Verrica Pharmaceuticals Announces Amendment to Company’s Collaboration and License Agreement with Torii Pharmaceutical Co. Ltd. to Fund Global Pivotal Phase 3 Clinical Trial to Study YCANTH for the Treatment of Common Warts

Global pivotal Phase 3 clinical trial would be conducted jointly by Verrica and Torii Pharmaceutical; trial expected to begin in the 1^st half of 2025

Amendment should benefit both parties from a cost and time to market standpoint; funding structure is expected to have a minimal impact on Verrica’s cash position

Common warts is one of the largest and most underserved patient populations in medical dermatology with a prevalence of ~22M in the U.S. and no FDA approved products; Verrica believes common warts represents a multibillion-dollar commercial opportunity; patient opportunity for common warts in the E.U. is believed to be at least equivalent to the U.S.

WEST CHESTER, Pa., May 15, 2024 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica” or “the Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that it has entered into an amendment to its existing licensing agreement with Torii Pharmaceutical Co. Ltd. (Torii), to jointly conduct a global pivotal Phase 3 clinical trial of YCANTH for the treatment of common warts.

“We are pleased to announce this significant amendment to our license agreement with Torii Pharmaceutical to advance YCANTH into a global pivotal Phase 3 clinical trial for the treatment of common warts,” said Ted White, President and Chief Executive Officer of Verrica Pharmaceuticals. “Torii has been an outstanding partner in the development of YCANTH for molluscum contagiosum, and we look forward to our continued collaboration to progress YCANTH through a pivotal global Phase 3 clinical trial for common warts, which represents the single largest and most underserved patient population in all of dermatology. If positive, the data from this global Phase 3 clinical trial would not only potentially allow Verrica to submit a sNDA in the U.S. seeking FDA approval for the use of YCANTH for the treatment of common warts, but may also be utilized by Verrica to seek future marketing authorizations in territories outside the U.S. and Japan, including potentially within the European Union.”

In March 2021, Verrica and Torii Pharmaceutical entered into an agreement granting Torii an exclusive license to develop and commercialize Verrica’s product candidates for the treatment of molluscum contagiosum and common warts in Japan, including YCANTH (TO-208 in Japan). The terms of the amendment would enable the two parties to equally split the cost of the global Phase 3 clinical trial in common warts, with Torii funding Verrica’s portion of the costs as an offset to Torii’s future payment obligations to Verrica based on regulatory milestones and sales of YCANTH for molluscum contagiosum and common warts in Japan. In addition, Torii would make a milestone payment of $8 million to Verrica upon the first patient dosed in Japan in the Phase 3 clinical trial. Initiation of the global study remains subject to feedback from the U.S. FDA and Japan’s Pharmaceuticals and Medical Device Agency (PMDA) on the proposed design of the Phase 3 clinical trial.