Aclaris at Goldman Sachs Conference: Strategic Focus on Immuno-inflammatory Pipeline

On Wednesday, 11 June 2025, Aclaris Therapeutics Inc (NASDAQ:ACRS) presented at the Goldman Sachs 46th Annual Global Healthcare Conference, highlighting its robust immuno-inflammatory R&D pipeline. The company emphasized its strategic focus on dermatologic and respiratory indications, while also addressing financial stability and potential partnerships. Aclaris expressed optimism about its pipeline’s potential to meet unmet medical needs, although challenges remain in securing partnerships for late-stage respiratory trials.

Key Takeaways

• Aclaris plans to independently develop dermatologic treatments while seeking partners for respiratory indications.
• The company highlighted the potential best-in-class status of Vosacitug (ATI-45) in atopic dermatitis.
• Aclaris maintains a strong cash position of over $190 million, supporting operations through mid-2028.
• Strategic acquisitions have bolstered Aclaris’s pipeline, including Vosacitug and a bispecific antibody.
• Data-driven decisions and shareholder-friendly operations remain a priority for Aclaris.

Financial Results

• Cash Position:

- Aclaris holds over $190 million in cash, extending its operational runway through mid-2028.

- The company has made strategic decisions to prolong its cash runway by more than a quarter and a half.

• Strategic Decisions:

- Aclaris is independently funding a phase two study in atopic dermatitis, with costs ranging from $12 million to $15 million.

- The company seeks partners for respiratory indications, given the high costs of phase three studies.

• Cost Management:

- Aclaris is committed to efficient, shareholder-friendly operations, focusing on key catalysts within its existing cash runway.

Operational Updates

• Pipeline Progress:

- Vosacitug (ATI-45) is undergoing a phase two trial for atopic dermatitis across the U.S., Canada, and Europe.

- A phase one trial for the bispecific antibody targeting TSLP IL4R will start this quarter.

- The ITK/JAK3 inhibitor (2138) is concluding an atopic dermatitis study, with plans to address alopecia areata.

• Strategic Acquisitions:

- Recent acquisitions include Vosacitug and ATI-52, a bispecific antibody.

• Respiratory Program:

- Partner CTTQ in China is advancing Vosacitug to phase three trials for severe asthma and COPD.

- Aclaris holds data-sharing rights with CTTQ and is actively seeking licensing partners.

Future Outlook

• Data-Driven Decisions:

- Aclaris will base its bispecific antibody program decisions on phase II Vosacitug data and phase 1b bispecific data expected by the end of next year.

- Indication selection for the bispecific antibody is slated for 2026.

• Strategic Partnerships:

- The company is pursuing licensing partners for respiratory indications, considering full asset or regional deals.

• ITK Program:

- An IND submission for the ITK-selective program is planned for 2026, focusing on vitiligo and alopecia areata.

Q&A Highlights

• Vosacitug Differentiation:

- Vosacitug’s 400-hour residence time on TSLP was emphasized as a key differentiator.

• Atopic Dermatitis Strategy:

- Aclaris aims to leverage superior molecules and clinical designs for success in atopic dermatitis.

• Bispecific Antibody Potential:

- Indication selection will be data-driven, with early patient data readouts anticipated.

• ITK/JAK3 Inhibitor (2138):

- The focus is on vitiligo and alopecia areata, with insights expected on the JAK and ITK pathways.

For more detailed insights, readers are encouraged to refer to the full transcript below.

Full transcript - Goldman Sachs 46th Annual Global Healthcare Conference:

Unidentified speaker, Host, Goldman Sachs: Afternoon, everyone. Welcome to day three of the Goldman Sachs Annual Healthcare Conference. I’m thrilled to be joined today by the team from Aclaris. Maybe I’ll let you guys introduce yourselves and then give us a bit of an overview on the company.

Hugh Davis, President and COO, Aclaris: Yeah, I’m Hugh Davis. I’m the President and COO. I have a thirty plus year history in developing biologic drugs. And I joined Aclaris with a deal made with Biocean in November.

