Aclaris at H.C. Wainwright Conference: Strategic Moves in Immuno-Inflammatory Diseases

On Thursday, 27 March 2025, Aclaris Therapeutics Inc (NASDAQ: ACRS) presented at the H.C. Wainwright 3rd Annual Autoimmune & Inflammatory Disease Virtual Conference. CEO Neil Walker and COO Hugh Davis shared insights into the company’s strategic focus on immuno-inflammatory diseases. They highlighted a strong cash position and a robust pipeline, while also addressing challenges in a competitive market landscape.

Key Takeaways

• Aclaris boasts a cash balance exceeding $200 million, ensuring financial stability until 2028.
• The company plans significant pipeline developments, including IND submissions and clinical data readouts.
• Aclaris is prioritizing Atopic Dermatitis (AD) with innovative treatments and seeking strategic partnerships in China.
• The company aims to differentiate its products by targeting the top of the inflammatory pathway.

Financial Results

• Cash Position: Aclaris reported a cash balance of over $200 million, expected to support operations into 2028.
• Financial Strategy: Emphasis on capital-efficient studies, particularly in AD, while pursuing partnerships for more resource-intensive respiratory programs.
• Upcoming Catalysts: Key pipeline milestones include the IND submission for a bispecific antibody this quarter and clinical data readout for AC2138 in AD in Q2.

Operational Updates

• Pipeline Development:

- IND submission for a bispecific antibody is expected this quarter.

- Clinical data readout for AC2138 in AD is anticipated in Q2.

- ITK inhibitor IND submission is planned for 2026.

- TSLP mAb study initiation in the US for AD.

• China Partnerships: Aclaris is exploring partnerships in China to leverage local biotech innovations and data reproducibility.

Future Outlook

• Strategic Goals:

- Focus on targeting the top of the inflammatory pathway to address unmet needs in dermatology and respiratory diseases.

- Leverage expertise in immunology and drug discovery to differentiate in a competitive market.

- Expand partnerships and explore opportunities in less competitive areas.

Q&A Highlights

• Competitive Landscape: Aclaris views the AD market as evolving, with potential for differentiation by targeting the inflammatory cascade.
• Data Reproducibility: The company is combining data from China and the US to assess development potential, with a focus on severe asthma trials.

For further details, please refer to the full transcript below.

Full transcript - H.C. Wainwright 3rd Annual Autoimmune & Inflammatory Disease Virtual Conference:

Mitchell Kapoor, Senior Biotech Analyst, H. C. Wainwright: Hi, everyone. My name is Mitchell Kapoor. I’m a senior biotech analyst at H. C. Wainwright.

Today, I’m pleased to be joined by the Aclaris team for our autoimmune healthcare day. Today, I have the CEO, Neil Walker, COO, Hugh Davis, and CSO, Joe Monahan. So we’re going to have a fireside chat and go back forth with some Q and A. But I wanted to just start off and let you all introduce the company for those who may not be familiar, just talk about the history and the overview of the Claris.

Neil Walker, CEO, Aclaris: Thanks, Mitchell. Thanks for having us here today. So, yeah, Claris is a is a clinical stage biotech company focused on treatments for immuno inflammatory diseases. We we’re pretty unique in that we have both a small molecule and a large molecule portfolio. We have a pretty healthy cash balance over $200,000,000 that gets us into 2028 and quite a data rich catalyst calendar through ’twenty five and ’twenty six.

We have an IND submission with our bispecific that’s going in this quarter. We have clinical data that reads out with 2,138, our oral small molecule in AD in Q2. And we have ITK inhibitor right behind that that comes into focus into an IND in in ’26. And then, of course, our t slit mAb, we have a study getting started in The US in in a topic. So a lot going on.

And and what underpins all that is our drug discovery expertise through our connect platform and, our world class immunology expertise across the board in various therapeutic areas.

Mitchell Kapoor, Senior Biotech Analyst, H. C. Wainwright: Great. Thank you. That’s a wonderful overview. Just to start off, you’ve had a long history in the dermatology space. You have a bit of a respiratory subvertical as well.

Could you just talk about kind of the implications for that and, what the that implies for the company as it evolves?

