Veradermics, Incorporated (MANE) Earnings Call Transcript & Summary

Good morning, ladies and gentlemen, and welcome to Veradermics conference call to discuss results for the female trial arms of Study 207, a Phase II open-label trial, evaluating VDPHL01 for mild-to-moderate pattern hair loss in males and females. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Dominic Carrano, Chief Financial Officer of Veradermics. Please go ahead, sir.

Thank you, operator, and good morning, everyone. Thank you for joining us today to discuss Veradermics positive female results from the Phase II open-label trial, Study 207 of VDPHL01 in males and females with mild to moderate pattern hair loss. This morning's press release is available on the Investors 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; Dr. Jerry Shapiro, a leading hair loss dermatologist at NYU Langone Health. Dr. Waldman will begin with opening remarks and will present female results from Study 207. We will then hear from Dr. Shapiro about his thoughts on the unmet need on female pattern hair loss and his impressions of the data and how that may fit into his practice. Mark will then provide commentary on the commercial opportunity for VDPHL01 in females, including insights from a recent qualitative research study. We'll close the call with remarks from Reid and Q&A. Before we begin, I'd like to remind everyone that today's discussion, including question-and-answer session will contain forward-looking statements. Any statements that relate to expectations or predictions of future events, results or performance are forward-looking statements. 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. And with that, I'll turn the call over to Dr. Reid Waldman.