Kevin Balthaser, CFO, Aclaris: Kevin Balthaser, CFO. Been with Aclaris for eight years now.

Unidentified speaker, Host, Goldman Sachs: And how about an overview? Particularly like over the last year, the complexion of Aclaris has changed relatively significantly with the acquisition that you just referenced of two assets. Maybe you can talk to us about the current pipeline and what you view as key value drivers over the next twelve months.

Hugh Davis, President and COO, Aclaris: Yeah, we have quite a catalyst calendar actually. Aclaris is a immuno inflammatory full R and D type of company. We have a great research group in St. Louis. And then we have three clinical assets in terms of the clinical catalysts.

We have 2,138, our IDKJAK3, that’s finishing up an AD study and moving into alopecia areata later in this year. And then the biologic assets, 45, which is the T SLP antibody, that just initiated a phase two globally, so U. S, Canada, and Europe. And then we have our bispecific antibody, which is a TSLP IL4R, And that was cleared by the FDA and we’ll be initiating our phase one in SADMAD and healthy volunteers this quarter.

Unidentified speaker, Host, Goldman Sachs: Okay, great. Okay, let’s spend some time on some of the new acquired piece of the business, the Sacatug and ATI-fifty two. Maybe let’s talk about the acquisition last year and just why you guys felt like this was an interesting set of assets for you. And why did you think the core competencies of Aclaris lend themselves well to developing this program?

Kevin Balthaser, CFO, Aclaris: Yep. So I think for us, the last year we were going through a strategic process. We looked at a lot of different assets. We’re fortunate, as Hugh mentioned, that we have a world class team of scientists in St. Louis.

For us, these assets were particularly interesting because we were able to replicate some of the preclinical data that the Biogen team had generated, not just in our own lab, but also at a party lab as well. And really the differentiation and the potential best in class characterization of those assets was confirmed with those preclinical tests. So for us, we thought it fit well strategically into our portfolio, particularly obviously because we have history in dermatologic indications as well.

Unidentified speaker, Host, Goldman Sachs: And how did you think about moving from small molecule development to more of an antibody approach? Did you have to add any competencies? And how did you kind of make that transition?

Kevin Balthaser, CFO, Aclaris: Sure, yeah. I think Hugh and team coming over as part of the deal was a big benefit in our eyes. Obviously, we were moving into large molecules. Hugh and team had that expertise. So really bolting that team on, I think, was particularly important and really has allowed us to really accelerate into the clinic, Hugh just mentioned.

Hugh Davis, President and COO, Aclaris: But just to add on to that, coming out of the BioShin side, looking at Aclaris and why Aclaris made sense for us as the licensing partner for these two key assets for BioShin. When we looked at Aclaris, even though the previous study had not shown promise, the team that’s there, right, the management and the clinical team and also the scientific expertise with a pipeline of kinase inhibitors that had already moved into the clinic, with the experience they had in derm, made a lot of sense. And then like, Kevin’s saying, myself and a few others that came on from the biologic side with tens of years, decades of experience in biologic drugs, it really merged together beautifully. And interestingly, now we’re even developing a discovery portfolio of assets in biologics with our team in St. Louis.

So it’s not just now bringing forward new small molecule discovery candidates, but also large molecule candidates for future development.

Unidentified speaker, Host, Goldman Sachs: Okay. But the commenting that runs through it is the focus on INI, the focus on derm?

Hugh Davis, President and COO, Aclaris: Well, and respiratory. So any immunoinflammatory diseases are certainly within our And so respiratory for sure, severe asthma, COPD, chronic rhinosinusitis, you can look at it, eosinophilic esophagitis, you can look at any of those. COPD is really key for us as we think about the bispecific.

Unidentified speaker, Host, Goldman Sachs: Great. Maybe we can drill in a little bit more on the individual assets then. For Vosacitug, the anti T slip monoclonal antibody, I guess how do you think about the avenues of differentiation within the class? This is somewhat of an increasingly well trodden target, and so where do you see potential for differentiation?

