Hello, ladies and gentlemen, and welcome to the Autolus Therapeutics Third Quarter 2020 Financial Results Conference Call. As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Dr. Lucinda Crabtree, Vice President of Investor Relations. Please go ahead..

Christian will provide a brief introduction, and that will be followed by our operational highlights for the third quarter of 2020. Andrew will next discuss the company's financial results, and then Christian will conclude with upcoming milestones and other concluding comments. And of course, we will welcome your questions following our remarks.

So with that, I'd like to turn the call over to Christian..

first, a very high level of antileukemic activity to cope with the rapid growth of the leukemic cells in the bone marrow; second, very long persistence to put long-term pressure on the leukemia and get to a transformational outcome; and third, a tolerable safety profile, which is particularly important for elderly patients.

In terms of the market opportunity within the U.S. and the top 5 European countries, approximately 3,000 patients every year reach the end of their treatment options having failed chemotherapy and stem cell transplant and often also blinatumomab or inotuzumab, therefore, requiring other options. Slide 8.

From our Phase I experience, we see that AUTO1 is about 2x as active as blinatumomab, the standard of care for these patients, while maintaining a comparable safety profile. At EHA, we could show first patients who reached 18 months in molecular complete remission without receiving a transplant. Data at ASH will provide a longer follow-up.

Currently, there are no CAR-T therapies approved for adult ALL, and we think we have a very significant opportunity with limited competitive pressure in this high medical need setting. So based on this data, turning to Slide 9, we have started enrollment into the pivotal program, AUTO1-AL1, in adult ALL.

As a reminder, the study has a Phase Ib running, and the pivotal program comprises a single-arm study of approximately 100 relapsed/refractory patients. The primary endpoint is complete remission rate and secondary endpoints include molecular complete remission rates, event-free survival and duration of response.

We're targeting data by the end of '21, assuming no COVID disruptions to clinical trial conduct. Finally, on Slide 10, I wanted to highlight the broader potential of the AUTO1 franchise. In collaboration with our academic partners at UCL, we're exploring AUTO1 across other B-cell malignancies.

Exploratory studies include primary CNS lymphoma with a planned study start in Q4 this year as well as obviously AUTO1/22 in pediatric ALL. Let's now turn to Slide 11, where I would like to switch gears and talk about AUTO3, a program that is designed for the treatment of patients with diffuse large B-cell lymphoma.

DLBCL is the largest NHL indication with approximately 10,000 patients in last-line setting with a very high medical need. Two CAR-T products are approved, Yescarta and Kymriah, plus liso-cel, or otherwise known as JCAR-17, is pending approval. AUTO3 is a dual targeting CAR-T product designed to minimize the risks of relapse due to antigen loss.

In addition to the unique molecular design of AUTO3, we're also using a short cover of pembrolizumab to counteract PD-L1 mediated checkpoint inhibition as a second potential cause of relapse. On Slides 12 and 13, as reported at ESMO, AUTO3 showed a high level of complete remissions, combined with very favorable safety profile.

Across all those cohorts, the overall response rate was 68%, and the CR rate was 54%. Both cytokine release syndrome and neurotoxicity rates are low across the study. In patients achieving a complete remission and despite robust CAR-T expansion, no patient had experienced any neurotoxicity or high-grade cytokine release syndrome. Turning to Slide 14.

Combining a high level of clinical activity with a good safety profile is particularly important in diffuse large B-cell lymphoma as the vast majority of patients are treated outside of centers of excellence and mostly in outpatient setting.

In contrast, over 70% of all patients receiving CAR-T products in 2019 were treated in only 17% of the accredited centers of excellence certified to administer these therapies. This concentration on such small number of centers illustrates how very underpenetrated the DLBCL market is with CAR-T therapies.

Also, Medicare patients make up a large portion of the DLBCL patients. However, less than 13% of patients treated are on Medicare due to the reimbursement challenges in the part A side. All in all, you can see this creates a significant opportunity for AUTO3 to provide a solution here. So let's turn to Slide 15.

As a reminder, the ALEXANDER expansion cohort is designed to further assess the feasibility of AUTO3 use in the outpatient setting. As I have mentioned, we expect to provide efficacy and safety data from patients treated in our outpatient core at ASH as well as an update across the completed other cohorts. Turning to Slide #16.

As we have discussed, AUTO3 is the first-in-class CD19, CD22 dual targeting CAR designed to combine a high level of clinical activity with a good safety profile for potential use across all settings of care.

