Veradermics, Incorporated (MANE) Earnings Call Transcript & Summary

I'm Reid Waldman. I'm Co-Founder and CEO of Veradermics. By background, I'm a Board-certified dermatologist. And prior to founding the company, I spent most of my time in clinical research. Very excited to talk to you today about what's coming in the second half of 2026 at Veradermics. Here's our disclosure slide that governs forward-looking statements as we move ahead. And I think as you all know, we're talking about pattern hair loss or androgenetic alopecia. And pattern hair loss is the single most prevalent chronic dermatologic condition affecting 80 million people in the United States. That's 50 million males, 30 million females, and it transcends being aesthetic. It's deeply personal. It's deeply psychological, and it's essentially universal. But even with that, it has been 30 years since we've had a new oral treatment for males, and we have never had an oral treatment FDA approved for female pattern hair loss. And we are developing VDPHL01, the first minoxidil extended-release tablet. And the premise is very straightforward. Minoxidil is validated biology for the treatment of hair loss and that it's approved in its topical format for both male and female pattern hair loss. It's also used off-label in its oral format, but that oral drug is a blood pressure medication. And the challenge with it is it does exactly what you would expect a blood pressure medication to do when you take it. It spikes quickly in the plasma. The majority is gone within 2 hours, almost all of it's gone within 4 hours. And so the question at Veradermics is why is the best tool in the dermatologist toolkit, a 40-year-old blood pressure medication that no one's revisited. And as we look at the pharmacokinetics of minoxidil, we identified that there is a 10x difference between the plasma concentration of which minoxidil grows hair and the plasma concentration at which it has cardiac effects and had the premise that if you could provide consistent and durable exposures to the drug throughout the day between those levels that you could drive hair growth while minimizing cardiac risk. And in addition to enabling the delivery of more minoxidil for longer, we believe we can drive the bioactivation of minoxidil to minoxidil sulfate. And many people don't realize this, but minoxidil itself does not do anything to the hair, it's sulfate metabolite does. And minoxidil is converted to that sulfate metabolite within the outer sheet of the hair itself via the SULT1A1 enzyme. Now that enzyme is capacity limited, meaning it can saturate with spikes in concentration, and it's time dependent, meaning it takes time to convert the minoxidil to a sulfate metabolite. When you think back to those spikes that we see with the immediate release blood pressure medication, minoxidil, they can overwhelm or saturate that enzyme and they're not around for very long. Whereas if you can provide consistent and durable exposures of minoxidil throughout the day, you can potentially drive the bioactivation of the drug and drive hair growth. Now all in, our goal here is to raise the hair growth ceiling by giving more minoxidil for longer throughout the day to improve tolerability and increased exposures, meaning we give more minoxidil than would otherwise be considered, but we believe we can do it safely by blunting the peaks that are responsible for cardiac effects. This is an inherently nonhormonal treatment, so we don't expect adverse events like erectile dysfunction or decreased libidia. (sic) [ libido ] And it's an oral treatment, which is what research tells us is preferred by both patients and their physicians. Finally, we've generated a host of Phase II/III data in males and Phase II data in females that we believe supports a potential best-in-indication profile in both male and female pattern hair loss. Specifically, that's a profile that is fast with visible results as early as 2 months that shows a consistent treatment effect with up to 86% of individuals showing an improvement in their hair coverage after 6 months of treatment that is intense and robust with objective and quantifiable changes in hair count that are out of proportion of those seen with other therapies, while maintaining strong tolerabilities with placebo-like overall AE rates and placebo-like AE-related discontinuation rates while maintaining the convenience of oral administration and the potential to be the first ever FDA-approved oral treatment for both male and female pattern hair loss. Now as mentioned, we currently have 3 ongoing registration-directed trials, 2 in males, 1 in females, and each of these has upcoming data. In the second half of this year, we will see long-term extension data come from 302 Part B. (sic) [ Study 302 Part B ] We will see confirmatory 6-month data come from Study 304. And in the first half of next year, we will see data from Study 306, a registration-directed trial in female pattern hair loss. Now we're going to start by talking about what is coming later this year. As mentioned, there are 2 studies in male pattern hair loss that will read out data in the second half. The first of those is Study 304. Study 304 is intended to provide confirmatory evidence of efficacy in male pattern hair loss. It is intended to be the final placebo-controlled efficacy data that is generated for the asset in male pattern hair loss, and it's intended to double the size of the safety database to get us over 300 exposures per dose regimen at 6 months. And all in, this is meant to show us reproduction independently of a commercially viable profile. In contrast, Study 302 B is a long-term extension study. And the primary reason that we run this extension study is to try and understand what happens with chronic administration safety. I think as you all can imagine, if all goes according to plan, millions of people will take this drug for years at a time. And so in this study, we're