Botanix Pharmaceuticals Limited · ASX:BOT
Botanix Pharmaceuticals — Non-Deal Roadshow (December 2019)
27 slides from Botanix Pharmaceuticals's roadshow presentation, Dec 9, 2019
Slide 1: Investor Presentation ASX/Media Release
ASX/Media Release 9 December 2019 For personal use only Investor Presentation Philadelphia PA and Sydney Australia, 9 December 2019: Clinical stage synthetic cannabinoid company Botanix Pharmaceuticals Limited (ASX:BOT, “Botanix” or “the Company”) is pleased to release an updated investor presentati
Slide 2: Cautionary Note on Forward-Looking Statements
Cautionary Note on Forward-Looking Statements For personal use only Any statements in this press release about future expectations, plans and prospects for the Company, the Company’s strategy, future operations, and other statements containing the words “anticipate,” “believe,” “estimate, ”expect,”
Slide 3: Botanix Pharmaceuticals Australian Non-Deal Roadshow
For personal use only Botanix Pharmaceuticals Australian Non-Deal Roadshow December 2019
Slide 4: World class team
World class team Global team with proven experience and an unrivalled track record For personal use only Vince Ippolito Dr Michael Thurn Howie McKibbon President and Executive Chairman COO and Board Director Chief Commercial Officer Operations + Regulatory • COO of Anacor and Medicis with 17 years a
Slide 5: Botanix overview
Botanix overview Botanix is a clinical stage synthetic cannabinoid company, focused on developing topical products for the treatment of skin diseases and bacterial infections For personal use only One of the world’s most advanced pharmaceutically focused synthetic Pharma focused cannabinoid (CBD) co
Slide 6: Advanced dermatology pipeline with near term milestones
Advanced dermatology pipeline with near term milestones Combination of clinical, safety and mechanism of action data from recent Botanix studies provide support for ongoing clinical programs, including near term completion of Phase 2 AD study For personal use only Product Indication Ph 1 Ph 1b Ph 2
Slide 7: Topical CBD is well suited to treat skin disease and infections
Topical CBD is well suited to treat skin disease and infections Botanix has generated strong scientific support for synthetic CBD’s anti-inflammatory and immune modulation mechanisms of actions, combined with newly identified antimicrobial effects1 For personal use only CBD anti-inflammatory / immun
Slide 8: BTX 1503 – acne
For personal use only BTX 1503 – acne Botanix Overview – December 2019 www.botanixpharma.com 6
Slide 9: Sizable acne market with a clear unmet medical need
Acne Sizable acne market with a clear unmet medical need Competitive products with tolerability and safety concerns, as well as antimicrobial resistance challenges, have generated significant annual sales For personal use only Acne prescription market Top brands at peak sales Peak US peak Rank Brand
Slide 10: 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 (QD) dose is the best treatment to take forward into Phase 3 studies For personal use only All doses of BTX 1503 were very safe – no serious adverse events or treatment BTX 1503 is safe related discont
Slide 11: Combined results: Inflammatory and Non-Inflammatory Lesions
Acne Combined results: Inflammatory and Non-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 Percentage Reductio
Slide 12: Australia & USA results: Inflammatory and Non-Inflammatory Lesions
Acne Australia & USA results: Inflammatory and Non-Inflammatory Lesions Australian data highlights the efficacy and separation expected from vehicle For personal use only Percentage Reduction in Inflammatory Percentage Reduction in Non-Inflammatory Lesions at Week 12 (Secondary Endpoint) Lesions at
Slide 13: Next steps
Acne Next steps Overall efficacy and safety combined with statistical significance of Australian data provide confidence to proceed with end of Phase 2 FDA meeting and preparation for Phase 3 clinical studies For personal use only Outcomes support and expand on Phase 1b results • Overall safety and
Slide 14: BTX 1204 – atopic dermatitis
For personal use only BTX 1204 – atopic dermatitis Botanix Overview – December 2019 www.botanixpharma.com 12
Slide 15: BTX 1204: CBD mechanism of action in atopic dermatitis
