Botanix Pharmaceuticals Limited · ASX:BOT
Botanix Pharmaceuticals — Investor Presentation (November 2018)
25 slides from Botanix Pharmaceuticals's investor presentation, Nov 15, 2018
Slide 1: Botanix Overview
Botanix Overview November 2018 1
Slide 2: Key investment highlights
Key investment highlights Botanix is a global dermatology company delivering synthetic cannabinoids topically for the treatment of skin diseases Dermatology Advanced clinical programs targeting multi-billion dollar prescription markets for acne, atopic focused dermatitis and psoriasis De-risked drug
Slide 3: Clinical programs with near term milestones
Clinical programs with near term milestones Phase 2 acne and atopic dermatitis programs supported by exciting development pipeline, with Permetrex™ collaborations to augment revenue and news flow Product candidate Indication Pre-clin Ph 1 Ph 1b Ph 2 Next milestones Moderate to BTX 1503 Phase 2 clini
Slide 4: Experienced team
Experienced team Global team with proven experience in dermatology and a track record of securing drug approvals 4 Botanix Overview – November 2018
Slide 5: Cannabinoid research interest is exploding
Cannabinoid research interest is exploding Cannabinoids are attracting strong interest as their efficacy and safety profiles are validated in clinical studies and the recent FDA approval of Epidiolex® (GW Pharma) Cannabidiol (CBD) Significant clinical trial interest • One of ~ 113 cannabinoids ident
Slide 6: Permetrex skin delivery technology
Permetrex™ skin delivery technology Proprietary Permetrex™ technology delivers high doses of drug into the layers of the skin without use of permeation enhancers, preservatives, or the use of irritating alcohol/petrolatum additives Unmodified Drug With Permetrex™ Formulation technology drives drug i
Slide 7: Permetrex technology enables superior delivery of cannabidiol
Permetrex™ technology enables superior delivery of cannabidiol Permetrex™ delivers more much more cannabidiol (CBD) into the target layers of the skin, even though the CBD concentration of the BTX 1503 formulation is only ¼ to ½ the concentration of alternative formulations Cannabidiol (CBD) percent
Slide 8: Development Pipeline
Development Pipeline BTX 1503: acne BTX 1204: atopic dermatitis BTX 1308: psoriasis BTX 1801: antimicrobial 8 Botanix Overview – November 2018
Slide 9: BTX 1503: acne – mechanism of action for acne
Acne BTX 1503: acne – mechanism of action for acne BTX 1503 is a safe and well tolerated topical treatment that addresses all 3 key pathologies of acne Inflammatory mechanisms involved in CBD has been shown to… different stages of acne1 Have anti-inflammatory effects on human sebocytes and to suppre
Slide 10: BTX 1503: acne – outperforms leading acne products
Acne BTX 1503: acne – outperforms leading acne products 4 week study data shows a marked reduction in inflammatory lesions, greater than any other FDA approved topical acne product 1 Lesion count reduction (%) Comparison with other FDA approved products Product Owner Lesion count reduction (%)2 2016
Slide 11: New data supporting anti-inflammatory effects of cannabidiol
Acne New data supporting anti-inflammatory effects of cannabidiol Newly processed images from the Phase 1b acne patient study, demonstrate a clear anti-inflammatory effect over the 4 week treatment course 1 Baseline (Day 1) Visit 4 (4 weeks) Nose not treated Nose not treated 11 Botanix Overview – No
Slide 12: BTX 1503: acne – Phase 2 study overview
Acne BTX 1503: acne – Phase 2 study overview 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: – absolute change from Baseline to Wee
Slide 13: BTX 1503: acne – next steps
Acne BTX 1503: acne – next steps Botanix is pursuing a rapid clinical development strategy to accelerate product commercialisation and timing to first revenues • Phase 2 clinical study started early 3Q CY2018 and will take approximately 12 months to complete • Study designed to deliver data that all
