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

Thank you, Crystal. Good morning or good afternoon, everyone, and thank you for taking part in today's call on the financial results and operational highlights for the second quarter 2020. I am Lucinda Crabtree, Vice President, 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 entitled Risk Factors in our annual report on Form 20-F filed on March 3, 2020, as amended, 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. On Slide 3, agenda, you'll see the agenda for today, and it is as follows: Christian will provide a brief introduction, and that would be followed by our operational highlights for the second 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 call -- turn the call over to Christian.

All right. Well, thank you very much, Lucinda. This is probably the most thorough all forward-looking statements that I think we had. So with that, good morning to everyone, and thank you for joining us. I'm pleased to review our progress for the second quarter 2020. First, on Slide 5, I would like to update you on the current and potential future impact of the COVID-19 pandemic on our business. At our last financial update call in May, we were at the height of the first peak of the COVID-19 infection in New York City metropolitan area, the U.K. and Spain. The patients, whilst -- and for some weeks, patients could not be enrolled into clinical trials in those areas. In contrast, sites in the south of the U.S. continued to operate normally during that period and continued to enroll AUTO3 patients. In parallel, the start-up of our AUTO1 pipe pivotal study in Q2 has been progressing to plan. While we are now in a more stable situation in the first-hit areas and patient enrollment resumed, we are monitoring with some concern the developments in the south and the west of the U.S. While we continue to enroll patients in those areas, we're closely monitoring the situation. Our key focus is on patient safety and ensuring data integrity in our trials. Most of our suppliers have been coping well through the first stretch of the pandemic, while some have experienced issues. We are working closely with all our suppliers to ensure uninterrupted supply of essential goods and services for our operations. Finally, we've been working closely with our logistics partners to ensure uninterrupted and timely continental and transatlantic deliveries of leukapheresed [indiscernible] and final products. To date, our lead programs, AUTO1 and AUTO3, have not been significantly impacted by the…

Thanks, Christian, and good morning or good afternoon to everyone. If we move to slide -- the next slide. It's my pleasure to review our financial results for the second quarter, that's for June 30, 2020, starting with our cash position. Cash and cash equivalents at the 30th of June totaled $212 million, and that compared with $243 million at the end of the previous quarter. Net total operating expenses for the 3 months ended 30th of June 2020, were $39.5 million. That's net of grant income of $0.3 million, and that compared to net operating expenses of $37.2 million, net of grant income of the same amount for the same period in 2019. Research and development expenses increased to $31.3 million for the 3 months ended 30th of June from $26.2 million for the 3 months ended 30th of June 2019. Cash costs, which exclude depreciation and amortization as well as share-based compensation, increased to $26.5 million from $20.2 million. The increase in research and development cash costs of $6.3 million consisted primarily of: one, an increase in compensation and employment-related costs, that's net, though, of lower travel cost as a result of the ongoing pandemic of $1.8 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 million in project expenses as a consequence of the advancement of our clinical portfolio, which includes all of the research process development and manufacturing activities necessary to prepare, activate and monitor the clinical trial programs; thirdly, an increase of $1.3 million in facility costs related to the commencement of the lease for an additional manufacturing suite and the continued scaling of operations in the manufacturing facility; and lastly, an increase in IT and telecoms general…

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 20. The upcoming 6 months will yet be another eventful period for us with multiple clinical milestones and opportunities for value creation. Our chief and most imminent operational focus will be continuing enrollment and dosing of patients in the pivotal Phase Ib/II trial for AUTO1 in adult ALL and completing the outpatient cohort for AUTO3 in DLBCL. We also expect to report clinical data on the AUTO3 ALEXANDER trial at the forthcoming ESMO meeting and a further update plan for ASH, an updated AUTO1 ALLCAR19 data also planned for ASH. In the second half of 2020, we'll look to progress AUTO1NG, our next-generation program for ALL, into a Phase I clinical study in the pediatric setting. And in the same period, we also expect our next-generation multiple myeloma program, AUTO8, to enter the clinic. Towards the end of the year, we expect to progress our first allogeneic program into clinical development as well. As we move through to the end of the year and into next year, we will look to progress a number of other -- our other preclinical candidates to a point of Phase I readiness, including AUTO5, AUTO6NG and AUTO7, which are the programs we updated you at AACR. We plan for these programs to enter into the clinic in 2021. Finally, in the first half of '21, we look forward to providing an interim update on AUTO4 in T-cell lymphoma, and we expect to present on a smaller number -- small number of additional patients. In conclusion, on Slide 21, I'd like to recap the major messages from today's call. AUTO1, our first pivotal program, has 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 program in adult ALL, a disease setting with very high unmet need. Second, AUTO3 in DLBCL will have additional clinical data updates at ESMO and possibly ASH. In Q2, we have initiated the outpatient cohort with planned data update on that cohort by year-end. The company is in good -- in a good position, and combined with cash on hand of $212 million, we feel well poised for success. We're now happy to take questions. Operator, please take the call.

