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.

Investor Webinar | March 2023

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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.

Special Report | Stockhead

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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.’’

Click here to read the article.

Botanix co-founder says interest for sweat-stopper gel is keeping him bullish ahead of FDA review | The West Australian

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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.

Read the article

This broker says Botanix Pharma’s share price could more than triple on an FDA approval | Stockhead

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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.

Read the full article.

Analyst Report by Euroz Hartleys – 01 February 2023

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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.”

Read the full report

Quarterly Activities Report and 4C Quarterly Cash Flow Report

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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:

  • FDA accepted NDA filing for Sofpironium Bromide as sufficiently complete for a substantive review
  • FDA confirmed that a mid-cycle review of the NDA is planned for 1Q 2023
  • Independent market research project completed by Triangle Insights confirms significant revenue opportunity for Sofpironium Bromide and positive feedback from key physician, payer (insurance) and patient stakeholders, who were surveyed on a blinded basis
  • Successfully raised $5.96M via a placement to institutional shareholder Antares Capital and Shareholder Purchase Plan to existing holders
  • Successful Phase 1b/2 clinical study for BTX 1702 in rosacea completed
  • Cash position of $8.72 million at quarter end, with pivotal Sofpironium Bromide mid-cycle review meeting due this quarter

Click here to read today’s ASX release

JP Morgan Healthcare Conference Presentation

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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.

Click here to view the presentation.

Research Report by Euroz Hartleys – 8 December 2022

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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.”

Read the full report.

SPP Now Open

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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.

Click here to read today’s ASX release.