Slide 14: BTX 1204: atopic dermatitis – mechanism of action
Atopic BTX 1204: atopic dermatitis – mechanism of action dermatitis Atopic dermatitis (and psoriasis) are both T-cell mediated inflammatory diseases of the skin 1. During the “acute phase”, dendritic cells cause excessive Th2 and Th17 cell activation 2. During the “chronic phase”, dendritic cells re
Slide 15: BTX 1204: atopic dermatitis – Phase 1b study design
Atopic BTX 1204: atopic dermatitis – Phase 1b study design dermatitis Successful 4-week treatment period, double-blind, vehicle controlled patient study concluded in late May 2018 Design Endpoints • ~36 subjects 18 years and older (24 active / 12 vehicle) • Primary endpoints: • 4 Australian dermatol
Slide 16: BTX 1204: atopic dermatitis – Phase 1b study results
Atopic BTX 1204: atopic dermatitis – Phase 1b study results dermatitis BTX 1204 was twice as effective as vehicle (with efficacy still increasing) and displayed a substantial improvement in the key signs of AD 1 Treatment success (%)2 Key takeaways 40% Efficacy still increasing at 4 week timepoint •
Slide 17: BTX 1204: atopic dermatitis – Phase 2 study design
Atopic BTX 1204: atopic dermatitis – Phase 2 study design dermatitis 12 week randomised, double-blind, vehicle controlled study to evaluate the safety and efficacy of BTX 1204 in patients with moderate AD Design Endpoints • 2 dose groups: ~200 subjects • Primary endpoint: – BTX 1204: ~100 subjects –
Slide 18: BTX 1204: atopic dermatitis – next steps
Atopic BTX 1204: atopic dermatitis – next steps dermatitis BTX 1204 complements existing products in development, allowing faster development and transition times through key regulators (FDA and DEA) • development program leverages existing data from BTX 1503 acne studies, lowering regulatory and sa
Slide 19: BTX 1308: psoriasis – overview
Psoriasis BTX 1308: psoriasis – overview Development pipeline also includes other synthetic cannabidiol and Permetrex™ enabled products targeting key dermatology markets BTX 1308: psoriasis • Target market: ~7.5m Americans have psoriasis (note: most have plaque psoriasis) BTX 1308 leverages prior da
Slide 20: BTX 1308: psoriasis – next steps
Psoriasis BTX 1308: psoriasis – next steps Botanix has commenced a Phase 1b study to test BTX 1308 against vehicle and a marketed psoriasis drug in patients • Novel multi-drug comparison study format in the same patient, provides high quality data on BTX 1308 efficacy • Biopsy data will elucidate MO
Slide 21: BTX 1801: antimicrobial – the problem of antimicrobial resistance
BTX 1801: antimicrobial – the problem of antimicrobial resistance More than 700,000 people die as a result of antimicrobial resistance globally every year and estimates predict that by 2050, 10m lives p.a. will be at risk. However, no new classes of antibiotics have been approved in 33+ years Deaths
Slide 22: BTX 1801: antimicrobial – results summary
BTX 1801: antimicrobial – results summary BTX 1801 data demonstrates potential for a new antimicrobial to treat unmet needs in skin infections together with additional benefits seen in prior Botanix studies (e.g. reduction in inflammation) Summary of data BTX 1801 may have the following benefits 120
Slide 23: Key catalysts
Key catalysts Significant clinical and operational milestones across multiple programs expected over the next 12 months Indicative activities and milestones 3Q CY2018 4Q CY2018 1Q CY2019 2Q CY2019 First patient enrolled in Phase 2 study BTX 1503 Acne Patient enrolment complete Phase 2 Phase 2 multi-
Slide 24: 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 25: Contact us
Contact us Matt Callahan Visit us Botanix Pharmaceuticals www.botanixpharma.com Founder and Board Executive Director Follow us on social media P: +1 215 767 4184 E: mcallahan@botanixpharma.com 25 Botanix Pharmaceuticals Limited (ASX:BOT)
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