– New Drug Software for VP-102 for the therapy of molluscum contagiosum was accepted for submitting by the U.S. Meals and Drug Administration; assigned PDUFA purpose date is July 13, 2020 –
– Just lately introduced execution of non-dilutive mortgage services totaling $55 million, of which $35 million was borrowed upon closing –
– New knowledge from Section Three CAMP research instructed statistically considerably larger molluscum lesion clearance with VP-102 in comparison with car throughout all physique areas, together with these deemed most delicate –
WEST CHESTER, Penn., March 13, 2020 (GLOBE NEWSWIRE) — Verrica Prescribed drugs Inc. (“Verrica”) (NASDAQ:VRCA), a dermatology therapeutics firm creating drugs for viral pores and skin ailments requiring medical interventions, right now introduced monetary outcomes for the fourth quarter ended December 31, 2019.
“2019 was a pivotal yr, as we made crucial developments that help our mission of creating doubtlessly the primary FDA-approved therapy for molluscum contagiosum, a extremely contagious viral pores and skin illness,” mentioned Ted White, President and Chief Government Officer of Verrica. “The spotlight of the yr was the FDA’s acceptance of the New Drug Software for VP-102, and we sit up for the PDUFA purpose date of July 13, 2020. We additionally added to the physique of medical proof supporting VP-102, and bolstered our management group, additional readying the group for the potential commercialization with 4 latest strategic hires. Within the coming yr, we anticipate the topline readout of Section 2 knowledge from our research of VP-102 for exterior genital warts, and initiating Section Three trials of VP-102 in frequent warts. As well as, we are going to begin a Section 2 medical trial in plantar warts, finding out VP-103, which is a brand new formulation and better focus of cantharidin.”
Enterprise Highlights and Latest Developments
- The U.S. Meals and Drug Administration (FDA) accepted for submitting the New Drug Software (NDA) for VP-102 (cantharidin 0.7% Topical Answer), a proprietary drug-device mixture containing a GMP-controlled formulation of cantharidin, being developed for the therapy of molluscum contagiosum, a extremely contagious viral pores and skin illness that impacts roughly six million folks, primarily youngsters, in america, and has no FDA-approved remedies out there; the Firm confirmed that if authorized, VP-102 can be marketed in america underneath the conditionally accepted model identify, YCANTH™.
- Verrica not too long ago introduced that it has secured $55 million in non-dilutive mortgage services, of which $35.Zero million was borrowed upon closing. Verrica believes the $35.Zero million in proceeds acquired at closing together with current money, money equivalents, and marketable securities shall be ample to help deliberate operations, which embrace bills for the commercialization of YCANTH™, if authorized, and continued full medical improvement of VP-102 for extra indications, together with frequent warts and exterior genital warts, in addition to VP-103 for plantar warts, not less than via the second quarter of 2021.
- Considerably strengthened the group’s management, and additional enhanced its manufacturing and industrial capabilities, via 4 strategic hires, together with the appointments of A. Brian Davis as Chief Monetary Officer, Eugene Scavola as Government Vice President, Technical Operations, Gerard DiGirolamo as Vice President, Gross sales, and Sheila Kennedy as Vice President, Advertising and marketing.
- Introduced constructive knowledge supporting the protection and efficacy of VP-102 on the Fall and Winter Scientific Dermatology Conferences. On the Fall session, pooled knowledge from the Section Three CAMP research confirmed VP-102 achieved statistically important reductions in molluscum lesions and full clearance of lesions. Outcomes from the first endpoint for Cohort 2 of the Section 2 COVE-1 research confirmed 51% of VP-102 handled topics achieved full clearance of all treatable frequent warts at Day 84. Knowledge introduced on the Winter Scientific assembly from a put up hoc evaluation of the pooled knowledge from the Section Three CAMP research confirmed a statistically considerably higher proportion of full lesion clearance in topics with molluscum contagiosum by the tip of the research (Day 84) throughout all physique areas analyzed amongst sufferers receiving VP-102, as in comparison with car.
Fourth Quarter Monetary Outcomes
- Verrica reported web losses of $7.6 million for each the fourth quarter of 2019 and the fourth quarter of 2018.
- Analysis and improvement bills had been $4.0 million within the fourth quarter of 2019, in comparison with $4.9 million for a similar interval in 2018. The lower was primarily attributable to a lower in prices related to the medical improvement of VP-102 for the therapy of molluscum, partially offset by a rise in prices related to the medical improvement of VP-102 for extra indications and elevated compensation prices.
- Normal and administrative bills had been $4.0 million within the fourth quarter of 2019, in comparison with $3.3 million for a similar interval in 2018. The rise was primarily a results of bills associated to elevated headcount, a rise in insurance coverage, skilled charges and different working prices, and a rise in bills associated to pre-commercial actions for VP-102.