[Operator Instructions]. Our first question is from Mara Goldstein, Mizuho Securities USA.

This is Mara. Can you hear me?

Yes, Mara.

Just a couple of questions. First of all, can you provide some more color regarding the data updates expected at ESMO, such as additional patients and durability and the like? And then I had a question on AUTO8 and really more around the environment for enrolling patients in multiple myeloma trials given the number of cell therapy trials currently underway and the competing late-line therapeutics for that disease, particularly under the umbrella of where we are now with COVID. And talk a little bit about that.

Sure. With regards to the second question, I think the environment we're seeing is certainly where there is a number of new therapeutic [indiscernible] that are becoming available. I think the primary focus we see with regards to the first approval is just clearly on the U.S., and we'll expect some delay for European approvals. Our initial work will be executed in Europe. And so we think that from that perspective, we will not yet feel an impact for -- by the -- from the new programs coming in. And then I'm -- ask -- maybe ask you to repeat the first question, really sorry.

Right. Just regarding data updates at ESMO. Would you be able to give us some additional -- some color on what we can expect in terms of additional patients, durability and the like?

Thanks, Mara. Yes, the -- so in terms of additional data updates, what we had updated at ASCO was based on a data cut, obviously, in early part of the second quarter. And it included, at that point, 8 patients that were at the recommended Phase II dose. We've completed that cohort, which is a total of about 15 patients. We'll have additional follow-up obviously on these patients, not only response data, but also follow update on these -- from these patients. So it will be sort of round out the recommended Phase II dose experience for the program. That will be some of the key focus for the ESMO presentation. And then as we go towards ASH, we expect to be able to add the patient experience from the outpatient cohort for the end [indiscernible]

And if I could just ask one more question, and it's on AUTO3 outpatient program. And within the protocol defined as outpatient, what -- I guess, what would be considered success from an outpatient perspective? At what point when patients are treated, if they have an emergent event and end up having to go to hospital, do they then -- are they then considered an outpatient failure, if you will?

No. I mean the key purpose of the outpatient cohort is actually to familiarize the centers with the product and gain experience with the patients in an outpatient setting, understand handling as well as the overall management. We have to also understand that, obviously, the patients, particularly at the very late-stage of the disease, often require actually hospitalization to manage the disease itself. So this is a lot about gaining experience, understanding the profile, understanding the management. And that is sort of what the key purposes of the outpatient cohort and is really laying the foundation to then include patients in outpatient setting in a pivotal study as well.

Our next question comes from Biren Amin from Jefferies.

Christian, just on the outpatient cohort, are patients dosed with prophylaxis regimen of IL-6 inhibitors and/or steroids?

The answer is no. They're not going to be managed by giving them IL-6 monoclonal or steroids for that matter. So this -- the patient will not be managed that way. That would not be, I think, a good way to go.

And just to clarify, on this outpatient cohort, will the data at the end of the year, will that inform you on its utility for use in the pivotal trial next year in DLBCL?

We believe it will. And as I pointed out, a lot of this is really about gaining experience. And I think in that sense, it's going to be important for the centers to actually gain experience in that setting, and that is important to lay the foundation to include these patients as well.

Got it. And then maybe just one last question. On the AUTO8 program, what learnings did you take from the AUTO2 and apply that to development of AUTO8?

So one of the key focus that we were putting on or putting into the design of the AUTO8 program is really to drive for the ability to make very deep cuts and be active at very low levels of target antigen. Both of those elements, we believe, are important to actually induce a profile or create a profile that can lead to a high level of molecular remissions, which is really what we need to aim for, which are very stringent molecular remissions in that setting. So that is what that program is designed to do, and there is also additional elements that we built in that we haven't yet disclosed.

Our next question comes from Eric Joseph with JPMorgan.

I also just had a follow-up on the [Technical Difficulty] and just talk about how to think about the data toward year-end when you describe patient experience. Can you just sort of help us with expectations on sort of duration of follow-up there? Do you expect to be reporting efficacy at that point or primarily safety? And maybe just an update on enrollment to date in that cohort.