trying to answer the question of are there emerging signals from a safety perspective that come up between 6 and 12 months of treatment that could not otherwise be detected in the first 6 months of treatment. Additionally, patients who are on active stay on active for 12 months of dosing and patients that are on placebo cross over from placebo to active, getting us incremental efficacy data. Now we're going to go into greater detail on Study 304. Now as a reminder, Study 304 is a Phase III registration-directed trial 0n male pattern hair loss that enrolled 536 subjects at 44 sites. Those sites are nonoverlapping with the sites that participated in Study 302, and we're looking at a male population that is aged 18 to 65 in age. From a study design perspective, the major question that we get is how similar is this design to Study 302. And we believe it to be a markedly similar study from an I&E perspective, a study procedure perspective with identical endpoints. Put differently, in this study, we're asking the same questions in the same way that we did in Study 302. Now in the second half of this year, we'll look at data from Part A, which is a 6-month placebo-controlled period in which patients were randomized to either receive VDPHL01 8.5 milligrams twice daily, once daily or placebo. And again, we'll talk about the co-primary efficacy endpoints in detail on the next slide, but these are the same endpoints that were studied in 302. Specifically, we're looking at target area hair count and patient-reported outcome. And the target area hair count is a way of asking how many hairs are there in a given square centimeter that are greater than 30 microns or what we call non-vellus hairs. And we measure this in a very specific quantifiable way. We tattoo the scalp, so we know that we're in the same spot every single time. We clip the hair, so we can visualize all the hairs in the area. We take a close-up standardized photograph. That photograph gets transmitted to the vendor that's done every approval in this space since 1997, and they have a validated digital image analysis algorithm that does 3 things. It makes sure that we're in the exact same spot, right it lines up the follicles because in the same way, you have a thumbprint, you have a hair print. It measures the width of the hairs to tell us which ones are greater than 30 microns or what we call non-vellus hairs and then it counts those hairs. That then goes for a 2-human quality assurance review to give us an ultimate count on the non-vellus hair count. And in this endpoint, we're looking at change over baseline in active versus placebo. The second co-primary endpoint is the patient-reported outcome. And the patient-reported outcome or what we call the subject's evaluation of hair coverage change is where the subject looks at standardized photographs of themselves at baseline and at their follow-up visit and they grade their hair coverage on a 7-point scale from much worse to much improved. And if they identify as being improved or much improved, they are considered a responder, and we do a responder analysis. Now again, the goals of Study 304 are threefold. One, we're trying to provide confirmatory evidence of efficacy in this study to what was shown in Study 302. Two, we're trying to double the size of the safety database to get over 300 exposures at 6 months in each of the treatment arms. And finally, we're trying to replicate our Phase III target profile or that commercial viability profile that we laid out prior to the initiation of Study 302. As a reminder, prior to the initiation of Study 302, we had laid out a commercially-viable target profile that was based on robust quantitative research that we had conducted in both patients and physicians. And in essence, the profile that we had tested was based on historic precedent where we had asked these patients and physicians their feelings on an FDA-approved oral agent with an efficacy profile that looks similar to Rogaine foam. And we saw a robust degree of enthusiasm from both patients and physicians and their willingness to use and willingness to prescribe, respectively. We believe that independently replicating this commercially viable profile on Study 302 would be highly valuable in terms of entrenching the commercially viable profile in male pattern hair loss. Prior to Study 302, we also helped characterize what safety looks like today with off-label use of immediate-release oral minoxidil. And shown here, we pulled data from one of the only studies that actively assessed safety outcomes with off-label use of immediate release oral minoxidil, and it found that the 6 events shown on the right side of this slide occur in more than 5% of subjects on a treatment-emergent basis. Those events are headache, edema, hypertrichosis, shedding, dizziness, lightheadedness, syncope and palpitations. We're also aware of more significant risks that can be seen with off-label use that are shown on the left. Importantly, in Study 302, the only events that occurred in more than 5% of subjects on a treatment-emergent basis were lower extremity edema and hypertrichosis, and we did not see any of the events shown on the left side of the screen. So in summary, as we think about a commercially viable profile and reproducing that in Study 304, we're looking at a profile like what is shown here, the profile that we had put up prior to initiation of Study 302. We're now going to transition to talking about Study 302 Part B. As mentioned, this is long-term extension data from the study that we had top line back in April. Here, you can see the study design for this trial. All subjects on active continue on the same active dose regimen that they were originally randomized to. So those on BID stay on BID, those on QD, stay on BID. Subjects that were originally randomized to placebo will cross over to active either to BID or QD as is shown here. Importantly, while there is 6 months of