Investor Webinar Replay | 26 September 2023

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Botanix (ASX: BOT) has received a communication from FDA in relation to its NDA submission for Sofpironium Bromide gel, 15% (SB) for the treatment of primary axillary hyperhidrosis.

Encouragingly, no clinical efficacy, safety or manufacturing issues were raised and no additional clinical studies are required by the FDA to support approval. We will be revising the printed Instructions for Use document proposed for inclusion with the product and our team is now focused on working with the FDA to address the points raised, with plans to resubmit the NDA for SB by 1Q CY24 and targeting approval for mid-CY24.

Earlier today Botanix hosted an investor webinar outlining details of the Response Letter from the FDA – and next steps for approval. The team was joined by Mr Dave Clissold, Director of Hyman, Phelps & McNamara – the largest dedicated FDA law firm in the United States advising pharmaceutical, biotechnology, medical device, food, and dietary supplement clients on regulatory matters.

Video | Investor Webinar

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Botanix (ASX: BOT) hosted a webinar recently to update investors on the Company’s progress during the FDA review period for its lead product, Sofpironium Bromide.

The webinar was hosted by Executive Director, Matt Callahan and Chief Operating Officer, Howie McKibbon.

Take a look.

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.

ShareCafe ‘Hidden Gems’ Webinar

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Botanix Executive Director, Matt Callahan, recently participated in the ShareCafe Small Cap ‘Hidden Gems’ Webinar.

His presentation provided an overview of our clinical pipeline, including the significant potential for new dermatology products and opportunities for adding new assets to our pipeline. Matt also shared an update on upcoming clinical and operational milestones for 2022.

Investor Roadshow Presentation

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Botanix has today released an updated corporate presentation to the ASX, to support a non-deal investor roadshow underway this week.

The latest developments in our antimicrobial resistance (AMR) and dermatology R&D programs, include:

  • Progress with our BTX1801 antimicrobial program and plans for Phase 2 clinical studies in early 2022
  • Advancement of our BTX1702 clinical trial for the treatment of rosacea
  • Acceleration of our canine BTX1204A dermatitis study

Click here to view the presentation.

Corporate Update Presentation

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Botanix Pharmaceuticals has released a corporate presentation to the ASX this morning, which is being shared with investors as part of meetings over the course of the next week.

Key highlights include:

  • Successful launch of BTX 1702 rosacea clinical study, with recruitment well underway
  • Design of the BTX 1204A pilot study of canines with atopic dermatitis, which is about to commence 
  • Preparation for the BTX 1801 Phase 2b clinical study targeting the nasal decolonisation of Staph aureus in haemodialysis patients
  • Reviewing new opportunities to leverage the unique properties of our Permetrex™ technology platform in dermatology 

Our Company remains in a strong financial position, holding a cash balance of A$21.56m at 30 June 2021, and is progressing strategically forward to deliver these core programs.

Read Presentation and ASX Release here.

New antimicrobial data and conference presentation

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Botanix Pharmaceuticals (ASX:BOT) has today shared a market update and new data pertaining to the BTX 1801 antimicrobial program, which is currently being studied as part of a Phase 2a clinical trial in Perth.  

The new data demonstrates BTX 1801 eliminates methicillin-resistant Staphylococcus aureus (‘MRSA’ or ‘Golden Staph’) from human skin explants infected with MRSA. It also confirms synthetic CBD’s novel mechanism of action, where treatment with CBD rapidly disrupts the bacteria’s membrane resulting in cell death.

The latest news was captured as part of a presentation shared by Botanix President and Executive Chairman, Vince Ippolito, for the ASX Small and Mid-Cap Conference today – which features a close-up look at the mechanism of action.

View the ASX Small & Mid-Cap Conference presentation:

The Botanix team is extremely encouraged by this new data and remains confident that BTX 1801 will be a valuable treatment option for the prevention of post-surgical infections, which are often serious and can be life-threatening. Addressing antimicrobial resistance (AMR) remains a foremost priority for the Company, alongside the  largest health agencies in the world.