I'm not sure whether the entire question was fully audible on the reporting. I think the key question is what is the type of data we expect by year-end for AUTO3 in terms of follow-up, safety, et cetera. So I think with regards to the cohort that defined the recommended Phase II dose, obviously, that cohort has been fully enrolled, and patients have been treated before middle of the year. And so we'll have a very good follow-up in that patient group of 3 months and more, which gives us a very good view in terms of not only the CR rate at 1 month but also starting to get a feel for to sustain CR rate. We've already obviously had patients that we have now observed for 18 months or longer. And obviously, that gives us a very good view in terms of the totality of the CRs that we have induced, give us a very good view over an extended period of time or how these patients are faring. And I think with that, we'll get a very good understanding of what the durable complete remission rate will look like with AUTO3. So I think that is a very important part of the data. The second part obviously is in a larger patient group, obviously a corroboration of the overall safety profile of the product, which is an important feature of AUTO3. And so I think we're going to have obviously a substantive addition in terms of with the additional 20 patients that we're enrolling to give us a very robust data set, both on the safety overall but also from an overall CR rate perspective. And with regards to durability of effect, obviously, all the patients we've treated until now will have at least 3 months of follow-up, and that gives us a very good view of the ability of those CRs to sustain over time.

Okay. Okay. Great. I guess short of seeing similar safety in the outpatient cohort, is there really anything in terms of logistics, the ability to manage patients in the outpatient setting that would -- or manage patients in the outpatient cohort that would lead you to not pursue it in a pivotal study?

I think it is really about corroborating the data we have in this setting and as I indicated, an ability for the centers to gain experience. The current experience with CAR-T is to use the CAR-Ts predominantly in inpatient setting. That is what all the guidelines are directed to. This is pretty much what the safety management, et cetera, is really focused on. And so it does take experience. And I think this is what the patient cohort actually allows us to start to build and I think will be important as we're looking forward in this program. But it is on the pure safety data side, I think corroborating the data is important, getting a better understanding of duration of adverse events and those types of information as well, I think, will be very helpful in understanding the overall profile and preparing ourselves to include those patients going forward as well.

Our next question is from Jim Birchenough from Wells Fargo.

Congrats on all the progress. A few questions for me. I guess first, just on the outpatient cohort, could you remind us again what the triggers are for patients to be readmitted were -- if they were dosed in the outpatient setting? And around fever, the time course of fever that would require readmission? And are you seeing anything early in the outpatient cohort that's giving you confidence that you've got a viable profile for that setting?

First of all, thanks for joining, Jim. Very good questions. Obviously, the current guidelines in the CAR-T fill and in general, for late-stage DLBCL patients is that when patients develop a fever, you want to be sure that you can exclude infectious disease. And so typically, these patients do get admitted, get put on an antibiotic and then are monitored. If obviously the patients are doing well and the fever subsides quickly, the patient can be discharged quickly as well. So the timings of around those will be important. And a lot of these patients do, whenever they develop fever, whether they're on the therapy or not, will have to go to the hospital, get checked for potential infections and obviously the risk of sepsis that could develop. And it is really around managing that risk that I think you have to be very mindful and very focused from a fever perspective. Now this is no different whether the patient is on CAR-T or the patient is just being managed at that stage of the disease. And there is no difference in terms of the rules that apply and how you actually manage those patients at that point in time of the disease. So in that regard, that is a key parameter we're looking at. In terms of kind of the early experience, I think it's -- we don't have enough patients, I think, to have a feel how this is going to develop through the trial. And we have to run the cohort and get a good feel for that as we're looking at the 20 patients in totality.

And then Christian, maybe a broader question on ability to navigate the pandemic. You referenced the Southern U.S. states and the West Coast. What's your exposure to sites in those areas? And is there a way to adapt the study to enroll in sites that are less hot spot?

