Autolus Therapeutics plc (AUTL) Earnings Call Transcript & Summary

June 13, 2023

NASDAQ US Health Care Biotechnology conference_presentation 35 min

Earnings Call Speaker Segments

Rajan Sharma

analyst
#1

All right. Good afternoon, everyone. My name is Rajan Sharma. I'm one of the European biotech analyst here at Goldman Sachs. I'm pleased to have Christian Itin, who's the CEO at Autolus, join us for a fireside this afternoon. Christian, thank you for taking the time. Maybe you want to kind of start by giving a high-level overview of Autolus and kind of the technology platforms that you have.

Christian Itin

executive
#2

Yes, happy to do that. First of all, thanks for the invitation. Always great to come out of California and get a bit of [indiscernible], although the June gloom certainly had its moments this morning. I'm Christian Itin, CEO of Autolus. We had a very exciting last few months actually behind us. We're just coming off ASCO, where we had shown pivotal data for our LEAP program called Obe-cel that we developed in patients with acute lymphoblastic leukemia, had very nice data, very good safety profile, high level of activity. And as you can imagine, developing such a program in a highly immune compromised patient population during the peak of the pandemic had its moment and to see the consistency in the data was very reassuring. The other aspect, obviously, that took a lot of, I think, focus for the last few months was certainly on getting the manufacturing base ready for commercial launch. We built a dedicated facility in the U.K. which allows us to actually serve about 2/3 of the U.S. and European market that we expect for this product. It's designed for about 2,000 products a year in its initial build-out, which is that comparable to what the current standard of care, Blincyto sort of reaching in that population, product that you may realize will probably make about $800 million this year. So very interesting proposition. I think what's very encouraging to see is that we had actually a safety profile that was better than Blincyto safety profile and an activity profile that substantially exceeds the standard of care. And what we're seeing is in our prior studies is that we can actually get long-term remissions in a significant proportion of the patients with about 35% of the patients in long-term remission. And here, we're looking at 2 to 4 years of follow-up at this point. All of those patients had continued persistence of the CAR T cells. And so one of the key aspects that we're looking for in the current study, obviously, was not only just the initial response rate and safety profile but also whether we were seeing a replication of the persistence. And in fact, we could show that in deep that we're tracking very nicely at the level that we had seen in our prior study, which gives us a lot of confidence in terms of the opportunity for long-term outcomes in this patient population as well.

Rajan Sharma

analyst
#3

Okay. So could you remind us on kind of what the long-term outcome was in the prior trial and whether you're kind of looking to that as a benchmark for FELIX [indiscernible]?

Christian Itin

executive
#4

Well, what we've been -- what we saw, as I indicated, is that 35% of the patients were in long-term remission, which is quite astounding when you think about the population where on standard of care, virtually no patients -- very few patients get beyond the year. And in fact, nobody gets into long-term remission on Blincyto. And so it's definitely gives us a good sense that this is a very unusual set of properties. And also, I think what gave us a lot of confidence around the data, and we presented that in quite some detail at ASCO is that we had -- when we looked at the tumor burden and its patients before dosing, versus the response rate, we could see if we have patients that were below 75% tumor burden in the marrow, which is a very significant level. And remember, this is even after bridging therapy still at those levels. We can actually see that the patients are somewhere in the range of 84%, 85% ORR, CRs and CRIs, which is obviously very remarkable in terms of the absolute level but also the consistency across the entirety of tumor burden up to that level. It was only when you get into very excessive levels of tumor burden beyond 75% after bridging which is basically a highly refractory disease and kind of [indiscernible] at quite an explosive stage. That's when the ORR dropped to about 60%. So it gives us, I think, a very good understanding of the breadth of activity and also the level that I think we can expect going forward. And as I mentioned, we did do that study through the peak of the pandemic, which obviously had an impact and we could actually see in the data that when you have the peak of the pandemic and infection rate, that also the patients were overall in a poorer condition at that point in time, typically with very poor bone marrow function, as you would expect.

