Botanix Pharmaceuticals Limited · ASX:BOT
Botanix Pharmaceuticals — Investor Presentation (September 2019)
33 slides from Botanix Pharmaceuticals's investor presentation, Sep 17, 2019
Slide 1: Investor Presentation ASX/Media Release
ASX/Media Release 17 September 2019 For personal use only Investor Presentation Philadelphia PA and Sydney Australia, 17 September 2019: Clinical stage cannabinoid company Botanix Pharmaceuticals Limited (ASX:BOT, “Botanix” or “the Company”) is pleased to release an updated investor presentation. Th
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 Overview
For personal use only Botanix Overview September 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 cannabidiol products for the treatment of skin diseases For personal use only One of the world’s most advanced pharmaceutically focused synthetic Pharma focused cannabinoid (CBD) companies Propri
Slide 6: Advanced dermatology pipeline with recent successful data read outs
Advanced dermatology pipeline with recent successful data read outs Combination of clinical, safety and mechanism of action data from recent Botanix studies provide support to near term completion of Phase 2 studies in acne and atopic dermatitis For personal use only Indication Pre-clin Ph 1 Ph 1b P
Slide 7: Topical CBD is well suited to treat skin disease
Topical CBD is a well suited to treat skin disease Botanix has generated strong scientific support for synthetic CBD’s anti-inflammatory and immune modulation mechanisms of actions, combined with newly identified antimicrobial effects For personal use only CBD anti-inflammatory / immune modulating e
Slide 8: Permetrex technology overview
For personal use only Permetrex™ technology overview www.botanixpharma.com 6
Slide 9: Permetrex
Permetrex™ Permetrex™ is a proprietary novel skin delivery technology Enables formulation of innovative topical products1 that deliver very high doses of drug into the layers of skin without using permeation enhancers, preservatives or irritating levels of alcohol / petrol derivatives For personal u
Slide 10: Permetrex delivers more CBD into the skin
Permetrex™ Permetrex™ delivers 3 to 5 times more CBD into the skin BTX 1503 (acne) outperforms the leading OTC CBD products in delivering drug to the targeted layers of the skin1 For personal use only Amount of CBD permeated through skin (time elapsed 48 hours) 60 50 Delivered dose in mg/cm2 40 ~5x
Slide 11: Clinical programs
For personal use only Clinical programs 1. BTX 1503: acne 2. BTX 1204: atopic dermatitis 3. BTX 1702: rosacea Botanix Overview – September 2019 www.botanixpharma.com 9
Slide 12: Large acne market opportunity with little innovation
Acne Large acne market opportunity with little innovation Most common skin condition in the US – affecting up to 50m patients For personal use only • Can occur at any stage of life — though acne affects 85% of teens, almost 70% of visits to physicians were ages 18 years+ • Acne patients often develo
Slide 13: Sizable acne market with a clear unmet medical need
Acne Sizable acne market with a clear unmet medical need Competitive products with less ideal safety profiles and potentially poorer efficacy, have generated more than US$1bn per annum For personal use only Acne prescription market Top brands at peak U.S. peak Rank Brands Peak gross sales prescripti
Slide 14: Phase 1b lesion count data for BTX 1503 (acne)
Acne Phase 1b lesion count data for BTX 1503 (acne) A 4 week Phase 1b open-label study showed a marked reduction in inflammatory lesions and was safe and generally well tolerated For personal use only Lesion count reduction (%)1 Other FDA approved products2 Lesion count Inflammatory lesions Non-infl
Slide 15: BTX 1503: moderate to severe acne
Acne BTX 1503: moderate to severe acne Acne is a chronic multifactorial inflammatory disease affecting the pilosebaceous follicles of the skin For personal use only The development of inflammatory acne involves the interplay of 4 key pathogenic factors 1 CBD has been shown in studies to… SEBUM PRODU
Slide 16: BTX 1503: CBD mechanism of action in acne
Acne BTX 1503: CBD mechanism of action in acne BTX 1503 is a safe and well tolerated topical acne treatment that potentially addresses all the key causes of acne For personal use only Inflammatory Lesion 1 CBD normalises sebum 3 CBD exerts a broad anti- production inflammatory effect • Inhibits lipo