Thank you, Dom, and good morning, everyone. Upfront, we believe the data is fantastic and demonstrates robust proof of concept for VDPHL01 in female pattern hair loss. Today is an exciting moment for the treatment of female pattern hair loss as this represents the first positive Phase II outcome for an oral treatment for pattern hair loss in females in the United States, and it increases our conviction as we approach our upcoming Phase II/III registration-directed female readout now anticipated in the first half of 2027. We believe that this data supports the potential for VDPHL01 to activate a population of 30 million underserved female patients and positions VDPHL01 to potentially become the first and only FDA-approved oral treatment for female pattern hair loss. Specifically, in this readout, we saw robust efficacy signals on both hair count and patient report outcome with consistency across all endpoints. We saw fast onset of hair growth in females with the majority of patients reporting improvement in their hair coverage as early as 2 months, something that key opinion leaders have consistently identified is a key unmet need in female pattern hair loss. And we showed a high degree of consistency of treatment effect with almost all female patients responding while maintaining strong tolerability with a safety profile in this study that is consistent with what we have previously seen in trials of VDPHL01 in males. Now again, we're talking about pattern hair loss or androgenetic alopecia in females. And I think everyone knows this, but this transcends being aesthetic. It's deeply personal, it's deeply psychological and it's essentially universal affecting 30 million women in the U.S. at any given time. That is half of all women in their lifetimes. And losing hair can feel like losing your identity. It can be pervasive into many aspects of life and even with such a high prevalence and such a high potential impact. Females with pattern hair loss are deeply underserved population as there are no FDA-approved oral treatment options and no FDA-approved prescription treatment options for women with pattern hair loss. This is a category that is defined by both physicians and patients as being a high unmet need and it's evidenced by the fact that there are no FDA-approved options. And this is a patient population that is highly motivated as they make up the majority of treatment spending in the majority of treatment seeking. These dynamics are largely driven by the significant negative impact that pattern hair loss has on quality of life for women. As mentioned, this is an active treatment-seeking population, but right now, they predominantly resort to over-the-counter products that are unlikely to achieve their treatment goals. And when we ask these patients why they are resorting to OTC, the answer and the answer far and away is that they're unaware of prescription options, which makes sense given that there are no FDA-approved prescription options in females. Finally, we see that this is a very frustrated population, and that indicates a high rate of treatment cycling with one study finding that nearly 90% of females using the only FDA-approved treatment of females topical minoxidil are discontinuing. All of these underlying dynamics create a scenario where physicians demonstrate a high willingness to prescribe VDPHL01 where patients report high willingness to use VDPHL01 and where the willingness to pay is extremely strong in this market. Now for those of you that are new to the story, we are developing VDPHL01 as an oral nonhormonal treatment for both males and females with pattern hair loss. VDPHL01 is an oral minoxidil extend release tablet, and the premise is very straightforward. Minoxidil is validated biology for hair growth as it is approved as a topical for both male and female pattern hair loss. It also exists as an immediate-release oral blood pressure medication that is prescribed off-label for the treatment of hair loss. Now the problem with this blood pressure medication is that it performs exactly as you would expect a blood pressure medication to. It spikes quickly in the plasma. The majority has gone within 2 hours, almost all of it within 4 hours, and those spikes drive the cardiac effects of minoxidil, but they're not required or conducive to hair growth as they do not provide the consistent and durable exposure of minoxidil to follicle the hair growth needs. We initially set out with the goal of optimizing minoxidil for oral administration, the maximization of hair growth and minimization of cardiac risk via the development of this extended-release tablet that provides consistent and durable exposures of minoxidil to the follicle throughout the day, while blunting those peak plasma concentrations that drive cardiac effects. More minoxidil for longer is meant to drive hair growth, blunting those peaks aims to reduce cardiac risk. Back in April, we top line data from Study 302, a Phase II/III registration-directed trial in males that supported our view that VDPHL01's optimized PK profile delivers a clinically differentiated profile of maximized hair growth with minimized cardiac risk. Today's data from Study 207 provides robust proof of concept that VDPHL01's hair growth effects translate to female patients. In addition to giving minoxidil for longer and enabling greater exposures of monoxide, we also believe we can drive hair growth by driving the bioactivation of minoxidil to its active metabolite monoxide sulfate. As a reminder, minoxidil itself has no effect on the hair follicle, it's sulfate metabolite and minoxidil sulfate does and minoxidil can be activated to minoxidil sulfate in the outer root [indiscernible] of the hair via the SULT1A1 181 enzyme. In that enzyme, like many enzymes, it's capacity limited, meaning that it can saturate with spikes and plasma concentration that are seen with the immediate release and time dependent, meaning that it takes time to activate them and oxygen. So when you think about the PK profile of that immediate release blood pressure medication, it spikes quickly, overwhelming and saturating the capacity enzyme, and it crashes quickly, giving insufficient time for the enzyme to activate minoxidil. Whereas an extended-release tablet can provide consistent and durable exposures to drive bio activation and potentially drive additional hair growth. We believe that we maximize hair growth by enabling safe delivery of more minoxidil for longer in driving its bio activation. Today, we are very excited to review 6-month data from Study 207 Phase II open-label study of females with pattern hair loss. As mentioned, we're looking at 6-month data of females who have been randomized to either receive