Hello, ladies and gentlemen, and welcome to the Autolus Therapeutics Second Quarter 2023 Financial Results Conference. 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. I would now like to turn the conference over to your host, Julia Wilson, Communications Consultant. Please go ahead.

Thank you, Corey. Good morning or good afternoon, everyone, and thank you for joining us to take part in today's call for Autolus' second quarter 2023 financial results and operational highlights. I'm Julia Wilson, Communications 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 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 regulatory timelines 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 second quarter of 2023. Lucinda will then discuss the company's second 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, Julia. Good morning to you all. Thank you for joining us. It's my pleasure to review our progress for the second quarter of 2023. Moving to Slide 4, we had a very productive second quarter with the ASCO and EHA data presentation of our pivotal FELIX study as the highlight. obe-cel has shown an excellent profile in adult patients with relapsed/refractory acute lymphoblastic leukemia. The ORR, based on complete remissions with either complete or incomplete hematological recovery was 76%, up from the interim analysis, which came in at 70%. The safety profile, which was remarkable with low levels of high-grade cytokine release syndrome in ICANS, and the data tracked very well on persistent and duration of response with our prior ALLCAR19 study where we have seen 35% of treated patients and long-term remissions without any need for additional anti-leukemia therapies. Next follow-up is planned for ASH with several obe-cel-related abstracts submitted to the organizers this week. Critical for the successful outcome of the FELIX study was our robust product delivery platform with high manufacturing success rate, short vein to delivery time, and high percentage of patients dosed with obe-cel. Key focus now is on the completion of the validation of the commercial manufacturing facility, which we call the Nucleus. We're on track for a filing of a biologics license application with the FDA at the end of 2023, and a market authorization application with EMA in the first quarter of 2024. As the program is progressing towards the regulatory review, we're also actively preparing obe-cel for launch, with critical activities underway in medical affairs, completion of value dossiers, and onboarding of clinical centers. On Slide 5, we have a short overview of the key pipeline progress. First, we continue to expand the obe-cel opportunity. In non-Hodgkin's lymphoma, in…

Thanks, Christian, and good morning or good afternoon to everyone. It's my pleasure to review our financial results for the second quarter ended June 30, 2023. Cash and cash equivalents and restricted cash at June 30, 2023, totaled $307.8 million. This compares to cash and cash equivalents and restricted cash of $382.8 million at December 31, 2022. Total net operating expenses for the three months ended June 30, 2023, were $47.9 million as compared to total net operating expenses of $46.5 million for the same period in 2022. Research and development expenses decreased by $1.5 million to $36.7 million for the three months. Ended June 30, 2023 from $38.2 million for the three months ended June 30, 2022, primarily due to the following; a decrease of $5.9 million in clinical costs and manufacturing costs, primarily related to our obe-cel clinical product candidate, a decrease of $0.6 million in legal fees and professional consulting fees in relation to our R&D activities, a decrease of $0.5 million in depreciation and amortization related to property, plant, and equipment and intangible assets, a decrease of $0.1 million in material transportation costs. These were offset by an increase of $3 million in salaries and other employment-related costs, including share-based compensation expense, which was mainly driven by an increase in the number of employees engaged in R&D activities, an increase of $1.7 million in facilities costs related to our new manufacturing facility, the Nucleus, which is based in Stevenage, UK, as well as increases in cost related to maintaining our current leased properties, and an increase of $0.9 million related to IT, infrastructure and support for information systems related to the conduct of clinical trials and manufacturing operations. General and administrative expenses increased by $2.8 million to $11.1 million for the three months ended June 30,…

