BTX 1801 trial early Q2 2020

New data released today, demonstrates synthetic cannabidiol rapidly kills MRSA bacteria within 10
minutes of exposure, by a novel mechanism of action, and without allowing resistance to develop.
Furthermore, studies conducted by Botanix have shown that BTX 1801 is more effective than the
market leading decolonisation agent, mupirocin, at decolonising MRSA and mupirocin resistance
strains of MRSA were utilized in the industry-accepted pig skin decolonisation model.

This combined with previous work showing that MRSA bacteria lack the ability to develop resistance to cannabidiol,
makes BTX 1801 an ideal candidate for nasal decolonisation of Staph and MRSA for the prevention of
SSIs. For additional information, refer to sections “Synthetic Cannabidiol’s Unique Anti-Microbial
Effects” and “First Target – Prevention of surgical site infection” in the attached presentation.

In light of these results, Botanix has designed a double-blind, vehicle-controlled Phase 2a study to
evaluate safety, tolerability and efficacy of two formulations of BTX 1801 to decolonise Staph and
MRSA from the nose of healthy adults.

Given one in three people in the community carry Staph and/or
MRSA in their nose on average, this study population is ideal to establish proof of efficacy of BTX 1801,
before moving into a pivotal clinical study involving patients undergoing surgery, for FDA registration.


As a result, this clinical study can also be completed efficiently and is highly cost effective, as it will
only involve 60 volunteers with a treatment period of five days. Final preparations for the BTX 1801
Phase 2a study are now underway and Botanix expects to enrol its first participants early in 2Q CY2020.
For additional information, refer to “BTX 1801 Program” section in attached presentation.