Earnings Labs

Autolus Therapeutics plc (AUTL)

Q3 2021 Earnings Call· Wed, Nov 3, 2021

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Transcript

Operator

Operator

Hello, ladies and gentlemen, and welcome to the Autolus Therapeutics Third Quarter 2021 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, Business Strategy. Please go ahead.

Dr. Lucinda Crabtree

Management

Thank you, Daniel. Good morning or good afternoon, everyone, and thank you for joining us to take part in today's call on the financial results and operational highlights for the third quarter of 2021. I am Lucinda Crabtree, Vice President of Business Planning and Strategy. With me today are Dr. Christian Itin, our Chief Executive Officer; Christopher Vann, our Chief Operating Officer; and Andrew Oakley, 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. All statements other than statements of historical facts on this call are forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the section titled Risk Factors in our annual report on Form 20-F filed with the Securities and Exchange Commission on March 4, 2021, which can be accessed on the EDGAR database at www.sec.gov, and in subsequent filings we make with the SEC from time to time. The forward-looking statements on this call reflect the company's views as of today, November 3, 2021, regarding future events and should not be relied upon as representing the speakers or the company's views as of any subsequent date. While the company may elect to update these forward-looking statements at some future point, the company specifically disclaims any obligations to do so even if the company's views change. These forward-looking statements should not be relied upon as representing the company's views as of any subsequent date to today. Please be advised that today's call is being recorded and webcast. So on Slide 3, you will see the agenda for today, and it is as follows. Christopher will provide an overview of our operational results for the third quarter of 2021. Andrew will then discuss the company's financial results before Christian will conclude with upcoming milestones and any other concluding comments. Finally, we will, of course, welcome your questions following our remarks. Turn to Christopher.

Christopher Vann

Management

Thank you, Lucinda, and good morning to you all. Thank you for joining us. It's my pleasure to review our operating progress for the third quarter 2021. If we move to Slide 5, I'd like to give a quick update on the key pipeline activities. And first of all, our multicenter FELIX study for our lead program, obe-cel, which is progressing very well. Enrollment in the Phase II portion of the study is on track. And consequently, we are reiterating our guidance that the primary endpoint data will be delivered in the middle of next year with the full pivotal data available by the end of 2022. Furthermore, we are pleased to be in the position to update you that the initial observations from the 16 patients in the Phase Ib running portion of this multicenter Felix study, where we observed the 1-month complete response rate and safety data, are so far consistent with the data reported from the academic ALLCAR study of over cell in relapsed/refractory adult acute lymphoblastic leukemia. Clearly, this is very encouraging, and we plan to present this early data from the Phase Ib cohort later this year at ASH. In addition, we also expect to update you at ASH on additional data from the ALLCAR19 extension study of obe-cel in indolent B-cell non-Hodgkin's lymphoma indications as well, as the first early clinical data from the CARPALL extension study, which is evaluating our next-generation product, AUTO 1/22, in pediatric . In addition to the obe-cel news flow, we also plan to provide an update on our Phase I trial of AUTO4 in peripheral T-cell lymphoma in the first half of 2022. If we move to Slide 6, we'd like to walk you through a general corporate updates from the third quarter. Firstly, during this period, we…

Andrew Oakley

Management

Thanks, Chris, and good morning or good afternoon to everyone. If we can move to Slide 22. It's my pleasure to review our financial results for the third quarter of 2021. So if we start with our cash position. Our cash at the end of September totaled $173.1 million, and that compares to $216.4 million that we had at the end of June. I will note, however, that this cash figure does not include an R&D tax credit that we received in October of this year to the tune of approximately $25 million. Net total operating expenses for the 3 months ending September 2021 were $40.4 million, and that's net of grant income of $0.2 million, and this compares with net operating expenses of $42.7 million, net of grant income of $0.4 million for the same period in 2020. The research and development expenses decreased to $32.3 million for the 3 months ended 30th of September 2021 from $33.5 million for the 3 months ending 30th of September 2020. Cash costs, which exclude depreciation and amortization as well as share-based compensation, decreased to $29.4 million from $30 million. Noncash costs decreased to $2.9 million for the 3 months ending 30th of September '21 from $3.5 million for the 3 months ending 30th of September 2020, and this decrease is primarily related to share-based compensation expense. General and administrative expenses decreased to $8.3 million for the 3 months ending 30th of September 2021 from $9.8 million for the 3 months ending 30th of September 2020. And cash costs, and I just said it, but I'll say it again, which exclude depreciation expense as well as share-based expense, compensation expense decreased to $7.2 million from $7.7 million. The noncash costs in G&A decreased to $1.1 million for the 3 months at review…

