Form 8-K

 

 

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): May 7, 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))

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.  ☒

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

symbol

 

Name of each exchange

on which registered

Common Stock   VRCA   Nasdaq Global Select Market

 

 

 


Item 2.02

Results of Operations and Financial Condition.

On May 7, 2019, Verrica Pharmaceuticals Inc. (the “Registrant”) issued a press release announcing its financial results for the quarter ended March 31, 2019. A copy of this press release is furnished herewith as Exhibit 99.1 to this Current Report 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 May 7, 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: May 7, 2019

     

/s/ Chris Degnan

     

Chris Degnan

     

Chief Financial Officer

EX-99.1

Exhibit 99.1

 

LOGO

Verrica Pharmaceuticals Reports First Quarter 2019

Financial Results

-Reported positive topline data from pivotal Phase 3 clinical trials of VP-102 for the treatment of molluscum contagiosum

-Preparing to submit NDA in second half of 2019

WEST CHESTER, PA – May 7, 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 first quarter ended March 31, 2019.

“The first quarter of 2019 was monumental for Verrica as we reported positive Phase 3 topline data of our lead product candidate, VP-102, for the treatment of molluscum contagiosum, and then presented that data to the medical community during a late-breaking session at the American Academy of Dermatology annual meeting,” commented Ted White, President and Chief Executive Officer of Verrica. “We are focused on continuing that momentum with healthcare providers, enhancing disease awareness for this under-treated condition, and preparing to submit the company’s first new drug application with the FDA in the second half of 2019. Molluscum is a highly contagious viral skin infection affecting approximately six million people, primarily children, in the United States and our ultimate goal is to bring a safe and efficacious, FDA-approved treatment option to them.”

Business Highlights and Recent Developments

 

   

Achieved positive topline results in two pivotal Phase 3 clinical trials of VP-102 (CAMP-1 and CAMP-2) in patients with molluscum contagiosum (molluscum). Both trials evaluated the safety and efficacy of VP-102, a potential first-in-class topical therapy containing 0.7% cantharidin, compared to placebo and both achieved statistical significance for the primary endpoint with p-values less than 0.0001.

 

   

Presented positive Phase 3 clinical results in the Late-Breaking Research: Clinical Studies/Pediatric Session at the American Academy of Dermatology annual meeting on March 2, 2019 in Washington, DC. Lead investigator, Dr. Lawrence F. Eichenfield, Chief of Pediatric and Adolescent Dermatology at Rady Children’s Hospital-San Diego, presented the results at the meeting.


   

Continued progress with the Phase 2 trial of VP-102 in common warts (COVE-1), with topline results anticipated during the second quarter of 2019.

 

   

Announced plans to initiate a Phase 2 trial of VP-102 in external genital warts in the second quarter of 2019.

 

   

Appointed Neil D. DeHenes as Vice President of Distribution, Trade and Channel Strategy.

Financial Results

Verrica reported a net loss of $7.5 million for the first quarter of 2019, compared to a net loss of $1.8 million for the same period in 2018.

Research and development expenses were $4.5 million in the first quarter of 2019, compared to $0.9 million for the same period in 2018. The increase was primarily due to the advancement of the VP-102 clinical development programs for the treatment of molluscum and common warts and an increase in costs associated with increased headcount and associated salary, bonus and stock-based compensation expense.

General and administrative expenses were $3.5 million in the first quarter of 2019, compared to $1.0 million for the same period in 2018. The increase was primarily due to increased corporate infrastructure and additional costs associated with operating as a public company.

As of March 31, 2019, Verrica had aggregate cash, cash equivalents and marketable securities of $83.3 million.

About Verrica Pharmaceuticals Inc.

Verrica Pharmaceuticals 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, a highly contagious viral skin infection affecting approximately six million people, primarily children, in the United States. There are currently no FDA-approved treatments for molluscum. Following positive topline results from two pivotal Phase 3 trials, a New Drug Application for VP-102 for the treatment of molluscum is planned for the second half of 2019. VP-102 is also currently in a Phase 2 trial for the treatment of common warts, with an additional Phase 2 trial planned in external genital warts. A second product candidate, VP-103, is in pre-clinical development for plantar warts. For more information, visit www.verrica.com.


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 second quarter 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 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 March 31,  
     2019      2018  

Operating expenses:

     

Research and development

   $ 4,487      $ 927  

General and administrative

     3,539        961  
  

 

 

    

 

 

 

Total operating expenses

     8,026        1,888  
  

 

 

    

 

 

 

Loss from operations

     (8,026      (1,888

Other income

     547        41  
  

 

 

    

 

 

 

Net loss

   $ (7,479    $ (1,847
  

 

 

    

 

 

 

Net loss per share, basic and diluted

   $ (0.30    $ (0.65
  

 

 

    

 

 

 

Weighted average common shares outstanding, basic and diluted

     24,857,771        2,850,640  
  

 

 

    

 

 

 

VERRICA PHARMACEUTICALS INC.

Selected Balance Sheet Data

(unaudited, in thousands)

 

     March 31,
2019
     December 31,
2018
 

Cash, cash equivalents and marketable securities

   $ 83,282      $ 89,809  

Total assets

     85,979        91,906  

Total liabilities

     3,218        2,477  

Total stockholders’ equity

     82,761        89,429  


IR Contacts:

Chris Degnan

Chief Financial Officer

484.453.3300 ext. 103

info@verrica.com

Patti Bank

Managing Director

Westwicke Partners, an ICR Company

415.513.1284

patti.bank@westwicke.com

Media Contact:

Mike Beyer

Sam Brown Inc.

312.961.2502

mikebeyer@sambrown.com