Atopic dermatitis BTX 1204: CBD mechanism of action in atopic dermatitis Ideal therapy that addresses multiple factors of disease pathology For personal use only 1 CBD inhibits itch 2 CBD repairs barrier dysfunction Suppresses itch by interacting with Inhibits p38 MAP Kinase activation and VR / TRPV
Slide 16: Atopic dermatitis market projected to be ~US$25B in 2027
Atopic dermatitis Atopic dermatitis market projected to be ~US$25B in 2027 BTX 1204 is being developed to address the need for a safe, non-steroid option for chronic use with multiple mechanisms of action including anti-inflammatory, anti-microbial and immune modulation For personal use only One of
Slide 17: BTX 1204 Phase 1b study results support efficacy and safety potential
Atopic dermatitis BTX 1204 Phase 1b study results support efficacy and safety potential BTX 1204 was twice as effective as vehicle (with efficacy still increasing at study completion) and displayed a substantial improvement in the study endpoints (key signs of atopic dermatitis)1 For personal use on
Slide 18: BTX 1204: atopic dermatitis – Phase 2 fully recruited
Atopic dermatitis BTX 1204: atopic dermatitis – Phase 2 fully recruited 12-week randomised, double-blind, vehicle-controlled study to evaluate the safety and efficacy of BTX 1204 in patients with moderate atopic dermatitis For personal use only Study Design Endpoints • 2 dose groups: ~200 subjects •
Slide 19: Additional Pipeline programs
For personal use only Additional Pipeline programs 1. BTX 1702: rosacea 2. BTX 1801: bacterial infections Botanix Overview – December 2019 www.botanixpharma.com 17
Slide 20: BTX 1702: impact of papulopustular rosacea
Rosacea BTX 1702: impact of papulopustular rosacea Papulopustular rosacea is a chronic skin disease characterised by redness (inflammation) and acne- like break-outs1 For personal use only ~16M Americans affected by rosacea2 Survey of 1,675 Literature review of 17 studies • Affects 5.5% of the world
Slide 21: BTX 1702: CBD mechanism of action in rosacea
Rosacea BTX 1702: CBD mechanism of action in rosacea CBD has the potential to target multiple points in the rosacea inflammatory cascade and other mediators3 For personal use only 1 CBD prevents barrier disruption KLK 5 & 7 Inhibits p38 MAP Kinase activation and IL-6 production in keratinocytes resp
Slide 22: New BTX 1702 Phase 1b study design
Rosacea New BTX 1702 Phase 1b study design 6 week randomised, double-blind, vehicle-controlled study to evaluate the safety and tolerability of BTX 1702 in patients with papulopustular rosacea For personal use only Study Design Endpoints • 4 dose groups: ~120 patients • Primary endpoint - BTX 1702 F
Slide 23: BTX 1801: prevention of post-surgical bacterial infections
Antimicrobial BTX 1801: prevention of post-surgical bacterial infections Cannabidiol is a powerful new antibiotic that is effective in tests against Staphylococcus aureus (“staph’”) and methicillin resistant Staphylococcus aureus (“MRSA or golden staph”)1 For personal use only Antibiotic S. aureus a
Slide 24: Near term milestones
Near term milestones Key near term milestones combine clinical and other meaningful study endpoints providing solid news flow through CY2020 For personal use only Event Timing BTX 1702 rosacea study ethics approval 4Q CY2019 BTX 1801 antimicrobial study kickoff 4Q CY2019 BTX 1204 atopic dermatitis s
Slide 25: Inflammation + bacterial infection are important to most skin diseases
Inflammation + bacterial infection are important to most skin diseases1 Newly announced data provide scientific support for synthetic CBD’s mechanism of action (MOA), which is highly relevant to all Botanix pipeline products For personal use only Acne Atopic dermatitis Relevance CBD mechanism of act
Slide 26: Disclaimer
Disclaimer For personal use only Any statements in this press release about future expectations, plans and prospects for the Company, the Company’s strategy, future operations, and other statements containing the words “anticipate,” “believe,” “estimate, ”expect,” “intend,” “may,” “plan,” “predict,”
Slide 27: Contact us
For personal use only Contact us Ric Peterson Botanix Pharmaceuticals Chief Financial Officer +1 445 300 3419 investors@botanixpharma.com Visit us www.botanixpharma.com Follow us on social media Botanix Pharmaceuticals Limited (ASX:BOT) www.botanixpharma.com 25
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