Aclaris Therapeutics at Leerink’s Conference: Strategic Pipeline Expansion

On Tuesday, 11 March 2025, Aclaris Therapeutics Inc (NASDAQ: ACRS) presented at Leerink’s Global Healthcare Conference 2025. The company highlighted its strategic shift towards large molecule therapeutics and a robust financial position, while addressing challenges such as elevated placebo responses in trials. Aclaris remains optimistic about its future, backed by a strong cash runway.

Key Takeaways

• Aclaris is shifting focus to large molecule therapeutics, with new antibody assets from Biochean.
• The company plans to conduct a Phase 2b study for atopic dermatitis with enhanced patient selection criteria.
• Aclaris has over $200 million in cash, providing financial runway into 2028.
• Seven or eight significant catalysts are anticipated over the next two years.
• The company is exploring both internal development and external partnerships in immuno-inflammatory disorders.

Pipeline and Strategy

Aclaris is committed to advancing its pipeline focused on immuno-inflammatory disorders, leveraging both large and small molecule therapeutics. The company has in-licensed antibody assets from Biochean, marking a strategic pivot towards large molecule drugs. This includes a bispecific antibody (ATI-fifty two) and an ITK/JAK3 small molecule (ATI 02/1938), both of which are key components of Aclaris’s pipeline.

With a dual approach targeting dermal and respiratory indications, Aclaris aims to differentiate itself through its expertise in dermatology and a multidisciplinary approach to drug discovery. The company is also actively seeking partnerships to enhance its topical JAK program.

Atopic Dermatitis Program

The company is targeting TSLP in atopic dermatitis due to its promising clinical data. Aclaris plans a Phase 2b study with rigorous patient selection and central reader scoring. The study will include both biologic-experienced and biologic-naive patients, with enrollment caps based on experience. Insights from China’s TSLP targeting studies will inform but not dictate the Phase 2b study design.

Financial Runway

Aclaris is in a strong financial position with over $200 million in cash, ensuring a runway into 2028. This financial stability supports the company’s strategic initiatives and upcoming clinical trials.

Future Outlook

Looking ahead, Aclaris expects to achieve several key milestones, including filing an IND for the bispecific antibody, starting and reading out the Phase 2 AD study, and reporting data on the ITK/JAK3 AD study. The company is also focused on potential in-licensing or acquisitions to bolster its pipeline.

For a detailed understanding, readers are encouraged to refer to the full transcript of the conference call.

Full transcript - Leerink’s Global Healthcare Conference 2025:

Tom Smith, Senior Biotech Analyst, Leerink Partners: All right, great. Good afternoon, everyone. Thanks for joining us here at the Leerink Partners Global Healthcare Conference. My name is Tom Smith. I’m one of the Senior Biotech Analysts here at Leerink.

And it’s my pleasure to welcome our next company to the stage, Aclaris Therapeutics. And really happy to be joined on stage here by Chairman CEO, Neal Walker, and President and COO, Hugh Davis. Gentlemen, thanks for joining us. Thank you, Tom. And Neal, you guys recently, I guess what I would call, reloaded the pipeline, with the in licensing of multiple antibody assets from Biochean.

There’s some really important data that’s coming here over the course of 2025, that we’ll walk through in more detail. But maybe, Neil, why don’t you, go ahead and kick us off with a little bit of an overview, for those in the audience who may be less familiar with the story and kind of what you guys have been up to at Aclaris.

Neal Walker, Chairman & CEO, Aclaris Therapeutics: Sure. So Aclaris is a development stage biopharmaceutical company focused on both now large molecule and small molecule therapeutics for various immuno inflammatory disorders. And we actually, with the addition of the two new assets, have quite a rich pipeline now. We have two clinical stage assets, one near to clinic, the bispecific will be filed in an IND this month. And then we have a preclinical ITK inhibitor.

