Veradermics, Incorporated Study result

Please go ahead, sir. Thank you, operator, and good morning, everyone.

Thank you for joining us to discuss Veradermics' positive top-line results from part A of Study 304, our second phase III trial of VDPHL01 in males with mild to moderate pattern hair loss. This morning's press release is available on the investor section of our website, where we will also post the slides used today following the conclusion of this call. Joining us on the call today are Dr. Reid Waldman, our Chief Executive Officer, Mark Neumann, our Chief Commercial and Strategy Officer, and we're also joined by Dr. Michael Payette, founder of Central Connecticut Dermatology, who will provide his clinical perspective later in this call. Reid will begin with opening remarks and present the results from part A of Study 304.

We will then hear from Dr. Payette about his experience treating pattern hair loss in clinical practice and what today's results could mean for patients in his practice, as well as other physicians. Mark will then provide commentary on the commercial opportunity of VDPHL01, and we'll close the call with remarks from Reid, followed by Q&A. Before we begin, I would like to remind everyone that today's discussion, including the question and answer portion, will contain forward-looking statements. Any statement that relates to expectations or predictions of future events, results, or performance is a forward-looking statement. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Please refer to the forward-looking statements section in today's press release and our most recent SEC filings for a discussion of these risks.

With that, I'll turn the call over to Dr. Reid Waldman.

Thank you, Dom, and good morning, everyone. I am extremely excited to walk you through the top-line readout from part A of Study 304, our second randomized, double-blind, placebo-controlled phase III study evaluating VDPHL01 in males with mild to moderate pattern hair loss. Beyond the positive data that now reinforces VDPHL01's efficacy and tolerability in males through evaluation in over 1,000 subjects across two phase III trials, today marks a profound milestone at Veradermics. Study 304 part A represents the completion of all planned placebo-controlled development of VDPHL01 in male pattern hair loss. To be able to share these results with you today is a testament to our efforts at Veradermics, and I am prouder than ever of what we have accomplished thus far and the direction we are headed as an organization.

We went into this readout with high confidence that these data would support our findings from Study 302, and now more than ever, believe that the magnitude, speed, and consistency of response reinforce VDPHL01's differentiated profile in male pattern hair loss. As we have shared before, Study 304 had three goals. One, to confirm efficacy in males with pattern hair loss. Two, to expand the male safety database. Three, to test the reproducibility of the phase III profile in a separate population at non-overlapping sites. We are pleased to say that VDPHL01 in Study 304 has achieved on all of these counts while maintaining the highly favorable tolerability profile demonstrated in trials to date, with a complete absence of treatment-related SAEs and a complete absence of adverse events of special interest of cardiac origin.

Study 304 results further demonstrated encouraging similarity to Study 302 across the clinical profile, with statistically significant separation from placebo on both co-primary endpoints and on all 17 secondary endpoints. Additionally, we see statistical separation from placebo on the PRO, the hair count, and the IGA as early as month two, the earliest time point measured. Across Studies 302 and 304, we believe that the totality of phase III data in males now supports the potential for VDPHL01, if approved, to be the highest confidence therapeutic option for patients and providers seeking positive outcomes when treating their pattern hair loss. As you all know, pattern hair loss transcends being aesthetic. It is deeply personal, it is deeply psychological, and it is essentially universal, as it is the single most prevalent chronic dermatologic condition in America, affecting 80 million people.

That makes it 10 times more prevalent than psoriasis, twice as prevalent as atopic dermatitis and psoriasis combined. That includes roughly 50 million men who haven't had a new oral treatment in 30 years, and roughly 30 million women who have no oral prescription treatment options at all. This is a market where the patients are motivated, yet they are frustrated, with only about 9% of treatment-seeking patients reporting satisfaction with existing therapies. This should come as no surprise. Today's treatments are slow, they are inconsistent, and they force patients to choose between side effects like erectile dysfunction and decreased libido, or messy topical application twice a day for the rest of their lives. For those of you who are newer to the story, we are developing VDPHL01 as an oral non-hormonal treatment for both males and females with pattern hair loss.

VDPHL01 is an oral minoxidil extended release tablet. Minoxidil is validated biology for the treatment of hair loss, as it is approved as a topical for both male and female pattern hair loss. It is also used off-label as an oral blood pressure medication. The problem with that blood pressure medication is that it does exactly what you would expect a drug that is intended to rapidly lower one's blood pressure to do. It spikes quickly in the plasma. The majority is gone within 2 hours, almost all of it within 4 hours. Those spikes drive the cardiac effects of minoxidil, but they are not required, nor are they conducive for hair growth, as they do not provide consistent and durable exposures of minoxidil at the follicle.

We initially set out with the goal of optimizing minoxidil for oral administration, maximization of hair growth, and minimization of cardiac risks via the development of an extended release tablet that can provide consistent and durable exposures of minoxidil to the hair follicle throughout the day while blunting those peak plasma concentrations that drive cardiac effects. In addition to enabling the delivery of more minoxidil for longer, we believe we can drive hair growth by driving the bioactivation of minoxidil to its active metabolite, minoxidil sulfate. As many of you may know, minoxidil itself has no effect on the hair follicle, its sulfate metabolite does, and minoxidil is activated to minoxidil sulfate in the outer root sheath of the hair via the SULT1A1 enzyme.

That enzyme, like many enzymes, is capacity limited, meaning that it can saturate, and it is time dependent, meaning it takes time to sulfate the minoxidil. When you think about the PK profile of that immediate release minoxidil, it spikes quickly, overwhelming and saturating that sulfotransferase enzyme, and then it is gone quickly, resulting in limited exposure to the enzyme, limited sulfation. Whereas with an extended release tablet, we can provide a consistent and durable exposure to the follicle in the attempts to drive bioactivation to minoxidil sulfate and potentially to drive additional hair growth. Before we get into the details of Study 304, I want to contextualize where it fits into our larger phase III development program for VDP-01. We have three registration-directed studies of VDP-01 that are ongoing. Study 302, our first phase II/III study, evaluated VDP-01 in 519 male subjects.

That study announced positive Part A top line data in April, and we are anticipating extension data before the end of the year. Today's top line data from Study 304 in 536 males represents the completion of all planned placebo-controlled data generation from both male registration-directed studies. Rounding out our active clinical development program is a phase II/III study, Study 306, which is the first ever phase III trial for an oral treatment for female pattern hair loss in the U.S., and it is evaluating VDP-01 in 556 females. Study 306 is now fully enrolled, and Part A data are anticipated in the first half of 2027. Now let's talk about the study design of Study 304. Study 304 is our second phase III trial in male pattern hair loss, and it was designed to be essentially identical to Study 302.

It enrolled 536 subjects, age 18 to 65, that have mild to moderate pattern hair loss. These subjects were randomized to receive either VDPHL01, 8.5 milligrams twice daily, VDPHL01, 8.5 milligrams once daily, or placebo at 45 sites across the U.S. Importantly, enrollment in Study 304 was conducted at non-overlapping sites with Study 302. Today, we're sharing data from the six-month placebo-controlled period for both the once daily, or QD, and twice daily, or BID, regimens of VDPHL01, 8.5 milligrams versus placebo. As a reminder, Study 304 utilizes identical co-primary endpoints to Study 302. The first is target area hair count, or TAHC. This is a quantitative and objective metric, and it's the only measurement methodology that's been used to support FDA approvals in the U.S. in pattern hair loss since 1997.