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Botanix Pharmaceuticals (ASX:BOT) - President, Vince Ippolito - The Market Herald
President, Vince Ippolito
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  • After a successful December quarter, Botanix Pharmaceuticals (BOT) rounded it off with $19.2 million in cash
  • Botanix completed a pre-investigational new drug meeting with the U.S. Food and Drug Administration (FDA) for BTX 1801
  • BTX-1801 is a synthetic cannabidiol antimicrobial product which was trialled in a clinical study completed in December
  • The trial evaluated two formulations of the drug to decolonise Staphylococcus aureus (Staph) and methicillin-resistant Staphylococcus aureus (MRSA) from the nose of healthy adults
  • Data from the phase 2a trial is expected to be released sometime this quarter
  • Over the quarter, Botanix spent $2.8 million on operating activities — most of which was put towards research and development costs
  • Looking ahead, it's planning to recruit patients for its BTX 1702 rosacea clinical trial once travel and trial restrictions have eased in Australia and New Zealand
  • Botanix is up 6.06 per cent and shares are trading at 17.5 cents

After a successful December quarter, Botanix Pharmaceuticals (BOT) rounded it off with $19.2 million in cash.

Clinical development

In November 2020, Botanix completed a pre-investigational new drug meeting with the U.S. Food and Drug Administration (FDA) for its synthetic cannabidiol antimicrobial product, BTX 1801.

This meeting gave the company some feedback on the drug development plan for BTX 1801 to support a new drug application (NDA) alongside its existing qualified infectious disease product (QIDP) designation.

The U.S. FDA also advised the development plan and data package were sufficient enough for Botanix to initiate clinical development in the U.S.

In December, the healthcare stock completed its phase 2a clinical study. The study aimed to evaluate the safety and tolerability of two formulations of BTX 1801 to decolonise Staphylococcus aureus (Staph) and methicillin-resistant Staphylococcus aureus (MRSA) from the nose of healthy adults.

The company expects to release the trial data at some point during this quarter.

Financials

Over the quarter, Botanix burnt through $2.8 million on operating activities — most of which was put towards research and development (R&D) costs.

However, the company submitted an application for an R&D tax incentive refund of roughly $6.8 million. If it receives the refund, the money will be invested in product development.

At the beginning of the quarter, Botanix had $22 million in the bank and ended with $19.2 million.

Outlook

Looking ahead, Botanix's BTX 1702 phase 1b clinical study is expected to recruit patients once travel and clinical trial restrictions have eased across Australia and New Zealand.

The eight-week randomised, double-blind vehicle-controlled study will evaluate the safety and tolerability of the drug in patients with papulopustular rosacea which is characterised by inflammation on the face.

The company hopes to begin recruitment in the first half of the year.

Botanix is up 6.06 per cent and shares are trading at 17.5 cents at 12:08 pm AEDT.

BOT by the numbers
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