WEST CHESTER, PA — Verrica Pharmaceuticals Inc. (Nasdaq: VRCA) has announced an amended collaboration and licensing agreement with Torii Pharmaceutical Co. Ltd. to initiate a global Phase 3 clinical trial for YCANTH®, targeting the treatment of common warts. The trial represents a significant milestone as there are currently no FDA-approved prescription therapies available for this condition, which affects an estimated 22 million patients in the United States alone.
Under the revised agreement, Verrica will receive an accelerated $8 million milestone payment in July 2025 for the trial’s initiation, ahead of the first patient being dosed later this year. Torii will also fund the first $40 million of the trial’s costs, covering approximately 90% of its current clinical budget. Additionally, Torii will provide another $10 million milestone payment upon the approval of YCANTH (TO-208) for molluscum contagiosum in Japan, an approval decision anticipated by the end of 2025.
“We are extremely excited to begin our global Phase 3 program in common warts, which has the potential to transform our company by expanding YCANTH’s label to one of the most prevalent skin conditions,” said Jayson Rieger, PhD, MBA, President and CEO of Verrica Pharmaceuticals. Rieger highlighted the strategic benefits of the agreement, stating, “This amendment reflects our extensive collaboration with Torii as we have together worked with regulatory authorities to optimize the clinical program across Japan and the United States, creating strategic, development and financial synergies for both companies.”
The initiation of the global Phase 3 trial is a pivotal step for Verrica, aiming to address the unmet medical needs of millions with common warts. This multi-billion dollar market remains underserved despite the high prevalence of the condition. With an expected first patient dosing date in the U.S. set for the fourth quarter of 2025, Verrica is positioning itself as a leader in dermatological treatments through innovative solutions like YCANTH.
“As part of the amended agreement, Verrica has now finalized a path to receive up to $18 million in new, non-dilutive capital in 2025,” added Rieger. “This includes an accelerated $8 million milestone payment from Torii to be paid in July 2025 and, if Torii obtains approval for molluscum contagiosum in Japan, which we expect to occur as early as the end of 2025, an additional milestone payment of $10 million in cash. Importantly, Verrica will also maintain its ownership of global rights to YCANTH for all indications in all territories outside of Japan.”
The amendments also set the stage for a manufacturing transfer of YCANTH applicators to Torii for supply to the Japanese market, ensuring a long-term collaboration between the two companies. This strategic partnership, alongside Verrica’s continued efforts to expand YCANTH’s commercial reach, underscores the company’s commitment to innovation in dermatological care.
With strengthened financial flexibility and support from Torii and lending partner OrbiMed, Verrica is preparing to drive the growth of YCANTH while expanding its label to include a broader range of skin conditions. “The added flexibility and non-dilutive cash resources from the amended agreements with Torii and OrbiMed place us in a far stronger position to continue executing on our YCANTH commercial strategy and moving forward with our label expansion efforts,” said Rieger.
By addressing the unmet needs of patients affected by common warts, Verrica aims to redefine the dermatological treatment landscape with YCANTH, marking a significant step forward for the company and the field at large.
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