Earnings Labs

Autolus Therapeutics plc (AUTL)

Q1 2020 Earnings Call· Sun, May 10, 2020

$1.48

+3.87%

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Autolus Therapeutics First Quarter 2020 Financial Results and Operation Highlights Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions] I would now like to hand your conference over to your speaker today, Mr. - excuse me, Dr. Lucinda Crabtree, Vice President of Investor Relations. Thank you. Please go ahead, ma'am.

Lucinda Crabtree

Analyst

Thank you, Kara. Good morning, and/or good afternoon, everyone, and thank you for taking part in today's call on the financial results and operational highlights for the first quarter 2020. I am Lucinda Crabtree, Vice President of Investor Relations. With me today are Dr. Christian Itin, our Chairman and Chief Executive Officer; and Andrew Oakley, our Chief Financial Officer. Before we begin, I would like to remind you that during this call, we will be making forward-looking statements. All statements other than statements of historical facts contained in this presentation are forward-looking statements. Our actual results, performance or achievements may be materially different from those expressed or implied by the forward-looking statements. For a discussion of the risks and uncertainties relating to our business and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, please see the section titled Risk Factors in our annual report on Form 20-F filed on March 3, 2020, as well as discussions of potential risks, uncertainties and other important factors in our other periodic filings with the SEC. The forward-looking statements contained in this presentation reflect the company's views as of the date of this presentation regarding future events. And the company does not assume any obligation to update any forward-looking statements. You should, therefore, not rely on these forward-looking statements as representing the company's views as of any date subsequent to the date of this presentation. So with that, on Slide 3, you'll see the agenda for today, and it is as follows: Christian will provide a brief introduction, and that will be followed by our operational highlights for the first 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 welcome your questions following our remarks. So with that, I'd like to now turn the call over to Christian. Thank you.

Christian Itin

Analyst

Thank you, Lucinda, and welcome to all of you, and thank you for joining us. I'm pleased to review our progress for the first quarter in 2020. First, on Slide 5, we are pleased to report on a very productive first quarter. We remain on track with our clinical programs, despite the challenges of COVID-19. As an organization, we have quickly adapted to this challenging environment, ensuring business continuity. Our focus has been on ensuring our clinical B-cell programs, AUTO1 and AUTO3, continue to progress, and we remain on track with recruitment ongoing and manufacturing operations uninterrupted. As such, we expect to deliver data in the time lines that we have previously guided. While some of our participating clinical centers have been infection hotspots and had to pause enrollment for a few weeks, others could continue to work unimpacted. We expect infections will continue throughout the year with flare-ups in places that were hit by the first wave of infections, while the areas spared for now may see a rise in infections at some point in the upcoming months. However, what is important to remember is that the patients we enroll in our trials have a very high medical need, no different from a severe COVID-19 patient and the drive for centers to continue to treat these cancer patients is very high. Typically, if a center gets under heavy pressure from COVID-19 infections, stem cell transplants and CAR-T therapy are among the last procedures to be stopped and are among the first to resume post-peak infection. As many of you have analyzed, the tie from establishing social distancing and stronger measures to reaching the other side of the first infection peak has in all impacted areas taken approximately eight weeks, irrespective of whether the measures were taken early or late…

Andrew Oakley

Analyst

Thanks, Christian, and good morning or good afternoon to everyone. We move to Slide 15, it's my pleasure to review our financial results for the first quarter of 2020. Net total operating expenses for the three months ending March 31, 2020, were $38.6 million, that was net of grant income of $300,000, and that compares to net operating expenses of $30.2 million, net of grant income of $2 million for the same period in 2019. The increase was due, in general, to the continued increase in clinical trial activity which is expected to deliver on key milestones throughout the rest of 2020; also increased headcount; and an increase in public company costs, primarily related to insurance. Research and development expenses increased to $31.3 million for the three months ended March 31, 2020, and that's up from $22.6 million for the same period in 2019. Our cash costs, which exclude depreciation and amortization as well as share-based compensation, increased to $25.6 million from $17.5 million. The increase in R&D cash costs, that's $8.1 million, consisted primarily of an increase in compensation-related costs of $2.2 million due to an increase in employee headcount that supports the advancement of our product candidates as well as an increase of $3.7 million in project expenses associated with a clinical activity. And that includes the research, process development, manufacturing activities necessary to conduct the studies. Plus an increase of $1.8 million in licenses, legal fees and consulting services, which - some of which is related to an option to negotiate a future license as well as IT infrastructure and support. The remainder was attributable to other additional costs in the amount of about $400,000. General and administrative expenses decreased to $7.6 million for the three months ending March 31, and that's down from $9.6 million for…

