UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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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).
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| Item 7.01 | Regulation FD Disclosure. |
On September 8, 2020, Verrica Pharmaceuticals Inc. (the “Company”) will be updating its company overview presentation on its website, a copy of which is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1) 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 Number |
Exhibit Description | |
| 99.1 | Company Presentation | |
| 104 | Cover Page Interactive Data File (embedded with Inline XBRL document). | |
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: September 8, 2020 | /s/ A. Brian Davis | |||
| A. Brian Davis | ||||
| Chief Financial Officer | ||||
Exhibit 99.1 Company Overview September 2020 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.Exhibit 99.1 Company Overview September 2020 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
DISCLAIMER Certain information contained in this presentation and statements made orally during The information in this presentation, including without limitation the forward-looking this presentation relates to or is based on studies, publications, surveys and other data statements contained herein, represent our views as of the date of this presentation. obtained from third-party sources and Verrica’s own internal estimates and research. Although we believe the expectations reflected in such forward-looking statements are While Verrica believes these third-party sources to be reliable as of the date of this reasonable, we can give no assurance that such expectations will prove to be correct. presentation, it has not independently verified, and makes no representation as to the Accordingly, readers are cautioned not to place undue reliance on these forward- adequacy, fairness, accuracy or completeness of, any information obtained from third- looking statements. Except as required by applicable law, we do not plan to publicly party sources. While Verrica believes its internal research is reliable, such research has update or revise any forward-looking statements contained herein, whether as a result not been verified by any independent source. 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 This presentation contains forward-looking statements. Forward-looking statements are involve risks and uncertainties that could cause actual results to differ materially from neither historical facts nor assurances of future performance. Instead, they are based on those reflected in such statements. Risks and uncertainties that may cause actual results our current beliefs, expectations and assumptions regarding the future of our business, to differ materially include uncertainties inherent in the drug development process and future plans and strategies, our clinical results and other future conditions. All the regulatory approval process, our reliance on third parties over which we may not statements other than statements of historical facts contained in this presentation, always have full control, and other risks and uncertainties that are described in our including statements regarding future results of operations and financial position, Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. business strategy, interactions with the FDA, including regarding the CRL Verrica Securities and Exchange Commission (SEC) on March 13, 2020, our Quarterly report on received related to its NDA submission for VP-102 for the treatment of molluscum, Form 10-Q for the quarter ended June 30, 2020, filed with the SEC on August 5, 2020, current and prospective product candidates, planned clinical trials and preclinical and our other filings made with the SEC. New risk factors and uncertainties may emerge activities, product approvals, degree of market acceptance of approved products, from time to time, and it is not possible to predict all risk factors and research and development costs, current and prospective collaborations, timing and uncertainties. There can be no assurance that the opportunity will meet your investment likelihood of success, plans and objectives of management for future operations, and objectives, that you will receive a return of all or part of such investment. Investment future results of anticipated product candidates, are forward-looking statements. The results may vary significantly over any given time period. The appropriateness of a words ”may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” particular investment or strategy will depend on an investor's individual circumstances “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of and objectives. We recommend that investors independently evaluate specific these terms or other similar expressions are intended to identify forward-looking investments and strategies. statements, although not all forward-looking statements contain these identifying words. 2 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.DISCLAIMER Certain information contained in this presentation and statements made orally during The information in this presentation, including without limitation the forward-looking this presentation relates to or is based on studies, publications, surveys and other data statements contained herein, represent our views as of the date of this presentation. obtained from third-party sources and Verrica’s own internal estimates and research. Although we believe the expectations reflected in such forward-looking statements are While Verrica believes these third-party sources to be reliable as of the date of this reasonable, we can give no assurance that such expectations will prove to be correct. presentation, it has not independently verified, and makes no representation as to the Accordingly, readers are cautioned not to place undue reliance on these forward- adequacy, fairness, accuracy or completeness of, any information obtained from third- looking statements. Except as required by applicable law, we do not plan to publicly party sources. While Verrica believes its internal research is reliable, such research has update or revise any forward-looking statements contained herein, whether as a result not been verified by any independent source. 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 This presentation contains forward-looking statements. Forward-looking statements are involve risks and uncertainties that could cause actual results to differ materially from neither historical facts nor assurances of future performance. Instead, they are based on those reflected in such statements. Risks and uncertainties that may cause actual results our current beliefs, expectations and assumptions regarding the future of our business, to differ materially include uncertainties inherent in the drug development process and future plans and strategies, our clinical results and other future conditions. All the regulatory approval process, our reliance on third parties over which we may not statements other than statements of historical facts contained in this presentation, always have full control, and other risks and uncertainties that are described in our including statements regarding future results of operations and financial position, Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. business strategy, interactions with the FDA, including regarding the CRL Verrica Securities and Exchange Commission (SEC) on March 13, 2020, our Quarterly report on received related to its NDA submission for VP-102 for the treatment of molluscum, Form 10-Q for the quarter ended June 30, 2020, filed with the SEC on August 5, 2020, current and prospective product candidates, planned clinical trials and preclinical and our other filings made with the SEC. New risk factors and uncertainties may emerge activities, product approvals, degree of market acceptance of approved products, from time to time, and it is not possible to predict all risk factors and research and development costs, current and prospective collaborations, timing and uncertainties. There can be no assurance that the opportunity will meet your investment likelihood of success, plans and objectives of management for future operations, and objectives, that you will receive a return of all or part of such investment. Investment future results of anticipated product candidates, are forward-looking statements. The results may vary significantly over any given time period. The appropriateness of a words ”may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” particular investment or strategy will depend on an investor's individual circumstances “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of and objectives. We recommend that investors independently evaluate specific these terms or other similar expressions are intended to identify forward-looking investments and strategies. statements, although not all forward-looking statements contain these identifying words. 2 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
Providing meaningful benefit for people living with skin diseases Reinventing Developing dermatology dermatology therapeutics by products focusing on development and commercialization Late-stage dermatology therapeutics company Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 3 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.Providing meaningful benefit for people living with skin diseases Reinventing Developing dermatology dermatology therapeutics by products focusing on development and commercialization Late-stage dermatology therapeutics company Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 3 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
