Announcement • Jun 23
Verrica Pharmaceuticals Announces First U.S. Patient Dosed in Second Pivotal Clinical Trial (Cove-3) of Its Phase 3 Program Evaluating Ycanth (Vp-102) for Treatment of Common Warts Verrica Pharmaceuticals Inc. announced that the first U.S. patient was dosed in the second clinical trial (COVE-3) in its global Phase 3 program evaluating YCANTH (VP-102) for the treatment of common warts. Verrica’s Japanese development partner, Torii Pharmaceutical Co. Ltd., a wholly-owned subsidiary of Shionogi & Co. Ltd. announced that the first Japanese patient in the COVE-3 study was dosed last week. Verrica maintains ownership of global rights to YCANTH for all indications in all territories outside of Japan, including common warts. The Phase 3 program has been designed to include two double-blind, randomized, vehicle-controlled studies evaluating the efficacy and safety of VP-102/TO-208 when applied once every 21 days for a total of up to four applications in patients aged 2+ years with common warts. The COVE-2 study is enrolling patients in the U.S. only and the COVE-3 study is enrolling patients in the U.S. and Japan. Based on the results of the Phase 3 program, Verrica and Torii intend to seek marketing approval in the U.S. and Japan, respectively. In January 2026, Verrica announced that the first patient was dosed in the first clinical trial (COVE-2) of the global Phase 3 program evaluating YCANTH (VP-102) for the treatment of common warts. The initiation of the global Phase 3 program in common warts was based upon positive results from the Phase 2 COVE-1 clinical trial that evaluated YCANTH (VP-102) for the treatment of common warts. COVE-1 was an open label clinical trial that evaluated the safety and efficacy of VP-102 in two cohorts of subjects with up to six warts. The primary efficacy analysis was conducted at Day 84 with an additional period of follow-up through Day 147. Topline analysis included data from the assessment of warts at study visits over 12 weeks. Results showed that 51% of subjects (18 of 35) treated with VP-102 in Cohort 2 achieved complete clearance of all treatable warts at Day 84. Adverse events were primarily expected local cutaneous reactions with no SAEs observed. Torii will split the costs of the global Phase 3 program with Verrica on a 50/50 basis and will fund the first $40 million of trial costs, representing approximately 90% of the current trial budget, with Verrica’s portion expected to be paid out of future milestones/royalties arising from sales of YCANTH in Japan. With a prevalence of approximately 22 million patients in the U.S. alone and no FDA approved therapies, common warts represent one of the largest unmet needs in all of dermatology, which Verrica believes could represent a multibillion-dollar commercial opportunity. In the United States, approximately 50% of the patients who seek treatment for common warts are children. YCANTH is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin delivered via a single-use applicator that allows for precise topical dosing and targeted administration for the treatment of molluscum. YCANTH is the first and only healthcare professional-administered product approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. Approval of YCANTH was based upon the positive results from two Phase 3 clinical trials in approximately 500 patients which demonstrated that YCANTH was a safe and effective therapeutic for the treatment of molluscum. YCANTH is also approved for the treatment of molluscum contagiosum in Japan and is being studied in a global phase 3 program in the US and Japan for the treatment of common warts. Approximately 250 million lives are eligible to receive YCANTH covered by insurance. Commercially insured patients pay just $25 per YCANTH treatment visit, for up to two applicators. Other uninsured patients may be eligible to receive YCANTH at a reduced cost if certain eligibility requirements are met for patient assistance. Announcement • May 07
Verrica Pharmaceuticals Inc. Presents Phase 2 Data on VP-315 Demonstrating Potential Abscopal Effects in Basal Cell Carcinoma Verrica Pharmaceuticals Inc. announced the presentation of Phase 2 clinical data highlighting the potential abscopal effects of the Company’s novel oncolytic peptide, VP-315 (ruxotemitide), in the treatment of basal cell carcinoma (BCC) at the 2026 Society for Investigative Dermatology (SID) Annual Meeting, taking place from May 13-16, 2026, in Chicago, Illinois. Patients with BCC frequently present with multiple tumors, and approximately one-third will develop additional primary tumors over their lifetime, highlighting the need for therapies that address diseases such as BCC with multifocal potential. The poster, titled “VP-315 Demonstrates a Potential Abscopal Effect in Untreated Non-Target Basal Cell Carcinoma (BCC) Lesions” will be presented by Noah Rosenberg MD, Verrica’s Chief Medical Officer. Presentation Details: Poster Number: LB1190 Category: Non-Melanoma Cancers and UV Biology/Injury Poster Session Dates and Time: Friday, May 15, 2026 (4:30 pm – 6:00 pm) Location: (Salons B, C, D – Lower Level, Hilton Chicago) Key Findings: Background VP-315 (ruxotemitide) is a potential first-in-class oncolytic chemotherapeutic peptide immunotherapy administered directly into a tumor to induce immunogenic cell death and thereby unleashing a broad spectrum of tumor antigens for T-cell responses, which may offer a non-surgical option for patients suffering from skin cancer. Verrica holds an exclusive worldwide license to develop and commercialize VP-315 for certain dermatologic oncology indications, including non-metastatic melanoma and non-metastatic merkel cell carcinoma, and intends to focus initially on basal cell and squamous cell carcinomas as the lead indications for development. VP-315 has demonstrated positive tumor-specific immune cell responses in multi-indication Phase 1/2 oncology trials. Type of Study: Open-Label Phase II trial Methods Subjects received <</u>8 mg (in 0.5mL) intratumoral VP-315 injections in up to 2 treated lesions (TLs). Up to 3 non-treated lesions (NTLs) per subject were monitored over 12 weeks. Changes in NTL size were assessed histologically after excision on digital images in relation to tumor bed size, histologic subtype and NTL location relative to TLs. Results: 14 untreated NTLs in 9 subjects demonstrated an overall 67% reduction in lesion size following treatment of TLs. Reductions ranged from 50-100% (superficial) and 25-100% (nodular). Complete histologic clearance was observed in 21% of NTLs (3 /14). Reductions in tumor size were observed in all NTL locations including proximal, distal and contralateral to TLs. No skip lesions were observed. Non-serious local skin reactions were reported in 1 NTL. Conclusions The therapeutic effects of VP-315 extended beyond treated lesions. Reductions in untreated NTLs suggest a potential abscopal effect consistent with broader immune activation within the tumor microenvironment of remote NTLs. Announcement • May 05
Verrica Pharmaceuticals Inc. to Report Q1, 2026 Results on May 12, 2026 Verrica Pharmaceuticals Inc. announced that they will report Q1, 2026 results on May 12, 2026