Hugh Davis, President and COO, Aclaris: Well, of all, virtually none of the other clinical candidates, from others are moving into atopic derm. And one of the differentiating points for us was not only did Aclaris do a really thorough due diligence bringing these assets in, but during that due diligence the team showed that we have four hundred hours of residence time on the target, TSLP, which compared to TESI is eight hours, Upstream Bio fifteen hours. You know, all of the other, the GSK, the Merck, these other ClinVev candidates are fifteen to twenty hours residence time, and Boisakotag is four hundred hours. That’s important because you really need to neutralize TSLP completely, and because it is an alarmin, it has a very potent effect of its own. And I think in the 2A data that were generated in atopic derm, where you saw ninety four percent EZ75 response and eighty eight percent response for IGA-one, clear, mostly clear.

I mean those numbers, even though it’s the caveat open label, placebo controlled, but those are objective numbers. And when you compare that to what’s going on, even if you took a discount of 30%, a off of those numbers, it would still be a very competitive asset against DUPI in AD. So, we think we have a best in class asset in the preclinical, but also have shown really the only AD data on an anti TSLP mAb to date. So we’re very excited about this opportunity.

Unidentified speaker, Host, Goldman Sachs: Okay. I want to touch on kind of both of the things you just said. In terms of the residence time, you mentioned four hundred hours versus fifteen. So what like technically enables that increased residence time? And also like what do you have to think about in terms of tradeoffs, or are there any liabilities with that kind of exposure?

Hugh Davis, President and COO, Aclaris: No, it’s a great question in terms of liability, something we considered also. So, the residence time was interesting because when BioShin developed the antibody, the screening was to look at low dissociation off of the target. And that’s how this was picked. And then when Aclaris showed that it’s four hundred hours of residence time and it hardly dissociates at all, we did some background work to understand that. And there is an understanding now that not only is the antibody, busaccutone binding to the C terminus of TSLP where it interacts with its receptor, but it also binds at the N terminus.

So there are two binding sites on TSLP, and so each of them have their own affinity, but together the antibody itself is not leaving the TSLP molecule, giving you that long residence time. And again, this is important because if it was just affinity, you say, oh, I have a high affinity anti TSLP. If it was only at one site and affinity is on rate and off rate, when you’re off of TSLP, it’s able to engender its activity. And in this case, it’s pathophysiological. So you need to keep it neutralized and have that residence time in order to really get that kind of deep neutralization and effect.

Unidentified speaker, Host, Goldman Sachs: Okay. One of the things too that I think I’ve seen in this space is there’s a, you know, ligand versus receptor targeting. You made the decision to go after the ligand. So why? And what do you think, how do you see that debate?

Hugh Davis, President and COO, Aclaris: The way I see it is when you go after a receptor, you have the risk of lower half life and shorter dosing interval. And this is dupilumab, this is what they’re up against, eight to ten day half life, because you have target mediated drug disposition at lower concentration, It gets cleared out of the blood. You lose receptor occupancy over time because of that. And once you get down below, I don’t know, 30% or 40% receptor occupancy, you’re now starting to have that receptor be activated again through the ligand. So it made sense in the case of an alarm in like TSLP to go after the actual target that’s driving that response.

Okay,

Unidentified speaker, Host, Goldman Sachs: and then you mentioned that you selected atopic derm. You’re really the only ones that have started there at least. So do you think about that versus asthma, is kind of the more traditional starting point for a TSLP molecule?

Hugh Davis, President and COO, Aclaris: Yeah, so it’s interesting because Aclaris, Neil likes to call this a free call option. It turns out that BioShin had an agreement already with CTTQ, a China based company. They’re a subsidiary of Sino BioPharm and the Hong Kong Exchange. They had licensed Bosacotog for China development. And they chose the normal route of going into respiratory disease initially.