Dr. Christian Itin

Management

Thanks, Andrew. Let me conclude this part of the management discussion with a review of the upcoming milestones and news flow to the end of this year and into 2022. Let's move to Slide 24. As we look at the remainder of this year and into next year, there are a number of clinical milestones and opportunities for value creation. Key and most eminent operational focus, obviously, is on the conduct of the pivotal FELIX study with initial primary endpoint data expected around the middle of next year. As Chris mentioned earlier, we are very encouraged by our observations that the CR rate and safety data on the multicenter Phase Ib part of the study is consistent with the data reported from the academic ALLCAR19 study of obe-cel, which, as you remember, was conducted exclusively within the U.K. We plan to provide a little more detail on this initial clinical experience later this year at ASH. Further, we expect to report an update from the obe-cel ALLCAR19 extension trial, particularly from the remaining cohorts in the relapsed/refractory B non-Hodgkin's lymphoma population, as well as CLL patients, again, planned for the end of the year at ASH. We're also hopeful that we're going to be updating you on the AUTO1/22 Phase I study in pediatric patients as well at that point in time. In Q1 next year, we plan to provide an update on the Phase I study called CAROUSEL, where we are testing obe-cel in patients with primary CNS lymphoma. And then as we go to the remainder of the first half of next year, we also expect an update on the AUTO4 clinical experience from the dose escalation portion of the Phase I program. As we then look forward into the next programs behind our lead programs, we expect to obviously move several programs forward. You heard from Chris. AUTO8 will get into the clinic still the end of this year. We expect our revised solid tumor program with additional cell programming modules, AUTO6 NG, to get into the clinic during the first half of next year, and we're also moving obviously forward with . Overall, we believe the company is in a very good position, combined with our cash on hand. We feel well polished for success across our pipeline. We're now happy to take questions. Operator?

Operator

Operator

Our first question comes from Mara Goldstein with Mizuho.

Mara Goldstein

Analyst

I wanted to ask on the FELIX program. You'll have the full data set in the first half of 2022. And then can you talk about just what the regulatory path is from there for that program? And then on the ALLCAR extension studies, you've said you want to gather the data and see where that information takes you in terms of looking at additional programs. And so I'm curious as to how quickly you are able to execute on that once you have the full data set, I'm assuming this year? And then lastly, I apologize. But I thought at your last comment, you said something about a revised solid tumor program, and I don't know if I heard that word revised incorrectly. So if you could just help me on that?

Dr. Christian Itin

Management

Hi, Mara. Great to hear your voice, and thanks for joining. So AUTO6 NG is, as you may remember, a program that we built on AUTO6, which is the original car, and we basically went back and reengineered the program and probably I should have used the term reengineered. So there's no change, absolutely consistent with what we have been reporting before. With regards to the ALLCAR extension, obviously, what we're doing within the ALLCAR extension is adding approximately 10 patients in this additional set of indications to get a feel for the activity of the program within those indications. That work is ongoing. And obviously, depending on the indication, we would like to have a certain amount of follow-up to understand the level of differentiation of the data that we can actually see across these various indications. And we'll be guiding accordingly as we go through the course of next year in terms of the next steps. Getting to the FELIX study and the program of obe-cel in adult All. As we pointed out, we expect to reach the primary endpoint middle of the year. That is based on complete remissions, the complete remission rate and which is obviously established early on after treatment has started within these patients. We will then, by the end of the year, expect to also then have the 6 months follow-up data on all of these patients. And the expectation is that, that will be the basis for the key regulatory filings that we're planning to do. And those filings are currently projected to be happening in 2023.

