2/6/2026

speaker
Operator
Conference Operator

Good day, and thank you for standing by. Welcome to the Roy Vant Third Quarter 2025 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Stephanie Lee. Please go ahead.

speaker
Stephanie Lee
Head of Investor Relations

Good morning, and thanks for joining today's call to review positive phase two results for brevacitinib and cutaneous sarcoidosis, and Reuven's financial results for the third quarter ended December 31, 2025. I'm Stephanie Lee with Reuven. Presenting today, we have Matt Klein, CEO of Reuven, and Ben Zimmer, CEO of Reuven. For those dialing in via conference call, you can find the slides being presented today as well as the press release announcing these updates on our IR website at www.investor.royvand.com. We'll also be providing the current slide numbers as we present to help you follow along. I would like to remind you that we will be making certain forward-looking statements during today's presentation. We strongly encourage you to review the information that we filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties. So with that, I'll turn it over to Matt.

speaker
Matt Klein
CEO

Thanks, Steph, and thanks, everyone, for dialing in and listening this morning. I'm going to start our presentation on slide five. You know, I was sitting, talking to the team, it was about a week ago today, looking at a draft of this morning's presentation and thinking that it was going to be a pretty boring 10Q. We had gotten together in December for the Investor Day. We had spoken at the David Morgan Conference, and it turned out to have been a really busy week. So we have some great updates, obviously, most notably the Phase 2 data in Brepo and CS, which Ben is going to present on momentarily. But truth is, terrific execution and progress across the board for us this quarter. Obviously, that data is a highlight, but we also can announce today that the NDA for Grepo is in endometriosis, that the Phase IIb study for 1402 in DCRA has fully enrolled, that the Phase II study for Moseley in PHLD has fully enrolled, and obviously all of the updates that were known before, including the Imunovan offering earlier, that gets us now financed to Graves Launch, all behind us. Just a terrific quarter and a terrific set of updates even since early January when we last got together. You know, on slide six, 2026 is again a very busy year for us ahead. Obviously some major events later in the year, the BREPO and IU phase three, the pivotal readout in the second half. We're now going to be starting this year a phase three study in BREPO and peritoneal sarcoidosis. Ben will talk a little bit more about that. It's early days. I'm getting that going, but that'll be this year. The Phase 2b data for Moseley is expected firmly in the second half of this year. We now know that because the study is fully enrolled, obviously. Same thing with the DTGRE data, where all of that, both the open-label period and the randomized withdrawal period, will be done by the second half of this year. We also are getting proof-of-concept data in 1402 in CLE. And finally, we are still on track for the jury trial against Moderna starting on March 9th. So, just a few weeks away now. So, a really, really busy year ahead for Reuven. And really, if you look at slide seven, before we get, again, to the data for CS, you know, just a pipeline we're really proud of that continues to deliver across multiple dimensions. Obviously, with now three indications in the pivotal registrational programs, multiple registrational programs for FCR and FranchiseMate, which we've talked about, and mostly with top line data coming in the second half. Really excited about where we are as a business, really excited about the pipeline. Couldn't be more excited for the beginning of 2026 here. Certainly off to a good start. And with that, what I'm going to do is turn to the phase two data for Brepo and Cirque de Roses. So I'm just really briefly on slide nine of the presentation, I'm just going to walk through a couple of highlights, but mostly I'm going to hand it over to Ben to take you through the data in detail. And the short answer, and we keep saying this, it's a tremendous force I think to be able to say, but this drug has done everything we could have asked for us, for it in this, or of it in this study. You know, we got a significant, . Remember, we had said before the bar for clinical success here we thought was sort of five points of CSAMI was clinically meaningful. you know we got a placebo adjusted almost 22 points 21.6 point uh delta with a p value and again the study was not powered for efficacy in this in this endpoint a hundred percent of patients on brepo 45 for real 14 on placebo uh had a 10-point improvement again clinically meaningful was five points 100 of patients on our high dose had at least a 10-point improvement uh so you know just a tremendous outcome across the board there's some great supportive data on some of the other endpoints as well and with safety and tolerability completely consistent with what we've seen for the compound in the past. So a really terrific outcome, and it is easy that needs it, where there's never been a positive placebo-controlled study in an industry-sponsored study to our knowledge. So really a terrific day for those patients. So with that, I'm going to hand it over to Ben to walk you through a little bit about cutaneous sarcoidosis as a reminder, and then on to the study as well. Ben, take it away.

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Investor presentation