VDPHL01 4.5 milligrams twice a day or once a day. The endpoints in this study are the same endpoints that we've previously studied in Study 302. Those are change in non-vellus hair count from baseline and patient-reported outcome. Now as a reminder, this is the first study in which we are evaluating VDPHL01 in females in the first study in which we're evaluating the 4.5 milligram dose strength. That dose strength was designed to achieve similar exposures to what we've already demonstrated to grow hair in males in Study 302, and it is designed to accommodate gender-specific differences in pharmacokinetics that are observed with minoxidil. Now let's dive a little deeper on the endpoints. The endpoints in this study are target area hair count and patient reported outcome. As a reminder, these are the same endpoints that will be conducted in the same manner in Study 306, our upcoming registration-directed Phase II/III study in female pattern hair loss. We'll start by discussing target area hair count. The target area hair count is a measurement of the number of pairs greater than 30 microns in a given square centimeter. And the way in which we measure this is that we tattoo an area in the part width. We clip the hairs so we can visualize all hair in the area. We take a close up photograph. That photograph then gets transmitted to the vendor who has done every approval since 1997 and they have a digital image analysis algorithm that does 3 things. One, it lines up the photo to make sure we're measuring the exact same square centimeter; two, it measures the width of the hairs to identify hairs that are greater than 30 microns or what we call non-vellus hairs; and then three, it counts those hairs. That count has been confirmed by 2 humans in a quality assurance review. What differentiates hair counts in the female population from the male population is that unlike males who have a focal bald spot in the vertex, females experience diffuse thinning. And so we study this within the part with itself. The second endpoint is patient reported outcome. The patient reported outcome or the subject's evaluation of hair coverage change is very straightforward. The patient looks at a superior photo of their part width at baseline and a follow-up and they grade their hair coverage on a 7-point scale from much worse to much improved as shown here. And if they are improved or much improved they're considered a treatment responder and we do a responder analysis. Now before we look at our data, we want to review precedent data in terms of what results look like on non-vellus hair count in the female population. We selected studies here in the same manner that we selected studies in the male population, namely that for approved treatments or treatments that have been studied in a regulatory manner, we pulled their most recent regulatory study. And the reason for that is that the way in which hair counts are measured has evolved over time. For topical minoxidil, we are reviewing data from Bergfeld 2016, which is the first and only placebo-controlled study that utilizes a digital image analysis to count hairs in female patients with topical minoxidil. For oral finasteride, there is only a single study Phase II study conducted in the 90s that did not show positive results. For off-label treatments, the 2 most frequently used off-label treatments in female are immediate-release oral minoxidil and spironolactone for each of these off-label treatments, we look for prospective studies that use a tattoo based digital image analysis to measure hair counts. And here for oral minoxidil, there's a single study evaluating the 1 milligram dose and for spironolactone. There is no monotherapy study, so we review a study that combines spironolactone minoxidil. On the first efficacy endpoint target area hair count, we see robust treatment response with the once-daily group showing 22.7 hairs per square centimeter to twice-daily group showing 23.3 hairs per square centimeter. This is the first time that there has been a positive increase in target area hair count in a Phase II study with an oral agent in women in the U.S. And we have strong conviction in the translatability of these hair counts into our larger Phase II/III study as the median target area hair count change is nearly identical to the mean and the range is narrow. Now I realize this is probably the first time a lot of you have seen female pattern hair loss data. So let's put this in context with those studies we already looked at. When we compare this data in a non-head-to-head manner, understanding that there are limitations to that comparison to historic precedent data we see that VDPHL01 outperforms topical minoxidil foam off label immediate-release oral minoxidil, oral finasteride and spironolactone by about 170% to nearly 400%. In fact, our data from Study 207 outperformed topical minoxidil foam, our base case target for commercial viability by 170%. And that is an even larger delta over topical minoxidil foam than in the same analysis that we conducted in our male VDPHL01 Phase II/III study. Again, these are not head-to-head studies and based on historic independent trials conducted by different sponsors. These objective changes in hair count been translated into clinically meaningful benefit that was visible to patients with 88.9% in the once-daily group and 90% in the twice-daily group reporting that they are improved or much improved in their hair coverage. Investigators were similarly enthusiastic about what they saw in their patients with 100% in the once-daily group and 90% in the twice-daily group, reporting increased hair coverage in month 6. In my opinion, as a dermatologist, this consistency of visible effect noticed by both patients and dermatologists is an impactful piece of data that represents a potential breakaway from practice today where patients often cycle from one treatment to another without reaching their treatment goals. And here, almost every single patient by their own accord and their doctors had visible improvement in their hair coverage. Now what does that mean in reality? Here, we're going to look at responder photos across severity scale of patients that would be eligible by severity to participate in Study 306, our registration-directed trial. First, this is a participant with 714 grade pattern hair loss that responded to treatment. Just so you know, 714 female pattern hair loss is the mildest severity of trial-eligible hair loss in Study 306. Now here you can see visible changes in our hair with a near renormalization of the part and a thickening of hair density in the area surrounding the part. Now we have a participant with 721 pattern hair loss. 721 is more severe than 714 and