Christian Itin

Analyst

Thanks, Andrew. Let me conclude this part of the management discussion with a review of the upcoming milestones and news flow through 2020. Let's move to Slide 17. The upcoming eight months will be an end full period for us with multiple clinical milestones and opportunities for value creation. Our chief and most imminent operational focus is to conduct, obviously, our pivotal trial for AUTO1 in adult ALL. We expect to report clinical data across multiple programs, including updated AUTO3 ALEXANDER data at the forthcoming ASCO Meeting and updated AUTO1 or CAR19 data as well as AUTO3 data at EHA, as previously mentioned. We will look to progress a number of our other preclinical candidates through the second half of 2020 and are looking forward to providing preclinical data updates in our solid tumor programs AUTO6NG and AUTO7 at AACR as well as our T-cell lymphoma program with AUTO5. Finally, towards the end of the year, we look forward to providing further data updates on both AUTO1 and AUTO3, as we expect for the end of the year. In conclusion, on Slide 18, I'd like to recap the major message raised from today's call. First AUTO1 is our first Autolus' program to move into pivotal stage. Given the positive safety and efficacy profile today, we believe that AUTO1 has the potential to be a best-in-class CD19 CAR-T program in adult ALL, a disease setting with a very high unmet medical need. Secondly, with regards to AUTO3 and DLBCL, which is expected and slated for additional clinical data updates at ASCO and EHA, we plan to conduct an outpatient cohort in the second half of this year. The company is in an excellent position, combined with a strong balance sheet, which provides us a run rate into 2022. We feel we're in a good position, and I think are looking forward to an exciting second half of the year. We're now happy to take questions. Thank you.

Operator

Operator

[Operator Instructions] Your first question comes from the line of Chad Messer with Needham & Company.

Unidentified Analyst

Analyst

This is Gil [ph] on for Chad. And congratulations on the progress in a difficult environment. So just a couple of questions from me. You discussed kind of the challenges that are related to DLBCL. And hypothetically, what would you consider more important, patient accessibility or the duration of and deepness of response?

Christian Itin

Analyst

Well, thanks a lot for joining. I really appreciate it. The - I think with regards to DLBCL, you want - you need both aspects actually to be addressed. You need a high level of sustained CRs, and you need an excellent safety profile to reach the population. Both aspects are important, and we believe that we have an ability to make a significant improvement on both sides of the program.

Unidentified Analyst

Analyst

So you do not consider one more important than the other in this instance?

Christian Itin

Analyst

Well, there's - it is - it's a life-threatening disease. The first thing you have to make sure is if the patient survives. So getting to a long-term remission is what the ultimate goal is, but then you also have to make sure that the patient has access to the therapy. And right now, in the U.S., there are only about 10% of the patients in that disease setting have access to CAR-T therapy, because it is confined to the inpatient segment of the centers of excellence. And that has actually created a situation where while there is a big demand for these types of therapies, the actual access that can be realized is very, very small. And that is all on the actual intensity of the management of these patients during the adverse events that occur in the - at the onset of the therapy. And that is sort of the key reason for the confinement to this relatively small number of centers. So you have to make fundamentally have the impact on the disease. That is what the sustained CR rates give you, but then you actually have to have a safety profile that allows you to further expand the delivery of this type of a therapy to centers beyond the relatively small numbers of academic centers of excellence.

Unidentified Analyst

Analyst

All right. And we are very much looking forward to seeing some of the preclinical data at the second half of AACR. I noted that it looks like AUTO6NG data would be presented in small cell lung cancer. So that's a very interesting indication, not just because of the target, but also because of the lack of immunogenicity that's seen in a lot of these cells. Kind of maybe you could kind of orient us what kind of data we should be expecting at AACR?

