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): January 3, 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. ☒
Item 7.01 Regulation FD Disclosure.
On January 3, 2019, Verrica Pharmaceuticals Inc. (the “Company”) issued a press release announcing positive topline results from two pivotal Phase 3 clinical trials of VP-102 for the treatment of molluscum contagiosum. The full text of the Company’s press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
Management of the Company will also host a conference call at 8:00 AM ET on January 3, 2019 to discuss these results. A copy of the presentation that will accompany the call is furnished as Exhibit 99.2 to this Current Report on Form 8-K.
The information in this Item 7.01 of this Current Report on Form 8-K (including Exhibits 99.1 and 99.2) is being furnished and 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 liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | ||
| 99.2 | ||
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: January 3, 2019 | /s/ Chris Degnan | |||||
| Chris Degnan | ||||||
| Chief Financial Officer | ||||||
Exhibit 99.1
Verrica Achieves Positive Topline Results from Two
Pivotal Phase 3 Clinical Trials of VP-102 in Patients
with Molluscum Contagiosum
CAMP-1 and CAMP-2 Phase 3 pivotal trials for molluscum contagiosum both achieve statistical significance for the
primary endpoint with p-values less than 0.0001
No serious adverse events in VP-102 treated subjects
Verrica to submit a Section 505(b)(1) New Drug Application (NDA) in 2H 2019
No FDA approved treatments are currently available for molluscum contagiosum, a highly contagious, primarily
pediatric, common skin disease affecting an estimated 6 million people in the United States
Management to host webcast and conference call today at 8 a.m. ET
WEST CHESTER, PA – January 3, 2019 (GLOBE NEWSWIRE) – Verrica Pharmaceuticals Inc. (Verrica) (Nasdaq: VRCA), a pharmaceutical company focused on identifying, developing and commercializing innovative pharmaceutical products for the treatment of skin diseases with significant unmet needs, today announced positive topline results from its Phase 3 CAMP-1 and CAMP-2 pivotal trials with VP-102 for the treatment of molluscum contagiosum (molluscum). Molluscum is a highly contagious skin disease affecting primarily children, with no current FDA approved treatment. Both clinical trials evaluated the safety and efficacy of VP-102, a proprietary drug-device combination containing a novel topical solution of 0.7% cantharidin, compared to placebo. In each trial, VP-102 exhibited a clinically and statistically significant proportion of subjects demonstrating complete clearance of all treatable molluscum lesions versus placebo. VP-102 was well-tolerated in both trials, with no serious adverse events reported in VP-102 treated subjects.
“The topline results from CAMP-1 and CAMP-2 validate our platform and bring us one step closer to our goal of providing patients with the first FDA approved treatment for molluscum contagiosum, a significantly undertreated skin disease affecting an estimated 6 million people in the United States,” commented Ted White, President and Chief Executive Officer of Verrica. “We believe the efficacy and safety profiles of VP-102 observed in these two trials provide a strong foundation for our U.S. NDA which we intend to submit in the second half of this year.”
The Phase 3 program for molluscum consisted of two clinical trials, CAMP-1 (study VP-102-101) and CAMP-2 (study VP-102-102). The two trials, identical in design, were randomized, double-blind, multicenter, placebo-controlled trials of VP-102 for the treatment of molluscum. CAMP-1 was conducted under an FDA Special Protocol Assessment (SPA). The primary objective of the trials was to evaluate the efficacy of dermal application of VP-102 relative to placebo, when treated once every 21 days for up to four applications, by assessing the proportion of subjects achieving complete clearance of all treatable molluscum lesions at Day 84 (Week 12/End of Study visit). Secondary endpoints included the proportion of subjects with complete clearance at study visits on Days 21 (Week 3), 42 (Week 6) and 63 (Week 9).
