Mature Product Pipeline

The primary asset in Botanix’s pipeline is Sofdra™ (sofpironium bromide) gel, 15%, a new chemical entity for which we have successfully submitted a New Drug Application (NDA) for US regulatory approval with the FDA. Three other clinical-stage programs have completed, or are currently undergoing Phase 2 studies, for dermatology and antimicrobial indications.

Indication	Product	Status
Axillary Hyperhidrosis (excessive underarm sweating)	Sofdra gel	Expecting FDA approval mid-2024
Moderate to severe acne	BTX 1503	Pending Phase 3 study
Rosacea	BTX 1702	Positive Phase 1b/2 results
Atopic dermatitis	BTX 1204A	Canine proof-of-concept study complete
Antimicrobial	BTX 1801	Phase 2a study (successfully completed). Phase 2b study (pending).

Novel treatment for Primary Axillary Hyperhidrosis

Sofdra™ (sofpironium bromide) gel, 15% is a new chemical entity for the treatment of primary axillary hyperhidrosis for which Botanix has successfully submitted a New Drug Application (NDA) for US regulatory approval with the United States Food and Drug Administration (FDA). US approval is expected in mid-2024. The product has promising potential as a best-in-class solution, backed by positive results from a Phase 3 pivotal clinical program, and has already been approved in Japan and launched by Botanix’s partner Kaken Pharmaceutical Co., Ltd (Ecclock^® Sofpironium Bromide 5%).

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Dermatology Pipeline

Antimicrobial Pipeline

Dermatology Pipeline

Indication	Product	Status
Axillary Hyperhidrosis (excessive underarm sweating)	Sofdra gel	Expecting FDA approval mid-2024
Moderate to severe acne	BTX 1503	Pending Phase 3 study
Rosacea	BTX 1702	Positive Phase 1b/2 results
Atopic dermatitis	BTX 1204A	Canine proof-of-concept study complete

Our clinical studies to date have proven the unique mechanism of action which drives synthetic cannabidiol (CBD) to produce anti-inflammatory and antimicrobial effects. We are now working hard to develop new pharmaceutical products in dermatology, targeting underserved market segments that are primed for new solutions. Our product pipeline targets the following skin diseases:

BTX1503 for Acne

BTX1503 is a transdermal gel formulation for the treatment of serious acne in adults and teenagers. Acne is a skin condition that manifests in pimples, lumps and cysts and is the leading cause of visits to dermatologists and psychological difficulties in adolescents. It is the most common skin disorder in the US affecting 40-50 million Americans and it is estimated the market will grow to a value of US$5.9bn by 2025. Acne has multiple pathogenetic pathways including sebum overproduction, unwanted sebocyte proliferation, inflammation and bacterial infection. Synthetic CBD has been shown in scientific studies to normalise excessive lipid synthesis of human sebocytes, suppress cell proliferation, and provide an anti-inflammatory effect to potentially reduce bacterial infection. In turn, this could help to reduce the occurrence or severity of serious acne.

BTX1702 for Rosacea

BTX1702 is a new product opportunity for the treatment of papulopustular rosacea. Rosacea is a chronic inflammatory skin disease that often begins with a tendency to blush or flush more easily than other people, but can progress into many subtypes, including papulopustular rosacea. Papulopustular rosacea is a highly visible and distressing chronic inflammatory skin disease characterised by intensely inflamed skin and acne-like breakouts across the face, which affects more than 16 million Americans. The BTX1702 program is being expedited based on mechanistic data generated by Botanix that shows synthetic CBD exerts powerful anti-inflammatory and antimicrobial actions in skin – two key activities that are critical for successfully treating rosacea.

BTX1204A for Atopic Dermatitis

Botanix is pleased to be progressing a BTX 1204A canine study in Australia and New Zealand for atopic dermatitis. This will enrol 45 canines and evaluate two formulations of BTX 1204A. Positive data from the pilot study in May has already demonstrated that a new higher dose of synthetic CBD, in a novel Permetrex™ formulation, reduces severity of atopic dermatitis over 28 days – providing strong foundations to extend this program into both animal and human health.

Antimicrobial Pipeline

Indication	Product	Phase 1	Phase 1b	Phase 2	Phase 3	Status
Antimicrobial	BTX 1801					Phase 2a study (successfully completed). Phase 2b study (pending).

BTX 1801 for hemodialysis patients

BTX1801 is an antimicrobial gel focused on targeting Staphylococcus Aureus and Methicillin Resistant Staphylococcus Aureus (MRSA). Botanix Pharmaceutical’s research to date shows synthetic cannabidiol rapidly kills MRSA within 10 minutes of exposure by a novel mechanism of action and without allowing resistance to develop. BTX 1801 is initially focused on preventing bloodstream infections in patients undergoing hemodialysis treatment, by removing or ‘decolonising’ bacteria in the patient’s nose. These patients have at least one such infection each year, and most die from an infection within three years of starting hemodialysis. Botanix plans to test the capabilities of synthetic cannabinoid for fighting antibiotic resistance more broadly – a major global issue in healthcare – and to develop a novel platform product for multiple human and animal health applications.