Finally, on Slide 17, I would like to remind you of the broader pipeline of the next-generation programs we're proud to be developing at the company. Most of the programs are set to move into first clinical trials in 2021.

The first is our AUTO1/22 dual targeting program, building on the strong pediatric data for AUTO1 and addressing CD19 antigen loss-driven relapse in pediatric ALL. With that, I will turn over the call to Andrew for the third quarter 2020 financial update.

Andrew?.

Thanks, Christian, and good morning or good afternoon. So we're on Slide 19, and it's my pleasure to review our financial results for the third quarter to September 30, 2020. So starting with our cash position, unrestricted cash at the end of the quarter totaled $177.7 million, and that compares with $212 million at the end of June of this year.

Net total operating expenses for the 3 months ending 30 September 2020 were $42.7 million, and that is net of grant income of $400,000 and also license revenues of $200,000. That compares to net operating expenses of $35.6 million, net of grant income of $300,000 for the same period in 2019.

Research and development expenses increased to $33.5 million for the 3 months ended 30 September from $27.3 million for the same period last year. Cash costs, which exclude depreciation and amortization as well as share-based compensation, increased to $30 million from $21.6 million.

The increase in research and development cash costs of $8.4 million consisted primarily of an increase in compensation and employment-related costs, that's net of actually lower travel costs as a result of the ongoing pandemic of $1.5 million, and that's due to an increase in employee headcount to support the advancement of our product candidates in clinical development; secondly, an increase of $3.6 million in project expenses as a consequence of the advancement of our clinical portfolio, and that includes research and process development, manufacturing activities necessary to prepare, activate and monitor clinical trial programs; thirdly, an increase of $2.1 million in facility costs related to the commencement of a lease for a manufacturing facility and the continued scaling of our manufacturing operations; and fourthly, an increase of $1.4 million in IT infrastructure and support for information systems that's related to the conduct of clinical trials; and fifth, an increase of $0.8 million related to cell logistics; and finally, an increase of $0.4 million in license fees, which is offset by decreases -- all that's offset by decreases in material purchases of $1.3 million.

Noncash costs decreased to $3.5 million for the 3 months ending 30 September from $5.7 million for the 3 months ending 30 September 2019.

This decrease is primarily related to share-based compensation expense that's included in research and development expenses, which decreased by $2.5 million as a result of the lower fair value of stock options recognized in the period, and this was offset by a $300,000 increase in depreciation.

General and administrative expenses increased to $9.8 million for the 3 months ended 30 September from $8.6 million for the same period last year. Cash costs, which again exclude depreciation expense as well as share-based compensation expense, increased to $7.7 million from $5.6 million for the corresponding period last year.

There was an increase, firstly, of $1 million in commercial activities; an increase of $700,000 in patent and legal fees and audit fees and other costs that -- as a result of being a public company; and thirdly, an increase of $300,000 in compensation and employment-related costs due to an increase of headcount.

Noncash costs decreased to $2.1 million for the 3 months ended 30 September 2020, and that's from $3 million for the corresponding period last year. That decrease is also attributed to a share-based compensation expense as a result of the lower fair value of stock options recognized during the period.

Interest income decreased by $0.5 million for the 3 months ended 30th of September 2020 due to lower interest rates that -- on cash that's held on deposit. Other expense income decreased by $5.8 million for the 3 months ending 30 September from other income of $3.3 million for the 3 months September 30, 2019, to another expense of $2.5 million.

This was primarily due to a decrease of $7.1 million with regard to the weakening of the U.S. dollar exchange rate relative to the pound during the 3-month period, and this is offset by lease termination gains of $1.3 million.

Income tax benefit increased to $7.9 million for the 3 months ending 30 September 2020 from $4.6 million for the same period last June, and this is due to increased research and development credits.

As research and development credits grew at a faster rate than our net loss before income tax, this led to a higher effective tax rate attributable to these losses.

Research and development credits are obtained at a maximum rate of 33.35% of our qualifying research and development expenses, and the increase in the net credit was primarily attributable to an increase in eligible research and development expenses.

Finally, net loss attributable to ordinary shareholders was $37.3 million for the 3 months ended 30 September 2020, and that compares to a loss of $27.2 million for the same period last year.

The basic and diluted net loss per ordinary share for the 3-month period this year is $0.72 compared to a basic and diluted net loss per ordinary share of $0.61 for the 3-month period ending 30 September 2019. And consistent with previous guidance, the company still anticipates that cash on hand provides a runway into 2022.

And with that, I will now hand the call back to Christian to give you a brief outlook on expected milestones.