Yes. We do have a significant number of studies across -- study centers across the U.S., and it's -- and this really allows us, and this is now speaking specifically first for all the 3, allows us to actually focus our enrollment more towards the sites that are less impacted. And that actually has worked well so far. But it's something you have to be very vigilant about and we have to monitor very carefully. We've seen, certainly, in the last -- the month of July, we've seen pretty significant and rapid surges in places like Miami or Houston that I think we all hope to wouldn't see, frankly. Now those centers still continue to operate. The cancer centers still continue to operate, but it's very clear that when you listen to the public health officials that some of those places are approaching or have been approaching maximal capacity on the ICU beds, et cetera, which obviously starts then to put or present a risk where that could spill over into cancer centers as well. So that's certainly one of the things we're looking very carefully at. From a geographic distribution perspective, we're very well distributed across the U.S. with our centers. And obviously, we're also having centers in the U.K. on the AUTO3 side, and there is an element of an ability to balance out. And as you can imagine, while we were pretty heavily hit in New York City in the middle of -- and towards the end of April, we now actually have enrolled quite a few patients out of New York. So it's really kind of managing as the pandemic kind of flows, frankly, through the country, managing accordingly and making sure we're sort of focusing on the centers that are less impacted or less likely to be impacted in a way that would actually put the patients, frankly, at risk. But it's going to be a topic we'll have to watch very carefully as we go through the second half of the year with the risk of having kind of a flu on top of COVID. And frankly, people's attitudes starting to wane, and people start to get fed up with where we are. And I think that aspect is probably on the biggest risks that we're all going to be dealing with is that we frankly keep our act together as a population. And depending where we are, we had, I think, our issues with actually doing that. And that is actually, I think, where the fundamental biggest risk is that we're dealing with.

Just a final question, Christian. Just in terms of maybe moving your cell therapies up to earlier lines and away from less -- more up from the brittle patients in the salvage setting. Could you maybe speak to that strategy to maybe move AUTO1 or AUTO1NG or AUTO3 or AUTO3NG up to earlier lines, what the strategy is there?

I think it's a very important point. It's an area we're looking at very intently. So we're looking at ways to -- for earlier lines of therapy settings for AUTO3 and DLBCL, which we believe is important. And we're also looking at that -- also at the opportunities in the ALL setting as well where clearly, we know from the experience with blinatumomab, going to an earlier line of therapy, basically, in that particular -- where that particular redirected T-cell therapy doubled the molecular CR rate by going earlier in the setting. So there's a very clear, very strong rationale for moving to earlier setting and a very significant opportunity for improved outcomes at a number of levels in these patients. Obviously, less beaten up. They have -- typically, the disease isn't quite as rapidly progressing as we have at the last line setting. And that actually -- together actually gives you an opportunity to have a much more profound impact for these patients.

Our next question comes from Asthika Goonewardene from Truist.

I was wondering about AUTO4. Could you maybe talk to us a little bit about what we would expect in the data in the first half of 2021 and what kind of follow-up? And then also, if I can add on to that, T-cell lymphoma is a very diverse set of diseases. I was wondering if there's potential for you to get a broad indication across all T-cell lymphomas by focusing on the 3 subtypes that you're looking at in the Phase I study?

First of all, thanks for joining, Asthika. The AUTO4 obviously is -- it's still in dose escalation. So it's going to be a smaller number of patients with dose escalation information, and we'll see whether -- where we are at that point in time in terms of the dose levels. But the information will predominantly be on activity of the product at certain dose levels in a small number of patients. In terms of the disease setting, you're right, T-cell lymphomas are quite heterogeneous in terms of a population. However, when you look at outcomes, the large settings actually have a very similar rather homogeneous outcome. So you can actually include the larger settings in a single trial and actually run it as a single trial in that -- that actually has the same outlook in terms of time line with regards to relapses, duration of responses, et cetera, in general, where they behave very similarly. And that is what we're doing. So we actually allow the major indications in T-cell lymphoma to be recruited into the study and have a indication like PTCL as a separate entity that would actually have to be developed as a separate label.

Our next question comes from Robert Andrew with William Blair.

This is Rob Andrew on for Matt Phipps. Just a couple from me. I noticed in the press release here that the manufacturing capacity has been increased at the cash flow side. Is that just in general to support the pivot of AUTO1 and the potential launch there? Or is that kind of also taking into consideration potential AUTO3 launch as well? And then I guess, given the number of candidates that are entering the clinic in the next kind of 6 to 12 months, is the capacity there now able to support all those studies without strain? Or does there have to be prioritization?

