UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 6, 2019
Verrica Pharmaceuticals Inc.
(Exact Name of Registrant as Specified in its Charter)
| Delaware | 001-38529 | 46-3137900 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) | ||
| 10 North High Street, Suite 200 West Chester, PA |
19380 | |||
| (Address of Principal Executive Offices) | (Zip Code) | |||
Registrant’s telephone number, including area code: (484) 453-3300
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934:
| Title of each class |
Trading symbol |
Name of each exchange on which registered | ||
| Common Stock | VRCA | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
| Item 2.02 | Results of Operations and Financial Condition. |
On November 6, 2019, Verrica Pharmaceuticals Inc. (the “Registrant”) issued a press release announcing its financial results for the quarter and nine months ended September 30, 2019. This press release has been furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
In accordance with General Instruction B.2. of Form 8-K, the information in this Item 2.02, and Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any of the Registrant’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit Number |
Exhibit Description | |
| 99.1 | Press Release, dated November 6, 2019 | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Verrica Pharmaceuticals Inc. | ||||
| Date: November 6, 2019 | /s/ A. Brian Davis | |||
| A. Brian Davis | ||||
| Chief Financial Officer | ||||
Exhibit 99.1
Verrica Pharmaceuticals Reports Third Quarter 2019 Financial Results
-Submitted New Drug Application to U.S. Food and Drug Administration for VP-102 for the treatment of molluscum contagiosum
-Presented three abstracts at the Fall Clinical Dermatology Conference, including two analyses of pooled results of the Phase 3 CAMP studies in molluscum, and the Phase 2 COVE-1 study in common warts
-Strengthened leadership and commercialization teams with three strategic hires
WEST CHESTER, Pa., Nov. 6, 2019 (GLOBE NEWSWIRE) — Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a medical dermatology company committed to the development and commercialization of novel treatments that provide meaningful benefit for people living with skin diseases, today announced financial results for the third quarter ended September 30, 2019.
“Verrica made several important strides this quarter to advance our lead product candidate, VP-102, for the treatment of molluscum contagiosum and common warts,” said Ted White, President and Chief Executive Officer of Verrica. “The highlight was the submission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for VP-102 for the treatment of molluscum, a highly contagious viral skin infection. If approved, VP-102 could potentially become the standard of care for this disease. We look forward to a possible acceptance of the NDA this quarter, and taking another step towards our goal of providing a safe and effective therapy to address a demonstrated unmet medical need.”
Business Highlights and Recent Developments
| • | Submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for VP-102 (cantharidin 0.7% Topical Solution), a proprietary topical therapy for the treatment of molluscum contagiosum, which affects an estimated six million people – primarily children – in the United States, and has no FDA-approved treatments available. |
| • | Advanced the research and development of VP-102 for the treatment of molluscum and common warts, with the presentation of positive results from three abstracts at the Fall Clinical Dermatology Conference, including pooled data from the Phase 3 CAMP studies in molluscum, and results of the Phase 2 COVE-1 study in common warts. VP-102 achieved statistically significant reductions in molluscum lesions and complete clearance of lesions in the CAMP studies, achieved complete clearance of common warts in 51.4% of subjects at the primary endpoint of Day 84 and 40% of subjects at Day 147 in Cohort 2 of the COVE-1 study, and was well-tolerated with a low rate of adverse events across all studies. |
| • | Continued to advance Company leadership and commercialization capabilities with three key appointments: A. Brian Davis was named Chief Financial Officer; Eugene Scavola joined the Company as Executive Vice President, Technical Operations; and Christopher Rofidal, was appointed Vice President, Market Access. |
Financial Results
| • | Verrica reported a net loss of $6.1 million for the third quarter of 2019, compared to a net loss of $5.9 million for the same period in 2018. |
| • | Research and development expenses were $3.0 million in the third quarter of 2019, compared to $3.5 million for the same period in 2018. The decrease was primarily attributable to a decrease in costs associated with the clinical development of VP-102 for the treatment of molluscum, partially offset by an increase in costs associated with the clinical development of VP-102 for the treatment of external genital warts and costs associated with manufacturing scale-up activities. |
| • | General and administrative expenses were $3.5 million in the third quarter of 2019, compared to $2.9 million for the same period in 2018. The increase was primarily a result of expenses related to increased headcount, an increase in insurance, professional fees and other operating costs, and an increase in expenses related to pre-commercial activities for VP-102. |
| • | As of September 30, 2019, Verrica had aggregate cash, cash equivalents, and marketable securities of $71.1 million. |
About Verrica Pharmaceuticals Inc.
Verrica is a medical dermatology company committed to the development and commercialization of novel treatments that provide meaningful benefit for people living with skin diseases. The Company’s late-stage product candidate, VP-102, is a potential first-in-class topical therapy for the treatment of molluscum contagiosum and common warts. Molluscum is a highly contagious viral skin infection affecting approximately six million people, primarily children, in the United States, and common warts are contagious skin growths affecting 22 million people. There are currently no FDA-approved treatments for molluscum or common warts. Following positive topline results from two pivotal Phase 3 trials, the Company submitted an NDA in September 2019 for VP-102 for the treatment of molluscum. Verrica is planning to meet with the FDA to determine next steps on the development of VP-102 for common warts following positive Phase 2 results. VP-102 is also currently in a Phase 2 trial for the treatment of external genital warts. A second product candidate, VP-103, is in pre-clinical development for plantar warts. For more information, visit www.verrica.com.
Forward-Looking Statement
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 benefits of VP-102 for the treatment of molluscum and the clinical development of VP-102 for additional indications, including common warts, external genital warts and plantar 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 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 December 31, 2018, filed with the U.S. Securities and Exchange Commission on March 7, 2019, 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.
Statements of Operations
(unaudited, in thousands except share and per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Operating expenses: |
||||||||||||||||
| Research and development |
$ | 3,049 | $ | 3,467 | $ | 11,464 | $ | 7,909 | ||||||||
| General and administrative |
3,494 | 2,865 | 10,626 | 5,781 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total operating expenses |
6,543 | 6,332 | 22,090 | 13,690 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Loss from operations |
(6,543 | ) | (6,332 | ) | (22,090 | ) | (13,690 | ) | ||||||||
| Other income |
453 | 426 | 1,520 | 620 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net loss |
$ | (6,090 | ) | $ | (5,906 | ) | $ | (20,570 | ) | $ | (13,070 | ) | ||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net loss per share, basic and diluted |
$ | (0.24 | ) | $ | (0.24 | ) | $ | (0.83 | ) | $ | (1.16 | ) | ||||
|
|
|
|
|
|
|
|
|
|||||||||
| Weighted average common shares outstanding, basic and diluted |
24,893,036 | 24,847,512 | 24,875,589 | 11,230,401 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
VERRICA PHARMACEUTICALS INC.
Selected Balance Sheet Data
(unaudited, in thousands)
| September 30, 2019 | December 31, 2018 | |||||||
| Cash, cash equivalents and marketable securities |
$ | 71,078 | $ | 89,809 | ||||
| Total assets |
76,074 | 91,906 | ||||||
| Total liabilities |
4,421 | 2,477 | ||||||
| Total stockholders’ equity |
71,653 | 89,429 | ||||||
FOR MORE INFORMATION, PLEASE CONTACT:
Investors:
A. Brian Davis
Chief Financial Officer
484.453.3300 ext. 103
info@verrica.com
Chiara Russo
Solebury Trout
617.221.9197
crusso@soleburytrout.com
Media:
Joshua R. Mansbach
Solebury Trout
646-378-2964
jmansbach@troutgroup.com
# # #