Rajan Sharma

analyst
#5

Okay. So we were expecting an update from FELIX, ASH now. Could you maybe just talk through what we should be expecting there?

Christian Itin

executive
#6

So obviously, the key -- the first key aspect is longer observation time. So I think we'll have a much better view on the time-dependent endpoints. At this point, obviously, it was still early. We had still a significant proportion of the patients that were below median that we had observed, substantial below the median. We had 9.5 months of follow-up on the median and just on duration of response, the median and the curve would have suggested around 14 months. But of course, a significant proportion of the patients are in the upper part of the curve in the early stage of the curve. So that actually will give us a lot more stability as we're seeing more of these patients actually move out. And what was obviously interesting is that I would say a lot of these patients that are in the upper part of the curve were in the second half of the trial, which is sort of [ active ] towards the end of kind of the very active phase in the pandemic. So it will be interesting to see how that translates, but we also did see obviously a slight increase in ORR as well as we went into the full data set. So certainly, I think an interesting update. The other aspect is that I think there's an opportunity to look into more sub-analysis, particularly the impact of tumor burden on both, efficacy as well as safety profile. I think what was interesting, and we did quote that we had 7% of the patients that did experience higher-grade neurological toxicity, which a total of 7 patients, 6 of the 7 actually were in the highest disease per group, so 75% and above at lymphodepletion at the time of when we're getting ready for dosing. So -- which also tells you a lot about the fact that if you have patients that have from lower disease burden to very sizable disease burden. They very consistently give you a very, I think, well tolerated and very well manageable safety profile which I believe will also actually allow you to consider hospital outpatient setting as we've done in my previous development with Blincyto.

Rajan Sharma

analyst
#7

Yes. And I guess that's kind of a good kind of segue on to the commercial piece, but how important do you think kind of the source of patients and kind of academic centers versus kind of community centers? And is that possible with a CAR T therapy?