Christian?.

Thanks, Andrew. Let me conclude this part of the management discussion with a review of the upcoming milestones and news flow through the remainder of 2020 and in 2021. Let's move to Slide 21. As we look at the rest of 2020 and into 2021, there are multiple clinical milestones and opportunities for value creation.

Our chief and most imminent operational focus will be on continuing enrollment in dosing of patients in the potential pivotal Phase Ib/II trial for AUTO1 in adult ALL. We expect to report clinical data on the AUTO3 ALEXANDER trial at the forthcoming ASH Meeting and to further update from the AUTO1 ALLCAR19 study.

AUTO4 data updated in PTCL is planned for 2021. In Q4 2020, we'll also look to progress AUTO1/22, our next-generation program for ALL, into Phase I clinical study in the pediatric setting, together with our academic partner, UCL.

In the first half of next year, we expect our next-generation multiple myeloma program, AUTO8, to enter the clinic, and we also expect to progress in the same time from our first allogeneic program into a first exploratory trial with our academic partners.

In '21, we will look to progress a number of other preclinical candidates to a point of Phase I readiness, including AUTO5 and our solid tumor programs, AUTO6NG and AUTO7, all of which we had recently updated you on at AACR. In conclusion, on Slide 22, I'd like to recap the major messages from today's call.

AUTO1, our first pivotal program, started in Q2 as planned. Given the positive safety and efficacy profile today, we believe that AUTO1 has the potential to be a best-in-class CD19 CAR-T in adult ALL, a disease setting with a very high unmet need. We'll have an update from the old CAR clinical study at ASH in early December.

Second, AUTO3 and DLBCL will have an additional clinical data update from our ALEXANDER study at ASH as well. The company is in good position, and combined with a cash on hand of $178 million, we feel we're well positioned for success. We're now happy to take questions..

[Operator Instructions]. Your first question comes from the line of Jim Birchenough from Wells Fargo..

Yes. Congrats on all the progress. I guess a couple from me. Just first, starting with AUTO3.

Christian, could you maybe remind us of your view on what profile would support outpatient use? Is there a certain time course to fever a certain level of CRS, an ability to discern CRS from other causes of fever? Just as we go at ASH, just interested in your perspective on what would support an outpatient offering..

Jim, thanks a lot for joining, and thanks for the question.

I think the most important aspect of the outpatient core is that we're replicating the safety profile that we have seen in our inpatient population because, obviously, that would give us a lot of confidence around the management of the patients and the consistency of the data, both in the outpatient setting compared to our current experience with the program.

And that is ultimately the most important element. For those patients that will -- for those patients experiencing an admission, obviously, we're interested to understand the time of admission, but then also the duration of the admission to understand actually what's driving that and what the impact is in the setting.

So those are the key parameters that we're looking for. And really, the core is to really make sure and be clear that we can replicate the data that we have seen before in the outpatient setting, which is really the foundation for the program to be positioned in the outpatient setting..

Great. That's helpful. And maybe just -- maybe for yourself and Andrew as well, just on comments around the supply chain as we go through COVID. It sounded like any disruption, if there would be any, would be around transport of the cells.

But are there other points of risk to the supply chain that you see? And maybe update us on progress towards expanding the manufacturing and -- both in terms of ability to supply the market and maybe diversifying across countries..

Yes. It's a very good question. Obviously, the infections can actually have impact at several levels.

What we have seen in spring is that we have centers that were basically at -- frankly, at some of the epicenters at the time of the epidemic, particularly in New York City, but also in London actually got to a point where they could no longer admit patients. They could not continue to care for patients. In New York, it was relatively short.

It was a few weeks. In London, actually, it stretched out substantially longer than that. So there is a risk that the centers that get overwhelmed or the areas that get overwhelmed with infections get to a place where they basically can no longer care for patients that have need of transplant and that have need of a CAR-T therapy.

So that is sort of the extreme end of the range of issues that you can run into that literally the centers cannot continue to operate, and that certainly did happen in spring.

As I mentioned, the way we could actually mitigate that risk and still continue to enroll was that we had other centers, particularly at the sites in the U.S., that actually were not impacted at all, and we could continue to enroll in those centers. So that's really managing kind of the navigating basically the hotspots.

Now obviously, as I indicated in my remarks, the situation is a bit more complex at this point from that perspective because we don't have just individual hotspots, we have a much more spread distribution of the infections, and we have to see kind of how the centers will cope.