So over the next two years, we’re going to have about, I’d say, seven or eight catalysts and runway with over $200,000,000 on the balance sheet into ’28.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Great. Awesome. A lot of programs, a lot going on. Let’s talk about the in licensed antibodies and maybe just start high level, walk us through sort of the diligence process that went into that. I guess the decision to pivot into antibodies historically have been focused and developed a lot of expertise around small molecule chemistry, pivoting into antibodies.

Just walk us through the diligence that went into licensing those programs.

Neal Walker, Chairman & CEO, Aclaris Therapeutics: Sure. It was quite extensive actually. And Hugh, who joined us from Biogen along with five of his colleagues, was a great help in shepherding this all along. But we spent about six months under an MTA doing a whole slew of tests, repeating all the testing and all the great work that Biogen had done, comping the t slip mAb to tesi and then also the bispecific and then extending that into the relevant competitive landscape. And what we were able to ascertain through all that was that our t slip mAb had an exceedingly long residence time, which we think is really important in an alarm and mediated disease, like AD and the various respiratory diseases, that you want to be able to bind to that t slip and stick to it, not bind to it, cycle off, and then allow it to hit the receptor again.

So that was a key finding and gave us a lot of confidence in heading to the next step of completing the deal. I think the other important thing, too, there was that we’re able to get a view on the clinical translation. It’s all well and good to show all these great in vitro studies and say that you’re best in class potency, etcetera. But being able to show the clinical translation in a single arm AD study was quite important

Tom Smith, Senior Biotech Analyst, Leerink Partners: for us. That’s great. And, yeah, we’ll get into the single arm data. I guess, high level, just talk through a little bit the rationale for targeting TSLIP in AD and maybe some of the learnings that have come from other programs, TSLIP targeted programs in atopic derm?

Hugh Davis, President & COO, Aclaris Therapeutics: Yes. Sure. So, like Neil mentioned, TESI obviously had looked at TSLP or Amgen looked at TSLP with Tezi and their 2a data looked very reasonable in terms of pursuing. So when we decided to go forward with AD, it was on that backdrop. And since then, a number of other players have come into the market as you saw in ClinDev where we’re looking at assets against both the receptor as well as bispecifics.

And so we really thought about 45 as

Tom Smith, Senior Biotech Analyst, Leerink Partners: a key

Hugh Davis, President & COO, Aclaris Therapeutics: indication being AD because of that potency and that long residence time. And as Neil mentioned, we also then did look across some of the other assets in this space, primarily moving into severe asthma and the respiratory indications. Not many are moving so far into AD. Well, and I think

Neal Walker, Chairman & CEO, Aclaris Therapeutics: AD is interesting in that we know from a biology perspective that it works at the top of the funnel, and we’ve seen some recent data come out of the folks that are studying OX40. It’s the same pathway. So I think there’s enough reasons to believe, including the literature, the mechanism and some of the clinical results that we’ve seen of late. So that’s why we’re excited about it.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Yes, that makes sense. And, you alluded to the Phase 2a open label experiences, the trial that was conducted in The U. S. And you just described, I guess, the rigor that went into that study. And then, we get a lot of questions from investors just broadly now, it feels like across the atopic derm space.

We have seen in the last several Phase two readouts what appears to be somewhat of an elevated placebo response. Maybe just talk through what gives you the confidence that the effects that you’re seeing in this open label study are true disease modifying effects rather than some sort of placebo response?

Neal Walker, Chairman & CEO, Aclaris Therapeutics: Yes. Hugh, do you want to since you presided over that study?

