Veradermics, Incorporated ($MANE)

Thank you, everyone, for coming. This should be a lot of fun this afternoon. I'm Reid Waldman, Co-Founder and CEO of Veradermics. And today, we have really 3 topics that we're going to address. One, we're going to do a brief rehash of favorable topline data from Study 302, a Phase II/III registration-directed trial for male pattern hair loss. Two, we are going to briefly review market insights that were disclosed last week at Jefferies during our presentation. And then finally, we're going to do a deep dive on female pattern hair loss ahead of upcoming data readouts. I think all of you are familiar with our disclaimer related to forward-looking statements. Please read this in your own time. But today, we're talking about pattern hair loss or androgenetic alopecia and as I think you all know, this is something that transcends being aesthetic. It's deeply personal. It's deeply psychological, it's essentially universal affecting 80 million Americans, that makes this the single most prevalent chronic dermatologic condition in America, 10x more prevalent than psoriasis, 2x more prevalent than eczema and psoriasis combined. And despite this high prevalence, this is a market that is deeply dissatisfied. Only 9% of current treatment seekers are satisfied with their hair loss treatment. And nearly half of all patients are actively seeking a new treatment. And that should come as no surprise given that today's treatments are slow, they're inconsistent, when they do work, they primarily deliver slight regrowth. And even with that lackluster efficacy profile, patients are forced to choose between tolerability issues like erectile dysfunction or decreased libido, or inconvenient and messy topical administration twice daily for the rest of their lives. And this is a market with a paucity of treatment options. It has been 30 years since there's been a new FDA-approved oral treatment for male pattern hair loss, and there has never been an oral treatment approved for female pattern hair loss. And so we are hoping to change that with the development of VDPHL01, the first minoxidil extended-release tablet. And the principle here is very straightforward. Minoxidil was validated biology for hair loss and that it's approved in its topical format for both male and female pattern hair losses as Rogaine. It is also used off-label as an oral treatment. But that oral medication is fundamentally a blood pressure medication, and it behaves like a blood pressure medication when you take it. It spikes quickly in the plasma, within 2 hours the majority is gone, within 4 hours almost all of it's gone. And those spikes drive the cardiac effects of the drug and don't provide those consistent and durable exposures at the follicle that drive hair growth. And so we founded Veradermics around the question, why is the best drug in the dermatologist toolkit a blood pressure medication that no one's revisited in 40 years? And we aim to change that through the development of an extended-release tablet that provides consistent and durable exposure of the follicle throughout the day while blunting peaks to try and optimize hair growth and minimize cardiac risk. Now we are currently in a large registration-directed profile consisting of 2 studies in males, 1 study in females that are meant to support approvals in both male and female pattern hair loss. Today, we will briefly review data from Study 302, which is the first of these registration-directed trials. We also have a second ongoing study in males that fully enrolled in February for which we anticipate top line data in the second half of this year. We are now actively enrolling the first ever registration-directed trial for an oral treatment for female pattern hair loss, Study 306. Now as mentioned, we'll look briefly at data from Study 302. Study 302 is a registration-directed Phase II/III study of approximately 519 male subjects at 44 sites in the U.S. Subjects were treated for 6 months during a placebo-controlled period from which we'll review data. They were randomized to receive either QD, BID or placebo. All subjects then extended into a treatment extension period that goes for 12 months with a follow-up period. The co-primary endpoints as mentioned, are target hair count and patient-reported outcome. Now we believe the data from this study is spectacular. And if you want a detailed walk-through that data, you can find it on the investor portion of our web page. In short, we achieved a high degree of both clinical and statistical significance on both co-primary endpoints, supporting a profile that suggests that VDPHL01 is positioned to become the only oral treatment that has the potential to deliver rapid hair growth as early as 2 months, a consistent treatment effect with up to 86% of patients reporting an improvement in their hair coverage, while maintaining strong tolerability with placebo-like overall AE rates, placebo-like AE-related discontinuation rate, all while having the convenience of oral administration and the potential to have the first approval for an oral treatment for male pattern hair loss in 30 years. Now on the heels of this exciting Phase II/III data, the company has undertaken extensive market research to better characterize the opportunity. And in doing so, we understand that both the prescription segment and the OTC nontreating segment are larger than we had previously estimated. Specifically, the prescription segment has grown 20% year-over-year since 2019 and now approaches nearly 3 million users. Importantly, our estimates are still an underestimation of the size of the prescription market and that we cannot account for all scripts that go through a cash pay telehealth channel. As we think about those patients that are OTC users, or who are not actively treating. We've tried to characterize that part of the market further using what's called the [ V ] database. And the short story here is that [ V ] is a database that collects both consumer purchase behavior as well as digital behavior, looking for indications that people have multiple intents to treat across their digital history. This has been used previously in the obesity market to better understand what percentage of patients have a high intent to treat. When we utilize this data, we