INVESTMENT HIGHLIGHTS Dermatology Oncology YCANTH™ in Development to Address Two of the Largest Unmet Needs in Dermatology • Worldwide rights to LTX-315: first-in-class oncolytic peptide injected directly into tumor (1) • Prevalence of ~6 million in molluscum contagiosum (2) • Positive tumor-specific immune cell responses in multi- and ~22 million in common warts in the U.S. indication Phase 1/2 oncology trials • No FDA approved drugs to treat molluscum or warts • Verrica to focus initially on development to treat basal cell and squamous cell carcinomas Type A Meeting Request with FDA submitted August 2020 for YCANTH™ (VP-102) for the Treatment of Molluscum • 5.4 million diagnoses annually in the U.S. of basal and (4) squamous cell skin cancers ; patients typically treated with • CRL received July 2020 focused on CMC and human factors surgery validation (no clinical safety or efficacy deficiencies) • Submission of U.S. IND anticipated during first half of 2021 Positive Phase 3 Results in Molluscum Contagiosum • Achieved statistical significance for primary endpoints in two Option Agreement with Torii Pharmaceuticals for pivotal trials for YCANTH™ (VP-102) Development and Commercialization of VP-102 in Japan • Torii option includes Verrica product candidates for the • P-value <0.0001 for primary endpoint in both pivotal trials treatment of molluscum and common warts in Japan Innovative Product Candidate Proven Team • Proprietary drug-device combination of formulation • Industry-leading, experienced management team with extensive and single-use applicator dermatology product launch experience Physician Acceptance • Strengthened clinical and drug development leadership in (3) August 2020 • 95% of pediatric dermatologists have used API (1) 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. (2) IMS National Disease and Therapeutic Index (NDTI) Rolling 5 Years Ending June 2016. Nguyen et al, Laser Treatment of Nongenital Verrucae A Systemic Review. JAMA Dermatology. 2016; 152(9): 1025-1033 (3) Based on a survey of 115 dermatologists the results of which have been extrapolated to pediatric dermatologists. (4) https://www.cancer.org/cancer/basal-and-squamous-cell-skin-cancer/about/key-statistics.html and Rogers JAMA Derm 2015 4 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.INVESTMENT HIGHLIGHTS Dermatology Oncology YCANTH™ in Development to Address Two of the Largest Unmet Needs in Dermatology • Worldwide rights to LTX-315: first-in-class oncolytic peptide injected directly into tumor (1) • Prevalence of ~6 million in molluscum contagiosum (2) • Positive tumor-specific immune cell responses in multi- and ~22 million in common warts in the U.S. indication Phase 1/2 oncology trials • No FDA approved drugs to treat molluscum or warts • Verrica to focus initially on development to treat basal cell and squamous cell carcinomas Type A Meeting Request with FDA submitted August 2020 for YCANTH™ (VP-102) for the Treatment of Molluscum • 5.4 million diagnoses annually in the U.S. of basal and (4) squamous cell skin cancers ; patients typically treated with • CRL received July 2020 focused on CMC and human factors surgery validation (no clinical safety or efficacy deficiencies) • Submission of U.S. IND anticipated during first half of 2021 Positive Phase 3 Results in Molluscum Contagiosum • Achieved statistical significance for primary endpoints in two Option Agreement with Torii Pharmaceuticals for pivotal trials for YCANTH™ (VP-102) Development and Commercialization of VP-102 in Japan • Torii option includes Verrica product candidates for the • P-value <0.0001 for primary endpoint in both pivotal trials treatment of molluscum and common warts in Japan Innovative Product Candidate Proven Team • Proprietary drug-device combination of formulation • Industry-leading, experienced management team with extensive and single-use applicator dermatology product launch experience Physician Acceptance • Strengthened clinical and drug development leadership in (3) August 2020 • 95% of pediatric dermatologists have used API (1) 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. (2) IMS National Disease and Therapeutic Index (NDTI) Rolling 5 Years Ending June 2016. Nguyen et al, Laser Treatment of Nongenital Verrucae A Systemic Review. JAMA Dermatology. 2016; 152(9): 1025-1033 (3) Based on a survey of 115 dermatologists the results of which have been extrapolated to pediatric dermatologists. (4) https://www.cancer.org/cancer/basal-and-squamous-cell-skin-cancer/about/key-statistics.html and Rogers JAMA Derm 2015 4 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
OUR PRODUCT PORTFOLIO NEXT EXPECTED PRE-IND PHASE 2 PHASE 3 NDA MILESTONE FDA Type A Meeting in September/October Molluscum Contagiosum 2020* Initiate pivotal Phase 3 Common Warts trials** Topline Phase 2 results External Genital Warts in 2H 2020 Initiate Phase 2 trial** Plantar Warts Non-Melanoma Submit US IND during 1H 2021 Skin Cancer*** * July 13, 2020 CRL focused on CMC and human factors validation - no clinical data requested ** Timing for initiating new clinical trials to be determined *** Initially focused on basal cell and squamous cell carcinomas 5 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. LTX-315 VP-103 VP-102 YCANTHOUR PRODUCT PORTFOLIO NEXT EXPECTED PRE-IND PHASE 2 PHASE 3 NDA MILESTONE FDA Type A Meeting in September/October Molluscum Contagiosum 2020* Initiate pivotal Phase 3 Common Warts trials** Topline Phase 2 results External Genital Warts in 2H 2020 Initiate Phase 2 trial** Plantar Warts Non-Melanoma Submit US IND during 1H 2021 Skin Cancer*** * July 13, 2020 CRL focused on CMC and human factors validation - no clinical data requested ** Timing for initiating new clinical trials to be determined *** Initially focused on basal cell and squamous cell carcinomas 5 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. LTX-315 VP-103 VP-102 YCANTH
YCANTH™ IN DEVELOPMENT TO ADDRESS TWO OF THE LARGEST UNMET NEEDS IN DERMATOLOGY Common Warts Molluscum (3) (1) US Prevalence of ~22 million with US Prevalence of ~6 million with (4) (2) ~1.5 million diagnosed annually ~1 million diagnosed annually 22M 85% Prevalence in U.S. Not Diagnosed 5.1 million 1.5M Patients Diagnosed Annually 15% Diagnosed 0.9 million (1) 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. (2) IQVIA projected dataset for 12 months ending October 2017 (3) IMS National Disease and Therapeutic Index (NDTI) Rolling 5 Years Ending June 2016. Nguyen et al, Laser Treatment of Nongenital Verrucae A Systemic Review. JAMA Dermatology. 2016; 152(9): 1025-1033 (4) IQVIA Anonymous Longitudinal Patient Level Data (APLD) for 12 months ending September 2018 6 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.YCANTH™ IN DEVELOPMENT TO ADDRESS TWO OF THE LARGEST UNMET NEEDS IN DERMATOLOGY Common Warts Molluscum (3) (1) US Prevalence of ~22 million with US Prevalence of ~6 million with (4) (2) ~1.5 million diagnosed annually ~1 million diagnosed annually 22M 85% Prevalence in U.S. Not Diagnosed 5.1 million 1.5M Patients Diagnosed Annually 15% Diagnosed 0.9 million (1) 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. (2) IQVIA projected dataset for 12 months ending October 2017 (3) IMS National Disease and Therapeutic Index (NDTI) Rolling 5 Years Ending June 2016. Nguyen et al, Laser Treatment of Nongenital Verrucae A Systemic Review. JAMA Dermatology. 2016; 152(9): 1025-1033 (4) IQVIA Anonymous Longitudinal Patient Level Data (APLD) for 12 months ending September 2018 6 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
THE PROBLEM Molluscum Contagiosum Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.THE PROBLEM Molluscum Contagiosum Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
MOLLUSCUM BACKGROUND ETIOLOGY AND CLINICAL PRESENTATION OVERVIEW • Skin to skin contact Caused by a pox virus Transmission • Sharing of contaminated objects (e.g., clothing, towels, swimming pool toys) Primarily infects children, with the highest incidence occurring in children <14 years old Diagnosis • Typically 10 to 30 lesions & Symptoms • 100+ lesions can be observed Highly contagious • Lesions may be the only sign of infection and are often painless If untreated, lesions persist an • Can be diagnosed with skin biopsy average of 13 months, with some cases to differentiate from other lesions remaining unresolved for 2+ years • Skin irritation, inflammation, and re-infection Complications Often leads to anxiety and social • Follicular or papillary conjunctivitis if lesions on eyelids challenges for the patients and parents and negatively impacts quality of life • Cellulitis Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 8 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.MOLLUSCUM BACKGROUND ETIOLOGY AND CLINICAL PRESENTATION OVERVIEW • Skin to skin contact Caused by a pox virus Transmission • Sharing of contaminated objects (e.g., clothing, towels, swimming pool toys) Primarily infects children, with the highest incidence occurring in children <14 years old Diagnosis • Typically 10 to 30 lesions & Symptoms • 100+ lesions can be observed Highly contagious • Lesions may be the only sign of infection and are often painless If untreated, lesions persist an • Can be diagnosed with skin biopsy average of 13 months, with some cases to differentiate from other lesions remaining unresolved for 2+ years • Skin irritation, inflammation, and re-infection Complications Often leads to anxiety and social • Follicular or papillary conjunctivitis if lesions on eyelids challenges for the patients and parents and negatively impacts quality of life • Cellulitis Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 8 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