Well, thanks, Lucinda, and thanks in particular for all your contributions over the last few years. You will definitely be missed, and wish you success with your next steps. Welcome, Rob. We're in a fantastic situation that with Rob Dolski, we have a great successor to Lucinda in the role of CFO. And I would just like to briefly introduce Rob, and then also ask Rob to introduce himself as well. So, first off, obviously, as I mentioned earlier, that Rob joins us from Checkmate Pharmaceuticals, obviously have been going through an interesting phase of the company, including the sale to Regeneron, which obviously gives him sort of a very nice and kind of rounded experience on that kind of last part of his experience. But his experience is much broader than that. And in fact, Rob brings a very unusual combination of financial experience, but also operational experience, including deep understanding of manufacturing, commercial aspects, launch-related issues, et cetera, which are really important in where we are now, and I think will set us up really well for the next steps that we're going to take with the company, and I think will help us drive the strategy, planning, execution, as well as then the next steps and expansions that we're all looking forward to as we're sort of taking our steps and becoming a commercial entity. So, with that, I'd like to hand over to Rob just to ask you, Rob, to introduce yourself directly.

Thank you, Christian, and good morning, or afternoon to everyone. I'm delighted to be joining Autolus at such an important time. With the upcoming obe-cel BLA filing and the expansion of the manufacturing and commercial efforts, it's going to be a very busy time, and I certainly look forward to interacting with our analysts and investors over the coming months. I'll now hand things back to Christian to wrap up with a brief outlook on expected milestones. Back to you, Christian.

Thanks, Rob. So, to summarize, and we're moving to Slide 36, we think we have an exciting time ahead of us. Key focus, obviously, is getting obe-cel into the regulatory process and review, which is really the primary focus of the organization. We expect the BLA filing towards the end of the year, followed by a filing in Europe in the early part of next year. Next up, obviously are the plan to have FELIX data presentations at ASH. So, we submitted as indicated a few abstracts and also, we're looking forward to obviously providing you update and more insights in the study. In addition, we're also preparing for commercial product supply and launch readiness as a very significant workstream associated with that. And we also expect to provide updates on the pipeline programs with additional data and follow-up during the year with our key programs, which at this point, obviously are on patent, and also gives us opportunity for conversations on that side. Moving to Slide 37, we believe we're at very attractive and interesting point with the company. We've taken a significant amount of risk out of the program with the successful data presentations for the FELIX study at ASCO and EHA. And I think that puts us into a position where we believe we have an opportunity to go through a fundamental value step with the lead program and thus the business. And obviously, we're looking forward to really driving this program through that process and hopefully onto the market with, I think, a very strong belief that the product has an ability to be transformational for a very challenging indication. And I think patients definitely need access to safer and more efficacious therapies. Alongside those opportunities that we have in ALL, and that we're obviously driving with a lot of focus, as indicated at today's call, we see the obe-cel opportunity substantially broader, and we see it as a franchise opportunity that gives us access to a range of indications with the program over time, and then expanding into the additional related programs with AUTO1/22 and AUTO8 as well. So, with that, I'd like to stop here and looking forward to your questions. Thank you.

[Operator Instructions] Our first question comes from the line of Matt Phipps at William Blair. Matt, your line is open.

Hello, thanks for taking my questions and all the updates. Christian, on the SLE study, just curious if you can say at this point if you'll test multiple dose levels, how the dose might compare to the FELIX indication. Do you think there's any reason to look at different lymphodepletion regimens? And just real quick, any update on the FELIX MRD cohort just given some real-world data that CARs has shown a lot of use in patients who are MRD negative. Thank you.

