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): June 26, 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 7.01 | Regulation FD Disclosure |
On June 26, 2019, Verrica Pharmaceuticals Inc. (the “Company”) issued a press release reporting positive topline results from the Phase 2 clinical study of VP-102 in patients with common warts, as well as information regarding a conference call to discuss these results and other clinical updates. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. A copy of the presentation that will accompany the conference call is furnished herewith as Exhibit 99.2 to this Current Report on Form 8-K.
The information included in this Item 7.01 of this Current Report on Form 8-K, including the attached Exhibit 99.1 and Exhibit 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit Number |
Exhibit Description | |
| 99.1 | Press Release, dated June 26, 2019 | |
| 99.2 | Verrica Pharmaceuticals Inc. Presentation | |
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: June 27, 2019 | /s/ Chris Degnan | |||||
| Chris Degnan | ||||||
| Chief Financial Officer | ||||||
Exhibit 99.1
Verrica Pharmaceuticals Achieves Positive Topline Results in Phase 2
Clinical Study of VP-102 in Patients with Common Warts
51% of subjects in Cohort 2 achieved complete clearance of all treatable warts
VP-102 was well-tolerated with no serious adverse events reported
Common warts affect approximately 22 million people in the United States
Based on positive outcome, Verrica to request an ‘End of Phase 2’ meeting with the FDA
Management to host webcast and conference call tomorrow at 8 a.m. ET
WEST CHESTER, PA – June 26, 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 positive topline results from its COVE-1 Phase 2 open label clinical study of VP-102 for the treatment of verruca vulgaris, or common warts. COVE-1 included two cohorts that evaluated the safety and efficacy of VP-102, a novel topical therapy containing a solution of 0.7% cantharidin in a proprietary single-use applicator, in subjects with up to six warts. In both cohorts, VP-102 achieved positive results on both the primary endpoint of complete clearance of all treatable warts at Day 84 and the secondary endpoint of the percentage reduction of warts. VP-102 was well-tolerated with no serious adverse events reported.
“This is exciting news for Verrica and our proprietary cantharidin product. Positive Phase 2 data of VP-102 for the treatment of common warts, after the successful Phase 3 results achieved with VP-102 for molluscum contagiosum, further increases our confidence in the broad clinical utility and large market potential of our lead product,” said Ted White, President and Chief Executive Officer of Verrica. “We are progressing the development of VP-102 for a broad range of skin diseases. We intend to request an ‘End of Phase 2’ meeting with the FDA for the treatment of common warts, and remain on track to submit an NDA for the treatment of molluscum contagiosum later this year.”
Study Results:
The COVE-1 Phase 2 open label clinical study included two cohorts that evaluated the safety and efficacy of VP-102 in subjects with up to six warts. Cohort 1 was conducted at a single site with 21 subjects age 2 years and older receiving up to 4 treatments with VP-102 at least 14 days between treatments with longer treatment intervals allowed at the discretion of the investigator depending on a specific subject’s clinical response. While the study was ongoing, Verrica amended the protocol to allow varying treatment intervals in Cohort 1 at the discretion of the investigator in order to identify the optimal treatment dosing regimen and added a second cohort to the study.
Cohort 2 was conducted at four sites with 35 subjects age 12 years and older receiving up to 4 treatments with VP-102 every 21 days. Paring of warts, a technique commonly used by dermatologists to prepare the wart for treatment, was allowed in Cohort 2 to remove any adherent thick scale from a wart prior to application of study drug. The primary analysis was conducted at Day 84 with an additional period of follow-up through Day 147. Topline analysis included data from the assessment of warts at study visits over 12 weeks. Results showed 51% of subjects (18 of 35) treated with VP-102 in Cohort 2 achieved complete clearance of all treatable warts at Day 84. Secondary endpoints included the percent change from baseline in the number of treatable warts and VP-102 achieved a 51% reduction in the number of warts (28 of 55 warts) compared to baseline by Day 84.