CURRENT DESCRIPTION LIMITATIONS TREATMENTS • Pain and scarring Freezing the lesions FOR MOLLUSCUM Cryotherapy with liquid nitrogen • Unsuitable for use in children ARE NOT FDA Using a curette or a surgical APPROVED AND • Pain and scarring instrument with a scoop at Curettage • Unsuitable for use in children HAVE MANY the tip to scrape the lesions LIMITATIONS • Pain, cost and lack Laser Applying a laser to target of availability and destroy the lesions Surgery • Unsuitable for use in children Applying various acids Topical (e.g. salicylic acid), creams • Unproven efficacy or blistering solutions to Broad use limited by Products destroy the lesions unproven efficacy, scarring, lack of availability, Retinoids, antiviral • Limited efficacy Off-Label safety concerns & pain medicines, or immune • Side-effects Drugs modulating therapies Significantly • Unproven efficacy Applying natural oils undertreated Natural (e.g. tea tree oil) with • Pain, irritation and Remedies antimicrobial properties patient population allergic reactions 9 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.CURRENT DESCRIPTION LIMITATIONS TREATMENTS • Pain and scarring Freezing the lesions FOR MOLLUSCUM Cryotherapy with liquid nitrogen • Unsuitable for use in children ARE NOT FDA Using a curette or a surgical APPROVED AND • Pain and scarring instrument with a scoop at Curettage • Unsuitable for use in children HAVE MANY the tip to scrape the lesions LIMITATIONS • Pain, cost and lack Laser Applying a laser to target of availability and destroy the lesions Surgery • Unsuitable for use in children Applying various acids Topical (e.g. salicylic acid), creams • Unproven efficacy or blistering solutions to Broad use limited by Products destroy the lesions unproven efficacy, scarring, lack of availability, Retinoids, antiviral • Limited efficacy Off-Label safety concerns & pain medicines, or immune • Side-effects Drugs modulating therapies Significantly • Unproven efficacy Applying natural oils undertreated Natural (e.g. tea tree oil) with • Pain, irritation and Remedies antimicrobial properties patient population allergic reactions 9 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
THE SOLUTION YCANTH™ (VP-102) Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.THE SOLUTION YCANTH™ (VP-102) Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
YCANTH™ (VP-102) IS A PROPRIETARY DRUG-DEVICE COMBINATION OF CANTHARIDIN ADMINISTERED THROUGH OUR SINGLE-USE PRECISION APPLICATOR GMP-controlled new formulation of 0.7% w/v cantharidin • Consistent and shelf-stable Single-use applicator to reduce cross-contamination and allow for more effective application of drug by HCP Visualization agent to identify treated lesions Bittering agent to deter oral ingestion Clinician administered, In-Office Procedure Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 11 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.YCANTH™ (VP-102) IS A PROPRIETARY DRUG-DEVICE COMBINATION OF CANTHARIDIN ADMINISTERED THROUGH OUR SINGLE-USE PRECISION APPLICATOR GMP-controlled new formulation of 0.7% w/v cantharidin • Consistent and shelf-stable Single-use applicator to reduce cross-contamination and allow for more effective application of drug by HCP Visualization agent to identify treated lesions Bittering agent to deter oral ingestion Clinician administered, In-Office Procedure Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 11 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
REGULATORY STATUS • NDA for VP-102 for molluscum contagiosum submitted in September 2019 • CRL received July 2020 • No clinical safety or efficacy issues identified • Requests for additional information regarding certain aspects of CMC and Human Factors validation • Next steps • Request Type A meeting with FDA to determine path forward to resubmission of NDA • Accelerating incorporation of ampule breaking tool • Previously planned to incorporate ampule breaking tool post-approval as a potential convenience for healthcare providers • Conduct human factors study and obtain additional supportive stability data on the fully assembled device 12 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.REGULATORY STATUS • NDA for VP-102 for molluscum contagiosum submitted in September 2019 • CRL received July 2020 • No clinical safety or efficacy issues identified • Requests for additional information regarding certain aspects of CMC and Human Factors validation • Next steps • Request Type A meeting with FDA to determine path forward to resubmission of NDA • Accelerating incorporation of ampule breaking tool • Previously planned to incorporate ampule breaking tool post-approval as a potential convenience for healthcare providers • Conduct human factors study and obtain additional supportive stability data on the fully assembled device 12 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
Molluscum Clinical Evidence Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.Molluscum Clinical Evidence Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
CANTHARIDIN ELICITS A DUAL RESPONSE IN THE SKIN 1 Superficial blistering of lesional skin 2 Elicits Inflammation & Immune Response Cantharidin is a vesicant, causing the Cantharidin stimulates leukocyte infiltration (e.g., pharmacodynamic response of blistering in the skin. neutrophils, macrophages, B and T cells and eosinophils) and the release of chemokines and cytokines including Once applied, cantharidin activates neutral (2) TNF-a, IL-8 and CXCL-5. serine proteases that cause degeneration of the (1) desmosomal plaque and intraepidermal blistering. Desmosome Cleavage and Blister Formation Lymphocyte Neutrophil Eosinophil Macrophage (1) J Invest Dermatol. 1962 Jul;39:39-45. (2) J Immunol Methods. 2001 Nov 1;257(1-2):213-20.2 14 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.CANTHARIDIN ELICITS A DUAL RESPONSE IN THE SKIN 1 Superficial blistering of lesional skin 2 Elicits Inflammation & Immune Response Cantharidin is a vesicant, causing the Cantharidin stimulates leukocyte infiltration (e.g., pharmacodynamic response of blistering in the skin. neutrophils, macrophages, B and T cells and eosinophils) and the release of chemokines and cytokines including Once applied, cantharidin activates neutral (2) TNF-a, IL-8 and CXCL-5. serine proteases that cause degeneration of the (1) desmosomal plaque and intraepidermal blistering. Desmosome Cleavage and Blister Formation Lymphocyte Neutrophil Eosinophil Macrophage (1) J Invest Dermatol. 1962 Jul;39:39-45. (2) J Immunol Methods. 2001 Nov 1;257(1-2):213-20.2 14 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
SIGNIFICANT CLINICAL PROGRESS OF YCANTH™ (VP-102) FOR THE TREATMENT OF MOLLUSCUM TRIAL FORMULATION / TRIAL TRIAL AND STATUS APPLICATION METHOD DESIGN OBJECTIVES Pivotal Trial VP-102 • N=266 • To evaluate the efficacy of dermal application CAMP-1 of VP-102 relative to placebo for complete • Conducted under SPA Complete clearance at day 84 • Randomized, double • To assess the safety and tolerability of VP-102 blind, multi-center, placebo controlled Pivotal Trial VP-102 • N=262 • To evaluate the efficacy of dermal application CAMP-2 of VP-102 relative to placebo for complete • Randomized, double Complete clearance at day 84 blind, multi-center, placebo controlled • To assess the safety and tolerability of VP-102 Innovate Trial VP-102 • Open-label, single-center • To determine possible systemic exposure from Complete a single 24-hour application of VP-102 • N=33 • To confirm safety and efficacy with applicator Pilot Trial Our proprietary formula of • Open-label, single-center • To evaluate safety and efficacy and determine Complete cantharidin used in VP-102, optimal treatment duration • N=30 applied with the wooden stick part of a cotton-tipped swab 15 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. PHASE 2 PHASE 3SIGNIFICANT CLINICAL PROGRESS OF YCANTH™ (VP-102) FOR THE TREATMENT OF MOLLUSCUM TRIAL FORMULATION / TRIAL TRIAL AND STATUS APPLICATION METHOD DESIGN OBJECTIVES Pivotal Trial VP-102 • N=266 • To evaluate the efficacy of dermal application CAMP-1 of VP-102 relative to placebo for complete • Conducted under SPA Complete clearance at day 84 • Randomized, double • To assess the safety and tolerability of VP-102 blind, multi-center, placebo controlled Pivotal Trial VP-102 • N=262 • To evaluate the efficacy of dermal application CAMP-2 of VP-102 relative to placebo for complete • Randomized, double Complete clearance at day 84 blind, multi-center, placebo controlled • To assess the safety and tolerability of VP-102 Innovate Trial VP-102 • Open-label, single-center • To determine possible systemic exposure from Complete a single 24-hour application of VP-102 • N=33 • To confirm safety and efficacy with applicator Pilot Trial Our proprietary formula of • Open-label, single-center • To evaluate safety and efficacy and determine Complete cantharidin used in VP-102, optimal treatment duration • N=30 applied with the wooden stick part of a cotton-tipped swab 15 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. PHASE 2 PHASE 3
