UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
CURRENT REPORT
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| Item 7.01 | Regulation FD Disclosure. |
On January 6, 2021, 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 No. |
Description | |
| 99.1 | Company Presentation | |
| 104 | Cover Page Interactive Data File (embedded within the 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: January 6, 2021 | /s/ A. Brian Davis | |||||
| A. Brian Davis | ||||||
| Chief Financial Officer | ||||||
Exhibit 99.1 Company Overview January 2021 1Exhibit 99.1 Company Overview January 2021 1
Disclaimer Certain information contained in this presentation and statements made orally The information in this presentation, including without limitation the forward- during this presentation relates to or is based on studies, publications, surveys looking statements contained herein, represent our views as of the date of this and other data obtained from third-party sources and Verrica’s own internal presentation. Although we believe the expectations reflected in such forward- estimates and research. While Verrica believes these third-party sources to be looking statements are reasonable, we can give no assurance that such reliable as of the date of this presentation, it has not independently verified, and expectations will prove to be correct. Accordingly, readers are cautioned not to makes no representation as to the adequacy, fairness, accuracy or completeness place undue reliance on these forward-looking statements. Except as required by of, any information obtained from third-party sources. While Verrica believes its applicable law, we do not plan to publicly update or revise any forward-looking internal research is reliable, such research has not been verified by any statements contained herein, whether as a result of any new information, future independent source. events, changed circumstances or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking This presentation contains forward-looking statements. Forward-looking statements. The forward-looking statements in this presentation involve risks statements are neither historical facts nor assurances of future performance. and uncertainties that could cause actual results to differ materially from those Instead, they are based on our current beliefs, expectations and assumptions reflected in such statements. Risks and uncertainties that may cause actual results regarding the future of our business, future plans and strategies, our clinical to differ materially include uncertainties inherent in the drug development results and other future conditions. All statements other than statements of process and the regulatory approval process, our reliance on third parties over historical facts contained in this presentation, including statements regarding which we may not always have full control, and other risks and uncertainties that future results of operations and financial position, business strategy, interactions are described in our Annual Report on Form 10-K for the year ended December with the FDA, including regarding the CRL Verrica received related to its NDA 31, 2019, filed with the U.S. Securities and Exchange Commission (SEC) on March submission for VP-102 for the treatment of molluscum, current and prospective 13, 2020, our Quarterly report on Form 10-Q for the quarter ended September product candidates, planned clinical trials and preclinical activities, product 30, 2020, filed with the SEC on November 9, 2020, and our other filings made approvals, degree of market acceptance of approved products, research and with the SEC. New risk factors and uncertainties may emerge from time to time, development costs, current and prospective collaborations, timing and likelihood and it is not possible to predict all risk factors and uncertainties. There can be no of success, plans and objectives of management for future operations, and future assurance that the opportunity will meet your investment objectives, that you will results of anticipated product candidates, are forward-looking statements. The receive a return of all or part of such investment. Investment results may vary words ”may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” significantly over any given time period. The appropriateness of a particular “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the investment or strategy will depend on an investor's individual circumstances and negative of these terms or other similar expressions are intended to identify objectives. We recommend that investors independently evaluate specific forward-looking statements, although not all forward-looking statements contain investments and strategies. these identifying words. 2Disclaimer Certain information contained in this presentation and statements made orally The information in this presentation, including without limitation the forward- during this presentation relates to or is based on studies, publications, surveys looking statements contained herein, represent our views as of the date of this and other data obtained from third-party sources and Verrica’s own internal presentation. Although we believe the expectations reflected in such forward- estimates and research. While Verrica believes these third-party sources to be looking statements are reasonable, we can give no assurance that such reliable as of the date of this presentation, it has not independently verified, and expectations will prove to be correct. Accordingly, readers are cautioned not to makes no representation as to the adequacy, fairness, accuracy or completeness place undue reliance on these forward-looking statements. Except as required by of, any information obtained from third-party sources. While Verrica believes its applicable law, we do not plan to publicly update or revise any forward-looking internal research is reliable, such research has not been verified by any statements contained herein, whether as a result of any new information, future independent source. events, changed circumstances or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking This presentation contains forward-looking statements. Forward-looking statements. The forward-looking statements in this presentation involve risks statements are neither historical facts nor assurances of future performance. and uncertainties that could cause actual results to differ materially from those Instead, they are based on our current beliefs, expectations and assumptions reflected in such statements. Risks and uncertainties that may cause actual results regarding the future of our business, future plans and strategies, our clinical to differ materially include uncertainties inherent in the drug development results and other future conditions. All statements other than statements of process and the regulatory approval process, our reliance on third parties over historical facts contained in this