Veradermics, Incorporated 12th Annual Cantor Fitzgerald Global Healthcare Conference

Yeah. Thank you so much for having us, and it's great to see such a good turnout this afternoon. I'm Reid Waldman. I'm co-founder and CEO of Veradermics, board certified dermatologist by background. Very excited to talk to you today about what is coming at Veradermics in the second half of this year, and then turn it over to Mark to share insights on the commercial opportunity in both male and female pattern hair loss. I think this should be a very exciting discussion. You'll see on the next slide our disclaimer related to forward-looking statements that you can review in your own time. But really today, we're going to talk about pattern hair loss or androgenetic alopecia. I think as you all know, this transcends being aesthetic. It's deeply personal, it's deeply psychological, and it's essentially universal, affecting 80 million people in the U.S.

That makes it 10 times more prevalent than psoriasis, 2 times more prevalent than psoriasis and eczema combined. Despite that, it has been 30 years since we've had a new oral treatment in men, and we have never had an FDA-approved oral treatment or FDA-approved prescription treatment in women. We're aiming to change that with the development of VDPHL01, the first minoxidil extended release tablet. The premise is very straightforward, as I think many of you know, that minoxidil is validated biology for the treatment of hair loss in both men and women, and that it's approved in its topical format as ROGAINE. It's also used off-label as a blood pressure medication in hair loss as well. The challenge with that blood pressure medication is that it does exactly what you would expect a drug that is intended to rapidly lower your blood pressure to do.

It spikes quickly in the plasma. Majority is gone within 2 hours, almost all of it within 4 hours. So those spikes are what drive the cardiac effects of the drug, but they're not necessary, nor are they conducive to hair growth in that they don't provide consistent and durable exposure at the follicle. So the question at Veradermics has become why is the best tool in the dermatologist toolkit a 40-year-old blood pressure medication that no one's revisited? So we've aimed to optimize it to maximize hair growth, minimize cardiac risk by developing an extended release tablet that provides consistent and durable exposures of minoxidil above the levels at which the drug is known to grow hair while staying below those at which it has cardiac effects.

In addition to enabling the delivery of more minoxidil for longer, one of the key pieces of nuance here is that we believe we can drive the bioactivation of minoxidil to its sulfate metabolite, minoxidil sulfate. I think many people don't recognize this, but minoxidil itself does not grow hair, its sulfate metabolite does. That sulfation occurs within the outer root sheath of the hair via the SULT1A1 sulfotransferase. That enzyme, like many enzymes, is capacity limited, meaning it can saturate, and time dependent, meaning it takes time to sulfate the minoxidil. I think as you can imagine, with the IR minoxidil blood pressure medication, if you spike quickly, you're going to overwhelm or saturate that enzyme. If you're not around for very long, you do not give sufficient time to sulfate.

With an extended release tablet, we were able to deliver consistent and durable exposures at the follicle to hopefully drive that bioactivation to minoxidil sulfate and resultantly drive hair growth. All in, our goal here is as follows. We aim to raise the hair growth threat or ceiling by giving more minoxidil for longer and driving its bioactivation to improve tolerability at increased exposures, meaning we give more minoxidil than would otherwise be reasonable, but we're able to achieve that by blunting those peaks responsible for cardiac effects. The drug is inherently non-hormonal. It is orally administered, which aligns with patient preference. Data to date from Study 302, our Phase II/III study in males, and Study 207, our Phase II study in females, supports a potential best-in-indication profile in both.

That's a very exciting time at Veradermics in that we have a lot of clinical milestones on the horizon. Currently, we have three ongoing registration-directed trials, two in males, one in females. The first of these is Study 302. As you may recall, we released top-line data from Part A, the six-month placebo-controlled period, in April of this year. Later this year, we will get long-term extension data from this study. Study 304 is a confirmatory trial in male pattern hair loss. We announced in February that that study fully enrolled and anticipate placebo-controlled six-month data in the second half of this year. Finally, we just announced that we have fully enrolled the first ever registration-directed Phase II/III study for an oral treatment for female pattern hair loss in the U.S., Study 306, and we now anticipate top-line data in the first half of 2027.

I think many people want to know what are we trying to learn as we have readouts later this year. In Study 304, there are three goals. One, we have the goal to provide confirmatory evidence of efficacy in male pattern hair loss, meaning that this is a study that is meant to replicate findings that were demonstrated earlier in Study 302, so that together they can form evidence of substantial evidence of efficacy in male pattern hair loss. We aim to double the size of the safety database in males, garnering more than 300 exposures in each dose regimen at the six-month mark. We aim to demonstrate reproducibility of a commercially viable target profile at non-overlapping sites in a confirmatory study. Study 302 Part B has a different intent. This is a long-term extension study.

For those of you who are less familiar with this protocol, in this study, patients who were originally randomized to active will continue on active treatment to the dose regimen to which they were originally assigned. Those on placebo will cross over to active. All patients get drug in this study. As a result, there are a couple of things that we're looking to see. Most importantly, we're looking to characterize the chronic administration safety of this drug. I think as you can all imagine, if all goes according to plan, our goal is to have millions of people take this drug for years at a time.

Getting one year of safety data helps characterize that chronic administration safety. Now importantly, we do not anticipate seeing new safety signals that emerge after six months of treatment, given that the mechanism of this drug is such that the peak vasodilatory effects of minoxidil are noted within one week of administration. In addition to the safety characterization, we'll also get incremental efficacy data from the study. That includes 12-month efficacy data, where we intend to demonstrate a profile that there is a maintenance of clinically significant benefit in patients who take this drug out to a year. We also aim to assess how placebo patients do when exposed to an active regimen.

A lot of excitement coming as the year goes, and as a result of all that excitement, we're looking forward to telling you about the market opportunity in both male and female pattern hair loss. I'll hand it to Mark.

Yeah, thanks, Reid. Good afternoon, everyone. As Reid mentioned, we've been doing a lot of market research over the last couple of months, both on the market dynamics that exist in pattern hair loss as well as getting reaction to the phase III clinical trial results for VDPHL01. I have to say, the more research that we do, the more excited we get about the findings and the more bullish we become on the opportunity. I'd like to share some of those findings with you here today, both in the male market as well as in the female market. As you know, as Reid mentioned, this is a massive market. There are 80 million people in the U.S. alone with pattern hair loss, 50 million men, 30 million women.

Over 20 million of those patients in the U.S. are already either treating their pattern hair loss or they are clearly demonstrating treatment-seeking digital behavior. These 20 million, we believe, have the highest propensity to adopt VDPHL01 at launch based on the market research that I am going to share with you in just a couple of moments. I just wanted to break down that 20 million for you in three buckets. I would ask you to remember these three buckets when we talk about some of the market research later in the presentation. Of those 20 million, there are about 3 million that are currently on prescription therapy. That is either low dose oral minoxidil being used off-label, or it is finasteride or dutasteride. You have another 10 million patients that are treating their condition with over-the-counter medicines.

Half of those, 5 million of those, are on ROGAINE or a generic form of topical minoxidil. Another 2 million are on Nutrafol, a supplement product, and the remaining 3 million are a variety of different serums and shampoos and other things that patients use to treat with over-the-counter products their pattern hair loss. Then there is another 7 million that we have identified that are actively seeking treatment, although they do not currently treat their pattern hair loss. We partnered with a digital firm called Vii, which has access to 95% of U.S. households. They evaluate consumers' digital footprint, looking at things like purchasing online activity, Google searches, website visits. They are able to reliably separate those consumers that are actively seeking new treatments, about to enter into treatment, from those that are just passively looking for information on the web.