Slide 17: BTX 1503: Phase 2 fully enrolled
Acne BTX 1503: Phase 2 fully enrolled 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: ~360 subjects • Primary endpoint ‒ High Dose twice a
Slide 18: Atopic dermatitis market projected to be ~US$25B in 2027
Atopic dermatitis Atopic dermatitis market projected to be ~US$25B in 2027 BTX 1204 addresses the need for a safe, non steroid topical option for chronic use with multiple mechanisms of action including anti-inflammatory, anti-microbial and immune modulating For personal use only One of the most com
Slide 19: 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) and displayed a substantial improvement in the key signs of atopic dermatitis1 For personal use only Treatment success (%)2 40% Efficacy
Slide 20: BTX 1204: moderate atopic dermatitis
Atopic dermatitis BTX 1204: moderate atopic dermatitis Atopic dermatitis (eczema) is a chronic, pruritic inflammatory skin disease of unknown origin that usually starts in early childhood For personal use only Mechanisms underlying atopic dermatitis1: Skin Barrier Dysfunction • Filaggrin deficiencie
Slide 21: 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-1
Slide 22: BTX 1204: atopic dermatitis Phase 2 recruiting
Atopic dermatitis BTX 1204: atopic dermatitis – Phase 2 recruiting 12-week randomised, double-blind, vehicle-controlled study to evaluate the safety and efficacy of BTX 1204 in patients with moderate to atopic dermatitis For personal use only Study Design Endpoints • 2 dose groups: ~200 subjects • P
Slide 23: 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 Affects ~16m Americans3 Survey of 1,675 Literature review of 17 studies • ~5.5% of the adult population is affe
Slide 24: BTX 1702: overview of papulopustular rosacea
Rosacea BTX 1702: overview of papulopustular rosacea Papulopustular rosacea is a chronic skin disease characterized by redness (inflammation) and acne like break-outs For personal use only Disease mechanisms for the development of rosacea1 BARRIER DISRUPTION • Vitamin D via UV • Infection • Injury V
Slide 25: 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 26: BTX 1702: Anti-inflammatory effects of CBD already demonstrated
Rosacea BTX 1702: Anti-inflammatory effects of CBD already demonstrated Photographic images from the Phase 1b acne patient study, demonstrate a clear anti-inflammatory effect over the 4 week treatment course1 For personal use only Baseline (day 1)2 Visit 4 (4 weeks)2 1. Botanix Pharmaceuticals data
Slide 27: BTX 1702: Phase 1b study
Rosacea BTX 1702: Phase 1b study 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 • 2 dose groups: ~36 patients • Primary endpoint - BTX 1702 twice daily:
Slide 28: Operations and summary
For personal use only Operations and summary Botanix Overview – September 2019 www.botanixpharma.com 26
Slide 29: Milestones for coming months and corporate information
Milestones for coming 12 months and corporate information Key milestone achievement drives rapid valuation appreciation For personal use only Milestones Event Timing BTX 1503 acne Phase 2b data Oct 2019 BTX 1702 rosacea Phase 1b study start 4Q CY2019 BTX 1503 acne end of Phase 2 meeting 1Q CY2020 BT
Slide 30: 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, which is highly relevant to both Phase 2 acne and atopic dermatitis studies For personal use only Acne Atopic dermatitis Relevance CBD mech
Slide 31: Intellectual property portfolio
Intellectual property portfolio Multiple patents filed in key jurisdictions covering each product, the PermetrexTM technology and the broader potential of CBD in different skin diseases For personal use only Patents • Botanix currently has 12 patent families pending that cover the: ‒ Combination of
Slide 32: 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 33: Contact us
For personal use only Contact us Ric Peterson Botanix Pharmaceuticals Chief Financial Officer investors@botanixpharma.com Visit us www.botanixpharma.com Follow us on social media Botanix Pharmaceuticals Limited (ASX:BOT) www.botanixpharma.com 31
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