Skye Bioscience, Inc. · NASDAQ:SKYE
Skye Bioscience — Investor Presentation (September 2023)
36 slides from Skye Bioscience's investor presentation, Sep 11, 2023
Slide 1: Unlocking the pharmaceutical potential of the endocannabinoid system
Unlocking the pharmaceutical potential of the endocannabinoid system August 2023
Slide 2: Forward Looking Statements
FORWARD LOOKING STATEMENTS This presentation contains “forward-looking statements”, including Skye Bioscience cannot give any assurance that such forward-looking statements regarding Skye Bioscience, Inc. (“Skye Bioscience and/or the statements will prove to be correct. The reader is cautioned not t
Slide 3: Skye is researching the endocannabinoid system and building a product pipeline
Skye is researching the endocannabinoid system and strategically establishing a product pipeline based on first-in-class and only-in-class therapies with potential to positively affect diseases with significant prevalence and unmet needs skyebioscience.com • 3
Slide 4: Compelling Value Proposition
COMPELLING VALUE PROPOSITION The right space, technology, team and investors Endocannabinoid system and particularly CB1 modulation have seen notable industry steps with STRATEGIC FOCUS well-positioned product development, strategic pharma acquisitions, and notable specialist healthcare investor sup
Slide 5: Endocannabinoid System: An Emerging Frontier
ENDOCANNABINOID SYSTEM: AN EMERGING FRONTIER • Endocannabinoid system (“ECS”) receptors throughout the body modulate and help maintain homeostasis of physiological functions. Over- or underactivation of these receptors is involved in an array of diseases • ECS has many receptors that are viable ther
Slide 6: CB1: High-Potential Target for Physiological Regulation
CB1: HIGH-POTENTIAL TARGET FOR PHYSIOLOGICAL REGULATION CB1 involved in many disease processes Inflammatory • Skye is researching multiple ECS targets but is initially focused on cannabinoid receptor 1 (“CB1”) • CB1 is a viable target as its modulation via agonism (activation) or inhibition can alte
Slide 7: Advancing Distinct CB1-Targeting Therapeutics
ADVANCING DISTINCT CB1-TARGETING THERAPEUTICS Skye has two clinical-stage programs with multiple clinical inflection points NIMACIMAB SBI-100 OE MOA Disease R&D Phase 1 Phase 2 MOA Disease R&D Phase 1 Phase 2 CB1 Chronic CB1 Receptor Kidney Receptor Glaucoma Inhibitor Disease Agonist Sub-cutaneous T
Slide 8: Exploiting Proven Targets with Improved Drug Design
EXPLOITING PROVEN TARGETS WITH IMPROVED DRUG DESIGN CB1 is a validated target for glaucoma and other inflammatory/fibrotic/metabolic diseases Dynamics Nimacimab SBI-100 OE Reduce inflammatory, fibrotic and/or Reduce intraocular pressure in the eye. Basic Goal metabolic processes that cause other Pot
Slide 9: Anticipated Clinical Milestones
ANTICIPATED CLINICAL MILESTONES Working toward four data catalysts in two key programs through end of 2024 2023 2024 SBI-100 OE Phase 1 (AUS) Phase 2a (US) Glaucoma P1 P2a P2a Final Interim Final Data Data Data NIMACIMAB Phase 2a Chronic Kidney Disease Basket Study P2a Interim Data skyebioscience.co
Slide 10: Nimacimab: Broad Potential. Initial Focus on Chronic Kidney Disease
Nimacimab Broad Potential. Initial Focus on Chronic Kidney Disease skyebioscience.com • 10
Slide 11: CB1 Overactivation: Role in Critical Diseases
CB1 OVERACTIVATION: ROLE IN CRITICAL DISEASES Upregulation of CB1 signaling involved in multiple inflammatory, fibrotic and metabolic diseases in various organs; significant prevalence and unmet needs CB1 Receptor Physiological activity Related disease area Adipose Tissue Kidneys Liver & Pancreas Lu
Slide 12: Need for Effective and Safe Inhibition of CB1 Signaling
