Botanix Pharmaceuticals Limited · ASX:BOT
Botanix Pharmaceuticals — Jefferies Healthcare Conference 2019
30 slides from Botanix Pharmaceuticals's conference presentation, Jun 6, 2019
Slide 1: Botanix at the Jefferies Healthcare Conference (ASX Media Release)
ASX/Media Release 6 June 2019 Botanix at the Jefferies Healthcare Conference Philadelphia PA and Sydney Australia, 6 June 2019: Medical dermatology company Botanix Pharmaceuticals (“Botanix” or “the Company”) is pleased to announce that its Founder and Executive Director, Matt Callahan, will be pres
Slide 2: Media release continued and contacts
completed in 3Q CY2019. Finally, Phase 1b BTX 1308 psoriasis mechanism of action study is nearing completion with data anticipated to be available in 2Q CY2019. Pipeline projects that leverage the anti-microbial properties of cannabidiol are also moving forward and are planned to enter the clinic in
Slide 3: Botanix Overview - Jefferies Healthcare Conference
Botanix Overview Jefferies Healthcare Conference June 2019
Slide 4: Botanix overview
Botanix overview Cannabinoid focused pharmaceutical company, with one of the world’s most advanced clinical pipelines, studying CBD in a range of inflammatory and antimicrobial applications Multiple value Significant clinical inflection points from completion of funded studies for inflection points
Slide 5: Corporate overview
Corporate overview Australian Stock Exchange (ASX) listed company showing stable share appreciation and a highly aligned Board and management team Trading information Share price performance Price ($) Volume (m) Share price (as at 5-Jun-2019) A$0.100 0.16 8 52 week low / high A$0.180 / A$0.069 Share
Slide 6: Significant re-rating potential if data continues to be positive
Significant re-rating potential if data continues to be positive Botanix has one of the most advanced CBD clinical programs globally, with potential for a significant value inflection points following multiple clinical study completions in 2019 Market cap (US$m)1 US$5.6bn Lead products: BTX 1503, BT
Slide 7: Our focus is on large markets that are poised for growth
Our focus is on large markets that are poised for growth Global medical dermatology market is expected to grow to US$43bn by 20241 2017 global dermatology market1 2024 global dermatology market1 US$22bn sales US$43bn sales Other Atopic Atopic dermatitis dermatology dermatitis 7.0 12.3 Other 1.2 derm
Slide 8: Rapidly advancing pipeline targeting large and growing markets
Rapidly advancing pipeline targeting large and growing markets Phase 2 trial completions for acne and atopic dermatitis trial and Phase 1b MOA study due for completion in 2019 Product candidate Indication Pre-clin Ph 1 Ph 1b Ph 2 Status Moderate to BTX 1503 Study complete 3Q 2019 severe acne Moderat
Slide 9: Overview Permetrex Technology
Overview Permetrex™ Technology Botanix Overview – June 2019 www.botanixpharma.com 7
Slide 10: Permetrex - proprietary novel skin delivery technology
Permetrex™ Permetrex™ - proprietary novel skin delivery technology Makes new types of gels, that deliver very high doses of drug into the layers of the skin without using permeation enhancers, preservatives, or irritating levels of alcohol / petrolatum additives Initial application Evaporation of so
Slide 11: Permetrex delivers 3-5 times more CBD into the skin
Permetrex™ Permetrex™ delivers 3-5 times more CBD into the skin BTX 1503 (acne) significantly outperformed the other tested CBD products in delivering drug to the targeted layers of the skin1 Amount of CBD permeated through skin (time elapsed 48 hours) 60 Delivered dose in mg/cm2 50 40 ~5x more than
Slide 12: Over-the-counter CBD products are not what they seem
Permetrex™ Over-the-counter CBD products are not what they seem Over-the-counter (OTC) or internet purchased CBD products often contain approximately one tenth of labelled CBD content, are not regulated and may come with other quality risks1 Label claim CBD Product name Manufacturer Product type Tes
Slide 13: Botanix Dermatology Development Programs
Botanix Dermatology Development Programs 1. BTX 1503: acne 2. BTX 1204: atopic dermatitis 3. BTX 1308: psoriasis 4. BTX 1801: antimicrobial Botanix Overview – June 2019 www.botanixpharma.com 11
Slide 14: BTX 1503 - moderate to severe acne
Acne 1. BTX 1503 – moderate to severe acne BTX 1503 is a safe and well tolerated topical treatment that potentially addresses all of the 3 causes of acne BTX 1503 potentially addresses 3 key acne pathologies 1 Attacks P. Reduces CBD has been shown in studies to… Acnes Inflammation bacteria 1 Exert a
Slide 15: Botanix's acne target market share exceeds US$1.5bn p.a.