Operator

Operator

Our next question comes from Nishant Gandhi with Needham & Company.

Nishant Gandhi

Analyst · Needham & Company.

Can you give us any updates on the that you're exploring with AUTO8 for multiple myeloma therapy? I believe you mentioned that you're exploring BCMA. And if you can give us any information about the second target. Apart from that, can you give us any update on AUTO5? Like obviously, initiate the Phase I study 4 to 5 in first half of 2022? Thank you.

Dr. Christian Itin

Management

On AUTO5, obviously, one of the key things we're doing is that we're taking information we're getting from AUTO4 to inform the way we're going to actually conduct the study around AUTO5. So that's key information that we're still collecting and it will sort of flow into the approach we're taking with AUTO5. With regards to AUTO8, we have disclosed, obviously, that we have generated a very sensitive BCMA CAR, which is a key component of the program, and that is going to be initially tested, and to establish the activity of that CAR on its own. And at that point, once that's established, we're expecting to add a second antigen, and we'll disclose that at that point in time.

Operator

Operator

Our next question comes from Nick Abbott with Wells Fargo.

Nick Abbott

Analyst · Wells Fargo.

First question, Christian. So we'll get an update on the ALLCAR extension study later on this year. And then very early next year, we'll get the data for -- or sorry, we'll also get the AUTO 1/22 data. So how do you choose between those 2 assets as you think about next steps beyond the adult ALL indication?

Dr. Christian Itin

Management

It's a very good question, Nick, and thanks for joining. And so basically, the underlying question you're asking is what is the profile and the opportunity you see in pediatric ALL versus the opportunity you would see for obe-cel in some of the non-Hodgkin's indications. It's sort of the underlying, I think, element of the question. And so what we'd like to see, obviously, with the -- when we look at these indications, we actually look at them independently. Because there is a -- I think, the thought process around AUTO1/22 is actually as part of the overall ALL program that we're conducting with obe-cel. We're looking at AUTO1/22 as the first next-generation program that we'll expect to build up over time. And obviously, pediatric ALL being the key indication to establish the utility of having a CD 22 CAR that is highly effective added to the obe-cel program. So that program stands on its own feet and its own merit. And one of the key things we want to see with that program is a reduction in the relapse rate in the pediatric patients. And that's the key entry point that we think would actually then trigger the full development in pediatric ALL. So that's sort of a part of the overall, if you think about it, overall ALL approach that we're taking, and it's a component of it. The opportunities that we look at for obe-cel itself outside the ALL space, I think, is a second question. And I think what we're going to understand is, obviously, where can we see a profile that is -- stacks up not just well, but potentially an improvement over and above of the other programs in the space, in the additional non-Hodgkin's settings. And this is what we're starting to explore with the extension program that we're doing on the ALLCAR study. And that data will help guide us actually to then the choices of the path that we are planning to develop within the non-Hodgkin's indications. So it's really going to be data-driven. But fundamentally, we're looking at those 2 approaches as sort of being separate in the sense, as AUTO1/22 really being part of the overall ALL strategy that we're building up to build a significant presence in that indication set. And secondly, it's then the branching out into the broader non-Hodgkin's opportunities.

Nick Abbott

Analyst · Wells Fargo.

And maybe just to add to that, you said the initial U.K. manufacturing facility will support 2,000 patients per annum, which obviously will cover the adult ALL indications. What do you need to see? And what would the timeline be for adding additional capacity to support, for example, a lymphoma or ped ALL?

Dr. Christian Itin

Management

So the way we're building the capacity around the facility in the U.K. gives us actually a very nice level of capacity in the ramp-up as we're launching the obe-cel program. And I think it will give us ample time to get a feel for the trajectory and then also a feel for the timing for additional indications to come online, to then actually time the build-out, not only of the facility in the U.K. but also consider establishing additional manufacturing capacity in the U.S. But it puts us in a very good space. It gives us a level of capacity that we believe actually will put us in a very good spot. And I think when you look at the trajectory we've seen in some of the other CAR-T programs, I think the 2,000 mark, we believe, is actually a good mark to work with, and it gives us an ability to react in time.

