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
Verrica Pharmaceuticals (Nasdaq: VRCA) has announced a significant amendment to its Collaboration and License Agreement with Torii Pharmaceutical for launching a global Phase 3 clinical trial of YCANTH® to treat common warts. The company will receive an $8 million milestone payment in July 2025 for initiating the study, and an additional $10 million milestone payment upon YCANTH's approval for molluscum contagiosum in Japan, expected by end of 2025.
The agreement includes Torii funding the first $40 million of out-of-pocket costs for the global study, covering approximately 90% of the current clinical budget. The study targets common warts, which affects 22 million patients in the United States alone, with no current FDA-approved prescription therapies. Verrica plans to dose the first patient in the U.S. Phase 3 trial in Q4 2025.
Under the amended agreement, Verrica maintains ownership of global rights to YCANTH for all indications outside Japan. The companies will split the Phase 3 program costs 50/50, with Verrica repaying its portion through offsets against future royalties and transfer price payments from Torii. Additionally, Verrica will initiate a manufacturing transfer to Torii for YCANTH applicators for the Japanese market.
Verrica Pharmaceuticals (Nasdaq: VRCA) ha annunciato una modifica significativa al suo Accordo di Collaborazione e Licenza con Torii Pharmaceutical per l'avvio di uno studio clinico globale di Fase 3 su YCANTH® per il trattamento delle verruche comuni. L'azienda riceverà un pagamento milestone di 8 milioni di dollari a luglio 2025 per l'inizio dello studio e un ulteriore pagamento milestone di 10 milioni di dollari al momento dell'approvazione di YCANTH per il mollusco contagioso in Giappone, prevista entro la fine del 2025.
L'accordo prevede che Torii finanzi i primi 40 milioni di dollari delle spese sostenute per lo studio globale, coprendo circa il 90% del budget clinico attuale. Lo studio è rivolto alle verruche comuni, che colpiscono 22 milioni di pazienti solo negli Stati Uniti, e per le quali non esistono terapie prescritte approvate dalla FDA. Verrica prevede di somministrare la prima dose al paziente negli Stati Uniti nella Fase 3 nel quarto trimestre del 2025.
Secondo il nuovo accordo, Verrica mantiene i diritti globali su YCANTH per tutte le indicazioni al di fuori del Giappone. Le due aziende divideranno i costi del programma di Fase 3 al 50%, con Verrica che rimborserà la sua quota tramite compensazioni sulle future royalty e pagamenti di prezzo di trasferimento da parte di Torii. Inoltre, Verrica avvierà il trasferimento della produzione degli applicatori di YCANTH a Torii per il mercato giapponese.
Verrica Pharmaceuticals (Nasdaq: VRCA) ha anunciado una enmienda significativa a su Acuerdo de Colaboración y Licencia con Torii Pharmaceutical para lanzar un ensayo clínico global de Fase 3 de YCANTH® para tratar verrugas comunes. La compañía recibirá un pago por hitos de 8 millones de dólares en julio de 2025 por iniciar el estudio, y un pago adicional de 10 millones de dólares al aprobarse YCANTH para molusco contagioso en Japón, esperado para finales de 2025.
El acuerdo incluye que Torii financie los primeros 40 millones de dólares de costos directos del estudio global, cubriendo aproximadamente el 90% del presupuesto clínico actual. El estudio se enfoca en verrugas comunes, que afectan a 22 millones de pacientes solo en Estados Unidos, sin terapias prescritas aprobadas por la FDA. Verrica planea administrar la primera dosis en el ensayo de Fase 3 en EE.UU. en el cuarto trimestre de 2025.
Bajo el acuerdo enmendado, Verrica mantiene los derechos globales de YCANTH para todas las indicaciones fuera de Japón. Las compañías dividirán los costos del programa de Fase 3 al 50/50, con Verrica reembolsando su parte mediante compensaciones contra futuras regalías y pagos de precio de transferencia de Torii. Además, Verrica iniciará la transferencia de fabricación a Torii para los aplicadores de YCANTH destinados al mercado japonés.
