Botanix Pharmaceuticals Limited · ASX:BOT
Botanix Pharmaceuticals — Investor Presentation (June 2019)
36 slides from Botanix Pharmaceuticals's investor presentation, Jun 20, 2019
Slide 1: Updated investor presentation with new BTX 1801 data
ASX/Media Release 20 June 2019 For personal use only Updated investor presentation with new BTX 1801 data Key highlights • Botanix releases an updated presentation focusing on the new BTX 1801 antimicrobial data and the recently released BTX 1308 mechanism of action data • New studies show cannabidi
Slide 2: About Botanix Pharmaceuticals
and other skin conditions. The active ingredient contained in Botanix products is a synthetic form of cannabidiol. Treatment targets include inflammation, deterioration of the of the skin barrier, skin cell proliferation, pruritus (itch), excess sebum production and bacterial infection. For personal
Slide 3: Botanix Overview - Investor Presentation June 2019
For personal use only Botanix Overview Investor Presentation June 2019
Slide 4: Botanix overview
Botanix overview Clinical stage cannabinoid company, with one of the world’s most advanced pipelines, studying cannabidiol (CBD) in a range of inflammatory and anti-microbial applications For personal use only Achieving First 2019 clinical milestone (psoriasis) achieved – awaiting near term mileston
Slide 5: Corporate overview
Corporate overview Multiple near term data read-outs in 2H 2019 For personal use only Trading information Share price performance Price ($) Volume (m) Share price (as at 17-Jun-2019) A$0.135 0.16 12 52 week low / high A$0.135 / A$0.069 Shares outstanding1 773m 10 Market capitalisation1 A$104.4m 0.12
Slide 6: Phase 1b clinical and MOA studies provide solid foundation
Phase 1b clinical and MOA studies provide solid foundation Clinical and safety data, as well as new mechanism of action (MOA) data from Botanix studies provide support to near term completion of Phase 2 studies in acne and atopic dermatitis For personal use only Product candidate Indication Pre-clin
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 For personal use only 2017 global dermatology market1 2024 global dermatology market1 US$22bn sales US$43bn sales Other Atopic Atopic dermatitis dermatology dermatitis 7
Slide 8: Overview Permetrex Technology
For personal use only Overview Permetrex™ Technology Botanix Overview – June 2019 www.botanixpharma.com 6
Slide 9: Permetrex - proprietary novel skin delivery technology
Permetrex™ - proprietary novel skin delivery technology Makes new types of topical products1, that deliver very high doses of drug into the layers of the skin without using permeation enhancers, preservatives, or irritating levels of alcohol / petrol derivatives For personal use only Initial applica
Slide 10: 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 skin 1 For personal use only Amount of CBD permeated through skin (time elapsed 48 hours) 60 Delivered dose in mg/
Slide 11: 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 come with other quality risks 1 For personal use only Label claim CBD Product name Manufactur
Slide 12: New mechanism of action data for CBD in skin disease
For personal use only New mechanism of action data for CBD in skin disease 1. BTX 1801: antimicrobial 2. BTX 1308: psoriasis Botanix Overview – June 2019 www.botanixpharma.com 10
Slide 13: Psoriasis disease overview
Psoriasis 1. Psoriasis disease overview Psoriasis is a chronic, inflammatory disease characterised by red patches and plaques with silvery scales on the skin For personal use only Psoriasis affects ~6m to ~8m people in the US • ~90% have mild to moderate disease • CDC surveys suggest only 2m patient
Slide 14: BTX 1308 Phase 1b mechanism of action study
Psoriasis 1. BTX 1308 Phase 1b mechanism of action study Phase 1b patient study tested BTX 1308 in a model that allows biopsies to be collected which helps validate the mechanism of action of CBD in psoriasis For personal use only Psoriasis plaque model Biopsies of each drug zone and also healthy
Slide 15: BTX 1308 targets anti-inflammatory and immune modulating pathways
Psoriasis BTX 1308 targets anti-inflammatory and immune modulating pathways PermetrexTM effectively delivers CBD to the skin Iayers involved in the pathogenesis of skin disease and triggers significant alterations in inflammatory and immune response pathways For personal use only Heat map of genes r
Slide 16: Dual mechanism of BTX 1308 has effect on skin barrier function
Psoriasis Dual mechanism of BTX 1308 has effect on skin barrier function Both p38 MAP kinase and Interleukin-6 (anti-inflammatory pathways) are positively modulated as well as Interleukin-13 (immune modulating pathway), after less than 3 weeks of treatment For personal use only CBD X IL-6 • BTX 1308
Slide 17: BTX 1801: first non-resistance forming antibiotic against superbugs