CAMP-1 and CAMP-2 enrolled 528 subjects in total and were conducted at 31 centers in the United States. The trials evaluated the safety and efficacy of VP-102 compared to placebo in subjects 2 years of age and older with molluscum contagiosum. Complete clearance was evaluated through assessment of lesion number at study visits
over 12 weeks. Results from CAMP-1 and CAMP-2 showed 46% and 54% of subjects treated with VP-102, respectively, achieved complete clearance of all treatable molluscum lesions at day 84 versus 18% and 13% of subjects in the placebo groups (p<0.0001). By the end of the trials (Day 84), VP-102 treated subjects had a 69% and 83% mean reduction in the number of molluscum lesions, a pre-specified endpoint, in CAMP-1 and CAMP-2, respectively, compared to 20% and 19% for subjects on placebo.
“Molluscum contagiosum can often have a negative impact on the quality of life of affected children, exacerbated by the skin irritation and inflammation that can result as complications of the disease. The high lesion clearance rate demonstrated at Day 84 for VP-102 compared to placebo in the Phase 3 trials is clinically significant and could potentially position VP-102 to become the standard of care for treating molluscum,” stated Lawrence Eichenfield, M.D., Chief of Pediatric and Adolescent Dermatology at Rady Children’s Hospital-San Diego and lead investigator for the VP-102 Phase 3 molluscum program.
Additional CAMP-1 Results
| • | The proportion of subjects achieving complete clearance at Week 9 (Day 63), a secondary endpoint, was 32% of subjects compared to 17% of placebo treated subjects (p=0.007). |
| • | The proportion of subjects achieving complete clearance at Week 6 (Day 42), a secondary endpoint, was 21% of subjects compared to 9% of placebo treated subjects (p=0.015). |
| • | The proportion of subjects achieving complete clearance at Week 3 (Day 21), a secondary endpoint, was 11% of subjects compared to 4% of placebo treated subjects (p=0.030). VP-102 demonstrated superiority over placebo with only one application of study drug. |
| • | In this trial, 160 subjects were randomized to receive VP-102 and 106 subjects were randomized to receive placebo. Of the subjects enrolled in the trial, 150 (94%) patients who received VP-102 completed the study, compared to 100 (94%) placebo treated subjects. |
Additional CAMP-2 Results
| • | The proportion of subjects achieving complete clearance at Week 9 (Day 63), a secondary endpoint, was 28% of subjects compared to 5% of placebo treated subjects (p<0.0001). |
| • | The proportion of subjects achieving complete clearance at Week 6 (Day 42), a secondary endpoint, was 13% of subjects compared to 4% of placebo treated subjects (p=0.010). |
| • | The proportion of subjects achieving complete clearance at Week 3 (Day 21), a secondary endpoint, was 5% of subjects compared to 2% of placebo treated subjects (p=0.138). |
| • | In this trial, 150 subjects were randomized to receive VP-102 and 112 subjects were randomized to receive placebo. Of the subjects enrolled in the trial, 139 (93%) subjects who received VP-102 completed the study, compared to 108 (96%) placebo treated subjects. |
Consistent with the results from the Phase 2 clinical trials, VP-102 was also well-tolerated in the Phase 3 trials, 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 treatment-related serious adverse events reported in CAMP-1 or CAMP-2.
The most frequently reported adverse events in the CAMP-1 trial (>10% in either group) were application site vesicles (81% and 25% for VP-102 and placebo, respectively), application site pain (59% and 14%), application site pruritus (55% and 30%), application site erythema (33% and 18%), application site scab (31% and 17%), application site discoloration (25% and 8%) and application site dryness (13% and 5%). Five subjects (3%) in the VP-102 group and no placebo subjects discontinued due to an adverse event.
The most frequently reported adverse events in the CAMP-2 trial (>10% in either group) were application site vesicles (94% and 30% for VP-102 and placebo, respectively), application site scab (57% and 20%), application site pain (55% and 14%), application site erythema (47%% and 25%), application site pruritus (43% and 33%), application site discoloration (31% and 8%) and application site dryness (26% and 18%). One subject each in the VP-102 and placebo groups (<1% each) discontinued due to an adverse event.
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 today 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/jka6gazi. 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 6174215 prior to the start of the call.
