Aclaris Therapeutics Inc at HC Wainwright Autoimmune & Inflammatory Disease Virtual Conference (Virtual) Transcript

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

Question: Ram Selvaraju - H.C. Wainwright & Co., LLC - Analyst : Thank you very much for that. Perhaps we could start with the kinase target that is the focus of your lead molecule, zunsemetinib, which is, of course, MK2. Maybe you could provide us with an overview of this target. I know that it's probably one with which our audience is less familiar as well as its applicability in autoimmune skin conditions. And in particular, maybe you could focus on some of the unique advantages of targeting this particular kinase.

Question: Ram Selvaraju - H.C. Wainwright & Co., LLC - Analyst : Thanks very much for that overview. I was thinking that perhaps it would also be helpful for you to frame for us your expectations for the upcoming data readout for zunsemetinib in rheumatoid arthritis and maybe delineate some of the next steps that you expect to take with this compound, assuming positive results; as well as the relationship between RA and psoriatic arthritis, which is obviously much more related to the derm domain as opposed to RA, which is more of a rheumatologic disease; and to what extent we could potentially expect the positive readout in RA, I think it's positive, to be predictive of a positive outcome in psoriatic arthritis.

Question: Ram Selvaraju - H.C. Wainwright & Co., LLC - Analyst : So if we think about, for example, the performance of zunsemetinib in the RA context versus the hidradenitis suppurativa context, a lot of commentary has been generated relatively recently regarding the distinctive characteristics of HS as a disease, the degree to which it poses a unique challenge, the fact that the cytokine underpinnings of HS are markedly different from those in RA. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 30, 2023 / 5:00PM, ACRS.OQ - Aclaris Therapeutics Inc at HC Wainwright Autoimmune & Inflammatory Disease Virtual Conference (Virtual) So maybe you could give us a sense of what it is about HS that might have contributed directly to the outcome that you saw with zunsemetinib in that specific context and whether we really shouldn't consider that to have any read-through really on zunsemetinib's potential in other inflammatory skin contexts.

Question: Ram Selvaraju - H.C. Wainwright & Co., LLC - Analyst : And I think, for the audience's benefit from our perspective, the drug clearly demonstrated biological activity. Obviously, with the proof-of-concept data that you have in RA, there is clear read-through, both for the ongoing RA clinical development as well as in psoriatic arthritis. And so, we look forward obviously to those readouts with zunsemetinib. Turning now to ATI-1777, this is a topical soft Janus kinase inhibitor or JAK inhibitor. First of all, I think it would be helpful for our audience if you could give some perspectives on the significance of JAKs, Janus kinases, as targets in the domain of inflammatory skin disease. There are obviously a number of notable orally bioavailable JAK inhibitors that are on the market or in late-stage development, and contrast and compare that to the pharmacological profile of ATI-1777, including in particular not only the selectivity profile on the various JAKs, but also the potential advantages of delivering this topically versus systemically as the oral JAK inhibitors are. Thank you.

Question: Ram Selvaraju - H.C. Wainwright & Co., LLC - Analyst : If we look now ahead to the Phase 2b readout that you're expecting in atopic derm, perhaps you could give us a sense of what you would classify as a solidly favorable outcome and how you expect this to position the drug for future development in the AD indication.

Question: Ram Selvaraju - H.C. Wainwright & Co., LLC - Analyst : So if we look at the competitive landscape in AD, for many years, there was little to no meaningful clinical advancement here. But obviously, the last few years have brought about the advent of multiple currently commercially available drugs that offer certain mechanistic advantages over the old-line lotions and potions. So perhaps you could give us a sense of where the current competitive landscape is in atopic dermatitis. Obviously, very, very large indication, clear potential for a blockbuster franchise. But where do you see ATI-1777 fitting into the current competitive landscape, the current armamentarium?

Question: Ram Selvaraju - H.C. Wainwright & Co., LLC - Analyst : Great. We're running down the clock here, so I thought that in closing, maybe we could discuss a few of the strategic perspectives. Clearly, both zunsemetinib and ATI-1777 are targeting very large markets very clearly, well-established derm indications that represent their own unique challenges and opportunities from a competitive landscape perspective. So as you're thinking about those, along with Aclaris's own history in commercializing derm drugs, how are you thinking about the way to best optimize the value proposition for shareholders with these two agents, assuming positive Phase 2 readouts across the board? Are you [taking this] from a self-commercialization standpoint, a blend of self commercialization and strategic and partnering -- licensing arrangements, or purely focusing on letting a more established entity, so to speak, do the heavy lifting from a commercial perspective as and when appropriate?

Question: Ram Selvaraju - H.C. Wainwright & Co., LLC - Analyst : Yes, I think that's probably all we have time for here. I would just remind our audience that Aclaris at this juncture remains very well-financed, guidances for the operational runway through at least the end of 2025. Clearly, the company has a plethora of near- and medium-term clinical data catalysts, not just with ATI-1777 and zunsemetinib but also with other elements of the portfolio, which we unfortunately didn't have time to discuss today. Clearly, the company is about a lot more than just derm, but I would invite our audience, those who don't know Aclaris well yet. Hopefully, this has served as a good introduction to learn more about the company and its exciting pipeline. And I want to thank the Aclaris management team for taking the time to speak with us today and thank our audience for their attention as well. Thank you.