Consistent with the results from the Phase 3 clinical trials in molluscum, VP-102 was also well-tolerated with side effects that were primarily mild-to-moderate. The most frequently reported adverse events were application site reactions that are well-known, reversible side effects related to the mechanism of action of cantharidin, a blistering agent, which is the active ingredient in VP-102. There were no serious adverse events reported.
“Behind acne, warts are the most common dermatological complaint and our treatment options are limited as there are no FDA-approved treatments,” said Scott T. Guenthner, MD, FAAD, founder of the Dermatology Center of Indiana and lead investigator for the COVE-1 study. “Further, common warts are very persistent and difficult to treat, which is frustrating to patients. The data results on the complete clearance of treatable warts and the percentage of wart reduction in this Phase 2 study is very meaningful and highlight the potential of VP-102 as an important new option for people with common warts.”
In addition to requesting an End of Phase 2 meeting with the FDA on next steps for the development of VP-102 for the treatment of common warts, Verrica plans to submit this data for presentation at future medical meetings and for publication in a peer-reviewed medical journal.
Verrica Conference Call
Management will conduct a conference call at 8 a.m. ET tomorrow, June 27, 2019, to discuss the results. The conference call will be webcast and can be accessed by logging on to the “Investors” section of the Verrica website, www.verrica.com, prior to the event.
The webcast will also be available via the following link: https://edge.media-server.com/m6/p/ju8namrg. A replay of the webcast will be archived on the Company’s website for 30 days following the call.
To participate on the live call, please dial 866-688-9534 (domestic) or 409-216-0837 (international), and reference conference ID 7183118 prior to the start of the call.
About Common Warts
Common warts (verruca vulgaris) are skin growths caused by a contagious viral skin infection, most commonly on the fingers or hands. The human papilloma virus (HPV), the causative agent in common warts, is transmitted by touch. The virus enters the skin and causes skin growths by inducing the skin cells to multiply rapidly. Common warts are benign, but treatment is recommended to prevent the spread of infection and relieve the patient’s physical and psychological discomfort.
About Verrica Pharmaceuticals Inc.
Verrica Pharmaceuticals Inc. 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, a New Drug Application for VP-102 for the treatment of molluscum is planned for the second half of 2019. 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. An additional Phase 2 trial is 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 further advancement of VP-102 for the treatment of common warts, submission of a NDA in the second half of 2019 for VP-102 for the treatment of molluscum and the large market potential of VP-102. 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.
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
For Media:
Mike Beyer
Sam Brown Inc. Healthcare Communications
312.961.2502
mikebeyer@sambrown.com
June 27, 2019 Topline Results from COVE-1: Phase 2 Clinical Trial of VP-102 in Patients with Common Warts Copyright © 2019 Verrica Pharmaceuticals. All rights reserved. Exhibit 99.2
Certain information contained in this presentation and statements made orally during this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and Verrica’s own internal estimates and research. While Verrica believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. While Verrica believes its internal research is reliable, such research has not been verified by any independent source. This presentation contains forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results and other future conditions. All statements other than statements of historical facts contained in this presentation, including statements regarding future results of operations and financial position, business strategy, current and prospective product candidates, planned clinical trials and preclinical activities, product approvals, degree of market acceptance of approved products, research and development costs, current and prospective collaborations, timing and likelihood of success, plans and objectives of management for future operations, and future results of anticipated product candidates, are forward-looking statements. The words ”may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The information in this presentation, including without limitation the forward-looking statements contained herein, represent our views as of the date of this presentation. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. The forward-looking statements in this presentation 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, our reliance on third parties over which we may not always have full control, and other risks and uncertainties that are described in our Annual Report on Form 10-K for the year ended December 31, 2018, filed with the U.S. Securities and Exchange Commission (SEC) on March 7, 2019, and our other filings made with the SEC. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. There can be no assurance that the opportunity will meet your investment objectives, that you will receive a return of all or part of such investment. Investment results may vary significantly over any given time period. The appropriateness of a particular investment or strategy will depend on an investor's individual circumstances and objectives. We recommend that investors independently evaluate specific investments and strategies. DISCLAIMER
VERRUCA VULGARIS (COMMON WARTS) ETIOLOGY AND CLINICAL PRESENTATION OVERVIEW Caused by human papilloma virus (HPV) Infects patients of all ages Persistent infection, highly refractory Typically 2-5 lesions No FDA approved drug for the treatment of common warts Transmission Skin to skin contact Touching of contaminated objects Diagnosis & Symptoms Dome shaped flesh-colored lesions commonly on the hands, fingers, knees or elbows Lesions may occur in groups or in a linear pattern Lesions can cause considerable pain and discomfort, may spread with skin trauma, and can be itchy Complications Scarring may occur Dyspigmentation of affected areas Bacterial superinfection of lesions Irritation, pain, and redness of surrounding skin Copyright © 2019 Verrica Pharmaceuticals. All rights reserved.
