VRCA Verrica Pharmaceuticals Inc.

12.8
+0.2  (+2%)
Previous Close 12.6
Open 12.52
52 Week Low 7.05
52 Week High 18.42
Market Cap $352,050,842
Shares 27,514,720
Float 13,027,725
Enterprise Value $310,126,212
Volume 41,167
Av. Daily Volume 150,368
Stock charts supplied by TradingView

Drug Pipeline

Drug Stage Notes
VP-102
Molluscum contagiosum
CRL
CRL
CRL announced July 14, 2020. NDA resubmitted. CRL announced September 20, 2021.
LTX-315
Phase 1
Phase 1
IND filing due 2H 2021.
VP-102
Common warts
Phase 2
Phase 2
Phase 2 trial completed.
VP-102
Genital warts
Phase 2
Phase 2
Phase 2 primary endpoint met - November 10, 2020.

Latest News

  1. No Specific Deficiencies Related to the Manufacturing of VP-102 Identified by FDA in its General Inspection of a Facility of the Contract Manufacturer

    No Clinical, Safety or CMC Issues Specific to VP-102 Identified

    WEST CHESTER, Pa., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (the "Company") (NASDAQ:VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum). The Company had previously disclosed that the FDA extended the Prescription Drug User Fee Act…

    No Specific Deficiencies Related to the Manufacturing of VP-102 Identified by FDA in its General Inspection of a Facility of the Contract Manufacturer

    No Clinical, Safety or CMC Issues Specific to VP-102 Identified

    WEST CHESTER, Pa., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (the "Company") (NASDAQ:VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum). The Company had previously disclosed that the FDA extended the Prescription Drug User Fee Act (PDUFA) goal date for the NDA by three months to September 23, 2021 to allow the Agency additional time to review information submitted by the Company in response to comments from the Agency regarding the Company's human factors study.

    According to the CRL, the FDA has identified deficiencies at a facility of a contract manufacturing organization (CMO), which are not specifically related to the manufacturing of VP-102 but instead raise general quality issues at the facility. At no time prior to the CRL was the Company notified by the FDA of any deficiencies at the CMO related specifically to the manufacturing of VP-102 or that their general investigation of the facility would have any impact on the Company's NDA. More importantly, the FDA did not identify any clinical, safety or product specific Chemistry, Manufacturing, and Controls (CMC) deficiencies related to VP-102.

    The Company understands from the CMO that it has implemented corrective actions to address the Agency's concerns and the CMO has advised Verrica that it is expecting a satisfactory resolution of the facility's identified deficiencies from the FDA within the next 30 business days. During this timeframe, the Company will engage with the Agency to demonstrate that the Company's good manufacturing practices, controls and processes ensure that any deficiencies at the CMO do not impact the efficacy, safety or quality of VP-102.

    "We remain confident that we have a path forward for VP-102 as a potential treatment option for molluscum, a highly contagious viral skin disease affecting approximately six million people in the United States - primarily children - for which there are currently no FDA-approved treatments," said Ted White, Verrica's President and Chief Executive Officer.

    About Molluscum Contagiosum (Molluscum)

    Molluscum is a highly contagious viral skin disease that affects approximately six million people — primarily children — in the United States. Molluscum is caused by a pox virus that produces distinctive raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching and bacterial infection. It is easily transmitted through direct skin-to-skin contact or through fomites (objects that carry the disease like toys, towels or wet surfaces) and can spread to other parts of the body or to other people, including siblings. The lesions can be found on most areas of the body and may carry substantial social stigma. Without treatment, molluscum can last for an average of 13 months, and in some cases, up to several years.

    About VP-102

    Verricaʼs lead product candidate, VP-102, is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator that allows for precise topical dosing and targeted administration. A Complete Response Letter was received from the FDA regarding the NDA for VP-102 on September 17, 2021. In addition, Verrica has successfully completed a Phase 2 study of VP-102 for the treatment of common warts and a Phase 2 study of VP-102 for the treatment of external genital warts.