And so they have conducted a phase II trial in severe asthma, a phase II trial in chronic rhinosinusitis with nasal polyps, and both of those studies have moved to phase three now. And in addition, they’ve initiated a COPD trial. So Aclaris has data sharing rights with CTTQ, and based on the data that comes into us, we’ve, you know, we’ll make decisions on looking for partners to go after those respiratory indications also.

Unidentified speaker, Host, Goldman Sachs: Okay, sounds good. Maybe you could get more specific then on the data set that we see from your Chinese partner. Maybe you can walk through what we saw in the Phase II readouts, and then talk to us about how those things can translate to a U. S. Market.

Hugh Davis, President and COO, Aclaris: Yeah. So like I said, we have data sharing rights. And so far what we’ve seen are partial data. And we put out a release earlier this month that put out a qualitative statement that we’ve seen some of the data that have come out of those trials, and we had three goals looking at the data that they presented to us. One, did it support the potency argument?

You know, we say we’re the most potent ClinVe anti T slip out there. Secondly, did it support the efficacy and show us that the drug had, you know, its expected effect in severe asthma and CRS? And thirdly, did the safety profile, and I forgot to answer your other question earlier, so I’ll come back to it right now, was the safety reasonable

Unidentified speaker, Host, Goldman Sachs: The liability.

Hugh Davis, President and COO, Aclaris: And the liability. And the answer is the safety profile was identical to what you see at tezepelumab. Okay. So we saw all three positives that came out of that. We were very happy about that.

And in fact, we are looking for licensing partners for the respiratory indications out of that. And of course, we made the decision then to move forward with the phase II AD trial and initiated that at the same time.

Unidentified speaker, Host, Goldman Sachs: Yeah. I think you guys have said that the respiratory studies in The U. S. Would require a partner. But you can take forward the acid and derm indications.

I guess talk to us about the strategic decision making there. And why do you think that bifurcation makes the most sense for Aclaris?

Kevin Balthaser, CFO, Aclaris: So I think from our perspective, there’s two things. One, on the respiratory side, obviously we’re getting into later stage development. I would think that those indications, phase three studies, they’re much more traditionally run by large pharma. There’s a huge capital investment that needs to take place to run those studies. Obviously, we’re on the smaller side.

And with the way the macro environment is right now, we’re not going to go out and raise $500,000,000 to run those types of studies. On the AD side, obviously the headwinds are that Amgen wasn’t successful with their study. From our perspective, running a efficient phase two study in AD that’s going to cost somewhere between 12,000,000 to $15,000,000 is a reasonable bet in what otherwise I think is seen as a show me story. So that’s kind of how we came to the conclusion that we wanted to progress the derm indications and look for a partner on

Unidentified speaker, Host, Goldman Sachs: the respiratory side. How do partners think about that, like taking on only a sleeve of the development, like the indications, while not taking on the whole asset? And is that something you would be open to considering, like a broader agreement?

Kevin Balthaser, CFO, Aclaris: Yeah, I think the answer is yes. I mean, devil’s in the details, obviously, with any type of BD partnership. But I think, yeah, historically, I think full asset goes traditionally in most of these types of deals. There’s very few that I can think of that sparse out indications now. If it’s something more like a regional deal, then probably more flexibility there.

But otherwise, I think we just have to wait and see how discussions progress.

Unidentified speaker, Host, Goldman Sachs: Sure. You are initiating these Phase II studies in AD this quarter. Maybe you could walk us through the trial designs there.

Hugh Davis, President and COO, Aclaris: Yeah, so when the 2A was done, there were a couple of considerations that we’ve carried over into the logic for the phase II trial now. And that is you need to have enough time for the drug to have its full effect. And so a short sixteen week study isn’t good enough. When you’re inhibiting the Th2 pathway and TSLP as an alarm at the top of that Th2 cascade, you need to inhibit that completely. You need to shut down the immune cell activation, the chemokine secretion, the eosinophil neutrophil recruitment.

