Skye Bioscience, Inc. · NASDAQ:SKYE
Skye Bioscience — Investor Presentation (June 2023)
31 slides from Skye Bioscience's investor presentation, Jun 12, 2023
Slide 1: Focal Point: Cannabinoids and the Eye
FOCAL POINT Cannabinoids and the Eye OTCQB: SKYE June 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 Highlights
INVESTMENT HIGHLIGHTS Unlocking the pharmaceutical potential of endocannabinoid system with novel therapeutics; Skye has near-term, meaningful proof-of-concept milestones ECS role in modulating vital functions in the body makes it a promising target for the development of cannabinoid derivatives and
Slide 4: Targeting Glaucoma: Large Market, Unmet Needs
TARGETING GLAUCOMA: LARGE MARKET, UNMET NEEDS World’s leading cause of irreversible blindness $7B drug MARKET PREDOMINANTLY USES LEGACY CLASSES OF DRUGS AND GENERIC market COMPOUNDS ROCK Inhibitor Carbonic Anhydrase Inhibitor Alpha Agonist Fixed Combo Beta Blockers Prostaglandin Analogs ~60M patient
Slide 5: Leading Cause of Blindness: Glaucoma
LEADING CAUSE OF BLINDNESS: GLAUCOMA Causes progressive damage to the optic nerve, resulting in irreversible vision 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; associat
Slide 6: Abnormal Aqueous Humor Dynamics: Key Role
ABNORMAL AQUEOUS HUMOR DYNAMICS: KEY ROLE Increased intraocular pressure due to imbalanced 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. Filtered and d
Slide 7: SBI-100 OE: Addresses Issues of Current Treatments
SBI-100 OE: ADDRESSES ISSUES OF CURRENT TREATMENTS 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 as well as uveoscleral pathways, and may increase flow through the eye § SBI-100
Slide 8: Address Clinical Unmet Needs of Glaucoma
ADDRESS CLINICAL UNMET NEEDS OF GLAUCOMA Key Unmet Needs Patient Adherence: Patient adherence is a significant hurdle clinicians face when ✓ 1 providing effective long-term care; greater adherence with current pharmacologic options would allow clinicians to properly assess treatment efficacy SBI-100
Slide 9: 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 10: History of Glaucoma and Cannabinoids
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 • Dosing last subjects in SBI-10
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 wea
Slide 12: Unlocking Cannabinoid Therapeutic Potential
UNLOCKING CANNABINOID THERAPEUTIC POTENTIAL Rationally designed drugs to prove potential of cannabinoids as therapeutic agents Mechanistic Rationale Shortcomings of Novel Cannabinoids Previous Research • Cannabinoid receptors are • Natural THC is insoluble • Prodrug approach and highly expressed in
Slide 13: 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 14: Increased Outflow via Trabecular Meshwork
INCREASED OUTFLOW VIA TRABECULAR MESHWORK § 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 § TM is avascular and depends on outflow for nutrients and health; res
Slide 15: 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 § Highlights multi-fact
Slide 16: SBI-100 OE Potential Neuroprotective Benefits
SBI-100 OE POTENTIAL NEUROPROTECTIVE BENEFITS Glaucoma: Without Introduction of THC Research has identified 3 key processes that Glutamate release Vasoconstriction Inflammation lead to neurodegeneration and death of retinal ganglion cells (RGC): Neurodegeneration/RGC Death • Destructive glutamate re
Slide 17: KOL and Clinician Feedback
KOL AND CLINICIAN FEEDBACK Eye care providers: high enthusiasm for CB1 agonist and class of drugs • Cannabinoids, including THC, intriguing to physicians and patients • Significant interest from physicians and patients on use of cannabis to treat glaucoma • Skye’s approach gives a defined pharmaceut
Slide 18: SBI-100 OE: Phase 1 SAD/MAD in Healthy Volunteers