Nick Abbott

Analyst · Wells Fargo.

And then last one for me is, it's a 2-parter. So can you provide us with an update on the MRD-positive cohort of FELIX? And also, you're comparing the sort of milestone slides back to previous ones. We're not seeing a mention of either AUTO ALLO or AUTO7 programs in the current slide. Can you provide some -- let us know what the status of those programs are as well?

Dr. Christian Itin

Management

So the other approach is continuing, obviously, with -- in our collaboration with our academic partners. So that's slated to go in first half of next year. And the AUTO7 program, we're planning to run in sequence to AUTO6 NG. We want to get in some experience around the various modules that we're introducing into that program, which obviously also is part of the AUTO7 program. So there will be a staging that we expect to run between those 2 solid tumor programs. So I think that was the totality of the questions or did I miss anything?

Nick Abbott

Analyst · Wells Fargo.

Yes, just on the MRD-positive cohort, how that's going?

Dr. Christian Itin

Management

Oh, the MRD-positive cohort, yes. So the MRD-positive cohort is obviously part of the FELIX study and runs alongside the FELIX study. And I’m sure we’ll be giving updates as we go through the course of next year on that patient pool. But right now, obviously, the enrollment focus is very much on the relapsed/refractory population with morphological relapse.

Operator

Operator

Our next question comes from Asthika Goonewardene with Truist Securities.

Asthika Goonewardene

Analyst · Truist Securities.

Christian, just want to connect back on that little Easter egg you dropped about giving us a little bit of a view on POX at ASH. Can you maybe talk to us a little bit more about that? In which presentation will that be and number of patients, et cetera, that we could expect? And then on that topic of ASH, could you maybe also give us a little bit more color on the number of patients we should be expecting for AUTO1 in NNHL and CLL as well as AUTO1/22?

Dr. Christian Itin

Management

So when we look at what we're planning to do with regards to the Phase Ib portion, obviously, the key question that we're asking with the Phase Ib portion was really to move from a single country, almost single center study, which is what the ALLCAR study is, to a multicenter, multi-country environment. And with that, obviously, a significant increase in complexity and logistics into everything else. So that was the goal to really make sure we're demonstrating that transition. We're demonstrating that we're replicating the data. Obviously, we also move to commercial supply for vector and so on. So there's a few changes that we made along the way to sort of transition the program into commercial stage -- towards commercial stage. And that's sort of one of the key topics that we expect to update at ASH. And then our context also will share key aspects of the Phase Ib trial that we've conducted, which obviously was designed to confirm the activity level that we've seen during the ALLCAR study. So that update will be given. We'll give that experience, which I think is important, as we indicated. The data that we're seeing is consistent in terms of the key parameters that we're looking at, which is really around safety. We want to obviously be sure we replicate the safety, but also replicating the overall activity, and that's sort of the high -- kind of high-level statement that we made today, and we're obviously going to show the corresponding data to that. When we look into the updates around the ALLCAR19 study and actually moving into the non-Hodgkin's side, what we did is we added additional cohorts with 10 patients in each. And we're going to give an update on the progress, on the exploration around these various cohorts. And some of the cohorts will be fully involved. Others will still be enrolling, so we'll see basically a snapshot as we're transitioning through those data sets as we go through the end of the year. And then on the pediatric study, obviously, we'll give an overview on the overall program, key characteristics, et cetera, but also kind of share some of the initial clinical data on that program. The key update we're expecting actually for the pediatric program will be towards the middle of next year when we have about 6 months of follow-up for the patient group, which we believes gives us a good feel for how we're tracking with regards to the ability to minimize relapses indicates once they achieve a response. So that's just a framework, I think, is sort of framing expectations for the end of the year.

Asthika Goonewardene

Analyst · Truist Securities.