And then you have to have keratinocytes allow time to heal the skin. So that takes time. And Jonathan Silverberg was our KOL at the time and suggested that that was one key consideration for the development in terms of the study design. The other thing we wanted to do was because no one, to your point, no one’s gone into TSLP and AD other than Amgen, and everybody looks at it as a failure. We didn’t look at that as a failure at the time, by the way.

They still had 29% response in IJ-one in their phase 2A trial. But we thought with a better molecule and a right clinical design that we would have a better chance of success. But we still went in with the highest dose we could at three hundred milligram every two weeks. I told you the half life is long and the residence time is long. The half life’s twenty three days.

So we put as much drug on board as we could safely and ran it for as long as we could through the twenty six weeks. And that’s what we’re doing now, is again we’re using the same dose and we’re dosing it every two weeks, three hundred milligrams, and with an induction, and we’re going to run a twenty four week study with that for full effect. And again, this is placebo controlled, highly powered. So if this by chance didn’t work, then I’ll be surprised, of all. But it would be, there’s no way that this study couldn’t work any better with the exposure, the half life, the time.

This is all in, and that’s what we wanted to do.

Unidentified speaker, Host, Goldman Sachs: What’s the primary endpoint for the trial?

Hugh Davis, President and COO, Aclaris: It’s EZ 75 response, percent change from baseline.

Unidentified speaker, Host, Goldman Sachs: Okay. And what would be considered a good outcome, an EZ 75 at twenty four weeks?

Hugh Davis, President and COO, Aclaris: So Dupi and others are at two thirds, sixty eight percent of subjects, a seventy five percent response. But it’s Aclaris’ goal to really show a much greater and robust effect. And so we would like to see upwards of that. But also we’re looking at IJ-one as a key secondary. And that’s really key for patients.

They want to be clear, mostly clear. Okay. They don’t want to be 75% responders.

Unidentified speaker, Host, Goldman Sachs: Okay. And how many patients are there going be in the study?

Hugh Davis, President and COO, Aclaris: Ninety.

Unidentified speaker, Host, Goldman Sachs: Okay. In terms of like the next steps from there, what would be the appropriate next steps in an outcome like you just described?

Hugh Davis, President and COO, Aclaris: Well, I mean to your original question before, if we can show real success in AD, that’s a huge benefit for patients. And so you need other modalities in your armamentarium. The safety profile for TESI has been great. We’re expecting this to be equally as good, and that’s important because you’re going to be going to younger and younger populations. So 45, Vosacutog, would definitely be moving forward in AD if we saw those kind of data that we did in 2A especially.

But as, you know, we also have the bispecific. And that’s a T SLP IL4R bispecific. And so there will be decisions to be made, but it will be data driven at the end of next year.

Unidentified speaker, Host, Goldman Sachs: Okay. I want to get to the bispecific, but last question on the monoclonal antibody. What are the timelines in terms of how quickly this kind of trial can get up and running, how quickly enrollment and when we

Kevin Balthaser, CFO, Aclaris: can get the data?

Hugh Davis, President and COO, Aclaris: Yes. So as Kevin mentioned, the key for us was to put together an efficient, reasonably cost trial where we can get an endpoint quicker. And so we went with the one active arm versus placebo so we can get TLR by fourth quarter next year.

Unidentified speaker, Host, Goldman Sachs: Okay. So let’s do the bispecific now. Obviously this is the other thing that came in with the deal. What do you view as like compelling mechanistically between the particular combination between TSLP and IL-four? There’s been kind of like a number of different mixing and matching that’s going on in this space.

So why these two?

Hugh Davis, President and COO, Aclaris: So this was all in approach, basically. So the T slip with the long residence time and the low dissociation is the key, is the same T slip antibody as part of the bispecific. So same four hundred hour residence time. And then we wanted to take TSLP down to as low as possible. At the same time, on the IL4R side, I mentioned the targeted drug disposition that Dupi has the issue.

Yeah. We also put a YTE into the FC. And that allows for extended half life. And that should overcome the TMDD that Dupi is seeing. But we also didn’t want to go after an IL4R that had more affinity than DUPI.

