Veradermics, Incorporated Citigroup’s Biopharma Back to School Summit 2026

I'm Reid Waldman. I'm co-founder and CEO of Veradermics. By background, I'm a board-certified dermatologist, and prior to founding the company, I spent most of my time in clinical research. Very excited to talk to you today about what's coming in the second half of 2026 at Veradermics. Here's our disclosure slide that governs forward-looking statements as we move ahead. I think as you all know, we're talking about pattern hair loss or androgenetic alopecia. Pattern hair loss is the single most prevalent chronic dermatologic condition, affecting 80 million people in the U.S. That's 50 million males, 30 million females, and it transcends being aesthetic. It's deeply personal, it's deeply psychological, and it's essentially universal. Even with that, it has been 30 years since we've had a new oral treatment for males, and we have never had an oral treatment FDA-approved for female pattern hair loss.

We are developing VDPHL01, the first minoxidil extended release tablet. The premise is very straightforward. Minoxidil is validated biology for the treatment of hair loss and that it's approved in its topical format for both male and female pattern hair loss. It's also used off-label in its oral format, but that oral drug is a blood pressure medication. The challenge with it is it does exactly what you would expect a blood pressure medication to do when you take it. It spikes quickly in the plasma. The majority is gone within 2 hours. Almost all of it's gone within 4 hours. The question at Veradermics is why is the best tool in the dermatologist's toolkit a 40-year-old blood pressure medication that no one's revisited?

As we look at the pharmacokinetics of minoxidil, we identified that there is a 10X difference between the plasma concentration at which minoxidil grows hair and the plasma concentration at which it has cardiac effects. Had the premise that if you could provide consistent and durable exposures to the drug throughout the day between those levels, that you could drive hair growth while minimizing cardiac risk. In addition to enabling the delivery of more minoxidil for longer, we believe we can drive the bioactivation of minoxidil to minoxidil sulfate. Many people don't realize this, but minoxidil itself does not do anything to the hair, its sulfate metabolite does. Minoxidil's converted to that sulfate metabolite within the outer root sheath of the hair itself via the SULT1A1 enzyme.

That enzyme is capacity limited, meaning it can saturate with spikes in concentration, and it's time dependent, meaning it takes time to convert the minoxidil to its sulfate metabolite. When you think back to those spikes that we see with the immediate release blood pressure medication minoxidil, they can overwhelm or saturate that enzyme, and they're not around for very long. Whereas if you can provide consistent and durable exposures of minoxidil throughout the day, you can potentially drive the bioactivation of the drug and drive hair growth. All in, our goal here is to raise the hair growth ceiling by giving more minoxidil for longer throughout the day to improve tolerability and increased exposures, meaning we give more minoxidil than would otherwise be considered, but we believe we can do it safely by blunting the peaks that are responsible for cardiac effects.

This is an inherently non-hormonal treatment, so we don't expect adverse events like erectile dysfunction or decreased libido. It's an oral treatment, which is what research tells us is preferred by both patients and their physicians. Finally, we've generated a host of phase II/III data in males and phase II data in females that we believe supports a potential best in indication profile in both male and female pattern hair loss.

Specifically, that's a profile that is fast with visible results as early as 2 months, that shows a consistent treatment effect with up to 86% of individuals showing an improvement in their hair coverage after 6 months of treatment that is intense and robust with objective and quantifiable changes in hair count that are out of proportion to those seen with other therapies while maintaining strong tolerabilities with placebo-like overall AE rates and placebo-like, AE-related discontinuation rates while maintaining the convenience of oral administration and the potential to be the first ever FDA-approved oral treatment for both male and female pattern hair loss. As mentioned, we currently have three ongoing registration-directed trials, two in males, one in females, and each of these has upcoming data. In the second half of this year, we will see long-term extension data come from 302 Part B.

We will see confirmatory 6-month data come from Study 304. In the first half of next year, we will see data from Study 306, a registration-directed trial in female pattern hair loss. We're going to start by talking about what is coming later this year. As mentioned, there are two studies in male pattern hair loss that will read out data in the second half. The first of those is Study 304. Study 304 is intended to provide confirmatory evidence of efficacy in male pattern hair loss. It is intended to be the final placebo-controlled efficacy data that is generated for the asset in male pattern hair loss. It's intended to double the size of the safety database to get us over 300 exposures per dose regimen at 6 months. All in, this is meant to show us reproduction independently of a commercially viable profile.

