Hello, ladies and gentlemen, and welcome to the Autolus Therapeutics First Quarter 2023 Financial Results Conference Call and Operational Progress. 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] As a reminder, today's conference is being recorded. I would now like to turn the conference over to your host, Alexandra Deschner, Investor Relations Consultant. Alexandra, please go ahead.

Thank you so much, Eric. Good morning or good afternoon, everyone, and thank you for joining us to take part in today's call for Autolus' first quarter 2023 financial results and operational highlights. I'm Alexandra Deschner, Investor Relations Consultant for Autolus. With me today are Dr. Christian Itin, our Chief Executive Officer; and Dr. Lucinda Crabtree, our Chief Financial Officer. Before we begin, I would like to remind you that during today's call, we will make statements related to our business that are forward-looking under federal securities laws and the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These may include, but are not limited to, statements regarding the status of clinical trials and development and/or regulatory time lines for our product candidates and our expectations regarding our cash runway. These statements are subject to a variety of risks and uncertainties that could cause actual results to differ materially from expectations and reflect our views only as of today. We assume no obligation to update any such forward-looking statements. For a discussion of the material risks and uncertainties that could affect our actual results, please refer to the risks identified in today's press release and our SEC filings, both available on the Investors section of our website. On Slide 3, you will see the agenda for today's call, which is as follows: Christian will provide an overview of our operational highlights for the first quarter of 2023. Lucy will then discuss the company's first quarter 2023 financial results before Christian will conclude with upcoming milestones and any other concluding comments. Finally, we will, of course, welcome your questions. Over to you, Christian.

Thank you, Alexandra, and good morning to you all. Thank you for joining us. It's my pleasure to review our progress for the first quarter in 2023. Moving to Slide number 4. We're really pleased with our program and operational progress during the first quarter of 2023, which is highlighted over the next four slides. We're making good progress with our pipeline of CAR-T programs, particularly with our elite product, Obe-cel, in relapsed/refractory adult ALL patients. You will recall that we announced in December that the Phase II pivotal clinical trial of Obe-cel in this patient population have met its primary endpoint based on a pre-planned interim analysis of 50 patients with morphological disease and as verified by an independent data monitoring committee. This positive data triggered a $35 million milestone for our partner Blackstone Life Sciences earlier than anticipated. We're looking forward to presenting the top line data of the FELIX study in an oral presentation at the American Society of Clinical Oncology Annual Meeting on June 2 in Chicago and a second oral presentation at the European Hematology Association Congress being held from the 8th to the 11th of June in Frankfurt. Updates on longer follow-up and additional sub-analysis of the data are planned for the American Society of Hematology meeting at the end of 2023 as well as at medical conferences in the first half of 2024. Operationally, the key goal for Obi-cel is the filing for a biologics license application to the U.S. Food and Drug Administration by the end of this year. In February, Dr. Claire Rode from UCL presented long-term follow-up data from our adult ALL patients in the ALLCAR19 Phase I study of Obe-cel at the Tandem Meetings of ASTCT and CIBMTR. The data demonstrated that 35% of adult patients remain in complete…

Thanks, Christian, and good morning or good afternoon to everyone. It's my pleasure to review our financial results for the first quarter ended March 31, 2023. The cash and cash equivalents and restricted cash at March 31, 2023, totaled $343.4 million as compared to $382.8 million at December 31, 2022. Net total operating expenses for the three months ended March 31, '23 were $43.1 million, net of license revenue of $1.3 million, as compared to net total operating expenses of $41.8 million, net of grant income of $0.2 million for the same period in 2022. Research and development expenses decreased by $2.7 million to $31.3 million for the three months ended March 31, 2023 from $34 million for the three months ended March 31, 2022, primarily due to a decrease of $5.5 million in clinical trial and manufacturing costs, which was offset by an increase of $0.8 million in manufacturing material costs due to increased validation activities undertaken, primarily related to our obe-cel clinical product candidate, a decrease of $0.2 million in depreciation and amortization related to property, plant and equipment and intangible assets due to the reduction in our depreciable asset base, a decrease of $0.1 million in legal fees and professional consulting fees in relation to our research and development activities, an increase of $1.4 million in salaries and other employment-related costs, including share-based compensation expense, which was primarily driven by an increase in the number of employees engaged in R&D activities, an increase of $0.7 million related to information technology infrastructure and support for information systems related to the conduct of clinical trials and manufacturing operations; and finally, an increase of $0.2 million in facilities costs related to our new manufacturing facility, the Nucleus in Stevenage, U.K. as well as increase in costs related to maintaining our…