Christian Itin

executive
#8

So I think there's a few considerations. First of all, when you look at what enabled the broad use of Blincyto, that was predominantly driven by having a very manageable product -- predictable, manageable product. A product where the physicians stayed in control or stays in control of the therapy. And I think that's the prerequisite to be able to consider the hospitalize patients use, which often is sort of just sitting on the side of the hospital business, that's sort of the ambulatory setting, where the patients often are actually staying for the initial part of the therapy in either a nearby hotel or a different wing of the hospital depending on how the hospitals are organized. And it was clearly that safety profile, which allowed over time, Blincyto to reach nonacademic transplant centers. And with that, significantly increased the footprint and make basically support the accessibility of the therapy. So for us to actually have a product that has a profile on the safety side, it actually is improved durable inside. And the key part here is really neurological toxicity. So the key parameters in terms of these types of products and the toxicity you're looking at is on the one hand, neurological toxicity on the other hand, cytokine release syndrome. Cytokine release syndrome, I think a lot of physicians got reasonably comfortable dealing with. It's intense, but you have tools you can use. You have toci, you have anakinra, and you have steroids. So it gives you tools to intervene. And typically, even if you get into a high-grade event, it is sort of in a relatively narrow band from a time perspective where you can manage this. It's quite different actually with neurological toxicity. Now in the case of Blincyto, one of the key areas that we were using at the time, and I developed the product with my old team, was to make it [indiscernible] understand actually what's the progression of the neurological toxicity, what kind of manifestations and how they scale. But the other aspect was that you had a way to intervene actively with steroids when it started to build. But you also have an ability to basically take the foot off the pedal and stop the infusion. And with that, you can basically quiet the entire reaction down. The T cells will start to actually get into sort of a normal state or an activated state. And you normally could actually get these patients within 2, 3, 4 days back to pretty much normal or normal. And so that gives you a lot of control. And the physicians exactly knew what to do and what basically the levers were in the approach. Now the challenge, of course, in the CAR-T is once it's in, it's in. You can't take it out. And you can't easily stop it. And so the tools you have is you can use steroids to manage neurological toxicity and you kind of use it typically, you want to use it when the neurological toxicity starts to build and then actually with that has sort of a dampening effect that buys a bit of time and actually sort of stretches basically the toxicity over slightly more time and with that, reduce the intensity. The problem, however, is it just doesn't really get it all the way down. It just gives you sort of an element to sort of impact. But the problem is once it's running and depending on the product, it can actually run for quite some time. We're talking weeks. So this can actually be a very different picture than what a Grade 3/4 looks like for Blincyto. Now the good thing with Obe-cel is that the intensity of the first of all, the rare overall neurological toxicity with Blincyto give you a sense, it's about 63%. And of any grade and about, give or take, 13%, 15% of the patients have high-grade neurological toxicity. With Obe-cel, we had about 25% of the patients experienced some form of neurological toxicity, about 1/3 compared to Blincyto. And when we look at high grades, we're at 7%. So it's substantially lower. But we also see that the quality tends to be on the low end of the spectrum and the patients tend to actually get back to normal fairly quickly. Now the problem is if you actually have a product where you need to actually very aggressively intervene and some of the products in the space, you have to do that. And the problem with them is that you actually start managing your CRS with steroids. So you have already a steroid cover on. You don't actually go through the CRS, you kind of manage that and at the end of the CRS, when you have maximal expansion of the T cell compartment and redistribution, that's when the ICANS build. And the problem with that is, is that if you have already actually had steroid onboard, actually, you have no tool left. So now you're basically managing the symptoms, but you can't really intervene in a proper way. And the problem with that is that the ICANS build up higher, much more intense. We're talking seizures and so on. These are not just walk-in-the-park type of adverse events. These are very severe. And then obviously get the normalized actual expense actually requires a very extended period of time. This binds, if you look at it from a hospital perspective, a significant amount of resources, it's not just a bed occupied. It's actually a lot of attention that you need to actually spend on these patients to manage them through. But the underlying issue that builds and it's a consequence of the management of the neurological toxicity is that this long, high-dose steroid use that you really have to keep going until the patient normalizes, actually creates a very severe level of immune suppression. With a lot of these patients get exposed to and they're certainly at a high risk is picking up infections. And you actually start to actually see death related to the therapy that are actually linked to the management of the ICANS. And actually, the ICANS typically still ongoing. So we have an ICANS/infection as the cause of death. So there's treatment-related mortality that builds as well. But the biggest issue when you think about it from a physician's perspective is if you have a patient that develops actually neurological toxicity, you can basically not predict which patients are going to get out of control. And that requires an enormous level of attention in terms of the management. And that's sort of the burden that you really see and clearly requires them for you to actually have the patient on the inpatient setting without question and to very, very carefully monitor that patient over an extended period of time, very different from what we believe Obe-cel will be able to do, which we believe for the most part, in particular, patients with not excessive tumor burden should be manageable actually in the -- on the ambulatory side as we're sort of building more experience with the product.

Rajan Sharma

analyst
#9

Okay. And as you think about kind of the evolution of the market and then obviously some CAR-T therapies in the initial indication already, how do you think about kind of relative importance of kind of the efficacy profile and the tolerability and safety?