Neil Walker, CEO, Aclaris: Yeah. So, you know, I mean, my background, of course, is is dermatology heavy, but have a lot of experience in various therapeutic areas. And and, of course, our our company is rooted in in, in in having a tremendous amount of immunology expertise vis a vis our acquisition of Confluence where we picked up Joe and and a number of the folks, there that were all ex Pfizer who ran the immunology group, and and they have expertise across the board in various therapeutic areas. And then in addition, when we did the transaction with Biogen, Hugh Davis, who’s now our president and COO, as well as five other folks came over giving us world class large molecule expertise and, again, across many therapeutic areas. So we feel comfortable with, the the respiratory drug development.

We do have a pulmonologist on our medical team, that’s been a long time clinical drug developer in addition to a wonderful SAB and Marian Mann and and, Susanna, who joined us, on our SAB that we formed recently, to help with with respiratory drug development. So we feel well equipped to operate in that space.

Mitchell Kapoor, Senior Biotech Analyst, H. C. Wainwright: Great. And can you talk a bit about the recent expansion of the portfolio into biologics with the BioSion deal and those assets? And, just talk about some of the driving prioritization between factors for prioritizing biologics versus small molecules?

Neil Walker, CEO, Aclaris: Yeah. It is. It’s a unique I think it’s a unique set of assets in that, we’re able to target the market in multiple different ways. Sometimes therapeutic areas are relevant for small molecules, some for large molecules. I think we can create a we can target a wider target addressable market having both.

And so we think both are quite important. And, you know, the t SLIP mAb and the t SLIP, IL four r bispecific that that we in licensed came about after we met with you and the team last year in May, and we did a tremendous amount of diligence on these assets. We compared the t slit mAb versus not only tessey, and we repeated these experiments in with three different shops multiple times, but we also compared against the relevant competitive landscape. And what we were able to show is best in class potency and also exceedingly long residence time, which we think is really critical for an alarming mechanism of action. If you bind to the target and you’re not coming off, then you don’t allow that alarming to hit the receptor.

And some of these other technologies that folks have, if it has a fast off rate, then all you’re doing is just waiting until it hits the receptor again. So I think with this mechanism, having the position of long residence time is quite key to at least our investment thesis. So we’re excited about that. And of course, you know, we’re starting a study in atopic derm, where we think very highly of that indication. And then there’s read through, of course, into the bispecific that we’re filing this quarter.

Mitchell Kapoor, Senior Biotech Analyst, H. C. Wainwright: Great. Okay. And just on the T SLIP target, could you talk about how hot this target is and contextualize that for the audience? Maybe talk about some unique scientific attributes that are driving the heightened interest in this target versus some of the older, more established pathways in the I and I space.

Neil Walker, CEO, Aclaris: Well, I’ll start and I’ll hand it off to Q. But, you know, I think when you look at all these therapy areas, it makes sense to target the path in a variety of different ways. There’s never a one size fits all for every patient. And I think you’re seeing this evolution now certainly in the respiratory space, but also in derm where if you can target at the top of the pathway and start knocking out the the inflammatory cascade there, then that ought to be, a great mechanism for for, patients, and certainly another tool that docs can use to address patients who aren’t responsive or in or don’t respond in an adequate way to other therapies. So I think there’s a lot of headroom in in both respiratory and and derm, quite frankly.

These, you know, atopic derm is a is an evolving market. It’s it’s a very nascent market. It’s in the early days like where psoriasis was, and and we’re just learning about how all these pathways, you know, influence clinical results. So maybe hand it off to Hugh for for more thoughts.

Hugh Davis, COO, Aclaris: Yeah. I would just expound on that, slightly. You know, we think about this almost like TNF was back in the day. And, you know, my experience at J and J for twenty years with REMICADE and SYMPHONY and the like, you know, so many indications, 16 in fact for REMICADE alone. But really, the reason why there were so many anti TNFs that came through clinical development ultimately to the market was because there was always room for better efficacy.

And so we see with our opportunity with the Aclaris portfolio with both the 45 TSLIP alone, but also with the bispecific, we see that, you know, easy scores of 90% and IGAs of clear mostly clear skin and AD and even better respiratory endpoints. I mean, look at the COPD approval for DUPI. It’s, you know, based on thirty five percent response rates. So as Neil said, there’s a lot of headroom in terms of enhanced efficacy, and that’s where Aclaris is really going forward with our highly potent assets because we’re looking to really drive greater and more robust disease amelioration. That’s the goal.