presentation, including statements regarding which we may not always have full control, and other risks and uncertainties that future results of operations and financial position, business strategy, interactions are described in our Annual Report on Form 10-K for the year ended December with the FDA, including regarding the CRL Verrica received related to its NDA 31, 2019, filed with the U.S. Securities and Exchange Commission (SEC) on March submission for VP-102 for the treatment of molluscum, current and prospective 13, 2020, our Quarterly report on Form 10-Q for the quarter ended September product candidates, planned clinical trials and preclinical activities, product 30, 2020, filed with the SEC on November 9, 2020, and our other filings made approvals, degree of market acceptance of approved products, research and with the SEC. New risk factors and uncertainties may emerge from time to time, development costs, current and prospective collaborations, timing and likelihood and it is not possible to predict all risk factors and uncertainties. There can be no of success, plans and objectives of management for future operations, and future assurance that the opportunity will meet your investment objectives, that you will results of anticipated product candidates, are forward-looking statements. The receive a return of all or part of such investment. Investment results may vary words ”may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” significantly over any given time period. The appropriateness of a particular “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the investment or strategy will depend on an investor's individual circumstances and negative of these terms or other similar expressions are intended to identify objectives. We recommend that investors independently evaluate specific forward-looking statements, although not all forward-looking statements contain investments and strategies. these identifying words. 2
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 Resubmitted U.S. NDA for YCANTH™ (VP-102) for the Treatment of Molluscum in December 2020 • 5.4 million diagnoses annually in the U.S. of basal and (4) squamous cell skin cancers ; patients typically treated with Positive Phase 3 Results in Molluscum Contagiosum surgery • Achieved statistical significance for primary endpoints in • Submission of U.S. IND anticipated during first half of 2021 two pivotal trials for YCANTH™ (VP-102) • P-value <0.0001 for primary endpoint in both pivotal trials Option Agreement with Torii Pharmaceuticals for Development and Commercialization of VP-102 in Japan Innovative Product Candidate • Torii option includes Verrica product candidates for the • Proprietary drug-device combination of formulation treatment of molluscum and common warts in Japan and single-use applicator Proven Team Physician Acceptance • Industry-leading, experienced management team with (3) • 95% of pediatric dermatologists have used API extensive dermatology product launch experience • Strengthened clinical and drug development leadership in August 2020 (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. 3 (4) https://www.cancer.org/cancer/basal-and-squamous-cell-skin-cancer/about/key-statistics.html and Rogers JAMA Derm 2015 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 Resubmitted U.S. NDA for YCANTH™ (VP-102) for the Treatment of Molluscum in December 2020 • 5.4 million diagnoses annually in the U.S. of basal and (4) squamous cell skin cancers ; patients typically treated with Positive Phase 3 Results in Molluscum Contagiosum surgery • Achieved statistical significance for primary endpoints in • Submission of U.S. IND anticipated during first half of 2021 two pivotal trials for YCANTH™ (VP-102) • P-value <0.0001 for primary endpoint in both pivotal trials Option Agreement with Torii Pharmaceuticals for Development and Commercialization of VP-102 in Japan Innovative Product Candidate • Torii option includes Verrica product candidates for the • Proprietary drug-device combination of formulation treatment of molluscum and common warts in Japan and single-use applicator Proven Team Physician Acceptance • Industry-leading, experienced management team with (3) • 95% of pediatric dermatologists have used API extensive dermatology product launch experience • Strengthened clinical and drug development leadership in August 2020 (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. 3 (4) https://www.cancer.org/cancer/basal-and-squamous-cell-skin-cancer/about/key-statistics.html and Rogers JAMA Derm 2015
Our Product Portfolio NEXT EXPECTED PRE-IND PHASE 2 PHASE 3 NDA MILESTONE FDA acceptance of NDA that was resubmitted in Molluscum Contagiosum December 2020 Evaluate potential * Common Warts second Phase 2 trial* Request End-of-Phase 2 External Genital Warts meeting in Q1 2021 Initiate Phase 2 trial** Plantar Warts Non-Melanoma Submit US IND during 1H 2021 Skin Cancer*** * Original Phase 2 program completed. Company evaluating potential for conducting an additional Phase 2 trial based on FDA feedback for Phase 3 trial protocol. ** Timing for initiating new clinical trials to be determined *** Initially focused on basal cell and squamous cell carcinomas 4 LTX-315 VP-103 VP-102 YCANTHOur Product Portfolio NEXT EXPECTED PRE-IND PHASE 2 PHASE 3 NDA MILESTONE FDA acceptance of NDA that was resubmitted in Molluscum Contagiosum December 2020 Evaluate potential * Common Warts second Phase 2 trial* Request End-of-Phase 2 External Genital Warts meeting in Q1 2021 Initiate Phase 2 trial** Plantar Warts Non-Melanoma Submit US IND during 1H 2021 Skin Cancer*** * Original Phase 2 program completed. Company evaluating potential for conducting an additional Phase 2 trial based on FDA feedback for Phase 3 trial protocol. ** Timing for initiating new clinical trials to be determined *** Initially focused on basal cell and squamous cell carcinomas 4 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 (2) (4) ~1 million diagnosed annually ~1.5 million diagnosed annually 22M 85% Prevalence in U.S. Not Diagnosed 5.1 million 1.5M Patients Diagnosed 15% Annually 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 5YCANTH™ 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 (2) (4) ~1 million diagnosed annually ~1.5 million diagnosed annually 22M 85% Prevalence in U.S. Not Diagnosed 5.1 million 1.5M Patients Diagnosed 15% Annually 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 5
THE PROBLEM Molluscum Contagiosum 6THE PROBLEM Molluscum Contagiosum 6
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 Complications • Skin irritation, inflammation, and re-infection 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. 7Molluscum 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 Complications • Skin irritation, inflammation, and re-infection 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. 7
