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): July 22, 2020

 

 

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 5.02    Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

Appointment of Gary Goldenberg as Chief Medical Officer and Resignation from Board of Directors

On July 23, 2020, Verrica Pharmaceuticals Inc. (the “Company”) announced that Gary Goldenberg would be replacing Patrick Burnett as the Company’s Chief Medical Officer, effective August 1, 2020. In connection with Dr. Goldenberg’s appointment as the Company’s Chief Medical Officer, on July 22, 2020, Dr. Goldenberg notified the Company of his decision to resign from the Company’s board of directors (the “Board”) and the Company’s audit committee, compensation committee, and nominating and corporate governance committee, also effective August 1, 2020.

Appointment of Lawrence Eichenfield to Board of Directors

On July 22, 2020, the Board approved the appointment of Lawrence Eichenfield to serve as a director of the Company, as a member of the Company’s audit committee and compensation committee, and as the chair of the Company’s nominating and corporate governance committee, effective August 1, 2020. Dr. Eichenfield will serve as a Class II director whose term will expire at the 2023 annual meeting of stockholders.

There is no arrangement or understanding between Dr. Eichenfield and any other person pursuant to which he was selected as a director of the Company, and there is no family relationship between Dr. Eichenfield and any of the Company’s other directors or executive officers. The Company is not aware of any transaction involving Dr. Eichenfield requiring disclosure under Item 404(a) of Regulation S-K. Additional information about Dr. Eichenfield is set forth below:

Lawrence Eichenfield, age 62, has been the chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego since 1991, as well as vice chair of the Department of Dermatology and a professor of dermatology and pediatrics at UC San Diego School of Medicine since 2009. He served as President of the Society for Pediatric Dermatology in 2002-3, on the board of the American Academy of Dermatology from 2005 to 2009, and served as chair for the 69th Annual Meeting of the American Academy of Dermatology. He is a co-Founder and former Chair of the Pediatric Dermatology Research Alliance (PeDRA), a collaborative research network, and a founding board member and past-president of the American Acne and Rosacea Society. He served as Editor-in-Chief of Pediatric Dermatology for 12 years and serves on the editorial boards of multiple journals and periodicals. Dr. Eichenfield earned his medical degree from Mount Sinai School of Medicine in New York, was a pediatric resident and chief resident at Children’s Hospital of Philadelphia, and completed dermatology training at the hospital of the University of Pennsylvania. He is board certified in pediatrics, dermatology and pediatric dermatology. He has been honored as a member of the Alpha Omega Alpha Honor Society during medical school, and as a recipient of multiple clinical excellence and teaching awards from the Children’s Hospital of Philadelphia, UC San Diego Pediatrics, UC San Diego Dermatology and Rady Children’s Hospital-San Diego.

In accordance with the Company’s non-employee director compensation policy, upon commencement of his service as a director, Dr. Eichenfield will be granted an initial option grant to purchase 17,502 shares of the Company’s common stock under its Non-Employee Director Compensation Policy, with one-third of the shares vesting on the first anniversary of the date of grant and the remaining shares vesting in 24 equal monthly installments thereafter, subject to his continued service as a director through the applicable vesting date. Additionally, Dr. Eichenfield will be entitled to receive a $40,000 annual retainer for his service as director, a $10,000 annual retainer for his service as the chair of our nominating and corporate governance committee, a $5,000 annual retainer for his service as a member of our compensation committee and a $5,000 annual retainer for his service as a member of our audit committee. At each annual stockholder meeting following which Dr. Eichenfield’s term as a director continues, Dr. Eichenfield will be entitled to receive an additional stock option to purchase 5,834 shares of the Company’s common stock, which option will vest and become exercisable in 12 equal monthly installments following the date of grant and in any event will be fully vested on the date of the next annual meeting of stockholders, subject to his continued service as a director though the applicable vesting date. Dr. Eichenfield has also entered into the Company’s standard form of indemnification agreement.


Item 7.01 Regulation FD Disclosure.

On July 23, 2020, the Company issued a press release announcing the drug development management changes and the appointment of Dr. Eichenfield to the Board. Copies of the press releases are furnished herewith as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K.

The information in this Item 7.01, including Exhibits 99.1 and 99.2, is being furnished pursuant to Item 7.01 of Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall the information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit
Number

  

Exhibit Description

99.1    Press release, dated July 23, 2020.
99.2    Press release, dated July 23, 2020.


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: July 23, 2020      

/s/ A. Brian Davis

 
      A. Brian Davis  
      Chief Financial Officer  
EX-99.1

Exhibit 99.1

 

LOGO

Verrica Pharmaceuticals Announces Clinical and Drug Development Leadership Changes

– Dr. Gary Goldenberg appointed Chief Medical Officer;

Dr. Brad Catalone assumes the role of Head of Drug Development –

– New leadership strengthens expertise in Clinical, Chemistry, Manufacturing, and Controls

(CMC), and Regulatory Affairs –

WEST CHESTER, Pa., July 23, 2020 (GLOBE NEWSWIRE) — Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for viral skin diseases requiring medical interventions, today announced key appointments to its drug development team.

