Botanix News Hub
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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.
“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.”
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
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
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.
Botanix (ASX: BOT) hosted a webinar to update shareholders on the Company’s preparations for the FDA mid-cycle review of Sofpironium Bromide in Q1 2023.
The webinar was hosted by Gautam Aggarwal, a Partner with Triangle Insights Group, who has conducted insightful market research in relation to the Sofpironium Bromide.
Other presenters included Botanix Executive Director, Matt Callahan and Botanix Chief Operating Officer, Dr Howie McKibbon.
Botanix has today appeared in Stockhead in an article titled, ‘As it awaits crucial FDA approval Botanix reckons Aussies have a penchant for backing high-risk companies.’
This special report explores the appetite for Australian investors to back companies with a high risk to reward ratio, and why Botanix stands out as a stock to watch as we move towards the mid cycle review milestone with the Food and Drug Administration (FDA) for our lead product, Sofpironium Bromide.
Botanix COO, Dr Howie McKibbon, has extensive experience at this stage of the biotech race and is quoted in the article:
“The drug has already been launched by our partner in Japan in 2020 and the reaction there has been great, so we are now very busy implementing a full-scale commercialisation
strategy, pending a final FDA approval in Q3 this year.’’
Botanix’s co-founder and Executive Director, Matt Callahan, was featured in a story in The West Australian newspaper by business reporter Cheyanne Encisco.
The article highlighted the FDA’s upcoming mid-cycle review of Botanix’s application for its lead product, Sofpironium Bromide gel, for the treatment of primary axillary hyperhidrosis, also known as excessive underarm sweating.
In the article, Mr Callahan spoke confidently of the imminent mid-cycle review, and that a positive outcome would substantially de-risk the probability of approval.
“We’re very confident going into this review, given all the work that we’ve done, that we’ve ticked all the boxes,” Mr Callahan said.