WE HAVE SUCCESSFULLY COMPLETED TWO PIVOTAL PHASE 3 TRIALS (CAMP-1 & CAMP-2) IN MOLLUSCUM Two identically designed, randomized, CAMP-1 conducted under 12-week double-blinded, multicenter, placebo FDA Special Protocol Trial Design study period controlled trials Assessment (SPA) Secondary: Primary: Percent of subjects with complete clearance at week 3, 6, and 9 Endpoints Percent of subjects with complete clearance of molluscum at Day 84 Safety & tolerability Subjects 2+ years of age with MC lesions who have not received any type of treatment within the past 14 days Population Enrollment complete with 266 subjects for CAMP-1 and 262 subjects for CAMP-2 Study drug (VP-102 or placebo) is administered VP-102 or placebo will be left topically to all treatable lesions every 21 days until on for 24 hours before removal Application clearance or a maximum of 4 applications with soap and warm water Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 16 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.WE HAVE SUCCESSFULLY COMPLETED TWO PIVOTAL PHASE 3 TRIALS (CAMP-1 & CAMP-2) IN MOLLUSCUM Two identically designed, randomized, CAMP-1 conducted under 12-week double-blinded, multicenter, placebo FDA Special Protocol Trial Design study period controlled trials Assessment (SPA) Secondary: Primary: Percent of subjects with complete clearance at week 3, 6, and 9 Endpoints Percent of subjects with complete clearance of molluscum at Day 84 Safety & tolerability Subjects 2+ years of age with MC lesions who have not received any type of treatment within the past 14 days Population Enrollment complete with 266 subjects for CAMP-1 and 262 subjects for CAMP-2 Study drug (VP-102 or placebo) is administered VP-102 or placebo will be left topically to all treatable lesions every 21 days until on for 24 hours before removal Application clearance or a maximum of 4 applications with soap and warm water Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 16 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
DEMOGRAPHICS IN PHASE 3 MOLLUSCUM TRIALS Vehicle VP-102 (N=216) (N=311) 17 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)DEMOGRAPHICS IN PHASE 3 MOLLUSCUM TRIALS Vehicle VP-102 (N=216) (N=311) 17 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)
MOLLUSCUM HISTORY FOR SUBJECTS IN PHASE 3 TRIALS VP-102 Vehicle (N=311) (N=216) * Active atopic dermatitis was determined by concomitant medication usage of the following medications during the study: topical corticosteroids, topical calcineurin inhibitors, and/or PDE-4 inhibitors. 18 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)MOLLUSCUM HISTORY FOR SUBJECTS IN PHASE 3 TRIALS VP-102 Vehicle (N=311) (N=216) * Active atopic dermatitis was determined by concomitant medication usage of the following medications during the study: topical corticosteroids, topical calcineurin inhibitors, and/or PDE-4 inhibitors. 18 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)
PHASE 3 STUDIES IN MOLLUSCUM DEMONSTRATE STATISTICALLY SIGNIFICANT EFFICACY ON PRIMARY ENDPOINT OF COMPLETE CLEARANCE 19 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)PHASE 3 STUDIES IN MOLLUSCUM DEMONSTRATE STATISTICALLY SIGNIFICANT EFFICACY ON PRIMARY ENDPOINT OF COMPLETE CLEARANCE 19 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)
PHASE 3 STUDIES IN MOLLUSCUM DEMONSTRATE STATISTICALLY SIGNIFICANT EFFICACY ON PERCENT REDUCTION OF LESIONS 20 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)PHASE 3 STUDIES IN MOLLUSCUM DEMONSTRATE STATISTICALLY SIGNIFICANT EFFICACY ON PERCENT REDUCTION OF LESIONS 20 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)
SAFETY SUMMARY FOR MOLLUSCUM PHASE 3 TRIALS 21 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)SAFETY SUMMARY FOR MOLLUSCUM PHASE 3 TRIALS 21 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)
PHASE 3 DISCONTINUATION RATES DUE TO TREATMENT-RELATED ADVERSE EVENTS N (%) VP-102 Vehicle (N=311) (N=216) Application Site Vesicles 5 (1.6) 0 (0) Application Site Pain 3 (1.0) 0 (0) Application Site Pruritus 1 (0.3) 0 (0) Contact Dermatitis 1 (0.3) 0 (0) Total Discontinuation Rate 6 (1.9) 0 (0) 22 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)PHASE 3 DISCONTINUATION RATES DUE TO TREATMENT-RELATED ADVERSE EVENTS N (%) VP-102 Vehicle (N=311) (N=216) Application Site Vesicles 5 (1.6) 0 (0) Application Site Pain 3 (1.0) 0 (0) Application Site Pruritus 1 (0.3) 0 (0) Contact Dermatitis 1 (0.3) 0 (0) Total Discontinuation Rate 6 (1.9) 0 (0) 22 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)
MC Commercial Opportunity Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.MC Commercial Opportunity Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
REALIZING THE MOLLUSCUM OPPORTUNITY (1) (2) US Prevalence of ~6 million in molluscum with ~1 million diagnosed annually 85% Not Diagnosed 5.1 million 15% Diagnosed 0.9 million (1) 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. (2) IQVIA projected dataset for 12 months ending October 2017 24 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.REALIZING THE MOLLUSCUM OPPORTUNITY (1) (2) US Prevalence of ~6 million in molluscum with ~1 million diagnosed annually 85% Not Diagnosed 5.1 million 15% Diagnosed 0.9 million (1) 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. (2) IQVIA projected dataset for 12 months ending October 2017 24 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
DERMATOLOGISTS ARE FAMILIAR WITH API USED IN YCANTH™ (VP-102) & WOULD USE IF AVAILABLE ~70% 87% Physicians who do not use the API of Physicians reported they YCANTH™ (VP-102) stated inaccessibility as a would use YCANTH™ (VP-102) if (1) (2) primary reason why they are not using the cost of the drug was covered (1) Pompei DT et al. Cantharidin Therapy: Practice patterns and attitudes of health care providers. Journal of the American Academy of Dermatology. 2013; 68(6). Survey of 400 healthcare providers, 87.7% of responders were US based dermatologists. (2) Company survey of 40 physicians. 25 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.DERMATOLOGISTS ARE FAMILIAR WITH API USED IN YCANTH™ (VP-102) & WOULD USE IF AVAILABLE ~70% 87% Physicians who do not use the API of Physicians reported they YCANTH™ (VP-102) stated inaccessibility as a would use YCANTH™ (VP-102) if (1) (2) primary reason why they are not using the cost of the drug was covered (1) Pompei DT et al. Cantharidin Therapy: Practice patterns and attitudes of health care providers. Journal of the American Academy of Dermatology. 2013; 68(6). Survey of 400 healthcare providers, 87.7% of responders were US based dermatologists. (2) Company survey of 40 physicians. 25 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
PHYSICIANS ARE HIGHLY FAVORABLE TO YCANTH™ (VP-102) PROFILE (1) Derms and Ped Derms KEY REASONS TO USE IF APPROVED Efficacy Precise and pain free application 5.6 FDA approval Convenience of administration (1) KEY REASONS TO USE IF APPROVED Pediatricians Efficacy Fits into their current office model 6.3 Frustrated with not treating and having no viable options Scale of 1 (unlikely to use at all) to 7 (highly likely to use) (1) Physician Qualitative research- one-hour individual interviews [n=30 Pediatricians, 13 Dermatologist, 5 Pediatric Dermatologists] 26 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.PHYSICIANS ARE HIGHLY FAVORABLE TO YCANTH™ (VP-102) PROFILE (1) Derms and Ped Derms KEY REASONS TO USE IF APPROVED Efficacy Precise and pain free application 5.6 FDA approval Convenience of administration (1) KEY REASONS TO USE IF APPROVED Pediatricians Efficacy Fits into their current office model 6.3 Frustrated with not treating and having no viable options Scale of 1 (unlikely to use at all) to 7 (highly likely to use) (1) Physician Qualitative research- one-hour individual interviews [n=30 Pediatricians, 13 Dermatologist, 5 Pediatric Dermatologists] 26 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
INITIAL PAYER RESEARCH SUGGESTS FAVORABLE REIMBURSEMENT LANDSCAPE FOR YCANTH™ (VP-102) COHORT SIZE AVERAGE LIVES COVERED The 15 Payer Organizations and Plans Represented in the Interviews Medical 7 9.8M Cover a Total of 105 Million Directors Commercial & Medicaid Lives Pharmacy 6 4.2M Directors IDN 2 6.5M Stakeholders Source: Third party study commissioned by the Company. 27 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.INITIAL PAYER RESEARCH SUGGESTS FAVORABLE REIMBURSEMENT LANDSCAPE FOR YCANTH™ (VP-102) COHORT SIZE AVERAGE LIVES COVERED The 15 Payer Organizations and Plans Represented in the Interviews Medical 7 9.8M Cover a Total of 105 Million Directors Commercial & Medicaid Lives Pharmacy 6 4.2M Directors IDN 2 6.5M Stakeholders Source: Third party study commissioned by the Company. 27 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
INITIAL PAYER RESEARCH SUGGESTS FAVORABLE REIMBURSEMENT LANDSCAPE FOR YCANTH™ (VP-102) Key Takeaways Payers interviewed recognize a significant unmet need for 1 molluscum contagiosum and lack of an effective treatment Some of the key concerns mentioned about the undertreatment of the 2 condition include the risk of infection, scarring, or spread of the disease Payers perceived YCANTH™ (VP-102) to be highly favorable 3 based on the majority of patients experiencing clearance within 12 weeks Given the unmet need and favorable clinical outcomes in Phase 2 trials, payers 4 anticipate the majority of patients would have access to YCANTH™ (VP-102) with minimal to no restrictions Source: Third party study commissioned by the Company. Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 28 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.INITIAL PAYER RESEARCH SUGGESTS FAVORABLE REIMBURSEMENT LANDSCAPE FOR YCANTH™ (VP-102) Key Takeaways Payers interviewed recognize a significant unmet need for 1 molluscum contagiosum and lack of an effective treatment Some of the key concerns mentioned about the undertreatment of the 2 condition include the risk of infection, scarring, or spread of the disease Payers perceived YCANTH™ (VP-102) to be highly favorable 3 based on the majority of patients experiencing clearance within 12 weeks Given the unmet need and favorable clinical outcomes in Phase 2 trials, payers 4 anticipate the majority of patients would have access to YCANTH™ (VP-102) with minimal to no restrictions Source: Third party study commissioned by the Company. Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 28 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