    About Verrica Pharmaceuticals Inc.

    Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica's late-stage product candidate, VP-102, is in development to treat molluscum, common warts and external genital warts, three of the largest unmet needs in medical dermatology. Verrica is also developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. The Company has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize LTX-315 for dermatologic oncology conditions. For more information, visit www.verrica.com.

    Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will," and similar expressions, and are based on Verrica's current beliefs and expectations. These forward-looking statements include expectations regarding the Company's expectations with regard to interactions with the FDA, including the FDA's potential favorable response, and the timing of such response to the CMO's corrective actions, the potential approval of the NDA for VP-102, and the potential benefits and potential commercialization of VP-102 for the treatment of molluscum, if approved. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the drug development process and the regulatory approval process, Verrica's reliance on third parties over which it may not always have full control, uncertainties related to the COVID-19 pandemic and other risks and uncertainties that are described in Verrica's Annual Report on Form 10-K for the year ended December 31, 2020 and other filings Verrica makes with the U.S. Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and are based on information available to Verrica as of the date of this release, and Verrica assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    FOR MORE INFORMATION, PLEASE CONTACT:

    Investors:

    Terry Kohler

    Chief Financial Officer

    484.453.3296

    info@verrica.com 

    William Windham

    Solebury Trout

    646.378.2946

    wwindham@soleburytrout.com 

    Media:

    Zara Lockshin

    Solebury Trout

    646.378.2960

    zlockshin@soleburytrout.com



    Primary Logo

    View Full Article Hide Full Article
  2. WEST CHESTER, Pa., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. ("Verrica") (NASDAQ:VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced financial results for the second quarter ended June 30, 2021.

    "This quarter, we continued to ramp up commercial preparations for the potential FDA approval of VP-102, our lead product candidate for the treatment of molluscum contagiosum, including strengthening our senior leadership team and ensuring patient access to VP-102 through productive dialogue with medical providers and payors," said Ted White, Verrica's President and Chief Executive Officer. "With a strong financial position, and a PDUFA goal date of…

    WEST CHESTER, Pa., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. ("Verrica") (NASDAQ:VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced financial results for the second quarter ended June 30, 2021.

    "This quarter, we continued to ramp up commercial preparations for the potential FDA approval of VP-102, our lead product candidate for the treatment of molluscum contagiosum, including strengthening our senior leadership team and ensuring patient access to VP-102 through productive dialogue with medical providers and payors," said Ted White, Verrica's President and Chief Executive Officer. "With a strong financial position, and a PDUFA goal date of September 23, 2021, we continue to invest in our commercial capabilities and, if approved, we look forward to the opportunity to launch VP-102 in the fourth quarter of 2021."

    Business Highlights and Recent Developments

    • In May 2021, the Company announced that the U.S. Food and Drug Administration (FDA) extended the Prescription Drug User Fee Act (PDUFA) goal date for the New Drug Application (NDA) for VP-102 (cantharidin 0.7% Topical Solution) for the treatment of molluscum contagiosum by three months to September 23, 2021 to allow the Agency additional time to review information requested and submitted regarding the Company's training program and distribution model.
    • The Company continued to expand its U.S. commercial operations during the quarter in preparation for the potential FDA approval of VP-102, and has made key hires in marketing, sales and payor functions to support product launch and commercialization. The Company will be focusing its sales efforts in Dermatology, Pediatric Dermatology and key academic centers and health systems.
    • The Company strengthened its management team in anticipation of the potential commercial launch of VP-102 with the appointment of Terry Kohler as Chief Financial Officer, effective July 16, 2021. Mr. Kohler is a strategic and operational finance leader with over 20 years of commercial business experience, most recently at a global pharmaceutical company with annual revenues over $2 billion.
    • The Company continues to prepare to submit an Investigational New Drug Application for LTX-315 in the second half of 2021 for use in all malignant and pre-malignant dermatological indications, other than metastatic melanoma and metastatic merkel cell carcinoma.