Christian Itin

executive
#10

So two observations. The first one is when we just talked about the safety aspect. Safety matters because it's immediately experienceable for the center. The use of resources, tying down your capacity at the center is an economic impact, which is very, very palpable, and it's very challenging for the patients. That's immediate. That's out of the gate what you immediately experience. The real benefit that this is a long-term benefit that builds obviously, over time. The fact that we do have long-term persistence, we have seen that linked to long-term outcome before, I think, gives us a lot of confidence. It also gives you actually a way to look for the ability or the probability of a patient achieving a longer-term outcome because you can score the presence of the CAR T cells, and it can score for the presence of T cells. If you have CAR T cells present and B cells absent, you know that the CAR T cells you have in the body are active. And that gives the physician a lot of confidence just to wait and see. And we could see that even in our very early trials where, in fact, the first patient that we treated, adult patients with Obe-cel, got treated, achieved a molecular CR, immediately was put on advanced plant because that was at the time, the only thing you could do to transfer that patient into a long-term outcome. After that, once it was clear, "Okay, this product actually sticks around," the behavior changed. And in fact, we had actually very low levels of patients going on to transplant, because there is a way you can actually monitor these patients, you can observe, and you can make much more rational treatment decisions than it [ stream. ] There's also the other aspect, which is that a lot of these patients already had a transplant and doing a second transplant is a risky thing to do. And in fact, when you look at the longer-term outcome, the transplant itself actually does not translate in a longer-term outcome. So we -- so you have a longer-term follow-up. There's some very nice studies that looked up to 5 years, and it could basically show that the outcome after 5 years was basically equal, whether you transplant to do a second transplant or not. So in Europe, the tends not to be done. In the U.S., there's a bit more of second transplants are being delivered, but the treatment-related mortality is an issue, and you tend to only do that with the younger patients, fitter patients where you think that, that risk-benefit profile is more attractive.

Rajan Sharma

analyst
#11

Okay. And then maybe we could kind of touch on manufacturing. That's obviously a known issue, and we've seen kind of a lot of excitement in the CAR-T space, but that's always been the limiting factor. So could you maybe give us an overview of where you are there?

Christian Itin

executive
#12

I think it's really critical, because we're in an interesting spot, I think, in terms of the cell therapy where we are right now, because on the one hand, we have clinical trials that show at times quite spectacular outcomes. But on the other hand, we have a clinical reality which is that patients have a hard time getting access to the product. And this twofold issue -- the issue is sort of twofold. One is capacity. And the other one is that even if you sort of have access and you get your product, certainly, with some of the products, not all, but some of the products did have sort of a higher level of [indiscernible] specification. Now why does it matter? It matters because the patient when the product is out of spec actually cannot be treated on the commercial side. Patient needs to be moved on to a clinical trial or some form of an expanded access program, where you then actually have to deliver product noncommercially. And there's a big challenge actually when you do that and a lot of work [indiscernible] within the centers for each of those patients to be able to do that and collect data around it. So that's one aspect. But the core really is having not sufficient capacity or having a safety profile that confines the product into a very small number of centers that are in a position to manage it, which also limits access quite significantly. So those are kind of the fundamental issues. So what we did, obviously, from a design perspective is design a product with its very fast off rate that actually minimizes over activation of the CAR T cell. And because of that design principle we introduced, we actually get a very different profile from a toxicity perspective, persistence perspective and so on. Now on the manufacturing side, we did spend a very significant effort, making sure that the manufacturing process is very robust. So you have to imagine the study that we just conducted, which was 94 patients dosed. We had 112 patients enrolled. So we have 84 patients that actually presented the patients that got dosed in this trial. We were doing an environment where we had about as much pressure on every aspect of product supplies you could think of. We're manufacturing in the U.K., where in most of our centers are in the U.S. with air traffic down to 5% of normal. And that had a huge impact. Instead of 10 flights or 20 flights a day between the Greater New York area and London, you have one. A lot of other areas, you have maybe one or two flights per week. So huge issue on logistics. Big issue on the actual manufacturer itself, because our manufacturing teams which work and shift actually could not overlap. So a lot of challenges there to keep everything stable. Despite all of that, we manufactured actually within an out-of-spec rate of 6%. And we manufactured reliably, and we had a reliable turnaround time. When we presented the data at ASCO, we did something that was a bit unusual. We actually showed every single batch manufactured in the data that characterized the products. Now that's usually not done. Normally, you show your median and then a good statistics that keep the [ air bars ] pretty tight. We didn't do that. And we didn't do that, because the reality that we see in the clinic experience is that while the data may look okay in the clinical trials, it doesn't translate. And this is why we provided that level of transparency. So we spend a lot of time on the process itself. The biggest challenge in ALL is the fact that you can have patients that have an enormous amount of leukemic cells in the blood. And that creates a very, very difficult starting material, because most of the cells we collect are leukemic cells that you have to get rid off first. They also create an environment for your T cells that actually is not very helpful to the T cells you collect. And so you have to really make sure that you have a process that can cope with this very, very wide range of starting material and get a consistent product out. So that's where the effort went into. The other part is you need very robust analytics. And you need rapid turnaround, which is mostly on the analytics, not on the manufacturing itself. So that's actually the areas we invested in. And then the final part is capacity. And so for us to actually have capacity that allows us to go to 2/3 of the market opportunity, obviously, was critical.