INTEGRATED COMMERCIAL APPROACH WITH MULTIPLE STRATEGIC LEVERS Commercial Strategy KOL Buy and Bill Specialized Dedicated Disease Engagement or Specialty Sales Team Institutional Awareness Pharmacy Team Strong Targeting Increase established office based treatment seekers Distribution Specialists to relationships dermatologists through cost- with supportive promote to pediatric and support and select efficient consumer HUB services dermatologists in pediatricians advertising academic settings Dedicated field and group practices reimbursement Team Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 29 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.INTEGRATED COMMERCIAL APPROACH WITH MULTIPLE STRATEGIC LEVERS Commercial Strategy KOL Buy and Bill Specialized Dedicated Disease Engagement or Specialty Sales Team Institutional Awareness Pharmacy Team Strong Targeting Increase established office based treatment seekers Distribution Specialists to relationships dermatologists through cost- with supportive promote to pediatric and support and select efficient consumer HUB services dermatologists in pediatricians advertising academic settings Dedicated field and group practices reimbursement Team Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 29 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
YCANTH™ (VP-102) DESIGNED TO BE CLINICIAN ADMINISTERED AND INTEND TO DISTRIBUTE THROUGH SPECIALTY PRODUCT CHANNELS, IF APPROVED Distribution model will be supported by a patient and HCP services platform (HUB) Specialty Specialty Distributor Pharmacy • Benefits investigation/verification to determine coverage “Buy and Bill” “White Bag” • Full reimbursement support for miscellaneous J-code under (1) medical benefit Physician Office • Prior authorization support • Co-pay/co-insurance assistance Potential Physician Reimbursement Opportunities “Buy and Bill” “White Bag” Office visit Office visit Dedicated field reimbursement team to support physician Procedure for lesion destruction Procedure for lesion destruction offices YCANTH™ (VP-102) = (ASP + X%) (1) Verrica intends to file for a product-specific J-code for VP-102 30 Note: For illustrative purposes only. If approved, actual distribution channels and support services may change as strategy is finalized. Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.YCANTH™ (VP-102) DESIGNED TO BE CLINICIAN ADMINISTERED AND INTEND TO DISTRIBUTE THROUGH SPECIALTY PRODUCT CHANNELS, IF APPROVED Distribution model will be supported by a patient and HCP services platform (HUB) Specialty Specialty Distributor Pharmacy • Benefits investigation/verification to determine coverage “Buy and Bill” “White Bag” • Full reimbursement support for miscellaneous J-code under (1) medical benefit Physician Office • Prior authorization support • Co-pay/co-insurance assistance Potential Physician Reimbursement Opportunities “Buy and Bill” “White Bag” Office visit Office visit Dedicated field reimbursement team to support physician Procedure for lesion destruction Procedure for lesion destruction offices YCANTH™ (VP-102) = (ASP + X%) (1) Verrica intends to file for a product-specific J-code for VP-102 30 Note: For illustrative purposes only. If approved, actual distribution channels and support services may change as strategy is finalized. Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
PRE-COMMERCIALIZATION ACTIVITIES ONGOING Engagement at Premier Venues & DISEASE AWARENESS Industry Channels Caregiver MC HCP MC education education through congresses, through digital speaker programs, and and social tools professional journal space Poster Presentation OTHER Trade distribution channel development National National Customer segment insights and Regional and Regional Meetings Meetings Brand strategy, customer segmentation, and targeting Commercial systems infrastructure 31 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.PRE-COMMERCIALIZATION ACTIVITIES ONGOING Engagement at Premier Venues & DISEASE AWARENESS Industry Channels Caregiver MC HCP MC education education through congresses, through digital speaker programs, and and social tools professional journal space Poster Presentation OTHER Trade distribution channel development National National Customer segment insights and Regional and Regional Meetings Meetings Brand strategy, customer segmentation, and targeting Commercial systems infrastructure 31 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
Our Opportunity in Common Warts Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.Our Opportunity in Common Warts Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
VERRUCA VULGARIS (COMMON WARTS) ETIOLOGY AND CLINICAL PRESENTATION OVERVIEW Transmission • Skin to skin contact Caused by human papilloma virus (HPV) • Touching of contaminated objects Infects patients of all ages Diagnosis • Dome shaped flesh-colored lesions commonly & Symptoms on the hands, fingers, knees or elbows Persistent infection, highly refractory • Lesions may occur in groups or in a linear pattern • Lesions can cause considerable pain and Typically 2-5 lesions discomfort, may spread with skin trauma, and can be itchy No FDA approved drug for the treatment of common warts Complications • Scarring may occur • Dyspigmentation of affected areas 1 2 U.S prevalence of 22 million , with 1.5 million • Bacterial superinfection of lesions diagnosed annually • Irritation, pain, and redness of surrounding skin (1) IMS National Disease and Therapeutic Index (NDTI) Rolling 5 Years Ending June 2016. Nguyen et al, Laser Treatment of Nongenital Verrucae A Systemic Review. JAMA Dermatology. 2016; 152(9): 1025-1033 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 33 (2) IQVIA Anonymous Longitudinal Patient Level Data (APLD) for 12 months ending September 2018 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.VERRUCA VULGARIS (COMMON WARTS) ETIOLOGY AND CLINICAL PRESENTATION OVERVIEW Transmission • Skin to skin contact Caused by human papilloma virus (HPV) • Touching of contaminated objects Infects patients of all ages Diagnosis • Dome shaped flesh-colored lesions commonly & Symptoms on the hands, fingers, knees or elbows Persistent infection, highly refractory • Lesions may occur in groups or in a linear pattern • Lesions can cause considerable pain and Typically 2-5 lesions discomfort, may spread with skin trauma, and can be itchy No FDA approved drug for the treatment of common warts Complications • Scarring may occur • Dyspigmentation of affected areas 1 2 U.S prevalence of 22 million , with 1.5 million • Bacterial superinfection of lesions diagnosed annually • Irritation, pain, and redness of surrounding skin (1) IMS National Disease and Therapeutic Index (NDTI) Rolling 5 Years Ending June 2016. Nguyen et al, Laser Treatment of Nongenital Verrucae A Systemic Review. JAMA Dermatology. 2016; 152(9): 1025-1033 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 33 (2) IQVIA Anonymous Longitudinal Patient Level Data (APLD) for 12 months ending September 2018 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
WE HAVE SUCCESSFULLY COMPLETED A PHASE 2 STUDY (COVE-1) IN COMMON WARTS Cohort 1: one center Efficacy, safety & tolerability Study Design Open label study with two cohorts Cohort 2: four centers Secondary Primary Percent of subjects achieving complete clearance of all treatable warts at Visits 2, 3, and 4 Endpoints Percent of subjects with complete clearance of all treatable warts (baseline and new) at Day 84 Change from baseline in number (%) of treatable warts at Day 84 Cohort 1: 21 subjects 2+ years of age with common warts, who have not received any type of treatment within the past 14 days Patients Cohort 2: 35 subjects 12+ years of age with common warts, who have not received any type of treatment within the past 14 days Study drug (VP-102) is administered Frequency of administration is topically to each treatable wart to a VP-102 will be left on at least 14 days (Cohort 1) or 21 maximum of 4 applications for 24 hours before Application days (Cohort 2) removal with soap Cohort 1 is treated until clear, Cohort 2 and warm water Paring was allowed in Cohort 2 receives one additional treatment at the first visit clearance was observed up to a maximum of 4 total applications Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 34 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.WE HAVE SUCCESSFULLY COMPLETED A PHASE 2 STUDY (COVE-1) IN COMMON WARTS Cohort 1: one center Efficacy, safety & tolerability Study Design Open label study with two cohorts Cohort 2: four centers Secondary Primary Percent of subjects achieving complete clearance of all treatable warts at Visits 2, 3, and 4 Endpoints Percent of subjects with complete clearance of all treatable warts (baseline and new) at Day 84 Change from baseline in number (%) of treatable warts at Day 84 Cohort 1: 21 subjects 2+ years of age with common warts, who have not received any type of treatment within the past 14 days Patients Cohort 2: 35 subjects 12+ years of age with common warts, who have not received any type of treatment within the past 14 days Study drug (VP-102) is administered Frequency of administration is topically to each treatable wart to a VP-102 will be left on at least 14 days (Cohort 1) or 21 maximum of 4 applications for 24 hours before Application days (Cohort 2) removal with soap Cohort 1 is treated until clear, Cohort 2 and warm water Paring was allowed in Cohort 2 receives one additional treatment at the first visit clearance was observed up to a maximum of 4 total applications Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 34 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
VP-102 DEMONSTRATED CLINICALLY MEANINGFUL EFFICACY ON PRIMARY ENDPOINT OF COMPLETE CLEARANCE IN COVE-1 STUDY 35 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.VP-102 DEMONSTRATED CLINICALLY MEANINGFUL EFFICACY ON PRIMARY ENDPOINT OF COMPLETE CLEARANCE IN COVE-1 STUDY 35 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
ADVERSE EVENTS IN COVE-1 STUDY (INCIDENCE≥5%)* 36 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.ADVERSE EVENTS IN COVE-1 STUDY (INCIDENCE≥5%)* 36 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
