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.
A recent analyst report by Euroz Hartleys predicting significant upside for Botanix if the Company’s Sofpironium Bromide New Drug Application (NDA) is successful, has been featured on Stockhead.
Journalist Eddy Sunarto highlighted the analyst’s prediction that the share price could triple if FDA approval for the treatment of primary axillary hyperhidrosis is achieved in Q3 of this year.
Euroz Hartleys has published an analyst note, reporting that the mid-cycle review for Botanix’s FDA New Drug Application (NDA) for Sofpironium Bromide remains on track for this quarter (Q1 CY23).
Analyst Seth Lizée noted the experience of the Botanix team in securing FDA-approval, and successfully commercialising over 30 products. He classified Botanix as a ‘Speculative Buy, Target Price $0.27’, commenting:
“We believe Sofpironium Bromide could potentially do A$130m of sales in the USA within its first year based on the number of prescriptions the drug is currently doing through its partner in Japan, a country which has a population nearly a third the size of the USA.”
Botanix (ASX:BOT) has today published its Quarterly Activities Report and 4C Quarterly Cash Flow Report, for the period ended 31 December 2022.
Key highlights from this period include:
Botanix will be attending the JP Morgan Healthcare Conference in San Francisco this week. The conference attracts more than 50,000 attendees from around the world, bringing together global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community.
As part of the conference, Botanix will be discussing the significant commercial potential of Sofpironium Bromide and sharing some of the independent market research recently completed by Triangle Insights.
With the formal filing of the Sofpironium Bromide NDA now accepted by FDA and a standard review period confirmed, we are pleased to report that the mid-cycle review remains on track for this quarter.
Botanix is pleased to share an analyst report published by Euroz Hartleys following this week’s announcement that our Company has received formal written communication from the FDA, confirming that our New Drug Application (NDA) for Sofpironium Bromide is suitable for substantive review, and that no issues have been identified.
Analyst Seth Lizee classified the Company as a ‘Speculative Buy, $0.27 Price Target’, and commented on this achievement:
“Overall, we view this is as yet another milestone met, bringing BOT one step closer to potential FDA approval, and in time commercialisation.”
Botanix’s recently announced Share Purchase Plan (SPP) to raise up to A$3 million is now open for eligible AU/NZ shareholders.
The SPP opens today, 9 November 2022 and will remain open until 8:00pm AEDT on Wednesday, 23 November 2022 (unless extended or withdrawn).
As the SPP is only open for two weeks, eligible shareholders are encouraged to apply for new shares as soon as possible.
Botanix (ASX:BOT) has today lifted its trading halt, sharing news that it has secured a commitment of A$5.0million from a highly respected institutional investor, Antares Capital. The Company will also offer a limited Share Purchase Plan (SPP) for eligible AU and NZ shareholders to raise up to A$3 million.