Christian Itin

Analyst

So at AACR, what we're going to be presenting are obviously a preclinical data on these - from these programs. As you may remember, the way we designed the programs is actually to include a set of cell programming modules that enable the cells to have a higher resilience and higher ability to cope with the challenging microenvironments that we find in these particular sets of tumors. And that is going to be a key part of the data that we're going to be presenting is the use of those modules in those settings and the impact the modules have to actually give us an appropriate level of activity in these, as you point out, very challenging tumor environments.

Unidentified Analyst

Analyst

Excellent. And just some kind of a last clarification. You're expecting to complete enrollment in the pivotal study by year-end '21 or first half...

Christian Itin

Analyst

First half next year.

Unidentified Analyst

Analyst

First half next year?

Christian Itin

Analyst

First half next year with data at year-end, next year.

Unidentified Analyst

Analyst

Congratulations on your progress.

Operator

Operator

Your next question comes from the line with Mara Goldstein with Mizuho Securities.

Mara Goldstein

Analyst · Mara Goldstein with Mizuho Securities.

If I could just ask on the AUTO3 outpatient program, can you just talk a little bit about what the profile of that patient would look like relative to inpatient within - to the extent that you can discuss protocol on that basis? And then just also if I could drill in a little bit on the sort of go, no-go decision as well expected later in this year and the decision tree that will help you get to making that decision, if you could discuss that?

Christian Itin

Analyst · Mara Goldstein with Mizuho Securities.

Yes, Mara, thanks for joining. So in terms of the patients, the patients actually, we don't expect to look different from the patients that we've treated so far. The reason why you treat the patients in an inpatient setting with the current CAR-T programs is not because of the state the patient is in, but it is the consequences of the toxicity induced at the onset of the therapy that you're providing. So there is not a - we don't expect to see a difference in the patients. And in fact, as you can imagine, with the majority of the patients treated outside of the academic centers, the patients are in a reasonable condition and can obviously normally manage - be managed in oncology clinics and networks, etcetera, much more in the periphery of the health care system. So we expect the same patients, but obviously, we're treating them in a slightly different setting than what the inpatient setting is. So this is not a difference of the patients, it's a difference on the level of patient management required to actually get these patients safely through the therapy. And that is what the profile of AUTO3 is actually enabling us to explore. And then with regards to decision points, obviously, we're going to provide an update of where we are with the program at ASCO. That gives us a very good view on the response rate level. We will have additional follow-up that we'd like to see, which gets us into - slightly into the second half of the year, at which point, we'll understand what the sustained CR rate looks like. And that will be the key piece of information that will inform us on the path forward. And as you can imagine, getting the data from the outpatient cohort would also enable us to actually design a pivotal study somewhat differently, including outpatients - an outpatient setting in the pivotal study as well, which we believe would actually be a very important component of the pivotal program. So that data will be very informative in terms of the design of the study as well.

Operator

Operator

Your next question comes from the line of Debjit with H.C. Wainwright.

Aaron Welch

Analyst · H.C. Wainwright.

This is Aaron on for Debjit. Congrats on the progress. So my first question is, so if a no-go decision were made on AUTO3, the Phase II portion, would you still continue with outpatient study of AUTO3? And what kind of learnings could you glean from that if it were discontinued?

Christian Itin

Analyst · H.C. Wainwright.

You're asking a good question, Aaron. Obviously, we have a good level of confidence about the program. You've seen the data early in the year. As I said, we're going to be about to provide an update on the program. We feel good about the program and believe that, that is an important data set to be generated.

Aaron Welch

Analyst · H.C. Wainwright.

Okay. And are there any plans for outpatient studies at AUTO1 as well?

Christian Itin

Analyst · H.C. Wainwright.

