Hey everyone. Welcome to day two of Cantor's Global Healthcare Conference. For the next session, we are very excited to host the Veradermics team. Thanks to Reid for joining us, and then thanks as well, Mark, for joining us. I think you guys are presenting a slide deck here, so why don't we take it away? 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 10x more prevalent than psoriasis, 2x 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 two hours, almost all of it within four 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. They validated this across multiple different therapeutic areas, most recently with the GLP-1s in the obesity category. So we have a high degree of conviction that those 7 million patients, we believe, will be rapid adopters of VDPHL01 as well. This market, as I am sure you have heard in the past, is characterized by a very high degree of unmet need that is due to the limitations of the existing therapies. Therefore, there is a great deal of dissatisfaction among patients and physicians with the existing treatment options. In a large quantitative survey, less than 10% of patients felt that they were satisfied with the current treatment options that were available to them, and almost half of those patients were actively seeking a new therapy, whether or not they were currently treating their pattern hair loss. These limitations of the existing treatment options span efficacy parameters like slow onset of hair growth, where it typically takes 4- 12 months to see clinically significant results. Inconsistent results, both within an individual patient and across multiple patients. Finally, insufficient density of hair growth, how much hair they actually grow. These are all limitations of current treatment options. Beyond efficacy, you have some side effect and tolerability issues with the hormonal products. You have hormonal side effects, mood side effects, and with IR minoxidil, you always have the risk of significant cardiovascular side effects. You have some of these that have inconvenient administration. Lastly, one of the things that really bubbles up for us, and I've been in this industry a long time, and this is a category where this seems to be more important than in other categories that I've been involved in, and that is FDA approval. I think what that relates to is there's a lot of products out there, a lot of claims that are being made out there that are unsubstantiated, and physicians and patients both see FDA approval as a very important benefit of any new product that's coming out. Despite all the challenges of the current treatment options, there is a tremendous amount of pent-up demand for this category. As Reid said, this is an emotionally very impactful, very resonant type of therapy. What you're looking at here are monthly prescriptions for low-dose oral minoxidil. This is all for pattern hair loss from January of 2009 to the most recent data that we have. You don't need to look too closely at this to see a very impactful event back in 2022 when there was a single The New York Times article by a couple of dermatologists that cited success they were having with minoxidil to treat pattern hair loss. You can see that the monthly prescriptions off-label for low-dose oral minoxidil went from about 60,000 a month up to almost 600,000 a month, with the current data that we're seeing now. What this says to us is just how desperate people are to find a treatment that's going to be effective and safe for their pattern hair loss. What was really exciting was when we first got the 302 data, our first phase III clinical trial, we took those clinical trial results and we put it into market research with about 150 physicians and almost 200 patients. We got their reaction to the emerging data that's coming out of our phase III program. What we saw was extremely encouraging. From a differentiation perspective, VDPHL01 has been seen as highly differentiated both by HCPs as well as patients. Over 90% of physicians and patients in this survey saw clear differentiation from the existing treatment options. That perceived differentiation translates into a very strong intent to adopt VDPHL01. On the physician side, over 90% of physicians said they were highly likely to prescribe this product, and on the patient side, a similar percentage said they were highly likely to talk to their doctor about VDPHL01. If we drill down on the physician side a little bit further, we also see the magnitude of their intended prescribing and where they're going to source those patients from. In other words, what will they use VDPHL01 instead of what they're using today? What these physicians told us in this survey was they would move over half of their patients from their existing therapy over to VDPHL01. On the right-hand side of this slide, you see where it would come from. Here's where I would ask you to think back to that first slide that I showed you. The three buckets that we talked about are those that are represented here. Over half of their existing ROGAINE patients would be moved over to VDPHL01. 50% of their finasteride patients would be moved to VDPHL01. Almost 50% of their low-dose oral minoxidil patients would be moved over to VDPHL01. What was really encouraging was physicians told us for their patients that are seeking treatment but aren't currently treating their pattern hair loss, almost 50% of those patients they think would be candidates for VDPHL01, which is a very strong signal that physicians are viewing the profile of this product very much as a first-line option for patients who present to them with initial pattern hair loss. How fast do they expect to adopt this therapy? On the left-hand side, physicians. On the right-hand side, patients. Over 70% of the physicians in this study said that in the first three months, they would expect to prescribe this product. Almost half of the physicians said they would do it in the first month that the product's available. Similar results on the patient side. Almost 80% of patients said they would ask their doctor about this product within three months, and almost 50% of them would do that within the first month. I've been doing these surveys for a long time. These are some of the highest numbers and the most rapid numbers that I've seen in a survey of this type. What were the reasons that they gave? Physicians