see that in addition to the 2.7 million patients in the Rx bucket, there are an incremental 10.4 million that are used in OTC only and 7.1 million who are actively engaged digitally with signs that suggest they are looking for a treatment and we believe that we can service each of these segments; it is high priority segments at the time of launch to not only become a dominant player in the existing Rx segment, but to grow that Rx segment. Importantly, this is supported by market research that we had conducted on the back end of Study 302 data with our actual 302 profile that supported the patients and HCPs prefer VDPHL01. In fact, more than 70% of HCPs in their patients were high likely to use, meaning top 2 boxes to use VDPHL01. And this translated to more than half of all patients ending up on drug in the minds of physicians. Ultimately, the question here becomes can we activate a market that currently has 7x greater number of patients that are in the OTC market or not actively treating that are in the Rx market? And we believe that analog markets support that the answer is absolutely yes. If you look at the weight loss market since the introduction of GLP-1, that's grown 16x; you look at the erectile dysfunction market, within 1 month of Viagra's launch, weekly scripts increased by 7x. And there are great parallels between weight loss, erectile dysfunction and hairloss; each of these are high prevalence markets that have lacked innovation in the Rx space, for which there is compelling latent demand that is signaled by strong OTC use and strong digital demand, for which you can easily facilitate onboarding on a drug with modern era patient-centric access. And importantly, we believe that VDPHL01 is well positioned to activate the latent demand that exists within both the OTC and nontrading segments because of its compelling clinical profile, combined with a comprehensive go-to-market commercialization strategy. When we think about the clinical profile, we believe based on market research that this clinical profile addresses the top unmet needs identified by both patients and physicians including an efficacy profile that provides faster onset, more consistent benefit and a more intense hair growth and a safety profile that, as mentioned, has placebo-like overall AE rates, placebo-like AE-related discontinuation rates, all while having the convenience of oral administration and an FDA approval potentially. On the market side, there are a number of ways in which we commercialize product. First, there is a dermatologist focused field force, that allows us to service the top 80% of existing prescriber of minoxidil products through about 100 to 150 reps. Second, there is a digital-first consumer strategy that aims to activate those that are showing high intent to treat. Importantly, this can be a very focused strategy, given that these patients are very clearly active information-seeking individual. We've gotten first-hand experience with this in our ongoing clinical trial recruitment in which we've had more than 100,000 people go to our trial website, submit interest in participating in a trial today using what is a relatively low budget advertising strategy to recruit those clinical studies. And then finally, we want to be where the patients are through a patient-first distribution strategy. Each of these, we believe, will increase overall treatment rates within the hairloss segment as well as allow us to become a dominant player with a potential best in indication profile. We're now going to switch to what I think is largely new information which is the discussion of pattern hair loss in females. And there are 3 messages that we want to get across today. One, we believe female pattern hair loss to be a large additive commercial market that includes 30 million highly motivated females and we stay highly motivated in that they make up the majority of spending within the hair loss space for whom there are no FDA-approved prescription treatments, no FDA-approved oral treatments. Two, we believe that the VDPHL01 upcoming female readouts are high probability readouts given that minoxidil has demonstrated to be effective in female pattern hair loss and that it is approved as a topical 2% solution, topical 5% solution and topical 5% foam. And we achieved similar exposures in females to the exposures that we achieved in males in Study 302. And then finally, we want to talk about what treatment success looks like in the female landscape based on a review of historic precedent data. Now as mentioned, this is a large additive market opportunity. There are 30 million women with pattern hairloss, that is half of all women in their lifetime. That makes this an eczema-sized market by prevalence and the motivation within this market is significant. As mentioned, the majority of spending within hair loss is female, the majority of doctors visits are female. And this is driven by robust quality of life impairment. You call dermatologists or have conversations with patients, I think it would be hard-pressed to come to any conclusion other than that females have greater quality of life impairment from pattern hair loss than their male patter counterparts. And this translates into strong consumer behavior and strong potential willingness to pay. When we look at the broader aesthetics landscape, things like facial injectables, so Botox, HA filler, of that $10 billion-or-so market, 85% of it is female. That has also translated through into the consumer aesthetics market in hair with neutrophil being a predominantly female product. Underscoring all of this is the idea that in this large, motivated and frustrated market, there is a lack of prescription options, right? There are no FDA-approved oral treatments, no FDA-approved prescription treatment, and so the demand for a new treatment may be even greater than in the male opportunity. Now we have 2 ongoing trials in females, the first of which is a Phase II proof-of-concept study in which we will get female data from approximately 20 females on the same co-primary endpoints conducted in the same way that they will be conducted in the Phase II/III Study 306. Those are target area hair count and patient-reported outcome. Importantly, we believe that this data will create a similar setup as we had