At this point in time, there is no and the reason for that is actually the state the patients are in themselves. So this is different from DLBCL. The adult relapsed/refractory, adult ALL patients typically are in a very difficult situation. A lot of them are prone to sepsis as a consequence of the disease and the progression of the disease. So they're at a significant risk of picking up infections. A lot of them actually have to be managed in ICUs for sepsis and other types of comorbidities on - as a part of the normal course of the progression of the end stage of the disease. So the disease is quite different. So in this setting, you - we obviously will treat the patients mostly in inpatient setting for the first few weeks, just to have an ability to observe them and be able to help manage the disease mostly, much less better than the therapy itself, it is mostly about managing the disease here. And obviously, as I think we see a larger group of the patients, we can then actually decide whether we might take a similar route as I was able to take with my previous program with blinatumomab, where we could do actually a lot more of the activities outside the hospital at some point in time. But for this study, the patients will be primarily treated in inpatient setting, driven by the state that the patients are in mostly, much less so than actually the consequence of the therapy itself.

Aaron Welch

Analyst · H.C. Wainwright.

Okay. And then...

Christian Itin

Analyst · H.C. Wainwright.

Aaron, do you have another question?

Aaron Welch

Analyst · H.C. Wainwright.

Yes, I do. So one more. In DLBCL, comparing allogeneic and autologous CAR-T approaches, so do you think that the additional 3- to 5-week vein-to-vein time could contribute to increased CRS or neurotoxicity?

Christian Itin

Analyst · H.C. Wainwright.

I don't think there is a connection between vein-to-vein time and cytokine release or neurotoxicity. If you would have a concern around vein-to-vein time or a long vein-to-vein times is that the disease may progress further. That would mean more tumor load and more tumor typically means is often related to more adverse events. So if there is a connection, that might be - there could be relationships there. It's not what we're seeing. It's not what we're picking up. But there is - the relationship you're suggesting, I don't think it's there.

Operator

Operator

Your next question comes from the line of Jim Birchenough with Wells Fargo.

Jim Birchenough

Analyst · Wells Fargo.

Congratulations on all the progress and initiation of your first pivotal. I guess, first, just on the midyear go, no-go decision, should we expect that in concert with ASCO and EHA update, is that midyear? And I guess the second part of it is just given the strong positioning statement, the strong data we've seen so far and the commitment to an outpatient study, should we consider a no-go decision unlikely? And would have to have something unusual happen between now and that decision? It just seems like you've made a pretty strong positioning statement. The data seems very strong. You're committing to further development in the outpatient setting. So just trying to understand a bit more on the timing and the bias towards go, no-go.

Christian Itin

Analyst · Wells Fargo.

Right. So obviously, we're - I cannot guide you through the data we're about to present. That's a few more weeks to go for that data. As I indicated, we feel good about the program. That's what you've also picked up from the presentation, and that is certainly a true statement. So this is where we'll obviously provide more update at ASCO. We'll have a bit more follow-up in terms of the time. I think one of the key parameters that we're looking at is obviously sustained CR rates. And we're going to give - we'll have a view, obviously, for ASCO, but we believe that in the - within the third quarter, we'll have, I think, a better visibility on kind of the full data set from the patients we've treated to date in terms of the sustained CR rate. So we'll get a very good view on that. And as you've pointed out, and clearly, the fact that we want to move forward and actually explore the potential of the program in an outpatient setting is obviously indicative of overall the positive view that we have on the program.

Jim Birchenough

Analyst · Wells Fargo.

And then, Christian, to the extent that when we get the update at the upcoming medical meetings, there'll be some need to make cross-trial comparisons. Do you feel like the baseline characteristics will hold up with Yescarta and JCAR-17, I think back on when the debate between JUNO and KITE was on relative tumor burden? So just maybe if you could give us a sense of tumor burden and whether you think it holds up and will allow for those comparisons on CR and durability of CR?

Christian Itin

Analyst · Wells Fargo.

I think that, first of all, if you have some tumor burden, I think you will obviously present the data on tumor burden as well. And you'll see that this is a very comparable patient population as was reported for Yescarta and JCAR-17 on tumor burden. In terms of kind of the patients that we have included, I think we're tracking very nicely with the Yescarta population. There is obviously the JCAR-17 population, it was somewhat different to what the Yescarta population. We're also - we're closer to the Yescarta population and the JCAR. In general, the Yescarta population was probably a bit tougher population to deal with.

Jim Birchenough

Analyst · Wells Fargo.