Thanks, Lucy. Moving to Slide 32. To summarize, we think we have an exciting time ahead of us. Obviously, the key focus on getting Obe-cel into the regulatory process with the BLA filing targeted towards the end of the year, followed by filings in Europe in the first half of next year. Next up, our planned FELIX presentation, data presentations as for DHA. And in addition, we're preparing for commercial product supply and launch readiness. We also expect to provide updates on the pipeline programs with additional data and follow-up during the year with our key programs that at this point are unpartnered and obviously create opportunity for setting up collaborations around them. Moving to Slide 33. We got cash to deliver a very significant value step. We've got the data to show that with Obe-cel, we have a differentiated product profile that addresses a high medical need with limited competition and with possibly a transformational outcome. Alongside that, we have additional opportunities for Obe-cel and broader indications and a valuable pipeline for other oncology programs. As I mentioned, we're excited about our manufacturing facility, and we have a strong technology foundation, validated our collaborators, BMS, Moderna Cabaletta, which recognize the value of our technology platform and allows us to monetize this value by way of function exercise fees milestone payments, et cetera. Importantly, we look to do more deals also of this nature in the future. With that, I would like to thank you first for listening to our prepared remarks, and we're happy to take questions.

Thank you. [Operator Instructions] All right. Please stand by while we compile the Q&A roster. And our first question comes from Mara Goldstein with Mizuho. Mara, your line is open. Please go ahead.

Great. Thanks so much for taking the question. So a couple of things. One is, I'm just curious about the data disclosure on FELIX at ASCO versus EHA and will there be anything that's different or incremental at EHA? And then, on the AUTO8 program and data expectation for data this year, can you speak to what the totality of that could look like? How many patients you might have data on?

Yeah. First off, thanks a lot for joining Mara, and thanks for the question. So the data that we're planning to release at ASCO, EHA, obviously are similar overall. What we're currently looking into is to look at certain additional sub-analysis that we could actually include into the AHA presentation. Obviously, the data cut for the two presentations is obviously the same because we're literally a few days apart. But there's going to be probably slight differences in some of the sub-analyses that we'll be discussing. In terms of the further flow of data that we go in terms of the totality of the data, obviously, we have enrolled a little bit more than 90 patients, which we'll be reporting on. And that gives us, obviously, a very good, I think, understanding of the overall profile of the product, and it gives us, I think, a good first look in terms of follow-up. And obviously, by the end of the year, we'll be able to add an additional about six months of follow-up, which will give us a start to give us, I think, a pretty good sense of where the product is sort of trending to.

Okay. And then if I could just ask, since you included it in the sort of news flow on the pipeline under collaboration, anything specifically related to the current collaborators that you think might occur in this year or is this a reference to potential new collaborations?

I think we'll keep that open. Both of those outcomes are possible.

Okay. Thanks.

Thanks, Mara.

And our next question comes from Matthew Phipps with William Blair. Matthew, your line is open. Please go ahead.

Thanks for taking my call and question. So the AUTO immune indication is obviously pretty interesting in Novartis and Bristol talked us up pretty significantly last week during their own earnings calls planning to move a kind of more rapid manufacturing process of their CAR-Ts into those indications. Do you think you'll take Obe-cel as is right into the autoimmune, would you look to maybe add any safety modules just in case of adverse events in that population. And just wondering, do you have any thoughts on what the ideal durability of a CAR-T is in an autoimmune disease? Is this something where you need consistent [indiscernible] or it's more of a reset of the [indiscernible]?