Antimicrobial 2. BTX 1801: first non-resistance forming antibiotic against superbugs Natural potential of CBD is enhanced by delivery with Permetrex™ technology For personal use only Target profile BTX 1801 Antibiotics Kills S. aureus and resistant S. aureus (MSRA - “Superbugs”) 1 Shows broad-sp
Slide 18: BTX 1801 is effective against different Gram-Positive bacteria
Antimicrobial BTX 1801 is effective against 132 different Gram-Positive bacteria 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 MIC90 S.aureu
Slide 19: MRSA bacteria do not form resistance to BTX 1801
Antimicrobial MRSA (‘golden staph’) bacteria do not form resistance to BTX 1801 If the antibiotic does not kill the bacteria quickly and completely, repeated dosing allows bacteria to mutate and form resistance to the drug For personal use only Antibiotic Minimum Inhibitory Concentration (MIC) daily
Slide 20: BTX 1801 animal proof of concept and biofilm tests successful
Antimicrobial BTX 1801 animal proof of concept and biofilm tests successful Not just effective in the laboratory – BTX 1801 shows efficacy in an independently tested animal model and also is effective against biofilms For personal use only In vivo mouse model1 Biofilm model2 Vehicle 2% Bactroban BTX
Slide 21: Inflammation + bacterial infection are important to most skin diseases
Inflammation + bacterial infection are important to most skin diseases1 Newly announced data from BTX 1308 and BTX 1801 studies provide scientific support for CBD’s mechanism of action, which is highly relevant to both Phase 2 acne and atopic dermatitis studies For personal use only Acne Atopic derm
Slide 22: Late stage clinical programs in Phase 2 studies
For personal use only Late stage clinical programs in Phase 2 studies 1. BTX 1503: acne 2. BTX 1204: atopic dermatitis Botanix Overview – June 2019 www.botanixpharma.com 20
Slide 23: 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 For personal use only BTX 1503 potentially addresses 3 key acne pathologies 1 Attacks P. Reduces CBD has been shown in studies to… Acnes Inflammat
Slide 24: 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 For personal use only Top oral brands Top topical brands Revenue Revenue Rank Brands Script
Slide 25: 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 For personal use only Lesion count reduction (%) 1 Other FDA approved products2 Lesion count 2017 annual Inflammatory lesions Non-inflammatory lesi
Slide 26: 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 For personal use only Baseline (day 1) Visit 4 (4 weeks) 1. Botanix Pharmaceuticals data on file – VISIA C
Slide 27: 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 For personal use only Design Endpoints • 5 dose groups: ~360 subjects • Primary endpoints: • High Dose
Slide 28: 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 in Q3 2019 For personal use only • No serious adverse events issues arising from treated patients to date • Positive feedback from dermatologists on study BTX 1503 indicative cl
Slide 29: BTX 1204: moderate atopic dermatitis
Atopic dermatitis 2. BTX 1204: moderate atopic dermatitis New data from BTX 1308 mechanism of action study and BTX 1801 antimicrobial studies provides support for CBD’s anti-inflammatory, antimicrobial and potential skin barrier preservation activities For personal use only • CBD inhibits P38 MAPK a
Slide 30: Atopic dermatitis market projected to be ~$25B in 2027
Atopic dermatitis Atopic dermatitis market projected to be ~$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 commo
Slide 31: 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 For personal use only Treatment success (%)2 40% Efficacy still in
Slide 32: 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) For personal use only Design Endpoints • 2 dose groups: ~200 subjects • P
Slide 33: BTX 1204: atopic dermatitis - Phase 2 study rapidly advancing
Atopic dermatitis BTX 1204: atopic dermatitis – Phase 2 study rapidly advancing Randomised, vehicle controlled study in 200 moderate patients For personal use only • Program leverages existing data from BTX 1503 acne studies, lowering regulatory and safety hurdles • Common DEA licensed dermatology c
Slide 34: Phase 1b clinical and MOA studies provide solid foundation
Phase 1b clinical and MOA studies provide solid foundation Clinical and safety data, as well as new mechanism of action (MOA) data from Botanix studies provide support to near term completion of Phase 2 studies in acne and atopic dermatitis For personal use only Product candidate Indication Pre-clin
Slide 35: Disclaimer
Disclaimer For personal use only 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,
Slide 36: Contact us
For personal use only 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.botanixpha
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