Maybe just a final question just on thoughts on outpatient treatment. Have you done much work talking to those 80% of centers that are treating patients away from tertiary care centers? And what their threshold is to move towards a greater level of comfort with CAR-T? Is a 100 patients' data enough to kind of rule out the bad things in their minds? And is there an in-between scenario where a strong profile could generate more referrals to tertiary centers before the communities actually pick up on it? Just trying to get a sense of level of comfort and your ability to address that with a pivotal study?

Christian Itin

Analyst · Wells Fargo.

It's a very good question, and it's sort of any change in sort of treatment paradigm or adoption is actually a process that will take some time and will need to require a buildup of confidence. And that is true when you start with your KOLs and the experience they make. And then that obviously experience then starts to propagate outwards. So it's a process where you go, where we expect to go from the university hospital outpatient setting, which is one of the categories of outpatient to the non-university hospital's outpatient setting, and then you can actually move from there. You have to expect that, that will be sort of a gradual motion through the various types of centers. And with that, obviously, you gain a lot of experience, not just from a pivotal study, but then also from the ongoing experience going forward in terms of the real overall data that will actually continue to support the rollout and the capture of that opportunity in full. All of these therapies, particularly with new therapies, take experience, which is personal experience with the product. And that needs to be developed, that needs to be rolled out appropriately.

Operator

Operator

Your next question comes from the line of Biren Amin with Jefferies.

Biren Amin

Analyst · Jefferies.

Maybe I could just start on the AUTO3 outpatient cohort. Are you planning to dose the outpatient cohort with pembrolizumab? And then I guess on that, what are your thoughts in terms of this data that we're expecting soon midyear? And should we be comparing these data to the ZUMA-6 data, which were presented at AACR recently, where I think they saw a 46% CR rate and a 75% ORR rate? So I guess, if you could address those questions?

Christian Itin

Analyst · Jefferies.

Yes Biren, thanks for joining. Obviously, the way that we're treating the patients is that we're giving a single dose of pembro on day minus 1, and that is going to be in any of the settings. Obviously, the nice thing about this approach is you can sort of bake it into the preconditioning regimen, which is a 3-day regimen, Flu/Cy regimen, so you can build it in and it can actually be nicely integrated in any setting, frankly. With regards to what we need to look at, I think the data using the PD-L1 monoclonal with Yescarta, it didn't seem different in any significant way from the Yescarta data in the absence of the PD-L1 monoclonal. So I think we just look at the Yescarta data as it stands, whether it's the original ZUMA trial or the ZUMA-6 trial. I think they're relatively close together. And there's not an indication, I think, that the addition of PD-L1 monoclonal has increased or changed the profile. So it's going to be against the Yescarta data as we know it today, which I think is very consistent. So that's what we'll be comparing to and what we're looking at and what we, at this point, clearly, has the most significant data set as we could tell from an efficacy perspective in the space.

Biren Amin

Analyst · Jefferies.

So, if pembrolizumab doesn't provide any additional contribution on efficacy, why not evaluate the outpatient cohort without pembro?

Christian Itin

Analyst · Jefferies.

I'm sorry, that's not what I said. I'm not sure what you're concluding.

Biren Amin

Analyst · Jefferies.

Well, I think the ZUMA-6, if you look at the cell kinetics, there was a - and when they showed us the data on ZUMA-6 versus ZUMA-1 cell kinetics, there wasn't really much of a change. And one would have concluded that maybe you get better cell kinetics within ZUMA-6 because you have pembrolizumab on board.

Christian Itin

Analyst · Jefferies.

There wasn't pembro onboard. Was it? It was atezo.

Biren Amin

Analyst · Jefferies.

Well, atezo, sorry. I mean, PD-1.

Christian Itin

Analyst · Jefferies.

Yes. It's - the interaction is not at the same place. We're acting on the T-cell - on the CAR-T cell, atezo acts on the tumor cell. So it's not necessarily the same biology to begin with. You have different - pembro has additional impact on the T cell itself. So what we're seeing is, obviously, and this is what we're - what we'll be talking about is what we'll be looking at the sustained CR rate, and you'll start to get a view of that at the ASCO presentation coming up. And that's probably worthwhile having a look at. And as we go forward, as indicated, we will include pembro as part of the preconditioning regimen, which is a single dose of pembro, which obviously on its own doesn't have any impact on the lymphoma as an agent itself.

