16 to talk more broadly about our technology base. Autolus has a wide range of technology covering mostly cell programming modules and product candidates. With over 100 patent families under prosecution, we have a very significant technology treasure chest that we're building on. Three new cell programming approaches will be presented at ASGCT, the annual meeting in May, which showcase our industry-leading T-cell programming technologies. Key areas covered by our cell program modules cover selective targeting of cancers, controlling CAR T-cell activity, shielding CAR T-cells from the cancer microenvironment, as well as the patient's immune system, and enhancing CAR T-cell persistence, as well as attracting the support of the patient's own immune system in the fight against the cancer. Moving to slide 17. Here we have tabulated next-generation programs alongside the progress in the clinic. Most advanced is AUTO4, our program to address T-cell lymphomas. AUTO5 is the sister program to AUTO4 and following AUTO4 into clinical development. Both programs are run internally. In collaboration with our academic partner, UCL, we have moved AUTO8 into the clinical, into the clinic in a phase I clinical study in multiple myeloma patients. I'm working on AUTO6NG to get into the clinic second half of this year, targeting neuroblastoma as solid tumor in children. Turning to slide 18, I'll give you further information about AUTO4. We're actively exploring T-cell lymphoma, which is an aggressive disease with very poor prognosis for patients. The primary challenge has been to find a structure or target on the surface of T-cells that would allow you to target the T-cell lymphoma without, at the same time, targeting all T-cells together. Of course, what that means is that you need to have a target that allows you to get the the lymphoma, leaving the T-cells behind, and with that preserving immunity in these patients. AUTO4 is targeting a structure called TRBC1, and it's just a program AUTO5 targets TRBC2. Both structures are related. They are part of the constant domain of the T-cell receptor beta chain and are commonly available in T-cells in either one or the other isoform. Both targets are novel, and we obviously are planning to show first data in an oral presentation at EHA for AUTO4 from our dose escalation experience in phase I. With that, I'd like to actually hand over into the financial section, and hand over to Lucy, who's moving to slide number 20. Thanks, Christian, and good morning or good afternoon to everyone. Moving to slide 20, it's my pleasure to review our financial results for the first quarter to March 31st, 2022. On the journey to transitioning Autolus into a fully integrated CAR T company, we continued in the first quarter of 2022 to focus our research and development efforts on our lead product, obe-cel, and our pipeline assets addressing cancers with limited treatment options. Starting with R&D expense for the three months ended March 31st, 2022, research and development expenses increased to $34 million from $30.7 million for the three months ended March 31st, 2021. Cash costs, being the biggest component of our R&D expense, were relatively flat at $30.6 million this quarter from $30.7 million for the quarter ended March 31st, 2021. The small decrease in research and development cash costs to the tune of $0.1 million consisted primarily of a $2.8 million decrease in compensation and employment-related costs, which was due to a combination of lower retention, severance payments, and the timing of salary mix of new employee hires. A $0.9 million decrease in facilities costs related to the termination and exits of our U.S. manufacturing facility in the prior year and shift in our manufacturing strategy. A $0.2 million decrease in research and development costs related to cell logistics. These decreases in R&D cash costs were offset by an increase of $2.9 million in clinical costs and manufacturing costs, primarily related to our obe-cel clinical product. $0.8 million increase in legal fees and professional consulting fees in relation to our research and development activities. A $0.1 million increase related to information technology infrastructure and supporting and support for information systems related to the conduct of clinical trials and manufacturing operations. Non-cash costs increased to $3.4 million for the three months ended March 31st, 2022, from $36,000 for the three months ended March 31st, 2021. The increase is primarily attributable to an increase of $3.1 million in share-based compensation expense included in R&D expenses as a result of the retention of employees post the reduction of workforce that was implemented during the three months ended March 31st, 2021. In addition, depreciation and amortization expense increased by $0.3 million. Just touching on the G&A side, expenses decreased by $0.7 million to $8 million for the three months ended March 31st, 2022, from $8.7 million for the three months in the first quarter of the prior year. Of which G&A cash costs, which exclude depreciation and amortization, as well as share-based compensation, decreased by $0.6 million to $7 million. All in all, including grant income and net total other expense, with the largest component being the interest expense of $1.8 million, which corresponds to the liability related to sales of