Current Treatments DESCRIPTION LIMITATIONS for Molluscum are • Pain and scarring Freezing the lesions not FDA-Approved Cryotherapy with liquid nitrogen • Unsuitable for use in children and Have Many Using a curette or a surgical • Pain and scarring Limitations instrument with a scoop at Curettage • Unsuitable for use in children the tip to scrape the lesions • Pain, cost and lack Laser Broad use limited by Applying a laser to target of availability and destroy the lesions Surgery • Unsuitable for use in children unproven efficacy, scarring, lack of Applying various acids Topical (e.g. salicylic acid), creams availability, safety • Unproven efficacy or blistering solutions to Products destroy the lesions concerns & pain Retinoids, antiviral • Limited efficacy Off-Label medicines, or immune Significantly • Side‐effects Drugs modulating therapies undertreated patient • Unproven efficacy Applying natural oils Natural population (e.g. tea tree oil) with • Pain, irritation and Remedies antimicrobial properties allergic reactions 8Current Treatments DESCRIPTION LIMITATIONS for Molluscum are • Pain and scarring Freezing the lesions not FDA-Approved Cryotherapy with liquid nitrogen • Unsuitable for use in children and Have Many Using a curette or a surgical • Pain and scarring Limitations instrument with a scoop at Curettage • Unsuitable for use in children the tip to scrape the lesions • Pain, cost and lack Laser Broad use limited by Applying a laser to target of availability and destroy the lesions Surgery • Unsuitable for use in children unproven efficacy, scarring, lack of Applying various acids Topical (e.g. salicylic acid), creams availability, safety • Unproven efficacy or blistering solutions to Products destroy the lesions concerns & pain Retinoids, antiviral • Limited efficacy Off-Label medicines, or immune Significantly • Side‐effects Drugs modulating therapies undertreated patient • Unproven efficacy Applying natural oils Natural population (e.g. tea tree oil) with • Pain, irritation and Remedies antimicrobial properties allergic reactions 8
THE SOLUTION YCANTH™ (VP-102) 9THE SOLUTION YCANTH™ (VP-102) 9
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 Ampule Tube Filter Cap Tip • 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 10YCANTH™ (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 Ampule Tube Filter Cap Tip • 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 10
U.S. 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 • Resubmitted NDA in December 2020 11U.S. 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 • Resubmitted NDA in December 2020 11
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 Trial Design FDA Special Protocol study period controlled trials Assessment (SPA) Secondary: Primary: Percent of subjects with complete clearance at week 3, 6, 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 Population days; 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 12We 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 Trial Design FDA Special Protocol study period controlled trials Assessment (SPA) Secondary: Primary: Percent of subjects with complete clearance at week 3, 6, 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 Population days; 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 12
Molluscum History for Subjects in Phase 3 Trials VP-102 Vehicle (N=311) (N=216) 13 * 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. 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) 13 * 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. 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 14 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 14 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 15 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 15 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) Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2) 16Phase 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) Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2) 16
MC Commercial Opportunity 17MC Commercial Opportunity 17
Realizing the Molluscum Opportunity (1) US Prevalence of ~6 million in molluscum with ~1 million (2) 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 18Realizing the Molluscum Opportunity (1) US Prevalence of ~6 million in molluscum with ~1 million (2) 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 18
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. 19Dermatologists 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. 19
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) Pediatricians KEY REASONS TO USE IF APPROVED 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] 20Physicians 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) Pediatricians KEY REASONS TO USE IF APPROVED 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] 20
Initial Payer Research Suggests Favorable Reimbursement Landscape for YCANTH™ (VP-102) COHORT SIZE AVERAGE LIVES COVERED Medical 79.8M Directors Pharmacy 64.2M The 15 Payer Organizations Directors and Plans Represented in the IDN Interviews Cover a Total of 26.5M Stakeholders 105 Million Commercial & Medicaid Lives Source: Third party study commissioned by the Company. 21Initial Payer Research Suggests Favorable Reimbursement Landscape for YCANTH™ (VP-102) COHORT SIZE AVERAGE LIVES COVERED Medical 79.8M Directors Pharmacy 64.2M The 15 Payer Organizations Directors and Plans Represented in the IDN Interviews Cover a Total of 26.5M Stakeholders 105 Million Commercial & Medicaid Lives Source: Third party study commissioned by the Company. 21
Initial Payer Research Suggests Favorable Reimbursement Landscape for YCANTH™ (VP-102) Key Takeaways Payers interviewed recognize a significant unmet need for molluscum contagiosum 1 and lack of an effective treatment Some of the key concerns mentioned about the undertreatment of the condition include 2 the risk of infection, scarring, or spread of the disease Payers perceived YCANTH™ (VP-102) to be highly favorable based on the majority of 3 patients experiencing clearance within 12 weeks Given the unmet need and favorable clinical outcomes in Phase 2 trials, payers anticipate the 4 majority of patients would have access to YCANTH™ (VP-102) with minimal to no restrictions 22 Source: Third party study commissioned by the Company.Initial Payer Research Suggests Favorable Reimbursement Landscape for YCANTH™ (VP-102) Key Takeaways Payers interviewed recognize a significant unmet need for molluscum contagiosum 1 and lack of an effective treatment Some of the key concerns mentioned about the undertreatment of the condition include 2 the risk of infection, scarring, or spread of the disease Payers perceived YCANTH™ (VP-102) to be highly favorable based on the majority of 3 patients experiencing clearance within 12 weeks Given the unmet need and favorable clinical outcomes in Phase 2 trials, payers anticipate the 4 majority of patients would have access to YCANTH™ (VP-102) with minimal to no restrictions 22 Source: Third party study commissioned by the Company.