Full 12 months Monetary Outcomes
- Verrica reported a web lack of $28.2 million for the yr ended December 31, 2019, in comparison with a web lack of $20.6 million for the yr ended December 31, 2018.
- Analysis and improvement bills had been $15.4 million for the yr ended December 31, 2019, in comparison with $12.8 million for a similar interval in 2018. The rise was primarily attributable to prices related to Section 2 and Section Three medical actions for VP-102 in addition to elevated payroll and stock-based compensation bills related to elevated headcount.
- Normal and administrative bills had been $14.6 million for the yr ended December 31, 2019, in comparison with $9.1 million for a similar interval in 2018. The rise was primarily a results of elevated payroll and stock-based compensation bills related to elevated headcount in addition to elevated insurance coverage, skilled charges and different working bills.
Money, Money Equivalents and Marketable Securities
- As of December 31, 2019, Verrica had mixture money, money equivalents, and marketable securities of $62.0 million.
About Verrica Prescribed drugs Inc.
Verrica is a dermatology therapeutics firm creating drugs for viral pores and skin ailments requiring medical interventions. The Firm’s late-stage product candidate, VP-102, is a possible first-in-class topical remedy for the therapy of molluscum contagiosum and customary warts. Molluscum is a extremely contagious viral pores and skin an infection affecting roughly six million folks, primarily youngsters, in the United States, and customary warts are contagious pores and skin growths affecting 22 million folks. There are at the moment no FDA-approved remedies for molluscum or frequent warts. Following constructive topline outcomes from two pivotal Section Three trials, the Firm submitted an NDA on September 13, 2019 for VP-102 for the therapy of molluscum; on November 26, 2019, the Firm acquired discover that the FDA accepted the NDA for submitting, with a Prescription Drug Consumer Payment Act (PDUFA) purpose date of July 13, 2020. If authorized, VP-102 shall be marketed in america underneath the conditionally accepted model identify YCANTH™. Verrica intends to begin a Section Three program within the first half of 2020 to guage VP-102 for frequent warts. VP-102 can be at the moment in a Section 2 trial for the therapy of exterior genital warts. A further product candidate, VP-103, is in pre-clinical improvement for plantar warts. For extra info, go to www.verrica.com.
Any statements contained on this press launch that don’t describe historic details could represent forward-looking statements as that time period is outlined within the Personal Securities Litigation Reform Act of 1995. These statements could also be recognized by phrases similar to “imagine,” “count on,” “could,” “plan,” “potential,” “will,” and related expressions, and are primarily based on Verrica’s present beliefs and expectations. These forward-looking statements embrace expectations relating to the potential advantages and potential approval of YCANTH™ for the therapy of molluscum and the medical improvement of product candidates for extra indications, together with frequent warts, exterior genital warts and plantar warts. These statements contain dangers and uncertainties that might trigger precise outcomes to vary materially from these mirrored in such statements. Dangers and uncertainties which will trigger precise outcomes to vary materially embrace uncertainties inherent within the drug improvement course of and the regulatory approval course of, Verrica’s reliance on third events over which it could not at all times have full management, and different dangers and uncertainties which might be described in Verrica’s Annual Report on Kind 10-Ok for the yr ended December 31, 2019, filed with the U.S. Securities and Trade Fee on March 13, 2020, and different filings Verrica makes with the U.S. Securities and Trade Fee. Any forward-looking statements communicate solely as of the date of this press launch and are primarily based on info out there to Verrica as of the date of this launch, and Verrica assumes no obligation to, and doesn’t intend to, replace any forward-looking statements, whether or not on account of new info, future occasions or in any other case.
VERRICA PHARMACEUTICALS INC.
Statements of Operations
(unaudited, in hundreds besides share and per share knowledge)
|Three Months Ended December 31,||12 months Ended December 31,|
|Analysis and improvement||$||3,972||$||4,917||$||15,436||$||12,826|
|Normal and administrative||4,018||3,271||14,644||9,052|
|Complete working bills||7,990||8,188||30,080||21,878|
|Loss from operations||(7,990||)||(8,188||)||(30,080||)||(21,878||)|
|Internet loss per share, fundamental and diluted||$||(0.31||)||$||(0.30||)||$||(1.13||)||$||(1.41||)|
|Weighted common frequent shares excellent, fundamental and diluted||24,922,080||24,847,877||24,897,889||14,662,751|
VERRICA PHARMACEUTICALS INC.
Chosen Steadiness Sheet Knowledge
(unaudited, in hundreds)
|December 31, 2019||December 31, 2018|
|Money, money equivalents and marketable securities||$||62,017||$||89,809|
|Complete stockholders’ fairness||65,015||89,429|
FOR MORE INFORMATION, PLEASE CONTACT:
A. Brian Davis
Chief Monetary Officer
484.453.3300 ext. 103
Joshua R. Mansbach