And if I may just add, so in this data that you talked about in terms of transitioning AUTO1 into commercial stage here. This present -- what should be showing at ASH. Will there be actual patient-level data from FELIX study then in this presentation?

Dr. Christian Itin

Management

Well, the data that we will be sharing, obviously, is exclusively from the Phase Ib portion. Because as you can imagine, you do not want to share pivotal data ahead of actually getting the study completed and everybody treated. So this will be focused on the Ib experience of the study.

Operator

Operator

Our next question comes from Matt Phipps with William Blair.

Matt Phipps

Analyst · William Blair.

I guess, Christian, we've had a couple of updates in the third quarter with some CD19 allogeneic CAR-T programs. And wondering if you have any high level thoughts on those. And if this is kind of influencing any of your allogenic approach, which I believe does not fully knock out the TCR, if I'm remembering correctly from the UCL presentation.

Dr. Christian Itin

Management

Thanks for the question. Obviously, there is a kind of limit to what we know about what’s going on in those programs. Obviously, there’ve been some public statements that I think most of you have commented on. I think most on the call actually are covering probably the companies involved. So I think we’re seeing, obviously, emerging data, which I think is interesting, and sort of gives us a sense of the performance of the product, and I would expect more updates also around ASH. I think that’s a development in its own light. Obviously, the various ways of technology and some of the players were pointing to elements of their technology that might give them an element of potential differentiation, either on efficacy or safety. I don’t think I want to comment on that. The approach we’re taking with regards to the program we’re exploring with our academic partners is really to trap the T-cell receptor within the secretory pathway. So in other words, what we’re doing is basically expressing a protein module that actively traps the actual protein, TCR protein, within the secretory pathway and it into the degradation pathways. Now, that’s a fundamentally different approach to any approach that actually aims to knock in or knock out genes in whatever way that technology actually does that. So it’s a different approach. We’re not operating in that sense, at the genome level, but we’re operating with at the protein level. And so there’s sort of quite a different technological approach that we’re taking here. But I don’t want to get to speculate on the current technologies in play with other companies. I think they will update. I think the field at the upcoming conferences, and I think we’ll learn what’s going on there in that context.

Operator

Operator

Our next question comes from Kelly Shi with Jefferies.

Unidentified Analyst

Analyst · Jefferies.

This is Dave on for Kelly Shi at Jefferies. So my question is regarding AUTO1 FELIX. Beyond AUTO1 FELIX in adult ALL, do you see the possibility that FDA might ask for randomized controlled trial instead of single-arm trial given the evolvement of a competitive landscape? And second question is, can you set expectation on data in first quarter of next year for primary CNS lymphoma?

Dr. Christian Itin

Management

With regards to the FELIX study. First of all, in terms of the way that the study obviously is designed, it's designed to give us the complete remission rate out of a single-arm study. When we look at the history of recent approvals within ALL, we have blinatumomab or Blincyto, which is approved in the single-arm study, approximately 100 patients. We have now the approval of Tecartus in adult ALL with just 54 patients in a single-arm study. And we expect that there is no change that we'll see here. So we expect that the single-arm study with level of robust data that we have seen in our early experience, I believe is absolutely adequate to submit or apply for registration for the program. And I think that is entirely consistent with what we've seen before. We've seen the same also on the pediatric ALL side. And obviously, we've also seen it in the various trials that led to approvals in the DLBCL space, which is obviously a much larger space, and the program is not showing much differentiation actually between themselves. So I don't think there is any change there. I think the fact that indeed, Tecartus got a full approval for relapsed/refractory independent of line, I think is a very good -- is a very positive development. And I think it bodes well for us and for our program. And so I think we're in a very good place there.

Operator

Operator

Our next question comes from Eric Joseph with JPMorgan.

Eric Joseph

Analyst · JPMorgan.

Maybe just a housekeeping one related to the upcoming Phase Ib FELIX screen-out. I guess how should we be thinking about what might be included in a submitted abstract? And should we be expecting sort of material data there as it runs into ? And then secondly, I'm wondering if you could give us a bit of an enrollment progress update with the Phase II . And are patients in the Phase Ib contributing at all to the Phase IIb readout s that we're expecting over the course of next year? Or are they completely distinct patient populations?

