Hello, ladies and gentlemen, and welcome to the Autolus Therapeutics Second Quarter 2022 Financial Results Conference Call. As a reminder, this conference call is being recorded. [Operator Instructions] Without further ado, I would like now to turn the conference over to your host, Olivia Manser, Director, Investor Relations. Olivia?

Thanks, Gory. Good morning or good afternoon, everyone, and thank you for joining us to take part in today's call on the financial results and operational highlights for the second quarter of 2022. I'm Olivia Manser, Director of Investor Relations. And with me on the call are Dr. Christian Itin, our Chief Executive Officer; and Dr. Lucinda Crabtree, our Chief Financial Officer. So on Slide 2, before we begin, I would just like to remind you that during today's call, our discussion will contain forward-looking statements. Please make sure you are familiar with this disclosure slide. On Slide 3, you should see the agenda for today, which is as follows: Christian, will provide an overview of our operational highlights for the second quarter of 2022. Lucinda, will then discuss the company's financial results before Christian will conclude with the upcoming milestones and any other concluding comments, and we'll then turn over for Q&A. I'll now hand over to Christian to begin the presentation.

Thank you, Olivia, and good morning to you all, and thank you for joining us. It's my pleasure to review our progress for the second quarter in 2022. Please move to Slide 4. For those who are new to Autolus and as a refresher for those of you who know us well, we are building a fully integrated CAR T company. Building on our broad platform of cell programming technologies, we're generating CAR T products that are tailored to the specific tumor setting we're addressing. We had a successful quarter with multiple readouts from our clinical programs at the European Hematology Association Congress in Vienna in June, which gives us great confidence in the inherent value of our pipeline and the progress achieved. We continue to enroll patients into the pivotal FELIX trial, where we're investigating obe-cel for the treatment of relapsed/refractory adult acute lymphoblastic leukemia patients. And in April, we obtained a Regenerative Medicine Advanced Therapy or RMAT designation from the FDA. As a consequence, we now have preferred regulatory access for obe-cel in all key territories, the U.S., Europe and the U.K. and have met with the FDA in the context of a Type B meeting to discuss the regulatory pathway going forward. We're on track to enhance the initial results for the FELIX trial in Q4 2022, which will be provided by way of a press release, and we're planning on presenting the full data set at a medical conference in mid-2023, most likely at ASCO.As previously announced, in addition to the primary morphological cohort in the FELIX trial, we have expanded the MRD cohort to enroll up to 50 patients. In clinical practice, patients get evaluated on a regular basis for recurrence of disease, typically using flow analysis or PCR of their bone marrow samples. Indication…

Thanks, Christian, and good morning or good afternoon to everyone. It's my pleasure to review our financial results for the second quarter to June 30, 2022. We continued in the second quarter of 2022 to focus our research and development efforts on our lead product candidate obe-cel, as well as certain pipeline assets addressing cancers with limited treatment options. Cash at June 30, 2022, totaled $216.4 million as compared to cash of $310.3 million at December 31, 2021. Total operating expenses for the three months ended June 30, 2022, were $46.5 million as compared to total operating expenses, which was net of grant income and license revenue of $1.6 million, up $37.7 million for the same period in 2021. Research and development expenses increased by $6.1 million to $38.2 million from $32.1 million for the three months ended June 30, 2022, as compared to the same period in '21. The net increase in research and development expenses of $6.1 million was primarily due to the following: An increase in clinical costs and manufacturing costs primarily related to the obe-cel clinical product candidate, which is $3.5 million, an increase of $1.4 million in salaries and other employment-related costs, including share-based compensation expense, which is mainly driven by an increase in the number of employees in Asian R&D activities, an increase of $1.4 million in legal and professional consulting fees in relation to the company's R&D activity, an increase of $0.5 million related to information technology infrastructure and support for information systems related to the conduct of clinical trials and manufacturing operations. And these increases were offset by a decrease of $0.5 million in facility costs related to the termination and closure of the company's U.S. manufacturing facility in 2021 and shift in its manufacturing strategy and also a decrease of $0.2…

Thanks, Lucy. Moving to Slide 26, and we're getting to next steps. We do believe we have an exciting period ahead of us with obe-cel in relapsed/refractory in adult ALL patients rating readout of the pivotal FELIX study starting in Q4 2022. And then obviously, as we indicated earlier, planning on presenting the full data at a medical conference in the first half of next year. We're also excited to sort of engage obviously, in more intense interactions with the FDA, and I did mention before that we had a very positive meeting Type B meeting with the FDA in the context of the RMAT process. Now the studies of obe-cel in relapsed/refractory, B-NHL, CLL and primary CNS lymphoma are ongoing as well as our AUTO1/22 program and our AUTO4 program, and we expect to have more data over the course of this year and next. As I mentioned, we dosed our first patient in our multi myeloma study. We look forward to AUTO6NG along getting started in neuroblastoma. And finally, as a result of our collaboration with Blackstone and it has the anticipation of the milestones we expect to receive, we do have and maintain a cash runway that sees us into 2024. We're now at the point, we're happy to take questions. So operator, please let's start the Q&A.