In contrast, Study 302B is a long-term extension study. The primary reason that we run this extension study is to try and understand what happens with chronic administration safety. I think, as you all can imagine, if all goes according to plan, millions of people will take this drug for years at a time. In this study, we're trying to answer the question of are there emerging signals from a safety perspective that come up between 6 and 12 months of treatment that could not otherwise be detected in the first 6 months of treatment? Additionally, patients who are on active stay on active for 12 months of dosing, and patients that are on placebo cross over from placebo to active, getting us incremental efficacy data. We're going to go into greater detail on Study 304.

Now, as a reminder, Study 304 is a phase III registration-directed trial on male pattern hair loss that enrolled 536 subjects at 44 sites. Those sites are non-overlapping with the sites that participated in Study 302, and we are looking at a male population that is aged 18 to 65 in age. From a study design perspective, the major question that we get is how similar is this design to Study 302. We believe it to be a markedly similar study from an I&E perspective, a study procedure perspective, with identical endpoints. Put differently, in this study, we are asking the same questions in the same way that we did in Study 302.

In the second half of this year, we will look at data from Part A, which is a six-month placebo-controlled period in which patients were randomized to either receive VDPHL01 8.5 milligrams BID, QD, or placebo. Again, we will talk about the co-primary efficacy endpoints in detail on the next slide, but these are the same endpoints that were studied in 302. Specifically, we are looking at target area hair count and patient-reported outcome. The target area hair count is a way of asking how many hairs are there in a given square centimeter that are greater than 30 microns, or what we call non-vellus hairs. We measure this in a very specific, quantifiable way. We tattoo the scalp so we know that we are in the same spot every single time.

We clip the hair so we can visualize all the hairs in the area. We take a close-up standardized photograph. That photograph gets transmitted to the vendor that has done every approval in this space since 1997, and they have a validated digital image analysis algorithm that does three things. It makes sure that we are in the exact same spot, or it lines up the follicles, because in the same way you have a thumbprint, you have a hair print. It measures the width of the hairs to tell us which ones are greater than 30 microns, or what we call non-vellus hairs, and then it counts those hairs. That then goes for a two-human quality assurance review to give us an ultimate count on the non-vellus hair count. In this endpoint, we are looking at change over baseline in active versus placebo.

The second co-primary endpoint is the patient-reported outcome, and the patient-reported outcome, or what we call the subject's evaluation of hair coverage change, is where the subject looks at standardized photographs of themselves at baseline and at their follow-up visit, and they grade their hair coverage on a seven-point scale from much worse to much improved. If they identify as being improved or much improved, they are considered a responder, and we do a responder analysis. Again, the goals of Study 304 are threefold. One, we are trying to provide confirmatory evidence of efficacy in the study to what was shown in Study 302. Two, we are trying to double the size of the safety database to get over 300 exposures at six months in each of the treatment arms.

We are trying to replicate our phase III target profile or that commercial viability profile that we laid out prior to the initiation of Study 302. As a reminder, prior to the initiation of Study 302, we had laid out a commercially viable target profile that was based on robust quantitative research that we had conducted in both patients and physicians. In essence, the profile that we had tested was based on historic precedent, where we had asked these patients and physicians their feelings on an FDA-approved oral agent with an efficacy profile that looks similar to ROGAINE foam. We saw a robust degree of enthusiasm from both patients and physicians, and their willingness to use and willingness to prescribe, respectively.

We believe that independently replicating this commercially viable profile in Study 302 would be highly valuable in terms of entrenching the commercially viable profile in male pattern hair loss. Prior to Study 302, we also helped characterize what safety looks like today with off-label use of immediate-release oral minoxidil. Shown here, we pulled data from one of the only studies that actively assessed safety outcomes with off-label use of immediate-release oral minoxidil, and it found that the six events shown on the right side of this slide occur in more than 5% of subjects on a treatment emergent basis. Those events are headache, edema, hypertrichosis, shedding, dizziness, lightheadedness, syncope, and palpitations. We are also aware of more significant risks that can be seen with off-label use that are shown on the left.