Integrated Commercial Approach with Multiple Strategic Levers Commercial Strategy Disease KOL Specialized Dedicated Buy and Bill Awareness Engagement Sales Team Institutional or Specialty Team Pharmacy Increase Strong Targeting office-based treatment seekers established and institutional Specialists to Forward Deployed through cost- relationships Dermatologists, and promote to Inventory efficient consumer and support select Pediatricians dermatologists in Supportive advertising academic settings HUB services and group practices Dedicated field reimbursement Team 23Integrated Commercial Approach with Multiple Strategic Levers Commercial Strategy Disease KOL Specialized Dedicated Buy and Bill Awareness Engagement Sales Team Institutional or Specialty Team Pharmacy Increase Strong Targeting office-based treatment seekers established and institutional Specialists to Forward Deployed through cost- relationships Dermatologists, and promote to Inventory efficient consumer and support select Pediatricians dermatologists in Supportive advertising academic settings HUB services and group practices Dedicated field reimbursement Team 23
Pre-Commercialization Activities Ongoing Engagement at Premier Venues & Industry Channels DISEASE AWARENESS Caregiver MC HCP MC education Poster Presentation education through congresses, through digital speaker programs, and and social tools professional journal space OTHER National National Trade distribution channel development and Regional and Regional Meetings Meetings Customer segment insights Brand strategy, customer segmentation, and targeting Commercial systems infrastructure 24Pre-Commercialization Activities Ongoing Engagement at Premier Venues & Industry Channels DISEASE AWARENESS Caregiver MC HCP MC education Poster Presentation education through congresses, through digital speaker programs, and and social tools professional journal space OTHER National National Trade distribution channel development and Regional and Regional Meetings Meetings Customer segment insights Brand strategy, customer segmentation, and targeting Commercial systems infrastructure 24
VP-102 in Common Warts 25VP-102 in Common Warts 25
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. 26 (2) IQVIA Anonymous Longitudinal Patient Level Data (APLD) for 12 months ending September 2018Verruca 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. 26 (2) IQVIA Anonymous Longitudinal Patient Level Data (APLD) for 12 months ending September 2018
We Have Successfully Completed a Phase 2 Study (COVE-1) in Common Warts Cohort 1: one center Study Design Efficacy, safety & tolerability 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 27We Have Successfully Completed a Phase 2 Study (COVE-1) in Common Warts Cohort 1: one center Study Design Efficacy, safety & tolerability 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 27
VP-102 Demonstrated Clinically Meaningful Efficacy on Primary Endpoint of Complete Clearance in COVE-1 Study 28VP-102 Demonstrated Clinically Meaningful Efficacy on Primary Endpoint of Complete Clearance in COVE-1 Study 28
Adverse Events in COVE-1 Study (Incidence≥5%)* 29Adverse Events in COVE-1 Study (Incidence≥5%)* 29
VP-102 in External Genital Warts 30VP-102 in External Genital Warts 30
Condyloma Acuminatum (Genital Warts) ETIOLOGY AND CLINICAL PRESENTATION OVERVIEW Transmission • Skin to skin contact Caused by human papilloma virus (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 Approximately 500,000 to 1 million • Dyspigmentation of affected areas cases of EGW are newly diagnosed • Scarring may occur 1 per year in the United States • Bacterial superinfection of lesions 31 (1) Yanofsky, Valerie & Patel, Rita & Goldenberg, Gary. (2012). Genital warts: A comprehensive review. The Journal of clinical and Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. aesthetic dermatology. 5. 25-36. Condyloma Acuminatum (Genital Warts) ETIOLOGY AND CLINICAL PRESENTATION OVERVIEW Transmission • Skin to skin contact Caused by human papilloma virus (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 Approximately 500,000 to 1 million • Dyspigmentation of affected areas cases of EGW are newly diagnosed • Scarring may occur 1 per year in the United States • Bacterial superinfection of lesions 31 (1) Yanofsky, Valerie & Patel, Rita & Goldenberg, Gary. (2012). Genital warts: A comprehensive review. The Journal of clinical and Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. aesthetic dermatology. 5. 25-36.
Phase 2 Study (CARE-1) in External Genital Warts (EGW) Study comprised of two parts (A and B) Dose regimen, Multi-center, double- efficacy, safety & Study Design blind, vehicle- Primary objective of Part A is to identify the two tolerability controlled 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 days 21, 42, and 63 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: 87 subjects 18+ years of age with 2-30 external genital and/or perianal warts for ≥ 4 weeks at baseline visit Part A: Three treatment groups with a 2-hour, 6- Study drug (VP-102) is Frequency of hour, and 24-hour duration of skin exposure administered topically to administration Application before removal with soap and warm water each treatable wart every is every 21 21 days until complete Part B: 6- and 24-hour duration of treatment days clearance for a maximum exposure (chosen based on Part A) with follow up of 4 treatments period through Day 147 32Phase 2 Study (CARE-1) in External Genital Warts (EGW) Study comprised of two parts (A and B) Dose regimen, Multi-center, double- efficacy, safety & Study Design blind, vehicle- Primary objective of Part A is to identify the two tolerability controlled 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 days 21, 42, and 63 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: 87 subjects 18+ years of age with 2-30 external genital and/or perianal warts for ≥ 4 weeks at baseline visit Part A: Three treatment groups with a 2-hour, 6- Study drug (VP-102) is Frequency of hour, and 24-hour duration of skin exposure administered topically to administration Application before removal with soap and warm water each treatable wart every is every 21 21 days until complete Part B: 6- and 24-hour duration of treatment days clearance for a maximum exposure (chosen based on Part A) with follow up of 4 treatments period through Day 147 32
