Verrica Pharmaceuticals Inc. Common StockVRCA
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Verrica Pharmaceuticals Inc. Common Stock H.C. Wainwright 28th Annual Global Investment Conference

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Jade MontgomeryAssociate Research Analyst

Good afternoon, everyone, and thank you for joining the 2026 H.C. Wainwright 28th Annual Global Investment Conference. My name is Dr. Jade Montgomery, an associate research analyst at H.C. Wainwright, and I'm happy today to introduce our presenter for this session, Dr. Jayson Rieger, CEO of Verrica Pharmaceuticals.

Jayson RiegerCEO

Jason? Thank you very much.

Jayson RiegerCEO

Thank you all for attending here today, and it's certainly an exciting time at Verrica. We've made much progress over the last few years since I took over as CEO, and I really look forward today to sharing some of the highlights of what we've accomplished. As an overview, Verrica is a therapeutics development company working on commercializing and developing medications for the treatment of dermatologic diseases, including skin cancers. Let me start with a quick snapshot of what is Verrica and what is in our pipeline, and what we are trying to accomplish. First, we have a commercially available asset in YCANTH, available in the U.S. and in Japan for the treatment of molluscum contagiosum. I'll share a little more details on molluscum, but it affects about 6 million patients in the U.S. each year, and mostly children.

Jayson RiegerCEO

We are working on a label expansion opportunity with YCANTH for the expansion into common warts. We have an ongoing global phase III program in collaboration with our Japanese partner, Shionogi, and I'll give updates on where that program is and the rapid progress we're making in the enrollment of those studies. We have a phase III-ready oncology program for basal cell carcinoma with our molecule VP-315, a small molecule peptide. This molecule is injected right into the lesions, and the intent is to mitigate the need or reduce any surgical needs for removing a basal cell. We've made exciting progress with the FDA, with regulatory feedback clarifying what is needed for phase III, and I'll highlight more details on that as well.

Jayson RiegerCEO

Lastly, as we look into the next 6-12 months, there are multiple key inflection points for the company, particularly around the phase III data for our common wart program, with top-line data expected for our phase III trials in Q1 for the first trial for COVE-2, and by mid-2027 for COVE-3. As you think about Verrica, it's important to think about YCANTH, a molecule as one platform with two large potential indications. The first one is molluscum contagiosum, the foundation of our commercial business at this time. YCANTH is the first FDA-approved HCP administered product for the treatment of molluscum contagiosum. Since commercial launch, we've administered about 120,000 applicators that have been dispensed. We've seen very meaningful increases in revenue and volume in 2025 over 2024, and continue to see growth as we begin 2026.

Jayson RiegerCEO

The product was approved in Japan late last year and launched earlier this year, and that partner, Shionogi, is handling that commercialization. Importantly, as we think about global expansion, YCANTH, we have approached the European Medicines Agency and reached alignment on no additional phase III trials required for registration, and we are working through the process to prepare for a regulatory filing in Europe. When it comes to expanding the population and the opportunity for YCANTH, we think about common warts. That trial has started last year and continued this year. There are 22 million patients affected by common warts each year, many who seek treatment and are frustrated with available therapies, but there are no FDA-approved therapies for the treatment of it. Relative to molluscum, it is three to four times larger in terms of the addressable population.

Jayson RiegerCEO

This makes common warts one of the largest unmet needs in dermatology and a potential billion-dollar market just in the U.S. The global phase III trials that we are conducting are with our partner, Torii Pharmaceutical, now Shionogi, and the arrangement we have made with them is they are going to provide the first $40 million of funding towards the conduct of that phase III program, which we expect to be about 90% of the cost. We will split those costs over time, 50/50 with them, with them fronting the cash part of the trials as it began. We plan to repay that out of future milestones and royalties in Japan, so it should have a minimal impact on our balance sheet if things go well.

Jayson RiegerCEO

Lastly, even though we set this program up with Shionogi, we still own the global rights to the market for YCANTH for both common warts and molluscum outside of Japan. A recent announcement we did with the licensing in Israel with a company called Medomie. As we think through our commercial business and what can happen, we are building the foundation of the company with the commercial effort in molluscum, targeting predominantly pediatricians and dermatologists. Many of those same patients are afflicted with common warts, and so our call points will have significant overlap and synergy. The drug device combination product is the same for both indications, so that also facilitates all of our commercial distribution, and pharmacy networks for the distribution of common warts indication if it is approved.