Hugh Davis, President & COO, Aclaris Therapeutics: Yes. You know, so when we went in, we had looked at all the placebo responses previously and you were looking at easy responses in 40%, fifty % from SOLAR-one and two, from Dopey and the like. And since then, to your point, we’ve seen upwards of 70%, eighty responses. Now more recently, it was really actually nice to see in the recent data set with

Tom Smith, Senior Biotech Analyst, Leerink Partners: the

Hugh Davis, President & COO, Aclaris Therapeutics: OX40 that we’re now looking at a more reasonable placebo response more around 15%, twenty %. And when we looked at the 2a trial, we made sure that we brought people into that study that were truly AD. And I think this is one of Neil’s points when I’ve listened to this to the story is being a dermatologist, he has the advantage of looking at PIKS coming into our trial. And so when we look forward to what we’re doing now moving the 2b forward, we really want to make sure that we get the appropriate patient into the trial and that’s really a key to success.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Right. And maybe you could just elaborate on that, like what, I guess, specific steps are you taking or implementing into at least how you’re thinking about the Phase 2b design to make sure that you’re getting, like, true AD patients and I guess working with investigators that also are comfortable scoring these patients appropriately so you end up with a true sense of treatment effect?

Neal Walker, Chairman & CEO, Aclaris Therapeutics: I mean, other than the inclusion exclusion criteria, which is a little bit generic, the single best thing you can do from my perspective is have a central reader and screening those patients in, have very tight criteria around what you want to see in those pictures. And the reason I say that is because EZ scores an EZ 20 in one study is not the same as an EZ 20 in another. It’s a composite index that you roll up extent and severity. So you’d much rather see something skewed more to the severity side, particularly if you’re doing placebo controlled work. Because if you see it, if it’s more weighted on the extent, that patient think about somebody who just has a lot of dry skin.

They might fall into the placebo group and respond quite well. So to to get rid of that, you have to really be rigorous and make sure you have dermatologist run sites where the derm is actually on-site doing the adjudicating. You don’t want to have people rotating through, because there’s a lot of inter rater variability, especially on EZ score. That’s the other big thing that’s a problem that people don’t often talk about. And so you want to have that same person adjudicating everything through the study.

And also, the other piece is maybe having a healthy dose of ex U. S. Patients. The fact is, is now we have a lot of approved treatments in The U. S, and so you’re losing that top end of the spectrum that otherwise would be great to have in a clinical study.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Got it. Okay. And yes, let’s, we’ll go through the plans on Phase 2b in just a minute. But you also alluded to there being some data, I guess, relative near term. I think you have a China partner who’s generating data, a couple indications in China.

Top line data, I think you’ve said is kind of first half twenty twenty five. Correct. Just, yes, walk us through sort of your expectations, what you hope to learn from those readouts and any, I guess, considerations around the fact that they’re generating the data in China in those sense.

Neal Walker, Chairman & CEO, Aclaris Therapeutics: Yes. So I think it’s a nice to have that we get to see this kind of play out, this clinical translation in short order post our transaction. And in the next sometime in the next four months, we don’t know exactly when, we’ll be getting severe asthma data, fifty two week data with over two hundred patients out of China. So a nice robust study. Also, CRS with NP, eighty patients, twenty four week data.

And I think we have to see what it all shows us. And I think when we think about investing in these indications, let’s say the data is fantastic, I still think it makes sense to think about partnerships from a U. S. Perspective. For us, these studies are quite expensive, quite involved.

And I think from my perspective, it makes sense to explore that option first as we get the data in, and then we’ll see. I think, obviously, TESI has shown very nice data in severe asthma and just released CRS with MP data. They also just put out some data out of China, which was interesting. So we’re optimistic about it.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Yes, that makes sense to me. And how does the dosing that’s being used in these studies in China, how does that compare to the open label atopic derm data that

Hugh Davis, President & COO, Aclaris Therapeutics: you have? Yes. So the asthma is two ten and four twenty every four weeks. And when we with the 2A and AD, we went with a three hundred milligram dose. And the idea was TSLP had not been fully validated in AD, so we wanted to make sure we had the right exposure or maximum exposure in order to be able to say, if this trial had failed, no one would ever have to look at TSLP as a target again in AD.

And so in fact, it didn’t fail. The data, as I mentioned, were quite good, with response rates of IGAs of eighty eight percent of subjects getting an IGA01. But as we think about that dose in The U. S, the two ten and four twenty as it relates to the three hundred, we’re going to consider bracketing that in our 2b trial as we move forward.