Verrica Pharmaceuticals (나스닥: VRCA)는 일반 사마귀 치료를 위한 YCANTH®의 글로벌 3상 임상 시험 개시를 위해 Torii Pharmaceutical과의 협력 및 라이선스 계약을 중대한 수정했다고 발표했습니다. 회사는 2025년 7월 연구 시작에 대해 800만 달러의 마일스톤 지급을 받고, 2025년 말까지 예상되는 일본에서의 몰루스쿰 전염증에 대한 YCANTH 승인 시 추가로 1000만 달러의 마일스톤 지급을 받게 됩니다.
계약에 따르면 Torii는 글로벌 연구를 위한 초기 4000만 달러의 직접 비용을 부담하며, 이는 현재 임상 예산의 약 90%를 차지합니다. 연구 대상은 미국 내 2200만 명의 환자가 있는 일반 사마귀로, FDA 승인 처방 치료제가 없습니다. Verrica는 2025년 4분기에 미국에서 3상 시험 첫 환자 투여를 계획하고 있습니다.
수정된 계약에 따라 Verrica는 일본 외 모든 적응증에 대한 YCANTH의 글로벌 권리를 유지합니다. 양사는 3상 프로그램 비용을 50대 50으로 분담하며, Verrica는 Torii로부터의 미래 로열티 및 이전 가격 지불을 통해 자신의 몫을 상환합니다. 또한 Verrica는 일본 시장용 YCANTH 적용기 제조 이전을 Torii에 시작할 예정입니다.
Verrica Pharmaceuticals (Nasdaq : VRCA) a annoncé une modification importante de son accord de collaboration et de licence avec Torii Pharmaceutical pour lancer un essai clinique mondial de phase 3 de YCANTH® destiné au traitement des verrues communes. La société recevra un paiement d'étape de 8 millions de dollars en juillet 2025 pour le démarrage de l'étude, ainsi qu'un paiement d'étape supplémentaire de 10 millions de dollars à l'approbation de YCANTH pour le molluscum contagiosum au Japon, prévue d'ici fin 2025.
L'accord prévoit que Torii finance les premiers 40 millions de dollars des coûts directs de l'étude mondiale, couvrant environ 90 % du budget clinique actuel. L'étude cible les verrues communes, qui touchent 22 millions de patients rien qu'aux États-Unis, sans thérapies prescrites approuvées par la FDA à ce jour. Verrica prévoit d'administrer la première dose au patient lors de l'essai de phase 3 aux États-Unis au quatrième trimestre 2025.
Selon l'accord modifié, Verrica conserve les droits mondiaux sur YCANTH pour toutes les indications en dehors du Japon. Les entreprises partageront les coûts du programme de phase 3 à parts égales, Verrica remboursant sa part par compensation sur les futures redevances et paiements de prix de transfert de Torii. De plus, Verrica initiera le transfert de fabrication des applicateurs YCANTH à Torii pour le marché japonais.
Verrica Pharmaceuticals (Nasdaq: VRCA) hat eine bedeutende Änderung seiner Zusammenarbeit- und Lizenzvereinbarung mit Torii Pharmaceutical bekanntgegeben, um eine globale Phase-3-Studie für YCANTH® zur Behandlung von gewöhnlichen Warzen zu starten. Das Unternehmen erhält im Juli 2025 eine Meilensteinzahlung von 8 Millionen US-Dollar für den Studienstart sowie eine weitere Meilensteinzahlung von 10 Millionen US-Dollar bei der Zulassung von YCANTH für Molluscum contagiosum in Japan, erwartet bis Ende 2025.
Die Vereinbarung sieht vor, dass Torii die ersten 40 Millionen US-Dollar der direkten Kosten für die globale Studie trägt, was etwa 90 % des aktuellen klinischen Budgets abdeckt. Die Studie richtet sich auf gewöhnliche Warzen, die allein in den USA 22 Millionen Patienten betreffen und für die es derzeit keine von der FDA zugelassenen verschreibungspflichtigen Therapien gibt. Verrica plant, im vierten Quartal 2025 den ersten Patienten in der Phase-3-Studie in den USA zu dosieren.