Our Opportunity in External Genital Warts Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.Our Opportunity in External Genital Warts Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
CONDYLOMA ACUMINATUM (GENITAL WARTS) OVERVIEW ETIOLOGY AND CLINICAL PRESENTATION Caused by human papilloma virus Transmission • Skin to skin contact (HPV) • Spread through sexual contact Lesions on the surface of the skin in Diagnosis • Can be flat, dome-shaped, keratotic, the genital and perianal regions & Symptoms pedunculated and cauliflower-shaped • Lesions may occur singularly, in clusters, or as Highly contagious and recurrences plaques are common • Lesions can be itchy, and can cause pain and discomfort Treatment options have limitations Complications • Irritation, pain, and redness of surrounding skin • Dyspigmentation of affected areas • Scarring may occur • Bacterial superinfection of lesions Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 38 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.CONDYLOMA ACUMINATUM (GENITAL WARTS) OVERVIEW ETIOLOGY AND CLINICAL PRESENTATION Caused by human papilloma virus Transmission • Skin to skin contact (HPV) • Spread through sexual contact Lesions on the surface of the skin in Diagnosis • Can be flat, dome-shaped, keratotic, the genital and perianal regions & Symptoms pedunculated and cauliflower-shaped • Lesions may occur singularly, in clusters, or as Highly contagious and recurrences plaques are common • Lesions can be itchy, and can cause pain and discomfort Treatment options have limitations Complications • Irritation, pain, and redness of surrounding skin • Dyspigmentation of affected areas • Scarring may occur • Bacterial superinfection of lesions Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 38 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
PHASE 2 STUDY (CARE) IN EXTERNAL GENITAL WARTS (EGW) Study comprised of two parts (A and B) Multi-center, double-blind, Dose regimen, efficacy, Study Design Primary objective of Part A is to identify the two placebo-controlled safety & tolerability best dosing regimens for evaluation in Part B Primary Secondary Endpoints Percent of subjects with complete clearance of Percent of subjects achieving complete clearance all treatable warts at Day 84 of all treatable warts at Visits 2, 3, and 4 Part A: ~18 subjects 18+ years of age with 2-30 external genital and/or perianal warts for ≥ 4 weeks at baseline visit Patients Part B: ~90 subjects 18+ years of age with 2-30 external genital and/or perianal warts for ≥ 4 weeks at baseline visit Part A: To include 3 treatment groups with a 2-hour, 6-hour and 24-hour duration of Study drug (VP-102) is administered Frequency of skin exposure before removal with soap topically to each treatable wart to a administration is every Application and warm water maximum of 4 applications or until 21 days complete clearance Part B: Two selected treatment dosing regimens (duration of skin exposure) based on Part A with follow up period through Day 147 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 39 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.PHASE 2 STUDY (CARE) IN EXTERNAL GENITAL WARTS (EGW) Study comprised of two parts (A and B) Multi-center, double-blind, Dose regimen, efficacy, Study Design Primary objective of Part A is to identify the two placebo-controlled safety & tolerability best dosing regimens for evaluation in Part B Primary Secondary Endpoints Percent of subjects with complete clearance of Percent of subjects achieving complete clearance all treatable warts at Day 84 of all treatable warts at Visits 2, 3, and 4 Part A: ~18 subjects 18+ years of age with 2-30 external genital and/or perianal warts for ≥ 4 weeks at baseline visit Patients Part B: ~90 subjects 18+ years of age with 2-30 external genital and/or perianal warts for ≥ 4 weeks at baseline visit Part A: To include 3 treatment groups with a 2-hour, 6-hour and 24-hour duration of Study drug (VP-102) is administered Frequency of skin exposure before removal with soap topically to each treatable wart to a administration is every Application and warm water maximum of 4 applications or until 21 days complete clearance Part B: Two selected treatment dosing regimens (duration of skin exposure) based on Part A with follow up period through Day 147 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 39 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
THE PROBLEM Non-Melanoma Skin Cancer Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.THE PROBLEM Non-Melanoma Skin Cancer Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
NON-MELANOMA SKIN CANCER OVERVIEW ETIOLOGY AND CLINICAL PRESENTATION Non-melanoma skin cancer includes 1 basal cell and squamous cell • Estimated 5.4 million diagnoses of basal cell (BCC) and squamous Patient population cell (SCC) carcinomas annually carcinoma • Increasing age and sun exposure are risk factors • New or changing lesions on sun exposed skin Diagnosis 2,3 & Symptoms • Common on the head/neck Basal cell carcinoma is the most 1 • BCC: Pink pearly papules with prominent blood vessels common malignancy in humans • SCC: Pink, rough scaly papules, patches, or plaques • Diagnosis through routine biopsy • Damage to healthy tissue, pain, permanent scarring 3,4 Complications Common treatments are invasive, • Surgical complications include disfigurement, bleeding painful, can cause scarring, and may and infection require destruction of healthy tissue • Metastasis to other areas of the body/organs (1) Rogers JAMA Derm 2015 (2) Combalia Derm Practic & Concept 2020 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 41 (3) Gruber StatPearls 2020 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. (4) Bailey Int J of Wom Derm 2019NON-MELANOMA SKIN CANCER OVERVIEW ETIOLOGY AND CLINICAL PRESENTATION Non-melanoma skin cancer includes 1 basal cell and squamous cell • Estimated 5.4 million diagnoses of basal cell (BCC) and squamous Patient population cell (SCC) carcinomas annually carcinoma • Increasing age and sun exposure are risk factors • New or changing lesions on sun exposed skin Diagnosis 2,3 & Symptoms • Common on the head/neck Basal cell carcinoma is the most 1 • BCC: Pink pearly papules with prominent blood vessels common malignancy in humans • SCC: Pink, rough scaly papules, patches, or plaques • Diagnosis through routine biopsy • Damage to healthy tissue, pain, permanent scarring 3,4 Complications Common treatments are invasive, • Surgical complications include disfigurement, bleeding painful, can cause scarring, and may and infection require destruction of healthy tissue • Metastasis to other areas of the body/organs (1) Rogers JAMA Derm 2015 (2) Combalia Derm Practic & Concept 2020 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 41 (3) Gruber StatPearls 2020 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. (4) Bailey Int J of Wom Derm 2019
DESCRIPTION LIMITATIONS • Invasive Using a scalpel to remove Surgical Excision • Can cause scarring/disfigurement, diseased tissue and healthy skin infection, pain CURRENT • Invasive, may take several rounds Used in high risk NMSC or in TREATMENTS Mohs Surgery • Can cause scarring, disfigurement special sites and pain FOR NON- • Invasive Minor surgical procedure to MELANOMA SKIN Electrodessication remove diseased tissue with • Painful 1-3 CANCER and Curettage sharp tool and cauterize the area • Likely to cause scarring • May only be efficacious in small, superficial tumors 5-FU, ingenol mebutate, or Topical Agents Invasive procedures may lead to imiquimod • Local inflammatory reactions, permanent scarring, pain, damage systemic size effects to healthy tissue, and recurrence • Approval limited to small subset of 4 BCC and metastatic BCC ERIVEDGE® (vismodegib) Oral Therapy • Systemic side effects • Approval limited to small subset of 5 BCC and metastatic BCC ODOMZO® (sonidegib) Oral Therapy • Systemic side effects (4) Per Prescribing Information: a hedgehog pathway inhibitor indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following (1) Camilio Oncoimmunology 2014 surgery or who are not candidates for surgery and who are not candidates for radiation. (2) Combalia Derm Practic & Concept 2020 (5) Per Prescribing Information: a hedgehog pathway inhibitor indicated for the treatment of adult patients with (3) Bailey Int J of Wom Derm 2019 locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those 42 who are not candidates for surgery or radiation therapy. Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.DESCRIPTION LIMITATIONS • Invasive Using a scalpel to remove Surgical Excision • Can cause scarring/disfigurement, diseased tissue and healthy skin infection, pain CURRENT • Invasive, may take several rounds Used in high risk NMSC or in TREATMENTS Mohs Surgery • Can cause scarring, disfigurement special sites and pain FOR NON- • Invasive Minor surgical procedure to MELANOMA SKIN Electrodessication remove diseased tissue with • Painful 1-3 CANCER and Curettage sharp tool and cauterize the area • Likely to cause scarring • May only be efficacious in small, superficial tumors 5-FU, ingenol mebutate, or Topical Agents Invasive procedures may lead to imiquimod • Local inflammatory reactions, permanent scarring, pain, damage systemic size effects to healthy tissue, and recurrence • Approval limited to small subset of 4 BCC and metastatic BCC ERIVEDGE® (vismodegib) Oral Therapy • Systemic side effects • Approval limited to small subset of 5 BCC and metastatic BCC ODOMZO® (sonidegib) Oral Therapy • Systemic side effects (4) Per Prescribing Information: a hedgehog pathway inhibitor indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following (1) Camilio Oncoimmunology 2014 surgery or who are not candidates for surgery and who are not candidates for radiation. (2) Combalia Derm Practic & Concept 2020 (5) Per Prescribing Information: a hedgehog pathway inhibitor indicated for the treatment of adult patients with (3) Bailey Int J of Wom Derm 2019 locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those 42 who are not candidates for surgery or radiation therapy. Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
