Botanix Pharmaceuticals Limited · ASX:BOT
Botanix Pharmaceuticals — American Academy of Dermatology Annual Meeting 2017
18 slides from Botanix Pharmaceuticals's conference presentation, Mar 6, 2017
Slide 1: Botanix presents at the American Academy of Dermatology annual meeting
ASX/Media Release 6 March 2017 For personal use only Botanix presents at the American Academy of Dermatology annual meeting Botanix presented at the AAD annual meeting in Orlando, Florida Botanix showcased the BTX1503 acne program and progression to near term clinical trials to key industry opin
Slide 2: For more information, please contact
For more information, please contact: For personal use only General enquiries Investor Relations Matt Callahan Ben Walsh Botanix Pharmaceuticals Ltd WE Buchan Executive Director P: (02) 9237 2801 P: +1 215 767 4184 E: bwalsh@buchanwe.com.au E: mcallahan@botanixpharma.com Media enquiries Arthur Chan
Slide 3: Restoring healthy skin - American Academy Dermatology
+ For personal use only restoring healthy skin American Academy Dermatology March 2017 ASX:BOT www.botanixpharma.com
Slide 4: Overview
+ Overview For personal use only 2 n ASX listed dermatology company focused on new treatments for serious skin diseases Business focus: n Lead product for acne uHlizes a syntheHc and – medical dermatology pharmaceuHcal grade form of cannabidiol n Permetrex™ is the drug delivery system that Lead prog
Slide 5: Team with significant FDA success
+ Team with significant FDA success For personal use only 3 Ma: Callahan Dr Bill Bosch Dr Michael Thurn Mark Davis Director Director COO VP Clinical/ Regulatory • 3 FDA approved • 6 FDA approved • Extensive acne • 30 years dermatology products products development and experience • IP and development
Slide 6: Experienced scientific team
+ Experienced scienHfic team For personal use only 4 Dr Gene Cooper Prof James Leyden Prof Diane Thiboutot Consultant ScienHfic Advisor ScienHfic Adviser • 5 FDA approved • Emeritus Professor • Professor of Dermatology products Dermatology at University at Penn State University • Expert in skin deliver
Slide 7: Nothing new for the last years and little expected
+ Nothing new for the last 10 years 5 and little expected For personal use only • No products have approved by FDA in the last 10 years containing a new drug • All “new products” launched in this period contain combinations of old drugs in new formulations or packaging • Multiple late stage new prod
Slide 8: Cannabidiol showing promising results
+ Cannabidiol showing promising results For personal use only 6
Slide 9: Cannabidiol mechanism of action
+ Cannabidiol mechanism of acHon For personal use only 7 Cannabidiol LipostaHc AnH-proliferaHve AnH-inflammatory ü Inhibits lipogenic ü Inhibits proliferaHon of ü Prevents the “pro- acHon in dose sebocytes which is as acne” elevaHon of dependent manner important as lipogenic TNFα ü Not endocannabinoi
Slide 10: Source and purity of drug material is important
+ Source and purity of drug material is important For personal use only 8 Extracted and purified SyntheHcally manufactured 100+ chemicals 1 chemical MulHple impuriHes 100% pure Scaled up to ≈ 1kg Scaled up to 50kg Not registered with FDA Registered with FDA Must comply with FDA’s “Guidance No addiHon
Slide 11: BTX1503 - leveraging a novel mechanism of action in acne
+ BTX1503 – leveraging a novel mechanism of acHon in acne For personal use only 9 Switches off excessive oil or ‘sebum’ producHon Reduces inflammaHon Blocks cell proliferaHon Reduces infecHon BTX1503 targe4ng a benign side effect profile
Slide 12: BTX1503 - planned positioning versus existing acne products
+ BTX1503 - planned posiHoning versus exisHng acne products For personal use only 10 Reduces Sebum ✓ ✗ ✗ ✗ ✗ ✗ ✓ AnH-inflammatory ✓ ✗ ✓ ✓ ✗ ✗ ✓ AnH-microbial ✓ ✓ ✗ ✗ ✓ ✓ ✓ Topical ✓ ✗ ✓ ✓ ✗ ✗ ✗ Minimal side effects ✓ ✗ ✓ ✓ ✗ ✓ ✗ “…the ‘Holy Grail’ of acne treatments would be a topical that can influenc
Slide 13: Permetrex - superior skin delivery
+ Permetrex™ - superior skin delivery For personal use only 11 Oral delivery of cannabidiol is only 6% bioavailable Unmodified Drug With Permetrex™ Epidermis Dermis Confidential Property of Botanix Pharma
Slide 14: BTX 1503 - timeline
+ BTX 1503 – Hmeline For personal use only 12 2016 2017 FormulaHon manufacturing and tesHng Pre-clinical tesHng and animal studies Permetrex™ GMP manufacturing Permetrex™ human safety/irritaHon trial BTX-1503 GMP manufacturing BTX-1503 tesHng Ethics applicaHon, import and licenses Phase 1a safety st
Slide 15: Pipeline - other products that utilize cannabidiol
+ Pipeline – other products that uHlize 13 cannabidiol For personal use only • 7.5 million Americans have psoriasis • Characterized by keraHnocyte hyper-proliferaHon and BTX 1308 increased expression of pro-inflammatory mediators (psoriasis) into the skin. • Cannabidiol has been shown to inhibit kera
Slide 16: Permetrex enabled product opportunities
+Permetrex™ enabled product opportuniHes For personal use only 14 n Variety of prescripHon, cosmeHc and OTC product opportuniHes are possible n No need for alcohols that sHng or dry out skin n No need for preservaHves that may irritate, as no water in formulaHons n AcHve load may vary from 0.5% - 40
Slide 17: Upcoming news flow and milestones
+ Upcoming news flow and milestones For personal use only 15 n Ethics approval for first Phase 1 study n Import licenses for BTX-1503 clinical trial material n CollaboraHve research arrangements n New product addiHons to pipeline (based on Permetrex™) n Commencement of Phase 1a study n CompleHon of Ph
Slide 18: Botanix summary
+ Botanix summary For personal use only 16 ü Significant unmet paHent needs in serious skin diseases ü Novel syntheHc cannabidiol treatment for acne with a growing evidence base ü Proprietary drug delivery system ü Fast and efficient development pathway, relaHve to usual pharmaceuHcal development ü Ver
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