On the positive side, obviously, a lot of the centers have learned an enormous amount about the patient management. And with that, we are, I think, in a much better position to cope with the infections and with the patients coming in. So that's one level. The second level is really around the logistics aspect.

And one of the things that we have seen certainly in spring, and we're clearly seeing it across Europe at this point but also in the transatlantic routes, is a massive reduction in available planes that are actually on a regular basis actually shuttling back and forth.

The level of reduction we've seen across the Atlantic at the peak of the first -- at first peak of the pandemic was in the single-digit range of what normal actually volume would be.

And that obviously has an impact on the number of flights that you have between destinations, and with that, obviously, the logistics becomes a much more important aspect to manage that and make absolutely sure you're going to get on those limited flights that are available, and we've managed to do that.

But it is something that you have to have a keen eye on. And when we look into the airline, a lot of the airlines, I think, are in a much weaker position than they've been, frankly, a few months ago, having been depleted of a lot of the resources and cash frankly over the last few months.

And then the final bit is with regards to the actual manufacturing operations. I think we've been able to navigate the pandemic in a remarkable good way with an enormous effort of our team on the manufacturing side to continue to operate and actually maintain and sustain a robust operations throughout the entire period.

And that's, obviously, all those principles we developed and all the processes we developed to sort of be able to do that actually continue to operate and certainly will continue to operate through the upcoming months as we get into -- probably into late second quarter of next year. And so from that perspective, I think we've been able to cope well.

But there are certainly risks if there is a very high frequency of infections that would actually occur in the area where we are manufacturing, that, that could eventually have an impact on, frankly, the workforce. That's something that's hard to predict at this point. I think we've been able to manage that very well last time around.

And obviously, we do everything and we apply everything we learn to make sure that we continue to do that. In terms of diversification of manufacturing base, that is obviously something that we're working on in a longer time frame. And obviously, we are planning to build up operations certainly for commercial supply in the U.S.

But in the short term and to deal with the current environment, we will not be able to sort of have a second site up and running to sort of cope with potential impact on the current manufacturing infrastructure..

Your next question comes from the line of Chad Messer of Needham & Company..

This is Gil on for Chad. And congrats on the progress. Just a quick one on -- all right. So we spoke about the data that's going to be presented at ASH from the outpatient cohort.

Is there any guidance about how many months post-treatment of these patients will be reported at?.

We haven't specifically guided on that, but it is -- what we, obviously, did do is we communicated that. That cohort started after ASCO. So it is actually a limited follow-up that we have on those patients. And we will not have the full data set for ASH as we're still actually managing patients and are finishing the dosing of the cohort..

All right.

And on your other programs in solid tumor and AUTO8, should we expect any additional preclinical presentations to be coming on in the next few months?.

Well, I think there's opportunity for the conferences next year to present additional information as well as opportunity for the, basically, publication of nonclinical data in peer review journals as well. I think both opportunities are there for the upcoming months and throughout, frankly, 2021..

And kind of lastly here, do you guys have any thoughts about the difficulties that we're seeing with some of the allogeneic programs that are currently ongoing? And how would that contrast with the programs you have planned?.

I think it's very difficult to answer that, Gil. I mean we've, obviously, also seen what everybody else has seen. It's information on a small number of patients. I think it's really hard to interpret. And I think we just have to see what the data releases actually are at the conference.

And I think, at that point, I think, everyone will have a better understanding of what the challenges are that the companies are dealing with. It's difficult to read at this point..

Your next question comes from the line of Gabriel Fung of Mizuho Securities..

The first question here is that, is there any chance that we could receive any more updates from CARPALL assessing AUTO1 in pediatric ALL? And are there any learnings here that you have transferred to the next-gen trial that you just started?.

We're not going to have an update, obviously, on CARPALL at ASH. But obviously, a significant part of the data has been published in the Nature Medicine paper. I think the key learning from the CARPALL study has been sort of several fold.

The first is, obviously, the product has a very significant level of clinical activity, very high molecular complete remission rate, combined with a good safety. We didn't have high-grade cytokine release syndrome in the kids, which is very different from the experience with other programs. And we had exceptional persistence.

At ASH last year, we could show that we can actually see circulating CAR-T cells after 3 years after dosing, and those -- and in fact, in numbers, that allow you to actually analyze them by facts and understand kind of what the composition of the product is after 3 years. So a very unusual profile.

But what we also did see that for those patients that were unfortunate enough to relapse that, actually, 80% of those kids had relapsed with CD19 negative disease.