this patient also demonstrated significant improvement again with near renormalization of the part and improvement of density in the surrounding areas. And finally, this is a participant with 722 pattern hair loss, the most severe trial-eligible grade of hair loss. Again, this is someone who has very advanced female pattern hair loss. And in clinical practice, this level of severity is relatively uncommon, so it is encouraging to see such a clear visible response in this potentially more challenging setting. I'm going to click through these again and think that for each of these women, the only approved option today is to rub a topical throughout their hair that leaves a residue on the scalp that can impact the appearance and stylability of the hair. With this oral treatment in these 3 patients, we show significant change in their hair coverage. And while we just looked at 3 patients' worth of photos, as a reminder, nearly 90% of study participants reported that they had visible improvement in hair coverage. We're now going to switch gears and talk about hair elsewhere on the body, specifically on the eyebrows. And this is information that I think is going to come as a surprise to most people on this call. Eyebrow loss or lateral eyebrow thinning, what we call eyebrow hypotricosis in dermatology is a common sign of facial aging. And when you lose contrast in your eyebrows it changes the definition of your facial features, and it not only makes you look older, it makes it so that your face is less recognized. In fact, the eyebrows are as distinctive a facial feature for facial recognition as your eyes. And as a result, people associate their eyebrows with their identity and loss of eyebrows can result in loss of self steam. If you look at each of the women shown on this slide, they're actually all the same person, but with modified eyebrow thickness and that variance and eyebrow appearance creates a sort of optical illusion that makes the face look completely different unless you hold your hand over the eyebrows. And I'm going to pause for a minute to let you all take a look. Now in this study, we aim to assess whether VDPHL01 could regrow eyebrows in individuals with age-related eyebrow thinning and assess the subject's eyebrow fullness at month 6 baseline using the GEBA scale, which has previously been used in clinical trials to evaluate treatment of eyebrow hypertrichosis. We're going to take a look at a number of before and after photos to highlight this, and you can see here before and after of a woman with slight eyebrow fullness at baseline who improves the full eyebrow fullness in follow-up. The contrast in the eyebrows is so much more defined after 6 months of treatment. Here's another patient with a similar degree of improvement. And I think it's really easy to envision how the changes we're seeing in these women's eyebrows have the potential to fundamentally change their appearance, the potential to make them look younger and the potential to make their faces look more defined. We found it very exciting to see that in addition to the potential to grow more scalp hair, there may be a potential to improve eyebrow definition and maybe even eyelash density. The other thing that I think is important is that many stakeholders ask us about hypertrichosis or unwanted hair growth. Now as you look at these facial photographs of these females, I think it's fairly clear, they're not getting substantive hypertrichosis that is visible on photographic eye examination. And so let's transition to a conversation about safety and consider all female patients in the study? Overall safety and tolerability are similar to what we've seen in prior trials with VDPHL01 with no new safety signals identified. Specifically, we saw no SAEs, no adverse events of special interest of cardiac origin so no pericardial effusion, pleural effusion, heart failure, angina, and no clinically significant changes to heart rate, blood pressure and ECGs. And interestingly, we did not observe post-treatment initiated shedding in the female population in the study, meaning that after initiating treatment, we did not have any reports of worsening of hair loss for worsening of hair shedding before things got better. And I think importantly, that's a common reason that people discontinue minoxidil-based products. And again, while there are no direct head-to-head studies in their inherent limitations to cross trial comparison, shedding is reported in up to 44% of women in the literature in one study using off-label immediate release oral minoxidil and so the absence of shedding of the study is very encouraging. So what do we see from a safety perspective? Well as mentioned, there are no SAEs, no AESIs of cardiac origin and the most common adverse events were expected as they're seen with topical minoxidil foam in women, and we have known greater exposures in the topical. The most common events in this study are hypertrichosis and peripheral edema. And while it's based on low patient numbers here, the prevalence of hypertrichosis looks directionally higher than what was observed in males, and that's consistent with our expectations historically but are more likely to note hypertrichosis if it occurs. Even with that, we only had one adverse event that led to study discontinuation, which is a case of hypertrichosis. The edema rate also looks generally consistent to what we've seen in the male population to date. All in, this data supports a potentially differentiated clinical profile for VDPHL01 and positions VDPHL01 as a potential first and only FDA-approved oral treatment and potential first and only FDA-approved prescription treatment for female pattern hair loss. Specifically, this is a profile that is fast with visible results as early as 2 months that is consistent with a high rate of treatment response in this population that is intense with robust hair count changes while maintaining tolerability consistent with what we've observed in prior trials and the convenience of oral administration. I am so excited to introduce Dr. Jerry Shapiro. Dr. Shapiro is one of the world's foremost authorities inherent disorders and hair restoration. He was among the first dermatologist to dedicate his practice exclusively to medical hair and has helped shape the field through clinical care, research and education of the future generations of dermatologists as the Director of the Hair Clinic and a Professor of Dermatology at the NYU Langone School of Medicine, Dr. Shapiro cares for thousands of patients with hair disorders, and he encounter some of the most challenging cases as patients travel from all over the world to see him. Dr. Shapiro, we are so excited to have you here with us today.