Rajan Sharma

analyst
#13

Okay. And I mean you mentioned now that you are kind of manufacturing within the U.K. So could you maybe just kind of talk to the rationale around that?

Christian Itin

executive
#14

So the -- you need to operate these manufacturing processes in a way that give you, number one, the right quality, number two, gives you an economic scale. Quality is linked to people to a large -- to a significant extent. We have a semi-automated process, but people matter a lot. We actually did actually train up the manufacturing team in the U.K. set up a training center to do that. And that became a core part of the asset we built, which is an operation of about 200 people, all in, every asset included. And that is the foundation for the commercial manufacturing. So there's a lot of managing risk, making sure quality is where it needs to be. And then one of the peculiar things that we sort of figured out during the pandemic is that it was an advantage to sit actually on the other side of the Atlantic, because the flights that actually are moving back and forth the U.S. to the U.K. tend to actually have priority. So it actually gave us a more stable, much more reliable logistics that we could actually operate.

Rajan Sharma

analyst
#15

Okay. And then I guess in the [indiscernible], you kind of presented the medium vein-to-vein time and -- of 21 days, I think. So could you maybe just talk around the range that you saw there and the factors driving that? And then to your point, you kind of operate the trial in a pandemic environment. Kind of what kind of upside you could see to those numbers?

Christian Itin

executive
#16

Right. So we had 21 days in [indiscernible] median and the median was actually the distribution. When you looked at the data, again, we showed all of that in detail is very tight. So the range is between about [ 18 and 25 ] for the most part with, I think, 2 or 3 outliers. So it's a very tight in terms of delivery. The opportunity we have commercially is to actually substantially reduce time. And part of that is related to the arrangement that we announced with Cardinal Health, which gives us an ability to actually ship product into depot where we actually maintain control over the product while we're finalizing the release process, that cuts at least 3 days out. And then we implemented a more rapid release analytics towards the end of the trial, which also will allow us to cut on average about 2 to 3 days. So we expect to be in the range of about 60 days commercially to start out with.

Rajan Sharma

analyst
#17

Okay. And I guess the other piece of the manufacturing is obviously kind of costs and gross margin. And how are you thinking about that?

Christian Itin

executive
#18

That was an important part in how we set up the manufacturing from the get-go. And one of the key things in this space, of course, is that you can't basically get your margin down or your costs down by increasing scale, because there's only the same amount that you basically be delivering to each one of the patients, so you can't just scale up and have a big volume and make basically create economies that way. The way you have to create economies is by having an ability to parallel process a large number of products. And that payroll processing to enable that, what you need to sort of think about is have an ability to do that with form of automation. So the current setup that we're using is built on Miltenyi Prodigy machines. We're using a semi-automated manufacturing process. And that actually allows us to reduce the amount of labor that we have to put in quite significantly. And in fact, as soon as we're getting closer to scale, actually labor is not anymore a significant driver of cost. It is mostly the actual materials that we use as well as some of the onetime-use [ batches, ] et cetera, that are sort of required to do this manufacturing. And then the other aspect is, of course, the actual analytics and the ability to multiplex and automate the analytics as well, which is the other key area. All of that allows us to actually be able to be in the range of 15% cost of goods or below.

