News Release Details
Verrica Reports Fourth Quarter and Full Year 2018 Financial Results
“We began the year with positive Phase 3 clinical data for our molluscum contagiosum program -- a transformational event for the company -- and remain on target to submit a new drug application for VP-102 in the second half of 2019,” stated
The company’s late-stage product candidate, VP-102, is a potential first-in-class topical therapy for the treatment of molluscum contagiosum, a highly contagious viral skin infection affecting approximately six million people, primarily children, in
Business Highlights and Recent Developments
- Two pivotal Phase 3 clinical trials of VP-102 in patients with molluscum contagiosum (molluscum) achieved positive topline results. Both trials evaluated the safety and efficacy of VP-102, a first-in-class topical therapy containing 0.7% cantharidin, compared to placebo. In each trial, it was observed that a clinically and statistically significant proportion of subjects treated with VP-102 achieved complete clearance of all treatable molluscum lesions compared to subjects treated with placebo. CAMP-1 and CAMP-2 both achieved statistical significance for the primary endpoint with p-values less than 0.0001. VP-102 was well-tolerated in both trials, with no serious adverse events reported in VP-102 treated subjects.
- Results from two pivotal Phase 3 clinical trials of lead product candidate, VP-102, were presented at the annual meeting of the
American Academy of Dermatology (AAD) which was heldMarch 1-5, 2019 inWashington, DC . The presentation, “CAMP-1 (Cantharidin Application in Molluscum Patients) and CAMP-2: Phase 3, Randomized, Double-Blind, Placebo-Controlled, Pivotal Studies Investigating VP-102, a Drug-Device Combination Containing a Novel Topical Formulation of Cantharidin, for the Treatment of Molluscum Contagiosum,” took place during theLate-Breaking Research : Clinical Studies/Pediatric Session with results presented by lead investigator, Dr.Lawrence F. Eichenfield , Chief of Pediatric and Adolescent Dermatology at Rady Children's Hospital-San Diego.
- Continued progress with the Phase 2 trial of VP-102 in common warts (COVE-1); topline results expected in the second quarter of 2019.
- Announced plans to initiate a Phase 2 trial of VP-102 in external genital warts in the first half of 2019.
- Appointed
Neil D. DeHenes as Vice President of Distribution, Trade and Channel Strategy. Previously, Mr. DeHenes was the Life Sciences Commercial Strategy Lead at Deloitte Advisory where he provided executive oversight and supervision on all commercial strategy engagements within Deloitte’s Life Science and Healthcare sector, including the design, evaluation, implementation and execution of channel strategy. Prior toDeloitte , Mr. DeHenes worked atCardinal Health for more than 10 years where he most recently served as National Director of Sales Management.
Financial Results
Fourth Quarter 2018 Financial Results
Verrica reported a net loss of
Research and development expenses were
General and administrative expenses were
Full Year 2018 Financial Results
Verrica reported a net loss of
Research and development expenses were
General and administrative expenses were
Cash,
As of
About
Cautionary Note Regarding 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 expectations regarding the potential submission of a new drug application in the second half of 2019 for VP-102 for the treatment of molluscum, clinical development of Verrica’s product candidates, including the receipt of topline results from the Phase 2 trial of VP-102 in common warts and the initiation of a Phase 2 trial in external genital warts in the first half of 2019. 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, and other risks and uncertainties that are described in Verrica’s Annual Report on Form 10-K for the year ended
VERRICA PHARMACEUTICALS INC. | ||||||||||||||||
Statements of Operations | ||||||||||||||||
(unaudited, in thousands except share and per share data) | ||||||||||||||||
Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
Operating expenses(1): | ||||||||||||||||
Research and development | $ | 4,917 | $ | 1,118 | $ | 12,826 | $ | 3,730 | ||||||||
General and administrative | 3,271 | 316 | 9,052 | 727 | ||||||||||||
Total operating expenses | 8,188 | 1,434 | 21,878 | 4,457 | ||||||||||||
Loss from operations | (8,188 | ) | (1,434 | ) | (21,878 | ) | (4,457 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Interest income | 610 | - | 1,231 | - | ||||||||||||
Other expense | - | - | (1 | ) | - | |||||||||||
Interest expense - related party | - | (1 | ) | - | (2 | ) | ||||||||||
Total other income (expense) | 610 | (1 | ) | 1,230 | (2 | ) | ||||||||||
Net loss | (7,578 | ) | (1,435 | ) | (20,648 | ) | (4,459 | ) | ||||||||
Deemed dividend on Series A preferred stock | - | (5,300 | ) | - | (5,300 | ) | ||||||||||
Net loss attributable to common stockholders | $ | (7,578 | ) | $ | (6,735 | ) | $ | (20,648 | ) | $ | (9,759 | ) | ||||
Net loss per share, basic and diluted | $ | (0.30 | ) | $ | (0.50 | ) | $ | (1.41 | ) | $ | (1.56 | ) | ||||
Deemed dividend on Series A preferred stock | - | (1.86 | ) | - | (1.86 | ) | ||||||||||
Net loss attributable to common stockholders | $ | (0.30 | ) | $ | (2.36 | ) | $ | (1.41 | ) | $ | (3.42 | ) | ||||
Weighted average common shares outstanding, basic and diluted | 24,847,877 | 2,850,640 | 14,662,751 | 2,850,269 | ||||||||||||
(1) In the fourth quarter of 2018, Verrica changed its policy for recognizing stock-based compensation expense for graded-vesting awards with service conditions only from the graded attribution method to the straight-line attribution method. This change was applied retrospectively. See note 2 to the financial statements included in Verrica’s Annual Report on Form 10-K for the year ended
VERRICA PHARMACEUTICALS INC. | |||||||
Selected Balance Sheet Data | |||||||
(unaudited, in thousands) | |||||||
December 31, 2018 | December 31, 2017 | ||||||
Cash, cash equivalents and marketable securities | $ | 89,809 | $ | 8,663 | |||
Total assets | 91,906 | 9,083 | |||||
Total liabilities | 2,477 | 616 | |||||
Total convertible preferred stock | - | 15,508 | |||||
Total stockholders' equity (deficit) | 89,429 | (7,041 | ) |
IR Contacts:
Chief Financial Officer
484.453.3300 ext. 103
info@verrica.com
Westwicke, an
415.513.1284
Patti.bank@westwicke.com
Media Contact:
Sam Brown Inc.
312.961.2502
mikebeyer@sambrown.com
Source: Verrica Pharmaceuticals Inc.