future royalties and sales milestones which arose upon entering into the Blackstone strategic collaboration. We ended the first quarter 2022 with a net loss on a pre-tax basis at $42.7 million versus $39 million in Q1 2021. Although income tax benefits related to qualifying research and development expenditures continue to play a role as a source of additional cash, and the tax credit for the three months ended March 31st, 2022 amounted to $5.6 million versus $5.7 million in the prior year quarter. All in all, this resulted in net loss attributable to ordinary shareholders of $37.1 million for the three months ended March 31st, 2022, versus $33.3 million in the prior year quarter. This, in turn, gave a basic and diluted net loss per ordinary share for the three months ended March 31st, 2022, totaling $0.41, compared to a basic and diluted net loss per ordinary share of $0.53 for the three months ended March 31st, 2021. Finally, we ended the quarter with a cash position at $268.6 million, and consistent with prior guidance, pointing to a corresponding cash runway into 2024, assuming receipt of the Blackstone milestones. Now let me turn back to Christian to give you an overview of the pipeline and a brief outlook on expected milestones. Christian? Thanks, Lucy. Moving to the final slide, number 22. Finally, next steps. We believe we have an exciting year ahead of us with obe-cel running through the pivotal study in adult ALL, delivering initial clinical data from this pivotal study later this year and full data expected in the first half of 2023. We plan to provide clinical updates from four of our programs at EHA this June. This is in addition to progress across the pipeline that we alluded to as well as we went through the presentation, and particularly with obviously also looking at AUTO6NG expecting to enter the clinic in the second half of this year. Finally, as a result of our collaboration with Blackstone, we're in a strong financial position with cash runway, including project financing payments from Blackstone into 2024. With that, we're happy to take questions. As a reminder to ask a question, you will need to press star one on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Once again, that's star one on your touchtone telephone. Your first question comes from the line of Matt Phipps from William Blair. Your line is open. Good morning, Christian. Or well, maybe it's not morning anymore there, but thanks for the call. I was wondering, Christian, if you could maybe help us set the stage a little bit for the AUTO4 results. We've seen other CAR T targets against T-cell malignancies such as CD5, CD7, do see some responses. A lot of patients maybe go to transplant. But I guess, you know, are you expecting a lot of patients in the AUTO4 trial to go on to transplant if they do achieve a complete response? I assume also looking at things like viral infections will be another key data point for this program and the first update. Good morning, Matt. Thanks for joining. Very good question. As you pointed out, obviously, T-cell lymphoma is a very tough disease to go after. There are a number of approaches that have been tried. What you refer to programs like CD5 or CD7 have sort of a limited application. CD7 is mostly present on the acute leukemia, T-cell acute leukemia, rather than T-cell lymphoma. It's only a very small subset of T-cell lymphomas that carry CD7. When you look at CD5, that's a general activation marker for T cells. Any T-cell that gets activated, including our CAR T cells, would actually become CD5 positives, which obviously creates a number of challenges. If you go after more general targets like CD4 as an example, you run the risk that you're actually eliminating the compartment as you're trying to attack and trying to tackle the disease itself with consequences for the patient's ability to actually maintain a healthy T-cell mediated immune response. What we're looking to do with AUTO4 and then also with the sister program, AUTO5, is really targeting a subset, on the one hand, the disease itself, but then also only a subset of healthy T-cells so that at least half of the remaining T-cells, in theory, would not be targetable with the CAR T and with that sustained T-cell mediated response over time. What we're looking to do and what we've been doing in the trial that we're gonna be updating on is obviously dose escalation. It's a wide range of doses, starting at very low levels to elevated levels. What we're looking to see are several points. Number one, want to understand the safety profile. Number two, obviously, do we have an ability to induce complete remissions in these patients? Number three, do we see any evidence that we're impacting the broader T-cell compartment in these patients, which obviously would be a concern from an overall safety perspective. As for in the dose escalation, we have varying degrees of follow-up, and we'll need to see and gain more experience to see whether indeed, some of these patients may need to receive transplant in the future, or whether this, the therapy on its own will be sufficient to sustain long-term remissions. That is too early to tell, but I think we're gonna get a very good understanding. It's a novel target. It's a novel approach. It's first in that experience, and I think it'll give us a very good initial experience and understanding, of