We wanted to match DUPI’s affinity and able to inhibit IL4 and 13 by going after the receptor, and then add on the complete neutralization of TSLP as best you can within the dosing. And so the combination of those in a potency experiment have shown that you could inhibit chemokine secretion five times more potently than TESI and DUBI combined in a PBMC activation assay.

Unidentified speaker, Host, Goldman Sachs: Okay.

Hugh Davis, President and COO, Aclaris: So we’ll be conducting a SAD and MAD initiating in healthy volunteers, and we’ll be able to show what that PK safety and tolerability looks like this year.

Unidentified speaker, Host, Goldman Sachs: Okay. So I think you just said that the IL-four and IL-thirteen piece of the bispecific is hitting the receptor. Guess talk to us why that makes sense in the context of IL-four and IL-thirteen.

Hugh Davis, President and COO, Aclaris: So DUPI obviously is the grill on the block. They’ve shown that by inhibiting both four and thirteen, they can get maximum effect, where I know there are a lot of IL-thirteen antibodies and bispecifics with T slip and IL-thirteen inhibitors, but you’re leaving IL-four out there to have its still direct effect on the receptor. So it doesn’t make sense to me. Didn’t make sense when we built the bispecific. So we want to be able to inhibit T slip, IL-four, and IL-thirteen action, and this molecule does it all.

Unidentified speaker, Host, Goldman Sachs: Okay. In terms of just like what these different kinds drive and like how they manifest clinically, is there, are they like parallel in terms of the type of information they drive, the way that they manifest, or are these orthogonal sort of approaches?

Hugh Davis, President and COO, Aclaris: A little of both, interestingly.

Unidentified speaker, Host, Goldman Sachs: Okay.

Hugh Davis, President and COO, Aclaris: So one is an immune component, of course, with IL-four and 13 on T cells. And then you have Th2 activation at the top of the cascade, goes through OX40 with dendritic cells, innate lymphoid cells. And so it’s able to inhibit a much broader path of both adaptive and innate immunity. And we know that atopic derm is a lot more challenging than psoriasis, for instance, which is a Th17 cascade for the most part. Here it’s very heterogeneous,

Unidentified speaker, Host, Goldman Sachs: and

Hugh Davis, President and COO, Aclaris: people seem to respond, some to doopy, some with other drugs, and they don’t necessarily cross over. And so by going after both types of inhibitors and pathway actions, we thought that had the best chance of success.

Unidentified speaker, Host, Goldman Sachs: Okay, understood. And so it sounds like it’s also a little bit like indication selection or context specific, why this pair makes the most sense. How are you thinking about indication selection and how you want to maybe sequence the indications you pursue with this program?

Hugh Davis, President and COO, Aclaris: Well, beauty is we get the phase II bosacotug data. Virtually at the same time we’ll get the 1b study data out of the bispecific. Okay. And so it’ll be a data driven process at that point. But we also know because of the really, the potency of the bispecific and its broad applicability across three target inhibitors that other diseases like COPD, where both dupi and tesi have shown modest success, thirty five percent response rates, if you had the combination of basically dupi and tezi in one molecule enabled to inhibit both types of targets in the pathway, we would hope for a chance of success in making a bigger difference for patients in challenging disease areas.

So in refractory disease, in AD for instance, COPD and the like. So we have a lot of opportunities. It’s going to be data driven in the end.

Unidentified speaker, Host, Goldman Sachs: Maybe can you give us a sense for the MAD study, like the scope of that trial, how many patients and you know, what, how many doses? What can we learn from that?

Hugh Davis, President and COO, Aclaris: Yeah, we haven’t publicized that just yet. But it’s a SAD single ascending dose. And then there will be a MAD complete. And those will read out at the end of the

Unidentified speaker, Host, Goldman Sachs: Okay. So the next steps was the MAD data, indication selection, and then moving into phase two. Maybe you could talk to us about how many like will you do one indication at a time, multiple indications?

