Autolus Therapeutics plc (NASDAQ:AUTL) Q4 2023 Earnings Call Transcript

Christian Itin: Yeah. It’s interesting. There’s obviously a lot of hypotheses and that sort of gets me back to actually what we know works. And so what we know works is a product that is a long positioning product in pediatric ALL when used in autoimmune patients, which have a very active immune system as a consequence, the persistence, of course, is shorter than in highly uncompromised pediatric ALL patients. That you do see that, that product with that type of properties gives us the type of outcome we’re seeing to suggest that a product that wouldn’t actually be active in pediatric ALL would be able to do the — get a significant outcome in — of the immune patients, I think it’s a postulate you can set up, but certainly, there’s no data that would support that at this point.

So, what we know is that a long persisting CAR T program, it gives you the right outcome that we were looking for. We know our product has exactly those properties. And I think everything else, people will have to actually run trials and actually figure that out. But it is not, I think, very easily understandable for why you would make that correlation if you start with a product that is not — may not be really active or substantially active in pediatric ALL and then conclude that it would still work in autoimmune. It may, but I think at this point, it’s sort of a statement in the absence of data.

Gil Blum: All right. Thanks for taking our questions.

Christian Itin: Thanks a lot, Gil.

Operator: Our next question comes from Eric Yeung with William Blair. Your line is open.

Eric Yeung: Hi. Eric on for Matt Phipps. I was wondering, firstly, with the additional cash on the balance sheet, I was wondering how you’re thinking about obe-cel development in other lymphoma indications. And if you plan on enrolling any additional patients within NHL or CLL?

Christian Itin: Thanks, Eric, for joining. So, we are currently looking at quite a range of indications and we’re sort of looking at where we want to actually put our bets down. And we’re clear we’re going to have at least one pivotal study in autoimmune. And we’re looking whether — where there would be a second autoimmune pivotal study or whether we’re going to be running, a, oncology study in one of the non-Hodgkin’s indications. And that’s currently actually under evaluation, that’s not yet decided. But we’re probably going to generate some additional data also for obe-cel in the non-Hodgkin’s indication to sort of round out the experience that we have made so far.

Eric Yeung: Great. And then just an additional question. So, I know you’ve had to do next-generation sequencing on patients for enrollment in AUTO4 and AUTO5 and that paper you guys published in the [Blood Journal Cancer] (ph) on the TRBC1 and 2 staining, I was wondering if you think that paper could be supportive of a potential companion diagnostic for AUTO4 and 5?

Christian Itin: It’s a really good question. And that’s obviously the reason why we’ve been working together with the parties we had on the paper. That obviously, if you can move away from NGS and go to an antibody that you can actually use and with classical staining, that obviously would simplify the approach and probably also accelerate it, because obviously, if you go with NGS, you actually you need to have the sequences, you need have the right primers, et cetera, specific and then actually run the analysis, it’s not trivial. This could be easier, and it also would actually allow you to include the staining procedures in a more standard panel of stains that we’d be using to characterize tumors. It may actually lead to already a determination of TRBC status in patients ahead of even having — basically include them in a therapeutic approach.

We have it like you have CD19 and other markers or standard markers to analyze, have them actually move also in that direction. And of course, as you point out, it gives you the opportunity for companion diagnostic based on staining procedures.

Eric Yeung: Great. Thank you.

Christian Itin: Thanks a lot, Eric.

Operator: Thank you. Our next question comes from Yanan Zhu with Wells Fargo. Your line is open.

Yanan Zhu: Great. Thanks for taking our questions. First on SLE, I know you mentioned you’re not guiding for dosing or not dosing. I’m curious about the level of interest at your first clinical site. And also, regarding your guidance for data late 2024, I was wondering about the number of patients at the time of readout and the duration of follow-up. Do you have a minimal kind of duration for follow-up? Thanks.

Christian Itin: Thanks, Yanan, and thanks for joining. So first of all, the study we’re conducting in the U.K. and in Spain. In the U.K., there are actually no competing studies for these types of patients. So that puts us in a good position and one where we think actually we have obviously, a very sort of interesting standout feature around the study and opportunity for patients. In terms of data end of the year, we obviously are expecting that we can involve the six patients, and we are able to report on those six patients, how much follow-up we’ll have of them. I think that’s premature to sort of point to. But the goal would be to actually have the cohort enrolled and then report on data from that cohort.

Yanan Zhu: Great. Thanks for those color. On FELIX, wondering for the mid-year data update. Would the data be a pooled analysis? Or would it be the pivotal cohort? Also, since you commented on your real-world bridging therapy strategy, I was wondering, does that have any implication for FDA review. Thanks.