going into Study 302, where there will be proof-of-concept data in a small number of patients as we prepare for a larger registration-directed trial. Study 306 will be a 552 subject registration-directed Phase II/III study that occurs at 72 sites across the U.S. This study is actively enrolling. And as you can see, study design looks markedly similar to Study 302, except that the dose strength that we study is lower. Now importantly, that dose strength is lower because of gender-based differences in pharmacokinetics and we achieved similar exposures in females to the exposures that we achieved in males in Study 302. Additionally, while the co-primary endpoints are the same here, as you'll see on this slide, we study them in a different part of the scalp. Females do not typically lose Vertex Scalp hair on their crown, they get widening of the part and diffuse thinning. And so we think about the co-primary endpoints of target area hair count and a patient-reported outcome, they are assessed within the part width. For the target area hair count, the way in which we conduct this is that we tattoo on scalp that we know we're in the same spot every time. We clip hair, so we can visualize all hairs within the area. We take a close-up standardized photograph. That photograph gets transmitted to a vendor who has done every approval in this category in 1997. They have a validated digital image analysis algorithm that does 3 things. One, it lines up the photo by matching hair follicle to hair follicle to ensure that we're in the same spot every single time because even a 1 to 2-millimeter move could impact hair count. Two, they measure the diameter of hairs because we're focused on hairs greater than 30 microns or what are called non-vellus hairs and then three, it counts the hairs. Those counts are then reviewed by 2 independent human reviewers. The second co-primary endpoint is a patient reported outcome. For the patient-reported outcome or what's called the subjects evaluation of hair coverage change, the patient has a photo taken of the superior view of their scalp as shown here after the hair is centrally parted. And we ensure standardization of that central parting. The patient then reviews the photo of themselves at baseline, a photo of themselves at followup, and they grade their hair coverage on a 7-point scale for much worsened to much improved. And if they're improved or much improved, they're considered to be a treatment responder. Now I think importantly, people say, well, what does treatment success look like in the female population. And we often think about this in terms of our perception of commercial viability, which means alignment with what existing treatments look like in the space. And so for the study shown here, we pulled these studies using the same methodology for which we previously pulled studies in the male population. What I mean by that is for drugs that have an approval and have been studied in a regulatory manner, we pull the most contemporary study. And the reason we focus on most contemporary study is that the endpoints in this space have changed in the way they're measured over time. Historically, we had an almost manual account-like approach with dot mapping. Over time, we now have validated digital image analysis algorithms that have higher reproducibility. The study that's shown for topical minoxidil here, Bergfeld 2016 is the first placebo-controlled study that uses a validated digital image analysis for topical minoxidil. And you can see the results. Oral finasteride is the other drug with regulatory-grade data that comes from a Phase II study that was conducted in the '90s. As you can see, the hair counts are negative in that study as it did not show treatment benefit. I think there is a common misconception in dermatology that the reason finasteride is not suitable for use in females is risk of [ teratogenicity ]. And while that's true, it also did not show treatment benefit in a large Phase II study. The 2 most commonly off-label prescribed treatments in female pattern hair loss are oral minoxidil 1 milligram, spironolactone. As we think about each of these treatments, we select studies for which there is prospective evaluation and for which a digital image analysis based on a tattoo-based image has been conducted. For each of these, there is a single study. For oral minoxidil 1 milligram, that study was conducted by the same investigators who conducted the JAMADerm and JAAD studies that we talked about in male pattern hair loss. For spironolactone, we didn't discuss this when we discussed male pattern hair loss given that anti-androgens are not used as a treatment for male pattern hair loss commonly. For spironolactone, there's no monotherapy prospective study. And so what we find is a study of combination with topical minoxidil versus topical minoxidil alone, which did not show a statistically significant separation on hair count from topical minoxidil alone. And I think that's not surprising given that additional work looking at more potent nonsteroidal anti-androgens has also failed to demonstrate a reliable profile in the female population. All in, I think many people might look at these numbers and compare them back to the numbers that we showed in males and said, the numbers appear lower than they do in males, and that's true. And I think that raises the question, well, do we think this drug doesn't work as well? Or do we think minoxidil doesn't work as well in females as it does in males. And I think the answer is no. Based on our conversations with KOLs and my personal clinical experience, we believe that minoxidil products are equa-efficacious in males and females. However, the way in which we assess hair counts are different in males and females. And there are really 2 items that we believe can drive down hair counts in females versus their male counterparts. One, in the female population, on average, we see less hair loss. And the less hair that you've lost, the less hair there is to regain, right? We can only grow hair. We can't make normal hair more normal. And so someone who has a more mild hair loss pattern, we anticipate less of a delta from where they need to go. The other point is that there's not always a clear transition zone in the female population. So in males, we