said they perceive this to be superior efficacy over the current treatment options, strong safety profile, and also that they're very comfortable today working with minoxidil in its various forms, whether that's IR minoxidil or it's in a topical form with ROGAINE. On the patient side, what you see come through here is patients are desperate and urgently wanting to stop the hair loss and regrow new hair. They also see superior efficacy in this profile over what they know to be available on the market today, and they also see the safety and tolerability. Therefore, to them, the efficacy that they see and the offset with any safety and tolerability concerns is favorable in favor of VDPHL01. We would expect a very rapid adoption in those patients. Lastly, the last piece of data when we did sort of our pre- and post-allocations in the survey. On the left-hand side, you can see the physicians that were in this study. This is what they currently use to treat their patients. About equal amounts of low-dose minoxidil, finasteride, and ROGAINE or topical minoxidil. On the right-hand side, after they were exposed to the clinical trial results, what do they see? They see VDPHL01 clearly becoming the dominant product in their practice with almost a 50% share, equally taking, as we saw, from finasteride, from minoxidil, and from ROGAINE. Very encouraging results with the initial VDPHL01 profile that we see in our phase III trials. Now I'd like to pivot just for a second about the female pattern hair loss market. This is a market that we believe internally is greatly underappreciated by the investment community today, and I'd like to share with you some of the market dynamics that make us believe that the female opportunity is every bit as exciting to us, if not more so, to the male opportunity that everyone is aware of. I'd start with the prevalence. As you saw on Reid's initial slide, there are 30 million women who experience pattern hair loss in the U.S. That makes it four times the size of the psoriasis market and almost as large as the eczema market just for female patients alone. As we talked about, there are very limited treatment options for female patients. There are no FDA-approved oral products, and there are no FDA-approved prescription products for women. They are left with various over-the-counter medicines or using something off-label, and many women are uncomfortable going that route, although they do that. Here are some of the findings that we are getting from the market research. When we talk to female patients about their pattern hair loss, what their experience is in the category, and the types of treatments that they are looking for to meet the great unmet need that is out there. First and foremost, as Reid said, there is a profound emotional impact on women. For many women, hair is central to their identity. As they begin to lose their hair, they begin to feel like they are losing their identity. This is something that they notice early on, whether they notice it on their hairbrush, they notice it in the drain in the shower, they notice it on the pillow. They tend to notice it a lot quicker than males do. This becomes an issue for them very early on in treatment, often before others can even tell that the woman may be starting to lose some of their hair. Female patients talk about the tremendous burden of managing this disease. Despite that, they have a very high motivation to seek out treatments and continue because of the profound emotional impact that it has on them. As we talked about, there is a low satisfaction with existing options and a corresponding very high unmet need as perceived by women patients. When they talk about what they are looking for, the ideal treatment for women is very clearly defined. Let me drill down a little bit into each one of these that you see here. When we talk about the impact of pattern hair loss, this is very distressing for female patients. It impacts their identity and how they feel about themselves and how they interact with the world. What do patients tell us? They tell us, as I mentioned, hair is part of their identity. When they start losing their hair, they feel like they are losing a piece of themselves. It takes a heavy emotional toll. They use words like devastation, shame, frustration, lost confidence, ugly, just terms that signal just how impactful this is emotionally to female patients when they begin losing their hair. As I mentioned, the distress that they have is triggered by very visible reminders. We do not have to go out and convince people that they have this condition. Every day they know that they are losing their hair. Our approach on the commercial side, when the time comes, will really be to generate awareness and drive awareness of the brand and VDPHL01 as a viable option for those patients. On the physician side, what do dermatologists observe with female patients? That they feel many times women feel blindsided by this. They did not expect to be losing their hair at the age that they start losing their hair. Many of them are unaware that there is a genetic component to the hair loss, and this is very surprising to them. As we said, this is emotionally charged for women. It is for the physicians that treat them as well. These are very difficult encounters when women present to the dermatologists or other healthcare providers to talk about their pattern hair loss. That high distress that females experience also drives early action. There is a bit of the physician wanting to work with the woman to help find the treatment that is right for them. All very important dynamics in the marketplace for female patients. Busy slide here, but I think the takeaway here is that the burden of managing this condition is extensive, and it really motivates patients. The sentiment that we heard expressed in interview after interview is, "I have tried everything. I have tried everything to try and stop my hair loss, and nothing works for me. Nothing works like I need it to work." Down at the bottom, you see some of the interesting facts that have come out, and insights from the research that we have been doing. In terms of willingness to pay for hair loss products, the average monthly spending typically is in the $50- $150 a month. There is a strong willingness to pay up to and even over that $100 a month price point that some