the potential of this approach. Thanks, Christian. If I could ask one additional question. A recent data from Stanford group at AACR with a GD2 CAR showed some encouraging results in a tough glioma setting, but also did use ICV infusions. I'm wondering if that's something you would look at any kind of intracranial infusions with the AUTO6 program. Right. The specific indication that the Stanford group went after is a form of a glioma, which is obviously a cancer that is localized in the brain. There are various ways in how we can think about accessing that, whether you access the brain through an infusion of CAR T-cells into the bloodstream and then have the CAR T-cells migrate across the blood-brain barrier into the brain and then have an ability to target the glioma. That's one approach you can take. What the Stanford team has done is take the ultimate approach. It's literally going directly into the brain and frankly delivering product directly onto the lesion in those patients. Obviously, that's an approach that's workable, as we're seeing obviously and we'll have data for obe-cel and primary CNS lymphoma, where we also approach the dosing from the systemic side, so from the blood side. I think we can start to see, you know, I think that both routes are possible and are usable. For our own GD2 CAR program, we would envisage a normal systemic approach because the disease we're treating neuroblastoma is a kidney-associated tumor that can actually very well access just through the standard administration into the bloodstream. I see. Thanks, Matt. Your next question comes from the line of Nick Abbott from Wells Fargo. Your line is open. Hello, good morning. Thanks for taking my question. Yes, lots of things going on here, team. I apologize that I had to join the call late, but the first question is on you know, what we might expect as a benchmark for primary CNS lymphoma. The MGH group just published in Blood some experience with axi-cell. I think it was quite surprising, to me at least, with low-grade ICANS, Grade 1, Grade 2, Grade 1 CRS. They reported a 60% response rate, 50% CR, with three of those complete responses showing significant durability of, you know, greater than six months at least. I'm wondering, you know, what we should be expecting for primary CNS lymphoma and, you know, whether you think this is a good benchmark. First of all, thanks. Thanks for joining, Nick. On primary CNS lymphoma, what we're planning to do is provide, obviously, initial information on the early patients that we have in the trial. Obviously, that gives us, you know, a view, an initial view. I don't think we're at the point where we can easily benchmark given the number of patients that we're able to report on at this point. I think in general, seeing, you know, a give or take 50% CR rate in these patients, I think is very encouraging. I think is certainly would be a good outcome for patients with this disease, considering also factoring the lack of any suitable other options. Okay. Thanks, Christian. Thank you. I noticed that you mentioned that, you know, AUTO8 has been initiated now. When do you think you'll be able to present some initial data from that trial? I would assume this is a phase I clinical trial. I would assume that we'll have to look at the second half of next year for early clinical data. Okay, great. Thanks a lot, Christian. Thanks a lot, Nick. Appreciate it. Your next question comes from the line of Mara Goldstein from Mizuho. Your line is open. Great. Thanks so much for taking the question. I wanted to ask just on the AUTO4 program. I think the upper dose limit has been raised there to 900 million cells. Can you talk a little bit about that and that dynamic? Lastly, just on obe-cel and the new MRD cohort, maybe you can talk a little bit about what are the challenges in that cohort and why obe-cel you know may be appropriate there. Yes, happy to do that, Mara. Thanks for joining. So first, with regards to AUTO4, as I indicated, AUTO4, we ran through a dose escalation, started at relatively low levels. The initial dose that we had, I think highlighted in clinical trial update was 225 million cells. We created an opportunity to go further than that. We will obviously provide an update on kind of the upper dose range that we went to. We didn't go all the way to 900. You'll see obviously overall kind of the efficacy and safety profile that we're starting to achieve at the higher dose levels. With regards to the MRD cohort for obe-cel, I think the importance of the MRD cohort is severalfold. First off, we do have a bit of a discrepancy between the regulatory data package that we need to get to an approval versus the data and the treatment algorithm that we do see taking hold at clinical centers. Most clinical centers, also based on the experience with Blincyto in patients with minimal residual disease, are preferring to start treating patients when they have a first inkling of the disease coming back. What normally happens with these patients is you actually take, you know, at periodic intervals, you take bone marrow biopsies, you run those bone marrow biopsies typically on flow, and you look for the presence of leukemic cells. The sensitivity of that methodology gives you somewhere in the range of 10 to -4, 10 to- 3 resolution, very reliably. That compares to a 5% level that you would have to cross the boundary to become a morphological patient. You do discover, and you actually look at that in the clinic for these patients, you look for these low levels of disease in these patients. Now, when you find that the patient actually does have low-level disease, typically, you would not want to wait for that patient to progress to full-blown disease before you start treating. 