Skye Bioscience, Inc. · NASDAQ:SKYE
Skye Bioscience — Investor Presentation (February 2023)
34 slides from Skye Bioscience's investor presentation, Feb 13, 2023
Slide 1: Focal Point: Cannabinoids and the Eye
FOCAL POINT Cannabinoids and the Eye OTCQB: SKYE February 2023 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 Innovation in ophthalmology to unlock the potential of novel cannabinoid derivatives Phase 1: dosing started for CB1R agonist program in Dec-22 Phase 2: Received FDA okay to proceed for its Investigational New Drug application; plan to start in USA H1 2023 Transformative new class
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: Targeting Glaucoma: Large Market, Unmet Needs
TARGETING GLAUCOMA: LARGE MARKET, 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 ~60M patients worl
Slide 6: Leading Cause of Blindness: Glaucoma
LEADING CAUSE OF BLINDNESS: GLAUCOMA Causes progressive damage to the optic nerve resulting in irreversible vison loss Open Angle § Chronic, progressive optic neuropathy characterized by acquired Glaucoma atrophy of the optic nerve and loss of retinal ganglion cells and their (OAG) axons; associated
Slide 7: Industry Glaucoma Pipeline Lacks Innovation
INDUSTRY GLAUCOMA PIPELINE LACKS INNOVATION Late-stage assets dominated by legacy mechanisms of action Compounds in Clinical Development1,2 § Prostaglandins Phase 1* 5 2 § Adrenergic § Rho Kinase § Combinations Phase 2 6 4 7 § Other** **Carbonic Anhydrase 2 Inhibitor, Receptor Type Tyrosine 4 1 2 Pr
Slide 8: Abnormal Aqueous Humor Dynamics: Key Role
ABNORMAL AQUEOUS HUMOR DYNAMICS: KEY ROLE Increased intraocular pressure due to reduced aqueous humor outflow is key issue § Aqueous humor (blue), produced from the ciliary body, provides nourishment and maintains shape of the eye § Flows from posterior chamber to anterior chamber, and is filtered a
Slide 9: The Long History of Glaucoma and Cannabinoids
THE LONG HISTORY OF GLAUCOMA AND CANNABINOIDS Since 2020 Skye has rapidly progressed SBI-100 OE into the clinic • Developed proprietary eye drop formulation LEGEND • Manufactured first GMP clinical batches 2022 Inhalation studies • Completed IND-enabling studies Oral studies • Treated 1st patients w
Slide 10: Unlocking Cannabinoid Therapeutic Potential
UNLOCKING CANNABINOID THERAPEUTIC POTENTIAL Rationally designed drugs to prove potential of cannabinoids as therapeutic agents Mechanistic Rationale Shortcomings of Previous Novel Cannabinoids Research • Cannabinoid receptors are • Natural THC is insoluble • Prodrug approach and highly expressed in
Slide 11: Lead Clinical Asset: SBI-100 Ophthalmic Emulsion
LEAD CLINICAL ASSET: SBI-100 OPHTHALMIC EMULSION Novel proprietary cannabinoid-derived eye drop formulation DESIGN FACTOR RATIONALE SBI-100 STRUCTURE Tetrahydrocannabinol (THC) SBI-100 is a prodrug of THC. The active drug is not water soluble and has poor bioavailability. Prodrug design Overcomes we
Slide 12: SBI-100 Demonstrates Superior IOP Lowering
SBI-100 DEMONSTRATES SUPERIOR IOP LOWERING Nonclinical comparison with standard of care drugs shows favorable characteristics 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-
Slide 13: 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 14: 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 15: SBI-100 Has Potential Neuroprotective Benefits
SBI-100 HAS POTENTIAL NEUROPROTECTIVE BENEFITS THC preserves retinal ganglion cells in glaucomatous rat model A. Mechanisms of RGC Death in Glaucoma and THC Neuroprotective Benefits Glaucoma 1Glutamate 2Vasoconstriction 3Inflammation release to optic nerve B. C. THC THC THC RGC Death 1 El-Remessey e
Slide 16: SBI-100 OE: Addresses Multiple Issues with Current Treatment Options
SBI-100 OE: ADDRESSES MULTIPLE ISSUES WITH CURRENT TREATMENT OPTIONS ü 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 17: SBI-100 OE: Phase 1 Safety SAD/MAD Design
SBI-100 OE: PHASE 1 SAFETY SAD/MAD DESIGN IN HEALTHY VOLUNTEERS Dosing for first cohort completed; third cohort planned for March 2023 § Randomized, double-masked, placebo- controlled Part A Part B § Objectives: Evaluate safety, tolerability, SAD MAD Safety Review and effect on intraocular pressure
Slide 18: Proposed Phase 2 Study Design