[Operator Instructions] Our first question is from Mara Goldstein at Mizuho. Mara, you're up.

Just with respect to the timing on the MRD study, how does that line up with BLA filing potentially? And then just to circle back on the RMAT and the meetings that you've had with FDA. From this point on, what's the next interaction with them? And how does manufacturing also fit into that discussion?

Yes. Very good question, Mara, and thanks for joining. So the MRD cohort will obviously continue enrolling into next year. Our plan is to file for BLA towards the end of next year, and so we will certainly have data from those patients that we can actually support and that is obviously an ability as we're going into the BLA review process to update also on clinical data and will give us an opportunity to add on some additional data there as well. So we'll definitely have information on that cohort with a reasonable level of follow-up. But I think it's important to understand that the primary data that will actually drive an approval of the product will come from the morphological cohort. So the data from the MRD cohort will be supportive or supplemental in that sense, it will not be the primary data for new. The second part of the question was related to the engagement of the interactions with the FDA. What it can do under the RMAT designation is obviously, you get facilitated a simpler access to the agency. And the first key meeting that you run through is the so-called Type B meeting. And what that allows you to do is really review the program across its entire range that includes manufacturing, non-clinical as well as the clinical side of the program, there's a very broad range of topics that you can cover within the Type B meeting and actually start to get appropriate guidance, et cetera, as you move forward. So that's sort of the way it starts out. There's been obviously opportunities for interaction, both as we move forward to continue to actually address questions related to the clinical data set, but also separate sets of track that actually then focuses more on the questions related to the CMC section of the BLA. So both of those actually will be ongoing, and it's - the nice thing about an RMAT is that it gets you into a collaborative setting with the agency and gives you an ability to really have a level of access during the process that is really helpful and supportive, just preparing for a BLA and then also get into the review process.

Next up is Rob Andrews with William Blair. Rob, you're in.

Okay. Good morning. This is Rob Andrew on for Matt Phipps. Thanks for taking our questions as well. Just also for the slide specifically called out along the follow-up in the second half. Should we assume there's going to be additional patients there? I think you mentioned at the time of the EHA update that you're implementing some manufacturing improvements. Are those in place for clinical trial product now currently being used in the trial? And would you expect some data from patients treated with that product in that okay, at the end of the year?

Well, thanks for joining, Rob. You're correct. Obviously, as we have the presentation of the analyst call following the EHA meeting, we did point out back that we're going to adjust the manufacturing process and actually get some improvements into the manufacturing process that we've sort of developed also originally in the context of the obe-cel program. That is ongoing. So that work is now available and the process can be used within the new patients coming in. So we are actually in the process of actually manufacturing four patients with the new manufacturing process, whether those patients and how many of those patients might be available by year-end. I think it's too early to tell from just an analysis perspective and having a reasonable level of data item. But we certainly expect, during the course of next year obviously the full data from that additional cohort of patients that are treated with the improved manufacturing process.

Okay. Great. And then just on AUTO8, yes kind of noted that dual BCMA CD19 design. I think the plan had originally been to start with just the BCMA cost, that's the efficacy of that CAR construct alone since it was a novel contract before adding in CD19. Is that still the case? And I suppose, if so, would you expect the data in the second half of next year to be primarily BCMA CAR alone or some dual CAR as well?

So first of all, your recollection is correct. This is a program that includes two targeting approaches, one against the BCMA, the other one against CD19. On the BCMA side, there's really the focus initially to test that novel and highly potent BCMA CAR. What we've done with this particular chimeric antigen receptor is really optimize it against multiple myeloma cells that carry very low levels of BCMA on their surface. So it's a highly potent approach. I will want to first see the impact of the BCMA CAR alone and then add on, as you pointed out, the CD19 CAR as we move forward. I think making a prediction to kind of the type of data we're going to be able to see at the end of next year, it's probably a bit premature. We're starting to treat patients or have to have initiated dosing patients now. And we'll have to see, let's say, how the study progresses and how the data comes along? But I think there should be a good chance for having. I think a very instructive and formative data set by the end of next year. But it is a dose escalation study, and it is a phase long study. So we'll have to see as we go through the course of the year and can better be for the nature of the data that we present at the end of next year.