Thank you very much. Great to be here. I've been working for 40 years, and this is one of the biggest things that I've seen in my career. My practice is just hair loss. Most of my patients, I'd say at least 60% to 65% of my patients, are women. And we spend a lot of time with the patients going over all the treatment options with them. And from seeing just hair cases, I understand the emotional impact of a woman losing their hair. When a woman loses her hair, part of her is lost, her identity. Many women have a signature to themselves. And many, it's the hair. If they're a red head, for instance, or they're a blonde or brunette and how they style their hair, the length of their hair whatever, that's their signature. If they lose that, they lose part of themselves. Usually dermatology is very upbeat. It's usually a good office visit. But when it comes to hair loss, it's not a good visit. It's a very sad visit. And so we always have Kleenex available for the patient because they cry a lot in our office. It's a devastating condition for women and so many women are affected by it. The unmet need for hair loss and especially in women is that things don't work that well. You have women who come in, they've tried all sorts of different things, and they haven't really worked that well. And in terms of an oral medication that is FDA approved, there is nothing there never really has been anything. So finally, we may have something that will make a difference. And the study initial Phase II study shows that 90% of people are happy with it. And if we can get 90% satisfaction rate as we've seen preliminarily, I think that's wonderful because right now, we have nothing that comes close. So I think patients reported outcomes are very positive. Secondly, the number of hairs per square centimeter or the total area hair count has increased, and it does it very quickly within just 2 months, nothing that we have works in 2 months. This is something that is quite incredible that within 2 months, you're starting to get new hairs growing in. So there's rapidity of response. There's also the eventual density is quite incredible as well. And when one looks at the before and after pictures, you can see significant differences. When comparing this to immediate release minoxidil, I think it's a huge difference. One is that the safety is super important. Sometimes with immediate release you end up with heart problems. I had a case of pericarditis. So the safety aspect is huge for this and needs to be emphasized to physicians who are prescribing it. Now everything has some side effects. One of the major side effects is too much hair on the face or on the body. But to me, if they start growing hair on the face, or on the body from an oral medication means it's working on the scalp too. It wouldn't just be working on the rest of the body and not on the scalp. So to me, that's a good sign. And we now have treatments to take care of this excess hair on the face or on the body. So we're very happy about that. I must commend Veradermics to do a study like this. It hasn't been done in ages in women -- an oral medication because this would be the first oral medication that shows efficacy in women, and it's crucial to have data like this. And the way it was done with the counting of the hairs as well as looking at the widths of the hairs and using the technology that we now have available and really getting to prove to the world that it does work. It really is a major event that the Phase II data is so convincing. We're now anxious to see the Phase III data to help confirm all these findings. Also, I would like to emphasize FDA approval really is important because it means they're safe. Safety is crucial. And we also know that it has effectiveness, that it's not snake oil, that it's something that really does work. And so when you have the FDA seal of approval, you know you're dealing with something that is safe and that work other medications that we sometimes use on female pattern hair loss [indiscernible] not approved, and it becomes a huge issue, once it's available, I'm going to swap everyone over from what we have now to something that works better, works faster. So I'm going to swap them over to something that is more efficacious in terms of the speed or rapidity of the response as well as the number of hair counts as well as patients being happier. And I mean that's what it's all about. And so if I can give them something that works better than what's available now, and it looks like this is one of these medications that will do this from the Phase II data, it's going to make a huge difference to patients. And when people start using it, they start telling their neighbors. They start telling their condo -- people in their condo. That's how I get a lot of my patients actually. They just tell one another in their own building, but they're also just they tell their friends, people see a difference in the hair of these patients. And so they tell everybody. Also, I expect other doctors to be educated about it, and there'll be presentations at various meetings that will tell dermatologists as well as general practitioners that it's something to use that's safe. And also nurse practitioners, they also be very interested in this as well as endocrinologists because they also treat hair loss. I'm very excited about it. I really think this is a huge step in the treatment female pattern hair loss. And once the word gets out. And once the company has all sorts of advertising like Instagram or infomercials or whatever, people will know about it. And once they know about it, they want to switch because hair is so important.

