Skye Bioscience, Inc. · NASDAQ:SKYE
Skye Bioscience — Investor Presentation (October 2021)
37 slides from Skye Bioscience's investor presentation, Oct 12, 2021
Slide 1: Investor Hour - October 12, 2021
SkKZE. NO LIMITS. Investor Hour October 12, 2021
Slide 2: Agenda
AGENDA Introduction, Vision, Overview & Evolution Intellectual Property & New Invention Punit Dhillon Opportunities CEO & Chair Tom Kim, LLB General Counsel & Director of IP Glaucoma Clinical Development Strategy & Program Overview Cannabinoid Research & Innovation Tu Diep, MSc Eduardo Muñoz, MD, Ph
Slide 3: Forward Looking Statements
FORWARD LOOKING STATEMENTS This presentation contains “forward-looking statements”, including All information contained in this presentation is provided as of the statements regarding Skye Bioscience, Inc. “Skye Bioscience and/or date of the presentation and is subject to change without notice. the
Slide 4: Punit Dhillon: Introduction, Vision, Overview & Evolution
INTRODUCTION VISION, OVERVIEW & EVOLUTION PUNIT DHILLON CEO & CHAIR SAN DIEGO, CA
Slide 5: Cannabinoid pharmaceuticals have the potential to disrupt many therapeutic unmet needs
Broad Therapeutic Potential • Ability to tackle complex therapeutic pathways • Ability to combine with other novel, synthetically- Cannabinoid derived molecules that enable precise modulation pharmaceuticals Platform Potential have the • Ability to affect multiple targets potential to • New platform
Slide 6: Large opportunity for first-in-class therapeutic portfolio
Large ü GO BIG product opportunity opportunity for ü Key existing data provides for higher probability of success – OPTIMAL DEVELOPMENT first-in-class ü Accelerated R&D timelines – GO FAST therapeutic ü Greater capital efficiency – we develop the portfolio. opportunities that have the optimal develo
Slide 7: Cannabinoid pharmaceuticals as a potential new class of medicines
Cannabinoids and cannabinoid- derivatives can be specifically designed to modify the ECS to positively impact multiple diseases Cannabinoid pharmaceuticals as a potential new class of medicines will have a significant impact on human health. CB1 and CB2 receptors are the most characterized ECS impac
Slide 8: Tu Diep: Glaucoma Development Strategy & Program Overview
GLAUCOMA DEVELOPMENT STRATEGY & PROGRAM OVERVIEW TU DIEP, MSc SVP, DEVELOPMENT SAN DIEGO, CA
Slide 9: 2021 Clinical Achievements
2021 CLINICAL ACHIEVEMENTS q Manufactured first batch of SBI-100 using a proprietary nanoemulsion formulation q Acceptance of two late-breaking abstracts related to the formulation of SBI-100 and its combination with currently approved therapies q Completed EpiOcular irritation study which demonstra
Slide 10: An Improved Development Strategy
AN IMPROVED DEVELOPMENT STRATEGY Neuroprotection Study AUS Ethics Approval for Phase 1 Jun 2021 Nov 2021 2021 2022 Original Timeline GLP Toxicology Studies Initiate Phase 1 Aug 2021 Dec 2021 • 10 • SKYE BIOSCIENCE
Slide 11: Opportunity to Generate Meaningful Data
OPPORTUNITY TO GENERATE MEANINGFUL DATA IND Clearance Sep 2022 Neuroprotection Study AUS Ethics Approval Dec 2021 for Phase 1 Mar 2022 2021 2022 2023 Revised GLP Toxicology Studies Timeline Initiate Complete Dec 2021 Phase 1 Phase 1 Apr 2022 Jul 2022 Initiate Phase 2 Oct 2022 FDA Pre-IND Meeting Dec
