Full Press Release Details
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
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
THE PROBLEM Molluscum Contagiosum 6THE PROBLEM Molluscum Contagiosum
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
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
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)
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