What were the “Human Factor comments” the FDA's second letter said would follow separately?

FDA Complete Response Letter, July 13, 2020 · page 15

We recommend you submit your revised HF validation study protocol for feedback from the Agency before commencing the study. Please note we will need 60 days to review and provide comments on the HF validation study protocol. Plan your development program timeline accordingly.

FDA Complete Response Letter, July 13, 2020 · page 15

In summary, we remain concerned that your proposed cantharidin combination product is not safe for use by HCPs. We are concerned that the risk of accidental exposure will outweigh the benefit of the treatment with this combination product. Inherent design issues exist with this product that may contribute to serious harm if accidental exposure occurs during use. Thus, additional mitigation strategies are needed and could include the need for device design changes to optimize applicator use along with other revisions to the product user interface taking into consideration our previously identified concerns and the data collected from your HF validation study. After you implement additional risk mitigation strategies/modifications, we recommend you conduct an additional HF validation study to ensure that these modifications address the observed use errors and use difficulties and do not introduce any new risks.

Verrica Pharmaceuticals Form 8-K, filed November 9, 2020

We have also received feedback from the FDA on our Human Factors study protocol, and believe we have clear alignment on the path forward to resubmit the NDA, which we anticipate in the first quarter of 2021.

FDA Complete Response Letter, September 16, 2021 · page 9

ADDITIONAL COMMENTS Labeling and Human Factor comments and recommendations will be conveyed in a separate correspondence.

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 November 12, 2021

On September 20, 2021, Verrica announced that the U.S. Food and Drug Administration (“FDA”) issued a Complete Response Letter (“CRL”) regarding its New Drug Application (“NDA”) for VP-102 (cantharidin 0.7% Topical Solution) for the treatment of molluscum contagiosum (“molluscum”). According to the CRL, the FDA identified deficiencies at a facility of a contract manufacturing organization (“CMO”), which were not specifically related to the manufacturing of VP-102 but instead raised general quality issues at the facility. The FDA did not identify any clinical, safety or product specific Chemistry, Manufacturing, and Controls (“CMC”) deficiencies related to VP-102. Following the CRL, on September 22, 2021 Verrica received a General Advice Letter from the FDA with recommendations to improve YCANTH’s user interface.

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

On November 29, 2021, the Company announced that it has resubmitted the New Drug Application (the “ NDA ”) for VP-102 for the treatment of molluscum contagiosum to the U.S. Food and Drug Administration (the “ FDA ”). The resubmission is limited to those sections and elements of the NDA that were identified as deficiencies in the Complete Response Letter issued by the FDA in September 2021.

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

Verrica received a Complete Response Letter (CRL) from the FDA on September 17, 2021 due to open general inspection items at a contract manufacturer (CMO) that were not specific to VP-102. The Company received a General Advice Letter (GAL) from the FDA on September 22, 2021 with recommendations to improve VP-102’s user interface. On November 5, 2021 Verrica was notified that the inspection of the CMO was classified as “voluntary action indicated” (“VAI”), is now closed and that the VAI classification will not directly negatively impact FDA’s assessment of the Company’s NDA. Verrica resubmitted the NDA for VP-102 on November 24, 2021; the resubmission is limited to address the successful resolution of inspection deficiencies identified at the CMO in the CRL, as well as the recommendations included in the General Advice Letter.