About VP-102
Verrica is currently advancing its lead product VP-102, a proprietary topical drug device combination therapy containing a novel topical solution of 0.7% cantharidin, for the treatment of molluscum and verruca vulgaris (common warts). Verrica is also currently evaluating and prioritizing other potential indications for VP-102 and the company’s proprietary topical solutions of cantharidin.
About Molluscum Contagiosum
Molluscum contagiosum, or molluscum, is a highly contagious, primarily pediatric, common skin disease affecting an estimated 6 million people in the United States caused by a pox virus that produces multiple raised flesh-colored papules, or skin lesions. Molluscum typically presents with 10 to 30 lesions and can present with over 100 lesions. If left untreated, molluscum lesions persist for an average of 13 months with some cases remaining unresolved for more than two years. There are currently no FDA approved drugs for molluscum.
About Verrica Pharmaceuticals Inc.
Verrica is a pharmaceutical company focused on identifying, developing and commercializing innovative pharmaceutical products for the treatment of skin diseases with significant unmet needs. Verrica is headquartered in West Chester, PA. For more information, please 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 timing of the planned submission of a new drug application for VP-102, the potential regulatory approval of VP-102 and the development of VP-102 indications in addition to molluscum. 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2018 and Verrica’s other periodic reports filed 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
415.513.1284
patti.bank@westwicke.com
For Media:
Mike Beyer
Sam Brown Inc. Healthcare Communications
312.961.2502
mikebeyer@sambrown.com
January 3, 2019 Topline Results from Phase 3 Clinical Trials of VP-102 in Patients with Molluscum Contagiosum 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 forward-looking statements in this presentation 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, filed with the U.S. Securities and Exchange Commission (SEC) on November 7, 2018, and our other periodic reports filed 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
MOLLUSCUM BACKGROUND ETIOLOGY AND CLINICAL PRESENTATION OVERVIEW Caused by a pox virus Primarily infects children, with the highest incidence occurring in children <14 years old Highly contagious If untreated, lesions persist an average of 13 months, with some cases remaining unresolved for 2+ years Often leads to anxiety and social challenges for the patients and parents and negatively impacts quality of life Transmission Skin to skin contact Sharing of contaminated objects (e.g., clothing, towels, swimming pool toys) Diagnosis & Symptoms Typically 10 to 30 lesions 100+ lesions can be observed Lesions may be the only sign of infection and are often painless Can be diagnosed with skin biopsy to differentiate from other lesions Complications Skin irritation, inflammation, and re-infection Follicular or papillary conjunctivitis if lesions on eyelids Cellulitis Copyright © 2019 Verrica Pharmaceuticals. All rights reserved.