CANTHARIDIN HAS A PROVEN DUAL MECHANISM OF ACTION Targeted Destruction of Infected Skin Leads to Lesion Clearance Once applied, cantharidin activates neutral serine proteases that cause degeneration of the desmosomal plaque, leading to detachment of tonofilaments from desmosomes.(1) This leads to intraepidermal blistering and nonspecific lysis of the skin, causing the tissues containing the virus to separate from the surrounding skin. Since acantholysis is intraepidermal, healing occurs without scarring. 1 Elicits Inflammation & Immune Response with Potential to Boost Viral Immune Response Leukocyte infiltration includes neutrophils, macrophages, B and T cells and eosinophils Release of chemokines and cytokines including TNF-a, IL-8 and CXCL-5 Cantharidin is used in the laboratory as a model for studying leukocyte trafficking and cytokine production.(2) 2 J Invest Dermatol. 1962 Jul;39:39-45. J Immunol Methods. 2001 Nov 1;257(1-2):213-20.2 Desmosome Cleavage and Blister Formation Lymphocyte Neutrophil Eosinophil Macrophage
WE HAVE successfully COMPLETED A PHASE 2 STUDY (COVE-1) IN common WARTS Study Design Cohort 1: one center Cohort 2: four centers Efficacy, safety & tolerability Endpoints Primary Percent of subjects with complete clearance of all treatable warts (baseline and new) at Day 84 Secondary Percent of subjects achieving complete clearance of all treatable warts at Visits 2, 3, and 4 Change from baseline in number (%) of treatable warts at Day 84 Patients Cohort 1: 21 subjects 2+ years of age with common warts, who have not received any type of treatment within the past 14 days Application Study drug (VP-102) is administered topically to each treatable wart to a maximum of 4 applications Cohort 1 is treated until clear, Cohort 2 receives one additional treatment at the first visit clearance was observed up to a maximum of 4 total applications Frequency of administration is at least 14 days (Cohort 1) or 21 days (Cohort 2) Paring was allowed in Cohort 2 VP-102 will be left on for 24 hours before removal with soap and warm water Open label study with two cohorts Cohort 2: 35 subjects 12+ years of age with common warts, who have not received any type of treatment within the past 14 days
VP-102 (N=21) VP-102 (N=35) Randomized 21 35 Age (years) Mean 38 38 Median 37 42 Min, Max 7, 83 12, 67 Gender Female 11 (52.4%) 22 (62.9%) Male 10 (47.6%) 13 (37.1%) Discontinued 4 (19.0%) 2 (5.7%) Lost to follow-up 2 (9.5%) 1 (2.9%) Withdrawal by subject 2 (9.5%) 0 Protocol violation 0 1 (2.9%) Demographics in cove-1 STUDY COHORT 1 COHORT 2
VP-102 (N=35) Time Since Clinical Diagnosis (months) Mean 15.9 Age at Diagnosis Mean 36.4 Any Previous Treatment for Common Warts? Yes 24 (68.6%) Wart number at Baseline Mean 1.65 VP-102 (N=21) Time Since Clinical Diagnosis (months) Mean 70.3 Age at Diagnosis Mean 32.1 Any Previous Treatment for Common Warts? Yes 3 (14.3%) Wart number at Baseline Mean 2.19 Wart history for subjects in cove-1 STUDY Cohort 2 Cohort 1