Jayson RiegerCEO

The phase III design is leveraged off of phase II data we conducted, and I will share some data with you later in the presentation, but where we saw almost 50% complete clearance of all the warts these patients had. Lastly, for the phase III programs that are ongoing, we conducted an interim powering promising zone analysis for that study just a few weeks ago, which confirmed that no additional patients are recommended for inclusion in that study. So we expect to read out that study in Q1 of next year with the second trial reading out in mid-year. Our second program in our pipeline is VP-315 for basal cell carcinoma. We believe it is one of the most compelling opportunities in late-stage oncology that is for unmet needs today.

Jayson RiegerCEO

The Phase III asset is ready, it's innovative, and the goal is to provide a non-surgical alternative to the treatment of non-malignant skin cancer, where most patients would prefer not to have surgery if there's an option. I'll share some recent survey data on that shortly. Importantly, oncology, as many of you are familiar, there's usually a wide variety of patient response rates. In our case, 97% overall objective response rate was observed in the study, meaning nearly every patient saw a reduction in the size of the lesions by at least 30%, on average across the entire study, about 86% reduction in lesions, with some patients of over 50 achieving complete clearance histologically of those lesions.

Jayson RiegerCEO

We've met with the FDA, and they have indicated an alignment on two Phase III trials, 100 patients each against placebo as the control, with a 12-week primary endpoint and all long-term follow-up studies, post-approval. That gives us a very expedited and efficient pathway towards approval, should the primary endpoint be met, and importantly brings a cost of a trial to tens of millions, not hundreds of millions, like traditional oncology programs, and likely timelines measured in quarters, not in years or longer. As you think about this, basal cell carcinoma, while often met and addressed with surgical alternatives, provides a very large addressable market. 3.6 million patients are affected by BCC each year, so very large addressable opportunity. Additionally, the molecule could be also relevant for squamous cell and other non-metastatic skin cancers. In summary, here's our pipeline. Commercial assets for YCANTH, for molluscum, that's already approved.

Jayson RiegerCEO

Common warts in Phase III with our first trial, 100% fully enrolled, and the second trial exceeding 50% enrollment. Some of those patients are also in Japan, so we will be pursuing a joint PMDA, FDA submission and approval with our partner. Then the basal cell carcinoma program that we just discussed. Importantly, YCANTH and VP-315 both have IP runways that could extend to mid-2030s or early 2040s, and we're working very hard to advance both these programs. For the BCC program, we are currently manufacturing clinical supplies and working with CROs to identify to be Phase III ready to start as early as next year. Obviously, we have a great team. I'm happy to share all the pictures here. More importantly, our team is entrepreneurial-minded. We're thinking about how to build a company, grow a company, and execute.

Jayson RiegerCEO

The team brings tremendous experience across dermatology, development, oncology, et cetera, with a mindset towards execution and product development. So, some brief background for everyone on molluscum. Molluscum is a pox virus. Think about chicken pox that you had when you were a child, but instead of going away in a week or two, it goes away in 12 to 18 months or perhaps longer. So, it affects children for a long period of time. The average is about 13 months. It can lead to social anxieties, challenges, et cetera, for these children, and most parents now would rather have it go away versus being told it'll go away on its own over 12 to 18 months. YCANTH is shown here, you can see the picture. The applicator contains a purple solution contained within a glass ampoule that keeps it stable for up to two years.

Jayson RiegerCEO

The applicator is broken, the ampoule is broken, and the drug is applied right on the lesions by the HCP or any medical professional in the office. The patient would come in, and often in about a 5 to a 10-minute visit, have all the lesions treated. Small amount of drug goes on, and those lesions are typically destroyed pretty quickly. It also helps to stimulate the immune system, which often the virus will hide from, and it's why it lasts so long. The lesions tend to incubate 2 to 3 weeks in your skin, which is why often several treatments can be required. But we're seeing on average, most patients are in the two-treatment range to significantly address their disease. Importantly, the molecule demonstrated significant safety in the clinical trials that were conducted. Adverse events were as what you expect for a local vasoconstrictant.

Jayson RiegerCEO

Majority were mild to moderate, and we had no serious adverse events reported in our clinical studies. Recently, we just announced some additional data to sort of help patients and clinicians decide on treatment modalities. What we saw was some patients can present with the disease for obviously 18 months or longer. So was there a real difference in the clearance rate for those patients? What we saw was meaningful numbers of patients cleared and statistically significantly more than placebo, whether you had the disease for 12 months or less, or much longer than that period of time. It's really important because some therapies will be applied and the patient's already on their way to clearance, so it just helps finish it. In our case, early on, these patients really would struggle, and the drug seems to work really well.

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