Biren Amin

Analyst · Jefferies.

Okay. And then, I guess just one more on the outpatient cohort. What do you - how - I guess, what are your plans for treating the Grade I/II CRS? Are these patients going to be truly outpatient like will they be able to go home? Or are they going to be at a separate facility outside of the hospital?

Christian Itin

Analyst · Jefferies.

Well, that varies a lot depending on the institution. Typically, if it is associated with an academic center, those are basically facilities relatively close by to the center that could be set up like a hotel, as an example, where patients can actually be managed. And obviously, if need be, they could be sort of looked at in the context of the hospital itself. That's one set of settings, and there's obviously the more distant settings in going out. As we're obviously collecting the data on the feasibility and the experience with it, obviously, what you want to make sure is you capture the data. What is the experience of the patient? What is the safety profile? What is the management requirement for these patients? And that's what you record. And that actually doesn't matter for that cohort, whether how far removed the patient is, whether a patient is far removed from the hospital or not. What you need to do, you need to be able to collect the data. So most of what we're going to be working with are obviously centers that have outpatient facilities in a reasonable distance to the center. All right. Operator, do we have any more questions?

Operator

Operator

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

Unidentified Analyst

Analyst · William Blair.

This is Rob [ph] on for Matt here. Just a very quick one on the - just on the outpatient setting again, the additional cohort that you're planning there. Is the idea to move the pivotal study kind of entirely into the outpatient setting? Should that be - should you make a good decision on that one? Or is that going to be kind of at the discretion of participating centers there? And then maybe if I could just quick one on AUTO4. It was good to see some initial data at the start of the year there. How has enrollment been on that AUTO4 city? And maybe what can we expect in data at the end of the year? Is that likely to be enough to make a decision on AUTO5? And maybe a possible a bit of outlook of that program into 2021, following on from that day there, if possible?

Christian Itin

Analyst · William Blair.

Okay. Rob, thanks for joining. With regards to the design of the pivotal study, what you want to make sure is that you have an ability to include centers that provide - that treat patients in the outpatient segment as part of the pivotal study, that was the idea to be able to do that. So there will be a mix of patients that will be treated in an inpatients and patients that are in an outpatient setting. But you want to generate sufficient data that gives you then an ability to move forward with the broader population and the broader treatment settings based on the data you generate in that study. So that's the first part. And the first question. The second question related to AUTO4. AUTO4 was somewhat impacted by the current COVID situation, and the challenges that we had in terms of the - within the U.K., where we had, obviously, hospitals had had to shut down the treatment for cancer patients that were impacted. We were not impacted with AUTO3 because we basically keep on operating in the U.S. at the same time. But AUTO4 is predominantly operating at a clinical trial within the U.K. and, therefore, we have been impacted. We're in the process of evaluating what the impact is. I think it's difficult to guide at this point in time what level of impact we'll have, and we'll guide probably later in the year once we have better visibility what we can expect by the year-end.

Operator

Operator

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

Graig Suvannavejh

Analyst · Goldman Sachs.

Congrats on the progress. I've got three questions, if you don't mind. My first is, again, just focusing on the outpatient opportunity. Any sense that you could give us? I know it's early days with kind of what the incremental magnitude of the revenue opportunity could be versus the inpatient setting? And then my second question. I just wanted to get an update on the allogeneic program. Super interested in that. And if you could remind us how that program and how you're engineering that - the candidate? How it might differ versus other approaches from other allogeneic companies? And then lastly, I just want to touch upon manufacturing. Can you just give us an update on where you are on the manufacturing side in terms of capabilities and scale up? And if there are any, what are the next key internal milestones you're looking for in terms of getting the company where you think it needs to be?

Christian Itin

Analyst · Goldman Sachs.