Thanks, Matt. Excellent question. So, first on SLE, clearly we believe that for the SLE indication, the dose that we need in that indication is substantially lower than what we need for acute lymphatic leukemia patients, because obviously there is - the amount of cells that has to be removed is very, very different. And we expect to be able to confirm a dose that is substantially lower in this indication. We don't expect to run a dose escalation, but I think we'll pick a dose with an ability to escalate or deescalate should that become necessary. But we actually do not expect that that actually will be necessary. So, we think we're pretty clear what the dose needs to be, but we need to also want to have that confirmed in a small number of patients so that we have a basis for conversations with regulators for design of future studies. We don't think there's a change that we want to play around with lymphodepletion. You could do that, but there is - I think we've seen a lot of work that went into the conditioning of the marrow to accept cells. A lot of that work comes from the original work in stem cell transplants that was adapted for the cell therapies and particularly also for CAR T therapies. And there's a good reason I think why we have a good level of consensus utilized across a wide range of indications and programs. I do not believe that that's an area where I go back and reevaluate. That would take substantial amount of time, and we do not believe the benefit actually warrants that type of high investment. With regards to MRD, that's an area we've also been very active in. We'll certainly provide update on low disease burden patients and MRD patients, which is an obvious thing to look at because clearly patients with lower disease burden have obviously less work factor for the CAR T-cells to accomplish. But also, it will help to further improve the already very, very attractive safety profile of the program, and should also allow us to consider at least patients with low disease burden and patients who are in relatively good shape to consider actually dosing patients, ultimately in a hospitalized patient setting as well, which I think will further, I think, support access and facilitate access to obe-cel as a therapy.

Thank you. Please stand by for our next question. Our next question comes from Asthika Goonewardene of Truist. Your line is open.

Hi, guys, good morning, and thanks for taking my questions. I want to build on Matt's previous question on SLE. Can you tell us how long the dose - the DLT monitoring will be required on this Phase 1 in SLE? I'm just trying to get an idea of how quickly you will be able to get this study recruited in 2024. And then if we just think back on the data presented from the FELIX study at ASCO, you showed that tumor burden is quite associated with the incidence of ICANS, and that's very predictive and probably very useful in the physician's hands. We also know adult ALL is a rapidly progressing disease. So, I'm wondering what shaving off that five days from the vein to delivery time on FELIX versus what you expect to go - when you go into commercial mode, would you be able to get more patients before they've reached that 20% bone marrow blast threshold?

So, really good question, Asthika. First off, the question related to the Phase 1 study design at the DLT period, I think what we're seeing in the work that was done by Andreas and (indiscernible) also would indicate that you could consider a relatively compact DLT period in their hands they're using a 10-day period for the patients. So, that's something that we're looking into, but it's clearly also - obviously, we're operating with a lot of clinical data from our experience in ALL and NHL. So, we have a lot of safety experience with the product, and we believe that that can be relatively compact. The question then related to obviously the tumor burden aspect and how that could be impacted by the vein to delivery time. So, first of all, I think a shorter vein to delivery time always helps because the disease can be quite explosive in growth. So, anytime you shave off between frankly identifying the patient and treating the patient, is going to be helpful. But I think what is really important is that you want to actually make sure ultimately that if you're not running the patients to - or waiting with the patients until they've actually reached very, very high levels of tumor burden before you actually identify them and involve them for therapy with a CAR T therapy. That's not a good idea. It’s obviously what can happen. And the beauty of the data is that we're highly active across the entire range of tumor burden and disease state and severity of disease, which also gives us an awful lot of confidence around the program. But just from a very practical perspective, if you have an opportunity to identify the patients earlier, again the patients relapse, and a lot of that is done by monitoring patients’ tumor burden based on the PCR or FACS or NGS, that actually gives you an opportunity to identify the recurrence of disease earlier, and that actually increases your chances of a successful therapy, and also gives you an ability to minimize toxicity of this. So, it's clearly an aspect you look at, and I think the shorter vein to delivery time overall helps, also because a lot of these patients are very immune -suppressed and there's always a risk that the patients could actually pick up an infection, which would then actually could delay the dosing because that infection needs de first be taken care of before you could dose the type therapy. So, speed is helpful. I think we're at an excellent spot in terms of the time and dose, which is a highly competitive position.

Great. Thanks for taking my questions, guys.

Thank you very much. One moment for our next call. Our next call comes from the line Kelly Shi at Jefferies. Your line is open.

