Good morning, ladies and gentlemen, and welcome to Veridermic's conference call to discuss results from the female trial arms of Study 207, a Phase II open-label trial evaluating BVPHL01 for mild-to-moderate pattern hair loss in males and females. At this time, all participants are in listen-only mode. A question-and-answer session will follow the form of presentation. As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Dominic Carano, Chief Financial Officer of Veridermics. Please go ahead, sir.

Thank you, operator, and good morning, everyone. Thank you for joining us today to discuss Veridermics' 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 investor section of our website, where we will also post the slides used today following the conclusion of this call. Joining us on the call today are Dr. Reed Waldman, our Chief Executive Officer, Mark Newman, our Chief Commercial and Strategy Officer, and Dr. Jerry Shapiro, a leading hair loss dermatologist at NYU Langone Health. Dr. Waldman will begin with opening remarks and will present FEMA results from study 207. We will then hear from Dr. Shapiro about his thoughts on the unmet need in 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 VDPHL1 in females, including insights from a recent qualitative research study. We'll close the call with remarks from Reed 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 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. Reed 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 2-3 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 reported 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 two months, something that key opinion leaders have consistently identified as 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 a 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 and 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're 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 is an oral non-hormonal treatment for both males and females with pattern hair loss. VDPHL-01 is an oral minoxidil extended 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 is gone within two hours, almost all of it within four 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 at the follicle that 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-lined data from Study 302, a Phase 2-3 registration-directed trial in males that supported our view that VDPH-L01'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 VDPH-L01's hair growth effects translate to female patients. In addition to giving minoxidil for longer and enabling greater exposures of minoxidil, we also believe we can drive hair growth by driving the bioactivation of minoxidil to its active metabolite, minoxidil sulfate. Now, as a reminder, minoxidil itself has no effect on the hair follicle. It's sulfate metabolite, minoxidil sulfate does. And minoxidil can be activated to minoxidil sulfate in the outer root sheath of the hair via the salt 1A1 enzyme. And that enzyme, like many enzymes, is capacity limited, meaning that it can saturate with spikes in plasma concentration that are seen with the immediate release, and time-dependent, meaning that it takes time to activate the minoxidil. So when you think about the PK profile of that immediate release blood pressure medication, it spikes quickly, overwhelming and saturating the capacity of the 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 bioactivation and potentially drive additional hair growth. We believe that we maximize hair growth by enabling safe delivery of more minoxidil for longer and driving its bioactivation. Today, we are very excited to review six-month data from Study 207, a Phase II open-label study of females with pattern hair loss. As mentioned, we're looking at six-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-vellous hair count over baseline and patient-reported outcome. Now, as a reminder, this is the first study in which we are evaluating VDPHL01 in females and 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 have 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 2-3 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 hairs 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 hair 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 three 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-vellous hairs. And then three, it counts those hairs. That count has been confirmed by two 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 width 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 at follow-up, and they grade their hair coverage on a seven-point scale from much worse to much improved, as shown here. And if they are improved or much improved, they are 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-vellous 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 our 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 two 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 one milligram dose. And for spironolactone, there is no monotherapy study. So we review a study that combines spironolactone with topical 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, the 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 VDPH-L01 outperforms topical minoxidil foam, Hoff 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%. That is an even larger delta over topical minoxidil foam than in the same analysis that we conducted in our male VDPHL01 phase 2-3 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 then 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 at once-six. 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 at month six. 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 have 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, 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 her 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 and these three patients, we show significant change in their hair coverage. And while we've just looked at three 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 Eyebrow loss or lateral eyebrow thinning, what we call eyebrow hypotrachosis 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 recognizable. In fact, the eyebrows are as distinct of 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-esteem. 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 in 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 who have age-related eyebrow thinning and assess the subject's eyebrow fullness at month six versus baseline using the Givas scale, which has previously been used in clinical trials to evaluate treatment of eyebrow hypotrachosis. 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 afters of a woman with slight eyebrow fullness at baseline who improves to full eyebrow fullness at follow-up. The contrast in the eyebrows is so much more to find after six 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 that 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 BDPHL01 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 this study, meaning that after initiating treatment, we did not have any reports of worsening of hair loss or 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 and there are 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 of oral minoxidil. And so the absence of shedding in 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 minoxidofoam in women, and we have known greater exposures than 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, women are more likely to note hyperdrichosis if it occurs. Even with that, we only had one adverse event that led to study discontinuation, which is a case of hyperdrichosis. 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 two 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 in hair disorders and hair restoration. He was among the first dermatologists 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 encounters 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 there were redheads for instance or they're a blonde or or brunette and how they style their hair the length of their 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 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 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, this initial phase two study shows that 90% of people are happy with it. And, you know, 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 patient-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 two months. Nothing that we have works in two months. This is something that is quite incredible, that within two 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, it 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 Veridermix 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 the 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 two data is so convincing. We're now anxious to see the phase three 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 works. Other medications that we sometimes use on female pattern hair loss, they're 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 the medications that will do this from the phase two 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 Most practitioners may 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 of female pattern hair loss. 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'll want to switch because hair is so important.