Thank you, Jerry. I'd now like to invite Mark Neumann, our Chief Commercial and Strategy Officer, to discuss the female pattern hair loss opportunity. Mark?

Thanks, Reid, and good morning, everyone. As Reed mentioned, the clinical outcomes we observed in the 207 study are very encouraging and demonstrate a robust proof of concept for VDPHL01 in female pattern hair loss. And we believe that this emerging clinical profile supports the potential to activate a population of 30 million female patients by potentially becoming the first and only FDA-approved oral treatment for female pattern hair loss. Over the past 18 months, we've conducted extensive qualitative and quantitative market research with more than 500 female patients and their physicians. That has provided us with a foundation of understanding of the female pattern hair loss treatment journey and the potential for VDPHL01 to address the significant unmet needs that exist. The female pattern hair loss market has a large addressable patient population of approximately 30 million women in the U.S., which makes it as large as the eczema market and nearly 4x the size of the psoriasis market. And this large patient population is very poorly served by today's treatment options. There are no FDA-approved oral or prescription treatment options for female pattern hair loss. So women are left to treat their condition with an existing assortment of off-label unproven or difficult-to-use treatment options. In our market research, physicians and patients provide a very clear picture of how female pattern hair loss can permeate into every aspect of a woman's life. This condition has a highly negative emotional effect that profoundly impacts a woman's quality of life. When asked the question, what 2 to 3 adjectives best describe how you currently feel about your hair loss. The most common words women used to communicate how they feel were fear, anxiety, sadness, upsetting, ugly, surprised and concerned. It's clear that female pattern hair loss has a high degree of negative impact on their daily lives and adding to that stress is the fact that they find their condition very challenging to manage. Another particularly important observation is that hair is the single most important aesthetic category for women compared to things such as weight, skin and teeth. The difficulty to manage pattern hair loss is an insight that has repeated itself across multiple research studies. This emotional impact creates a dynamic where female pattern hair loss patients are highly motivated and active treatment seekers with a high willingness to pay to treat their condition. In our market research, we saw a very high HCP willingness to prescribe a product with a profile like VDPHL01, driven by the high unmet need and the limitations of existing options. From the patient's perspective, the negative quality of life impact, combined with a desire to actively seek treatment, drive a high willingness to use with females often using multiple treatment options at the same time. Significant treatment cycling has, in general, not been observed to deliver desired results, and this ultimately leads to treatment discontinuation for many patients. The female pattern hair loss patient journey typically starts with over-the-counter products, often in combination for many months. Our market research identified a large segment of more than 4 million female pattern hair loss patients that try and cycle through multiple OTC options. Women often take OTC products long enough that improvement could potentially be seen as often as long as 12 months or more. However, a general lack of adequate response pushes patients to see an HCP typically a dermatologist, which leads to initiating a prescription treatment that is off label. This is a much smaller segment of the population, driven by the absence of approved oral treatments for women. Eventually, and after what could be up to 2 years of total treatment time, most female pattern hair loss patients ultimately discontinue with minimal or no noticeable improvement. In addition, some patients go back to the beginning, restarting an OTC cycling regimen all over again. The nature of this treatment journey offers multiple opportunities to introduce a novel prescription treatment option shown to improve growth. Female treatment-seeking behavior suggests that the option of an FDA-approved prescription option clinically proven to grow hair could easily find its way into the treatment journey. Another key insight common across our research is that female pattern hair loss patients have a very low level of satisfaction with current treatment options. This fact undoubtedly is a key driver of their high level of treatment-seeking behavior. Digging into some of the factors that patients consider to be limiting, the lack of an FDA-approved oral option typically is at or near the top of the list. Almost equally important are key efficacy attributes, including, but not limited to, poor hair regrowth and slow onset of action. On the tolerability side of the equation, it's not surprising to see concern with hypotrichosis, edema and the risk of cardiac side effects. In addition, while IR/minoxidil is used to treat female pattern hair loss, the majority of patients are not satisfied with the effectiveness of the immediate release minoxidil. The low treatment satisfaction and the reasons supporting this insight demonstrate a clear unmet need for female pattern hair loss. To meet this unmet need, our research identified several critical treatment attributes that female patients consider essential. From an efficacy point of view, proven efficacy and speed of action consistently rises to the top of the list. In addition, there's a clear preference for oral treatments versus topical. Treatment safety is important and generally cited after efficacy and formulation attributes. And with our first look at how VDPHL01 works in females, we now have an initial point of view as to how well the treatment could potentially address the unmet needs and desired treatment attributes. Looking at efficacy, Study 207 demonstrated a rapid responsive effect with improvements seen as early as 2 months. In addition, we believe the increase in total area hair count for women is robust, and is the best result observed in females to date. Importantly, nearly all patients in the study showed an improvement. While Phase II studies enrolled relatively few patients, initial safety attributes in the study included an absence of SAEs, no signs of a negative cardiac impact and a generally favorable tolerability profile. We believe the oral formulation can represent a convenient treatment option for women that avoids the complication of topical treatment. So in summary, we are very encouraged by the results of Study 207 and the emerging clinical profile of VDPHL01 for female pattern hair loss. Female pattern hair loss is a large underserved patient population that we believe is primed for activation. Thank you for your time today, and I look forward to continuing to update you on our go-to-market commercialization plan and our launch readiness in the coming months. And with that, I'll turn it back to you, Reid.