SIGNIFICANT CLINICAL PROGRESS OF VP-102 FOR THE TREATMENT OF MOLLUSCUM TRIAL AND STATUS FORMULATION / APPLICATION METHOD TRIAL DESIGN TRIAL OBJECTIVES PHASE 3 Pivotal Trial CAMP-1 Complete VP-102 N=266 Conducted under SPA Randomized, double blind, multi-center, placebo controlled To evaluate the efficacy of dermal application of VP-102 relative to placebo for complete clearance at day 84 To assess the safety and tolerability of VP-102 Pivotal Trial CAMP-2 Complete VP-102 N=262 Randomized, double blind, multi-center, placebo controlled To evaluate the efficacy of dermal application of VP-102 relative to placebo for complete clearance at day 84 To assess the safety and tolerability of VP-102 PHASE 2 Innovate Trial Complete VP-102 Open-label, single-center N=33 To determine possible systemic exposure from a single 24-hour application of VP-102 To confirm safety and efficacy with applicator Pilot Trial Complete Our proprietary formula of cantharidin used in VP-102, applied with the wooden stick part of a cotton-tipped swab Open-label, single-center N=30 To evaluate safety and efficacy and determine optimal treatment duration
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
Population WE HAVE successfully COMPLETED TWO PIVOTAL PHASE 3 TRIALS (CAMP-1 & CAMP-2) IN MOLLUSCUM Trial Design Two identically designed, randomized, double-blinded, multicenter, placebo controlled trials CAMP-1 conducted under FDA Special Protocol Assessment (SPA) Endpoints Primary: Percent of subjects with complete clearance of molluscum at Day 84 Secondary: Percent of subjects with complete clearance at week 3, 6, and 9 Safety & tolerability Subjects 2+ years of age with MC lesions who have not received any type of treatment within the past 14 days Enrollment complete with 266 subjects for CAMP-1 and 262 subjects for CAMP-2 Application Study drug (VP-102 or placebo) is administered topically to all treatable lesions every 21 days until clearance or a maximum of 4 applications VP-102 or placebo will be left on for 24 hours before removal with soap and warm water 12-week study period
VP-102 (N=160) Placebo (N=106) VP-102 (N=150) Placebo (N=112) Randomized 160 106 150 112 Completed 150 (94%) 100 (94%) 139 (93%) 108 (96%) Age (years) Mean 7.5 6.3 7.4 7.3 Median 6.0 5.0 6.0 6.0 Min, Max 2, 41 2, 40 2, 60 2, 54 Gender Female 85 (53%) 61 (58%) 69 (46%) 46 (41%) Male 75 (47%) 45 (42%) 81 (54%) 66 (59%) Demographics CAMP-1 CAMP-2
Molluscum history VP-102 (N=150) Placebo (N=112) Time Since Clinical Diagnosis (days) Mean 118 124 Median 28 31 Min, Max 1, 977 1, 957 Age at Diagnosis Mean 7.1 7.0 Any Previous Treatment for Molluscum? Yes 48 (32%) 42 (38%) Active Atopic Dermatitis Yes 11 (7%) 7 (6%) Baseline Lesion Count Mean 19 20 Min, Max 1, 184 1, 86 CAMP-2 CAMP-1 VP-102 (N=160) Placebo (N=106) Time Since Clinical Diagnosis (days) Mean 127 129 Median 25 32 Min, Max 1, 1247 1, 1302 Age at Diagnosis Mean 7.1 6.1 Any Previous Treatment for Molluscum? Yes 44 (28%) 32 (30%) Active Atopic Dermatitis Yes 12 (8%) 13 (12%) Baseline Lesion Count Mean 22 25 Min, Max 1, 107 1, 110
PHASE 3 Studies in molluscum DEMONSTRATE statistically significant efficacy on Primary endpoint of complete CLEARANCE * Lesion count p<0.05 (pre-specified exploratory endpoint) Percentage of Subjects with Complete Clearance CAMP-2 Complete Clearance: ITT Population 83%* 71%* 58%* 24%* Lesion Count % Change from Baseline 19% 20% 13% 9% P=.010 P<.0001 P<.0001 Weeks Percentage of Subjects with Complete Clearance CAMP-1 Complete Clearance: ITT Population 69%* 51%* 45%* 38%* Lesion Count % Change from Baseline 20% 10% 5% 5% P=.015 P=.007 P<.0001 Weeks P=.030 P=.138