SBI-100 OE: PHASE 1 SAD/MAD IN HEALTHY VOLUNTEERS Enrollment and dosing completed; expect preliminary data report in Q3 § Randomized, double-masked, placebo- controlled; evaluating safety, tolerability, and SAD Arm MAD Arm effect on intraocular pressure of topically administered SBI-100 OE or placeb
Slide 19: 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 14 days Primary endpoint Population • Change in IOP from • Male and female age >18 Dose Arm 1 baseline versus placebo • POAG/OHT patients SBI-1
Slide 20: SBI-100 OE – Regulatory and Clinical Development
SBI-100 OE – REGULATORY AND CLINICAL DEVELOPMENT 2022 2023 2024 2025 and Beyond Phase 1 (AUS) PDA EOP-2 Meeting • Safety/tolerability/PK of SBI-100 OE in Phase 2a (US) Phase 2b (US) Phase 3 (Global) healthy volunteers • Safety/tolerability • Safety/tolerability 6-month efficacy and safety of SBI-100
Slide 21: Targets to Expand Ophthalmology Drug Development
TARGETS TO EXPAND OPHTHALMOLOGY DRUG DEVELOPMENT ECS receptors in the eye CB1 CB2 Relate to many ocular pathologies § Intraocular pressure § Nociception (pain) PPAR-ɣ § Inflammation § Neovascularization § Wound healing § Neuroprotection GPR55 § Fibrosis § ECS plays vital role in controlling an array
Slide 22: R&D Platform for Ocular Diseases
R&D PLATFORM FOR OCULAR DISEASES Cannabinoid Pharmaceutical Innovation Program (CPIP) IN VITRO TARGET ENGAGEMENT OCULAR DISCOVERY SCREENING IN VIVO MODELS INDICATIONS Dry eye Ocular pain Uveitis 80+ novel compounds AMD Diabetic retinopathy Uveitis skyebioscience.com • 22
Slide 23: 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 24: Management
MANAGEMENT Punit Dhillon Kaitlyn Arsenault, CPA Chris Twitty, PhD Tu Diep, MSc Chief Executive Officer & Chief Financial Officer Chief Scientific Officer Chief Development Officer Chair 14+ years of experience in 25+ years in R&D, drug pipeline 15+ years' experience in Co-founded and led OncoSec acc
Slide 25: Board of Directors
BOARD OF DIRECTORS Punit Dhillon Keith Ward, PhD Praveen Tyle, PhD Deborah Charych, PhD Margaret Dalesandro, PhD Chair Over 25 years of experience Over 37 years of broad Over 20 years' scientific Over 25 years of drug in the biotech and pharmaceutical executive leadership and pre-clinical developmen
Slide 26: Advisors
ADVISORS CLINICAL Robert Ritch, MD Louis Pasquale, MD Jeffery Goldberg, MD, PhD Prof. of Ophthalmology, Mt. Sinai Prof. of Ophthalmology, Mt. Sinai Prof. of Ophthalmology, Stanford Shelley and Steven Einhorn Professor Ophthalmology, Icahn Professor and Chair of Ophthalmology Distinguished Professor
Slide 27: Capitalization
CAPITALIZATION Cash and securities1 Common shares o/s 972.5 M1 OTCQB SKYE Options, warrants and RSUs 223.7 M1 Market cap: $15M2 Common shares f/d 1,196 M1 Cash $2.7 M1 Incremental capital: sale of non-core operating facility Closed sale of Verdélite to C3 Souvenir Holding for aggregate purchase pric
Slide 28: Strategic Focus on Growth and Value Creation
STRATEGIC FOCUS ON GROWTH AND VALUE CREATION Advance distinct new classes of proprietary therapeutics to positively impact health of patients with ocular and other diseases by uniquely affecting the endocannabinoid system Expand ophthalmology-focused pipeline with new target indications/products in
Slide 29: Milestones Achieved and Ahead
MILESTONES ACHIEVED AND AHEAD 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 the FDA assess SB
Slide 30: Case Study: Value Creation via Clinical Development
CASE STUDY: VALUE CREATION VIA CLINICAL DEVELOPMENT Ocular applications to unlock potential of novel class of cannabinoid derivatives Rocklatan Positive Phase 3 data ~$1.8B valuation Rhopressa Rhopressa Phase 3 Rhopressa Positive IPO study Poor Phase 3 Phase 3 data ~$246M initiated data valuation Rh
Slide 31: Thank You
THANK YOU To learn more, please contact: Punit Dhillon Chief Executive Officer & Chair [email protected] +1 (858) 410-0266 skyebioscience.com • 31