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Verrica Pharmaceuticals Announces Amendment to Collaboration and License Agreement with Torii Pharmaceutical to Launch Global Pivotal Phase 3 Clinical Trial to Study YCANTH® for the Treatment of Common Warts

Core Points - Verrica Pharmaceuticals is set to receive an $8 million milestone payment for the initiation of a global Phase 3 clinical trial for its product YCANTH, scheduled for July 2025, ahead of the previous timeline [1][3] - Common warts affect approximately 22 million patients in the United States, with no FDA-approved prescription therapies available, representing a significant multi-billion dollar market opportunity [1][2] - The company anticipates dosing the first patient in the Phase 3 trial in the United States in the fourth quarter of 2025 [1][9] - Verrica will retain global rights to YCANTH for all indications outside of Japan [1][2] Financial Aspects - The amended agreement with Torii Pharmaceutical includes a potential total of $18 million in new, non-dilutive capital for 2025, comprising the accelerated $8 million milestone payment and an additional $10 million upon approval for molluscum contagiosum in Japan [2][4] - Torii will cover the first $40 million of out-of-pocket costs for the global study, which constitutes approximately 90% of the current clinical budget [4][9] Product Information - YCANTH is a proprietary drug-device combination product containing a GMP-controlled formulation of cantharidin, approved by the FDA for treating molluscum contagiosum in patients aged two years and older [5][6] - The product is the first and only FDA-approved treatment for molluscum contagiosum, which affects around 6 million people in the U.S., primarily children [5][6] Strategic Partnerships - The collaboration with Torii has been described as extensive, optimizing the clinical program across Japan and the United States, creating strategic and financial synergies for both companies [2][9] - Verrica has also secured support from OrbiMed, which has assisted in restructuring the company and implementing a new commercial strategy for YCANTH [2]