THE SOLUTION LTX-315 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.THE SOLUTION LTX-315 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
LTX-315 OVERVIEW 1 INDUCES IMMUNOGENIC CELL DEATH AND A TUMOR-SPECIFIC IMMUNE RESPONSE Kills the Tumor Cells 1 OVERVIEW LTX-315 enters the cells and disturbs cell membranes, causing cell death and release of a patient’s tumor specific antigens First-in-class oncolytic peptide that is 2 Triggers Immune Responses Targeting Tumor Cells injected directly into a tumor to induce This allows the immune system to recognize, infiltrate, and attack cancer cells via immunogenic cell death dendritic cells and cytotoxic T cells Worldwide license in dermatology 2 oncology from Lytix Biopharma in August 2020 Verrica intends to focus initially on basal cell and squamous cell carcinomas as lead indications IND submission anticipated during 1H 2021 (1) Camilio Oncoimmunology 2014 (2) All malignant and pre-malignant dermatological indications, except for metastatic melanoma and metastatic Merkel cell carcinoma 44 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.LTX-315 OVERVIEW 1 INDUCES IMMUNOGENIC CELL DEATH AND A TUMOR-SPECIFIC IMMUNE RESPONSE Kills the Tumor Cells 1 OVERVIEW LTX-315 enters the cells and disturbs cell membranes, causing cell death and release of a patient’s tumor specific antigens First-in-class oncolytic peptide that is 2 Triggers Immune Responses Targeting Tumor Cells injected directly into a tumor to induce This allows the immune system to recognize, infiltrate, and attack cancer cells via immunogenic cell death dendritic cells and cytotoxic T cells Worldwide license in dermatology 2 oncology from Lytix Biopharma in August 2020 Verrica intends to focus initially on basal cell and squamous cell carcinomas as lead indications IND submission anticipated during 1H 2021 (1) Camilio Oncoimmunology 2014 (2) All malignant and pre-malignant dermatological indications, except for metastatic melanoma and metastatic Merkel cell carcinoma 44 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
Regulatory Exclusivity and Intellectual Property Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.Regulatory Exclusivity and Intellectual Property Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
VERRICA HAS SEVERAL POTENTIAL WAYS TO MAINTAIN EXCLUSIVITY FOR VP-102 Regulatory 5 years of exclusivity for cantharidin as API potentially available upon approval (potential for additional 6 months for pediatric exclusivity for common warts and plantar warts indications) Exclusivity If VP-102 is approved, traditional compounding pharmacies The FDA has the authority to regulate Compounding will NOT be able to continue compounding cantharidin compounders. Improper compounding can result regularly or in inordinate amounts, except under patient in monetary fines plus felony convictions in case Pharmacies specific circumstances as prescribed by a physician. of repeat offenses and intent to fraud/mislead. VP-102 has the potential Limited commercial Entered into a supply agreement for naturally-sourced to address stability CMOs with facilities for cantharidin; subject to specified minimum annual purchase handling highly potent orders and forecasts, supplier agreed that it will not supply issues with standard Manufacturing and highly flammable cantharidin, any beetles or other raw material from which packaging and container/ liquid products cantharidin is derived to any other customer in North America closure systems Unlikely to receive approval under an ANDA Cannot do traditional May require new clinical studies with due to uniqueness from patent pending PK/bioequivalence True Generic new formulation and new delivery protection and significant differences likely study (no blood level approach that shows equivalence Unlikely between YCANTH™ (VP-102) and potential profile for YCANTH™ without violating any of Verrica's IP competitors (VP-102) ) 46 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.VERRICA HAS SEVERAL POTENTIAL WAYS TO MAINTAIN EXCLUSIVITY FOR VP-102 Regulatory 5 years of exclusivity for cantharidin as API potentially available upon approval (potential for additional 6 months for pediatric exclusivity for common warts and plantar warts indications) Exclusivity If VP-102 is approved, traditional compounding pharmacies The FDA has the authority to regulate Compounding will NOT be able to continue compounding cantharidin compounders. Improper compounding can result regularly or in inordinate amounts, except under patient in monetary fines plus felony convictions in case Pharmacies specific circumstances as prescribed by a physician. of repeat offenses and intent to fraud/mislead. VP-102 has the potential Limited commercial Entered into a supply agreement for naturally-sourced to address stability CMOs with facilities for cantharidin; subject to specified minimum annual purchase handling highly potent orders and forecasts, supplier agreed that it will not supply issues with standard Manufacturing and highly flammable cantharidin, any beetles or other raw material from which packaging and container/ liquid products cantharidin is derived to any other customer in North America closure systems Unlikely to receive approval under an ANDA Cannot do traditional May require new clinical studies with due to uniqueness from patent pending PK/bioequivalence True Generic new formulation and new delivery protection and significant differences likely study (no blood level approach that shows equivalence Unlikely between YCANTH™ (VP-102) and potential profile for YCANTH™ without violating any of Verrica's IP competitors (VP-102) ) 46 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
OVERVIEW OF VP-102/103 INTELLECTUAL PROPERTY PORTFOLIO KEY CLAIMS AND PATENT APPLICATIONS VALUE TO VERRICA Our specific formulation, YCANTH™ (VP-102), key safety May prevent generics from copying our ether-free formulation or from additions and novel cantharidin formulations making similar formulations (PCT/US2014/052184) (PCT/US2018/036353) 1 May prevent generics from utilizing a single-use applicator for cantharidin that contains Single use applicator containing cantharidin formulations both a glass ampule to maintain product stability and a filter placed prior to dispensing tip, (PCT/US2014/052184) (PCT/US2018/037808) which helps increase administration accuracy and prevents direct contact with skin May prevent generics from utilizing a similar applicator Specific design of our commercial applicator 2 (PCT/US2018/037808) (US 29/607744) Design patent application allowed in the US Methods of use for cantharidin in the treatment 3 of molluscum (PCT/US2018/037808 and May prevent generics from a similar treatment regimen and label PCT/US2018/036353) (PCT/US2014/052184) Methods for purifying cantharidin and analyzing cantharidin May force generics to find alternative methodologies to produce GMP 4 or cantharidin solutions (PCT/US2016/14139) cantharidin or determine if their API or drug product is GMP compliant Synthetic version would reduce risks of outside contaminants and 5 Methods for complete cantharidin synthesis environmental factors affecting the naturally-sourced API. May prevent (PCT/US2015/066487) (PCT/US2018/054373) generics competing with a synthetic version of cantharidin Any patents issued from our applications are projected to expire between 2034 and 2039, excluding any patent term adjustment and patent term extensions 47 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.OVERVIEW OF VP-102/103 INTELLECTUAL PROPERTY PORTFOLIO KEY CLAIMS AND PATENT APPLICATIONS VALUE TO VERRICA Our specific formulation, YCANTH™ (VP-102), key safety May prevent generics from copying our ether-free formulation or from additions and novel cantharidin formulations making similar formulations (PCT/US2014/052184) (PCT/US2018/036353) 1 May prevent generics from utilizing a single-use applicator for cantharidin that contains Single use applicator containing cantharidin formulations both a glass ampule to maintain product stability and a filter placed prior to dispensing tip, (PCT/US2014/052184) (PCT/US2018/037808) which helps increase administration accuracy and prevents direct contact with skin May prevent generics from utilizing a similar applicator Specific design of our commercial applicator 2 (PCT/US2018/037808) (US 29/607744) Design patent application allowed in the US Methods of use for cantharidin in the treatment 3 of molluscum (PCT/US2018/037808 and May prevent generics from a similar treatment regimen and label PCT/US2018/036353) (PCT/US2014/052184) Methods for purifying cantharidin and analyzing cantharidin May force generics to find alternative methodologies to produce GMP 4 or cantharidin solutions (PCT/US2016/14139) cantharidin or determine if their API or drug product is GMP compliant Synthetic version would reduce risks of outside contaminants and 5 Methods for complete cantharidin synthesis environmental factors affecting the naturally-sourced API. May prevent (PCT/US2015/066487) (PCT/US2018/054373) generics competing with a synthetic version of cantharidin Any patents issued from our applications are projected to expire between 2034 and 2039, excluding any patent term adjustment and patent term extensions 47 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