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

Thanks, Reed, 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. In the past 18 months, we've conducted extensive qualitative and quantitative market research with more than 500 female patients and their physician that has provided us with a foundation of understanding of the female pattern hair loss treatment journey and the potential for VDPH-L01 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 four times the size of the psoriasis market. And this large patient population is very poorly served by today's treatment options. 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. Our market research, physicians and patients provide 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. Ask the question, what two to three adjectives best describe how you currently feel about your hair loss? The most common words women use to communicate how they feel were fear, anxiety, sadness, upsetting, ugly, surprised, and concerned. Hair 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. It's 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 BDP-HL01, 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. 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. 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-latel. This is a much smaller segment of the population, driven by the absence of what could be up to two 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. And 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. A female pattern hair loss patient 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 hypertrichosis, 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. 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. From an efficacy point of view, proven efficacy, and speed of action consider. In addition, there's a clear preference for oral treatments versus topics. Treatment safety is important and generally cited after efficacy and formula. Look at how VDPH-L01 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. Looking at efficacy, study 207 demonstrated a rapid response of effect with improvements seen as early as two 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 enroll 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 complications. In summary, we are very encouraged by the results of study 207 and the emerging clinical profile of VDPH-L01 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, Reed.

Thanks, Mark. We believe the data provides robust proof of concept for BDPHL01 in females and supports a potentially differentiated profile that we believe can be fast, with objective and visible results as early as month two, 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 VDP-HL01 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 individual's lives. I'm going to take a moment to allow you to read all these quotes. In conclusion, we believe that these results position VDPH-L01 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 2-3 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.

Thank you. If you'd like to ask a question, please press star 1-1. If your question has been answered and you'd like to remove yourself from the queue, please press star 1-1 again. One moment while we compile the Q&A roster. And our first question comes from Mark Goodman with Lyric. Your line is open.

Can 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 three study? And then will the doctor answer a question? I'm just curious what he thinks about neutrophil and how this product compares to neutrophil and what will happen when this product hits the market and how will those neutrophil patients kind of act?

Thank you, Mark. So, I'll start off by addressing your first question about 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 INE 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, you know, the ability to place a tattoo in a carefully selected location, you know, having patients who have a more visibly widened part is more conducive to that. You know, Dr. Shapiro, do you want to come off mute and give commentary about how you think this data compares to neutrophil and how, you know, 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. Nutrafol does work in some people, but I feel that this, if we get the FDA approval and and we get all the seal of approval and safety and everything, then I'm very, very excited about this. The neutrophil 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 neutrophil is. And a neutrophil could be used as a juncture, possibly. But I feel that this will overtake any of that neutrophil.

Thank you, Dr. Shapiro.

Thank you. Our next question comes from Serge Bellinger with Needham. Your line is open.

Hi, good morning, and congrats on the data. I guess the first one for Reed, were you surprised at the lack of shedding that was observed in the study relative to, I think you mentioned, about 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 females currently? Is it around minoxidil, or do you even push them towards some of these OTC products like Nutrafoil? Thanks.

So, Serge, I think it's a great question. And, you know, 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, you know, 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, you know, when we look to the literature, up to 44% of patients taking the immediate release of 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, you know, the potential tolerability of VDPH-L01. You know, Dr. Shapiro, do you want to talk a little bit about, you know, kind of where, how you approach the female patient today from a therapeutic selection perspective, whether it's, you know, minoxidil-based products, spironolactone, nutraceutical, you know, 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, you know, we give them a choice, topical or oral. I tell them, you know, oral's the way to go, and we use it a lot. It's like water in our clinic, 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 number one treatment in our clinic for women who come in with pattern hair loss.

Thank you, Dr. Shapiro.

Thank you. Our next question comes from Roger Song with Jeffries. Your line is open.