Mitchell Kapoor, Senior Biotech Analyst, H. C. Wainwright: Okay. Very helpful. And moving to the competitive landscape and how you all view that, both for the atopic derm side as well as asthma as well. Could you just talk about, you know, what what does that look like for you? You know, what how attractive is each indication based on the degree of which it’s being addressed by existing drugs and just any other factors about, you know, how you’re positioning in the competitive landscape?

Neil Walker, CEO, Aclaris: Yeah. I mean, I think for for right now, we’re focused on on atopic derm. That’s the study that that we’re, initiating in in The US, and we’re really excited about that. I I think there’s a ton of headroom with with AD right now. Again, we’re learning about all the aspects of this pathway, and it it makes total sense that if you’re gonna have a disrupted epithelial barrier that kicks off all of this inflammation, that’s central to the pathophysiology of AD.

So from my perspective, the biology is quite sound if if you look at the literature there, and and, you know, we think there’s an opportunity there to really drive a tremendous amount of value in that space, right? Right now, DUPI is dominating the market. You have JAK inhibitors and you have, you know, things like OX40 and others that actually OX40 is directly in that same pathway as as TSLIP. So, you know, we think that makes a lot of sense. On the respiratory front, again, still a lot of room to improve the efficacy.

I think people are taking two different approaches these days. They’re they’re looking at driving better efficacy and they’re also looking at at, basically extending the dosing interval. In my mind, it makes more sense to go after optimizing the efficacy because that’s what really patients care the most about is is does it work. And on the respiratory front, you know, what we’ve what we’ve told people, to date and and and this is still true is that, you know, once we get data out of China from our partner there, we do have data sharing rights, but, you know, our our main position is that, you know, if it’s great data, we will immediately look for a partner on that front. Those studies are quite capital intensive in in these markets.

I don’t think it makes sense to be to be, you know, messaging that you’re gonna go and raise $500,000,000 and and these are big pharma indications from my perspective. So the data is really good. Then, you know, we ought to be able to find a partner on that front and move that forward in that manner.

Mitchell Kapoor, Senior Biotech Analyst, H. C. Wainwright: Okay. Very helpful. And I want to move the conversation. You touched a bit on it in China. It’s a huge topic in biotech right now.

As you know, Aclaris and several other companies have entered into licensing transactions to get things out of China. Could you just talk about the trend that’s going on here, your expectations? What kind of innovation in the space, whether it be target validation, new biology or fast followers, is likely to come out of China in the near to medium term? And and how do you position, you know, in that in that field?

Neil Walker, CEO, Aclaris: Yeah. I you know, it’s I’ll I’ll start and hand it off to Hugh who’s had a many, many years of experience work working in China with with J and J and then Bioshin, of course. But, look, it’s expanded the ecosystem. I think everybody’s got to be thinking about the competitive landscape in a much broader fashion. You know, our colleagues in China are quite good at moving assets along in the discovery process.

There’s a lot of folks that trained at large pharma companies here that went back home basically and started companies. And now you’re seeing now you’re kind of seeing the output of that. So I think you have to look across the board for interesting asset opportunities and that is, as we all know, influences the competitive landscape, which I think no matter what area you’re in, know, from our perspective as a management team and all management teams have to be thinking long and hard about how you’re positioned, not just today, but but three, four years down the road. And, Kyu, maybe some additional thoughts there.

Hugh Davis, COO, Aclaris: No. I’ll I’ll just say quickly. Yeah. I’ve been in China for twenty years as a China Biologic Leader for J and J. And as Neil pointed out, you know, many returnees, they had a thousand talent program where they brought a lot of Chinese back into China and really supported the biotech industry.

And so what you’re seeing is is is just a global ecosystem. It’s always been ready to go in terms of novel, novel new assets. So there’s there’s really just a greater opportunity to bring more of those to to clinical development.

Neil Walker, CEO, Aclaris: Yeah. One and one of maybe just to build on that a little bit more. I mean, one of the things that we tend to think about is how can you continue to to leverage, you know, our core competencies with various partners, you know, that may be in China. And, you know, there are opportunities, I think, to look at establishing stronger relationships there where, you know, perhaps they’re handling a lot of the discovery work and then they hand it off and, you know, you carve up, you know, whether it’s China and or global markets. So, you know, there’s new models that I’m hopeful will evolve that perhaps can give companies like ours a competitive advantage.