    Financial Results

    Second Quarter 2021 Financial Results

    • Research and development expenses were $3.4 million in the second quarter of 2021, compared to $3.5 million for the same period in 2020. The decrease was primarily attributable to lower clinical costs related to Verrica's development of VP-102 for external genital warts and common warts.

    • General and administrative expenses were $7.3 million in the second quarter of 2021, compared to $5.1 million for the same period in 2020. The increase was primarily driven by increased headcount and other expenses related to pre-commercial activities for VP-102, as well as an increase in insurance, professional fees and other operating expenses.
    • For the second quarter of 2021, net loss on a GAAP basis was $11.8 million, or $0.43 per share, compared to a net loss of $9.4 million, or $0.38 per share, for the same period in 2020.
    • For the second quarter of 2021, non-GAAP net loss was $9.6 million, or $0.35 per share, compared to a non-GAAP net loss of $7.9 million, or $0.32 per share, for the same period in 2020.

    Year-to-Date June 2021 Financial Results

    • Verrica recognized license revenues of $12.0 million for the six months ended June 30, 2021 related to the Collaboration and License Agreement (the "Torii Agreement") with Torii Pharmaceutical Co., Ltd ("Torii"). There were no license revenues recognized in 2020.
    • Research and development expenses were $8.8 million for the six months ended June 30, 2021, compared to $8.4 million for the same period in 2020. The increase was primarily attributable to a one-time $2.3 million milestone payment to Lytix Biopharma AS upon the achievement of a regulatory milestone for LTX-315, partially offset by decreased Chemistry, Manufacturing and Controls ("CMC") and clinical costs related to Verrica's development of VP-102 for molluscum contagiosum, external genital warts, and common warts.
    • General and administrative expenses were $13.9 million for the six months ended June 30, 2021, compared to $10.1 million for the same period in 2020. The increase was primarily driven by increased headcount and other expenses related to pre-commercial activities for VP-102, as well as an increase in insurance, professional fees and other operating expenses.
    • For six months ended June 30, 2021, net loss on a GAAP basis was $12.7 million, or $0.46 per share, compared to a net loss of $19.2 million, or $0.77 per share, for the same period in 2020.
    • For the six months ended June 30, 2021, non-GAAP net loss was $8.8 million, or $0.32 per share, compared to a non-GAAP net loss of $16.7 million, or $0.67 per share, for the same period in 2020.
    • As of June 30, 2021, Verrica had aggregate cash, cash equivalents, and marketable securities of $90.1 million. The Company believes that its existing cash, cash equivalents, and marketable securities as of June 30, 2021 will be sufficient to support planned operations at least into the first quarter of 2023.

    Non-GAAP Financial Measures

    In evaluating the operating performance of its business, Verrica's management considers non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share. These non-GAAP financial measures exclude stock-based compensation charges and non-cash interest expense that are required by GAAP. Verrica believes that non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share provides useful information to both management and investors by excluding the effect of certain non-cash expenses and items that Verrica believes may not be indicative of its operating performance, because either they are unusual and Verrica does not expect them to recur in the ordinary course of its business, or they are unrelated to the ongoing operation of the business in the ordinary course. non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. Non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share have been reconciled to the nearest GAAP measure in the tables following the financial statements in this press release.

    About VP-102

    Verrica's lead product candidate, VP-102, is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator that allows for precise topical dosing and targeted administration. VP-102 is currently under U.S. Food and Drug Administration (FDA) review, with a PDUFA goal date of September 23, 2021, and could potentially be the first product approved by the FDA to treat molluscum contagiosum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. If approved, VP-102 will be marketed in the United States under the conditionally accepted brand name YCANTH™. In addition, Verrica has successfully completed a Phase 2 study of VP-102 for the treatment of common warts and a Phase 2 study of VP-102 for the treatment of external genital warts.