see Vertex balding. And when we see this Vertex balding, you can think of there as being a circumferential area where there is normal hair and then that transitions into an area of balding. And we tattoo in this very stark contrast between normal hair and that area of balding. And the reason that's important is that, that area is enriched with vellus hairs. So it has high numbers of hairs that are smaller than 30 microns. And that is significance is it is those hairs that can be activated back into or can be converted back into a non-vellus hair. And so males, there's this enriched area, whereas in females, we see more diffuse thinning as opposed to a single area for which we anticipate an enriched area of vellus hairs. Now as we talk about tolerability in the female population, we often get asked about hair growth, not on the scalp. And this is something that we saw in the male patients in Study 302. It's something that's seen with Rogaine. It's something that's seen with off-label use of minoxidil and it's something we anticipate seeing with VDPHL01. Importantly, we don't anticipate that this is a meaningful tolerability concern. The reason for that is that it's typically mild. Many dermatologists will describe it as peach fuzz and manageable, right? You can wax it, you can pluck it, you can dermaplan it, you can shave it. Whatever you do for hair removal normally, you can do for these hairs and you won't make the unwanted hair growth worse by removing it. And importantly, 85% of women in the U.S. are already employing hair removal techniques independent of use of minoxidil. Furthermore, when we look at existing data with off-label immediate release minoxidil, we see that discontinuation rates related to unwanted hair growth are rather low. There's a study from Mount Sinai that looks at more than 100 females treated in their clinic who are taking a minoxidil-based product for female pattern hair loss and found that while they saw hypertrichosis, the rates of discontinuation were rather low. In my clinical practice, there were really 2 reasons we saw people go off drug. Reason number one would be that they weren't growing scalp hair and they also had a little bit of peach fuzz and they said, "Well, I'm not going tolerate if I'm not getting the benefit I want." Reason number two, and this was pretty uncommon would be they say, "I won't accept any unwanted hair growth whatsoever." And I think when you think about the target population here, it's typically perimenopausal women are older, where there is a high rate of already unwanted hair growth. So if you're already removing some chin hair, removing a little more is not a meaningful consideration. People are also well aware, right, that minoxidil in its oral form today is a blood pressure medication. So they ask about other considerations related to tolerability. Based on the same study for Mount Sinai, we see here that there are 6 adverse events that occur in more than 5% of patients on a treatment-emergent basis with off-label use of oral minoxidil today. Those are headache, edema, hypertrichosis, shedding, dizziness, lightheadedness, syncope and palpitations. Importantly, we blunt peak plasma concentrations of minoxidil similarly in the female population to the way we blunt it in males. And we do believe, based on the results of Study 302, that blunting Cmax is key to minimizing risk of cardiac effects. Now with all this said, we believe the market opportunity for female pattern hair loss to be extremely excited and extremely underestimated. There is a high unmet need here. When we survey physicians, they identify the unmet need in female pattern hair loss to be greater than that of the unmet need in male pattern hair loss. And that translates into a very high willingness to prescribe, more than 70% very likely to prescribe to female patients. We see high activity of treatment seeking. Now as mentioned, the OTC market is larger than the Rx market. But when we survey females explicitly about why they're using an OTC treatment instead of an Rx treatment, the #1 reason by far is that they're unaware of prescription options, and that shouldn't really be a surprise given there's no FDA-approved prescription option for the female population. So you can imagine if we promote this as the only FDA-approved oral treatment for female pattern hair loss that, that could have the potential to activate those OTC treaters in the market. And our commercial research supporting a high willingness to use product among females is further evidence for that. Finally, we see significant treatment cycling and low treatment satisfaction among females. Topical minoxidil is the only approved treatment for female pattern hair loss, nearly 90% of people who started, the majority within the first few months. That results in significant treatment-related dissatisfaction, and that translates into a high willingness to pay. In fact, in our commercial work, we see that females have a higher willingness to pay than their male counterparts. Now our last slide today related to female pattern hair loss is a list of quotes from patients from our market research. And I'm not going to read these out loud to you, but I do think it's worth you each taking the time to read these from patients from Study 302, our male study. You'll see the impact is greater, the willingness to seek treatment is greater, the willingness to pay is greater. So I'm going to just take a moment to let you all read this. Now in conclusion, the first half of 2026 was a tremendous, tremendous 6 months for Veradermics, and we anticipate that the second half has equal promise to be exciting and that we have 3 upcoming clinical readouts. We have a second male confirmatory study data from Study 304 in the second half of the year. We have long-term extension data out of Study 302, and we have additional data, including female proof-of-concept data from Study 207. We are very excited about the remainder of the year and how it positions us to have the first FDA-approved oral treatment for male pattern hair loss in 30 years, the first FDA-approved oral treatment for female pattern hair loss ever. Thank you so much for your time today. It's a lot of fun. Certainly, happy to meet up with anyone outside and answer any questions you might have.