And so what we're aiming to do with the AUTO1/22 program is building on these exceptional properties of AUTO1 with this very unusual level of persistence and add to that an optimized CD22 chimeric antigen receptor so that we can actually minimize the risk of antigen loss-driven relapse in those children.

So those are -- I think that's -- in a nutshell, I think, are the key learnings that we have from the study and frankly what informed the design of the next-generation version of the product for kids..

Great. And another question here on AUTO5.

And when, in particular, are you looking for in the AUTO4 interim that would prompt the green light for the AUTO5 clinical trial?.

Well, we're obviously working through the nonclinical work for AUTO5. Obviously, we didn't start at the same time with the 2 programs. We had AUTO4 first and then we're engineering the AUTO5, and we share some of the information, particularly around the way we generated the particular binder for AUTO5 at the AACR meeting in the middle of the year.

So that program is actually running at this point, not dependent on the progress of the AUTO4 program. But we're looking to catch up as much as we can with the AUTO5 program..

Awesome. And just one really last -- quick last one.

On the allogeneic program, I'm just wondering whether -- would you be able to disclose what the source of the cells would be there?.

We will do that when the study is up and running and we're introducing the study at that point in time..

Your next question comes from the line of Matt Phipps of William Blair..

It's Hunter [ph] on for Matt. I was just wondering if you could give us an idea of how many patients we'll see data for here coming at ASH, and then any color on what the next steps will be for AUTO3 coming out the other side of ASH..

Yes. Well, thanks a lot for joining. And with regards to the update, obviously, that we're going to give at ASH, it obviously is over and above what we have presented at ESMO, where we presented the recommended Phase II dose cohort with a bit longer follow-up as well.

What we're doing now with [indiscernible] is obviously enroll patients into the outpatient cohort, and we're going to have somewhere in the range of about 10 to 15 patients worth of data over and above of what we have been able to present at ESMO.

And then with regards to kind of the path into next year, obviously, one of the key decisions is going to be based on that data is then actually the design of the next study. And I will be -- we'll inform on that at the appropriate time..

Your next question comes from the line of Graig Suvannavejh of Goldman Sachs..

I've just got a couple. One, I noticed the latest update on AUTO8. That study was moved to the first half of next year. Just wondering if that's just COVID-related, logistics-related, anything else beyond that. My second question has to do -- competitive landscape in DLBCL.

We just saw J&J and Genmab take a bispecific CD3, CD20 into a Phase III for refractory DLBCL. And so I would love to get your thoughts on, if not that particular program, but CD3, CD20 bispecifics in DLBCL. And then my third question actually is for Andrew.

Andrew, you've got a lot of programs that are moving into the clinic in 2021, and some study starts in fourth quarter this year.

So as we're thinking about R&D, and while I don't anticipate you giving formal guidance for 2021, but can you just give us a sense of kind of R&D spend from this point going forward versus what we've seen previously?.

Thanks, Graig. Appreciate it. So the first question was related to AUTO8. That program, we initially expected to be able to get going before the end of the year. That will happen now beginning of next year. It is in part related to kind of the impact that COVID had middle of the year at our academic partner.

It took -- a few weeks basically were lost in the process. And I think we're in a good place now in terms of catching up time. So not a significant change from where we look at the program.

The second question related to the bispecifics and T-cell engagers, in particular case, CD20, CD3 T-cell engagers, are obviously a whole series of programs with Genmab. You got Regeneron, you got Benitec, you got others as well.

I think what we've seen across all of these programs is the sort of single-agent activity in the range of about 20% CR rate that then actually were combined with other modalities to sort of increase the activity. I think what we see is clearly activity. The durability, I think, is still something that needs to be -- we need to see.

And in fact, there's more information required. But it's an active therapeutic modality, there's no question about it. But it also seems to be not quite at the level in terms of activity of what we can see with the autologous CAR-T programs.

So a relevant modality, a modality that also will be -- is in competition with the CD19 ADCs as well that are also moving into the space, all having very similar types of outcomes. And I think there's going to be a range of opportunities in that range of activity.

As far as we can tell at this point, there is a difference -- still quite a significant level of difference in terms of the outcome if we compare to the autologous CAR-T programs at this stage. And then the final question was related to the R&D expenses.

I think one of the important things is, as you'll see with our earlier pipeline, is that we're collaborating quite extensively with academic institutions to run the early part of those trials.

It actually allows us to manage the R&D expenses in quite a significant way so that the key investments that we're making by sort of a vast margin are going into the late-stage trials.