VP-102 demonstrated Clinically meaningful efficacy on Primary endpoint of complete CLEARANCE in COVE-1 STUDY Percentage of Subjects with Complete Clearance COHORT 1 Weeks1 44% 35% 20% 2% Wart count: % Change from Baseline Percentage of Subjects with Complete Clearance COHORT 2 Weeks 51% 31% 29% 24% Wart count: % Change from Baseline Cohort 1 was amended to allow varying treatment intervals beyond every 14 days depending on a specific subject’s clinical response
Subjects with at least one… VP-102 (N=21) n (%) TEAE (Treatment Emergent AE) 20 (95.2) Mild TEAE 20 (95.2) Moderate TEAE 9 (42.9) Severe TEAE 2 (9.5) TEAE related to drug 20 (95.2) Serious TEAE 0 (0) TEAE leading to discontinuation 0 (0) Local Skin Reaction TEAE 20 (95.2) TEAE of Papilloma Viral Infection 0 (0) COHORT 2 Safety summary for COVE-1 STUDY Subjects with at least one… VP-102 (N=34) n (%) TEAE (Treatment Emergent AE) 32 (94.1) Mild TEAE 32 (94.1) Moderate TEAE 19 (55.9) Severe TEAE 4 (11.8) TEAE related to drug 32 (94.1) Serious TEAE 0 (0) TEAE leading to discontinuation 0 (0) Local Skin Reaction TEAE 32 (94.1) TEAE of Papilloma Viral Infection 3 (8.8) COHORT 1 AE= Adverse Event
adverse events in cove-1 study Cohort 1 (N= 21) n (%) Cohort 2 (N=34) n (%) PREFERRED TERM NAME Application site vesicles 20 (95.2) 27 (79.4) Application site pain 20 (95.2) 26 (76.5) Application site erythema 13 (61.9) 19 (55.9) Application site pruritus 9 (42.9) 16 (47.1) Application site scab 8 (38.1) 19 (55.9) Application site discoloration 1 (4.8) 8 (23.5) Application site dryness 6 (28.6) 14 (41.2) AEs occurring in >20% of subjects in any arm
Realizing the common warts Opportunity Nguyen et al, Laser Treatment of Nongenital Verrucae A Systemic Review. JAMA Dermatology. 2016; 152(9): 1025-1033 IQVIA Anonymous Longitudinal Patient Level Data (APLD) for 12 months ending September 2018 Prevalence in U.S. US Prevalence of ~22 million in common warts(1) with ~1.5 million diagnosed annually(2) 22M 1.5M Patients Diagnosed Annually
DATE EVENT 1Q 2018 Received go ahead from FDA to initiate two Phase 3 trials in molluscum, including SPA on pivotal trial 1Q 2018 Initiated Phase 3 trials for molluscum and Phase 2 trial for common warts 3Q 2018 Completed enrollment in two pivotal Phase 3 trials in molluscum 1Q 2019 Positive topline results from two pivotal Phase 3 trials in molluscum 2Q 2019 Positive topline results from Phase 2 trial in common warts 2Q 2019 Initiate Phase 2 trial in external genital warts 2H 2019 VP-102 NDA submission in molluscum 2H 2019 VP-103 IND submission in plantar warts 1Q 2020 Initiate pivotal trials in common warts SIGNIFICANT recent and EXPECTED clinical MILESTONES
VP-102 exhibited a clinically meaningful proportion of subjects demonstrating complete clearance of all treatable warts with a treatment regimen of up to 4 applications administered every 21 days VP-102 was well-tolerated, with no serious adverse events reported No FDA approved treatments are currently available for common warts, a contagious viral infection of the skin affecting an estimated 22 million people in the United States Based on positive outcome, Verrica to request an ‘End of Phase 2’ meeting with the FDA summary & path forward