Founder Spotlight: Dr. Reid Waldman

Amy Hourigan: Great to talk with you again, Reid. Last time we spoke, you were filing an IND [Investigational New Drug] application for your wart product—a dissolvable patch that releases the active ingredient right into the skin. Can you tell us where that stands?  

Dr. Reid Waldman: Right! Our product is currently being tested as a treatment for common warts in a phase II study; we’re actively dosing the initial cohort of 60 subjects, with a plan to dose 150 subjects total in this study.

AH: How long until the product is available?

RW: We are targeting filing the BLA in early 2027. [A biologic licensing application, or BLA, is a request for the FDA to approve a given product—ed.] Then there’s a review period prior to the approval. Our goal is to finish the phase II program in 2024 so we can initiate the phase III program in early 2025 and complete the phase III program in 2026.

AH: How will the product change the way we treat warts? 

RW: You may remember that no FDA-approved prescription treatment exists for common warts, even though warts are one of the most common reasons people seek treatment for skin conditions in this country. The tools we dermatologists have, like liquid nitrogen, are painful and not particularly effective, while over-the-counter treatments require daily applications for months at a time, which is too burdensome for most people. We are aiming to become the first at-home prescription treatment for common warts and believe that a patient-friendly treatment for warts would address a major therapeutic challenge faced by dermatologists and their patients.

AH: Sounds great! Do you have any other products in development?

RW: We do. We founded the company with the idea that there are thousands of skin conditions, many of which we see on almost a daily basis, that have seen very limited innovation when it comes to treatment. My team and I set out to identify therapeutics that would address real challenges in dermatology—persistent conditions with little to no treatment options available.

AH: Can you talk about the other assets in your pipeline?

RH: Sure. There are five. Besides the wart product, we’ve got a candidate to treat pattern hair loss in men and women; one for alopecia areata, which is an autoimmune form of hair loss; another for atopic dermatitis, or eczema, and one for molluscum contagiosum, which is a viral skin infection that mainly affects toddlers.

AH: I’ve read about that one. The pictures are distressing.

RW: Right. People who have had kids with the infection hated going through it. There are 6 million kids who get it in the U.S. alone each year, and those cases result in about a million office visits, yet there are no antivirals approved for treatment.

AH: How is molluscum contagiosum treated today?

RW: The current approved therapeutic is blister beetle juice—medicine derived from the blister beetle. It’s existed for a long, long time, and the goal is to cause little blisters on the skin that destroy the molluscum. As you might imagine, putting lots of blisters on a toddler scares the parents and the toddler. It’s not a great therapeutic paradigm. By contrast, we’re creating a topical antiviral gel—the first specific antiviral for molluscum. We’re excited for that to enter clinical trials in early 2024.

AH: You’re a board-certified dermatologist, and I heard that you’re in the top 5 percent of the most cited physicians in America, but your background is in clinical research, correct?

RW: Yes. Prior to founding Veradermics, I was a clinical trial investigator on multiple phase II and phase III studies. Some of the products that were in development back then are now major approved products. I have more than 100 publications, and I authored a textbook, Dermatology for the Primary Care Provider, that I’m really proud of. It’s a reference for busy physicians that covers the diagnosis and management of common dermatologic conditions.

AH: Can you tell us a little bit more about your corporate strategy?

RW: Sure. There are a few elements to our strategy. The first is that we’re addressing large market opportunities within dermatology. They’re worldwide, but even within the U.S., they’re big. We have two assets that a third-party analyst estimated will do greater than $1.5 billion a year in net sales, and we have a third asset that hovers near a billion dollars in net sales. We’re seeing great market opportunities and have very near-term value catalysts as a company. We have two readouts that we’re anticipating later this year, and we anticipate initiating our third clinical program this year. In fact, we’re hoping to get all our programs into the clinic by this time next year. Finally, as we talked about, we’re doing all of this in a differentiated manner. As founders who are also clinicians, we can use our end-user knowledge to identify therapeutic areas of opportunity.

AH: Are you anticipating making these therapies available outside the U.S.?

RW: Yes. We develop our therapeutics with a conscious understanding of, and by addressing, regulatory needs elsewhere. For example, the European Medicines Agency, or EMA, which is the agency in Europe responsible for the scientific evaluation, supervision and safety monitoring of medicines there, has certain regulations that differ from those in the U.S. Even in our earlier programs, our team made sure we were considering worldwide regulatory elements.

AH: Investors prioritize strong management teams. When you and I last talked, one of your bigger challenges was assembling the right team. Can you talk about your progress there?

RW: The team grows day by day. We have people with tremendous dermatologic backgrounds, which is great, but we’ve expanded to bring on key subject matter experts as well. These include our vice president of product development, Michael Smolinski, who was previously in charge of preclinical development for the approval of Klisyri, which is a treatment for actinic keratosis and one of three novel topical products that has been approved since 2020. We also brought on a vice president of finance, Dominic Carrano, who has a long track record of success in biotech and is highly regarded in the industry. So, yes, we’re balancing our strong existing outsourced network with clearly rationalized in-sourcing of certain roles.

AH: What else is Veradermics doing differently?

RW: A lot of the current focus in dermatology is on inflammation, immunology and related conditions. We’ve seen many trends where a target is identified—for example, janus kinase, a family of non-receptor proteins vital to our immune cells—and then lots of people race to develop a best-in-class therapeutic for that target. While these efforts have benefited the specialty tremendously, our approach is different. We go after markets for which we believe there is a prevailing need, the competitive landscape is knowable, and where we can develop therapeutics that will address the challenge presented by the condition.

Our portfolio model is also unique. If you look in recent years, there are few, if any, portfolio medical dermatology companies that have a diverse array of product candidates addressing under-innovated markets. We’re diverse not only by having five different chemical entities under development, but also by having different routes of administration, including semisolid topical products, oral products and a dissolvable microarray. There’s a great deal of diversity, which, for a prospective investor, mitigates risk substantially.

One of the things I really like about what we’re doing is that when I meet with prospective investors and vendors, many of the conditions we’re addressing are common enough that people connect with them. For example, the first time I was talking to our commercialization team about hair loss, they looked around the room at all the people who were missing some hair. It made them say, “We think people will pay for this product.” Or they know someone in their family with the condition. Or maybe they watch the NFL and see that the starting quarterback for the Arizona Cardinals is raising awareness about alopecia areata because he has it, as does one of the team’s cheerleaders. These conditions are coming to society’s attention, and there is tremendous opportunity because no one has capitalized on it by addressing the conditions’ true therapeutic challenges.

Oh—another example that comes to mind is nail fungus. There’s an approved topical product to treat it, but you need to apply it every day for about a year to see results. That’s crazy, and it’s not even particularly effective, but it does almost $300 million in net sales in the U.S. It highlights the importance of these markets: These conditions are bothersome to people.

AH: What’s next for the company?

RW: Hair loss is one of the most prevalent skin conditions: 80 million Americans experience it, and of those, 12.4 million seek treatment each year. We think it’s an exciting area for development and believe that a safe oral therapeutic could be revolutionary for that category. The biggest thing for us right now, though, is that we have assets in clinical development, as well as additional assets that we anticipate will be in clinical development very soon.

The most exciting part about what we do is getting to see, after all the work and research, whether these treatments work. The clinical trial is the arbiter of truth, so we’re very excited to advance the products that we have in clinical development and see the readouts.

AH: This all sounds very exciting, Reid. Thanks for the update!

RW: My pleasure.