Current Board of Directors (the “Board”) member Dr. Gary Goldenberg, a renowned thought leader in the field of dermatology, is stepping down to become Verrica’s Chief Medical Officer, effective August 1, 2020. Verrica announced separately today that Dr. Lawrence Eichenfield is joining the Board on August 1, 2020, replacing Dr. Goldenberg. In addition, Dr. Brad Catalone is being appointed to the newly created position of Head of Drug Development on that same date.

“Our new colleagues bring a wealth of expertise that strengthens our drug development team in ways that are critical for the next stage of growth,” said Ted White, Verrica’s President and Chief Executive Officer. “Dr. Goldenberg’s previous role as a member of our Board, as well his experience in academia and as a practicing dermatologist, gives him familiarity with our strategy and deep expertise to help lead our clinical programs as Chief Medical Officer. We are also excited to welcome Dr. Brad Catalone, whose CMC, regulatory affairs, and medical devices expertise will be of vital importance to Verrica in the coming months and years. Having these prominent industry leaders join Verrica at this time underscores the potential value of our pipeline and the strength of our science.”

As Chief Medical Officer, Dr. Goldenberg will oversee medical affairs and all aspects of clinical development and strategy related to Verrica’s product candidates, as well as provide scientific guidance for potential business development initiatives. He joined Verrica’s Board in May 2018. He is an Assistant Professor of Dermatology and Pathology at The Icahn Sinai School of Medicine at Mount Sinai Hospital in New York City. Prior, he was Director of Dermatopathology at University of Maryland School of Medicine. Dr. Goldenberg is board certified in dermatology and dermatopathology, and has authored more than 75 original articles, abstracts, and book chapters. Dr. Goldenberg serves on the editorial boards of multiple dermatology journals, and is a frequent contributor to national media outlets’ reporting on dermatological diseases, including CNN, Fox News, ABC, NBC, and The Wall Street Journal. Dr. Goldenberg will replace Patrick Burnett, MD, who has decided to pursue other opportunities outside of Verrica.

“I believe Verrica is on the precipice of important advancements in dermatological therapeutics,” said Dr. Goldenberg. “Having worked with the team for the past two years as a member of its Board, I am confident in the Company’s R&D approach, and look forward to advancing VP-102 through the regulatory process while exploring its potential in follow on indications where there is significant need for improved treatments of skin diseases.”

As Head of Drug Development, Dr. Brad Catalone will oversee all non-clinical aspects of drug development for Verrica’s product candidates, including CMC (“Chemistry, Manufacturing, and Controls”) and Regulatory Affairs. Prior to joining Verrica, he served as Chief Science Officer, leading Scientific and Regulatory Device Strategy for the TSO3 Corporation. In this capacity, he successfully led efforts to obtain multiple 510(k) clearances for new and expanded device claims. Previously, Dr. Catalone held multiple positions of increasing responsibility at Alcami Corporation, ultimately ascending to the role of Vice President, Laboratory Services. During his tenure, he oversaw more than 250 laboratory staff across four sites developing both small and large molecule drugs. Earlier in his career, Dr. Catalone served as Unit Head, R&D Safety Microbiology at Alcon, where he oversaw all aspects of preclinical development for the company’s pipeline. Dr. Catalone earned a Masters degree in Biology from Villanova University, obtained his Ph.D. in Microbiology and Immunology at the Penn State College of Medicine, and an MBA from Pennsylvania State University.


About Verrica Pharmaceuticals Inc.

Verrica is a dermatology therapeutics company developing medications for viral skin diseases requiring medical interventions. The Company’s late-stage product candidate, VP-102, is a potential first-in-class topical therapy for the treatment of molluscum contagiosum. Verrica submitted an NDA for VP-102 for the treatment of molluscum in September 2019. A Complete Response Letter was received from the FDA regarding the NDA for VP-102 on July 13, 2020. 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 is currently conducting a Phase 2 study of VP-102 for the treatment of external genital warts. The Company is also developing VP-103, its second cantharidin-based product candidate, for the treatment of 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 Company’s expectations with regard to its interactions and communications with the FDA, including its expectation to discuss with the FDA regarding the issues raised in the CRL and the Company’s plans to address them, the potential approval of the NDA for VP-102 following resubmission, the potential benefits and potential approval and commercialization of VP-102 for the treatment of molluscum, and the Company’s plans with respect to planned clinical trials of VP-102 for common warts and VP-103 for 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, 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 March 31, 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.

