Aclaris Therapeutics Inc Corporate Update Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Louis Chen - Cantor Fitzgerald - Analyst : Deal and thanks for taking my questions here. So I had a few for you. I wanted to ask you basically first for the B SI 0.45 B study. How many patients are moderate versus severe and what are the ages of those patients in your study? Neal Walker - Aclaris Therapeutics Inc - Non-Executive Chairman of the Board, President, Interim Chief Executive Officer, Co-Founder Thanks Louise. Yeah, most of them were, were moderate. I think the average age was around in the 40s, but it extended from about 18 to 70 or. So.

Question: Louis Chen - Cantor Fitzgerald - Analyst : Okay. And then why do you think your drug keeps working post, you're stopping the last dose versus other drugs just you know, revert back for the B si 45 B. Thank you. Neal Walker - Aclaris Therapeutics Inc - Non-Executive Chairman of the Board, President, Interim Chief Executive Officer, Co-Founder Sure. Well, I, I let me comment first and then I'll, I'll hand it over to you. I, I think the key is and this is something in the slides that, that we took great pains to, to include because we did all this work. We want to understand and characterize this molecule versus the competitive set. And it really comes down to the long residence time when you look at that tr front data. It, it's quite stark that it's a very sticky molecule and, and I think that's a key contributor duty of any of the thoughts on that. But.

Question: Thomas Jonathan Smith - Leerink Partners LLC - Analyst : Hey guys. Good morning. Thanks for taking the questions and congrats on the updates. Just I was wondering if you could comment on how competitive this process was, Neil and then they just elaborate on how much diligence you're able to do on the 045 B. And the buy specific both on the assets as well as the existing clinical data just to get comfortable with these contents. Neal Walker - Aclaris Therapeutics Inc - Non-Executive Chairman of the Board, President, Interim Chief Executive Officer, Co-Founder Sure. Well, you know, it's interesting that there's a lot of transactions out there, Tom with, with the China based assets and, you know, we were fortunate to get introduced to by ocean. And you know, they're brilliant discovery chemists and they've been doing this a long time. A lot of these guys have pedigrees reaching back into companies like Abby and other multinationals. So just phenomenal work by them and their team and then they get to a point where you almost have to pass the baton off to do the rest of the clinical work. And, and so you can imagine there, there there's been increasing interest in, in China based assets. And so there, there was a lot of interest, you know, we came into a process that was pretty much towards towards the end and we were able to, to prevail in that basically on, on the heel of having our comp the team and kind of a grander story around combining both assets. So, you know, that's kind of 0.1 on the diligence front. You know, we've been working on this for about 56 months and, and the key to this was doing a lot of of repeat work. You know, the the ocean team did a phenomenal job of generating a lot of great pre clinical data showing how they stacked up to Teze. We want to repeat all that work. And unfortunately, for us, we have this phenomenal resource in Saint Louis where we can do all this testing in house against various assets, including the competitive landscape. So we added in addition to retesting, repeating all the work at Biosan and then having Wuji repeat all that work. So we did it in triplicate, we did it across both assets and what we presented to you. It's just a snapshot of that. There's a lot of other data behind it, but it all represents the same trend, the same pattern. And, REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 18, 2024 / 1:30PM, ACRS.OQ - Aclaris Therapeutics Inc Corporate Update and again, I'll just point to the tre data, I mean, when you're able to quantitate that res long residence time that that really is the reason to believe why you're going to get the functional inhibition that we're seeing in other assays. Plus now in the clinic.

Question: Thomas Jonathan Smith - Leerink Partners LLC - Analyst : Got it. That's. Helpful. All right guys. Thanks for taking the questions. Appreciate it.

