EX-99.2 3 d737187dex992.htm EX-99.2 EX-99.2

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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


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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


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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.


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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