Demographics (CARE-1, ITT Population)* VP-102 Vehicle VP-102 Vehicle 6-hour 6-hour 24-hour 24-hour (N=30) (N=24) (N=27) (N=18) Age Mean (SD) 38.93 (9.9) 35.83 (7.8) 34.33 (7.1) 33.83 (6.3) Min, Max 26, 59 26, 58 25, 53 25, 43 Gender, n (%) Male 17 (56.7) 14 (58.3) 15 (55.6) 11 (61.1) Female 13 (43.3) 10 (41.7) 12 (44.4) 7 (38.9) Race, n (%) White 24 (80.0) 13 (54.2) 24 (88.9) 12 (66.7) Black or African American 6 (20.0) 8 (33.3) 2 (7.4) 6 (33.3) American Indian or Alaska Native 0 (0) 1 (4.2) 0 (0) 0 (0) Other 0 (0) 2 (8.3) 1 (3.7) 0 (0) Ethnicity, n (%) Hispanic or Latino 6 (20.0) 1 (4.2) 2 (7.4) 5 (27.8) Not Hispanic or Latino 24 (80.0) 23 (95.8) 25 (92.6) 13 (72.2) *Pooled data from Part A and B 33Demographics (CARE-1, ITT Population)* VP-102 Vehicle VP-102 Vehicle 6-hour 6-hour 24-hour 24-hour (N=30) (N=24) (N=27) (N=18) Age Mean (SD) 38.93 (9.9) 35.83 (7.8) 34.33 (7.1) 33.83 (6.3) Min, Max 26, 59 26, 58 25, 53 25, 43 Gender, n (%) Male 17 (56.7) 14 (58.3) 15 (55.6) 11 (61.1) Female 13 (43.3) 10 (41.7) 12 (44.4) 7 (38.9) Race, n (%) White 24 (80.0) 13 (54.2) 24 (88.9) 12 (66.7) Black or African American 6 (20.0) 8 (33.3) 2 (7.4) 6 (33.3) American Indian or Alaska Native 0 (0) 1 (4.2) 0 (0) 0 (0) Other 0 (0) 2 (8.3) 1 (3.7) 0 (0) Ethnicity, n (%) Hispanic or Latino 6 (20.0) 1 (4.2) 2 (7.4) 5 (27.8) Not Hispanic or Latino 24 (80.0) 23 (95.8) 25 (92.6) 13 (72.2) *Pooled data from Part A and B 33
Baseline EGW Characteristics (CARE-1, ITT Population*) VP-102 Vehicle VP-102 Vehicle 6-hour 6-hour 24-hour 24-hour (N=30) (N=24) (N=27) (N=18) Duration of Warts, No. (%) <1 year 15 (50.0) 12 (50.0) 13 (48.1) 9 (50.0) 1-2 years 3 (10) 1 (4.2) 2 (7.4) 0 (0.0) >2-5 Years 4 (13.3) 5 (20.8) 8 (29.6) 3 (16.7) >5 years 8 (26.7) 6 (25.0) 3 (11.1) 6 (33.3) Wart Count Mean 8.5 6.71 9.48 7.56 SD 7.3 5.5 6.2 6.8 Median 6 5 9 4.5 Min, Max 2, 30 2, 26 2, 25 2, 28 Prior Wart Treatment, No. (%) Yes 17 (56.7) 13 (54.2) 14 (51.9) 9 (50) *Pooled data from Part A and B 34Baseline EGW Characteristics (CARE-1, ITT Population*) VP-102 Vehicle VP-102 Vehicle 6-hour 6-hour 24-hour 24-hour (N=30) (N=24) (N=27) (N=18) Duration of Warts, No. (%) <1 year 15 (50.0) 12 (50.0) 13 (48.1) 9 (50.0) 1-2 years 3 (10) 1 (4.2) 2 (7.4) 0 (0.0) >2-5 Years 4 (13.3) 5 (20.8) 8 (29.6) 3 (16.7) >5 years 8 (26.7) 6 (25.0) 3 (11.1) 6 (33.3) Wart Count Mean 8.5 6.71 9.48 7.56 SD 7.3 5.5 6.2 6.8 Median 6 5 9 4.5 Min, Max 2, 30 2, 26 2, 25 2, 28 Prior Wart Treatment, No. (%) Yes 17 (56.7) 13 (54.2) 14 (51.9) 9 (50) *Pooled data from Part A and B 34
Efficacy (CARE-1, ITT Population) Mean Percentage Change in EGW Percentage of Subjects with Lesions from Baseline Complete Clearance of all Baseline ⸸ and New Treatable EGW Lesions VP-102 Vehicle VP-102 Vehicle 6-hour 6-hour 24-hour 24-hour 100 (n=30) (n=24) (n=27) (n= 18) ** 80 10 1.24 0 60 -10 -7.04 -20 35.1 -30 40 -40 -50 20 -60 2.4 -70 0 -80 -74.3 Pooled VP-102 (N=57) Pooled Vehicle (N=42) -90 -79.4 -100 ⸸ Pooled data from Part A and B *P<0.001 * 35 ** **P≤0.0001Efficacy (CARE-1, ITT Population) Mean Percentage Change in EGW Percentage of Subjects with Lesions from Baseline Complete Clearance of all Baseline ⸸ and New Treatable EGW Lesions VP-102 Vehicle VP-102 Vehicle 6-hour 6-hour 24-hour 24-hour 100 (n=30) (n=24) (n=27) (n= 18) ** 80 10 1.24 0 60 -10 -7.04 -20 35.1 -30 40 -40 -50 20 -60 2.4 -70 0 -80 -74.3 Pooled VP-102 (N=57) Pooled Vehicle (N=42) -90 -79.4 -100 ⸸ Pooled data from Part A and B *P<0.001 * 35 ** **P≤0.0001
Safety: Treatment Emergent Adverse Events ≥ 5% (CARE-1, Safety Population)*,⸸ VP-102 Vehicle VP-102 Vehicle TEAEs, N 6-hour 6-hour 24-hour 24-hour (N=29) (N=22) (N=28) (N=20) (%) Subjects reporting at least one 29 (100.0) 8 (36.4) 28 (100.0) 6 (30.0) TEAE Application site vesicles 25 (86.2) 0 (0.0) 26 (92.9) 1 (5.0) Application site pain 20 (69.0) 3 (13.6) 19 (67.9) 4 (20.0) Application site erythema 14 (48.3) 3 (13.6) 19 (67.9) 1 (5.0) Application site pruritus 14 (48.3) 5 (22.7) 10 (35.7) 1 (5.0) Application site scab 13 (44.8) 1 (4.5) 14 (50.0) 0 (0.0) Application site discoloration 7 (24.1) 4 (18.2) 6 (21.4) 0 (0.0) Application site dryness 7 (24.1) 2 (9.1) 6 (21.4) 1 (5.0) Application site erosion 6 (20.7) 0 (0.0) 7 (25.0) 0 (0.0) Application site edema 3 (10.3) 1 (4.5) 7 (25.0) 1 (5.0) Application site exfoliation 3 (10.3) 2 (9.1) 5 (17.9) 0 (0.0) TEAEs = Treatment Emergent Adverse Events *Pooled data from Part A and B. No subjects discontinued the study due to AEs. 36 ⸸ No serious adverse events as deemed related to study drug by investigator.Safety: Treatment Emergent Adverse Events ≥ 5% (CARE-1, Safety Population)*,⸸ VP-102 Vehicle VP-102 Vehicle TEAEs, N 6-hour 6-hour 24-hour 24-hour (N=29) (N=22) (N=28) (N=20) (%) Subjects reporting at least one 29 (100.0) 8 (36.4) 28 (100.0) 6 (30.0) TEAE Application site vesicles 25 (86.2) 0 (0.0) 26 (92.9) 1 (5.0) Application site pain 20 (69.0) 3 (13.6) 19 (67.9) 4 (20.0) Application site erythema 14 (48.3) 3 (13.6) 19 (67.9) 1 (5.0) Application site pruritus 14 (48.3) 5 (22.7) 10 (35.7) 1 (5.0) Application site scab 13 (44.8) 1 (4.5) 14 (50.0) 0 (0.0) Application site discoloration 7 (24.1) 4 (18.2) 6 (21.4) 0 (0.0) Application site dryness 7 (24.1) 2 (9.1) 6 (21.4) 1 (5.0) Application site erosion 6 (20.7) 0 (0.0) 7 (25.0) 0 (0.0) Application site edema 3 (10.3) 1 (4.5) 7 (25.0) 1 (5.0) Application site exfoliation 3 (10.3) 2 (9.1) 5 (17.9) 0 (0.0) TEAEs = Treatment Emergent Adverse Events *Pooled data from Part A and B. No subjects discontinued the study due to AEs. 36 ⸸ No serious adverse events as deemed related to study drug by investigator.