Nach der geänderten Vereinbarung behält Verrica die globalen Rechte an YCANTH für alle Indikationen außerhalb Japans. Die Kosten des Phase-3-Programms teilen sich die Unternehmen zu gleichen Teilen, wobei Verrica seinen Anteil durch Verrechnung mit zukünftigen Lizenzgebühren und Transferpreiszahlungen von Torii zurückzahlt. Zudem wird Verrica den Herstellungsübergang der YCANTH-Applikatoren an Torii für den japanischen Markt einleiten.
- Accelerated receipt of $8 million milestone payment in July 2025
- Additional $10 million milestone payment expected by end of 2025 upon Japan approval
- Torii to fund first $40 million of clinical trial costs (90% of budget)
- Large addressable market of 22 million U.S. patients with no FDA-approved prescription alternatives
- Maintained ownership of global rights outside Japan
- Secured waiver for 'going concern' qualification requirement from OrbiMed for remainder of 2025
- Manufacturing transfer to Torii expected to take several years
- Company must repay its 50% share of trial costs through future revenue offsets
Insights
Verrica secures $18M non-dilutive funding and favorable trial cost structure for YCANTH common warts program with blockbuster potential.
Verrica Pharmaceuticals has announced a significant amendment to its collaboration agreement with Torii Pharmaceutical that substantially improves its capital position and development outlook. The company will receive
The amended agreement creates a favorable financial structure for Verrica's global Phase 3 trial of YCANTH for common warts. While costs will ultimately be split 50/50, Torii will fund the first
This development targets a substantial unaddressed market. Common warts affect approximately 22 million patients in the United States alone with no FDA-approved prescription therapies currently available. The indication represents a multi-billion dollar opportunity that could transform Verrica's commercial profile if successful.
The agreement terms indicate strong confidence from Torii in YCANTH's potential across multiple indications. Importantly, Verrica maintains ownership of global rights outside Japan, preserving long-term value. The company has also secured a waiver from lender OrbiMed regarding "going concern" qualifications in financial statements for 2025, providing additional operating flexibility.
This amendment significantly strengthens Verrica's financial position, accelerates non-dilutive capital inflows, and creates a capital-efficient path to potentially expand YCANTH into a much larger market while maintaining strategic optionality. Management expects to dose the first patient in Q4 2025, with an update on current commercial progress expected this month.
– Verrica to receive a
– Verrica to receive a
– Torii to fund the first
– Common warts affects approximately 22 million patients in the United States alone, and there are no FDA approved prescription therapies for this multi-billion dollar addressable market –
– Company expects to dose first patient in the Phase 3 trial in the United States in the fourth quarter of 2025 –
– Verrica to maintain ownership of global rights to YCANTH for all indications in all territories outside of Japan –
WEST CHESTER, Pa., July 01, 2025 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing and selling medications for skin diseases requiring medical interventions, today announced that it has entered into the second amendment to its existing Collaboration and Licensing Agreement with Torii Pharmaceutical Co. Ltd. (“Torii”) to initiate a global pivotal Phase 3 clinical trial of Verrica’s product, YCANTH®, for the treatment of common warts.
“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 Chief Executive Officer of Verrica. Dr. Rieger continued, “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. With no currently FDA approved prescription products available to address the approximately 22 million people in the U.S. impacted by common warts, we believe that expanding YCANTH’s label to include this indication would provide millions of patients with a new treatment option in this multi-billion dollar market. As part of the amended agreement, Verrica has now finalized a path to receive up to
Dr. Rieger continued, “Verrica is proud to embark on this clinical program with Torii, who continues to be an outstanding and supportive development partner. We also appreciate the continued support from OrbiMed, our lending partner, who has been of great assistance throughout the restructuring of our company and the implementation of our new commercial strategy for YCANTH. As a result of our continued execution of our strategy, we recently secured an amendment to our Credit Agreement with OrbiMed whereby the requirement that there be no ‘going concern’ qualification to our financial statements was waived for the remainder of 2025.”
