How did Verrica's account of its three FDA letters change from 2020 to 2022?

FDA Complete Response Letter, July 13, 2020 · page 16

Please refer to correspondence dated, December 6, 2019 which addresses the proposed proprietary name, Ycanth. This name was found conditionally

Verrica Pharmaceuticals Form 8-K, filed July 14, 2020

Complete Response Letter Requests Additional Chemistry, Manufacturing, and Controls (CMC) and Human Factors Information – – No Clinical Safety or Efficacy Issues Identified

Verrica Pharmaceuticals Form 8-K, filed July 14, 2020

If approved, VP-102 will be marketed in the United States under the conditionally accepted brand name YCANTH

Verrica Pharmaceuticals Form 8-K, filed July 14, 2020

According to the CRL, the FDA is seeking additional information regarding certain aspects of the CMC (Chemistry, Manufacturing, and Controls) process for the drug/device combination, as well as Human Factors validation. Importantly, the FDA did not identify any clinical deficiencies.

Verrica Pharmaceuticals Form 8-K, filed February 17, 2021

The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this NDA is June 23, 2021.

FDA Complete Response Letter, September 16, 2021 · page 8

described at FDA.gov.3 CARTON AND CONTAINER LABELING (2) We reserve comment on the proposed labeling until the application is otherwise adequate. PROPRIETARY NAME Please refer to correspondence dated, March 23, 2021, which addresses the proposed proprietary name, Ycanth. This name was found acceptable pending approval of the application in the current review cycle. Please resubmit the proposed proprietary name when you respond to the application deficiencies.

FDA Complete Response Letter, September 16, 2021 · page 11

KENDALL A MARCUS 09/16/2021 02:20:43 PM

Verrica Pharmaceuticals Form 8-K, filed September 20, 2021

announced that it received a complete response letter from the U.S. Food and Drug Administration (the “ FDA ”) identifying deficiencies at a facility of a contract manufacturing organization for its New Drug Application (the “ NDA ”) for VP-102 for the treatment of molluscum contagiosum. The identified deficiencies do not specifically relate to the manufacturing of VP-102, but instead raise general quality issues at the facility. The FDA did not identify any clinical, safety or product specific chemistry, manufacturing, and controls deficiencies related to the NDA.

Verrica Pharmaceuticals Form 8-K, filed September 29, 2021

Verrica received a Complete Response Letter (CRL) from the FDA in September 2021 due to open general inspection items at a contract manufacturer (CMO) that were not specific to VP-102. The Company will request a Type A meeting with the FDA in Q4 ‘21 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. The CMO has also advised Verrica that it is expecting a satisfactory resolution of the facilities identified deficiencies from the FDA prior to the Type A meeting.

Verrica Pharmaceuticals Form 8-K, filed May 25, 2022

announced that it received a complete response letter (“ CRL ”) from the U.S. Food and Drug Administration (the “ FDA ”) as a direct result of deficiencies identified at a general reinspection of a facility of Sterling Pharmaceutical Services, LLC (“ Sterling ”), a contract manufacturing organization for its New Drug Application (the “ NDA ”) for VP-102 for the treatment of molluscum contagiosum. The CRL did not identify any other deficiencies. Sterling advised the Company that it received notice on May 19, 2022 that it is on Official Action Indicated (“ OAI ”) status. None of the issues identified by FDA during the reinspection were specific to the manufacturing of VP-102. The Company was informed by the FDA that it had completed its review of the NDA and product label, there were no open questions on the NDA review, and the VP-102 label was ready to be communicated.

Verrica Pharmaceuticals Form 8-K, filed August 11, 2022

Verrica expects to resubmit the NDA for VP-102 for the treatment of molluscum in the first quarter of 2023 and in its resubmission will seek conditional approval to market VP-102 in the United States under the brand name YCANTH

Verrica Pharmaceuticals Form 8-K, filed August 11, 2022

According to the CRL, the only deficiency listed was related to the deficiencies identified at a general reinspection of the contract manufacturing organization (CMO) that manufactures Verrica’s bulk solution drug product. None of the issues identified by FDA during the reinspection were specific to the manufacturing of VP-102.

Verrica Pharmaceuticals Form 10-K, filed March 11, 2026

On July 21, 2023, YCANTH (VP-102) (cantharidin) 0.7% topical solution was the first product approved by the FDA for the treatment of molluscum in adult and pediatric patients two years of age and older. We commercially launched YCANTH (VP-102) in August 2023 in the United States for the treatment of molluscum.