I think our next question is from Bill with Truist and it looks like your line is open. So Bill, go ahead with your question.

Hi, this is Bill. I am on for Asthika. We just had a question about the AUTO8 program and some of the recent updates we saw over the summer. We saw Grace's fast manufacturing update, and we assume that there's a preferable phenotype in their bag of cells as well along with their results, and we saw long-term follow-up with Catapult and I think there's about a 10% differential in response rates between those 2. We were wondering what you think is the appropriate bar for AUTO8. And we're hoping you could comment on discrete contract differences between the three contracts.

Well, first of all, Bill, thanks for joining. I think interesting set of questions. Obviously, we do know for - from the CARTITUDE trial that we do have a very significant level of activity we're seeing with the program. And obviously, now we are getting longer-term observation, which look very encouraging, and I think will be a big improvement for this patient group. The design of that product in terms of the way that it the binding is described to the BCMA are two binders, single domain binders that seem to be acting in conjunction and provide a very tight, very efficient binding to BCMA, which seems to be part of the mechanism that drives the high level of activity. So that's kind of what certainly what's noted by that. I think we'll have to see where some of the other programs are getting to. I think it's still early days for some of those. I think what we focused on with our program is really to make sure we do get this very high level of activity against BCMA expressing multi myeloma cells, and in our case, obviously optimized very much on the binder itself as well as, in fact, actually the actual construct of the CAR, which looks slightly different than what is more broadly used in the space. There's quite a bit of optimization that went it I think from a molecular perspective, the product looks different from obviously, the Legend J&J program and also as far as the sales program. But I think that's probably what we do know at this point in time. And I think we need to see kind of how these programs shape up over time and to that point, I think we'll have more information to share.

Next up is Gil Blum with Needham & Company.

Thanks for taking our question. Maybe a broader question first. So given kind of the emerging data from bispecifics in B cell lymphoma, do you think there's still a lot of honors on developing novel T cell-based therapeutics, particularly non-Hodgkin's lymphoma?

It's a really interesting question, Gil. And I think what we do know, I think where we probably have the best data to sort of compare contrast activities and outcomes. Obviously is an ALL where we're active or we do have Blincyto, which is still the most active bispecific T-cell engager that we have seen to describe. And when we look at the activity between Blincyto and obe-cel, there is a very significant level of difference that we do pick up in that setting inside sort of a highly comfortable on the data set, including the ability to provide long-term remissions, which is certainly what the obe-cel would suggest from the ALLCAR study, which is something that was not feasible to not be demonstrated with title after the model bispecific and the initial data. Now the bispecifics and non-Hodgkin's obviously are interesting because in the sense from that they might be able to combine with some of the other antibody mediated or antibody-based modalities. And that certainly kind of was a big play that you've seen play out with a number of companies. I think it is interesting just to note that Roche decided to enter into the home cell therapy actually with the product that targets CD20 and CD19 as well. So clearly going into the iNHL space, which before the primary focus of the company was the bispecifics and they still felt that that's an area that we wanted to get into, which to me it certainly is interesting and suggests that as we have seen in the space, it looks like the level of activity described by the initial CAR T programs that came to market in DLBCL, the activity of those programs appears to be higher and potentially more sustained compared to what we're seeing today on the bispecific role. So I think it's interesting, but it also seems to be a motion, and it looks like some of the parties who have some very specific stakes in the game seem to be considered and seem to broaden that, including moving into cell therapy.

Considering we're expecting quite a few updates across your heme platform in the second half. Should we expect this presentation at ASH or you're not giving guidance right now?

Yes. I think for the most part. I mean, we're - if you look kind of the heme segment of conferences, you got two time points typically in the year. You got at the end of the year, you got the ASH meeting at the middle of the year, at the European meeting, the EHA meeting. And those are kind of the two primary events for data releases. And certainly, as we're looking towards the end of the year, the primary focus is going to be ASH.

And on AUTO4, how would you describe the data that's evolving for TRBC targeting CAR T when they compare to data evolving from CD70 targeting CAR Ts in the same indication?

I think what we're seeing with our own data is that we're able to induce complete remissions at a pretty significant or elevated level. I think more patients to sort of be - I think precise around it, obviously very encouraging that the first three patients dosed the highest dose level achieved the metabolic CR. I think, we're still continuing to observing - observation of the patients that have achieved the CR to understand for how long these CRs can be maintained. I think that's something we do not know yet at this point in time. And I think the data is very encouraging because we seem to be getting to that level of CR without inducing a significant level of toxicity, particularly without inducing a major - or having a major impact on the actual overall B cell compartment and thus, I would say, are in a good position to maintain immunity in these patients. So that looks really encouraging. I think the data on CD70, which is - I don't think we know enough about it at this point in time to really get a good feel for that data. But what we do have with TRBC1 targeting is certainly a very unique way of targeting and a very selective way of targeting T cells and being really focused on that population. So it will be interesting to see how some of these programs evolve. There's a huge medical need. These patients need desperately additional treatment options. And we're very - I think, excited about the fact that clearly, with the TRBC1 and we also expect TRBC2 providing and having two novel ways of actually going after this disease setting in a way that exactly as well as tolerating.