NEED FOR EFFECTIVE AND SAFE INHIBITION OF CB1 SIGNALING • Early-generation CB1 inhibitors showed efficacy in models of obesity, pulmonary fibrotic diseases, fibrotic liver disease, and kidney disease • But their therapeutic window was very limited, and central nervous system safety concerns were obs
Slide 13: Nimacimab: First- & Only-in-Class CB1 Inhibitor
NIMACIMAB: FIRST- & ONLY-IN-CLASS CB1 INHIBITOR Unique mechanism of action to inhibit CB1 signaling; Phase 2-ready • Humanized monoclonal antibody • Negative allosteric modulator • Inhibits ligand-mediated and intrinsic CB1 signaling • Highly selective for CB1, with no detectable binding of CB2 or o
Slide 14: Chronic Kidney Disease: Attractive Path for Nimacimab
CHRONIC KIDNEY DISEASE: ATTRACTIVE PATH FOR NIMACIMAB Appealing development considerations CKD disease progress • Chronic kidney disease involves a combination of • All potential disease targets involving CB1 inflammatory, fibrotic, and metabolic processes. overactivation have significant unmet need
Slide 15: Compelling Evidence: CB1 Inhibition/Nimacimab & CKD
COMPELLING EVIDENCE: CB1 INHIBITION/NIMACIMAB & CKD Preclinical and clinical data demonstrate CB1 affects metabolic, inflammatory and fibrotic pathways important in the development of chronic kidney disease and indicate nimacimab as a potential treatment Parameters CB1 Expression in human disease In
Slide 16: Targeting CKD: Huge Prevalence & Unmet Needs
TARGETING CKD: HUGE PREVALENCE & UNMET NEEDS $13B drug market2 “Chronic kidney disease has emerged as one of the most prominent causes of death and ~844M suffering in the 21st century1.” affected worldwide (2017)1 Predicted: ~37M 5th highest affected in cause of U.S.3 years of life lost 20401 1 Epid
Slide 17: Competitive Landscape Validating CB1 MOA
COMPETITIVE LANDSCAPE VALIDATING CB1 MOA Nimacimab sets itself apart from other CB1 peripherally-targeted agents GFB-024 INV-202 NIMACIMAB Molecule Type Antibody Small Molecule Antibody Allosteric Modulator Inverse Agonist Favorable Safety Phase 1 data No CNS Accumulation Preclinical data N/A Immuno
Slide 18: Glaucoma Program: SBI-100 Ophthalmic Emulsion
SBI-100 Ophthalmic Emulsion Glaucoma Program skyebioscience.com • 18
Slide 19: Increased Intraocular Pressure: Key Role in Glaucoma
INCREASED INTRAOCULAR PRESSURE: KEY ROLE IN GLAUCOMA Imbalanced aqueous humor inflow/outflow is key issue § Aqueous humor (blue) provides nourishment and maintains shape of the eye. In healthy eye, production and drainage are balanced to maintain optimal intraocular pressure (IOP) § Aqueous humor dr
Slide 20: Targeting Glaucoma: Large Market, Unmet Needs
TARGETING GLAUCOMA: LARGE MARKET, UNMET NEEDS World’s leading cause of irreversible blindness Market predominantly uses legacy $7B drug classes of drugs and generic market compounds – lack of innovation! ROCK Inhibitor Carbonic Anhydrase Inhibitor Alpha Agonist Fixed Combo Beta Blockers Prostaglandi
Slide 21: Current Treatment Paradigm
CURRENT TREATMENT PARADIGM Once ocular hypertension progresses to the point of requiring Treatment Paradigm treatment, PGA IOP-lowering monotherapy becomes the dominant 1L treatment option • First-line treatment can either be a PGA monotherapy Selective Laser Prostaglandin regimen or SLT; use of SLT
Slide 22: Clinical Unmet Needs in Glaucoma
CLINICAL UNMET NEEDS IN GLAUCOMA Physician input regarding key concerns and desires regarding glaucoma drugs Key Unmet Needs Patient Adherence: Patient adherence is a significant hurdle KOLs face when providing effective long-term care; greater adherence with current pharmacologic options would 1 al
Slide 23: Potential of CB1 Agonism as New Class of Glaucoma Drug
POTENTIAL OF CB1 AGONISM AS NEW CLASS OF GLAUCOMA DRUG CB1 agonists proven to reduce IOP; Skye’s SBI-100 OE first to offer new approach Ability of CB1 agonist to lower intraocular pressure well- SBI-100 Ophthalmic Emulsion (“OE”): established by animal studies and human clinical trials. • CB1 agonis