of the products in the marketplace are. One of the things that we heard that we were unaware of is many women spend an additional 30- 60 minutes every day in order to try to conceal their hair loss or to work with their hair so it is not as impactful to them, which takes a big part of their day away. The treated patients have tried, on average, three different hair loss treatments, and many reported being on as many as five, and there is a lot of combination use. Up to two-thirds of female patients talk about combination use in trying to treat this condition. We talked about the high motivation to treat. These are some of the top drivers. Obviously, the hope of stopping the loss that they have with their hair and regrowing new hair is a top driver. Restoration, of how that makes them feel, the confidence that they get back, the emotional bandwidth that they have, and for them, an early self-awareness and concern. We get a lot of quotes from the market research. The middle one here is one of my favorites because I think it says it all. If you cannot read it, the woman says, "I would walk over hot coals and lie in a bed of tarantulas to get my hair back. If it means taking a prescription, yes, absolutely, I would take a prescription to get my hair back." We talked about the satisfaction being low because of the limitations of the existing treatment options in the large quantitative study that we did. In this one, less than 20% of female patients were satisfied with the current treatment options. Patients reported widely that they are dissatisfied with the generic IR oral minoxidil as well, with 63% of those saying, who have used it, that they are not satisfied with its effectiveness. There is clearly a huge unmet need, low satisfaction, and we believe this market is primed for an innovative new approach to treating their hair loss. When they talk about the ideal treatment that they're looking for, both on the patient side, on the left-hand side of this slide, and physicians on the right-hand side, you find that there's highly similar characteristics for what both are looking for. The way women talk about it is they want confidence that this is going to work. They hear a lot of claims that are out there that are unsubstantiated. They've tried these products, they don't work. They're a bit skeptical about claims. They want confidence that it works. This is where the rigor of clinical trials and the approval by FDA really comes into play in helping female patients get confident that the product that they're going to use works. They want proven safety. They want to see improved safety and tolerability. They refer to a less stress with no mess. This really speaks to the ROGAINE use and the topical use. Something that you have to apply to your scalp twice a day is really difficult, very difficult to maintain compliance with that over an extended period of time. They want quick results, obviously. They're distressed by their hair loss. They want something that's going to work for them very quickly. Physicians, they use different language, but they say the same things. They want better efficacy. They want a well-characterized safety profile. They want convenient dosing, and they want faster onset. What is really encouraging to us is the emerging clinical trial profile that's coming out for VDPHL01 in the phase II results that we reported out recently. We see a rapid onset of effect. We see a robust increase in hair count, consistent response across participants with a well-characterized safety profile, all in a convenient oral administration. What they're asking for and telling us is their ideal treatment, what we're seeing begin to emerge from the clinical trials is exactly the type of product that they're looking for. These are the reasons why we're so excited about the female opportunity in addition to the existing male opportunity. With that, I'm going to turn it back to Reid and have him make a few closing remarks. Absolutely. I actually may skip through some slides because I know that we're coming up on time. In short, as we think about the opportunity here, the opportunity in hair loss is one of the most exciting opportunities in pharma, period. The dynamics that we see in this market are highly analogous to the dynamics that have driven explosive growth of other consumer-directed healthcare products like the GLP-1s, like the erectile dysfunction markets. Namely, it's a high prevalence condition. There has been a lack of innovation in the space. We see tremendous latent demand, and we see an OTC domination. If we can access these patients with easily facilitated patient-centric access, we believe we can drive explosive growth of the RX market. All in, as Mark has told you, the emerging clinical profile that we are seeing aligns with patient desires, and that when you combine that with a commercial strategy that provides for activation to consumer and easy adoption and maintenance of treatment, then we can see market growth and share capture. All in, we believe this to be a market that is hugely primed for innovation. It is the single largest chronic dermatologic condition. We have an investigational product that we believe to be highly differentiated as viewed by both patients and physicians, and that we believe with a strong commercialization effort, we are able to both grow the market and take existing market share. That is supported by these analog consumer-directed markets where we have watched things like the weight category be completely transformed with the introduction of new therapies. Now, for all of you here who have sat through a lot of talks today, it has been a long day, and you want to know what are the critical takeaways. There are two here. One is that this is one of the most exciting times at Veradermics, period, and that we have data that is coming. We have the second male phase III study and long-term extension data from the first study that are coming in the second half of this year. In the first half of next year, we will read out the first ever phase II/III study for an oral treatment for female pattern hair loss. The second critical takeaway is that it is hard to imagine a market that is as exciting as male and female pattern hair loss. So thank you all for your time. We really appreciate it today. Thank you
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