Slide 12: Phase 1 SAD/MAD Design for SBI-100
PHASE 1 SAD/MAD DESIGN FOR SBI-100 Study Objectives: A randomized, double-masked study to evaluate safety, tolerability, pharmacokinetics, and intraocular pressure (IOP)-reducing effects of SBI-100 in 48 healthy subjects following single and multiple ascending doses of SBI-100. Part A: Single Ascend
Slide 13: Miguel Gonzalez-Andrades: SBI-100 Effectiveness & Glaucoma Therapeutic Landscape
MIGUEL GONZALEZ- ANDRADES, SBI-100 EFFECTIVENESS & GLAUCOMA THERAPEUTIC LANDSCAPE MD, PhD CLINICAL ADVISOR CORDOBA, SPAIN
Slide 14: THCVHS: Our Drug and Formulation
Gonzalez-Andrades et al, Essentials in Oph 2019 THCVHS: OUR DRUG AND FORMULATION
Slide 15: THC and CB1 receptor in glaucoma
A B AAO BCSC 2020-21 • 15 • SKYE BIOSCIENCE
Slide 16: THC acting on the CB1 receptor
THC CB1 receptor AAO BCSC 2020-21 • 16 • SKYE BIOSCIENCE
Slide 17: H2H Pharmacology Study (Non-GLP) in Rabbits
H2H PHARMACOLOGY STUDY (NON-GLP) IN RABBITS AAO BCSC Average IOP vs Time profile of Latanoprost (0.005%) vs 2020-21 ] THCVHS (1.0%) vs Timolol (0.25%) Average IOP vs Time profile of Latanoprost vs THCVHS vs THCVHS + Rhopressa (Netarsudil) 25.0 24.0 23.0 22.0 21.0 IOP (mmHg) 20.0 19.0 18.0 17.0 16.0
Slide 18: Neuroprotection and Anti-inflammatory Effects
NEUROPROTECTION AND ANTI-INFLAMMATORY EFFECTS THC and CBD known to affect Anti-fibrosis these pathways Doozandeh and Yazdani, J Oph Vis Res 2016 • 18 • SKYE BIOSCIENCE
Slide 19: Rhea Williams: Regulatory Strategy Overview
REGULATORY STRATEGY OVERVIEW RHEA WILLIAMS, MPH HEAD OF REGULATORY AFFAIRS & QUALITY ASSURANCE SAN DIEGO, CA
Slide 20: The Drug Development Process
THE DRUG DEVELOPMENT PROCESS Once a disease target is identified, drugs are designed and tested. Both public and privately funded research are involved. The majority of the research at Human trials are completed. FDA this stage is publicly funded at approval. Industry is responsible universities, co
Slide 21: Tom Kim: Intellectual Property & New Invention Opportunities
INTELLECTUAL PROPERTY & NEW INVENTION OPPORTUNITIES TOM KIM, LLB GENERAL COUNSEL & DIRECTOR OF IP SAN DIEGO, CA
Slide 22: Our Existing Patent Portfolio Landscape
OUR EXISTING PATENT PORTFOLIO LANDSCAPE SBI-100: Amino Acid Ester Prodrugs of Delta-9-Tetrahydrocannabinol • 2 US granted: 8,809,261; 9,630,941 • 16 EU countries validated: EP 2,352,497 • Canada, Australia, Hong Kong, and Japan patent grants SBI-200: Biologically Active Cannabidiol Analogs • 1 US gr
Slide 23: Eduardo Muñoz: Cannabinoid Research & Innovation
EDUARDO CANNABINOID RESEARCH & INNOVATION MUÑOZ, MD, PhD SCIENTIFIC ADVISOR CORDOBA, SPAIN
Slide 24: The Endocannabinoid System: Modulating ECS activity at different levels
Cannabinoids and cannabinoid- THE ENDOCANNABINOID SYSTEM derivatives can be specifically designed to modify the ECS to positively impact multiple diseases Modulating ECS activity at different levels holds therapeutic promise for a broad range of diseases. CB1 and CB2 receptors are the most character
Slide 25: Cannabinoid Research & the Endocannabinoid System
CANNABINOID RESEARCH & THE ENDOCANNABINOID SYSTEM CB1R activation with THC, one of the major cannabinoids in the plant, has been associated with important therapeutic benefits in different preclinical models. • 25 • SKYE BIOSCIENCE