Very good questions, Matt, and thanks for joining. Obviously, I think we've always been, I think, watching the team in Airline very closely and have the opportunity to also review the data obviously [Technical Difficulty] as well. I think what we're seeing is quite an interesting profile in that the reset of the B-cell compartment, those seems to be important for -- in a number of ways. But what it basically would show or shows is that once the compartment is properly reset that over time, although B cells eventually come back, it doesn't look like the autoreactive sales are coming back. So -- and it appears to be actually a longer-term effect. Obviously, the follow-up is still limited, but it looks very encouraging in that regard that it could actually have been a proper reset of the compartment. The exact duration for how long yeah, actually have to have [indiscernible] to achieve that goal. I think it's very difficult to tell. What we do see is that in these patients that have overall a relatively normal immune system. Obviously, they're not like ALL patients have not gone through the same kind of rigor of therapeutic pressure. We do see actually that the persistence actually is not as long as in some of the products that were being evaluated to what was seen in AML is an example or in other indications. So there's probably going to be a bit of a difference, but I think there is sort of a certain amount of period that he would like to see the B-cell aplasia to be in place to be sure that you really captured all these potentially autoreactive B cells and be sure that you haven't properly said. But I think there's more to be learned in the space around that. And I think at this one, probably premature to sort of actually give you an exact number because I think it's just not known. In terms of design, we believe the design of the product actually is a really good design. It fits very well. And obviously, with the safety profile that we now demonstrated in lots of different -- a number of different indications with very different challenging patients, I think, sets us up very well in that setting. And then the final basis, obviously, you have to be able to manufacture, manufacture efficiently and also at the reasonable cost level and it's also one of the key areas we've been focusing on for obe-cel and we believe we are very well positioned.

Thanks, Christian. And I have one quick follow-up. For the AUTO4 update at ICML, will that include the full cohort of patients that were treated with the streamlined manufacturing process?

Probably not the full cohort as far as I can tell at this point, but there's going to be some additional update, obviously, a longer follow-up of the patients as well as some translational data that I think will be helpful to understand kind of what the traction of travelers.

Great. Thanks for taking the question.

All right. Thanks a lot, Matt.

Please standby for our next question. And our next question comes from Yanan Zhu from Wells Fargo Securities. Yanan, please go ahead. Your line is open.

Hi. Thanks for taking our questions. You mentioned that the FELIX study was enrolled during the pandemic, and that presented some challenges such as patient loss to COVID-19. I was wondering whether conducting the study during the pandemic could have also affected the response rate or duration of response and other metrics of the study's endpoints, around the same line of thinking, I was wondering whether the second half of the enrolled population was in any way less affected by the pandemic due to the timing of enrollment? And lastly, regardless of pandemic impact, I was wondering whether the second half of the enrolled patients have any differences in terms of their disease severity, such as the extramedullary involvement compared with the first 50 patients in the interim analysis. Thanks you for taking the questions.

Thanks a lot Yanan. These are very insightful questions. And obviously, one of the things that we certainly were keenly observing but also we're concerned about as we're going through the involvement of the study. Obviously, you've seen the data for the interim analysis. Obviously, we have a very high level of response rate -- we have an excellent safety profile. So I think overall, we do know that the program has done really well in this population and during this period of time. Now one of the key things that we're in the process of evaluating, but we don't have the full answers at this point. It is what is -- what are sort of the individual impact that we did see during that period of time attributable to the conditions that we were having, restrictions on travel for patients, which like the delays for some of the patients to actually get access to treatment, et cetera. So a number of variables there. But as you pointed out, this is not a constant, but it was a period where we had a lot of activity on the infection cycle in the first quarter of 2022 and then different is if you were beforehand, and you feel afterwards. So we'll do a full analysis of that. We'll evaluate that in more detail. I'm sure we're going to be basically presenting that data in more detail at one of the later conferences, most likely looking at cash, what kind of full review of that. And so I think at this point, it's premature, I think, to speculate on the questions you were asking. I think they're all very good questions and they're exact questions that we're evaluating in the data, and we're looking for various potential signs of impact, et cetera., over time. And we'll absolutely going to share that with you once these analyses are completed, and we also have enough follow-up with all patients to understand the full impact that might have been there.

Understood. Thanks for taking the questions.

Thanks, Yanan.

Okay. Please standby for our next question. And our next question comes from Gil Blum from Needham & Company. Gil, your line is open. Please go ahead.