Mitchell Kapoor, Senior Biotech Analyst, H. C. Wainwright: And and one of the questions we get a lot from investors on many different companies is about the, reproducibility of data. Can you talk about for o four five, you know, what that might look like to be you know, to reproduce that data in The US?

Neil Walker, CEO, Aclaris: Right. Yeah. I mean, I think it depends what indication you’re talking about, you know, how the study was conducted, size, design. You know, if we if we look at the dermatology data that that HUE and Biogen produced, that was conducted in The US. It was a single arm study, but it was in The US with seven US sites run by dermatologists.

So, you know, all folks that actually I’ve worked with in the past. So I think even though it was single arm data, it’s a robust dataset. And then on the respiratory front, you know, there are some differences just just demographic wise, baseline characteristics between China patients and and US patients, and you just gotta keep those in mind. And so long as the study is is run-in a, in an acceptable way, then then, you know, I think you can learn a lot. And at the end of the day, it’s always better in my mind to have, you know, a little bit more data than less to help inform your decision.

And then you just have to look at the aggregate of the data and how it stacks up when you’re making your decision to to evolve in a different indications. And and maybe, Hugh, since you’ve had a ton of experience working in China.

Hugh Davis, COO, Aclaris: Yeah. No. When when you know, China now is OECD and ICH compliant. So they’re following global expectations and companies like TigerMed, which was part of Frontage Labs where I was a CBO. TigerMed is one of the world’s clinical CROs that does the same quality work that, you know, our CROs do around the globe.

So, yeah, I think the quality of the data, like Neil says, is really key to look understand those demographics, standard of care, and how you design those studies in order to be useful in the global submissions.

Mitchell Kapoor, Senior Biotech Analyst, H. C. Wainwright: Great. And, you know, for the trials that are being conducted for o four or five b in China, are there any, you know, key things you’re looking for to come out of that trial that could be clear indicators that you could accelerate development on your side?

Neil Walker, CEO, Aclaris: Yeah. I think it’s it’s it’s really the aggregate of the data. There’s lots of endpoints, you know, like, just take severe asthma as an example. You’d want to look at FEV1 and AAER and then, you know, all of the rest of the clinical endpoints, ECQ, things like that. So there’s probably about 10 plus that you want to look at when you’re trying to understand like how you stack up versus the competition and, you know, of course, the safety profile, etcetera, and dosing.

But it is more of an aggregate sort of analysis and then taking into consideration the context of the baseline characteristics of the patients in China. But it is what we like about it is that, you know, technically, we’re the most advanced t slip. We’ve got data in severe asthma, CRS with MP, this through the first half of this year. And like I said, if it’s really good, we’ll seek a partnership on that front and stay focused on conducting the more capital efficient study in AD, where actually there’s nobody else that’s playing in that space at the moment that has a t slip. So I like that positioning better than trying to butt heads with, you know, 10 other folks.

Mitchell Kapoor, Senior Biotech Analyst, H. C. Wainwright: Very helpful. Okay. And, you know, thinking about a little bit further into the competition and the benchmark for success, how do you think about that optimal target profile target product profile for o four five b? And do you think about it as benchmarking against currently marketed drugs or do you think about anything else in development that you’re keeping an eye on?

Neil Walker, CEO, Aclaris: I think you have to look at it across the landscape. And I think, you know, as as we both know, Mitchell, like, these are super choppy times in in the biotech space. I think you have to really be rigorous in how you think about how you’re gonna stack up before you start throwing, you know, hundreds of millions of dollars into a Phase three program and try to really have that crystal ball about how the market will evolve because it’s, you know, we all always look at these things and on a static basis, but but you have to look at it two, three, four years out. And, you know, just as an example, like, look at the evolution of bispecifics. Right?

You you you talk to some people who think that bispecifics are gonna trump, you know, the mAbs, and that may be true. But we’re still very early on in that cycle. And that’s why I like, you know, kind of our approach in that we have a t slit mAb that we’re focused on, you know, one indication in The U. S. At the moment.

We have a follow on bispecific that will be in the clinic, should the IND get allowed this year. And then we have, you know, on the next front, small molecule therapeutics that are targeting, indications that we think have less competitive intensity. So our job is to be good stewards of the capital and allocate it appropriately, particularly during these choppy times.