FOR MORE INFORMATION, PLEASE CONTACT:

Investors:

A. Brian Davis

Chief Financial Officer

484.453.3300 ext. 103

info@verrica.com

Luke Brown

Solebury Trout

646.378.2944

lbrown@troutgroup.com

Media:

Joshua R. Mansbach

Solebury Trout

646.378.2964

jmansbach@troutgroup.com

# # #

EX-99.2

Exhibit 99.2

 

LOGO

Verrica Pharmaceuticals Announces Dr. Lawrence Eichenfield Joins Board of Directors

– Leading pediatric dermatologist brings significant expertise in the treatment of skin diseases to help inform development of the Company’s product candidates –

WEST CHESTER, Pa., July 23, 2020 (GLOBE NEWSWIRE) — Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for viral skin diseases requiring medical interventions, today announced that Dr. Lawrence Eichenfield, Chief of Pediatric and Adolescent Dermatology, Rady Children’s Hospital, San Diego, CA, is joining the Company’s Board of Directors (the “Board”), effective August 1, 2020. Dr. Eichenfield will replace Dr. Gary Goldenberg who will be stepping down from the Board to assume the role of Verrica’s Chief Medical Officer, which the Company announced separately today.

“Dr. Eichenfield’s research has shaped the field of pediatric dermatology,” said Paul B. Manning, Chairman of the Board, Verrica. “His addition to our Board is extraordinarily valuable as the Company advances VP-102, and we are confident that he will play a critical role in guiding the future development of our pipeline.”

“I am extremely pleased to have the opportunity to join a pioneering company that is advancing the treatment of skin diseases that have a substantial burden,” said Dr. Eichenfield. “I believe Verrica has the capabilities and scientific acumen to be a leader in dermatological therapeutics, and I’m excited to help advance VP-102 and Verrica’s other product candidates, and explore their potential applications for patients.”

Dr. Lawrence Eichenfield is Chief of Pediatric & Adolescent Dermatology at Rady Children’s Hospital in San Diego, California, and is a Professor of Dermatology & Pediatrics, and Dermatology Department Vice-Chair, at UC San Diego School of Medicine. He is board certified in dermatology, pediatric dermatology, and pediatrics. Dr. Eichenfield is the co-founder and co-chair of the Pediatric Dermatology Research Alliance, and has worked with the American Academy of Dermatology as well as the National Institute of Allergy and Infectious Disease to create professional treatment guidelines and shape consensus for multiple dermatological conditions including atopic eczema and dermatitis. He is the recipient of numerous awards, including two Presidential Citations from the American Academy of Dermatology, and was named one of the nation’s top doctors by U.S. News & World Report. Dr. Eichenfield has authored or contributed to more than 400 peer-reviewed journal articles and books, and has served as Editor-in-Chief of the journal Pediatric Dermatology for 12 years. He was also the Principal Investigator for Verrica’s Phase 3 CAMP clinical trial program evaluating the safety and efficacy of VP-102 for the treatment of molluscum.


About Verrica Pharmaceuticals Inc.

Verrica is a dermatology therapeutics company developing medications for viral skin diseases requiring medical interventions. The Company’s late-stage product candidate, VP-102, is a potential first-in-class topical therapy for the treatment of molluscum contagiosum. Verrica submitted an NDA for VP-102 for the treatment of molluscum in September 2019. A Complete Response Letter was received from the FDA regarding the NDA for VP-102 on July 13, 2020. 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 is currently conducting a Phase 2 study of VP-102 for the treatment of external genital warts. The Company is also developing VP-103, its second cantharidin-based product candidate, for the treatment of 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 Company’s expectations with regard to its interactions and communications with the FDA, including its expectation to discuss with the FDA regarding the issues raised in the CRL and the Company’s plans to address them, the potential approval of the NDA for VP-102 following resubmission, the potential benefits and potential approval and commercialization of VP-102 for the treatment of molluscum, and the Company’s plans with respect to planned clinical trials of VP-102 for common warts and VP-103 for 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, 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 March 31, 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.

FOR MORE INFORMATION, PLEASE CONTACT:

Investors:

A. Brian Davis

Chief Financial Officer

484.453.3300 ext. 103

info@verrica.com

Luke Brown

Solebury Trout

646.378.2944

lbrown@troutgroup.com

Media:

Joshua R. Mansbach

Solebury Trout

646.378.2964

jmansbach@troutgroup.com

# # #