Graig, thanks for joining. Obviously, first, starting with the AUTO3 program and the question in terms of the impact on market potential. When you look at the centers of excellent inpatient segment, which is where currently the CAR-T therapies are being used, that is - represents 10% of the actual commercial opportunity within the DLBCL third-line setting in the U.S. So asking the question differently. If you - in terms of the increase, there were 90% of the market that are - we're looking to find a way to actually get tapped into. There's an enormous opportunity weigh substantially beyond the current profiles that we're seeing at the current opportunities that are sort of being visible from the CAR-T cells that you're seeing because they're literally catching about 10% to 11% of the total. So that's - I think, hopefully gives a sense for the importance of having a profile that allows you to go beyond the center of excellent inpatient setting. With regards to the manufacturing question. Obviously, we have been able and continue to manufacture throughout the peak of the COVID crisis. I think which gives you and should give you a good sense of the ability that we've developed now to be able to deliver, including managing the complex supply chain in the U.S. with a vast reduction in commercial flights, and that was still feasible. So we feel good about the way - where we are on the commercial - on the manufacturing side and our ability to deliver for our clinical studies and also are now gearing up to the full conduct of the pivotal study and as well as other activities on the clinical side, as we've alluded to in the context of the presentation. So we're on-track where we want to be with…

Operator

Operator

And your final question comes from the line of Daniel [ph] with Polygon Global.

Unidentified Analyst

Analyst

It seems like a really good update. So happy to hear that for sure. two quick questions. One, could you be really kind and just give us a reminder of sort of approximate cost savings that treating patients and also, it's really - in an outpatient setting would bring, again, sort of a total cost of treatment? And two, it's interesting to see [indiscernible] is going to be talking at ASCCT. The presentation coming up, I think, next week, about sort of some optimization techniques he has been using, using AUTO1 product. And I was just wondering sort of are there further manufacturing tweaks that can be still brought in at this stage of development across the programs. It seems sort of very interesting, but I just wonder how much flexibility the FDA will give you changing manufacturing processes at this stage?

Christian Itin

Analyst

Thanks, Dan, and thanks for joining. I'll start with the second question. The - in terms of the manufacturing processes, obviously, there's a certain degree of improvements you can make that allows you to stay within still the same product. And you can do, obviously, quite a bit of work as you go through the early stages of development, as you point out. Once you get into a pivotal study, you obviously want to be sure that the process you're running actually remains consistent throughout the trial so that indeed, you have a proper integrity of the data set. So to that part of the question, you don't want to move or change your manufacturing process in a pivotal study. You want to actually keep it steady and make sure that there is a consistent data set. With regards to, in general, process improvement in the - for CAR-T therapies, very clearly lots of ways on how you over time can improve processes, not that is similar to what we had seen when we were developing kind of the from the early stages of antidevelopment to the kind of manufacturing processes we have now. A lot of that was continuous tweaking and optimizing of individual processing steps. And absolutely, those are areas that we're very actively working on, and looking for ways to continue to improve the processes going forward. And I think that will continue to be an activity, as you would have with any biological approach and certainly with approaches as complex and with as much opportunity for optimization as a cell-based manufacturing process. But you're absolutely right. You don't want to run changes through a pivotal study. That would not be a good idea because it risks the integrity of the study. So that's the first -…

Unidentified Analyst

Analyst

Okay, that's very interesting. And so has it been quite easy to find people who are interested in doing the outpatient setting, so in terms of going out and finding the new clinics?

Christian Itin

Analyst

I mean it is obviously an interesting thing to do also because even if you run an academic center of excellence, if you have a lot of resources owned by an individual patient means that there is just less other patients you can care for. So resources is also a challenge, and it's an issue also at academic centers. So the interest is equally big, whether this is on the inpatient or the outpatient side to actually limit the source of the amount of resources that are needed to sort of manage the patient through. And if you can then actually further relieve that burden by having an ability to actually move the patients either from your normal wards, that in addition actually is a support and significant help for actually any of the centers or practices.

Operator

Operator

And there are no further questions at this time.

Christian Itin

Analyst

All right. Well, thank you very much. I'd like to thank everyone for joining. Looking forward to obviously keeping updated through a very busy second set of the quarter with obviously several calls that we're planning to update you on the data presentations at ASCO, EHA and the second part of the AACR Meeting. With that, I'd like to wish you a great day and looking forward to connecting with you obviously over the next few weeks. Thank you. Bye-bye.

Operator

Operator

This concludes today's conference call. Thank you for your participation. Have a great day.