'Cause there are two things that happen. On the one hand, you have obviously a lot more tumor burden, which means you have a higher, typically when you intervene with any kind of therapy, a higher amount of toxicity, but you also have a lower probability of actually inducing a longer-term benefit in these patients. It's both from the safety and efficacy side, not desirable from a patient, from a physician's perspective to wait. What we're doing with the MRD cohort is really initiate alongside the dataset that we need to have in place, to support the regulatory approval of the product. We're also looking to generate data that actually support and basically characterize the profile of the product against patients with lower disease burden, which is closer to what actually we're seeing in many clinical practices, both in the U.S. and in Europe, the physicians moving to. That's a bit of backdrop to what we're doing in the work with the MRD cohort. All right. Thanks so much. Thank you. Your next question comes from the line of Gil Blum from Needham. Your line is open. Good morning, everyone, and thanks for taking our questions. Maybe a clarification on the MRD population. Are current approved CAR Ts used in patients that are MRD positive? Good morning, Gil. Thanks for joining. What we do see is that certainly in the pediatric patients, physicians have been moving to treating the kids very early on, typically when they have minimal residual disease. That's an observation that we certainly see across, I think, many of the centers, within this disease setting and where you would start using a particular Kymriah very early on. I think in general, there is a view that you would like to actually treat early. I think the best visibility at this point we have from the pediatric population, 'cause it's also where obviously the CAR T therapy is probably most established. Okay. Thank you. Maybe a question on- Sorry, Gil. Oh, sorry. Sorry, Gil. The second part, obviously, of the answer is that the experience that physicians have gained with Blincyto, also with adult patients, also moves quite significantly towards patients with minimal residual disease, rather than waiting for the patients to develop full-blown morphological disease. The difference in response rate is quite significant. You have about 43%-44% CR rate in the morphological disease of Blincyto, but you do have about 78% CRs in molecular CRs if you go into the MRD population for Blincyto. All right. It makes sense to have earlier treatment. Maybe a question on AUTO1/22. You said Kymriah is ineligible. Can you remind us if any of these patients that are being enrolled have experienced CAR T's in the past? AUTO1/22, obviously, which is a dual targeting CAR T, we treated in our first-line experience now kids that are ineligible for Kymriah. You can be ineligible for Kymriah for a set of reasons. One is that you already have Kymriah, and you cannot get a second dose. That is obviously part of the population that we have enrolled. Secondly, it can be that the disease is localized in an area where you actually have to exclude patients from the treatment of Kymriah, and in particular, a localization obviously would be CNS localized disease. It's typically related to either prior therapy with Kymriah and not being eligible anymore for a second go or having disease that is basically extramedullary disease outside of the marrow, that actually would disqualify you from being offered Kymriah as a therapeutic option. All right. Maybe a follow-up there. Will the presented data be stratified based on patients who are, you know, experienced previous CAR T therapy, or is it more of a like, mixed bag? We'll have both categories of patients. It's obviously a phase I experience, so it's a limited number of patients. You have both patients who've either relapsed post Kymriah or patients that have disease outside of the normal localization. All right. Maybe a last one. I know you guys are showing a bunch of the really interesting new technologies, modular technologies coming up at ASGCT. Considering the current laser focus on obe-cel, are you guys considering out-licensing some of these technologies to other firms? You know, I mentioned the fact that we have a very broad portfolio with about 100 patent families covering the various inventions. There clearly is opportunity for that, and opportunity for out-licensing. You know, part of that is what you saw us do last year with the collaboration we put in place with Moderna. There's additional opportunity. There's some smaller licenses we've granted as well over the years to aspects of technology. There is clearly opportunity for that outside of the portfolio that we're pushing ourselves. All right. Thank you for taking all of our questions. Thanks a lot, Gil. Appreciate it. Your next question comes from the line of Asthika Goonewardene from Truist. Your line is open. Hi. Thanks for taking our question. This is Bill on for Asthika. We