Very good question. So we're adding capacity at the Cell Therapy Catapult to actually support a launch for AUTO1. Supporting launch for AUTO3, we believe, will actually require more capacity, and that's one of the reasons why we're obviously working on the Rockville facility that we have introduced a little while ago. With regards to the capacity for the conduct of clinical studies, obviously, we do have quite a bit of capacity at this point in terms of our ability to run clinical studies and will, with the capacity we're building up also towards commercial launch, will actually have quite a good level of access to cell manufacturing capacity that we believe will not limit us with regards to the clinical programs. I think also worthwhile in mentioning in this context is that we're obviously also collaborating with academic centers on some of our programs, including AUTO1NG and AUTO8, where the same types of processes -- process that we're running, our AUTO1 and AUTO3 programs, those are actually being run at GMP facilities at some of those academic partners as well. So we're actually having quite a network of capacity that we can work with, particularly for the earlier translational studies.

Okay. Great. And then if I could just follow up on maybe an earlier question on the AUTO8 program. Seeing that we're still on track for initiation in the second half year, any kind of additional information on where we might hear some more about the design of the new CARs that are in there? Maybe any preclinical data that kind of supported this advancement?

I think for now, we're obviously working on publishing quite a bit of our data across our programs. In AUTO8, we're probably going to hold back a bit. We want to see kind of how the product actually behaves in the clinic and then actually, we'll make the determination of when and how to present. This program is obviously in a very competitive space, and it's also, frankly, has to hit a very significant biological hurdle that we set for the program. And so we want to actually run it out and see where we get to, and we'll update in due time.

Our next question comes from Graig Suvannavejh from Goldman Sachs.

Congrats on the progress that you're making. I had 2 questions, if I could. The first is just on the competitive landscape, we recently saw approvals for Monjuvi, which is in a second-line setting for DLBCL, and BLENREP, which is BCMA-targeting asset and perhaps in a fifth-line setting for multiple myeloma. So just with that in mind, could you just remind us how you're thinking about AUTO3 and AUTO8, respectively, and how they are going to be positioned relative to those products? And then my second question is actually maybe best for Andrew. I'm just thinking about as you advance, particularly AUTO1, and you're getting closer to potential filing and hopefully, commercialization. Just trying to get a better sense of when, as a company, you guys are thinking about increasing investment around precommercialization activities or commercial infrastructure ahead of that.

All right. Well, thanks a lot for joining, Graig. Thanks for the questions. So with regards to competitive landscape, obviously, on the -- within the DLBCL segment, there's obviously quite a good number of programs that are active in this space. We had, as you pointed out, the recent approval of the CD19 monoclonal antibody from MorphoSys and Xencor. And -- but there is also obviously quite a wide range of activities with bispecific antibodies, ADCs as well as obviously a range of different types of CAR T approaches. So absolutely a competitive environment. With regards to the CD19 monoclonal antibody, I think the attractive part about that program and the current setting is that it's a setting where the patients actually have a hard time tolerating significant adverse events. It's patients that are not eligible for an organ transplant. And what we basically need for these patients is a very well-tolerated approach that still gives them an opportunity to actually get a longer-lasting remission in that particular setting. And that is really what the program managed to do, combined obviously with a rather mild chemotherapy component, which I think was the critical piece there to sort of created therapeutic options for patients that otherwise would have a hard time taking on a lot of toxicity. So that is, I think, where that program is. When you look at the data in last-line setting, the CRs actually come down dramatically. And there may be a 20% -- whether they're sustainable, I think it's too early to tell. So they're very similar to other approaches that we've seen in last-line setting and where, in fact, the CAR-T programs are set apart significantly. When you look at the Yescarta data, which is still today the best long-term data that we have in…

Yes, I do. It's -- Graig, thanks for the question. I mean look, I mean, in terms of where we are talking about commercial sort of ramp-up, et cetera, that will be a question, I think, we'll be addressing in '22. There's not a huge need at the moment for that. We're very fortunate that we have a very experienced commercial group. It's a very small commercial group but a very experienced commercial group. And so they're providing all of the thinking and the input that we need at this point. The physical sort of boots on the ground side of thing is certainly a question that I'd be happy to talk to you about when we get to 2022.

Thank you. So it looks like that's all the time that we have for questions. The company will be happy to take any follow-up questions directly. And I'll now turn you back over to Dr. Christian Itin.

All right. Well, thank you all for joining us today. It's great to actually be able to give you an update. Great to see many of you joining the call in the middle of August or beginning of August here. So we're looking forward to the end of the quarter and update you on AUTO3. And then obviously, at the end of the year at ASH for the additional updates on both our hemo-on programs in B-cell malignancies. With that, thanks a lot for your continued support, and we're looking forward to also being in touch and keeping you updated. Thanks a lot. Bye.