incremental treatment beyond what was shown in Part A, this is a 7-month study in duration as there is 1-month safety follow-up on the back end. As we think about the goal of this study, the goal of this study is twofold. One, we're trying to characterize the chronic administration safety of this. As mentioned, we anticipate that if successful, millions of people could take this drug for years. And so having 12 months of safety data helps us answer whether there are emergent risks that come up after 6 months of treatment that would not be identified in those first 6 months. Now importantly, we do not anticipate that there are new emerging events that occur over time. And the reason for that is largely driven by the mechanism of the drug. When we think about minoxidil's mechanism as a blood pressure medication, it is an arterial vasodilator that has a very early onset of action. In fact, the peak arterial vasodilation that occurs with minoxidil is noted to occur within 1 week. And so adverse events are thought to occur early. Importantly, with off-label use of oral minoxidil and its use as a blood pressure medication, we similarly see that adverse events occur early in the course of treatment. So as we look to the future, we do not anticipate seeing new events that emerge between 6 and 12 months in chronic administration safety. That is not to say that another patient couldn't have hypertrichosis or edema or something like that, but rather that there would not be a fundamental change in the safety profile over time. The second item here is to assess long-term efficacy. Now realistically, in clinical practice in dermatology, we prescribe patients or recommend to patients minoxidil-based products for years at a time, and it's recognized that there is maintenance of clinically meaningful effect over time. So as we think about the purpose of this study, the purpose of this study is to show a strong safety and tolerability profile after 12 months while also demonstrating similarly a maintenance of clinical effect that is clinically significant over time. The final element of this study is that the placebo group crosses over to active. And so we will have patients that have been on placebo the first 6 months of treatment that are then on active for the second 6 months of treatment. That will let us assess what happens to patients who delay the course of treatment. Whether those patients catch up to active, suggesting that in any course in time that you can get a clinically meaningful benefit or they do not, suggesting an urgency to treatment, we think that data will be interesting and helpful to the commercial profile. I now want to transition to talking about what's coming beyond this year and talk about female pattern hair loss. As many of you know, in July, we put out the first ever positive Phase II data for an oral treatment for female pattern hair loss in the U.S. And female pattern hair loss is an extremely exciting area to work, and it affects 30 million women, and there are no FDA-approved prescription treatments, no FDA-approved oral treatments for the category despite this being something that is extremely bothersome to those affected. And as a reminder, in Phase II, we demonstrated a profile that demonstrated rapid onset of action as early as 2 months, a consistent treatment effect with visible response in the vast majority of subjects, a robust increase in hair count out of proportion to what's been seen in prior female pattern hair loss trials, strong safety and tolerability and then the convenience of oral administration. This all lines up for potentially the first ever FDA-approved oral treatment -- first FDA-approved prescription treatment for female pattern hair loss. Now the big update in female pattern hair loss that we announced in our quarterly earnings release is that we have now fully enrolled Study 306. Study 306 is our Phase II/III registration-directed trial in female pattern hair loss. This study enrolled 552 subjects at 72 sites throughout the United States. These are females 18 to 65 with mild to moderate pattern hair loss. In the first half of 2027, we will see data from the study from the 6-month Part A placebo-controlled period where patients were randomized to either receive the drug twice daily, once daily or placebo. Again, the co-primary endpoints are the same as those that were evaluated in the male studies and the same as those evaluated in Study 207, our female Phase II study. Now importantly, one of the reasons we're so excited about the enrollment of the study is that it came in much faster than we had anticipated. When we thought about initiating a female Phase II study, one of the questions we had would be the rate of enrollment, given that we do shave an area of hair on the scalp and we anticipated that there may be a greater degree of resistance to enrollment as a result. Nonetheless, we saw a marked rate of enrollment that was largely driven by strong performance of our digital strategy. We have 2 exemplary ads shown here, and these ads contributed the majority of subjects in the study with more than 60,000 female patients clicking on one of our advertisements, going to our trial website, phlstudy.com, and completing an online screener successfully to try and participate in the study. So we're very pleased with that strong performance that brought this study in earlier than we had anticipated. In summary, it's a very exciting next couple of months at Veradermics. We have clinical data coming from both male studies that we believe helps inform the male profile as we move towards commercial and helps improve the probability of regulatory and technical success. Next year, we will also put out data from this initial Phase II/III study in females, the first ever registration-directed study for an oral treatment for female pattern hair loss in the U.S. Thank you very much for your time. We look forward to talking to you in the near future.