Thanks, Mark. We believe the data provides robust proof of concept for VDPHL01 in females and supports a potentially differentiated profile that we believe can be fast with objective and visible results as early as month 2, consistent with a high rate of patients who responded to treatment and intense with high clinically meaningful hair count changes, all the while maintaining convenience of oral administration, demonstrating a favorable tolerability profile in females and positioning VDPHL01 to become the first and only FDA-approved treatment for both male and female pattern hair loss. Now before we conclude, I'd like to share some quotes from the qualitative research we've done in females. As you think about this compared to what we've shown in our work with males, it speaks to how dramatic the impact is on these individuals' lives. I'm going to take a moment to allow you to read all these quotes. In conclusion, we believe that these results position VDPHL01 as a potential foundational treatment for pattern hair loss in females and that this data supports a high degree of conviction in our ongoing Phase II/III registration-directed clinical trial in women. As mentioned at the top of the call, we are now providing guidance on the timing of Study 306, and we anticipate results from this female registration-directed trial in the first half of 2027. Thank you so much for your time today. We'll now take questions.

[Operator Instructions] And our first question comes from Marc Goodman with Leerink.

Reid, could you talk about the severity of the hair loss in these women and how that matches up with the type of women that you have in the Phase III study? And then will the doctor ask -- to answer your question, I'm just curious what he thinks about Nutrafol and how this product compares to Nutrafol and what will happen when this product gets to market and how will those Nutrafol patients kind of act?

Thank you, Marc. So I'll start off by addressing your first question about the severity of hair loss patients. So as mentioned, in Study 306, we look at patients who are 714, which is our mildest severity in that study, which means they have a visibly widened part to a 722, which is the robust widening of the part that was visualized in that image. Importantly, from an I&E perspective, we did select a slightly more severe population for Study 306, having included 713s in Study 207. And the reason for that is that as we have a co-primary endpoint that involves the ability to place a tattoo in a carefully selected location, having patients who have a more visibly widened part is more conducive to that. Dr. Shapiro, do you want to come off mute and give commentary about how you think this data compares Nutrafol and how this could impact neutrophil utilization among female patients?

I feel this data that you have is very robust. It is extremely robust and gives us great hope that this is going to really work well. Neutrophil does work in some people. And -- but I feel that this -- if we get the FDA approval and we get all the the seal of approval and safety and everything, then I'm very, very excited about this. The Nutrafol market -- it's a nutraceutical. It's not a medication that's prescribed. And it does have some efficacy in some people, but I think this will basically really become more powerful than a Nutrafol is and Nutrafol could be used as adjunctive possibly. But I feel that this will overtake any of that Nutrafol.

