Botanix Pharmaceuticals Limited · ASX:BOT
Botanix Pharmaceuticals — Shareholder Meeting (November 2020)
21 slides from Botanix Pharmaceuticals's shareholder meeting presentation, Nov 23, 2020
Slide 1: Botanix Annual General Meeting Presentation
23 November 2020 Botanix Annual General Meeting Presentation Philadelphia PA and Sydney Australia, 23 November 2020: Clinical stage cannabinoid company For personal use only Botanix Pharmaceuticals Limited (ASX:BOT, “Botanix” or “the Company”) is pleased to release the presentation to be made at the
Slide 2: Cautionary Note on Forward-Looking Statements
Cautionary Note on Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for the Company, the Company’s strategy, future operations, and other statements containing the words “anticipate,” “believe,” “estimate, ”expect,” “intend,” “may,” “plan
Slide 3: Unlocking the potential of synthetic cannabinoids
For personal use only Unlocking the potential of synthetic cannabinoids AGM Presentation 23 November 2020 www.botanixpharma.com
Slide 4: Investment Highlights
Investment Highlights For personal use only Pharma focused Leading pharmaceutical company leveraging unique properties of synthetic cannabinoids, including cannabidiol (CBD) Antimicrobial opportunities Dermatology opportunities Novel antimicrobial platform with positive Targeting key dermatology ind
Slide 5: Key Achievements
Key Achievements March 2020 For personal use only Launch of BTX 1801 Phase 2a clinical study April 2020 FDA grants a Qualified Infectious Disease Product designation for BTX 1801 July 2020 Successful completion of the End of Phase 2 meeting for BTX 1503 with FDA August 2020 Initiation of recruitment
Slide 6: Synthetic Cannabinoids are well suited to treat Skin Diseases and Infections
Pharma focused Synthetic Cannabinoids are well suited to treat Skin Diseases and Infections For personal use only Botanix’s studies show synthetic cannabinoids: Safe and well tolerated Broad anti-inflammatory properties relevant to infections Strong and consistent impact on inflammatory lesion
Slide 7: Advanced Clinical Pipeline
Pharma focused Synthetic Cannabinoids Advanced Clinical Pipeline For personal use only Ph 1 Ph 1b Ph 2 Ph 3 Status Planning underway BTX 1503 for Phase 3 clinical Acne studies BTX 1801 Phase 2a study fully Antimicrobial recruited BTX 1702 Targeting initiation of Rosacea Phase 1b in 1Q CY2021 5 www.b
Slide 8: BTX 1801 – First CBD-Based Program To Receive QIDP
ANTIMICROBIAL BTX 1801 – First CBD-Based Program To Receive QIDP For personal use only Strict QIDP criteria: FDA QIDP creates multiple commercial benefits Requires provision of a detailed package of data Exclusivity Priority Fast track Must be a novel product 5 additional years of Eligible for a
Slide 9: Encouraging new pre-clinical data
ANTIMICROBIAL Encouraging new pre-clinical data For personal use only Human explant data demonstrates BTX 1801 eliminates MRSA from infected human skin Human Skin Explant Model Efficacy of different concentrations of BTX 1801 in MRSA infected human skin explants Freshly sourced Shave skin and Cut 5m
Slide 10: Novel Mechanism of Action Confirmed
ANTIMICROBIAL Novel Mechanism of Action Confirmed The time-lapse shows CBD causes rapid permeabilization of the bacterial membrane and cell death For personal use only S.aureus treated with 2.5% methanol (negative control)1 S.aureus treated with synthetic cannabidiol1 Staph bacteria treated Staph ba
Slide 11: Initial Target – Surgical Site Infections
ANTIMICROBIAL Initial Target – Screening patients for SA nasal carriage and decolonising Surgical Site Infections carriers prior to surgery decreases the risk of SSIs1 For personal use only Surgical site infections (SSIs) – 1 PERSON IN 3 significant health care challenge Carry SA on their skin or in
Slide 12: BTX 1801: Clinical Development Strategy
ANTIMICROBIAL BTX 1801: Clinical Development Strategy For personal use only Study update Study design Phase 2a study is well advanced and being conducted Double-blind, vehicle-controlled Phase 2a clinical study wholly in Western Australia 4 dose groups: ~60 healthy volunteers: On target for
Slide 13: Significant upside potential – Multiple AMR Opportunities
ANTIMICROBIAL Significant upside potential – Multiple AMR Opportunities For personal use only Multitude of potential applications… … further novel cannabinoid work underway Dialysis related infections- from catheter usage Awarded Innovation Connection Grant2 to accelerate the Skin infections –
Slide 14: BTX 1503: Successful End-of-Phase FDA Meeting
DERMATOLOGY BTX 1503: Successful End-of-Phase 2 FDA Meeting For personal use only Study update Sizable acne prescription market End of Phase 2 meeting with FDA successfully completed The global acne market expected to reach US$7bn by 20242 FDA highlighted excellent safety profile of BTX 1503, an
Slide 15: BTX 1702: Impact of Rosacea and Triggers
DERMATOLOGY BTX 1702: Impact of Rosacea and Triggers For personal use only Papulopustular rosacea is a chronic skin disease Rosacea triggers3 characterised by redness (inflammation) and acne- When I'm overheated, or when it is very hot outside 55% like-break-outs1 When I am stressed 52% Being in t
Slide 16: BTX 1702: Significant Market Opportunity
DERMATOLOGY BTX 1702: Significant Market Opportunity and Study Primed to Kick Off in the New Year For personal use only A rapidly growing market: Rosacea market projected to grow to US$2.6bn by 20251 US$2.6bn A nticipated to regis ter Study update US$1.9bn C A G R of ~6.8% 1 over the forecast period
Slide 17: BTX 1702: Phase 1b Rosacea Study Updated Design
DERMATOLOGY BTX 1702: Phase 1b Rosacea Study Updated Design For personal use only Study design Four dose groups, ~120 patients: Endpoints: – BTX 1702 high dose - twice daily: 40 patients – Safety and tolerability – BTX 1702 low dose - twice daily: 40 patients – Change in inflammatory lesion coun
Slide 18: World-Class Team
WORLD-CLASS TEAM World-Class Team For personal use only Board Vince Ippolito Matt Callahan Dr Michael Thurn Dr Stewart Washer Dr Bill Bosch President and Executive Chairman Executive Director Executive Director Director Executive Director COO of Anacor and Medicis with 17 Serial founder and ex-i
Slide 19: Executing on Key Near-Term Milestones
NEAR-TERM CATALYSTS Executing on Key Near-Term Milestones For personal use only Antimicrobial: BTX 1801 Phase 2a study completion Fully recruited - study completion on target for 4Q CY2020 Rosacea: BTX 1702 Phase 1b study start Targeting study initiation in 1Q CY2021 Acne: BTX 1503 planning fo
Slide 20: Disclaimer
DISCLAIMER For personal use only Any statements in this press release about future expectations, plans and prospects for the Company, the Company’s strategy, future operations, and other statements containing the words “anticipate,” “believe,” “estimate, ”expect,” “intend,” “may,” “plan,” “predict,”
Slide 21: General enquiries
For personal use only General enquiries Botanix Pharmaceuticals Corporate communications +61 8 6555 2945 investors@botanixpharma.com www.botanixpharma.com
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