    About Molluscum Contagiosum (Molluscum)

    There are currently no FDA-approved treatments for molluscum, a highly contagious viral skin disease that affects approximately six million people — primarily children — in the United States. Molluscum is caused by a pox virus that produces distinctive raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching and bacterial infection. It is easily transmitted through direct skin-to-skin contact or through fomites (objects that carry the disease like toys, towels or wet surfaces) and can spread to other parts of the body or to other people, including siblings. The lesions can be found on most areas of the body and may carry substantial social stigma. Without treatment, molluscum can last for an average of 13 months, and in some cases, up to several years.

    About Verrica Pharmaceuticals Inc.

    Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica's late-stage product candidate, VP-102, is in development to treat molluscum, common warts and external genital warts, three of the largest unmet needs in medical dermatology. Verrica is also developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. The Company has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize LTX-315 for dermatologic oncology conditions. For more information, visit www.verrica.com.

    Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will," and similar expressions, and are based on Verrica's current beliefs and expectations. These forward-looking statements include expectations regarding the Company's expectations with regard to the potential approval of the NDA for VP-102 and the potential benefits and potential commercialization of VP-102 for the treatment of molluscum, if approved, including the timing of launch, the clinical development of Verrica's VP-102 for additional indications and Verrica's other product candidates, and Verrica's cash, cash equivalents and marketable securities being sufficient to support planned operations at least into the first quarter of 2023. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the drug development process and the regulatory approval process, Verrica's reliance on third parties over which it may not always have full control, uncertainties related to the COVID-19 pandemic and other risks and uncertainties that are described in Verrica's Annual Report on Form 10-K for the year ended December 31, 2020 and other filings Verrica makes with the U.S. Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and are based on information available to Verrica as of the date of this release, and Verrica assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.



    VERRICA PHARMACEUTICALS INC.

    Statements of Operations

    (unaudited, in thousands except share and per share data)

                     
      Three Months Ended June 30,  Six Months Ended June 30, 
      2021  2020  2021  2020 
    License revenue: $-  $-  $12,000  $- 
    Operating expenses:                
    Research and development  3,447   3,521   8,809   8,413 
    General and administrative  7,284   5,110   13,861   10,098 
                     
    Total operating expenses  10,731   8,631   22,670   18,511 
                     
    Loss from operations  (10,731)  (8,631)  (10,670)  (18,511)
    Interest income  33   126   65   404 
    Interest expense  (1,077)  (904)  (2,106)  (1,124)
                     
    Net loss $(11,775) $(9,409) $(12,711) $(19,231)
                     
    Net loss per share, basic and diluted $(0.43) $(0.38) $(0.46) $(0.77)
                     
    Weighted average common shares

        outstanding, basic and diluted
      27,513,665   24,965,634   27,697,985   24,964,900 



    VERRICA PHARMACEUTICALS INC.

    Selected Balance Sheet Data

    (unaudited, in thousands)

            
      June 30, 2021  December 31, 2020
    Cash, cash equivalents and marketable securities $90,129  $65,470
    Total assets  99,030   74,154
    Short term debt  41,005   35,315
    Total liabilities  46,874   41,168
    Total stockholders' equity  52,156   32,986



    VERRICA PHARMACEUTICALS INC.

    Reconciliation of Non-GAAP Financial Measures (unaudited)

    (in thousands except per share data)

              
      Three Months Ended June 30, 2021 
      Loss from Operations  Net loss 



    Net loss per

    share
     
             
    GAAP$(10,731) $ (11,775)$ (0.43)




    Non-GAAP Adjustments:
               
              
    Stock-based compensation – General & Admin (a) 1,423   1,423   
    Stock-based compensation – Research & Development (a) 425   425   
    Non-cash interest expense (b) -   344   
               
    Adjusted (8,883)  $ (9,583$ (0.35)



