Quarterly Activities Report and 4C Quarterly Cash Flow Report

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

Research Report by Euroz Hartleys – 8 December 2022

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

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opens today, 9 November 2022 and will remain open until 8:00pm AEDT on Wednesday, 23 November 2022 (unless extended or withdrawn).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.

A$5 million strategic Placement + Share Purchase Plan

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.

Click here to read today’s ASX release.

Significant R&D Tax Incentive Refund

Botanix has today announced it has received a Research and Development (R&D) Tax Incentive Refund of A$3,669,439 for the 2021/2022 financial year.

Click here to read today’s ASX release.

Promotion of Dr Howie McKibbon to Chief Operating Officer

Botanix has announced the promotion of Dr Howie McKibbon to the role of Chief Operating Officer, from his current position as Chief Commercial Officer.

Howie has more than 20 years of leadership experience in the pharmaceutical industry. He has launched 15 products including 11 in dermatology, and managed over 30 dermatology products. Importantly too, he played a significant role in two of the world’s largest dermatology acquisitions with combined valuations of $7.8 billion. 

Howie’s role will be expanded to include responsibility for all commercial, manufacturing, medical affairs and regulatory activities. We believe the breadth and depth of his experience will be invaluable as the Company prepares for FDA mid-cycle review of our lead asset, Sfpironium Bromide in late Q1 2023.  

Click here to read today’s ASX release.

Research Report by Euroz Hartleys – 14 October 2022

Botanix is pleased to share a recent analyst report published by Euroz Hartleys following last week’s announcement of positive results from our BTX 1702 Phase 1b/2 clinical trial for rosacea. 

Analyst Seth Lizee noted:

“We believe the rosacea treatment universe is prime for disruption, with a gap in the market for drugs that can deliver similar efficacy without the side effects and limitations. 

“Overall, these results strengthen BOTs already valuable pipeline of products, led by its lead asset Sofpironium Bromide, which the company recently submitted a New Drug Application (NDA) for to the FDA (12 month review process).”

Read the full report.

Research Report by Euroz Hartleys – 17 August 2022

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

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

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.