PROPOSED PHASE 2 STUDY DESIGN First ever cannabinoid eye drop for glaucoma to enter human efficacy study Placebo Ophthalmic Emulsion Vehicle Twice a day for Primary endpoint Population 7 days • Change in IOP from • Male and female age >18 baseline versus placebo • POAG/OHT patients Dose Arm 1 • 21mm
Slide 19: SBI-100 OE – Regulatory and Clinical Development
SBI-100 OE – REGULATORY AND CLINICAL DEVELOPMENT 2022 2023 2024 2025 and beyond PDA EOP-2 Meeting PHASE 1 (AU) Safety/tolerability and PHASE 2a (US) PHASE 2b (US) PHASE 3 (Global) PK of SBI-100 OE in 6-month efficacy and safety • Safety/tolerability • Safety/tolerability of SBI- healthy volunteers o
Slide 20: Novel Class of Targets for Ophthalmology
NOVEL CLASS OF TARGETS FOR OPHTHALMOLOGY Cannabinoid receptor-rich environment of eye creates emerging opportunity for drugs targeting these receptors to affect ocular diseases and specifically glaucoma Endocannabinoid system (ECS) receptors in the eye CB1 Relate to many ocular CB2 pathologies § Int
Slide 21: Proprietary Ocular Disease Screening Platform
PROPRIETARY OCULAR DISEASE SCREENING PLATFORM Cannabinoid Pharmaceutical Innovation Program (CPIP) IN VITRO OCULAR DISCOVERY IN VIVO MODELS SCREENING INDICATIONS Dry eye Ocular pain Uveitis 80+ novel compounds AMD Diabetic retinopathy Uveitis skyebioscience.com • 21
Slide 22: 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 23: Catalysts to Advance Our Innovation & Growth
CATALYSTS TO ADVANCE OUR INNOVATION & GROWTH Ocular applications to unlock potential of novel class of cannabinoid derivatives SBI-100 OE: PHASE 1 SBI-100 OE: PHASE 2 STRATEGIC MILESTONES ü Q1-22: Completion of GLP ü Q4-21: Pre-IND meeting with ü Q4-21: Neuroprotection study to toxicology studies th
Slide 24: Case Study: Value Creation via Clinical Development
CASE STUDY: VALUE CREATION VIA CLINICAL DEVELOPMENT Rocklatan Positive Phase 3 data ~$1.8B valuation Rhopressa IPO Rhopressa Rhopressa Positive Phase ~$246M Phase 3 study Poor Phase 3 3 data valuation initiated data Rocklatan Rhopressa Rhopressa Positive Phase 2b Revised FDA Positive Phase data requ
Slide 25: Senior Management
SENIOR MANAGEMENT Punit Dhillon Kaitlyn Arsenault, CPA Chief Executive Officer & Chair Chief Financial Officer § Co-founded and led OncoSec § Over 14 years of experience in (NASDAQ: ONCS), a cancer accounting, auditing, financial immunotherapy company, through reporting, mergers and acquisitions, ea
Slide 26: 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 27: 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 28: Investment Summary
INVESTMENT SUMMARY Bold innovation in ophthalmology to unlock the potential of proprietary cannabinoid derivatives Enrolling Phase 1 for CB1R agonist program; Received FDA okay for IND to start studies in US, enabling planned Phase 2 Transformative new class of therapeutics may play a role in multip
Slide 29: Capitalization
Capitalization Cash and securities1 Common shares o/s 912.2 M Options, warrants and RSUs 247.2 M OTCQB SKYE Market cap: $33.7 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 30: Thank You
THANK YOU To learn more, please contact: Punit Dhillon Chief Executive Officer & Chair ir@skyebioscience.com +1 (858) 410-0266 skyebioscience.com • 30
Slide 31: Appendix
Appendix skyebioscience.com • 31
Slide 32: Clinical Research Shows Cannabinoids Lower IOP
CLINICAL RESEARCH SHOWS 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 0.044 mg/kg of
Slide 33: Prodrug Strategy to Effectively Deliver THC
PRODRUG STRATEGY TO EFFECTIVELY DELIVER THC Ion-pairing of prodrug allows for enhanced permeability at physiological pH § Hingorani et al aimed to improve the transcorneal permeability of THC through prodrug derivatization and formulation § In vitro corneal permeability of THC and its hemisuccinate
Slide 34: What's Different About Topical Administration
WHAT'S DIFFERENT ABOUT TOPICAL ADMINISTRATION THC is very hydrophobic/lipophilic and insoluble; the ocular surface is aqueous 18 Solubilizing agents (15-18) 15 Detergents (13-15) Hydrophilic 12 o/w Emulsifying agents (8-16) (water soluble) THC THC THCVHS SBI-100 Wetting and spreading 9 agents (7-9)
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