Hugh Davis, President and COO, Aclaris: So with the bispecific at least, we’ll go into patient population to get some early data readout. And whether it’s respiratory and or derm, that’s still to be determined in 2026. And then beyond that, we do have the capability. And in our clinical catalyst calendar, we’ve covered both the bosacotog Phase II as well as the bispecific going into a patient population in 1B, two populations in 1B, as well as the 2138 LLP GERIATA study.

Unidentified speaker, Host, Goldman Sachs: Okay. Before I move on to the ITKJAK3 inhibitor, anything else to note on these programs? No? Okay. So people generally are pretty familiar with JAK inhibition.

We’ve talked about that with many agents. But can you just talk about the biology you’re targeting with ITK inhibition, why does it make sense to combine that with JAK-three?

Hugh Davis, President and COO, Aclaris: Yeah. So, you know, JAK-one and two, of course, is where we’re seeing the black box warning and the like. But with ITKJAK-three, it’s really interesting because you’re hitting both the T cell with the ITK, so through the T cell receptor. So you’re inhibiting its differentiation, proliferation, activation. At the same time on the JAK3 side, being at a T cell dependent cytokine release inhibition.

And so really again it’s this kind of bispecific approach. Our 2138 is about equipotent on both ITK and JAK3. And so as a follow on to rituximab, we’re about 40 times more potent on ITK and five times more potent on JAK3. And so you know, rituximab is already approved in alopecia areata and doing very well. But as a follow on, this would be a much more potent molecule that would be able to hit both of those equally.

And if you look at the data with rilacitinib, at their fifty milligram QD dosing and the potency that they have on ITK, they’re probably not having full occupancy of that kinase inhibition. We’ve shown pre clinically in our work, and we have a publication out on this, we’re showing fifty to ninety percent occupancy at the doses that we’re using, and that’s even at about 20 fold less than what ritalicitinib is. So there’s advantage to inhibiting both the ITK and JAK3 pathway with this molecule, because you get both the T cell activation inhibition as well as the T cell dependent cytokine inhibition.

Unidentified speaker, Host, Goldman Sachs: Okay. There’s been a number of different kind of indications proposed for this molecule. How does like the biology that you just described map to indications that would be of most interest in INI, and what are you guys thinking now?

Hugh Davis, President and COO, Aclaris: Yeah, so we did our proof of concept study in AD, but that was a function of having enough tox data to support twelve weeks of dosing. So AD made sense, but that wasn’t the plan in terms of the phase

Kevin Balthaser, CFO, Aclaris: two We

Hugh Davis, President and COO, Aclaris: look at Ripilacitinib and alopecia areata, and we look at vitiligo, and those make a lot of sense for us. We couldn’t go there initially because we didn’t have the tox coverage to do that, and those are longer term studies. But that’s where we see the competitive market potential. And in fact, the market is growing. We have some knowledge around that because we collect royalty stream off of alopecia areata with JAK inhibition.

And so we’re looking forward to moving 2138 forward

Kevin Balthaser, CFO, Aclaris: on that. And I would just add on to that as well. I think the TPP of 02/1938, because it has the JAK component, I think you have to kind of go in with a base case that you’re going to get the black box, even though we would argue that maybe JAK3 is the safer JAK relative to JAK1two. We think two thousand one hundred thirty eight is probably better positioned in alopecia areata like, and vitiligo, like Hugh mentioned, maybe where there’s a little less concern about dosing with the JAK. And then leaving kind of atopic derm potentially for something like our ITK specific program, which we anticipate getting to IND in 2026.

Unidentified speaker, Host, Goldman Sachs: Okay. So I do think we have Phase IIa data coming later this year or soon, Next

Hugh Davis, President and COO, Aclaris: couple months, yeah.

Unidentified speaker, Host, Goldman Sachs: Next couple months, yeah. So in terms of like a win from that readout, what would be a win in support kind of moving into the next phase of development?