Question: Christopher Joseph Raymond - Piper Sandler & Co - Analyst : Hey, thanks for taking the question and congrats on this deal. Very intriguing data, I guess maybe on 045 B. Just curious, you measured response at 26 week. I, I think, you know, depiction and other ad therapies have looked at 16 week, maybe just curious why that time point was, was chosen. And then maybe a second question. You know, there's been some debate about t slip in ad. You know, and I, I get the comparison to test fire. Do you think it was really just potency that caused you know, that, that they cause sort of a middling sort of data that they had there or is there some other aspect to tey that you think? Drove that? Thanks. Neal Walker - Aclaris Therapeutics Inc - Non-Executive Chairman of the Board, President, Interim Chief Executive Officer, Co-Founder Yeah, sure, thank, thank you, Chris. So I think, you know, the, the endpoint for this first kind of what I would call a signal generating study was, you know, it was purposeful. If you, if you look at like, you know, similar targets like ox 40 they go out to 24 weeks, et cetera because there does, when you target this pathway, it takes a little bit of time. But as you can see in our data that the the curves were, were pretty sharp, you know, even in the beginning, but you want to make sure when, when you're trying to figure out the signal that you take it all the way in, in this regard. So, but even at 16 weeks, the data is, you know, quite good. And I think moving forward, we'll look at, at perhaps an earlier time point. But I, I think in something where you're in a disease where you're treating the flare and this is a big difference between ad and, and psoriasis. You're much better off having a smooth, deep effect, that kind of persists over time rather than a choppy effect. You know, because you've had that inherent in the disease. So I think that was, you know, at least for this design, it, it made a lot of sense. You want to, you want to load you, you want to load up a drug and then we did or I should say you and the team did every two weeks, even though we think we have AP D to, to support longer dosing intervals. Because we want, we really to understand is ad a viable target as it relates to the, the, the Tezi data. You know, I think there's always nuances in all these studies, you know, you can critique maybe some clinical study designs, you know, going back and looking at the initial endpoint was, was 12 weeks and it was almost a categorical endpoint of greater than 50% but they still almost hit it. It was a AP value of 0.09 and, and they hit AP value on on IG A 01 at, at week 16. And I think they're just, you know, whenever you commingle the use of topical corticosteroids in, in a study, particularly group three, it, it can be challenging. So I, I prefer personally mo monotherapy studies if you're really looking to understand the, the drug effect. But I do believe again, just go back to the preclinical data that, that we showed you, I mean, all the other competitors in this space, of course, comp against Teze and, you know, we took it a step further to comp against them and Teze and I, I think that residents time and, and all the other characteristics that we talked about are important, you know, and, and, and I think that's how, you know, we think about this differentiation.

Question: Roger Song - Jefferies LLC - Analyst : Thank you for taking the question and congrats for the licensing deal. So quick question about the ad data, you know, given a lot of most of the patients they have prior therapy, just curious about the wash out period and then given there is no placebo control in this mostly moderate patients. So do you expect the placebo effect will be similar to a mother severe patient? Thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 18, 2024 / 1:30PM, ACRS.OQ - Aclaris Therapeutics Inc Corporate Update Neal Walker - Aclaris Therapeutics Inc - Non-Executive Chairman of the Board, President, Interim Chief Executive Officer, Co-Founder Yeah, thanks Roger. Roger. And I imagine you're in London. But yeah, so prior therapy wise, there was, you know, a considerable majority had prior therapy, whether it be topical corticosteroids, biologics, you know, or oral drugs like jack inhibitors. So, you know, we had a smattering of those patients who were quite exposed and certainly there's a, there's a wash out there and, and, you know, prior history. So, you know, I, I was comfortable that it was a, it was a suitable patient population to generate the, the signal and, you know, relative to placebo control. You're right. You know, look, you always expect a little bit of that. It is these studies. But, you know, when you're talking about the numbers, we're talking about, you know, north of 80 90% particularly on, on some of these categorical variables, you know, even assuming a little bit of that, it's still it is, is a very robust signal and, you know, now it's up to us to do the phase two B you know, placebo control and move forward. But what I like most about this opportunity is I've got the pre clinical data that again over the last five months and even previous was, was done with a lot of rigor and looking at it multiple different ways and assessing it versus the competitive landscape. And now you've got this clinical translation piece with the ad study and oh, by the way, you've got two large respiratory studies that are on the cusp of, of reading out in the short term. So it, it's, it's quite a package to get on this on this first molecule.

Question: Roger Song - Jefferies LLC - Analyst : Excellent. Thank you, Neil. Neal Walker - Aclaris Therapeutics Inc - Non-Executive Chairman of the Board, President, Interim Chief Executive Officer, Co-Founder Thank you.