Dr. Rieger added, “As we enter the second half of 2025, 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. We remain focused on driving demand for YCANTH as the only FDA approved and commercially available therapy for the treatment of molluscum contagiosum, and we look forward to providing an update on YCANTH dispensed applicator unit growth in July.”
Amendments to YCANTH Collaboration and License Agreement with Torii
- Torii has agreed to accelerate the
$8 million milestone payment to Verrica for initiating the global Phase 3 program to be triggered now, rather than waiting until the first patient is dosed in the trial, providing Verrica with a significant source of non-dilutive capital earlier than expected under the prior arrangement. Verrica expects to receive the$8 million cash payment from Torii in July 2025. - Torii has agreed to pay Verrica a
$10 million milestone payment for the Japanese approval of YCANTH (TO-208 in Japan) for molluscum in cash, rather than as an offset to trial costs. The approval decision is expected to occur by the end of 2025. - Verrica expects to dose the first patient in the global Phase 3 program in the United States in the fourth quarter of 2025.
- Torii will continue to split the costs of the global Phase 3 program with Verrica on a 50/50 basis and will pay the first
$40 million of the trial costs, representing approximately90% of the current trial budget. To repay its half of the trial costs, Verrica will offset amounts otherwise owed by Torii for future royalties, certain transfer price payments and remaining development milestones (not including the$8 million and$10 million milestone payments noted above). - Verrica will initiate a manufacturing transfer to Torii for YCANTH (TO-208) applicators to be sold in Japan, which is expected to take several years. In the interim, Verrica will continue to receive from Torii a transfer price for applicators manufactured by Verrica’s manufacturing partners. After the transfer of at least one component of the manufacturing process, Verrica will begin receiving royalties related to net sales in Japan of applicators manufactured by Torii and/or its manufacturing partners.
About YCANTH® (VP-102)
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 commercially available 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. Approximately 225 million lives are eligible to receive YCANTH® covered by insurance. Commercially insured patients pay just
About Verrica Pharmaceuticals Inc.
Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica’s product YCANTH® (VP-102) (cantharidin), is the first and only commercially available treatment approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. YCANTH® (VP-102) is also in development to treat common warts, the largest remaining unmet need in medical dermatology. Verrica has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize VP-315 (formerly LTX-315 and VP-LTX-315) for non-melanoma skin cancers including basal cell carcinoma and squamous cell carcinoma. For more information, visit www.verrica.com.
About Dispensed Applicator Units
Dispensed applicator units represent applicators (a) shipped to healthcare professionals from Verrica’s contracted pharmacy partners for fulfillment, (b) sold by Verrica’s distribution partners to independent and regional pharmacies, and (c) sold to physician offices, hospitals and other clinics on a buy and bill basis.
Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Verrica’s current beliefs and expectations. These forward-looking statements include statements about the commercial opportunity for YCANTH, the expectations and timing related to potential milestone payments in 2025, the initiation of the global study of YCANTH for the treatment of common warts, the timing of the first patient dosed in the Phase 3 trial in the United States, the potential approval of YCANTH for the treatment of common warts in Japan, YCANTH’s dispensed applicator unit growth, the commercialization of YCANTH and the clinical development and benefits of Verrica’s product candidates, including YCANTH (VP-102) and VP-315. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include risks and uncertainties related to market conditions, satisfaction of customary closing conditions related to the proposed public offering and other risks and uncertainties that are described in Verrica’s Annual Report on Form 10-K for the year ended December 31, 2024, and other filings Verrica makes with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Verrica as of the date of this release, and Verrica assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
FOR MORE INFORMATION, PLEASE CONTACT:
Investors:
John Kirby
Interim Chief Financial Officer
jkirby@verrica.com
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
FAQ
What are the key financial terms of Verrica's amended agreement with Torii for YCANTH?
When will Verrica Pharmaceuticals (VRCA) begin its Phase 3 trial for YCANTH in common warts?
What is the market potential for YCANTH in common warts treatment?
How will Verrica repay its share of the clinical trial costs to Torii?
When is YCANTH expected to receive approval in Japan for molluscum contagiosum?
