Ann: FDA Confirms Approach to Sofdra NDA Resubmission, page-2

4 December 2023

FDA confirms approach to SofdraTM NDA resubmission and materials required

Key highlights

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Philadelphia and Phoenix US, 4 December 2023: Clinical dermatology company, Botanix Pharmaceuticals Limited (ASX: BOT, “Botanix” or “the Company”), is pleased to announce that the Company has received feedback from FDA following its “end of review” Type A meeting request in respect to the Sofpironium Bromide gel, 15% (“SofdraTM”) new drug application (“NDA”) review that was completed in September 2023.

FDA confirmed that the planned content of materials proposed by Botanix would be acceptable for the resubmission of the Sofdra NDA package which is scheduled to be provided to FDA in early 1Q CY2024. These materials are limited to the revised patient instructions for use (“IFU”); the new human factors validation study protocol and report; an updated use-related risk analysis and updated draft prescribing information, carton, and container labels; and the proposed proprietary name (Sofdra) submission. Botanix will also bring forward the annual safety update to FDA including the pharmacovigilance report from Japan and any new safety findings reported in the scientific literature (which would otherwise usually be filed in March each year). All of these materials are either prepared or will be finalized in preparation for the planned resubmission in early 1Q CY2024.

Botanix has received the expected feedback from FDA following its “end of review” Type A

meeting request, in respect to the Sofdra new drug application (NDA) review

FDA confirmed that the planned content of materials proposed by Botanix would be acceptable

for the planned resubmission of the Sofdra NDA package

No additional materials have been requested by FDA as part of the resubmission

Submission of the final component required for FDA approval of Sofdra remains on target for

early Q1 CY2024, with a likely 6-month review process targeting FDA approval in mid-CY2024

Botanix CEO, Dr Howie McKibbon said: “We are thankful to the Division for confirming the approach and materials proposed to be included in the resubmission of the NDA for Sofdra which we are on track to file in early 1Q CY2024.

The team will be working over the holiday break to ensure we complete the human factors study and assemble the materials for resubmission to allow a rapid turnaround and filing with FDA for Sofdra approval.”

This ASX announcement is authorised for release by the Board.