Slide 1: BTX 1503 acne Phase 2 study results presentation
ASX/Media Release 23 October 2019 For personal use only BTX 1503 acne Phase 2 study results presentation Philadelphia PA and Sydney Australia, 23 October 2019: Clinical stage cannabinoid company Botanix Pharmaceuticals Limited (ASX:BOT, “Botanix” or “the Company”) is pleased to release a presentatio
Slide 2: Contacts and Cautionary Note on Forward-Looking Statements
For more information, please contact: General enquiries Investor enquiries Media enquiries For personal use only Corporate Communications Joel Seah Haley Chartres Botanix Pharmaceuticals Vesparum Capital Hales2 Communications P: +61 8 6555 2945 P: +61 3 8582 4800 P: +61 423 139 163 investors@botanix
Slide 3: Phase 2 Acne Top-Line Results Overview
For personal use only Phase 2 Acne Top-Line Results Overview 23 October 2019
Slide 4: BTX 1503: Phase 2 Top Line Data
Acne BTX 1503: Phase 2 Top Line Data Solid efficacy and safety results show BTX 1503 5% once-a-day dose is the best treatment to take forward into Phase 3 studies For personal use only BTX 1503 is safe and All doses of BTX 1503 were very safe - no serious adverse events or treatment effective relate
Slide 5: BTX 1503: Phase 2 Study Design
Acne BTX 1503: Phase 2 Study Design 12-week randomised, double-blind, vehicle-controlled study to evaluate the safety and efficacy of BTX 1503 in patients with moderate to severe acne For personal use only Study Design Endpoints • 5 dose groups: 368 subjects in total • Primary endpoint ‒ 5% twice a
Slide 6: Summary of safety and tolerability data
Acne Summary of safety and tolerability data All doses of BTX 1503 were very safe - there were no serious adverse events or treatment related discontinuations while achieving positive effects on acne lesion reductions For personal use only BTX 1503 is very safe • No ‘Serious Adverse Events’ reported
Slide 7: Combined (USA and Australia) – Inflammatory Lesions
Acne Combined (USA and Australia) – Inflammatory Lesions BTX 1503 5% once-a-day (QD) was the best performing active dose, but statistical significance was not reached for this primary endpoint, due to the very high vehicle response from the USA sites For personal use only Absolute Reduction (by numb
Slide 8: Inflammatory Lesions – Australia and USA results separated
Acne Inflammatory Lesions – Australia and USA results separated Australian data highlights the efficacy and separation expected from vehicle For personal use only Absolute Reduction (by number) in Inflammatory Percent Reduction (as a percentage) in Lesions at Week 12 Inflammatory Lesions at Week 12
Slide 9: Combined (USA and Australia) – Non-inflammatory lesions
Acne Combined (USA and Australia) – Non-inflammatory lesions BTX 1503 5% once-a-day (QD) achieved statistical significance in reducing non-inflammatory lesions vs vehicle for this secondary endpoint For personal use only Absolute Reduction (by number) in Non - Percent Reduction (as a percentage) in
Slide 10: Secondary Endpoint – Australia and USA results separated
Acne Secondary Endpoint – Australia and USA results separated Australian data is statistically significant across the two endpoints For personal use only Absolute Reduction (by number) in Non - Percent Reduction (as a percentage) in Non- Inflammatory Lesions at Week 12 Inflammatory Lesions at Week 1
Slide 11: High vehicle response in the USA? Manufacturing questions
Acne High vehicle response in the USA? Manufacturing questions The vehicle response in the USA was unusually twice to four times higher than that seen in Australia for inflammatory and non-inflammatory lesion reduction measures respectively – manufacturing For personal use only differences stand out
Slide 12: Manufacturing process evolution
Acne Manufacturing process evolution Optimisation of the manufacturing scale, emergence of commercial suppliers of synthetic cannabidiol and DEA licensing changes over the last 2 years has supported improvements in the process For personal use only Newly announced supply agreement with world’s large
Slide 13: Key takeaways and next steps
Acne Key takeaways and next steps Strength and statistical significance of Australian data combined with the overall efficacy and safety from Phase 2 Study provide confidence to proceed with preparation for Phase 3 clinical studies For personal use only Outcomes support and expand on Phase 1b result
Slide 14: BTX 1503: Glossary of terms
Acne BTX 1503: Glossary of terms Term Meaning BTX 1503 The synthetic cannabidiol drug product tested in the Phase 2 study in 3 different doses – 5% twice For personal use only a day, 5% once a day and 2.5% once a day Vehicle or Combined The formulation without synthetic cannabidiol – there were 2 ve