Botanix Pharmaceuticals Ltd (ASX: BOT) shares are lifting off today after the company released its quarterly report. At the time of writing, the Botanix share price is trading 6.06% higher at 17.5 cents.
What is driving the Botanix share price?
The Botanix share price is climbing higher today as the cannabinoid company released its quarterly report to the ASX.
In its clinical development sector, Botanix completed a successful meeting with the United States Food and Drug Administration (FDA) regarding clinical studies for its BTX 1801 synthetic cannabidiol product in the US. According to Botanix, the FDA provided feedback on how the company might obtain fast-track designation for the product’s new drug application (NDA).
Additionally, the FDA advised that the proposed drug development plan and data package presented were sufficient to initiate clinical development in the US and ultimately support an NDA submission. The FDA encouraged Botanix to request a fast-track designation for BTX 1801 following the submission of an IND application.
Furthermore, Botanix reported that its dermatology program, BTX 1702, is poised to commence. The company’s phase 1 clinical study will begin recruitment once travel and clinical trial restrictions across Australia and New Zealand cease.
During the quarter, Botanix had net cash flows of $2.8 million, with $2.2 million being invested in research and development.
Botanix retained $19.2 million in cash at the end of the quarter and claims to be in a strong financial position.
About the Botanix share price
Botanix is a clinical stage synthetic cannabinoid company focused on developing safe and effective treatments for serious skin diseases. It aims to leverage the anti-inflammatory, immune modulating and antimicrobial properties of synthetic cannabidiol to this point.
Investors will be anticipating the outcome of the company’s application for an R&D tax incentive refund of approximately $6.8 million. If received, funds will be invested into product development. In addition, Botanix continues to assess opportunities and partnerships in the development of new products that can be rapidly brought to market for antimicrobial or dermatological applications.
The Botanix share price has increased 75% over the past twelve months and is currently trading just shy of its 52-week high. Based on the current Botanix share price, the company has a market capitalisation of around $141 million.