Verrica Pharmaceuticals Inc. · NASDAQ:VRCA
Verrica Pharmaceuticals — Technical Presentation (January 2019)
15 slides from Verrica Pharmaceuticals's technical presentation, Jan 3, 2019
Slide 1: Topline Results from Phase 3 Clinical Trials of VP-102 in Molluscum Contagiosum
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
Slide 2: Forward-looking statements and third-party data
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
Slide 3: Molluscum Background
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
Slide 4: Significant Clinical Progress of VP-102 for the Treatment of Molluscum
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 eff
Slide 5: Cantharidin Has a Proven Dual Mechanism of Action
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 in
Slide 6: Successfully Completed Two Pivotal Phase 3 Trials (CAMP-1 & CAMP-2)
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 sub
Slide 7: Demographics CAMP-1 and CAMP-2
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%)
Slide 8: Molluscum History
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 2
Slide 9: Phase 3 Studies Demonstrate Statistically Significant Efficacy on Complete Clearance
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 %
Slide 10: Safety Summary CAMP-1 and CAMP-2
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)
Slide 11: CAMP-1 Adverse Events
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
Slide 12: CAMP-2 Adverse Events
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
Slide 13: Realizing the Molluscum Opportunity
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
Slide 14: Significant Recent and Expected Clinical Milestones
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
Slide 15: Summary & Path Forward
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
Verrica Pharmaceuticals — Technical Presentation (January 2019) on 6ix