Tom Smith, Senior Biotech Analyst, Leerink Partners: And do you, I imagine the learnings from the dosing experience in China quite informative for the Phase 2b AD study, but is that a gating factor for you?

Neal Walker, Chairman & CEO, Aclaris Therapeutics: Well, we’re kind of looking at that, but we can’t keep holding things up in perpetuity. So we’re moving forward with some assumptions. And if we get that data sooner than expected, we may change course.

Hugh Davis, President & COO, Aclaris Therapeutics: Okay.

Tom Smith, Senior Biotech Analyst, Leerink Partners: And just the last point, I guess, on the China data, when we look to kind of benchmark those results against TESI or other antibodies, what would you consider, I guess, a win there? Is it just in line? Is it a little bit better? Like, what are you guys thinking?

Neal Walker, Chairman & CEO, Aclaris Therapeutics: I mean, of course, in an ideal world, I’d love it to be a little bit better. I think we have to look at the aggregate of all the endpoints. Obviously, you have FEV1, Pheno, AAER, how rapid is the response, looking at all the subsets. So as just kind of an example, if we won on 75 of those, I’d be pretty happy, right? And I think if it validates the thesis that we’ve generated pre clinically, that would go a long way to getting even further support for AD in The U.

S. Right. Okay.

Tom Smith, Senior Biotech Analyst, Leerink Partners: And, on the planned Phase 2B AD study, I guess, like any specific considerations that you would call out, any kind of tweaks that you’re thinking about or you think about this as more of a traditional severe moderate to severe atopic derm study? And then, I guess, playing that forward, like how should

Neal Walker, Chairman & CEO, Aclaris Therapeutics: we think about expectations for that readout? So we haven’t officially guided on anything like that, but it would be, you can imagine, later in ’twenty six, just assuming we’re initiating all these activities now. I think going back again, the special considerations would be all the things I mentioned to stack the deck in our favor for success. And I’m willing to take some lag on enrollment just to make sure we get the right patients in and making sure that we educate the folks that, look, if you have an easy 16 cutoff, it’s okay to way overshoot that because part of the problem is that people like, you don’t want easy 14 is just making their way into an easy 16 study. So just being super rigorous on that front is the way to go.

And I’ve done enough of these studies now to know how many people actually slip in that not for any other reason except that sometimes AD looks like other types of eczema, right? And when you get those patients in, they’re more apt to respond to the placebo. Right.

Tom Smith, Senior Biotech Analyst, Leerink Partners: And in this Phase 2b study, are you considering are we enrolling biologic experience patients or JAK inhibitor experience patients? What’s the what’s the

Neal Walker, Chairman & CEO, Aclaris Therapeutics: Yes. We’re looking at both. We’re going to have some caps on that, which we’ll message later. But I think predominantly, the ex U. S.

Contribution to that will mainly be biologic naive. And then in The U. S, you’ll pick up some more who have experience there. But we’re certainly not going to like overweight it to the experience side. Right.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Okay. That makes sense. Especially this, kind of like signal to finding. Exactly. Please.

Yep. But I guess playing that forward commercially, it would seem I mean, we’re in the very early stages of kind of building out second line, third line, etcetera, in AD. Where do you think TSLIP targeted antibody falls into the treatment paradigm?

Neal Walker, Chairman & CEO, Aclaris Therapeutics: So I mean, from my perspective, what we hope to see is a better smoothing out of the flares over time. So I think DUPI is a reasonable acute use medication, but I think over the course of the year, it tends to fall off. So to me, from a dermatology perspective, I think you want to see those flares just muted and just create a more uniform experience for the patient over the years. So there’s still a ton of room. We’re just at the very front end of this market.

