Botanix submits NDA for FDA approval of Sofpironium Bromide

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Botanix has today announced the submission of a New Drug Application to the FDA for approval of Sofpironium Bromide for the treatment of severe primary axillary hyperhidrosis (excessive underarm sweating).

Phase 3 studies of Sofpironium Bromide showed very high statistical significance for the treatment of primary axillary hyperhidrosis. In the US alone, there are approximately 7.3 million people who suffer from this disorder, with more than half of them actively seeking treatment.

Botanix President and Executive Chair, Vince Ippolito, said:

“We are delighted with the achievement of this submission milestone, and are targeting FDA approval in the US for 4Q CY2023 (following the usual 12-month FDA assessment and review period) to enable the commencement of sales in the US market.”

Click here to view ASX release

Capital Raise Update

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Botanix has announced it has now closed the first tranche of its anticipated $7.5 million placement to new and existing institutional and sophisticated investors.

The second tranche of the Placement is an issue of New Shares to Botanix directors, who have  committed to subscribe for a total of $0.5 million of New Shares, which is subject to shareholder approval.  

Click here to view ASX release

$7.5m Capital Raise

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Botanix has today announced it has received strong commitments to raise $7.5m through a placement to Australian and international institutions and sophisticated investors.

Funds will support the development of the Company’s lead asset – Sofpironium Bromide (SB) – a novel dermatology asset with positive Phase 3 data to treat primary axillary hyperhidrosis, a medical condition which results in excessive underarm sweating.

This will include support for the FDA approval process and preparation for commercial launch. The New Drug Approval (NDA) filing with the FDA remains on track for submission this quarter with a 12-month review process.

Click here to view ASX release

Research Report by Euroz Hartleys – 17 August 2022

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Botanix (ASX:BOT) is pleased to advise that leading adviser Euroz Hartleys has released an analysis outlining the strong market opportunities for our most recent asset acquisition, Sofpironium Bromide.

Within the report, analyst Seth Lizee commented:

“Sofpironium Bromide’s target patient population is estimated to be ~3.7 million people in the United States, equal to the estimated number of patients with severe axillary hyperhidrosis seeking treatment…Even modest market penetration can translate into significant revenues.”

Read the full report.

Euroz Hartleys Report | 7 July 22

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Botanix (ASX:BOT) is pleased to share a research report from leading stockbroking firm, Euroz Hartleys, following the release of the Company announcement that the FDA filing timeline for Sofpironium Bromide had been accelerated.

Click here to view the report.

Euroz Hartleys Report | 22 June 2022

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Botanix (ASX:BOT) is pleased to share a research report from leading stockbroking firm, Euroz Hartleys, following the acquisition of our dermatology asset Sofpironium Bromide.

Click here to view the report.

Euroz Hartleys Report | 4 May

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Botanix (ASX:BOT) is pleased to share a Quick Comment research report from leading stockbroking firm, Euroz Hartleys, following the acquisition of our dermatology asset Sofpironium Bromide.

Click here to view the report.

New dermatology asset acquisition

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Botanix has today announced acquisition of a novel dermatology asset known as Sofpironium Bromide, which has been developed to treat primary axillary hyperhidrosis – a medical condition which results in excessive underarm sweating.

Sofpironium Bromide is the first and only new chemical entity developed for primary axillary hyperhidrosis, and this product is primed for market following successful pivotal studies conducted in late 2021.

This is a defining deal for Botanix, cementing our credentials as a global leader in the development and commercialisation of novel dermatology products. Sofpironium Bromide complements our existing dermatology pipeline and will leverage the core skills of our newly-expanded management team, with an enviable track record of successfully launching products.

Click here to view ASX release and presentation.

Euros Hartley Report | 29 April 2022

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Botanix (ASX:BOT) is pleased to share a research report from leading stockbroking firm, Euroz Hartleys, following the release of the Company’s March quarterly report.

Click here to view the 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 March 2022

Key highlights from this period include:

  • Strategic appointments to Botanix’s executive leadership team,including Dr Patty Walker as Chief Medical Officer and Mr Howie McKibbon as Chief Commercial Officer
  • Danny Sharp also joins as Non-Executive Director bringing 30+ years capital markets experience and an extensive network of institutional investors
  • Completion of pre-clinical work to support initiation of Phase 2 BTX 1801 antimicrobial study
  • Advancement of clinical programs, with the completion of recruitment for both the Phase 2 BTX 1702 rosacea study and BTX 1204 canine atopic dermatitis study, both of which are on track for 2Q 2022
  • Significant progress on broadening and maturing the Botanix pipeline with a number of new opportunities in late-stage assessment

Botanix maintains a strong cash position, with approximately $16.4 million in cash at closing of Q1 2022.

Read today’s ASX release here.