Slide 1: Updated investor presentation (ASX media release)
ASX/Media Release 13 August 2018 For personal use only Updated investor presentation Philadelphia PA and Sydney Australia, 13 August 2018: Medical dermatology company Botanix Pharmaceuticals (“Botanix” or “the Company”) is pleased to release an updated investor presentation. The presentation will be
Slide 2: Investor presentation August 2018
For personal use only Investor presentation August 2018 1
Slide 3: Agenda
Agenda For personal use only 1. Executive summary 2. Cannabidiol – target drug with significant potential 3. Phase 2 products – BTX 1503: acne and BTX 1204: atopic dermatitis 4. Pipeline products – BTX 1308: psoriasis and BTX 1801: antimicrobial 5. Outlook 2 Investor presentation – August 2018
Slide 4: 1. Executive summary
For personal use only 1. Executive summary 3 Investor presentation – August 2018
Slide 5: Key investment highlights
Key investment highlights Botanix is an emerging global dermatology company with advanced clinical programs and an exciting pipeline For personal use only Dermatology Advanced clinical programs targeting multi-billion dollar prescription markets for acne and Focused atopic dermatitis where no new pr
Slide 6: Corporate overview
Corporate overview Clear path to commercialisation and a highly aligned Board and management team For personal use only Trading information Share price performance Share price (as at 10-August-2018) A$0.100 Share price (A$) Volume (m) 52 week low / high A$0.043 / A$0.185 0.20 100 Shares outstanding1
Slide 7: Clinical programs with near term milestones
Clinical programs with near term milestones Rapidly advancing acne and atopic dermatitis programs, with deep pipeline in development and Permetrex™ collaborations to augment revenue and news flow For personal use only Product candidate Indication Pre-Clin Ph 1 Ph 1b Ph 2 Next milestones Moderate to
Slide 8: 2. Cannabidiol: Target drug with significant potential
2. Cannabidiol For personal use only Target drug with significant potential 7 Investor presentation – August 2018
Slide 9: Cannabinoids are emerging as a hot new class of drugs
Cannabinoids are emerging as a hot new class of drugs Cannabinoids are attracting strong interest as their efficacy and safety profiles are validated in clinical studies and as a result of the first FDA approval for cannabidiol use in epilepsy (Epidiolex® - GW Pharma) For personal use only Significa
Slide 10: FDA approval is the pathway to value
FDA approval is the pathway to value Just like cannabidiol for epilepsy – FDA approval means doctors can prescribe and insurance companies can reimburse a cannabidiol product that is quality controlled, effectively delivered and has undergone well-controlled clinical studies For personal use only FD
Slide 11: 3. Phase 2 products
3. Phase 2 products For personal use only BTX 1503: acne BTX 1204: atopic dermatitis 10 Investor presentation – August 2018
Slide 12: BTX 1503: how does BTX 1503 work to treat acne?
BTX 1503: how does BTX 1503 work to treat acne? BTX 1503 potentially address all 3 key pathologies of acne with a very safe side effect profile For personal use only Attacks P. Acnes Reduces Inflammation bacteria Retards formation of sebum “plugs” Switches off excess production of sebum Source: Cann
Slide 13: BTX 1503: global acne market
BTX 1503: global acne market Despite being a significant market, the global acne market is highly genericised and warrants products with novel mechanisms of action For personal use only Global acne market size (US$m) 7,350 Large demand with limited recent product development 4,920 Value of the glo
Slide 14: BTX 1503: outperforms leading acne products
BTX 1503: outperforms leading acne products Study data resulted in a reduction in inflammatory lesions greater than any other FDA approved topical acne product - after only 4 weeks For personal use only Lesion count reduction (%) Comparison of other FDA approved products Product Owner Lesion count r
Slide 15: BTX 1503: new data provides confidence cannabidiol is very effective
BTX 1503: new data provides confidence cannabidiol is very effective Newly processed cross-polarized images from the Phase 1b patient study, demonstrate deep penetration of BTX 1503 into skin layers and clear anti-inflammatory effect and improvement over the treatment course of only 4 weeks For pers
Slide 16: BTX 1503: Phase 2 study overview