Slide 24: SBI-100 OE Demonstrates Superior IOP Lowering
SBI-100 OE 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, S
Slide 25: Supported by Other Indicators of Utility
SUPPORTED BY OTHER INDICATORS OF UTILITY Increased outflow via trabecular meshwork Reduced markers of inflammation & fibrosis • Restricted outflow through trabecular meshwork and • SBI-100 significantly reduce markers associated fibrosis in tissue may be key to underlying pathophysiology with fibros
Slide 26: Potential Neuroprotective Benefits
POTENTIAL NEUROPROTECTIVE BENEFITS Glaucoma: Without Introduction of THC Research has identified key processes that lead to neurodegeneration and death of retinal ganglion cells Glutamate release Vasoconstriction Inflammation (RGC): • Destructive glutamate release1 Neurodegeneration/RGC Death • vaso
Slide 27: Phase 1 SAD/MAD Enrolled; No Serious Adverse Events
PHASE 1 SAD/MAD ENROLLED; NO SERIOUS ADVERSE EVENTS Dosing completed June 2023 § 14-day animal toxicology studies with up to 2% concentration administered daily topically SAD Arm MAD Arm in two different species COHORT § Open IND for glaucoma with FDA 3 COHORT § Randomized, double-masked, placebo- 3
Slide 28: SBI-100 OE Phase 2a Glaucoma Proof-of-Concept Study
SBI-100 OE PHASE 2A GLAUCOMA PROOF-OF-CONCEPT STUDY 54 patients with primary open-angle glaucoma or ocular hypertension; start dosing Q4 Key Inclusion Criteria Primary Endpoint Secondary Endpoint • 21mmHg ≥ IOP < 34mmHg • Change in diurnal IOP vs placebo • Safety and tolerability • No prior surgical
Slide 29: SBI-100 OE: Potential to Fulfill Clinical Unmet Needs
SBI-100 OE: POTENTIAL TO FULFILL CLINICAL UNMET NEEDS Key Unmet Needs in Glaucoma Following initial approval of topical drug format, Skye would explore Patient Adherence: Patient adherence is a significant hurdle KOLs face when providing innovative delivery technologies to improve patient adherence
Slide 30: Physician Feedback About SBI-100 OE
PHYSICIAN FEEDBACK ABOUT SBI-100 OE A new drug with novel mechanism of action would be well accepted by physicians About SBI-100 “I have conducted extensive research about [SBI-100’s] About SBI- “Patients that are intolerant to PGA “A lot of patients are going to be therapy are subjected to less ext
Slide 31: 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 array of
Slide 32: Leadership, Financial Position & Next Steps
Leadership, Financial Position & Next Steps skyebioscience.com • 32
Slide 33: Leadership: Executive Management and Board of Directors
LEADERSHIP Contributed to commercialization of 47+ drugs/diagnostics, led high-value strategic transactions and co-founded multiple companies Executive Management Board of Directors Punit Dhillon Tu Diep, MSc Andy Schwab Deborah Charych, PhD Keith Ward, PhD CEO & Chair of BOD Chief Development Offic
Slide 34: Capitalization
CAPITALIZATION Cap Table (proforma unaudited1) Common shares o/s 12.3 M Options and RSUs 0.5 M OTCQB SKYED* * till approximately Oct 5, Warrants 3.3 M then it will revert to SKYE Convertible note (as-converted basis) 1.0 M Common shares f/d 17.1 M Float2 3.2 M Net New Capital Raised* $8.4M *Excludes
Slide 35: Skye Next Steps
SKYE NEXT STEPS Achieve SBI-100 OE/glaucoma proof-of-concept milestone; advance nimacimab into clinic with longer-term view toward franchise expansion • SBI-100 OE Phase 1 glaucoma clinical data Q3 2023 • SBI-100 OE Phase 2a glaucoma clinical trial first dosing Q4 2023 • Nimacimab Phase 2a chronic k
Slide 36: Thank You
THANK YOU To learn more, please contact: Punit Dhillon Chief Executive Officer & Chair ir@skyebioscience.com +1 (858) 410-0266 skyebioscience.com • 36
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