Slide 26: Cannabinoid Research
CANNABINOID RESEARCH Systemic activation of CB1R with cannabinoids (THC) may lead No side effects described for GPR55 activation is [1] THC to positive and negative effects CB2R agonists associated with cancer CB2 GPR55 CB1 CB2 (+) (-) (+) (+) Neuroprotection Psychotropic effects Regulation of synap
Slide 27: Areas of Research in the Cannabinoid Field (CB1R)
AREAS OF RESEARCH IN THE CANNABINOID FIELD (CB1R) “Next generation” of CB1R modulators inspired in natural cannabinoids Positive Allosteric Modulators (PAMs) “Benefit of CB1R activation without side effects” Negative Allosteric Modulators (NAMs) “Benefit of CB1R inhibition without side effects” Biol
Slide 28: CBDVHS
CBDVHS However, its oral absorption is very low CBD is a pleiotropic cannabinoid widely and limits its biomedical application in used for different indications most diseases CBD CBDVHS CBDVHS IS LIKE CBD, BUT BETTER… • 28 • SKYE BIOSCIENCE
Slide 29: Cannabinoid Pharmaceutical Innovation Program
CANNABINOID PHARMACEUTICAL INNOVATION PROGRAM v Preclinical development of CBDVHS for unmet medical needs v Identification of novel allosteric modulators of CB1R: - Positive allosteric modulators: pain, inflammatory diseases, neurological diseases… - Negative allosteric modulators: fibrotic diseases
Slide 30: Punit Dhillon: Closing Remarks
CLOSING REMARKS PUNIT DHILLON CEO & CHAIR SAN DIEGO, CA
Slide 31: Progression Toward a New Class of Medicine
PROGRESSION TOWARD A NEW CLASS OF MEDICINE Narrowing focus for Broad applications Ophthalmology Impact identified using prodrugs Formulation of drug based on commercial need Prodrug approach Proof-of-concept, identified as novel delivery, and Clinical-enabling R&D to and effective way to formulation
Slide 32: A Lot Has Changed in 12 Months
A LOT HAS CHANGED IN 12 MONTHS …. Objective Achievements Strengthen new product development - Cannabinoid pharmaceutical innovation program; expanded team and capability budget - Pipeline expansion focused on novel cannabinoid pharmaceuticals addressing unmet needs beyond ophthalmology Enhance organ
Slide 33: Skye Academic Collaborations
SKYE ACADEMIC COLLABORATIONS • 33 • SKYE BIOSCIENCE
Slide 34: Long-Term Vision: Cannabinoid Pharmaceutical Innovation Program
LONG-TERM VISION: CANNABINOID PHARMACEUTICAL INNOVATION PROGRAM • 34 • SKYE BIOSCIENCE
Slide 35: Upcoming Catalysts to Advance Our Growth
UPCOMING CATALYSTS TO ADVANCE OUR GROWTH SBI-100 q Neuroprotection study results from assessment of SBI-100 potential to spare vision loss q Results of GLP toxicology studies assessing safety of topical delivery of SBI-100 and systemic exposure to THC q Pre-IND meeting with the FDA to discuss Phase
Slide 36: Investment Highlights
INVESTMENT HIGHLIGHTS Transformative new class of ocular therapeutics Cannabinoid receptors discovered in the eye demonstrated to impact multiple ocular disease indications. Lead glaucoma program SBI-100 demonstrated proof-of-concept that CB1 receptors can be targeted with synthetic cannabinoids Ani
Slide 37: Thank You
THANK YOU Have questions? Email us at [email protected]
Skye Bioscience — Investor Presentation (October 2021) on 6ix