Skye Bioscience, Inc. · NASDAQ:SKYE
Skye Bioscience — Investor Presentation (July 2022)
32 slides from Skye Bioscience's investor presentation, July 2022
Slide 1: Focal Point: Cannabinoids and the Eye
FOCAL POINT Cannabinoids and the Eye July 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, nc. “Skye Bioscience and/or date of the presentation and is subject to change without notice. the C
Slide 3: Investment Summary
INVESTMENT SUMMARY Bold innovation in ophthalmology to unlock the potential of proprietary cannabinoid derivatives Regulatory approval to start Phase 1 for CB1R agonist program; enrollment starting Q3-22; filing IND for Phase 2 by year-end Transformative new class of therapeutics may play a role in
Slide 4: Transformative Transaction
TRANSFORMATIVE TRANSACTION Acquisition to fund operations into late 2023 and through Phase 2 glaucoma study § Licensed producer under Health Canada’s Summary of proposed transaction Cannabis Act & Cannabis Regulations § Skye to acquire all outstanding shares of § Emerald in Q4-21 announced intent to
Slide 5: Focused on Delivering Value for Shareholders
FOCUSED ON DELIVERING VALUE FOR SHAREHOLDERS Complete asset acquisition and wind down of discontinued operations in an efficient manner Strengthened balance sheet to support investment in growth and value creation Clinical development to be funded through meaningful inflection points Exclusive focus
Slide 6: Glaucoma: Significant Unmet Need
GLAUCOMA: SIGNIFICANT UNMET NEED 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% 1
Slide 7: Pathophysiology of Glaucoma
PATHOPHYSIOLOGY OF GLAUCOMA Intraocular pressure (IOP) is currently the main addressable risk factor Generating progressive Normally, aqueous vision loss and blindness humor circulates in if not treated the eye but.. Damaging blood vessels When drainage canal is and optic nerve... blocked, more aque
Slide 8: Why Cannabinoids for Glaucoma?
WHY CANNABINOIDS FOR GLAUCOMA? § CB1 receptors are in the tissues 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 studie
Slide 9: 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
Slide 10: 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 11: SBI-100 Demonstrated Superior IOP Lowering Compared to Standard of Care
SBI-100 HAS DEMONSTRATED SUPERIOR IOP LOWERING COMPARED TO STANDARD OF CARE 19 25 24 18 23 22 17 IOP (mmHg) IOP (mmHg) 21 16 20 SBI-100 SBI-100 Netarsudil netarsudil 19 15 Latanoprost latanoprost 18 SBI-100 SBI-100 SBI-100 + Netarsudil + netarsudil timolol 17 14 Netarsudil netarsudil + + latanoprost
Slide 12: 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 13: Reduced Markers of Inflammation & Fibrosis
REDUCED MARKERS OF INFLAMMATION & FIBROSIS § THC treatment 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
Slide 14: 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) § THC directly targets the TM and increases flow through the eye as well as uveoscleral pathways §
Slide 15: SBI-100 OE: Phase 1 Safety SAD/MAD Design in Healthy Volunteers
SBI-100 OE: PHASE 1 SAFETY SAD/MAD DESIGN IN HEALTHY VOLUNTEERS § Objectives: Evaluate safety, tolerability, PK of SBI-100 Arm A Arm B OE/THC/metabolite, and effect SAD MAD on intraocular pressure (IOP) in Safety Review COHORT 3 healthy subjects in single and multiple COHORT 3 ascending dose arms Sa
Slide 16: 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 ü Nonclinical MOA POC ü Nonclinical safety and § Long-term chronic toxicology § Reproductive toxicology ü Nonclinical
Slide 17: 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 6 4 7 § Combinations Phase 2 § Other** **Carbonic Anhydrase 2 Inhibitor, Receptor Type Tyrosine 4 1 2 Pr
Slide 18: Unlocking Pharmaceutical Potential of Cannabinoids
UNLOCKING PHARMACEUTICAL POTENTIAL OF CANNABINOIDS Decades of research merging with modern biotechnology techniques Skye’s pharmaceutical approach with synthetic cannabinoid derivatives Increased use of cannabinoids for medicinal purposes Impact First FDA approved plant-derived natural cannabinoid m
Slide 19: Building Cannabinoid Platform for Ophthalmology
BUILDING CANNABINOID PLATFORM 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
Slide 20: Developing In Vitro Screening Platform for Ocular Diseases
DEVELOPING IN VITRO SCREENING PLATFORM FOR OCULAR DISEASES Cannabinoid Pharmaceutical Innovation Program (CPIP) IN VITRO OCULAR DISCOVERY SCREENING IN VIVO MODELS INDICATIONS Dry eye Ocular pain Uveitis AMD DR Uveitis skyebioscience.com • 20
Slide 21: Cannabinoid Pharmaceuticals: A Class of New Therapies
CANNABINOID PHARMACEUTICALS: A CLASS OF NEW THERAPIES FDA approval of a natural cannabinoid New chapter: synthetic novel cannabinoid derivative 1st FDA approval of natural Synthetic Cannabinoid Derivatives cannabinoid product § Patented new chemical entities § Reliable manufacturing $269M in 2019 §
Slide 22: Investment Summary
INVESTMENT SUMMARY Bold innovation in ophthalmology to unlock the potential of proprietary cannabinoid derivatives Regulatory approval to start Phase 1 for CB1R agonist program; enrollment starting Q3-22; filing IND for Phase 2 by year-end SKYE Transformative new class of therapeutics may play a rol
Slide 23: 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 ü Q1-22: Completion of GLP ü Q4-21: Pre-IND meeting with ü Q4-21: Neuroprotection study toxicology st
Slide 24: Management Team
MANAGEMENT TEAM
Slide 25: 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 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 full potential of proprietary cannabinoid derivatives Advancing lead CBR1 agonist program into Phase 1 in Q2-22 and IND in Q4-22 Transformative new class of therapeutics may play a role in multiple ocular indications SKYE Ticker $6.0
Slide 29: Investment Summary
INVESTMENT SUMMARY Bold innovation in ophthalmology to unlock the full potential of proprietary cannabinoid derivatives Approval to advance lead CBR1 agonist program into Phase 1 in Q2-22 and IND in Q4-22 Transformative new class of therapeutics may play a role in multiple ocular indications SKYE Ti
Slide 30: Thank You
THANK YOU To learn more, please contact: Punit Dhillon Chief Executive Officer & Chair [email protected] +1 (858) 410-0266 skyebioscience.com • 30
Slide 31: Competitors in the Cannabinoid Space
COMPETITORS IN THE CANNABINOID SPACE Skye is leading the field and will be in the clinic before competitors § Mechanism of Action: CB1/CB2 § Mechanism of Action: CB1/CB2 receptor agonist receptor agonist § Highlights: Indicated for pain, § Highlights: Targets activation nausea, vomiting, epilepsy, o
Slide 32: Glaucoma: Major Eye Disease with Significant Need
GLAUCOMA: MAJOR EYE DISEASE WITH SIGNIFICANT NEED Irreversible and progressive eye disorder with a continued need for more effective treatment options § “Open angle glaucoma”: chronic, progressive optic neuropathy Description characterized by acquired atrophy of the optic nerve and loss of retinal g