Acne Botanix’s acne target market share exceeds US$1.5bn p.a. Competitive products with less ideal safety profiles and potentially poorer efficacy generate more than US$1.5bn per annum between them in revenue Top oral brands Top topical brands Revenue Revenue Rank Brands Scripts (‘000) Rank Brands S
Slide 16: Phase 1b patient data for BTX 1503 (acne)
Acne Phase 1b patient data for BTX 1503 (acne) 4 week Phase 1b study data shows a marked reduction in inflammatory lesions and no serious adverse events Lesion count reduction (%) 1 Other FDA approved products2 Lesion count 2017 annual Inflammatory lesions Non-inflammatory lesions Product Owner redu
Slide 17: BTX 1503 (acne) - anti-inflammatory effects of CBD
Acne BTX 1503 (acne) - anti-inflammatory effects of CBD Canfield RBX® images from the Phase 1b acne patient study, demonstrate a clear anti-inflammatory effect over the 4-week treatment course1 Baseline (day 1) Visit 4 (4 weeks) 1. Botanix Pharmaceuticals data on file – VISIA Complexion Analysis Sys
Slide 18: BTX 1503: acne - Phase 2 study well advanced
Acne BTX 1503: acne – Phase 2 study well advanced 12-week randomised, double-blind, vehicle controlled study to evaluate the safety and efficacy of BTX 1503 in patients with moderate to severe acne Design Endpoints • 5 dose groups: ~360 subjects • Primary endpoints: • High Dose twice a day: ~90 subj
Slide 19: BTX 1503 Phase 2 patient study schedule
Acne BTX 1503 Phase 2 patient study schedule Recruitment is complete with final subjects completing in-life phase of study • No serious adverse events / issues arising from treated patients to date • Positive feedback from dermatologists on study BTX 1503 indicative clinical timeline (CY) 4Q 2018 1Q
Slide 20: BTX 1204: moderate atopic dermatitis
Atopic dermatitis 2. BTX 1204: moderate atopic dermatitis Atopic dermatitis is a T-cell mediated inflammatory disease of the skin Acute phase Chronic phase 1. During the “acute phase”, dendritic cells cause excessive Th2 and Th17 cell activation 2. During the “chronic phase”, dendritic cells recruit
Slide 21: Atopic dermatitis market projected to be ~US$25bn in 2027
Atopic dermatitis Atopic dermatitis market projected to be ~US$25bn 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 One of the most common skin diseases1 Pr
Slide 22: Phase 1b study results support efficacy and safety potential
Atopic dermatitis 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 Treatment success (%)2 40% Efficacy still increasing at 4 week tim
Slide 23: BTX 1204: atopic dermatitis - Phase 2 study underway
Atopic dermatitis BTX 1204: atopic dermatitis – Phase 2 study underway 12 week randomised, double-blind, vehicle controlled study to evaluate the safety and efficacy of BTX 1204 in patients with moderate atopic dermatitis (AD) Design Endpoints • 2 dose groups: ~200 subjects • Primary endpoint - BTX
Slide 24: BTX 1204: atopic dermatitis - Phase 2 study advancing
Atopic dermatitis BTX 1204: atopic dermatitis – Phase 2 study advancing Randomised vehicle controlled study in 200 moderate patients • Program leverages existing data from BTX 1503 acne studies, lowering regulatory and safety hurdles • Common DEA licensed dermatology clinics from BTX 1503 acne Phase
Slide 25: BTX 1308 for psoriasis
Psoriasis 3. BTX 1308 for psoriasis Phase 1b patient study is testing BTX 1308 in a model that allows biopsies to be collected which may help validate the mechanism of action of cannabidiol in psoriasis Psoriasis plaque model Novel multi-drug comparison study format Biopsies of each drug zone and
Slide 26: BTX 1801: novel antimicrobial for serious skin diseases
Antimicrobial 4. BTX 1801: novel antimicrobial for serious skin diseases Natural potential of cannabinoids is enhanced by delivery with Permetrex™ technology Minimum Inhibitory Concentration (MIC) effect of BTX 1801 against industry standard antibiotics 1 BTX 1801 may have the following benefits: 2
Slide 27: Market for skin infections exceeds US$6.5bn per annum
Antimicrobial Market for skin infections exceeds US$6.5bn per annum The market for skin infection drugs continues to increase with the challenges of resistance driving the price of more effective products higher Skin infection drugs market forecast 2014-2025 (US$m) 10,000 • Skin infections are the m
Slide 28: Botanix leads the way in synthetic CBD clinical development
Botanix leads the way in synthetic CBD clinical development Phase 2 acne trial completion in 3Q and phase 2 atopic dermatitis trial completion in 4Q 2019 Product candidate Indication Pre-clin Ph 1 Ph 1b Ph 2 Status Moderate to BTX 1503 Study complete 3Q 2019 severe acne Moderate atopic Synthetic CBD
Slide 29: Disclaimer
Disclaimer This presentation prepared by Botanix Pharmaceuticals Limited ("Company") does not constitute, or form part of, an offer to sell or the solicitation of an offer to subscribe for or buy any securities, nor the solicitation of any vote or approval in any jurisdiction, nor shall there be any
Slide 30: Contact us
Contact us Matt Callahan Botanix Pharmaceuticals Founder and Board Executive Director P: +1 215 767 4184 E: mcallahan@botanixpharma.com Visit us www.botanixpharma.com Follow us on social media Botanix Pharmaceuticals Limited (ASX:BOT) Botanix Overview – June 2019 www.botanixpharma.com 28
Botanix Pharmaceuticals — Jefferies Healthcare Conference 2019 on 6ix