Our next question comes from Serge Belanger with Needham.

And congrats on the data. I guess the first one for Reid. Were you surprised at the lack of shedding that was observed in the study relative to -- I think you mentioned about 44% has been observed -- 44% of shedding has been observed in prior studies, I think, with the IR minoxidil. And then secondly, for Dr. Shapiro, just curious what is kind of your treatment paradigm for for females currently? Is it around minoxidil or do you even push them towards some of these OTC products like Nutrafol?

Yes. So Serge, I think it's a great question. And I think we were extremely encouraged by the absence of shedding that was observed in this study. interestingly enough, actually last night, I went out to dinner with about a dozen dermatologists and one of the big conversations around the table was what's called the dread shed and how that can impact compliance adherence with females because if you're already distressed about losing your hair getting worse before you get better can be even more distressing. And so as you mentioned, when we look to the literature, up to 44% of patients taking the immediate release oral minoxidil can demonstrate shedding. So I think this is a very positive sign. It's highly consistent with what we saw in Study 302. And I think it importantly speaks to the potential tolerability of VDPHL01. Dr. Shapiro, do you want to talk a little bit about kind of where -- how you approach the female patient today from a therapeutic selection perspective, whether it's minoxidil-based products, spironolactone, nutraceutical, all of the above and give them some color as to how you approach patients in your practice?

Sure. I've presented this internationally at many, many conferences. Minoxidil is very high up there. Almost everybody gets oral minoxidil. We give them a choice, topical or oral. I tell them oral is the way to go, and we use it a lot. It's like water in our clinics. So there's no question, that's number one. Do I use other things? Yes. There are other things like spironolactone or bicalutamide. -- but they affect hormones, and they may cause irregular menstrual cycles. So they're not like my go-to. The go-to is going to be minoxidil, okay? And so we use it a lot in our clinic. Now in terms of nutraceuticals, I actually don't use nutraceuticals that much at this point. I'd like to see more data myself before I really tell people to use it that much. So I'm more with the minoxidil, I use it a lot, and it is like the #1 treatment in our clinic for women who come in with pattern hair loss.

Our next question comes from Roger Song with Jefferies.

Congrats for the great data. Two sets of questions. One is understanding this is a Phase II open-label study, how the companies think this data will translate into Phase III, particularly around the baseline [indiscernible] and then maybe the placebo expectation around THC and the PRO? And then maybe the question for Dr. Shapiro, this Phase II data looks very strong, as you mentioned, how do you think a Phase III profile you would like to see can recommend the first line and why do they adopt or driving the wide clinical use?

Yes. Roger, thank you for the question. And I think this is a great question. We have a high degree of conviction that data here, in particular, hair count data is well positioned to translate into the upcoming registration-directed trial. And the reason I say that is that when we look at the presented data, obviously, we're looking at means. However, when we look at the median, it looks essentially identical to the mean. And when we look at the range, it's very narrow, much narrower than what we saw in the male population, giving us a very high degree of conviction translating there. I think, obviously, for patient reported outcomes, we are aware that this is an open-label study. However, when you think about clinical practice, clinical practice is certainly open label. So seeing that 90% patient-reported outcome response of improved or much improved hair coverage is really meaningful. And I think finally, from a tolerability perspective, we continue to amass data that supports that when you blunt the peak plasma concentration of minoxidil you drive the tolerability of the [indiscernible]. So I think we're very, very encouraged. Maybe Dr. Shapiro, do you want to give some color about as you see data in 550 women, what that means or what you're thinking about?

Well, I think that I'm going to be so convinced once the Phase III data comes out and it's positive, which sounds like it will be. I mean, I'm going to swap everyone over from immediate release to this extended release. I feel that this is a huge improvement in what we have right now in terms of the repetitive response as well as the number of pairs per square centimeter. It's going to really change the way I practice and what's going to be my #1. What's going to be the water in our clinic. Right now, it's the immediate release, but it will definitely be swapped over once we see the data in the Phase III study. I mean once you have a placebo, double-blind controlled study, I mean, that's going to be huge, and it's going to change a lot of people's minds. They're going to go right for it.