Vyne Therapeutics Inc at TD Cowen Healthcare Conference Transcript

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

Question: Stacy Ku - TD Cowen - Analyst : So real brief, just an introduction on Vyne. A little bit of a transformation over the last few years. Now we're -- all eyes are on your BET inhibitors VYN201, VYN202. So just give some brief wrap around and we'll dig into recent updates.

Question: Stacy Ku - TD Cowen - Analyst : Wonderful. So we're going to stick with 201 just for the sake of my ability to pronounce. I get it, I promise. But as we think about the proof-of-concept results, we saw that Phase 1B for 201 and in vitiligo, we're approaching kind of the Phase 2 even bigger de-risking for the vitiligo program. So maybe just talk, remind us, talk about the results we've seen so far and kind of what level of conviction you have for Phase 2. 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 04, 2025 / 4:10PM, VYNE.OQ - Vyne Therapeutics Inc at TD Cowen Healthcare Conference

Question: Stacy Ku - TD Cowen - Analyst : Do you want to talk about maybe the biomarker results you disclosed so far? And then, In addition to biomarker, I think the safety is key as we think about vitiligo in the competitive, let's say, market. So curious if you could cover both.

Question: Stacy Ku - TD Cowen - Analyst : Wonderful. So let's talk about the ongoing Phase 2B trial. You alluded a little bit to some of the differences that you're bringing forward for vitiligo, but let's discuss. Longer duration of treatment, different types of patients, I believe you're bringing forward change from ointments to gel. So maybe talk through those different Phase 2B considerations?

Question: Stacy Ku - TD Cowen - Analyst : Okay, wonderful. I believe you disclosed enrollment was completed in early January. It is for the first part, a six-month study. So is it fair to assume disclosures could come somewhere, I know you said middle of '25, but could it maybe come some in, let's say, June, late June, early July time frame?

Question: Stacy Ku - TD Cowen - Analyst : Okay, wonderful. So obviously, as we're expecting the results to come, let's talk about the hurdle for success. What's the criteria in your view for efficacy and safety?

Question: Stacy Ku - TD Cowen - Analyst : Okay. And as a reminder, F-VASI50, so the 50% reduction is going to be the primary endpoint and the key secondary endpoint, which is regulatory approval will be 75%.

Question: Stacy Ku - TD Cowen - Analyst : Wonderful. Sounds like you are going to push forward a six-month additional open label extension trial. So obviously in viligo is slow moving progressive disease. This will allow us to really get a good full sense of the efficacy for 201. But as we think about maybe that primary endpoint at six months. Iain, how are we thinking about a hurdle of efficacy versus OPZELURA? Do we have to be better? Do we have to be similar? Is safety enough?

Question: Stacy Ku - TD Cowen - Analyst : Okay. Maybe let's say a little bit the picture before we then move to your asset. Let's talk about the market for vitiligo. What are you seeing so far OPZELURA instead of adoption? What's the size of the market and what level of penetration do you think you'd expect?

Question: Stacy Ku - TD Cowen - Analyst : Okay, understood. Obviously, the vitiligo update is near term. We are going to get the oral VYN202 update for psoriasis by year end. In general, we get more questions on the oral asset, would say. So just as we drill down into kind of the nitty gritty on the Phase 1 results. Just let's walk through the single ascending dose, multiple ascending dose results that you've seen so far. And again, talk about the design of the MAD study that really allowed you to interrogate the safety profile of oral BET inhibitors.

Question: Stacy Ku - TD Cowen - Analyst : And obviously, prior studies for Phase 1 were done in oncology patients. But as you look through, I'm sure very diverse data, when do kind of the neutropenia start showing up?

Question: Stacy Ku - TD Cowen - Analyst : And then as for GI toxicity, when would you expect something like that would show up as you interrogate the --

Question: Stacy Ku - TD Cowen - Analyst : Okay, understood. And we do get occasionally questions around genotoxicity -- toxicity. Sounds like you've done a series of kind of approaches to make sure you've addressed that question. So can you talk through that?

Question: Stacy Ku - TD Cowen - Analyst : Understood. So again, just initiated the Phase 1B trial for psoriasis, guiding for results by year end. Just talk about the clinical trial design, and how

Question: Stacy Ku - TD Cowen - Analyst : Okay. And how did you select the doses from the Phase 1 single dose, multiple setting dose? And I'll tack on one more question before you answer. Do you -- just given the safety, do you give any consideration to maybe increasing the dose? What are the different kind of thought process behind that?

Question: Stacy Ku - TD Cowen - Analyst : Okay, understood, appreciate that explanation. Sounds like this is proof-of-concept trial, a little bit of a gateway approach. Maybe first, decision around selecting psoriasis versus rheumatoid arthritis for your first proof of concept. And then we'll follow up with some other questions.

Question: Stacy Ku - TD Cowen - Analyst : Okay, wonderful. And as we think about the competitive landscape, maybe in just remind us again, the decision for BD2 selectivity as for your oral BET inhibitor, and then maybe some of the other assets that are in development as we think about BET inhibition?

Question: Stacy Ku - TD Cowen - Analyst : Okay. Understood. Obviously, a lot of applicability as we think about kind of I&I approaches for inhibition. In the last few moments, just as a quick reminder, do you want to talk about IP for Vyne 202 and 201?

Question: Stacy Ku - TD Cowen - Analyst : Okay, wonderful. Number of different catalysts expected this year. I'm really excited to get more data.