And a last one for Lucy. Can you provide any information on potential cadence of Blackstone milestones, particularly given that you're going to have a pivotal readout in the fourth quarter and a filing in 2023?

Yes. And I mean, as you know, we haven't specifically broken out those milestone payments. But what we have said is that these are related to development and regulatory milestones. So I mean, read into that as you will go.

Okay. Very helpful. Congrats on the progress.

Next up is Kelly Shi from Jefferies.

Question is for pediatric ALL. Could you share any color on the enrollment pace? And is the focus only on Kymriah in eligible patients? And in time line you're targeting for the next phase of the study. And also, I'm curious which programs beyond AUTO1 will be prioritized for internal pipeline development, given the focus on commercialization, about ALL probably should be expected for the next two years?

So with regards to the patient population we've been targeting in pediatric ALL. Obviously, for the initial patients we were going for kids who have basically no option left to be - to have access to a proper therapy. And that is certainly the case with children who sort of passed or beyond issues. And what we could demonstrate is obviously the very high level of activity, good safety. And with that, I think we have sort of established kind of the basic profile of the product. As we go forward, I think there's an opportunity to also enroll patients that are - will be eligible. I think that becomes a possibility as we start to move forward. Some of the key activities that we're engaged in, in that program is also to do some modifications of the manufacturing process as well and kind of actually will explore that in a group of additional patients. And I think that data set will then actually sort of form the basis for any decision on moving the program forward. So we expect that data to become available of this initial cohort during probably the middle of next year. And that also then actually gives us the basis for moving the program forward. In terms of prioritization, you're correct. We have obviously quite a set of interesting opportunities we're building to. The key focus is going to be on delivering obe-cel and get obe-cel to market. That's clear where the primary focus of the organization is. But there will be opportunities as we go through the course of next year to actually look at advancing some of the earlier programs, including AUTO1/22 as well as AUTO4, which I think both of them will start reaching interesting data points during the course of next year, and I think will become programs that can be fully developed at that point in time.

Next up, we have Chuan Hong from JPMorgan.

Hi, this is Chuan on for Eric Joseph. Thanks for taking our question. So just a follow-up. On the AUTO4 program. So since the update for EHA, are there any new interpretation of the lack of AUTO4 expansion in the porphyria? And do you expect the product made from the modified manufacturing process to have an impact, the full sale of phenotype and expansion potential. So yes, that's it.

So what we did see, obviously, with AUTO4 is we did see the clinical responses, and we also see nicely expanding CAR T cells in the actual tumor lesions, that data that we shared at the conference. What we did not see is elevated levels of CAR T cells in the periphery. Obviously, we can detect CAR T cell, but we don't see significant elevated levels. Now this is not too uncommon, if you have also depending on looking at the B cell patients as an example, that you can also have patients that actually do show complete information without actually showing any significant increase in level of CAR T cells. Now what we're expecting to do with the changes in the manufacturing process is really to help us in this patient pool, which obviously has - what we collecting cells from the patient that could also potentially include lymphoma cells, the first step in the manufacturing process is you actually have to get removed cells that potentially could also include lymphoma cells and is to take our case we're removing TRBC1 from the B cells. So we start actually with a reduction of cells at the first step and then we go into the manufacturing process. So the process is somewhat different than what you normally would use. And what we're going to do is adjust the process such that we can actually run the process in a shorter period of time, and that may actually have an impact on some of the cells behavior, as we've seen in some of the other programs as well. Whether that ultimately will show a difference in terms of the T cells we see in vivo formed and these patients are not. I think that remains to be seen. This is frankly an experiment that actually hasn't been done. There's no really precedent that I think we can build on here. But it will be interesting to look at that and they all see [indiscernible].

All right. That's very much. Now I'd like to turn it back to Olivia for closing remarks.

All right. So this is Christian. I'd like to thank everyone for joining for - and take the time for today's update. And we're looking forward to keeping you posted. Meanwhile, and see you probably back in September and onwards. And meanwhile, for those of you who can get away, I wish you a great summer break and get some rest, and we're looking forward to seeing you and keeping you updated on what's going to be an exciting second half of the year for us. Thank you.