Question: Julian Reed Harrison - BTIG, LLC - Analyst : Hi, good morning. Congratulations on getting this deal done. And thank you for taking my questions. First, I'm wondering if you could talk about the significance of steroid free efficacy in atopic dermatitis and, and how much that reinforces your confidence in the early efficacy scene with B si 45. Neal Walker - Aclaris Therapeutics Inc - Non-Executive Chairman of the Board, President, Interim Chief Executive Officer, Co-Founder B? Yeah, I, I think it means a lot, you know, I mean, having practiced as, as a dermatologist back in a prior life, you know, group three topical steroids work quite well. And especially again in a treat the flare disease where there's a lot of waxing and waning. So to me, you know, if you layer on REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 18, 2024 / 1:30PM, ACRS.OQ - Aclaris Therapeutics Inc Corporate Update steroids into a study like this, I just, it makes it awfully hard to interpret and, and I do think that that is, that's also true of these placebo controlled studies. So, to me that was a big factor. I don't know that I'd, I'd be as, as interested if, if I didn't, you know, have that, have that fact pattern. So, and, and, and certainly moving forward, we're going to be looking at monotherapy and not including topical corticosteroids because we want to understand what the drug does. You know, we, we can worry about combo and layered on treatment, you know, for, for the next set of studies.

Question: Julian Reed Harrison - BTIG, LLC - Analyst : Excellent. Thank you. And congrats again. Neal Walker - Aclaris Therapeutics Inc - Non-Executive Chairman of the Board, President, Interim Chief Executive Officer, Co-Founder Thank you.

Question: Alexander Thompson - Stifel - Nicolaus & Company - Analyst : Hey guys, congrats on the deal. This is pat for Alex. Could you guys just talk a little bit more about the bar for differentiation with this asset? And then for 502, the IND submission is planned for one Q25 I guess. How quickly do you expect to get into the clinic? Thanks. Neal Walker - Aclaris Therapeutics Inc - Non-Executive Chairman of the Board, President, Interim Chief Executive Officer, Co-Founder Yeah. So, you know, look the, just guide you back to some of the pre clinical data. I mean, that's, that's what you know, anybody in our position or anybody in the competitive landscape has like until you get into the clinic and in the long residence time, the deep response, the durable response. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 18, 2024 / 1:30PM, ACRS.OQ - Aclaris Therapeutics Inc Corporate Update If you really look at that data, you know, you're getting about, you know, almost to, to, to eight weeks, but it, but definitely six weeks of continuing effect. And you know, that that tells you you got nice duration without even doing a bunch of ite stuff. So I think, you know, that that is the real cool feature about this, this molecule. And then when you differentiate in the clinic, you expect some of that to bleed over into the indication, you ought to see some more robust response. You, you, you, you ought to see more dosing flexibility. So, you know, that's kind of how we think about it. And then again, like that's why when we first saw this asset, we really concentrated on, on doing all this pre clinical work and doing it in like in, in triplicate basically. And that took many months. So I think it's exciting and, and we clearly have a differentiation story on 502. How quickly into the clinic, you know, look, we're, we're, we're built to be, you know, in the in the clinic, we're good drug developers, you know that getting to an ID, we'll have everything prepped. We know that it takes, you know, 30 days until you hear back and you get the green light and so we'll we'll be in the clinic and in you know, early 25. Awesome. Thank you. Thank you.

Question: Kevin Johnson - Goldman sachs - Analyst : Good morning. This is Omari Fur at. We have a couple questions for the by specific. Why do you like the combo of TSOP plus IO four versus other potential combinations? And in the past, you've talked about seeking partners for face through development in indications like ad, do you still view that is appropriate for the portfolio or are you inclined to get through development alone? Neal Walker - Aclaris Therapeutics Inc - Non-Executive Chairman of the Board, President, Interim Chief Executive Officer, Co-Founder Yeah, let me answer the, the phase three question. Look, it, it, it, it just depends, right. You know, there's always, there's always good reasons to get a partner for perhaps, you know, when you're engaging in, you know, very large comparative Respiratory studies, you know, I think you know, indications like ad we've done so many trials in that space and we've done phase three word ourselves in other indications. So, you know, you could certainly look at that possibility but, you know, there's always deals to be had there and, and often times it does make sense to, to pass the baton after after two B. So I would just make that comment and let me hand it to you on, you know, the, the choice of A L four TSLT, the BCI construct. Yeah. Hi.