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Verrica Pharmaceuticals Announces First Patient Dosed in Phase 3 Program Evaluating YCANTH® (VP-102) for the Treatment of Common Warts

MWN-AI** Summary

Verrica Pharmaceuticals Inc. recently announced a significant milestone in its clinical development journey: the first patient has been dosed in the Phase 3 program evaluating YCANTH® (VP-102) for the treatment of common warts. This condition affects around 22 million individuals in the United States, representing a substantial unmet medical need as there are currently no FDA-approved prescription therapies available for this widespread skin issue.

The decision to advance to Phase 3 follows promising results from the Phase 2 clinical trial, COVE-1, which demonstrated a 51% complete clearance rate of treatable warts in the trial’s second cohort. Given the high prevalence of common warts, particularly among children, the potential commercialization of YCANTH is projected to tap into a multibillion-dollar market opportunity. YCANTH operates as a proprietary drug-device combination, utilizing a precise topical applicator to deliver its active ingredient—cantharidin—effectively.

Verrica retains global rights to YCANTH outside Japan, enhancing its commercial strategy. The company also recently completed a $50 million financing round, alleviating some financial burdens, and seeks to leverage the extensive market potential of YCANTH alongside its ongoing promotion of related treatments for molluscum.

As part of a collaborative venture, Torii will share the costs of the Phase 3 program, funding 90% of the trial's budget, which positions Verrica to optimize its resources for future developments. The company’s confidence in YCANTH is rooted in its prior achievements and the projected synergies with its existing product portfolio, ultimately aiming to address one of the most significant gaps in dermatological care today.

MWN-AI** Analysis

Verrica Pharmaceuticals (Nasdaq: VRCA) has recently achieved a significant milestone by dosing its first patient in the Phase 3 clinical trial evaluating YCANTH (VP-102) for the treatment of common warts. The potential size of this market, given the estimated 22 million affected individuals in the U.S. alone and the absence of FDA-approved therapies, presents a multi-billion-dollar opportunity for Verrica. The favorable results from the Phase 2 COVE-1 study, which indicated that over 50% of subjects achieved complete wart clearance, provide a strong foundation for the ongoing development.

Investors should closely monitor the progression of the Phase 3 trial, as successful outcomes could establish YCANTH as the first approved treatment for common warts, enhancing Verrica's portfolio and market position. With full commercial rights retained outside Japan, any forthcoming approval could lead to significant revenue streams. Additionally, Verrica has demonstrated strategic financial planning through a recent $50 million financing, which not only alleviated debt constraints but also positions the company for future growth.

Given the high prevalence of common warts, particularly among children, there is potential for cross-marketing synergies with Verrica’s existing product, YCANTH for molluscum. This overlap may facilitate quicker adoption among healthcare professionals. Moreover, participation in the trial costs being shared with Torii Pharmaceuticals mitigates financial risk for Verrica.

However, investors should be aware of market volatility and the inherent risks in biotechnology stocks, particularly given the reliance on clinical trial outcomes and regulatory approvals. A cautious stance is advised until more data is released. Continued vigilance on clinical progress and market trends will be crucial as Verrica navigates this promising path forward.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: GlobeNewswire

– Common warts affects approximately 22 million patients in the United States alone, and there are no FDA approved prescription therapies for what is believed to be a multibillion-dollar market opportunity–

– Verrica has global rights to YCANTH for all indications in all territories outside of Japan –

WEST CHESTER, Pa., Jan. 07, 2026 (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 the first patient was dosed in December 2025 in the global Phase 3 program evaluating YCANTH (VP-102) for the treatment of common warts.

“The dosing of the first patient in the global Phase 3 program in common warts represents an important clinical milestone for our label expansion strategy of YCANTH,” said Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica. “The clinically meaningful activity observed for the primary endpoint of complete clearance in the Phase 2 COVE-1 study provides strong evidence that YCANTH has the potential to become the first therapy ever approved in both the United States and Japan for the treatment of common warts – a condition that impacts over 22 million people in the U.S. alone. Having retained full commercial rights for all potential YCANTH indications outside of Japan, common warts represents a substantial commercial and licensing opportunity for our company. Coupled with our recently completed $50 million financing and repayment of our debt facility with OrbiMed, this significant clinical milestone is another key step towards the expansion of the YCANTH franchise and the future growth of Verrica.”

COVE-1 Phase 2 Data and Phase 3 Program in Common Warts

The initiation of the global Phase 3 program in common warts is 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 for YCANTH in Japan.

Market Opportunity in Common Warts

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. If YCANTH is successfully developed, approved and commercialized for the treatment of common warts, Verrica anticipates a high degree of call point overlap and marketing synergies with its promotion of YCANTH for the treatment of molluscum. Verrica further believes that the common wart patient opportunity in the European Union is comparable to that in the United States.

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 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. 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. Please visit YCANTHPro.com for additional information.

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 healthcare professional-administered 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 (ruxotemitide, formerly known as LTX-315 and VP-LTX-315) for non-melanoma skin cancers including basal cell carcinoma and squamous cell carcinoma.

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 commercialization of YCANTH, clinical development, clinical timelines and potential benefits of YCANTH for the treatment of common warts, 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, Verrica’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 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 specific competitive advantages does Verrica Pharmaceuticals Inc. (VRCA) believe YCANTH offers compared to other potential treatments for common warts, given the absence of FDA-approved therapies in this multibillion-dollar market?

Verrica Pharmaceuticals Inc. posits that YCANTH offers a targeted, non-invasive treatment with a favorable safety profile and potential for improved efficacy, positioning it as a revolutionary solution in the multibillion-dollar market for common warts, devoid of FDA-approved options.

How does Verrica Pharmaceuticals Inc. (VRCA) plan to leverage the positive Phase 2 COVE-1 results to ensure significant commercial uptake of YCANTH for common warts once it receives approval, particularly in terms of marketing and physician engagement strategies?

Verrica Pharmaceuticals plans to utilize the positive Phase 2 COVE-1 results by implementing targeted marketing campaigns and robust physician engagement strategies that emphasize clinical efficacy and patient outcomes to drive significant commercial uptake of YCANTH for common warts upon approval.

Given the enrollment of the first patient in the Phase 3 trial, what specific milestones does Verrica Pharmaceuticals Inc. (VRCA) anticipate achieving over the course of the trial, and how will these impact the company’s timeline for potential drug commercialization?

Verrica Pharmaceuticals Inc. (VRCA) anticipates achieving key milestones such as patient enrollment updates, interim results, and data readouts during the Phase 3 trial, which will collectively influence their timeline for potential drug commercialization and future strategic decisions.

Considering the overlapping marketing strategies for YCANTH in treating both common warts and molluscum contagiosum, what measures is Verrica Pharmaceuticals Inc. (VRCA) putting in place to optimize its sales force and customer outreach efforts across these indications?

Verrica Pharmaceuticals Inc. (VRCA) is optimizing its sales force and customer outreach for YCANTH by implementing targeted training for sales representatives, enhancing cross-promotional strategies, and utilizing data analytics to identify key healthcare providers across both common warts and molluscum contagiosum.

**MWN-AI FAQ is based on asking OpenAI questions about Verrica Pharmaceuticals Inc. (NASDAQ: VRCA).

Verrica Pharmaceuticals Inc.

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