It’s just like psoriasis in that regard. And there’s just a ton of efficacy headroom. There’s still some safety headroom. And this market is growing both on the oral side and the injectable side and it’s got a long way

Tom Smith, Senior Biotech Analyst, Leerink Partners: to go yet. Yes. Yes, I agree with that. Okay. Let’s shift gears a little bit and talk about your bispecific, now ATI-fifty two, TSLIP IL-four bispecific antibody.

And we get a lot of questions from investors around the multi targeted bispecifics versus combination approaches. I guess, what drew you specifically to the multi targeted bispecific? Why do you feel like that’s the best approach?

Hugh Davis, President & COO, Aclaris Therapeutics: Well, the way the way it was built, first of all, we used the same TSLP antibody as we have in 45 and that has that very long residence time and a high potency. It’s also been YTE extended for half life and on top of that with the SCFVs against IL4R, the combination is a two plus two, so you’re going to get avidity against both targets, but you’re also going to be able to have that extended half life. When you have the high residence time on TSLP, you’re able to really inhibit that completely. And then with IL4R, we’re able to make sure that we’re also at least severely limiting the impact of IL-four and IL-thirteen and inflammatory cascade. And we saw this with the 2A trial in that when you can turn that pathway the Th2 pathway around, then you can really get to a place where you see extended response over time.

And that’s what we think that the bispecific can do for us. In fact, the potency, when we compared it to tesi and DUPI and a CCL17 release assay from PBMCs, we actually saw that it was about five fold more potent than that combination of tessey and DUPI in inhibiting CCL17. So we’re really excited about it and I think there’s a lot of opportunity for multiple types of indications for that.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Got it. Okay. And you’ve got into an ID filing, I think later this quarter. What are the gating factors to getting that filed? And then what are the subsequent plans?

Hugh Davis, President & COO, Aclaris Therapeutics: Now it’s in publishing, it’s very it’s really a couple of weeks away. So there are no gating factors to the filing. And then beyond that, we’ll move into a sad, mad and healthies, and that’s primarily PK, safety and tolerability and then we’ll move into a 1b setting. At the end of the year, we should have some of the some of those plans put together for looking at patient data in 2026.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Got it. And yes, talking about getting to patient data, how are we thinking about indication selection and prioritization of this versus the TSLIP antibody?

Hugh Davis, President & COO, Aclaris Therapeutics: It’s really a function of the data as it comes in. So when we’re looking at the China data that’s going to come in as well as other competitor factors, I think we can look at different you can look at dermal or respiratory indications by the time we get there, but we’ll make that decision later in the year.

Neal Walker, Chairman & CEO, Aclaris Therapeutics: We’ve created plans for both, just as an in case because it is going to be a little bit fluid.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Got it. That makes sense. In terms of kind of post in licensing, can you just remind us, I guess, on like a manufacturing drug product level, like where is the manufacturing being done? Have you guys kind of brought that in house? Is there a tech transfer aspect to it?

Like where are we on CMC?

Neal Walker, Chairman & CEO, Aclaris Therapeutics: Are we

Hugh Davis, President & COO, Aclaris Therapeutics: talking about 52 devices, both of them? Yes. So both of them are manufactured in China at the moment, 45 with Wuxi and 52 with Xencor. And they’re both world class GMP facilities. We used both of them to create all the batches we need that takes us through the Phase II studies.

And we’re considering moving them into Europe or U. S. In tech transfers, but we haven’t made that call.

Neal Walker, Chairman & CEO, Aclaris Therapeutics: Got it.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Okay. Let’s shift gears and talk about ATI 02/1938. This is your ITK JAK3 small molecule, you have it in an open label atopic dermatitis study. Neil, just remind us sort of the design for that study and then we’re looking for data from that in the relative near term expectations for that?

Neal Walker, Chairman & CEO, Aclaris Therapeutics: Yes. Over the next three months or so, we’ll be top lining that data. And it’s a twelve week study, one dose, ten milligrams BID, looking at moderate to severe AD patients. And our whole idea here is to show both safety and efficacy in patients with disease and also get a view on the PD profile, particularly of the ITK component. And that will serve as a bridge for the reason to believe in the ITK selective that’s coming down the pike in ’twenty six.