LTX-315 37LTX-315 37
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 immunogenic cell death cells via 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 38 (2) All malignant and pre-malignant dermatological indications, except for metastatic melanoma and metastatic Merkel cell carcinomaLTX-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 immunogenic cell death cells via 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 38 (2) All malignant and pre-malignant dermatological indications, except for metastatic melanoma and metastatic Merkel cell carcinoma
Non-Melanoma Skin Cancer OVERVIEW ETIOLOGY AND CLINICAL PRESENTATION • Estimated 5.4 million diagnoses of basal cell (BCC) and Patient squamous cell (SCC) carcinomas annually 1 population Non-melanoma skin cancer includes • Increasing age and sun exposure are risk factors basal cell and squamous cell carcinoma • New or changing lesions on sun exposed skin Diagnosis 2,3 & Symptoms • Common on the head/neck • BCC: Pink pearly papules with prominent blood vessels Basal cell carcinoma is the most 1 • SCC: Pink, rough scaly papules, patches, or plaques common malignancy in humans • Diagnosis through routine biopsy • Damage to healthy tissue, pain, permanent scarring Common treatments are invasive, 3,4 Complications painful, can cause scarring, and may • Surgical complications include disfigurement, bleeding 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 39 (3) Gruber StatPearls 2020 (4) Bailey Int J of Wom Derm 2019Non-Melanoma Skin Cancer OVERVIEW ETIOLOGY AND CLINICAL PRESENTATION • Estimated 5.4 million diagnoses of basal cell (BCC) and Patient squamous cell (SCC) carcinomas annually 1 population Non-melanoma skin cancer includes • Increasing age and sun exposure are risk factors basal cell and squamous cell carcinoma • New or changing lesions on sun exposed skin Diagnosis 2,3 & Symptoms • Common on the head/neck • BCC: Pink pearly papules with prominent blood vessels Basal cell carcinoma is the most 1 • SCC: Pink, rough scaly papules, patches, or plaques common malignancy in humans • Diagnosis through routine biopsy • Damage to healthy tissue, pain, permanent scarring Common treatments are invasive, 3,4 Complications painful, can cause scarring, and may • Surgical complications include disfigurement, bleeding 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 39 (3) Gruber StatPearls 2020 (4) Bailey Int J of Wom Derm 2019
DESCRIPTION LIMITATIONS • Invasive Using a scalpel to remove Current Treatments Surgical Excision • Can cause scarring/disfigurement, diseased tissue and healthy skin infection, pain For Non-Melanoma 1-3 • Invasive, may take several rounds Skin Cancer Used in high risk NMSC or in Mohs Surgery • Can cause scarring, disfigurement special sites and pain Invasive procedures may lead to permanent scarring, pain, damage • Invasive Minor surgical procedure to Electrodessication to healthy tissue, and recurrence remove diseased tissue with • Painful 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 imiquimod • Local inflammatory reactions, systemic size effects • 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 (1) Camilio Oncoimmunology 2014 ODOMZO® (sonidegib) Oral Therapy (2) Combalia Derm Practic & Concept 2020 • Systemic side effects (3) Bailey Int J of Wom Derm 2019 (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 surgery or who are not candidates for surgery and who are not candidates for radiation. (5) Per Prescribing Information: a hedgehog pathway inhibitor indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those 40 who are not candidates for surgery or radiation therapy.DESCRIPTION LIMITATIONS • Invasive Using a scalpel to remove Current Treatments Surgical Excision • Can cause scarring/disfigurement, diseased tissue and healthy skin infection, pain For Non-Melanoma 1-3 • Invasive, may take several rounds Skin Cancer Used in high risk NMSC or in Mohs Surgery • Can cause scarring, disfigurement special sites and pain Invasive procedures may lead to permanent scarring, pain, damage • Invasive Minor surgical procedure to Electrodessication to healthy tissue, and recurrence remove diseased tissue with • Painful 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 imiquimod • Local inflammatory reactions, systemic size effects • 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 (1) Camilio Oncoimmunology 2014 ODOMZO® (sonidegib) Oral Therapy (2) Combalia Derm Practic & Concept 2020 • Systemic side effects (3) Bailey Int J of Wom Derm 2019 (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 surgery or who are not candidates for surgery and who are not candidates for radiation. (5) Per Prescribing Information: a hedgehog pathway inhibitor indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those 40 who are not candidates for surgery or radiation therapy.