Good morning, everyone and thank you for taking our question. So just one sort of multiple myeloma here. It feels like the field is getting -- the standards are getting higher and higher. And I have to admit there is evidence to show the dual targeting can be a good approach. But given the early stage of your program, where do you think this treatment could fit? And what is the best strategy to move it forward and maybe going allogeneic in some way. I'd love your insights here.

Yeah. Very good question, Gil. Obviously, an interesting field. And I think I feel we're all learning a lot about. Obviously, we have on the long hand. We have remarkable data coming out of the approved programs in early line therapy. And I think that is certainly one of the key areas where I think everyone can be really excited about, and we hope that this obviously will have a big impact on patients. At the same time, we do see a massive gap between the demand for therapy and the interest for therapy and the actual ability to deliver the therapy. And that certainly has been sort of one of the biggest challenges that I think we've seen in the field is that ability to deliver the market and to serve the market is, at this point, very far apart and quite disconnected. And now obviously, on the one hand, is a real challenge to manage because there are a lot of patients that would need access to therapy and do not have that access. But on the other hand, it also points to the fact that there is room for a certain number of additional programs to actually help serve the market and to really be able to sort of provide that remarkable type of transition and activity that we have seen to our longitation pool. When we look in terms of the profile, and I think some of the areas that you obviously want to see is, I think with -- in this disease setting, you'd like to see a product that has a safety profile that can [indiscernible] managed and handled in a broader range of centers, not just at a smaller number of academic transplant centers, but be able to go more broadly than that. So I think safety is important also with the age sort of average of the population as well. And the other aspect, I think, is that we obviously haven't yet seen whether those initial remarkable activities do translate into true long-term outcomes. And I think that's an area that I think will keep watching. And certainly, when we look at the ability to go after potentially driving sales, which is one of the reasons why we're including a CD19 component into AUTO8, but also having a more sustained presence of the product and persistence may actually be helpful to sort of actually create longer-term outcomes. That's what we're interesting and interested in understanding from our own product from AUTO8. And it's one of the key things from evaluating in this initial Phase I study. And I think depending on the outcome, I think there are sort of different paths that we can take from there forward, but I think it's somewhat premature in the absence of the data to sort of guide on a portion.

Thank you, Christian. Very helpful. And just a quick one on AUTO4. How is the company thinking on this program I'm testing early data, but do you think this is more of a company-sponsored effort overall or maybe more partnership material or the jury still out on that one? Thank you.

Yes. Good question. So obviously, at this point, we are very focused on delivering OVC. It's a full-out effort to deliver the program and really establish the kind of initial infrastructure for commercialization, both in manufacturing and from an actual delivery perspective, commercial delivery perspective. And that certainly required us to sort of focus very substantially on Obe-cel. And I think there's opportunity across the pipeline to consider entering into partnerships for some of the programs. also as a way to be able to actually move them more and more aggressively and more imperial to the activities that we're conducting with Obe-cel. So there's opportunity there. Obviously, we're excited about all the four. We think it's a very interesting program that starts to have very interesting data and certainly is a program that we feel has a real potential in a high medical need setting.

Thank you for taking our question.

Thanks a lot, Gil. Appreciate it.

Standby for our next question. Next, we have Kelly Shi with Jefferies. Kelly, your line is open. Please go ahead.

Thank you for taking my question. For AUTO1 CD22, could you have to elaborate the definition of Kymriah therapy [indiscernible] criteria? Do you see post the CD19 car market attractive to pursue for AUTO1 CD22? And also, we saw two auto new targeting program targeting CD19 CD20 running trials in post-CD19 settings. Could you share your view between CD20 and CD22, which one is still a better antigen to tackle CD19 relapse. Thank you.