Oh, great. Congrats for the great data and thank you for taking our question. Two sets of questions. One is understanding this is a phase two open-label study, how the companies think this data will translate into phase three, particularly around the baseline IME and then the placebo expectation around THC and then PRO. And then maybe the question for Dr. Spiro is, you know, this phase two data looks very strong, as you mentioned. How do you think a phase three profile you would like to see, can I recommend this as a first line and then why they adopt or driving the wide clinical use? Thank you.

Yeah, Roger, thank you for the question. And I think this is a great question. We have a high degree of conviction. The 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 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 percent 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 this drug. 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 three 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 what we have right now in terms of the repetitive response, as well as the number of hairs per square centimeter. It's going to really change the way I practice and what's going to be my number one. 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 three 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.

Thank you, Dr. Shapiro.

Thank you. Our next question comes from Jeff Meacham with Citi. Your line is open.

All right. Hey, guys. Thanks so much for the question. Congrats on the data. Just have a few questions. Reed, now that you're giving guidance on the timing of study 306, you know, do you think you'll wait for that data to mature to file or do you think you could file on men only you know first I guess the bigger picture is what is the value of having both on the label potentially you know on day one the second question for Dr. Shapiro maybe just give some context for hypertrichosis in the female population you know as an adverse event how much of a focus do you think this could be when you walk through the profile of your drug with your patients is there sort of a rate or a level that, you know, is problematic, or is it something that you think your patients will definitely manage?

Thank you. Yeah, Jeff, thank you for the question. And, you know, I think certainly, as you mentioned, there is a lot of excitement around the female opportunity, market opportunity, and what that could mean, you know, to potentially have the only oral treatment labeled for both male and female pattern hair loss. At this point, you know, we're not giving guidance around regulatory filing strategy, but certainly as is consistent with previous commentary, there's considerations around together versus sequentially, and we'll come back to you as we, you know, as we progress. But, you know, very, very encouraged that today's data represent a meaningful de-risk as we move towards study 306, and that it creates a similar setup to what we had at the IPO in the male population, but now for females. Dr. Shapiro, So I think the question they want to know is about hypertrichosis and, you know, how big of a deal is hypertrichosis in your mind?

Well, hypertrichosis is to be expected. We tell every patient, for instance, who's going on immediate release, that there is a 15% chance that they're going to have some kind of hypertrichosis. And for most people, I would say at least 98% of them, they say, okay, is there something I can do about it? And yes, there's tons of stuff you can do about it. There's something called dermaplaning. There's using certain razors that are made for women, waxing, lasers. There are all sorts of ways to combat it, and they don't mind it as long as it's growing hair on their head. And if it's growing hair on their body, it's going to grow hair on their head too. So it's actually a very good sign that they have hair on other parts of their body because it means it's working on their scalp as well in these women. And so I really think it's not a big issue for the patients that I've treated with immediate release. As long as they understand this is a side effect, they may have to take care of it. And it doesn't occur in everybody. It only occurs in 15%. So there's 85% of people where it doesn't occur. And there are ways to remediate that. So it really isn't a big deal. People will find a way to get rid of the excess hair that they have as long as they know it's growing hair on their head. Growing hair on their head is pivotal, crucial. As we spoke before, it's their signature. It's so important to so many women that that's what many women are known for frequently, for their style, for their color, and all sorts of things. So I think that this is a very important point, that people will take some of the negative aspects, they'll deal with it as long as they're growing hair on their head.

Thank you, Dr. Shapiro.

Thank you. Our next question comes from Prakar Agrawal with Cancer Fitzgerald. Your line is open.

Hi. Thank you for taking my questions, and congratulations on these data sets. So maybe first question for both the company and Dr. Shapiro. The eyelash growth figures you showed were pretty impressive. So maybe just expand on how important is the eyelash growth here. Do you see that with low-dose minoxidil too, and whether the magnitude that you are seeing in the trial looks a little bit better? And second one for the company, one steady dose and twice steady dose here perform very similarly. So are you thinking about the dosing frequency in the female population? And the one steady dose perform pretty good in male population as well. So what are the implications there as well as you think about just broadly across men and females for dosing frequency. Thank you so much.