              
      Three Months Ended June 30, 2020 
      Loss from

    Operations
      Net loss 



    Net loss per

    share
     
             
    GAAP$(8,631) $ (9,409)$ (0.38)




    Non-GAAP Adjustments:
               
              
    Stock-based compensation – General & Admin (a) 1,039   1,039   
    Stock-based compensation – Research & Development (a) 213   213   
    Non-cash interest expense (b) -   263   
               
    Adjusted (7,379  $ (7,894$ (0.32)



     

      Six Months Ended June 30, 2021 
      Loss from

    Operations
      Net loss 



    Net loss per

    share
     
             
    GAAP$ (10,670) $ (12,711 )$ (0.46)




    Non-GAAP Adjustments:
               
              
    Stock-based compensation – General & Admin (a) 2,528   2,528   
    Stock-based compensation – Research & Development (a) 723   723   
    Non-cash interest expense (b) -   707   
               
    Adjusted (7,419  $ (8,753$ (0.32)



              
      Six Months Ended June 30, 2020 
      Loss from

    Operations
      Net loss 



    Net loss per

    share
     
             
    GAAP$(18,511) $ (19,231)$ (0.77)




    Non-GAAP Adjustments:
               
              
    Stock-based compensation – General & Admin (a) 1,860   1,860   
    Stock-based compensation – Research & Development (a) 390   390   
    Non-cash interest expense (b) -   328   
               
    Adjusted (16,261  $ (16,653$ (0.67)
                

          (a)   The effects of non-cash stock-based compensation are excluded because of varying available valuation methodologies and subjective assumptions. Verrica believes this is a useful measure for investors because such exclusion facilitates comparison to peer companies who also provide similar non-GAAP disclosures and is reflective of how management internally manages the business.

          (b)   The effects of non-cash interest charges are excluded. Verrica believes such exclusion facilitates an understanding of the effects of the debt service obligations on the Company's liquidity and comparisons to peer group companies and is reflective of how management internally manages the business.



    FOR MORE INFORMATION, PLEASE CONTACT:

    Investors:

    Terry Kohler

    Chief Financial Officer

    484.453.3296

    info@verrica.com

    William Windham

    Solebury Trout

    646.378.2946

    wwindham@soleburytrout.com

    Media:

    Zara Lockshin

    Solebury Trout

    646.378.2960

    zlockshin@soleburytrout.com



    Primary Logo

    View Full Article Hide Full Article
  3. Company strengthens management team in anticipation of the potential commercial launch of VP-102, if approved

    WEST CHESTER, Pa., July 09, 2021 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. ("Verrica") (NASDAQ:VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced the appointment of Terry Kohler as Chief Financial Officer. Mr. Kohler is a strategic and operational finance leader with over 20 years of commercial business experience, most recently at a global pharmaceutical company with annual revenues over $2 billion. Mr. Kohler is replacing Brian Davis, who is leaving Verrica to pursue other opportunities.

    "Terry's extensive commercial finance experience across…

    Company strengthens management team in anticipation of the potential commercial launch of VP-102, if approved

    WEST CHESTER, Pa., July 09, 2021 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. ("Verrica") (NASDAQ:VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced the appointment of Terry Kohler as Chief Financial Officer. Mr. Kohler is a strategic and operational finance leader with over 20 years of commercial business experience, most recently at a global pharmaceutical company with annual revenues over $2 billion. Mr. Kohler is replacing Brian Davis, who is leaving Verrica to pursue other opportunities.

    "Terry's extensive commercial finance experience across the pharmaceutical product development landscape, including buy and bill business model, as well as his commercial acumen across all classes of trade, will support our commercial preparations for the potential launch of VP-102 this fall," said Ted White, Verrica's President and Chief Executive Officer. "We are pleased to welcome Terry to our team and look forward to leveraging his expertise. On behalf of the company and the Board, I thank Brian for his dedicated service to Verrica and wish him well."