Maybe, Andrew, do you want to continue on that?.

Yes. No, I can, Christian. But I think you've hit sort of the nail on the head there, which is the use of academic programs to manage expenditure through the early part of these studies. So R&D expenses will obviously increase.

But there's an element that we've seen through sort of '19 and '20 that there's sort of an establishment sort of cost in the -- particularly in terms of the manufacturing side of things that effectively then gets -- as that sort of comes down, obviously, the trial expenditure sort of goes up.

So there will be an increase sort of through, particularly sort of the middle of next year in terms of -- when you look at Q2, Q3, but then it probably starts to come down a little bit in Q4. So we're still confident that the statements that we make in terms of cash runway, we'll have cash into '22..

And our final question comes from the line of Kelly Shi of Jefferies..

I will continue the question regarding the outpatient setting cohort. And what type of data would support a pivotal trial? For example, do you set a threshold on certain proportions of like patients for readmission or getting into ICU? And also a related question regarding the tox profile of AUTO3.

Do you see the pattern of CRS on your tox occurrence differentiated from other CD19 CAR-Ts? For example, have you observed the laydown side of CRS and the Neurotox? And also what's the middle duration of each toxic now?.

Thanks, Kelly. Thanks for the questions. The -- in terms of the outpatient cohort, as I indicated to Jim's question as well, is really to demonstrate that we have -- that we can replicate the adverse event -- safety profile that we've seen in the inpatient cohort as well so that we can basically show that behavior of the product is the same.

Whether we're treating the patient inpatient or outpatient, we see the same manifestations.

Now one of the important things with regards to the toxicity profile of the program is that when we look at patients that are responding to CAR-T therapy, so get into complete remission, those patients tend to have a lot of CAR-T expansion, and that is actually where you see with most other programs a significant level of adverse events directly related to the CAR-T expansion and the activity of the CARs in those patients.

Surprisingly, that is actually not what we're seeing. When we look at those patients that are actually achieving a CR, we don't see actually that they develop neurotoxicity. They have no neurotoxicity that we have observed. And they also have limited cytokine release. They have no high-grade cytokine release that we've observed so far.

And that, I think, is important because it gives us a profile that is actually quite remarkable in terms of the CAR-T mediated adverse events. Obviously, these patients do have all sorts of adverse events that's disease-related. But those are obviously shared across any therapeutic modality you'd be applying to these patients.

So when it comes to the specific CAR-T-related adverse events, we believe that our profile is remarkably good and give us a lot of opportunity and room. And so from an outpatient perspective, obviously, we want to see that replicated. Obviously, if there are admissions, we're obviously interested in what are the reasons for those, the duration of it.

But also, obviously, what is important is get an understanding whether those patients need it, any form of intense management. And clearly, that is sort of the key challenge when you think about these patients out, when they have to get admitted, if you actually have to have ICU access.

That is actually a much more significant burden on the respective institution than if you just actually have to do an antibiotics or prophylaxis just to manage patients and be sure that there is no infection ongoing. So I think those are the parameters that we're looking at.

And obviously, we want to see that, in fact, we can replicate the adverse event profile, but also that if there are reasons for admission, that those admissions actually are relatively short and also do not require an ICU intervention..

It's very helpful.

May I have a follow-up question that regarding -- as the CAR-T space -- the competition in CAR-T space is actually heating up, especially in the cell B setting, do you have plan to moving AUTO1, AUTO3 into earlier lines of therapy?.

I think with every oncology indication, I think you'll start at the back end of the disease, and you work your way up towards the earlier lines of therapy. And that is certainly what we would intend to do, both in the ALL setting, but also in a DLBCL setting.

But the first thing to establish is establish yourself in the last-line setting and then actually move from there.

Obviously, as you go up into earlier lines of therapy, you're also, at that point, you're moving and basically have to demonstrate activity and profile against the established standard of care so the nature of the trial start to look different and the time it takes to conduct the trials also tends to increase versus the third-line setting.

And that's also one of the key reasons why you start in third line, to establish yourself and then actually move from there..

There are no further questions at this time. I would now like to turn the call back over to Christian Itin, CEO, for any additional or closing comments..

All right. Well, thank you very much. Thanks all for joining. We appreciate -- this is an incredibly busy season, particularly with the overlay of the ASH abstract coming out and a lot of them released quite a bit early. So appreciate your taking time for the presentation today, and we'll give you an update, obviously, when we get to ASH.

Thank you very much. Bye-bye..

Thank you. That does conclude today's conference call. You may now disconnect..