Analyst Report | 6 April 2023

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Euroz Hartleys has published an analyst note, reporting on the successful completion of Botanix’s FDA mid-cycle review meeting for Sofpironium Bromide, as well as the Company’s recent capital raise.

Analyst Seth Lizée noted that $BOT remains considerably undervalued in comparison to its peers approaching an imminent FDA approval decision and soli data supporting commercial success.

He wrote:

“Importantly, what splits BOT apart from some of its peers, is its capacity to go-to-market and execute on a commercial strategy in house. This places BOT in a significantly stronger negotiating position, as the company is not dependent on securing a licensing agreement or selling the asset to an external party.”

Read the full report

Botanix secures commitments for A $10 million via institutional placement

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Botanix lifted a trading halt this morning, sharing news that it has secured commitments of
A$10.0million via institutional investors to accelerate the marketing and launch activities for
Sofpironium Bromide.


Proceeds from the Placement will be used to progress Botanix’s lead development
program, Sofpironium Bromide gel (15%), including costs associated with completing
FDA review, manufacturing, satisfying milestone payments and preparing for commercial
launch in the United States, as well as general working capital purposes and costs of the offer.


Botanix Executive Chairman, Vince Ippolito, commented:
“We are very pleased to announce this placement to institutional investors who have
actively researched and engaged with Botanix and are prepared to invest at this pivotal point in
the Company’s development.

“We are particularly pleased by the support from new institutional investors as they take
the opportunity to join Botanix on its journey towards FDA approval and
commercialisation of our lead product, Sofpironium Bromide for primary axillary
hyperhidrosis.”


Click here to read today’s ASX release.

Mid-Cycle Review Complete + Capital Raise

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Botanix has today released an update regarding the progress of its lead product, Sofpironium Bromide, for the treatment of primary axillary hyperhidrosis – a medical condition where excessive sweating occurs beyond what is needed to maintain normal body temperature.

The U.S. Food and Drug Administration (FDA) has now conducted the mid-cycle review meeting for Sofpironium Bromide, and no significant issues have been identified, as a result of the review. This includes no major clinical safety issues, no risk management issues, or advisory board requirements.

The Company has also announced a capital raise to support the next stage of our New Drug Application (NDA) filing.

Click here to read ASX release.