    "I am thrilled to join Verrica and oversee commercial financial strategy to advance Verrica's medical dermatology product portfolio," said Mr. Kohler. "I look forward to working with Verrica's Chief Commercial Officer and senior management to bring Verrica's proprietary treatments to medical providers and patients."

    Prior to joining Verrica, Mr. Kohler served as Vice President, Corporate Development and Treasurer and Vice President, U.S. Branded and Specialty Pharmaceuticals at Endo International PLC, a publicly traded global specialty pharmaceutical company focused on branded, sterile and generic pharmaceuticals with annual revenues over $2 billion and locations in the United States, Ireland, India and Canada. Previously, Mr. Kohler served as a senior professional with a middle market investment banking firm, and also held various roles at Johnson & Johnson. Mr. Kohler holds a B.A. in International Business and Management from Dickinson College and an M.B.A. in Finance & Entrepreneurship from the University of North Carolina. He is a Certified Management Accountant.

    About Verrica Pharmaceuticals Inc.

    Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica's late-stage product candidate, VP-102, is in development to treat molluscum, common warts and external genital warts, three of the largest unmet needs in medical dermatology. Verrica is also developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. The Company has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize LTX-315 for dermatologic oncology conditions. For more information, visit www.verrica.com.

    Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will," and similar expressions, and are based on Verrica's current beliefs and expectations. These forward-looking statements include expectations regarding the potential approval and commercial launch of VP-102 for the treatment of molluscum and the clinical development of VP-102 for additional indications. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the drug development process and the regulatory approval process, Verrica's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Verrica's Annual Report on Form 10-K for the year ended December 31, 2020, filed with the U.S. Securities and Exchange Commission on March 17, 2021, and other filings Verrica makes with the U.S. Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and are based on information available to Verrica as of the date of this release, and Verrica assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    FOR MORE INFORMATION, PLEASE CONTACT:

    Investors:

    William Windham

    Solebury Trout

    646.378.2946

    wwindham@soleburytrout.com

    Media:

    Zara Lockshin

    Solebury Trout

    646.378.2960

    zlockshin@soleburytrout.com



    Primary Logo

    View Full Article Hide Full Article
  4. – Prescription Drug User Fee Act (PDUFA) goal date extended by three months to September 23, 2021 –

    WEST CHESTER, Pa., May 28, 2021 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. ("Verrica") (NASDAQ:VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum). The Prescription Drug User Fee Act (PDUFA) goal date has been extended by three months to September 23, 2021.

    The FDA extended the PDUFA goal date to allow the Agency to have additional time to review information submitted by Verrica…

    – Prescription Drug User Fee Act (PDUFA) goal date extended by three months to September 23, 2021 –

    WEST CHESTER, Pa., May 28, 2021 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. ("Verrica") (NASDAQ:VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum). The Prescription Drug User Fee Act (PDUFA) goal date has been extended by three months to September 23, 2021.

    The FDA extended the PDUFA goal date to allow the Agency to have additional time to review information submitted by Verrica, including its training program and distribution model, in response to comments from the agency regarding the Company's human factors study. On May 26, 2021, the FDA informed Verrica that the information submitted has been designated a major amendment, which allows FDA to take an additional three months to review the submitted information.

    "We remain confident in VP-102 as a potential treatment option for patients with molluscum," said Ted White, Verrica's President and Chief Executive Officer. "Importantly, the FDA has recently completed one of the two pre-approval inspections required for approval. We look forward to our continued productive discussions with the FDA as it completes its review of our VP-102 NDA."

    About VP-102

    Verricaʼs lead product candidate, VP-102, is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator that allows for precise topical dosing and targeted administration. VP-102 is currently under U.S. Food and Drug Administration (FDA) review, with a PDUFA goal date of September 23, 2021, and could potentially be the first product approved by the FDA to treat molluscum contagiosum ― a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. If approved, VP-102 will be marketed in the United States under the conditionally accepted brand name YCANTH™. In addition, Verrica has successfully completed a Phase 2 study of VP-102 for the treatment of common warts and a Phase 2 study of VP-102 for the treatment of external genital warts.