Mitchell Kapoor, Senior Biotech Analyst, H. C. Wainwright: Okay. And for five zero two versus o four five b, could you just talk about, you know, how complementary these assets are to one another?

Neil Walker, CEO, Aclaris: David, do you want to take that?

Hugh Davis, COO, Aclaris: Yeah. Sure. Yeah. So so the really nice thing, having both of these assets really gives us a lot of opportunity to think about segmenting indications. And o four five and a d, if we can recapitulate the two a data that we saw in the open label, will be, you know, a great success for that asset.

As we think about o five two, it has the same t slip antibody. So we have the same great potency and very long residence times greater than four hundred hours relative to tesi at twenty hours, for instance. And then, and so you could go after indications like COPD or even refractory AD with a more potent and long acting bispecific hitting both targets validated IL four r as well as T SLIP. So so we see opportunities for both of those, assets to move forward. And, in the potency and long lived PK of the bispecific will certainly be playing to its strength.

Mitchell Kapoor, Senior Biotech Analyst, H. C. Wainwright: Okay. And for 02/1938, the open label trial in atopic derm, what are you looking for there to constitute success?

Neil Walker, CEO, Aclaris: Yeah. There’s really three things. So we designed this study to get an idea of the efficacy and safety profile in patients with disease. It is single arm, and and it’s a twelve week study in in a topic. And what we wanna see, of course, is is a good safety profile.

Given that this is unique pharmacology with the dual ITK JAK mechanism, which actually is a lot more differentiated than I think people give it give it credit for. It’s really the only one of its kind out there. So we wanna understand the safety profile. And then, of course, just driving the efficacy because JAK3 and ITK have been shown from a biologic perspective that they should be effective in an inflammatory disease like AD, which hopefully will give us read through into two other indications. And then importantly, we want to see the pharmacodynamic profile.

We’re able to look at the differential effect of JAK3 and also ITK, in this study. And what that will do importantly is serve as a bridge to our next gen highly selective ITK inhibitor that will come into focus in in in ’26. So that’s we’re trying to, you know, I guess, kill a number of persons with one stone in in the study and get read through into some alternate programs as well.

Mitchell Kapoor, Senior Biotech Analyst, H. C. Wainwright: Okay. And and moving on to the, rest of the pipeline, the legacy Aclaris pipeline, could you just talk about, you know, your views on on how that, looks, you know, in the near to medium term? Do you plan to outlicense or otherwise partner any of these particular assets? And, is there kind of a timeline on that?

Neil Walker, CEO, Aclaris: Yeah. We’re we’re still working on partnering seventeen seventy seven, which is our topical soft JAK that that showed a positive result last year in in a large phase two study. And so we’re optimistic on that front. Relative to legacy asset of the MK two inhibitor, that is in a oncology study. It actually works through a completely different mechanism.

It’s not something that we’re spending against, but we’re partnered with with WashU through some grant funding, and and they’re looking at metastatic breast cancer and pancreatic cancer. So, you know, we’ll we’ll see on that, but that’s not a focus for us from a from a cost perspective.

Mitchell Kapoor, Senior Biotech Analyst, H. C. Wainwright: Okay. Great. And and so the last thing I wanted to, round the discussion out with is the current cash runway and upcoming catalysts, you know, and if there are any particular catalysts we should be focused on in terms of the most significant value inflection points and just how your cash runway gets through those particular inflection points.

Neil Walker, CEO, Aclaris: Yeah. We’re very well capitalized. So with our current development plan, we will read out the AD study with the t slit mAb. We’ll obviously move the bispecific along, which I think is very important through SADMAT work and POC work. And those will be two catalysts in 2026.

And then we get the ITK selective into an IND, which I think is another big catalyst. So, and all that comes, you know, almost two years ahead of of of dry well on the cash runway. So, you know, we we feel like we’re in a great position there to deliver on a number of catalysts and and not really have to worry about, you know, fundraising at the moment.

Mitchell Kapoor, Senior Biotech Analyst, H. C. Wainwright: Great. Thank you so much to Neil, Hugh, Joe, and the rest of the team. Really appreciate you all joining us today, and thank you to our investors for joining the discussion as well.

Neil Walker, CEO, Aclaris: Have a great day. Appreciate it.

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