Post this AD study, where we’re likely to go with 02/1938 because it’s a fast follower to ritlosetinib is to go into alopecia areata. It’s kind of they’ve already paved the way there. They had good data. They’re obviously approved

Tom Smith, Senior Biotech Analyst, Leerink Partners: in that

Neal Walker, Chairman & CEO, Aclaris Therapeutics: indication. We like that indication. I think it’s a little bit less frenzied competition than AD. And I think that’s important whenever you have Jack in the name. Although, I think the interesting thing about this molecule, and this was designed on purpose this way, it has very unique pharmacology.

We’re hitting, if you think about it almost in a bispecific construct way, is a oral small molecule. It’s like we got half the power is going into ITK, the other half is JAK3. And a lot of people forget that JAK3 is not ubiquitous like JAK1 or two. It is a theoretic theoretically a better safety profile and that it just hits the hematopoietic cell. So we are excited about that molecule and we’re excited about the whole ITK franchise.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Yes. I guess maybe if you could just expand on that and some of the biology behind like what you’re trying to target here in NAD and alopecia. And is there a world where, I guess you think you could perhaps escape some of the JAK inhibitor class box warning language that’s been applied pretty ubiquitously?

Neal Walker, Chairman & CEO, Aclaris Therapeutics: Yeah. I would say it would be tough to do that, like, with the 02/1938. Like, I wouldn’t go in with a base case on that. But I would certainly hope to get better language, which is the trend you’ve seen. And I think that the JAK3 and ITK are relevant for atopic and some of these other diseases in that JAK3 sits below the common gamma chain.

ITK definitely has a TH2 skew, hits TH17, balances out Tregs. There’s just a lot of horsepower there. And again, it’s a pretty unique molecule. We know a competitor has an ITK Selective out there and ritlacitinib is the only other one that kind of tickles the TEC kinase family, but not to the same extent we do.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Got it. And just on the competitor, ITK data, they had some initial data towards the end of last year. I think they updated it a little bit in January. Maybe you could just comment on the signal that seems to be coming out of their program and then how 2,138 stacks up versus that program?

Neal Walker, Chairman & CEO, Aclaris Therapeutics: Yes, I think we’ve shown in a variety of models that were more potent than that molecule, but I like their data. I think they showed good signal in the first slug and then and then they doubled down and showed nice dose response going up from 100 to 200 and so far so good on the safety. So I think they’ve done everything they said they were going to do.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Got it. And, so you feel like Advantage on Potency, a number of advantages. Are there specific benchmarks that we should be looking for in the open label sort of proof of signal, proof of concept study? Like, how would you benchmark it?

Neal Walker, Chairman & CEO, Aclaris Therapeutics: I mean, I think just looking we have the same endpoints that every AD study has, so looking at all those plus the the PD biomarker data. So those would be what I would look to.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Okay. That’s great. And how quickly, I guess, can we move with next steps post that open label study?

Neal Walker, Chairman & CEO, Aclaris Therapeutics: Pretty quickly. We already have a design. We’ve worked extensively in alopecia areata in the past. We know that indication well. So, this is not going to be a heavy lift to get this up and running.

And what we would hope is to have data by the end of ’twenty six.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Got it. Okay. That’s great. You also have a, topical JAK program where you’ve generated Phase 2b data. Maybe you could just remind us, like, what you saw in that study?

And this is one, I know we have kind of positioned it for strategic partnering, I guess, where you feel like we are in that process or what you’re looking for from a strategic partner?

Neal Walker, Chairman & CEO, Aclaris Therapeutics: Yes. Still ongoing discussions on that front. The 2b data that we generated was from an absolute responder basis quite good. It was right in line with the 2a. We saw a little bit of compression on the placebo adjusted response, which had some various reasons for that.

