– FDA accepts resubmitted NDA for VP-102 for the treatment of molluscum contagiosum with PDUFA goal date of June 23, 2021 –
– Verrica Announces Torii Pharmaceutical Has Exercised Option to Acquire Exclusive License Agreement to Develop and Commercialize VP-102 in Japan Triggering 60-Day Period to Finalize and Execute License Agreement –
WEST CHESTER, PA – March 4, 2021 (GLOBE NEWSWIRE) – Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced financial results for the fourth quarter ended December 31, 2020.
“Over the past year, we worked rapidly to resubmit the NDA for our lead product candidate, VP-102, in molluscum contagiosum, which we recently announced has been accepted for filing and assigned a PDUFA goal date of June 23, 2021,” said Ted White, Verrica’s President and Chief Executive Officer. “We are excited to announce today that Torii Pharmaceutical Co., Ltd. has exercised the option we granted to them in August to develop and commercialize VP-102 in Japan for the treatment of molluscum contagiosum and common warts. The prevalence of molluscum contagiosum alone in Japan was approximately 1.6 million cases in 2017. The option exercise triggers a 60-day period for Torii and us to finalize and execute a license agreement. Further, new analyses of Verrica’s pivotal Phase 3 molluscum trials and Verrica’s Phase 2 study in external genital warts continue to generate positive results, which have been published in medical journals and presented at top dermatology conferences.”
Business Highlights and Recent Developments
Clinical Program Results
Fourth Quarter 2020 Financial Results
Full Year 2020 Financial Results
Verricaʼs lead product candidate, VP-102, is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator that allows for precise topical dosing and targeted administration. VP-102 is currently under U.S. Food and Drug Administration (FDA) review, with a PDUFA goal date of June 23, 2021, and could potentially be the first product approved by the FDA to treat molluscum contagiosum ― a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. If approved, VP-102 will be marketed in the United States under the conditionally accepted brand name YCANTH™. In addition, Verrica has successfully completed a Phase 2 study of VP-102 for the treatment of common warts and a Phase 2 study of VP-102 for the treatment of external genital warts.
About Molluscum Contagiosum (Molluscum)
There are currently no FDA-approved treatments for molluscum, a highly contagious viral skin disease that affects approximately six million people — primarily children — in the United States. Molluscum is caused by a pox virus that produces distinctive raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching and bacterial infection. It is easily transmitted through direct skin-to-skin contact or through fomites (objects that carry the disease like toys, towels or wet surfaces) and can spread to other parts of the body or to other people, including siblings. The lesions can be found on most areas of the body and may carry substantial social stigma. Without treatment, molluscum can last for an average of 13 months, and in some cases, up to several years.
About Verrica Pharmaceuticals Inc.
Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica’s late-stage product candidate, VP-102, is in development to treat molluscum, common warts and external genital warts, three of the largest unmet needs in medical dermatology. Verrica is also developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. The Company has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize LTX-315 for dermatologic oncology conditions. For more information, visit www.verrica.com.
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 expectations regarding the Company’s expectations with regard to the potential approval of the NDA for VP-102 and the potential benefits and potential commercialization of VP-102 for the treatment of molluscum, if approved, the clinical development of Verrica’s VP-102 for additional indications and Verrica’s other product candidates, the potential entry into a license agreement with Torii and the terms of such license agreement, and Verrica’s cash, cash equivalents and marketable securities being sufficient to support planned operations at least into the first quarter of 2022. 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 uncertainties inherent in the drug development process and the regulatory approval process, Verrica’s reliance on third parties over which it may not always have full control, uncertainties related to the COVID-19 pandemic and other risks and uncertainties that are described in Verrica’s Annual Report on Form 10-K for the year ended December 31, 2019, Verrica’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and other filings Verrica makes with the U.S. Securities and Exchange Commission. 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.
VERRICA PHARMACEUTICALS INC.
Condensed Statements of Operations
(unaudited, in thousands except share and per share data)
|Three Months Ended December 31,||Twelve Months Ended December 31,|
|Research and development||$||2,272||$||3,972||$||15,673||$||15,436|
|General and administrative||9,761||4,018||24,508||14,644|
|Total operating expenses||12,033||7,990||40,181||30,080|
|Loss from operations||(12,033)||(7,990)||(40,181)||(30,080)|
|Net loss per share, basic and diluted||$||(0.52)||$||(0.31)||$||(1.71)||$||(1.13)|
|Weighted average common shares outstanding, basic and diluted||25,062,817||24,922,080||24,995,556||24,897,889|
VERRICA PHARMACEUTICALS INC.
Selected Balance Sheet Data
(unaudited, in thousands)
|December 31, 2020||December 31, 2019|
|Cash, cash equivalents and marketable securities||$||65,470||$||62,017|
|Total stockholders’ equity||32,986||65,015|