OVERVIEW OF LTX-315 INTELLECTUAL PROPERTY PORTFOLIO 1 In force in: UK, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland and Turkey 48 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.OVERVIEW OF LTX-315 INTELLECTUAL PROPERTY PORTFOLIO 1 In force in: UK, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland and Turkey 48 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
OUR PRODUCT PORTFOLIO NEXT EXPECTED PRE-IND PHASE 2 PHASE 3 NDA MILESTONE FDA Type A Meeting in September/October Molluscum Contagiosum 2020* Initiate pivotal Phase 3 Common Warts trials** Topline Phase 2 results External Genital Warts in 2H 2020 Initiate Phase 2 trial** Plantar Warts Non-Melanoma Submit US IND during 1H 2021 Skin Cancer*** * July 13, 2020 CRL focused on CMC and human factors validation - no clinical data requested ** Timing for initiating new clinical trials to be determined *** Initially focused on basal cell and squamous cell carcinomas 49 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. LTX-315 VP-103 VP-102 YCANTHOUR PRODUCT PORTFOLIO NEXT EXPECTED PRE-IND PHASE 2 PHASE 3 NDA MILESTONE FDA Type A Meeting in September/October Molluscum Contagiosum 2020* Initiate pivotal Phase 3 Common Warts trials** Topline Phase 2 results External Genital Warts in 2H 2020 Initiate Phase 2 trial** Plantar Warts Non-Melanoma Submit US IND during 1H 2021 Skin Cancer*** * July 13, 2020 CRL focused on CMC and human factors validation - no clinical data requested ** Timing for initiating new clinical trials to be determined *** Initially focused on basal cell and squamous cell carcinomas 49 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. LTX-315 VP-103 VP-102 YCANTH
INVESTMENT HIGHLIGHTS Dermatology Oncology YCANTH™ in Development to Address Two of the Largest Unmet Needs in Dermatology • Worldwide rights to LTX-315: first-in-class oncolytic peptide injected directly into tumor (1) • Prevalence of ~6 million in molluscum contagiosum (2) • Positive tumor-specific immune cell responses in multi- and ~22 million in common warts in the U.S. indication Phase 1/2 oncology trials • No FDA approved drugs to treat molluscum or warts • Verrica to focus initially on development to treat basal cell and squamous cell carcinomas Type A Meeting Request with FDA submitted August 2020 for YCANTH™ (VP-102) for the Treatment of Molluscum • 5.4 million diagnoses annually in the U.S. of basal and (4) squamous cell skin cancers ; patients typically treated with • CRL received July 2020 focused on CMC and human factors surgery validation (no clinical safety or efficacy deficiencies) • Submission of U.S. IND anticipated during first half of 2021 Positive Phase 3 Results in Molluscum Contagiosum • Achieved statistical significance for primary endpoints in two Option Agreement with Torii Pharmaceuticals for pivotal trials for YCANTH™ (VP-102) Development and Commercialization of VP-102 in Japan • Torii option includes Verrica product candidates for the • P-value <0.0001 for primary endpoint in both pivotal trials treatment of molluscum and common warts in Japan Innovative Product Candidate Proven Team • Proprietary drug-device combination of formulation • Industry-leading, experienced management team with extensive and single-use applicator dermatology product launch experience Physician Acceptance • Strengthened clinical and drug development leadership in (3) August 2020 • 95% of pediatric dermatologists have used API (1) 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. (2) IMS National Disease and Therapeutic Index (NDTI) Rolling 5 Years Ending June 2016. Nguyen et al, Laser Treatment of Nongenital Verrucae A Systemic Review. JAMA Dermatology. 2016; 152(9): 1025-1033 (3) Based on a survey of 115 dermatologists the results of which have been extrapolated to pediatric dermatologists. (4) https://www.cancer.org/cancer/basal-and-squamous-cell-skin-cancer/about/key-statistics.html and Rogers JAMA Derm 2015 50 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.INVESTMENT HIGHLIGHTS Dermatology Oncology YCANTH™ in Development to Address Two of the Largest Unmet Needs in Dermatology • Worldwide rights to LTX-315: first-in-class oncolytic peptide injected directly into tumor (1) • Prevalence of ~6 million in molluscum contagiosum (2) • Positive tumor-specific immune cell responses in multi- and ~22 million in common warts in the U.S. indication Phase 1/2 oncology trials • No FDA approved drugs to treat molluscum or warts • Verrica to focus initially on development to treat basal cell and squamous cell carcinomas Type A Meeting Request with FDA submitted August 2020 for YCANTH™ (VP-102) for the Treatment of Molluscum • 5.4 million diagnoses annually in the U.S. of basal and (4) squamous cell skin cancers ; patients typically treated with • CRL received July 2020 focused on CMC and human factors surgery validation (no clinical safety or efficacy deficiencies) • Submission of U.S. IND anticipated during first half of 2021 Positive Phase 3 Results in Molluscum Contagiosum • Achieved statistical significance for primary endpoints in two Option Agreement with Torii Pharmaceuticals for pivotal trials for YCANTH™ (VP-102) Development and Commercialization of VP-102 in Japan • Torii option includes Verrica product candidates for the • P-value <0.0001 for primary endpoint in both pivotal trials treatment of molluscum and common warts in Japan Innovative Product Candidate Proven Team • Proprietary drug-device combination of formulation • Industry-leading, experienced management team with extensive and single-use applicator dermatology product launch experience Physician Acceptance • Strengthened clinical and drug development leadership in (3) August 2020 • 95% of pediatric dermatologists have used API (1) 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. (2) IMS National Disease and Therapeutic Index (NDTI) Rolling 5 Years Ending June 2016. Nguyen et al, Laser Treatment of Nongenital Verrucae A Systemic Review. JAMA Dermatology. 2016; 152(9): 1025-1033 (3) Based on a survey of 115 dermatologists the results of which have been extrapolated to pediatric dermatologists. (4) https://www.cancer.org/cancer/basal-and-squamous-cell-skin-cancer/about/key-statistics.html and Rogers JAMA Derm 2015 50 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
Appendix Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.Appendix Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
HISTORICAL COMPOUNDED CANTHARIDIN PRESENTS A NUMBER OF LIMITATIONS 1 2 3 Varying Inconsistent Lack of concentration purity and lack reimbursement of controlled • Evaporation of volatile • Not FDA approved solvents leads to and therefore not product concentration increases eligible for drug manufacturing reimbursement • Patients can receive • Risk of impurities more drug than clinically present such as necessary resulting in residual solvents and excessive blistering pesticides 4 5 Inconvenient and variable Limited availability administration • Illegal to import formulated cantharidin • Application with the wooden stick • Generally not available in hospitals part of a cotton-tipped swab can and academic settings, which require lead to patients receiving more drug FDA approved product than necessary • Only an estimated 7% of 503B • Inability for physicians to identify compounders produce formulations (1) where the drug has been applied containing cantharidin (1) Based on 57 503B facilities and 4 compounders of cantharidin per FDA database (January – June 2019). 52 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.HISTORICAL COMPOUNDED CANTHARIDIN PRESENTS A NUMBER OF LIMITATIONS 1 2 3 Varying Inconsistent Lack of concentration purity and lack reimbursement of controlled • Evaporation of volatile • Not FDA approved solvents leads to and therefore not product concentration increases eligible for drug manufacturing reimbursement • Patients can receive • Risk of impurities more drug than clinically present such as necessary resulting in residual solvents and excessive blistering pesticides 4 5 Inconvenient and variable Limited availability administration • Illegal to import formulated cantharidin • Application with the wooden stick • Generally not available in hospitals part of a cotton-tipped swab can and academic settings, which require lead to patients receiving more drug FDA approved product than necessary • Only an estimated 7% of 503B • Inability for physicians to identify compounders produce formulations (1) where the drug has been applied containing cantharidin (1) Based on 57 503B facilities and 4 compounders of cantharidin per FDA database (January – June 2019). 52 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
MANAGEMENT TEAM WITH EXTENSIVE PRODUCT LAUNCH AND DERMATOLOGY EXPERIENCE Ted White A. Brian Davis Gary Goldenberg, MD Joe Bonaccorso President & Chief Chief Financial Chief Medical Chief Commercial Executive Officer Officer Officer Officer Selected Launched Products Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 53 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.MANAGEMENT TEAM WITH EXTENSIVE PRODUCT LAUNCH AND DERMATOLOGY EXPERIENCE Ted White A. Brian Davis Gary Goldenberg, MD Joe Bonaccorso President & Chief Chief Financial Chief Medical Chief Commercial Executive Officer Officer Officer Officer Selected Launched Products Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 53 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.
BOARD OF DIRECTORS Lawrence Mark Paul Ted Craig Sean Eichenfield, MD Prygocki Ballaron Manning Stalfort White Director Director Director Chairman Director President & Chief Executive Officer 54 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.BOARD OF DIRECTORS Lawrence Mark Paul Ted Craig Sean Eichenfield, MD Prygocki Ballaron Manning Stalfort White Director Director Director Chairman Director President & Chief Executive Officer 54 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.