Subjects with at least one… VP-102 (N=160) n (%) Placebo (N=106) n (%) TEAE (Treatment Emergent AE) 130 (82) 61 (58) Mild TEAE 128 (81) 51 (48) Moderate TEAE 89 (56) 35 (33) Severe TEAE 16 (10) 1 (1) TEAE related to drug 129 (81) 45 (43) Serious TEAE 0 (0) 1 (1) TEAE leading to discontinuation 5 (3) 0 (0) Local Skin Reaction TEAE 129 (81) 45 (43) CAMP-2 Safety summary Subjects with at least one… VP-102 (N=150) n (%) Placebo (N=112) n (%) TEAE (Treatment Emergent AE) 143 (95) 74 (66) Mild TEAE 141 (94) 74 (66) Moderate TEAE 60 (40) 18 (16) Severe TEAE 4 (3) 0 (0) TEAE related to drug 143 (95) 67 (60) Serious TEAE 0 (0) 0 (0) TEAE leading to discontinuation 1 (1) 1 (1) Local Skin Reaction TEAE 143 (95) 67 (60) CAMP-1 AE= Adverse Event
Camp-1 adverse events (1) VP-102 (N=159) n (%) Placebo (N=106) n (%) PREFERRED TERM NAME MILD MOD SEV MILD MOD SEV Application site vesicles 60 (37.7) 61 (38.4) 8 (5.0) 22 (20.8) 4 (3.8) 0 (0.0) Application site pruritus 71 (44.7) 16 (10.1) 0 (0.0) 28 (26.4) 4 (3.8) 0 (0.0) Application site pain 42 (26.4) 45 (28.3) 6 (3.8) 13 (12.3) 2 (1.9) 0 (0.0) Application site erythema 25 (15.7) 27 (17.0) 0 (0.0) 14 (13.2) 5 (4.7) 0 (0.0) Application site scab 35 (22.0) 14 (8.8) 0 (0.0) 17 (16.0) 1 (0.9) 0 (0.0) Application site discoloration 36 (22.6) 4 (2.5) 0 (0.0) 8 (7.5) 0 (0.0) 0 (0.0) Application site dryness 20 (12.6) 1 (0.6) 0 (0.0) 5 (4.7) 0 (0.0) 0 (0.0) AEs occurring in >10% of subjects in any arm
Camp-2 adverse events (1) VP-102 (N=150) n (%) Placebo (N=112) n (%) PREFERRED TERM NAME MILD MOD SEV MILD MOD SEV Application site vesicles 108 (72.0) 30 (20.0) 3 (2.0) 34 (30.4) 0 (0.0) 0 (0.0) Application site scab 74 (49.3) 11 (7.3) 0 (0.0) 20 (17.9) 2 (1.8) 0 (0.0) Application site pruritus 60 (40.0) 5 (3.3) 0 (0.0) 29 (25.9) 8 (7.1) 0 (0.0) Application site pain 69 (46.0) 14 (9.3) 0 (0.0) 16 (14.3) 0 (0.0) 0 (0.0) Application site erythema 41 (27.3) 28 (18.7) 1 (0.7) 22 (19.6) 6 (5.4) 0 (0.0) Application site dryness 35 (23.3) 4 (2.7) 0 (0.0) 19 (17.0) 1 (0.9) 0 (0.0) Application site discoloration 39 (26.0) 7 (4.7) 0 (0.0) 9 (8.0) 0 (0.0) 0 (0.0) AEs occurring in >10% of subjects in any arm
Realizing the Molluscum Opportunity Prevalence in the US of 5.1% to 11.5% in children aged 0-16 years. (Fam Pract. 2014 Apr;31(2):130-6). US Census estimates ~69.4MM children aged 0 to 16 years in 2016. IQVIA projected dataset for 12 months ending October 2017 Not Diagnosed 5.1 million US Prevalence of ~6 million in molluscum(1) with ~1 million diagnosed annually(2) 85% 15% Diagnosed 0.9 million
DATE EVENT 1Q 2018 Received go ahead from FDA to initiate two Phase 3 trials, 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 1H 2019 Initiate Phase 2 trial in genital warts 2Q 2019 Topline results from Phase 2 trial in common warts 2H 2019 VP-102 NDA submission in molluscum 2H 2019 VP-103 IND submission in plantar warts 2H 2019 Initiate pivotal trials in common warts SIGNIFICANT recent and EXPECTED clinical MILESTONES
VP-102 exhibited a clinically and statistically significant proportion of subjects demonstrating complete clearance of all treatable molluscum lesions versus placebo in both Phase 3 pivotal trials 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 No FDA approved treatments are currently available for molluscum contagiosum, a highly contagious, primarily pediatric, common skin disease affecting an estimate 6 million people in the United States Verrica to submit a Section 505(b)(1) New Drug Application in 2H 2019 and potentially positioning VP-102 to become the standard of care for the treatment of molluscum summary & path forward