were wondering if the MRD cohort would that data be ready for the first half 2023 update? Also subsequently, we're just wondering, in your hands and your experience, on average, how many multiple myeloma cells are double positive for CD19 and BCMA? Thanks. Thanks for joining, Bill. First question related to data becoming available from the MRD cohort, whether that's gonna be coinciding with the main data release from the morphological cohort. That's something we need to look at. Obviously we will have a range of follow-up on these patients, and one of the determinations we'll need to make is how much of a minimal follow-up we wanna have in that patient group. There may be possibility to include some of that data, at least on the initial experience, in that group, from a safety and a basic activity perspective. We'll see how that progresses. I think there's an opportunity, but in general what you would love to have with the MRD cohort is a longer follow-up and actually see how these patients do over time, not only in terms of the initial response you can induce and the safety profile associated with that treatment. Thanks. Thank you. The CD19 and BCMA double positive- Yes. In the multiple myeloma population. Right. The two aspects to that. BCMA is the main target that you would find on multiple myeloma cells. The interest in CD19 is sort of twofold. Number one, there is what is believed to be a driving population of multiple myeloma that is CD19- positive. That's one aspect. It's a smaller number of cells, but having a key role in driving the disease. Secondly, the fact that if you have your therapy and if you have an ongoing activation of your compartment using with the de novo generation of CD19- positive cells, not myeloma cells, but generally positive cells, that probably is gonna be helpful to actually sustain activity of the CAR T-cells over time as well. There are likely two elements there that play into the rationale for choosing the targets. Thank you so much. Thank you. Your next question comes from the line of Kelly Shi from Jefferies. Your line is open. Hi. Good morning. This is Dev on for Kelly Shi. Just a couple of questions from me. One is on futility analysis. Can you provide more color whether it's safety or efficacy analysis or how many patients were in that analysis? Second is dual CAR. What kind of bar do you think will be suitable to move that program into next step? Thank you. All right. Thanks a lot, Dev. Appreciate it. The futility analysis, that was a predefined analysis point, obviously, for the study. As you typically do in futility analysis, you look at primarily aspects of the program. One is the likelihood of the program to succeed, and that's basically a certain statistical power. You wanna see that the program is going to succeed. Secondly, you also obviously look at the overall adverse event profile, and you wanna make sure that the profile of that product is as expected, and you do not pick up any undue adverse events in the program. That was prespecified, and ultimately it's driven by the statistical analyses on your likelihood of success in the program as well. With regards to AUTO1/22, obviously the start of the phase I, as indicated in Kymriah eligible patients, is obviously the initial data set that we're getting. Ultimately, this type of product, you would like to position a lot at the same level of Kymriah. You do not actually wanna have sequential CAR T therapy. That would not be a smart thing to do. Actually have a product that has an ability to overall improve the ultimately event-free as well as overall survival in that patient group by minimizing relapses due to antigen loss, and that's ultimately what you'd be looking at. When you look at the space, you see that the event-free survival at one year for pediatric patients is around 50%. That's the number that you would like to actually look to improve and see improved in a product with a dual targeting approach in pediatric patients. Got it. Thanks. Just to follow up on the BCMA and CD19 CAR. What would be the bar for that product because of this changing treatment paradigm for multiple myeloma? Right. You have to really postulate a very high bar for the program to proceed into the next steps of development. We do see obviously very good, a very good profile for the J&J program, and we see good sustained activity on the BMS program. I think what you would want to see is you want to see very deep molecular CRs that you can induce, and you also would like to see an improved pattern with regards to persistence as well in the product. I think those are two parameters that I think can be picked up relatively early, or in the evaluation of the program. I think those are certainly two of the parameters we'd be tracking very carefully. Got it. Thank you. Thank you. Your next question comes from the line of Simon Baker from Redburn. Your line is open. Thank you very much for taking my questions. Three, if I may. Generally of a more general nature. I just wonder if you could give us your latest observations on the normalization of enrollment rates as we start, certainly in parts of the world, to emerge from the pandemic. Are we close to normal, or is there still some distance to go? Secondly, on the Stevenage facility, you talked about the capacity of 2000 batches per year. Is that from second half of 2023 