Dr. Christian Itin

Management

Thanks for the question. So obviously, the way that we designed the study does not make any distinction or differentiation in terms of inclusion criteria between the Phase Ib and the Phase II. So we're enrolling the exact same patients into the Phase II portion as we have enrolled into the Phase Ib portion. And that's obviously one of the values of the Phase Ib data that it actually gives us a good read on not only the inclusion-exclusion, that sort of -- and the characteristics of the patients. But also, it obviously also enrolls the patients at the centers that were enrolling the majority of the centers in the Phase Ib were in the U.S. And we're enrolling patients in the U.S. So it reflects very well what we expect the composition of the patients be in the Phase II portion. So in that sense, we believe that the data actually is very meaningful and is important in that context. And it also obviously includes, as I indicated before, complexities related to logistics, et cetera, which all obviously have an impact on delivery time and so on and so forth. So it gives you that overall level of consistency across. And so from that perspective, we expect the data to be very helpful and a very good guidance as we go forward. And the other way, actually, I think that is worthwhile thinking about the data is that this is now going to be the third set that will become available around obe-cel in ALL. We obviously have the first dataset in the pediatric ALL population, which is, obviously, was published in . We then have the experience in the adult population, the ALLCAR setting, and we're now adding the experience in the FELIX Phase Ib portion. And I think that's another way of looking at the data and actually, just looking at the level of consistency of the data across datasets, which I think is another way to sort of actually get a good understanding of the profile of the product, and I think, an understanding of consistency between these various slightly different populations. But of course, and I indicated, the Ib population is the same population that the Phase II population actually is. So I think that's where the real value is and I think where the key opportunity is.

Eric Joseph

Analyst · JPMorgan.

I think actually misspoke a little bit, Christian. I just wanted to clarify that none of the Phase Ib patients roll over or comprise the cohort that we're looking at in Phase II. That the readout -

Dr. Christian Itin

Management

I get it. No, these are distinct in terms of actual datasets. So there is a Phase Ib dataset. There is a Phase II dataset. And there is -- actually, there are 2 data sets. I mean, what you did see, when you looked at the Tecartus review that the FDA did, the FDA actually took into account its Phase I experience for Tecartus, at least in some aspects on safety. That's what we've seen certainly in that dataset. So there may be some view -- a broader view on safety, but from an efficacy perspective, we expect that that will be focused on the Phase II dataset alone.

Eric Joseph

Analyst · JPMorgan.

So just an update on -- or can you give us a progress update on enrollment in the Phase IIb, and if you're just kind of thinking about the size and duration of follow-up in the midyear readout from FELIX Phase II? I guess, how should we be thinking about that?

Dr. Christian Itin

Management

Right. So what we're guiding is that we expect the study to be fully enrolled during the course of the first half of next year with the primary endpoints reading out in the middle of next year. So that's the guidance. The primary endpoint is established by 2 measurements. One measurement at 1 month and then a confirmatory measurement at 2 months after dosing. And in both cases, in order for a CR to be counted as a CR, you want the CR to be actually established at both time points. And that actually goes into the assessment of the primary endpoint. And so that's sort of the key data you have at that point. And then obviously, the full follow-up of these patients is then with all patients 6-month follow-up will be expected to read out towards the end of next year.

Eric Joseph

Analyst · JPMorgan.

And then final question. Are you providing further updates, further follow-up from the adult ALL cohort of ALLCAR 19? Either at ASH or in 2022?

Dr. Christian Itin

Management

We expect to do that. Obviously, we're updating the non-Hodgkin's experience, and there's an opportunity to sort of update on the durability data.

Operator

Operator

Our next question comes from Gil Blum with Needham & Company.

Gil Blum

Analyst · Needham & Company.

Just a quick one on the indolent lymphoma. There's been some pretty good results for autologous CAR-Ts and other programs for FL. Maybe you could kind of put in context for us, how important it is to have an autologous option that is relatively safe in this particular patient population.

