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5/6/2026
Good day, and thank you for standing by. Welcome to the Acutis Bioterapeutics, Inc. first quarter 2026 earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please advise that today's conference is being recorded. On the night of the conference with your first speaker today, Brian Shulkoff, Head of Investment Relations. Please go ahead.
Thank you, Marvin. Good afternoon, everyone, and thank you for joining us today to review our first quarter 2026 financial results and business update. Slides for today's call are available on the Investors section of the Arcutus website. Joining me on the call today are Frank Watanabe, President and CEO of Arcutus, Todd Edwards, Chief Commercial Officer, Patrick Burnett, Chief Medical Officer, and Lata Vajravan, Chief Financial Officer. I'd like to remind everyone that we will be making forward-looking statements during this call. These statements are subject to certain risks and uncertainties, and our actual results may differ. We encourage you to review all the company's filings with the Securities and Exchange Commission, including descriptions of our business and risk factors. With that, let me hand it over to Frank to begin today's call.
Thanks, Brian, and good afternoon, everyone. As always, we appreciate you guys making the time to join us. I want to start today's call with an overview of the latest developments at Arcutis and the progress we're making against our grow, expand, build strategy. I'll then turn things over to Todd for a commercial update, then Patrick for an R&D update, and finally Latha for a review of the quarter's financial results as well as how we're thinking about investing in 2026 to drives or even flexion. So I'm starting on slide five. Hopefully by now you're all familiar with the grow, expand, build framework. that we have adopted to define our strategy to sustain near and long-term growth for both Zareve and the company overall. In a nutshell, our plan is to continue to grow our core Zareve business in our currently approved indications, to expand Zareve into additional indications, and to build our innovative pipeline beyond Zareve. So starting with the grow pillar for driving momentum in our core approved indications, we're very excited to have submitted a supplemental NDA for Zareve Cream 0.05% in atopic dermatitis patients aged 3 to 24 months in April. This is a segment of patients who are significantly impacted by AD and who are in dire need of safe and effective treatment options beyond the very small number of currently approved therapies. Patrick will comment on the opportunity more, but we see this as a very significant new opportunity for Zareve, and there's a lot of excitement amongst dermatology clinicians about our data and the possible approvals. We also completed enrollment in a MUSE trial for xerif foam, 0.3% in children with scalp and body psoriasis ages two to 11 years of age. And that should serve as the basis for submission to extend the label to this age group, aligning it with the 0.3 cream. On the commercial front, we've successfully completed, we've essentially completed, excuse me, the expansion of our dermatology sales force to enable deeper reach into the dermatology landscape. And I'm happy to report that our expanded Durham sales force is in the field as of this week. But of course, we probably won't begin to see an impact on sales for a few months. We also began the build out of our dedicated PCP and pediatric sales team, starting with the recent hiring of our head of primary care franchise. This team will embark on a targeted effort to engage with those primary care and pediatric clinicians who are already using a fair bit of topical therapies in their practice. We also continue to make important progress against our expand pillar as we work to bring the unique benefits of Zareve to people impacted by chronic inflammatory skin conditions beyond our currently approved indications who are also in need of targeted innovative treatment solutions. With a focus on diseases where we've already seen compelling potential of Zareve based on case reports and case series. And specifically, we're nearing full enrollment of our phase two proof of concept trial in vitiligo and we continue to enroll patients in our Phase II POC trial in Hydrentonid and Suprativa, or HS. We're also evaluating additional Phase II proof-of-concept trials and indications beyond vitiligo and HS, and we'll obviously update you guys on our further decisions. And finally, we reached an important milestone in our pipeline building activities with initiation of a Phase Ia, Phase Ib trial for ARQ234. The investments we're making and the efforts we're taking to advance our initiatives across these three pillars are laying groundwork for further Zareve sales inflection and operating leverage expansion in 2027 and far beyond, as well as positioning us to sustain growth for the long term, and most importantly, expanding our impact on individuals living with chronic inflammatory dermatoses. Despite now having a successful commercial franchise in Zareve, we continue to be at our core a biotechnology company championing meaningful innovation within medical dermatology. These investments in innovation and growth reflect that intent. And with that, I'll hand the call over to Todd to give you a Q1 commercial update.
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