Verrica Pharmaceuticals Announces First U.S. Patient Dosed in the Second Pivotal Clinical Trial (COVE-3) of its Phase 3 Program Evaluating YCANTH® (VP-102) for the Treatment of Common Warts 

Rhea-AI Summary

Verrica Pharmaceuticals (Nasdaq: VRCA) reported dosing the first U.S. patient in COVE-3, the second pivotal Phase 3 trial of YCANTH (VP-102) for common warts. Torii Pharmaceutical recently dosed the first Japanese patient. A prior Phase 2 trial showed 51% complete clearance at Day 84. Torii will fund the first $40 million of Phase 3 costs, about 90% of the current budget, under a 50/50 cost-sharing agreement.

Positive

• First U.S. and Japanese patients dosed in pivotal COVE-3 Phase 3 trial
• Over 50% of targeted enrollment achieved in COVE-2 Phase 3 trial
• COVE-4 long-term follow-up study enrolling U.S. patients
• Phase 2 COVE-1 showed 51% of subjects (18/35) with complete clearance at Day 84
• No serious adverse events observed in Phase 2 COVE-1 trial
• Torii funding first $40 million, about 90% of current Phase 3 trial budget

Negative

• None.

News Market Reaction – VRCA

+0.18%

4 alerts

+0.18% Session close to close

+4.4% Peak Tracked

$106.34M Market Cap

0.6x Rel. Volume

In the Jun 22 session, VRCA gained 0.18%, reflecting a mild positive market reaction. Argus tracked a peak move of +4.4% during that session. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement advances YCANTH’s global Phase 3 program, adding COVE-3 to COVE-2 on the back of a...

Analysis

This announcement advances YCANTH’s global Phase 3 program, adding COVE-3 to COVE-2 on the back of a 51% clearance signal and Torii’s commitment to fund $40 million. Ongoing financing needs from recent filings remain an important watchpoint.

Key Figures

Complete clearance rate: 51% (18 of 35 subjects) Dosing schedule: Once every 21 days, up to 4 applications Patient age range: Patients aged 2+ years +5 more

8 metrics

Complete clearance rate 51% (18 of 35 subjects) COVE-1 Phase 2 Cohort 2, Day 84 primary efficacy analysis

Dosing schedule Once every 21 days, up to 4 applications Phase 3 VP-102/TO-208 regimen for common warts

Patient age range Patients aged 2+ years Eligibility for Phase 3 common-warts program

Wart count per subject Up to 6 warts COVE-1 Phase 2 trial design

Primary endpoint timing Day 84 COVE-1 primary efficacy analysis with follow-up to Day 147

Torii trial funding $40 million Torii to fund first $40M of global Phase 3 costs

Budget coverage 90% of current trial budget Portion of Phase 3 costs initially funded by Torii

U.S. prevalence 22 million patients Estimated annual U.S. common-warts population

Previous Clinical trial Reports

5 past events · Latest: Jan 07 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jan 07	YCANTH Phase 3 start	Positive	+0.9%	First patient dosed in global Phase 3 YCANTH trial for common warts.
Nov 10	VP-315 Phase 2 data	Positive	+11.8%	Phase 2 VP-315 data showed high response rates and favorable safety in BCC.
Jul 01	Torii deal amendment	Positive	+13.4%	Amended Torii agreement to fund global Phase 3 YCANTH study with milestones.
Jan 21	VP-315 topline data	Positive	+5.1%	Conference posters reported strong tumor clearance and safety for VP-315 in BCC.
Oct 24	VP-315 abstracts	Positive	-0.7%	Positive VP-315 preliminary data accepted for presentation at dermatology conference.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Clinical trial updates for Verrica have usually triggered positive share reactions, with only occasional negative divergences.

Key Terms

phase 3, open label, double-blind, randomized, +2 more

6 terms

phase 3 medical

"global Phase 3 program evaluating YCANTH® (VP-102) for the treatment of common warts."

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

open label medical

"COVE-1 was an open label clinical trial that evaluated the safety and efficacy"

Open label is a clinical trial design in which both the participants and the researchers know which treatment or intervention is being given. For investors, this matters because knowledge of the treatment can influence reported effects and side effects—like how seeing a product label can change a shopper’s opinion—so open-label results are useful for safety and real-world experience but are generally viewed as less rigorous evidence of effectiveness than blinded studies.

double-blind medical

"include two double-blind, randomized, vehicle-controlled studies evaluating the efficacy"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

randomized medical

"include two double-blind, randomized, vehicle-controlled studies evaluating the efficacy"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

vehicle-controlled medical

"two double-blind, randomized, vehicle-controlled studies evaluating the efficacy and safety"

A vehicle-controlled study compares a drug or therapy against the same formulation without the active ingredient — the “vehicle” is the inactive carrier or delivery medium. Think of testing a recipe by serving two dishes that look and taste the same except one lacks the key ingredient; any difference shows the ingredient’s real effect. Investors watch vehicle-controlled results because they provide a cleaner measure of a treatment’s benefit and safety, shaping regulatory decisions, clinical value, and company valuation.

serious adverse events medical

"Adverse events were primarily expected local cutaneous reactions with no SAEs observed."