Regulatory Exclusivity and Intellectual Property 41Regulatory Exclusivity and Intellectual Property 41
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 CMOs with facilities for cantharidin; subject to specified minimum annual purchase to address stability issues with standard handling highly potent orders and forecasts, supplier agreed that it will not supply Manufacturing packaging and container/ and highly flammable cantharidin, any beetles or other raw material from which 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) ) 42Verrica 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 CMOs with facilities for cantharidin; subject to specified minimum annual purchase to address stability issues with standard handling highly potent orders and forecasts, supplier agreed that it will not supply Manufacturing packaging and container/ and highly flammable cantharidin, any beetles or other raw material from which 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) ) 42
Overview of VP-102/103 Intellectual Property Portfolio KEY CLAIMS AND PATENT APPLICATIONS VALUE TO VERRICA Our specific formulation, YCANTH™ (VP-102), key safety 1 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) May prevent generics from utilizing a single-use applicator for cantharidin that contains both Single use applicator containing cantharidin formulations a glass ampule to maintain product stability and a filter placed prior to dispensing tip, which (PCT/US2014/052184) (PCT/US2018/037808) 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 Methods for complete cantharidin synthesis 5 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 43Overview of VP-102/103 Intellectual Property Portfolio KEY CLAIMS AND PATENT APPLICATIONS VALUE TO VERRICA Our specific formulation, YCANTH™ (VP-102), key safety 1 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) May prevent generics from utilizing a single-use applicator for cantharidin that contains both Single use applicator containing cantharidin formulations a glass ampule to maintain product stability and a filter placed prior to dispensing tip, which (PCT/US2014/052184) (PCT/US2018/037808) 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 Methods for complete cantharidin synthesis 5 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 43
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 44Overview 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 44
Investor Relations—NASDAQ: VRCA (1) As of September 30, 2020 Analyst Coverage Ken Cacciatore, Cowen • Cash and marketable securities: $71.8M • Long-term debt: $35.0M Oren Livnat, H.C. Wainwright • Outstanding shares: 25.9M • Outstanding option shares and RSUs: 4.1M David Steinberg, Jefferies Serge Belanger, Needham Tim Chiang, Northland Capital Markets (1) Disclaimer: Any opinions, estimates or forecasts regarding Verricaʼs performance made by the above-referenced analysts are theirs alone and do not represent opinions, forecasts or predictions of Verrica or its management, and no endorsement of such opinions, estimates or forecasts shall be implied. 45Investor Relations—NASDAQ: VRCA (1) As of September 30, 2020 Analyst Coverage Ken Cacciatore, Cowen • Cash and marketable securities: $71.8M • Long-term debt: $35.0M Oren Livnat, H.C. Wainwright • Outstanding shares: 25.9M • Outstanding option shares and RSUs: 4.1M David Steinberg, Jefferies Serge Belanger, Needham Tim Chiang, Northland Capital Markets (1) Disclaimer: Any opinions, estimates or forecasts regarding Verricaʼs performance made by the above-referenced analysts are theirs alone and do not represent opinions, forecasts or predictions of Verrica or its management, and no endorsement of such opinions, estimates or forecasts shall be implied. 45
Our Product Portfolio NEXT EXPECTED PRE-IND PHASE 2 PHASE 3 NDA MILESTONE FDA acceptance of NDA that was resubmitted in Molluscum Contagiosum December 2020 Evaluate potential * Common Warts second Phase 2 trial* Request End-of-Phase 2 External Genital Warts meeting in Q1 2021 Initiate Phase 2 trial** Plantar Warts Non-Melanoma Submit US IND during 1H 2021 Skin Cancer*** * Original Phase 2 program completed. Company evaluating potential for conducting an additional Phase 2 trial based on FDA feedback for Phase 3 trial protocol. ** Timing for initiating new clinical trials to be determined *** Initially focused on basal cell and squamous cell carcinomas 46 LTX-315 VP-103 VP-102 YCANTHOur Product Portfolio NEXT EXPECTED PRE-IND PHASE 2 PHASE 3 NDA MILESTONE FDA acceptance of NDA that was resubmitted in Molluscum Contagiosum December 2020 Evaluate potential * Common Warts second Phase 2 trial* Request End-of-Phase 2 External Genital Warts meeting in Q1 2021 Initiate Phase 2 trial** Plantar Warts Non-Melanoma Submit US IND during 1H 2021 Skin Cancer*** * Original Phase 2 program completed. Company evaluating potential for conducting an additional Phase 2 trial based on FDA feedback for Phase 3 trial protocol. ** Timing for initiating new clinical trials to be determined *** Initially focused on basal cell and squamous cell carcinomas 46 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 Resubmitted U.S. NDA for YCANTH™ (VP-102) for the Treatment of Molluscum in December 2020 • 5.4 million diagnoses annually in the U.S. of basal and (4) squamous cell skin cancers ; patients typically treated with Positive Phase 3 Results in Molluscum Contagiosum surgery • Achieved statistical significance for primary endpoints in • Submission of U.S. IND anticipated during first half of 2021 two pivotal trials for YCANTH™ (VP-102) • P-value <0.0001 for primary endpoint in both pivotal trials Option Agreement with Torii Pharmaceuticals for Development and Commercialization of VP-102 in Japan Innovative Product Candidate • Torii option includes Verrica product candidates for the • Proprietary drug-device combination of formulation treatment of molluscum and common warts in Japan and single-use applicator Proven Team Physician Acceptance • Industry-leading, experienced management team with (3) • 95% of pediatric dermatologists have used API extensive dermatology product launch experience • Strengthened clinical and drug development leadership in August 2020 (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. 