But we I think it’s a good product. It’s a soft Jack. It replicates what an Absolomay do, but it has no systemic absorption. So I think it’s a great asset. We at the time we made the decision just given where we were at, at that point in time to put that on the block for partnership.

But just because we didn’t want to invest in that, just deploy capital against that given the other areas we’re funding.

Tom Smith, Senior Biotech Analyst, Leerink Partners: And with the profile and the data that you generated there, this concept of it being a soft jack, it did seem like you at least had your eye on potentially avoiding the class labeling.

Neal Walker, Chairman & CEO, Aclaris Therapeutics: Yeah. I think that is a, you know, you can never totally predict and you never know till you get to the end of an NDA review. But for sure, if you show essentially no systemic absorption, I don’t know how one would make the argument that you should get class labeling there.

Tom Smith, Senior Biotech Analyst, Leerink Partners: David Osterholm: Right. Okay. I want to take a step back and talk, I guess, kind of bigger picture here as, you know, we’ve made the move to in license the antibodies. We still have the CONNECT platform and all of the medicinal chemistry and expertise around the JAK STAT pathway. As we think about things that could emerge, I guess, from the organic Aclaris pipeline, like, how are you guys thinking about that?

Are there intentions to build out maybe antibody discovery capabilities? Are we still like, how should we think about that?

Neal Walker, Chairman & CEO, Aclaris Therapeutics: No, it’s a great question. And actually, the guys have such a rich set of experiences. This is part of the value of the Confluence acquisition is the multidisciplinary approach, all ex Pfizer guys. And it’s not just small molecule expertise. They’ve actually dived right in, and we are looking at some interesting antibody targets.

And the beauty is we can do a lot of this work in house because we have all that full kind of soup to nuts capability, which is important from a testing funnel perspective and just finding the right concepts. Obviously, we have a proprietary chemical library for our small molecule platform. But Joe and the guys have been working with you to identify those kind of next gen biologic targets as well. So you know, it feels pretty good. We got a pretty unique offering.

Tom Smith, Senior Biotech Analyst, Leerink Partners: A lot on the plate clinically, also a lot of, I guess, potential to advance things out of that pipeline organically. That said, you know, we just did this in licensing deal. Are you still, I guess, engaged in external conversation?

Neal Walker, Chairman & CEO, Aclaris Therapeutics: Are you still looking externally at other opportunities? We always keep that faucet going because you never know, you know, and we have a lot, that just like with the Biogen transaction, just our expertise in being able to evaluate these assets all internally and robustly, we always keep our eye out there because you never know what’s going to shake loose in these markets.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Right. Okay. And the clinical focus being exclusively now INI, except there is still is there still an ongoing MK2 program in oncology?

Neal Walker, Chairman & CEO, Aclaris Therapeutics: There is, but that’s a investigator driven process out of Wash U. And so we’re not really other than providing some drug supply there, we’re not really involved in that. Yes.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Okay. Great. And maybe last question, I know we have a little bit of time left, but we’re kind of running up against it. Just, when we think about, you know, we did the raise on the back of this in licensing deal, your cash resources and I guess how you think about runway, what explicitly is kind of contemplated in that runway and what data sets are we going to get here over the next twelve to eighteen months?

Neal Walker, Chairman & CEO, Aclaris Therapeutics: Yes. So within that runway, we get the following. We filed the bispecific IND this month. We start the AD study and read that out in ’26. On the bispecific, we do the SAD MAD and read out a POC sometime in ’26.

With 02/1938, we read out the AD study, then roll in and report out on an alopecia areata study. And then with the ITK selective, we get to IND and then get through POC. So we get for all four programs, at the end of that kind of total two and a half years or whatever, we get four at four clinical stage assets clipping along in a variety of indications. Great.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Perfect. All right. Well, thank you, Neil and Hugh for sharing the updates and a lot of data to look forward to here over the next twelve to eighteen months and we’ll stay tuned to the Claro story. Thank you.

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