Serious adverse events are significant problems or negative outcomes that occur during a medical treatment or clinical trial, such as severe side effects, hospitalizations, or life-threatening conditions. They matter to investors because such events can impact a company's reputation, lead to regulatory scrutiny, or delay the development of new products, ultimately affecting the company’s financial performance.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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– Development Partner Torii Pharmaceutical also recently announced dosing of the first Japanese patient in this trial evaluating YCANTH (TO-208) in Japan –

– Verrica maintains ownership of global rights to YCANTH for all indications in all territories outside of Japan, including common warts –

WEST CHESTER, Pa., June 22, 2026 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a therapeutics company developing and commercializing medications for the treatment of dermatological diseases, including skin cancers, today announced that the first U.S. patient was dosed in the second clinical trial (COVE-3) in its global Phase 3 program evaluating YCANTH^® (VP-102) for the treatment of common warts. Verrica’s Japanese development partner, Torii Pharmaceutical Co. Ltd. (“Torii”), a wholly-owned subsidiary of Shionogi & Co., Ltd., announced that the first Japanese patient in the COVE-3 study was dosed last week.

“We are excited to get the COVE-3 clinical trial started with the enrollment of our first patient in the U.S. and would like to congratulate our development partner, Torii Pharmaceutical, for also reaching this important and exciting clinical milestone for YCANTH in Japan,” said Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica. “Throughout our joint efforts to develop YCANTH for the global markets, Torii has served as an outstanding and supportive development partner, and the advancement of YCANTH into both of the planned pivotal Phase 3 studies reflects our companies’ steadfast commitment to address a significant unmet need for the millions of individuals, including an estimated 22 million people in the U.S. alone, impacted by common warts each year. If approved, YCANTH would be the first approved therapy for common warts in the U.S.”

“As we reported last month, we have achieved over 50% of the current targeted enrollment in the first trial in this Phase 3 program (COVE-2) in the U.S. and have also been enrolling U.S. patients in the long-term follow-up study (COVE-4),” Dr. Rieger continued.

The Phase 3 program has been designed to include two double-blind, randomized, vehicle-controlled studies evaluating the efficacy and safety of VP-102/TO-208 when applied once every 21 days for a total of up to four applications in patients aged 2+ years with common warts. The COVE-2 study is enrolling patients in the U.S. only and the COVE-3 study is enrolling patients in the U.S. and Japan. Based on the results of the Phase 3 program, Verrica and Torii intend to seek marketing approval in the U.S. and Japan, respectively.

COVE-1 Phase 2 Data and Phase 3 Program in Common Warts
In January 2026, Verrica announced that the first patient was dosed in the first clinical trial (COVE-2) of the global Phase 3 program evaluating YCANTH^® (VP-102) for the treatment of common warts. The initiation of the global Phase 3 program in common warts was 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 arising from sales of 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.

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. YCANTH is also approved for the treatment of molluscum contagiosum in Japan and is being studied in a global phase 3 program in the US and Japan for the treatment of common warts.

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 therapeutics company developing and commercializing medications for the treatment of dermatological diseases, including skin cancers. 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 ASA 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. For more information, visit www.verrica.com.

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 clinical development and potential benefits of Verrica’s product candidates, including YCANTH (VP-102). 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, and other risks and uncertainties that are described in Verrica’s Annual Report on Form 10-K for the year ended December 31, 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 did Verrica (Nasdaq: VRCA) announce about the COVE-3 Phase 3 trial for YCANTH on June 22, 2026?

Verrica announced that the first U.S. patient was dosed in COVE-3, its second pivotal Phase 3 trial for YCANTH in common warts. According to Verrica, its partner Torii also recently dosed the first Japanese patient in the same global COVE-3 study.

How is Verrica structuring its global Phase 3 program (COVE-2, COVE-3, COVE-4) for YCANTH in common warts?

The Phase 3 program includes COVE-2, COVE-3, and COVE-4, all evaluating YCANTH in common warts. According to Verrica, COVE-2 enrolls only U.S. patients, COVE-3 enrolls U.S. and Japanese patients, and COVE-4 is a long-term U.S. follow-up study.

What were the Phase 2 COVE-1 clinical trial results for YCANTH (VP-102) in treating common warts?

Phase 2 COVE-1 showed 51% of subjects (18 of 35) achieved complete clearance of all treatable warts at Day 84. According to Verrica, adverse events were mainly expected local skin reactions, and no serious adverse events were observed during the study.

How are Verrica and Torii Pharmaceutical sharing costs for the YCANTH Phase 3 common warts program?

Verrica and Torii are splitting global Phase 3 costs 50/50, with Torii funding the first $40 million. According to Verrica, this $40 million represents about 90% of the current trial budget, and Verrica’s share is expected to come from future Japan milestones and royalties.

What is the market opportunity for YCANTH (VP-102) in treating common warts for VRCA investors?

Verrica views common warts as a large commercial opportunity, citing about 22 million U.S. patients and no FDA-approved therapies. According to Verrica, this prevalence and unmet need could represent a multibillion-dollar market, with significant pediatric treatment and marketing synergies with molluscum.

Could YCANTH become the first FDA-approved therapy for common warts in the United States?

YCANTH is not yet approved for common warts, but Verrica plans to seek U.S. marketing approval after Phase 3. According to Verrica, if successfully developed, approved, and commercialized, YCANTH would be the first approved therapy for common warts in the United States.

How often is YCANTH (VP-102/TO-208) applied in Verrica’s Phase 3 COVE-2 and COVE-3 trials?

In COVE-2 and COVE-3, YCANTH is applied once every 21 days, for up to four applications in patients aged two or older. According to Verrica, both double-blind, randomized, vehicle-controlled studies assess efficacy and safety in common wart treatment using this dosing schedule.