Rajan Sharma

analyst
#19

Okay. And then just on capacity, and you kind of mentioned that your -- the expectation is that this kind of 2,000 patient batches with your current facility. And I think previously you've talked to a total opportunity of around 3,000 patients. So is that sort of how you're thinking about the penetration and the commercial potential of Obe-cell?

Christian Itin

executive
#20

We think actually to increase capacity is something that we're probably going to get to either with moving the product up to line or starting to add additional indications where that becomes, I think, relevant. The facility itself has some follow space. So we actually have more capacity, more room to build out, which gives us actually quite an increase in capacity. And the other aspect is that indications other than ALL, we can manufacture a process that actually is shorter. And so you actually get more units per time that you can actually run for each machine that you're running that actually increases your capacity in of itself. So 3,000 is very comfortable, and there is quite a bit of an upside to it. And the facility is set up to actually have the space to have an adjacent and ultimately, connected second part of the facility that can be put up, which is already part of the original plan. The manufacturing facility itself is modular in build. And it was designed a model a way to really increase the speed at which we could sort of get it into operation. We started with this product -- this build greenfield in November '21. We actually had the first clean room in operation November '22. And we have the capacity challenge completed end of May or about 18 months after we had basically the start on the site from a building perspective. So it's a very rapid build, could only be done with a highly modular approach. We did choose that it did actually test that, that type of approach, because also will allow us to actually replicate the facility elsewhere and also actually replicate the actual operating model elsewhere. And so it actually will allow us to build capacity as we need.

Rajan Sharma

analyst
#21

Okay. And then in terms of just kind of thinking ahead to kind of a potential launch for oversell, what is kind of the health economics argument? And will that be kind of a potential focus of the work that you use to kind of launch the product?

Christian Itin

executive
#22

So in order to sort of get ready for launch, the sort of 3 key streams of activity. One is [ HDA ] dossiers, value proposition as you're asking. The second is around the onboarding of the centers. And the third is around medical affairs and making sure there is the level of awareness for the program. Those are the key activities we're currently engaged in. The onboarding will start as we get through the middle of the year, and we'll get into high gear at that point in time. We've done a lot of the work on the value dossiers, and I think that the value proposition is really sort of in at least two dimensions. One is the fundamental opportunity to generate outcomes, particularly also longer-term outcomes. The other aspect is actually the ability to manage the product with substantially less effort than what we're seeing with other types of products, whether this is bispecifics or CAR Ts in this particular indication. And that actually is in of itself a very significant part of the value proposition. So it's the intrinsic one in terms of the outcome for the patient, but it's also the resource use and the costs related to resource use where we think we're going to have a significant edge.

Rajan Sharma

analyst
#23

Okay. And then you talked about kind of additional capacity may be required in if you were to kind of go into other indications with Obe-cel. And we've heard a lot from other developers about the potential of CAR T in autoimmune disorders, for example. So could you maybe just talk through your thoughts around that?

Christian Itin

executive
#24

Sure. I mean it's -- first of all, the data is quite remarkable that the German team developed in [indiscernible]. And they've done really a true pioneering study with probably the most spectacular outcome that I think I've seen in a long time in an early clinical study. It's a really good team. We know the team for a long time. Part of also worked in part the [ Obe-cel ] side, the development with that team as well. So the data, we think, is real. And I think there's a real opportunity for what looks like to be potentially transformational outcomes. When it comes down then to, in my view, two factors. One is you have to have a safe product. And number two, you have to be able to make it, and you make it reliably. And those are the two key things that you need to be able to, I think, be successful in that space. And what's becoming interesting is obviously that the principle of sort of taking that significant part of the B cell compartment out, and with that resetting at least B-cell mediated or predominantly B cell-mediated autoimmune disease, appears to be extending beyond lupus where the [indiscernible] data was coming from and is likely much more broadly applicable. And I think that creates a very interesting opportunity for the field in general, but I think particularly for products like Obe-cel. I think, very attractive opportunity going forward.

