Ann: Appendix 4C - Quarterly, page-26

4C Summary for those who may not have the time to read the full report

Moving forward with preparations for BTX 1503 Phase 3 clinical program and an end-of Phase 2 meeting with the US FDA

BTX 1204 Phase 2 atopic dermatitis study entering the final stages, with recruitment on track to be completed in 4Q CY2019 and study data in 1Q CY 2020

BTX 1503: ACNE

A strong and consistent impact on inflammatory lesions was seen across the entire study, with even greater non-inflammatory lesion reductions

BTX 1204: AD

The formulations used in the BTX 1204 Phase 2 study, differ from those that were used in the BTX 1503 Phase 2 acne study, both in terms of vehicle composition and synthetic cannabidiol concentration. The study materials for the BTX 1204 study were also manufactured in only two batches for each country, using a more developed manufacturing process and set of controls than those used for BTX 1503.

BTX 1702 : ROSACEA

The expedited BTX 1702 Phase 1b study is based on recent mechanistic data generated by Botanix demonstrating synthetic cannabidiols exerts powerful anti-inflammatory and antimicrobial actions in skin – two key activities critical to successfully treating rosacea.

My comment from the AGM 'They appeared impressed by the potential for Rosacea with current treatments taking approx 2 hours to take effect and patients unable to wear makeup compared to BTX 1702 which takes about 15 minutes and makeup can be applied.' may be seen as best in the industry hence the push to expedite $$$

Antimicrobial platform:

In July 2019, Botanix released data from its new development program, AB 2367, conducted in collaboration with Prof. Dena Lyras at Monash University’s Biomedicine Discovery Institute Department of Microbiology. The data from these new studies showed that AB 2367 is:

• A potent antibiotic effective against human and veterinary hypervirulent strains of the GramPositive bacteria Clostridium difficile (“C. difficile”)
• Effective against the super hypervirulent epidemic strain of C. difficile, ribotype 027
• Effective against the hypervirulent epidemic strain of C. difficile, ribotype 078

I think they have something massive here and Dr Michael Thurn was clearly excited by the potential as stated by another AGM attendee.

In August 2019, it was announced that Executive Director Matthew Callahan was taking a temporary leave of absence from the Botanix Board, for personal reasons. Mr Callahan continues to consult to Botanix and intends to rejoin the Botanix Board shortly.

Great report put out by Botanix considering all the info recently released so cudos to them.

I asked Vince during AGM question time 'If the results from AD are superior to those of acne would they look at bypassing acne P3 in favour of AD'
he replied 'great question'

Newsflow :

Rosacea - Phase 1B starting now - Results Q4
AD : Study Data Q1
Acne : End of P2 meeting
BTX 1801 Antimocrobial = x factor

Half price sale ending shortly