Page 1

botanix PHARMACEUTICALS 22 January 2021 Botanix Pharmaceuticals Quarterly Activities Report and 4C Quarterly Cash Flow Report Key highlights • Completed successful Pre - IND meeting with the FDA for BTX 1801 , enabling clinical development in the US towards a New Drug Application Botanix's BTX 1801 antimicrobial Phase 2a clinical study completed and remains on track for data read out in 1Q CY2021 BTX 1702 study poised to commence as restrictions are eased in Australia and New Zealand Botanix remains in a strong financial position , holding cash balance of A $ 19.2m as at 31 December 2020 Application for R & D Tax Incentive Refund totalling approximately A $ 6.8m lodged Philadelphia PA and Sydney Australia , 22 January 2021 : Clinical stage cannabinoid company Botanix Pharmaceuticals Limited ( ASX : BOT , “ Botanix ” or “ the Company " ) is pleased to release its Quarterly Activities Report and Appendix 4C Quarterly Cash Flow report for the period ended 31 December 2020 . Clinical development Antimicrobial platform : Phase 2a study completed and awaiting data In November 2020 , Botanix successfully completed a Pre - Investigational New Drug ( Pre - IND ) meeting with the US Food and Drug Administration's ( FDA ) Office of Infectious Diseases for the BTX 1801 synthetic cannabidiol antimicrobial product . The meeting provided Botanix with an opportunity to seek advice and clarification from the FDA on the development plan and data package required to initiate clinical studies for BTX 1801 in the US . In addition , Botanix gained feedback from the FDA on the drug development plan required for BTX 1801 to support a Fast - Track designation and New Drug Application ( NDA ) in light of its existing Qualified Infectious Disease Product ( QIDP ) designation . 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 submission of an IND application . In December 2020 , all participants successfully completed the BTX 1801 antimicrobial Phase 2a clinical study and on track to announce data in 1Q CY2021 . The double - blind , vehicle - controlled Phase 2a clinical study is designed to evaluate the safety and local tolerability of two formulations of BTX 1801 to decolonise Staphylococcus aureus ( ' Staph ' ) and methicillin - resistant Staphylococcus aureus ( ' MRSA ' or ' Golden Staph ' ) from the nose of healthy adults . Volunteers underwent twice - daily treatments across a 5 - day period . Following the clinical treatment period , Botanix commenced data collection to support database lock , data analysis and generation of top - line data . In addition to the clinical development program for the prevention of post - surgical infections , Botanix is also actively exploring opportunities for its synthetic cannabidiol and cannabinoid analog