Very good question. Thanks for joining, Kelly. So first one, with regards to AUTO1/22 and the fact that we were describing these -- the patients [Technical Difficulty] can ineligible. The two basic sort of settings that sort of exclude currently the patients certainly in the U.K. from Kymriah therapy. One is if you already have been on Kymriah and have failed, you're not eligible for a second round of Kymriah therapy. So that's one group of patients. And that includes also patients that actually have relapsed with CD19-negative disease that I did refer to before. The second part of the population is it if you have isolated extramedullary disease, which also excludes you currently from Kymriah therapy. And then there's certainly certain patients that are just too in probably too poor condition to be considered and to be included on the commercial product. But it's a truly refractory population that we have treated here that we also would have expected if we had treated these patients with Obe-cel, we might have been able to get about 40%, maybe for lucky 50% into a CR, but certainly not anywhere close to the 83% that we have seen in the -- in this extension of the CARPALL study. Now with regards to kind of the dual targeting approach and the choice of antigen, there was say a number of considerations here. And we've seen programs actually for quite some time on the one hand, targeting CD19 together with CD22 targeting or CD19 with CD20 targeting, we and others have been active in this space. Our focus has been on CD22. And the reason for adding CD22 was sort of two-fold. First, similar to CD19, the expression of CD22 is actually seen in a wider range of B-cell differentiation stages, particularly also present…

Very insightful. Thank you.

Thank you.

Thank you very much and stand by for our next caller. And our next question comes from Asthika Goonewardene at Truist. Asthika, your line is open. Please go ahead.

Hi, guys. Thanks for taking my questions. So I just want to dig into the answer you gave to the Gil’s question for a minute, Christian. And maybe just how do you compare the type of number of centers where you can get BLINCYTO versus the number at the centers where you can get to [indiscernible]. And then as you plan to commercialize obe-cel, what is your strategy for targeting these medical centers where it's likely to be used and the size of the sales force they should need? And then I have a couple of quick follow-ups.

Very good. Thanks for joining us. This is a very interesting question. And so when you look at where BLINCYTO got launched, it was launched basically initially in the transplant centers in the U.S. and also in Europe, which is in the U.S., give or take, 60 centers to sort of really represent the real core of enters treating ALL patients with advanced disease. So you do have a pretty significant concentration of these very severe -- severely sick patients to be treated in this smaller number of centers. So that's -- I think that's the first aspect. And obviously, we have in the current trial in the FELIZ study, we got 24 of those 60 centers in the trial included and having gained experience with the product. When you think about the broader opportunity, that is really one of the key things. I think the learnings for pension, I think there will be that will also be relevant for obe-cel is that the patients that have lower disease burden tend to be better manageable, tend to have less adverse events. And also in the case of BLINCYTO also then have elevated levels of responses that were observed. And it is that profile that I think allows you to consider actually treating these patients in non-academic transplant centers in the U.S., which actually allows you to expand the footprint quite a bit and frankly, allows you to get closer on average, get closer to where the patients actually do live. And that actually takes risk out. It makes access easier. And I think it's certainly an important part. And what we do know with BLINCYTO that if you look at the second course of treatment, the third course of treatment, actually those courses tend to actually induce very little adverse…

Great. Thank you, Christian. And then if I can follow up with a couple of quick ones. At ASCO, what proportion of patients -- of the 50 patients in the efficacy analysis will have six months of follow-up. And then at EHA, I was just wondering if you could maybe give me a little color of what kind of sub analyses will be presented. I might need a little help convincing my DOR (ph) as to why we need to go to Frankfurt?

Well, there's always the opportunity to have a beer, and that seems like a good reason for why you might want to go. There you go. There you go. Okay. Look, when we went obviously we're going to report on all the 90-plus patients that were dosed in the study, when we look overall in the study, we will be close to lower between eight and nine months of follow-up of the median. So that gives you, I think, a pretty good sense of what that may look like. So that's what that in terms of the overall data. The nature of what we're going to show ultimately on any additional potential analysis, I think that is still actually being finalized. It would be too early to guide on. So I think it comes down to -- you'd probably have to go for the beer to be on the safe side, so there, you're not going to miss anything.

Okay. Appreciate the color, guys. Thanks so much.

Thank you.

Okay. That concludes our Q&A for today. I would like to now turn it back to Dr. Christian Itin, Chief Executive Officer for closing remarks.

All right. Well, thank you very much. First of all, thanks all for joining today. Fantastic to have you all well and you taking the time. And we're obviously looking to -- forward to hopefully seeing you in person during one of the two main conferences this summer. And if not, hopefully, upon our recent upcoming trips to the respective your respective areas. And with that, I'd like to conclude at this point. Thanks again, and looking forward to keeping you updated with the next update, obviously at ASCO in a few weeks' time. Thank you.

And thank you very much for your participation. This does conclude our program. You may now disconnect.