47 (4) https://www.cancer.org/cancer/basal-and-squamous-cell-skin-cancer/about/key-statistics.html and Rogers JAMA Derm 2015 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 Resubmitted U.S. NDA for YCANTH™ (VP-102) for the Treatment of Molluscum in December 2020 • 5.4 million diagnoses annually in the U.S. of basal and (4) squamous cell skin cancers ; patients typically treated with Positive Phase 3 Results in Molluscum Contagiosum surgery • Achieved statistical significance for primary endpoints in • Submission of U.S. IND anticipated during first half of 2021 two pivotal trials for YCANTH™ (VP-102) • P-value <0.0001 for primary endpoint in both pivotal trials Option Agreement with Torii Pharmaceuticals for Development and Commercialization of VP-102 in Japan Innovative Product Candidate • Torii option includes Verrica product candidates for the • Proprietary drug-device combination of formulation treatment of molluscum and common warts in Japan and single-use applicator Proven Team Physician Acceptance • Industry-leading, experienced management team with (3) • 95% of pediatric dermatologists have used API extensive dermatology product launch experience • Strengthened clinical and drug development leadership in August 2020 (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. 47 (4) https://www.cancer.org/cancer/basal-and-squamous-cell-skin-cancer/about/key-statistics.html and Rogers JAMA Derm 2015
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 48Management 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 48
Appendix 49Appendix 49
Providing meaningful benefit for people living with skin diseases Developing Reinventing dermatology dermatology therapeutics by products focusing on development and commercialization Late-stage dermatology therapeutics company 50Providing meaningful benefit for people living with skin diseases Developing Reinventing dermatology dermatology therapeutics by products focusing on development and commercialization Late-stage dermatology therapeutics company 50
Molluscum Clinical Evidence 51Molluscum Clinical Evidence 51
Cantharidin Elicits a Dual Response in the Skin 1 2 Superficial blistering of lesional skin 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 52Cantharidin Elicits a Dual Response in the Skin 1 2 Superficial blistering of lesional skin 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 52
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 blind, multi- • To assess the safety and tolerability of VP-102 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 blind, multi- Complete clearance at day 84 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 53 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 blind, multi- • To assess the safety and tolerability of VP-102 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 blind, multi- Complete clearance at day 84 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 53 PHASE 2 PHASE 3
Demographics in Phase 3 Molluscum Trials 54 Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)Demographics in Phase 3 Molluscum Trials 54 Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)
Safety Summary for Molluscum Phase 3 Trials 55 Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)Safety Summary for Molluscum Phase 3 Trials 55 Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)
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 Physician miscellaneous J-code under medical Office (1) benefit Potential Physician Reimbursement Opportunities • Prior authorization support “Buy and Bill” “White Bag” • Co-pay/co-insurance assistance Office visit Office visit Dedicated field reimbursement team to Procedure for lesion destruction Procedure for lesion destruction support physician offices YCANTH™ (VP-102) = (ASP + X%) (1) Verrica intends to file for a product-specific J-code for VP-102 Note: For illustrative purposes only. If approved, actual distribution channels and support services may change as strategy is finalized. 56YCANTH™ (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 Physician miscellaneous J-code under medical Office (1) benefit Potential Physician Reimbursement Opportunities • Prior authorization support “Buy and Bill” “White Bag” • Co-pay/co-insurance assistance Office visit Office visit Dedicated field reimbursement team to Procedure for lesion destruction Procedure for lesion destruction support physician offices YCANTH™ (VP-102) = (ASP + X%) (1) Verrica intends to file for a product-specific J-code for VP-102 Note: For illustrative purposes only. If approved, actual distribution channels and support services may change as strategy is finalized. 56
Non-Melanoma Skin Cancer 57Non-Melanoma Skin Cancer 57
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). 58Historical 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). 58