Hugh Davis, President and COO, Aclaris: Luke, the goal was really to look at the safety to make sure that inhibiting both targets equally with high potency that we have in 2138 still had a very good safety profile. And then on top of that, it’s a JAK. So in fact, it should still have the type of efficacy that you would expect out of a JAK. So those were the two things we wanted to see.

Kevin Balthaser, CFO, Aclaris: Okay. Just to clarify, too, we’re expecting data this month. And just want to clarify or add on to what Hugh said that the PD that we’re going to have as part of that study is important, because we’re going to

Hugh Davis, President and COO, Aclaris: try to

Kevin Balthaser, CFO, Aclaris: tease out the relative impact of the JAK pathway and the ITK pathway, which then provides a nice bridge again into our ITK specific program. In

Unidentified speaker, Host, Goldman Sachs: terms of safety tolerability thresholds, guess like what do you think is a reasonable thing to see as you think about moving into alopecia areata or vitiligo or one of these?

Hugh Davis, President and COO, Aclaris: I think it’s already sort of accepted safety profile just with the other JAKs. So I would think as long as we weren’t any different than that, and certainly if we were slightly better. But I think they’re already accepted in alopecia areata quite well.

Unidentified speaker, Host, Goldman Sachs: Are there any on target effects of ITK inhibition that are not seen with JAK that you are monitoring for?

Hugh Davis, President and COO, Aclaris: It’s a good question. We haven’t had that one. I don’t know.

Kevin Balthaser, CFO, Aclaris: The only thing I would point to is the Corvus data. Obviously, have the ITK inhibitor. They’ve had it in T cell lymphoma. Now they’re doing the AD study as well. Commented in terms of tox liabilities or AD liabilities.

So I think at least the literature, at least what we’ve seen so far, would suggest that the safety profile is pretty favorable.

Unidentified speaker, Host, Goldman Sachs: You talked a little bit about discovery efforts. How should we think about the right cadence for IND? Is there new assets coming into the clinic from here?

Hugh Davis, President and COO, Aclaris: Like Kevin said, the ITK selective, we’re looking at an IND submission in ’26. And we’re looking right now at an ITK, TXK approach, and then a follow on ITK selective. So that’ll be moving forward to candidate selection this next year. And as I mentioned, there’s also now some biologic ideas around candidates that we’re building And they’ll be moving forward, but those are still very early days.

Unidentified speaker, Host, Goldman Sachs: Okay, understood. As a company, you guys have done a lot to preserve the balance sheet over the past year or so. Where do you stand now with respect to cash runway? And what are the activities you’re embedding in that guidance?

Kevin Balthaser, CFO, Aclaris: Yeah, so obviously we’ve done a lot of work. And we always try to run the company in a kind of shareholder friendly, efficient manner. You see that with the decisions we made around the 45 AD study. We currently have a little more than $190,000,000 of cash on the balance sheet. In our most recent release, we publicly stated that some operational decisions that we made allowed us to extend that runway by over a quarter and a half.

So now we’re saying through mid-twenty twenty eight. And really, was important for us to make sure that within that runway, we can hit all these key catalysts that we’ve been discussing. And particularly to have kind of that eighteen months post the 45 data and the bispecific data to be able to really hit what we feel are going to be major catalysts for us, particularly late next year. So we’re pretty excited. Obviously, we’ve got a lot going on.

And we feel like we have a really good portfolio of differentiated assets and in a fortunate position that we have the balance sheet to be able to execute against that.

Unidentified speaker, Host, Goldman Sachs: I think that brings me to the end of my questions. Anything else you’d like to highlight?

Hugh Davis, President and COO, Aclaris: No, I think Kevin said it best. You know, we have a lot of excitement ahead of us and certainly a lot of readouts over this next eighteen months that are going to be key to success for Aclaris. We have the team that can drive this. And we have the discovery engine that’s coming through to continue the sustainability as we continue to move forward.

Unidentified speaker, Host, Goldman Sachs: Thanks, guys. Really appreciate the time this afternoon.

Kevin Balthaser, CFO, Aclaris: Thank you.

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