Thank you for taking my questions. I have two quick ones. The first is regarding the subgroup analysis at ASH of this year. What kind of patient stratification are you going to use for this analysis? And also, what is the reason for 30% of the patients receive transplant while still in remission? Thank you.

Hi, Kelly. Thanks a lot for the questions. The first is with regards to kind of the subgroup analysis. I think there's obviously quite a lot. It's a very rich data set. And this is one of the larger studies that actually have been conducted. If we take the Phase 1 component, it's one of the largest studies conducted in relapsed/refractory patients. So, we have a very rich data set and that allows us to look at aspects in more detail of impact of tumor burden, impact of risk parameters on outcome, both on efficacy and safety outcome. And those are clearly key areas of focus that we're sort of looking, expecting to provide updates on. So, it's a very rich data set. What we’ve seen at ASCO is obviously just scratching the surface of the data that we've collected. And we’re looking forward to obviously providing these much more detailed views, which also I think are some of the key reasons for the level of confidence in the consistency of the data that we have sort of articulated in the last few months. The patients that we had in the study, 30% of the patients did receive a stem cell transplant. That is pretty much kind of the range you sort of would expect based on clinical practice. I think if you have a patient - as an example, you have a patient that's a younger patient, still relatively fit, that has an ability or capacity to actually tolerate a stem cell transplant, or may not have had one before, I think in those cases, certainly until you have long-term follow up in the study. I think physicians will have to make a choice whether or not to follow the patient and follow the persistence, follow the dysplasia and…

Super helpful, thank you. And I also have one quick one regarding the lupus trial. So, does the manufacturing process require additional steps to increase purity compared to oncology CAR T product? Thanks.

That's a really good question, Kelly. And the answer is actually, the lupus patients are a lot simpler to manufacture because you do not have the contamination by higher levels of leukemia cells floating in the blood. So, the starting material you collect from these patients is a much better starting material. And it's also - because of that, we believe that also will allow us to actually shorten the manufacturing process for these patients because we need less cells and we actually have a much better - much more homogeneous starting material. So, it's actually just the other way around. It is an easier material to work with than what we've done in ALL, which we believe is probably the single most challenging patient population from a production perspective.

Great. Thanks.

Thank you very much. Please stand by for our final question, and please remember that management will follow up with everyone directly who didn't get to ask the questions. Our next question comes from Eric Joseph of J.P. Morgan. Your line is open.

Hi guys, this is Noah on for Eric. Thanks for taking our question. We were wondering regarding the SLE trial what clinical parameters will inform an optimal dose selection. Thanks.

Hi, Noah, thanks for joining. Really good question. So, what you want to see is the two parameters that you'd like to see and that I think you can actually get out of this study. The first one is you want to see that therapy at the level you dose gives you a very profound B-cell aplasia removal of B-cells in these patients, and a rapid decline of autoreactive antibodies in that patient. And then you also want to see that the lupus-related composite scores actually track down, and you would expect most of those to actually go to baseline. At the same time, you want to see that that clinical activity can be induced without triggering any significant level of toxicity to the patient. So, it is both the safety that obviously will be important, as well as the pharmacodynamic parameters, as well as then the disease parameters that will be following that will inform the understanding of the dose and activity relationship.

Thank you very much. At this time, I would now like to turn the conference back over to Christian Itin for closing remarks.

Well, thank you very much for joining today. Obviously, this was a full presentation. There's a lot of updates that we had in this quarter. I think an exciting stage for the company. I think it's fair to say we're kind of moving flat out across the entire organization to deliver a BLA by the end of the year, which requires obviously the completion of the work on the manufacturing facility, and then also all the work that's going on, on the clinical analysis - the analysis of the clinical data from the FELIX study. So, an exciting time, very intense, but also I think very rewarding because we're feeling that we're working with a product that has a very unusual profile, and I think that promise to really have a big impact on patients' lives going forward. So, with that, I’d like to thank you all for joining today and looking forward to keeping you updated as we go through the second half of the year. Thank you.

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