BTX 1503: Phase 2 study overview 12-week randomised, treatment-blinded, 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 twice a day
Slide 17: BTX 1503: next steps
BTX 1503: next steps Botanix is pursuing a rapid clinical development strategy to accelerate product commercialisation and timing to first revenues For personal use only • Phase 2 clinical trial started mid-CY2018 and will take approximately 12 months to complete • Trial designed to deliver data tha
Slide 18: BTX 1204: atopic dermatitis disease overview
BTX 1204: atopic dermatitis disease overview Atopic dermatitis (AD) is a chronically relapsing skin disorder with an immunologic basis, but for which environmental factors (allergens, stress, food and skin flora) all play a part For personal use only AD - disease overview • The exact cause of AD is
Slide 19: BTX 1204: global atopic dermatitis market
BTX 1204: global atopic dermatitis market The global AD market is forecasted to grow at a CAGR of 12.8% from ~US$7bn in 2017 to ~US$24bn by 2027 For personal use only Projected AD market by revenue (US$bn) Leading topical branded AD products by revenue (US$m) $25 $400 PROTOPIC® (0.1% & 0.03%) ELIDEL
Slide 20: BTX 1204: Phase 1b study results
BTX 1204: Phase 1b study results After only 4 weeks of treatment, study data indicated BTX 1204 was twice as effective over the vehicle (with efficacy still increasing) and substantial improvement in the key signs of AD observed For personal use only Treatment success (%)1 Key takeaways 40% Efficacy
Slide 21: BTX 1204: Phase 2 study design
BTX 1204: Phase 2 study design 12 week randomised, double-blind, vehicle controlled study to evaluate the safety and efficacy of BTX 1204 in patients with moderate AD For personal use only Design Endpoints • 2 dose groups: ~200 subjects • Primary endpoint: – BTX 1204: ~100 subjects – proportion of s
Slide 22: BTX 1204: next steps
BTX 1204: next steps Botanix is pursuing a rapid clinical development strategy to accelerate product commercialisation and timing to first revenues For personal use only • Development program leverages existing data from BTX 1503 acne studies, so regulatory and safety risk is low BTX 1204 indicative
Slide 23: 4. Pipeline products
4. Pipeline products For personal use only BTX 1308: psoriasis BTX 1801: antimicrobial 22 Investor presentation – August 2018
Slide 24: BTX 1308: overview
BTX 1308: overview Development pipeline also includes other synthetic cannabidiol and Permetrex™ enabled products targeting key dermatology markets For personal use only BTX 1308: psoriasis • Target market: ~7.5m Americans have psoriasis (note: most have plaque psoriasis) BTX 1308 leverages prior da
Slide 25: BTX 1308: next steps
BTX 1308: next steps Botanix is preparing for a Phase 1b study to test BTX 1308 against placebo and another psoriasis drug in patients starting in Q3 CY2018 For personal use only BTX 1801 indicative development timeline (CY) 3Q 2018 4Q 2018 1Q 2019 2Q 2019 Ethics approvals for • Development program
Slide 26: BTX 1801: the problem of antimicrobial resistance
BTX 1801: 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 For personal use only
Slide 27: BTX 1801: Permetrex formulation of cannabidiol
BTX 1801: Permetrex™ formulation of cannabidiol In two of the common antibiotic resistant bacteria strains, Permetrex™ significantly improves the killing power of cannabidiol, to achieve close to 100% bacteria killing effect (at low concentrations) For personal use only Summary of data MRSA Bacteria
Slide 28: BTX 1801: results summary
BTX 1801: 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) For personal use only Summary of data BTX 1801 may have the following benefi
Slide 29: 5. Outlook
For personal use only 5. Outlook 28 Investor presentation – August 2018
Slide 30: Key catalysts
Key catalysts Significant clinical and operational milestones across multiple programs expected over the next 12 months For personal use only Indicative activities and milestones 3Q CY2018 4Q CY2018 1Q CY2019 2Q CY2019 Milestones First patient enrolled in Phase 2 trial Phase 2 All US and Australian
Slide 31: 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 32: Contact us
For personal use only Contact us Matt Callahan Visit us Botanix Pharmaceuticals www.botanixpharma.com Executive Director Follow us on social media P: +1 215 767 4184 E: mcallahan@botanixpharma.com 31 Botanix Pharmaceuticals Limited (ASX:BOT)