Skye Bioscience, Inc. · NASDAQ:SKYE
Skye Bioscience — Investor Presentation (December 2022)
26 slides from Skye Bioscience's investor presentation, Dec 2, 2022
Slide 1: Focal Point: Cannabinoids and the Eye
FOCAL POINT Cannabinoids and the Eye OTCQB: SKYE December 2022 skyebioscience.com • 1
Slide 2: 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 3: Investment Summary
INVESTMENT SUMMARY Bold innovation in ophthalmology to unlock the potential of proprietary cannabinoid derivatives Phase 1 initiated for CB1R agonist program; dosing starting Dec-22; filed Investigational New Drug application; Phase 2 start in USA H1 2023 Transformative new class of therapeutics may
Slide 4: Strategy for Growth and Value Creation
STRATEGY FOR GROWTH AND VALUE CREATION Advance distinct new class of therapeutics to positively impact health of patients with ocular and other diseases Seeking to affect the endocannabinoid system for therapeutic outcomes via the development of cannabinoid derivatives and small molecule drugs Expan
Slide 5: Glaucoma: Large, with Unmet Needs
GLAUCOMA: LARGE, WITH UNMET NEEDS World’s leading cause of irreversible blindness MARKET PREDOMINATLY LEGACY CLASSES $7B drug OF DRUGS AND GENERIC COMPOUNDS market ROCK Inhibitor Carbonic Anhydrase Inhibitor Alpha Agonist Fixed Combo Beta Blockers Prostaglandin Analogs ~80M patients worldwide 1% 7%
Slide 6: Pathophysiology of Glaucoma
PATHOPHYSIOLOGY OF GLAUCOMA Intraocular pressure (IOP) currently the main addressable risk factor Normally, aqueous Generating progressive humor circulates in vision loss and blindness the eye if not treated but.. When drainage canal is Damaging blood vessels blocked, more aqueous and optic nerve...
Slide 7: New Frontier for Glaucoma
NEW FRONTIER FOR GLAUCOMA CB1 receptors are in tissue responsible for fluid production (ciliary body) and drainage (trabecular meshwork, Schlemm’s canal) Activation of CB1 receptors by an agonist such as THC has been shown to be involved in IOP-lowering activity Multiple human studies dating t
Slide 8: Designing an Effective Therapy
DESIGNING AN EFFECTIVE THERAPY A cannabinoid prodrug allows local delivery into the eye, with increased efficacy and limiting systemic exposure THC is lipophilic and not easily delivered into the eye topically SBI-100 is a prodrug of THC that increases solubility and polarity of THC, allowing it
Slide 9: SBI-100 Has Demonstrated Superior IOP Lowering Compared to Standard of Care
SBI-100 HAS DEMONSTRATED SUPERIOR IOP LOWERING COMPARED TO STANDARD OF CARE 19 18 17 IOP (mmHg) 16 15 SBI-100 timolol 14 latanoprost 13 0 60 120 180 240 300 360 420 480 Time (mins) In multiple preclinical studies, SBI-100 In preclinical studies, SBI-100 demonstrated enhanced demonstrated superior IO
Slide 10: Increased Outflow via Trabecular Meshwork
INCREASED OUTFLOW VIA TRABECULAR MESHWORK The trabecular meshwork (TM) accounts for 90% of aqueous humor outflow (drainage) Restricted outflow through TM and fibrosis in tissue may be key to underlying pathophysiology of glaucoma The TM is avascular and depends on outflow for nutrients and hea
Slide 11: Reduced Markers of Inflammation & Fibrosis
REDUCED MARKERS OF INFLAMMATION & FIBROSIS SBI-100 significantly reduced markers associated with fibrosis and inflammation, which are associated with glaucoma Potentially disease-modifying through extracellular matrix remodeling of the trabecular meshwork Healthy Diseased Multi-factorial mecha
Slide 12: SBI-100 OE: Addresses Multiple Issues with Current Treatment Options
SBI-100 OE: ADDRESSES MULTIPLE ISSUES WITH CURRENT TREATMENT OPTIONS Targets area of disease Most drugs do not target the main site of disease-causing increased IOP -- the trabecular meshwork (TM) SBI-100 OE directly targets the TM and may increase flow through the eye as well as uveoscleral p
Slide 13: SBI-100 OE: Phase 1 Safety SAD/MAD Design in Healthy Volunteers
SBI-100 OE: PHASE 1 SAFETY SAD/MAD DESIGN IN HEALTHY VOLUNTEERS Recruiting for first cohort initiated; dosing expected in December 2022 Randomized, double-masked, placebo-controlled Part A Part B Objectives: Evaluate safety, SAD MAD Safety Review COHORT tolerability, and effect on intraocular CO
Slide 14: SBI-100 OE – Clinical Development Plan