or is there a ramp up? Could you give us some idea of the scope to expand? You talked about the option. I wonder if you could give us an idea of how much it could be expanded by. Finally, short couple of weeks after your full year results, the FDA published their draft industry guidance document on CAR T development. I just wondered if you could give us your perspectives on that document, and the direction the FDA is moving in now that you've had a good chance to review it. Thanks so much. Well, thanks for joining, Simon. The first is question was related to the enrollment and frankly, the ability of clinical trial centers to support clinical trials. As I think many of us have seen, there's obviously during the peak of the pandemic, many of the institutions were impacted heavily, not only by a lot of workload, but also as a consequence of losing a substantial amount of staff or a number of staff that are particularly the in those individuals who are active in the ICU entities, et cetera. That's been certainly a significant issue. We've seen a lot of that normalize. There's still some geographic differences, but the vast majority of centers are back in a normal mode of operation, certainly for patients that have the level of medical need as we're seeing here with obe-cel in patients with acute leukemia that actually do have to get treated. You cannot wait to treat those patients. We're seeing a normalization, certainly for those patients. I think for some of the less life-threatening diseases, that may still actually take a bit more time. But I think that's where we are. A big chunk is actually, or a big, big aspect is going to be the training of nurses and frankly, both the hiring and training of nurses, which will take time. It certainly will be a significant effort we see all across both the U.S. as well as Europe and the U.K. Second question was related to the capacity at Stevenage. The capacity at scale at the new facility will be at 2,000 batches. We're obviously gonna ramp up that capacity operationally as we're rolling out the product and as we're sort of growing the product. Doesn't make sense to actually have a full standing operation for that level of capacity and then not fully using that. That needs to be an adapted approach as you go up. The design of the facility, setup of the facility supports about 2,000 products a year. The scope to expand actually would allow us to actually expand physically, the facility and with that, increase the capacity overall. The last question was related to the CAR T guidance documents. The document that was coming out from the agency. I think an important aspect is obviously we're in a relatively new field still. There's a lot of learning going on. I think having that type of learning and best practices sort of being started to be consolidated and sort of agreed upon, I think is very helpful. We're, you know, I think, you know, glad to see that we're seeing some of that guidance to be more formalized as it is outlined now in that direction. Great. Thanks so much. Thank you. Your next question comes from the line of Eric Joseph from JP Morgan. Your line is open. Hi, thanks. This is Sean on for Eric Joseph. Sorry, my line was dropped for a little bit. I apologize if that's a repeat of the question. We are basically wondering about a follow-up question on the futility analysis. Whether you can talk about some more details on the statistical assumptions on patient numbers comprising that analysis. Having passed it, is there a minimum CR rate or duration of response that can be inferred from that? Thanks. Thanks for joining, Sean. Yes, indeed, the question has been asked before. The futility analysis, it's the statistical hypothesis we obviously haven't communicated. What you typically want to know is whether the study actually is in a position to reach the design primary endpoint that you have set and the statistical outcome that you've set for the overall study. That is what you want to make sure that indeed the program can reach that outcome. That's typically what you do in your futility analysis. That's it, you know, from as indicated, it's primarily based on the clinical activity side. In our case, the primary endpoint being the complete remission rate. Also obviously looking at the overall safety, which is also gonna be taken into account as well. Those are kind of the key parameters. We haven't actually given more detail or more resolution on that. Obviously, we nicely passed that point, and we're progressing well with the program. Yeah. All right. Thank you. Thank you. There are no further questions at this time. I would now like to turn the conference back to Mr. Christian Itin. All right. Well, thank you very much all for joining today. Obviously an exciting first quarter. We're really looking forward to the second quarter with seven abstracts to be presented in the upcoming weeks. We also will take the opportunity, in particular around the EHA data, to give you a more in-depth update around the conference as well, and obviously put the data in context as well outside of just a pure clinical data perspective. All right. With that, I'd like to thank you all for joining, and wish you a great day. Thank you. Ladies and gentlemen, this concludes today's conference. Thank you for your participation, and have a wonderful day. You may all disconnect.