    About Molluscum Contagiosum (Molluscum)

    Molluscum is a highly contagious viral skin disease that affects approximately six million people — primarily children — in the United States. Molluscum is caused by a pox virus that produces distinctive raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching and bacterial infection. It is easily transmitted through direct skin-to-skin contact or through fomites (objects that carry the disease like toys, towels or wet surfaces) and can spread to other parts of the body or to other people, including siblings. The lesions can be found on most areas of the body and may carry substantial social stigma. Without treatment, molluscum can last for an average of 13 months, and in some cases, up to several years.

    About Verrica Pharmaceuticals Inc.

    Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica's late-stage product candidate, VP-102, is in development to treat molluscum, common warts and external genital warts, three of the largest unmet needs in medical dermatology. Verrica is also developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. The Company has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize LTX-315 for dermatologic oncology conditions. For more information, visit www.verrica.com.

    Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will," and similar expressions, and are based on Verrica's current beliefs and expectations. These forward-looking statements include expectations regarding the Company's expectations with regard to the PDUFA date and potential approval of the NDA for VP-102 and the potential benefits of VP-102 for the treatment of molluscum, if approved. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the drug development process and the regulatory approval process, Verrica's reliance on third parties over which it may not always have full control, uncertainties related to the COVID-19 pandemic and other risks and uncertainties that are described in Verrica's Annual Report on Form 10-K for the year ended December 31, 2020 and other filings Verrica makes with the U.S. Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and are based on information available to Verrica as of the date of this release, and Verrica assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    FOR MORE INFORMATION, PLEASE CONTACT:

    Investors:

    A. Brian Davis

    Chief Financial Officer

    484.453.3300 ext. 103

    info@verrica.com

    William Windham

    Solebury Trout

    646.378.2946

    wwindham@soleburytrout.com

    Media:

    Zara Lockshin

    Solebury Trout

    646.378.2960

    zlockshin@soleburytrout.com



    Primary Logo

    View Full Article Hide Full Article
  5. WEST CHESTER, Pa., May 26, 2021 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. ("Verrica") (NASDAQ:VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that Ted White, Verrica President and CEO, will present a business overview at the Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021, at 2:00 p.m. ET.

    Participants may access a live webcast of the event through the following link:
    https://wsw.com/webcast/jeff174/vrca/1848852

    The webcast can also be accessed in the Investors/Presentations & Events section of the Verrica website at www.verrica.com. The webcast replay will be available shortly after conclusion of the event for 30 days.

    About Verrica

    WEST CHESTER, Pa., May 26, 2021 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. ("Verrica") (NASDAQ:VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that Ted White, Verrica President and CEO, will present a business overview at the Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021, at 2:00 p.m. ET.

    Participants may access a live webcast of the event through the following link:

    https://wsw.com/webcast/jeff174/vrca/1848852

    The webcast can also be accessed in the Investors/Presentations & Events section of the Verrica website at www.verrica.com. The webcast replay will be available shortly after conclusion of the event for 30 days.

    About Verrica Pharmaceuticals Inc.

    Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica's late-stage product candidate, VP-102, is in development to treat molluscum, common warts and external genital warts, three of the largest unmet needs in medical dermatology. Verrica is also developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. The Company has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize LTX-315 for dermatologic oncology conditions. For more information, Visit www.verrica.com.

    FOR MORE INFORMATION, PLEASE CONTACT:

    Investors:

    A. Brian Davis

    Chief Financial Officer

    484.453.3300 ext. 103

    info@verrica.com

    William Windham

    Solebury Trout

    646.378.2946

    wwindham@soleburytrout.com

    Media:

    Zara Lockshin

    Solebury Trout

    646.378.2960

    zlockshin@soleburytrout.com



    Primary Logo

    View Full Article Hide Full Article
View All Verrica Pharmaceuticals Inc. News