Dr. Christian Itin

Management

It's a really good question. I mean, one of the interesting things about follicular lymphoma, if you compare it to the ALL setting that we're active in is that in follicular lymphoma, you have basically an indolent disease. So a disease that is relatively slowly progressing, relatively slowly growing. But it is a disease that we actually have no way at this point to cure. So everything we do in that disease setting is designed to buy time. Now, we do have many options for these patients. They have obviously a lot of chemotherapy backbones combined with biologicals as to the mainstay of the options that are available to those patients, buying them years of time, but not curing actually the patients along the way. What they do experience is obviously the level of burden of toxicity, but also quote-unquote, the convenience of a lot of these therapies to obviously be administered in outpatient settings, so they typically don't have to go into a hospital to be treated, but they get managed actually in the periphery for the most part. So that's sort of the setting. So what you need in order to sort of actually reach these patients, I think there's 2 things. First of all, you want to actually be able to show that indeed, you have a safety profile where the patients can get treated in much more into the periphery and certainly in an outpatient setting because that is sort of what they're used to and what they're comparing to. Secondly, I think you would want to see long-term remissions in these patients so that indeed, this onetime intervention gives you a meaningful amount of time hopefully. But that data is still outstanding in the field, converting some of these patients into cures. And what you…

Gil Blum

Analyst · Needham & Company.

And if I may, maybe a related question. So we've been seeing the allogeneic space, particularly in DLBCL, kind of moving towards multiple doses of the cellular therapeutic. We're also involving additional chemo. Do you think that this might provide kind of an opening again for an autologous CAR-T therapy with a better safety profile like what you have with AUTO3?

Dr. Christian Itin

Management

Well, I think first of all, I think it's a very interesting question. And what we're seeing, and I think Matt asked the question before in a slightly different way. And is that we're seeing that the data start to actually come forward in terms of some of the allogeneic approaches. And the fact that many of the companies talk about multiple dosings that are sort of heading towards obviously indicates that while there is activity, in order to sort of get a more sustained activity in DLBCL patients, which is really -- you need to get, frankly, you have to get to a certain level of cures in these patients to make your therapy worthwhile. But that may take a few more steps. And of course, the more you add in terms of dosings and reconditioning and so on and so forth, you add complexity to the therapy. You add complexity from a management perspective, complexity from a treatment group perspective. And you take away differentiation from a, frankly, a standard chemotherapy, antibody drug conjugate, antibody type of combination approach that we also are a bispecific approach, that is also active in this space. And I think that's one of sort of the key questions will be, what's the stand-alone activity? And can you really differentiate yourself away with those approaches from other approaches that are currently being pushed. What we do see is that still the level of sustained CRS that are seen on the CAR-T side and the autologous CAR-T side, at this point, at least, has not been matched by any other therapeutic modality. And I think that, I think, certainly creates an opening and to part of the comment I made before about follicular lymphoma, having a good safety profile will be important in order for patients to really gain access to the therapy. Because those patients, as we pointed out many times during the course of the last 24 months or so, tend not to be treated at the academic hospitals in DLBCL. They're actually much more further out into the periphery. And with that, you need a product that actually has a good level of safety. And those are obviously hallmarks. We're seeing both. We've seen it with AUTO3, and we're now obviously exploring with AUTO1, obi-cell, and I think we're going to get a very good feel where that's going to go. But certainly, there's more complexity in the DLBCL space than probably, I think, many folks anticipated earlier this year.

Gil Blum

Analyst · Needham & Company.

All right. Congrats on the continued progress.

Operator

Operator

I'm showing no further questions at this time. I would now like to turn the conference back over to Christian Itin.

Dr. Christian Itin

Management

All right. Well, thanks, everybody, for joining. Much appreciated you took the time today, and we’re looking forward to obviously updating you around the ASH meeting. And looking forward to an exciting 2022. And with that, I’d like to thank you all and looking forward to connecting hopefully in person not too far out. Thanks a lot. Bye-bye.

Operator

Operator

This concludes today's conference call. Thank you for participating. You may now disconnect.