SBI-100 OE – CLINICAL DEVELOPMENT PLAN Preclinical Proof-of- Phase 1 Safety & Phase 2 Clinical Proof-of- Phase 2/3 Efficacy & Concept Tolerability Concept Safety Nonclinical and CMC Nonclinical MOA POC Nonclinical safety and Long-term chronic toxicology Reproductive toxicology Nonclinical
Slide 15: Industry Glaucoma Pipeline Lacks Innovation
INDUSTRY GLAUCOMA PIPELINE LACKS INNOVATION Late-stage assets dominated by legacy MOAs or combinations Compounds in Clinical Development1,2 Prostaglandins Phase 1* 5 2 Adrenergic Rho Kinase Phase 2 6 4 7 Combinations Other** **Carbonic Anhydrase 2 Inhibitor, Receptor Type Tyrosine 4 1 2 Pr
Slide 16: Novel Class of Targets for Ophthalmology
NOVEL CLASS OF TARGETS FOR OPHTHALMOLOGY ECS receptors in the eye CB1 Relate to many ocular CB2 pathologies Intraocular pressure Nociception (pain) Inflammation PPAR-ɣ Neovascularization Wound healing Neuroprotection Fibrosis Endocannabinoid system (ECS) plays GPR55 vital role in con
Slide 17: Proprietary In Vitro Screening Platform for Ocular Diseases
PROPRIETARY IN VITRO SCREENING PLATFORM FOR OCULAR DISEASES Cannabinoid Pharmaceutical Innovation Program (CPIP) DISCOVERY IN VITRO OCULAR IN VIVO MODELS SCREENING INDICATIONS Dry eye Ocular pain Uveitis 80+ novel compounds AMD Diabetic retinopathy Uveitis skyebioscience.com • 17
Slide 18: Expert Drug Development Capability
EXPERT DRUG DEVELOPMENT CAPABILITY Internal/external resources provide knowledge/flexibility to advance controlled substances through the pharmaceutical drug development path Research & Nonclinical Clinical Clin Ops / Discovery Development CMC Research Development Regulatory • Skye • Skye • Skye • C
Slide 19: Catalysts to Advance Our Growth
CATALYSTS TO ADVANCE OUR GROWTH Bold innovation in ocular applications to unlock full potential of novel class of cannabinoid derivatives SBI-100 OE: PHASE 1 SBI-100 OE: PHASE 2 STRATEGIC MILESTONES Q1-22: Completion of GLP Q4-21: Pre-IND meeting with Q4-21: Neuroprotection study to toxicology
Slide 20: Senior Management
SENIOR MANAGEMENT Punit Dhillon Kaitlyn Arsenault, CPA Tu Diep, MSc Chief Executive Officer & Chair Chief Financial Officer Chief Development Officer Co-founded and led OncoSec Over 14 years of experience in Over 15 years' experience in research, (NASDAQ: ONCS), a cancer accounting, auditing,
Slide 21: Board of Directors
BOARD OF DIRECTORS Punit Dhillon Margaret Dalesandro, PhD Praveen Tyle, PhD Chair Director Director Co-founded and led OncoSec Over 25 years of drug Over 37 years of broad (NASDAQ: ONCS), a cancer development experience in pharmaceutical executive immunotherapy company, through pharmaceutical,
Slide 22: Advisors
ADVISORS CLINICAL SCIENTIFIC Robert Ritch, MD Louis Pasquale, MD Eduardo Muñoz, MD, PhD Prof. of Ophthalmology, Mt. Sinai Prof. of Ophthalmology, Mt. Sinai Prof. of Immunology, U. Córdoba Shelley and Steven Einhorn Professor Ophthalmology, Icahn Over 30 years of experience in Distinguished Pro
Slide 23: Investment Summary
INVESTMENT SUMMARY Bold innovation in ophthalmology to unlock the potential of proprietary cannabinoid derivatives Enrolling Phase 1 for CB1R agonist program; filed IND for Phase 2 Transformative new class of therapeutics may play a role in multiple ocular indications Solid clinical and preclinical
Slide 24: Capitalization
Capitalization Cash and securities1 Common shares o/s 912.2 M Options, warrants and RSUs 247.2 M OTCQB SKYE Market cap: $16.9 M2 Common shares f/d 1,165 M Cash $8.6 M Working capital $7.5 M Incremental capital: sale of non-core asset for $9.3M Entered share purchase agreement for non-core operating
Slide 25: Thank You
THANK YOU To learn more, please contact: Punit Dhillon Chief Executive Officer & Chair [email protected] +1 (858) 410-0266 skyebioscience.com • 25
Slide 26: Clinical Studies Have Demonstrated Cannabinoids Lower IOP
CLINICAL STUDIES HAVE DEMONSTRATED CANNABINOIDS LOWER IOP Subjects Administration route Observations 15 male, 18-30 years old Smoking marijuana (12 mg △9 THC) Significant IOP decrease after 80 min, more frequent users showered lower or no IOP drop 10 healthy volunteers, 20-30 years old 0.022 or 0.04
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