Rajan Sharma

analyst
#25

Okay. And when might you think about kind of potentially doing some work with Obe-cel in autoimmune disorders? And I guess the second is kind of a 2-pronged question, is that piece being: Would it be something that you would do alone? Or would it make sense to license or partner?

Christian Itin

executive
#26

I think there's opportunity, obviously, when we think about the broader range of utility of Obe-cell, we have some really nice data non-Hodgkin's lymphoma across the range of non-Hodgkin's lymphoma. Very nice data also obviously in pediatric patients. But then, I think, a fantastic opportunity, I think, as well in -- for autoimmune. So I think there's a lot to do with Obe-cel. And it's certainly one of the areas we're looking into and whether it makes sense for us to actually enter into some form of a partnership to, frankly, put more capital behind the program and develop it much more broadly and more quickly.

Rajan Sharma

analyst
#27

Okay. On the topic of capital, can we you've kind of discussed cash horizon? So you obviously did the kind of equity raise with the FELIX top line back in December. Could you just kind of give us an idea of where you are right now and where you think that takes you kind of from an operational perspective?

Christian Itin

executive
#28

Right. So at the end of Q1, we ended with $340 million in cash. The guidance is that this gets us well into 2025. And that is unchanged, the guidance around that, with a targeted BLA filing by the end of the year.

Rajan Sharma

analyst
#29

Okay. So would that provide enough liquidity to kind of launch Obe-cel or [indiscernible]?

Christian Itin

executive
#30

I think it allows us to really get the product ready for launch and initiate. Clearly, to get all the way to profitability, there's probably additional capital needed at that point, at a later point in time.

Rajan Sharma

analyst
#31

Okay. And then additional kind of CapEx from a manufacturing perspective, is there anything that we should be aware of in the near term?

Christian Itin

executive
#32

Not significant, because most of the CapEx actually investment, we already have made, because it was a prerequisite to be able to actually get the facility into operation. So from a CapEx perspective, we think we're in good shape, more of it when we think about the cost received more from the CapEx and the clinical trial-related costs over to the launch cost. So there's some transition there but reasonably steady in terms of the actual cash needs over time.

Rajan Sharma

analyst
#33

Okay. And conscious that we're into kind of the last 2 minutes, but if we could just touch on the wider pipeline beyond Obe-cel. What are you kind of particularly excited about?

Christian Itin

executive
#34

I think, first of all, we've basically generated the life cycle program to Obe-cel already and have regenerated, which is dual targeting program, CD19, CD22, we're building on obe-cel with a highly potent CD22 component, proven that it actually in patients that are ineligible for Kymriah that we get very high levels of activity. And we're also active in kids that have [ lost ] CD19 antigen surface of their leukemia. So really nice proof of concept, very significant opportunity there also to consider into indications outside of ALL as well. Second T-cell lymphoma, we're back to present additional follow-up on the T-cell lymphoma program, AUTO4, at the Lugano Lymphoma meeting, which is happening this week. And then we're getting -- we're in the clinic with a multi-myeloma dual targeting approach. We expect first data at the end of the year, working on that with UCL. And we're also working with UCL, expect to have our solid tumor program, AUTO6 in neuroblastoma get back into the clinic now in Q3. And that's kind of an interesting one, because we have a number of the cell programming modules we've developed the last few years actually integrated into that program. So it will be a very important program to really evaluate sort of where, frankly, CAR-Ts can go, beyond the hematology indications where we know they're highly active in.

Rajan Sharma

analyst
#35

Okay, brilliant. With that, I think we're exactly up to time. So well timed. Christian, thank you very much for joining us.

Christian Itin

executive
#36

Thank you. Thanks for your time, and thanks for those of you who listen. Thank you.

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