Perfect. Yeah, I'll answer your second question first, which is to say, you know, obviously this is a small data set, but it is so encouraging to see tremendously strong data in the once daily group, right? I think that that, as you said, we were surprised to see that in study 302. We're obviously pleasantly surprised to see that again in study 207. At this point in time, you know, too early to make a dosing decision. But again, seeing, you know, robust signals in both the once and twice daily dose strength, we believe, you know, supports, again, a further de-risking profile as we move to study 306. In terms of, you know, the eyebrow, you know, eyebrow hypotrachosis or eyebrow thinning, you know, it's very interesting. And this was an exploratory point in the study, you know, that had come as a recommendation, something that, right, there's not a lot of literature about, not something that there's a lot of, you know, consideration about, you know, today from a minoxidil perspective. But importantly, eyebrows impact the way in which people are perceived. And, you know, I think that if you look at a photo yourself and you imagine what you'd look like without eyebrows or with thin eyebrows, it signals facial aging. And so being able to see, you know, this improvement in the contrast and in the definition of the eyebrows here, you know, we believe is an ancillary aesthetic benefit that could be very meaningful to patients as they look to, you know, combat facial aging.

Thank you. Our next question comes from Rami Katkuda with Lifeside Capital. Your line is open.

Hey, guys. I wanted to pass along Mike and Gratz as well, and thanks for taking my questions. Two quick ones for me. First, did you see a difference in any key AEs like edema or hypertrictosis between the once-daily and twice-daily treatment arms? And then secondly, did you also see a meaningful improvement in hair width as well as kind of density and everything else?

Yeah, we pooled the data because we thought that, you know, that in these numbers there was not a clear difference between once daily and twice daily from a safety perspective. So, again, we were very encouraged by the tolerability profile on both those strengths. In terms of hair thickness, you know, we do look at hair, you know, at hair count and hair width. And, you know, while we didn't put specific measures into the presentation for this morning, we can tell you that we saw a robust increase in hair width as well as hair count. And I think that that is important because when you think about the determinant of hair coverage, hair coverage is determined by both hair count and hair width. And as a reminder, you know, hair width was a secondary endpoint in study 302 that we showed positive results on, you know, in both the once and twice daily groups.

Got it. Thank you.

Thank you. And our next question comes from Mayank Mamthani with B-Raleigh Securities. Your line is open. One moment, please. Mayank, your line is open.

Yes, can you hear me now?

Now we can hear you.

Okay, thanks for taking that question, and congrats. Very impressive result. So on the kinetics point read, you know, month two, you see a very fast onset. I was just curious on the beyond month 6, both count and PRO data, I don't know to the extent you have that. I was just wondering, is there a catch up to the mail efficacy that we've seen that you expect at a longer time point?

And I also ask from a compliance standpoint, maybe for Dr. Shapiro, you know, we see these varying ranges of compliance rates with current options, you know, some somewhere 80 percent others are like 30 40 percent what would you expect in the real world compliance with this profile to be longer term yeah so first i'll take the question about you know how we anticipate you know long-term uh results to look i think the short answer is at this point we don't have guiding data as to what happens over time what i will say is that there is one critical difference between females and males which is that females obviously typically have longer hair than their male counterparts. And, right, we can't give you shoulder length hair overnight. Your hair grows about a centimeter a month. And so as we think about the kinetics of outcomes, you know, obviously it takes time for people to get their hair to their desired hair length. If you think about someone like myself, maybe, you know, every couple of months I'm hitting kind of my terminal length for hair, but for someone with shoulder length hair, that's not the same. So I think that that'll be interesting from a patient perspective of improvement, investigator perspective of improvement over time. Dr. Shapiro, I guess based on this data, do you expect patients to adhere or be compliant with treatment? And are there any percentages you would think about about what percentage of patients you think would be willing to stay on this treatment in one year?

Oh, I think people will be very compliant if they're convinced that their hair is thicker, that there's less shedding, less scalp showing. People will be on it indefinitely. This is a lifelong treatment and people will be very compliant for it if they see it works. The problem with the topical minoxidil, for instance, it wasn't working as well. I mean, and there are other treatments that we use that don't work as well. This looks like it really works well. 90% of people seem to be very happy with it in this small study. And I've never seen a study that shows 90% of people be happy with something. So I think this is a huge, huge thing. And people will, I feel, will take it forever.

Thank you.

Thank you. I'm showing no further questions at this time. I'd like to turn the call back over to Reid Waldman for closing remarks.

Thank you, everyone, for spending your morning with us. Again, I think this is a tremendous day for female pattern hair loss, and that we believe this represents the first positive Phase II study for an oral treatment for female pattern hair loss in the U.S., and it gives us great conviction as we move towards study 306 data, the first ever registration-directed trial for an oral treatment for female pattern hair loss in the first half of 2027. Thank you all, and have a wonderful morning.

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