Skye Bioscience, Inc. · NASDAQ:SKYE
Skye Bioscience — Investor Presentation (October 2023)
33 slides from Skye Bioscience's investor presentation, October 2023
Slide 1: Unlocking the potential of the endocannabinoid system
Unlocking the potential of the endocannabinoid system OCTOBER 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: Our Mission
OUR MISSION Developing next generation ― first-in-class and only- in-class CB1 receptor modulating technologies to treat diseases with significant prevalence and unmet needs skyebioscience.com • 3
Slide 4: A Convergence of the Right Space, Technology and Team
A CONVERGENCE OF THE RIGHT SPACE, TECHNOLOGY AND TEAM • Two clinical stage Phase 2 first- and only-in class pharmaceuticals in development, targeting the endocannabinoid system, a renewed area of interest through next ENDOCANNABINOIDS generation engineering. • Lead-asset acquired through transformat
Slide 5: Key Milestones Position Skye for Near Term Value Generation
KEY MILESTONES POSITION SKYE FOR NEAR TERM VALUE GENERATION Multiple data catalysts across two key programs through end of 2024 2023 2024 Activity Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 NIMACIMAB Nimacimab Ph. 2 ready asset Phase 2 Cardio-Metabolic Indication acquired through Bird Rock Bio Ph. 2 acquisition interi
Slide 6: Strong Execution Track Record and Clear Clinical Roadmap
STRONG EXECUTION TRACK RECORD AND CLEAR CLINICAL ROADMAP Execution and First-in-human 5AM Ventures advisory team Cannabinoid Pharmaceutical clinical trial of lead Versant Ventures Anticipated initiation buildout and Innovation Program (CPIP) asset SBI-100 OE investment of nimacimab rebranding R&D pr
Slide 7: Leadership
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 8: Endocannabinoids: A Renewed Drug Development Frontier
ENDOCANNABINOIDS: A RENEWED DRUG DEVELOPMENT FRONTIER ECS (Endocannabinoid system) receptors help modulate and maintain homeostasis of physiological functions Over- or under-activation of these receptors is involved in an array of diseases Notable ECS Transactions Company Acquirer Deal Value Lead As
Slide 9: CB1: High-Potential Target for Physiological Regulation
CB1: HIGH-POTENTIAL TARGET FOR PHYSIOLOGICAL REGULATION CB1 involved in many disease processes Inflammatory • CB1 (cannabinoid receptor 1) a renewed target of interest for drug discovery. • CB1 is an agonist/inhibitor of neuronal transmissions which can therapeutically alter: • Inflammatory, metabol
Slide 10: 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 11: Nimacimab
Nimacimab Broad Metabolic Potential With Clinically Validated Mechanism of Action skyebioscience.com • 11
Slide 12: The Promise of CB1 Inhibition – Clinically Validated MOA
THE PROMISE OF CB1 INHIBITION – CLINICALLY VALIDATED MOA Rimonabant RIO-Lipids Phase 3 study Placebo (n=342); 5 mg rimonabant (n=345); 20 mg rimonabant (n=346) • Rimonabant (Accomplia) developed by Sanofi and approved for weight loss in 2006 in EU • Demonstrated up to 10% weight loss over 1 year • I
Slide 13: 2nd Generation CB1 Inhibitors "Peripherally Restricted"
2ND GENERATION CB1 INHIBITORS “PERIPHERALLY RESTRICTED” • Since the demise of rimonabant, multiple groups have tried to develop new CB-1 inhibitors that are peripherally restricted • Most are small molecules and also inverse agonists similar to rimonabant • However, even current lead 2nd generation
Slide 14: Nimacimab: Truly Restricted from the CNS
NIMACIMAB: TRULY RESTRICTED FROM THE CNS Skye’s P1C4 (NHP data) 124I-labeled nimacimab 3000 Tissue Level (nCi/mL) 2000 1000 B/P B/P 50 0.8% 0.5% 25 0 Plasma Brain CNS NHP Tissue • 124I-labeled nimacimab single IV dose • Little to no nimacimab found in the brain • High levels of nimacimab found in th
Slide 15: Nimacimab: Next Generation CB1 Inhibitor
NIMACIMAB: NEXT GENERATION CB1 INHIBITOR Nimacimab is effective at inhibiting CB1 signaling; similar antagonist activity to rimonabant • Cisbio’s competitive cAMP assay was used to quantify nimacimab’s antagonist activity • RYI-018 (nimacimab) compares favorably to neutral agonists (AM6545) and equi
Slide 16: Nimacimab: Significantly Improved Safety Profile
NIMACIMAB: SIGNIFICANTLY IMPROVED SAFETY PROFILE Preclinical and Phase 1 study outcomes ― no CNS accumulation, no impact on cognitive function, no signs of anxiety or depression • 3-week and 26-week toxicology studies completed: • Up to 75 mg/kg administered bi-weekly subcutaneously in cynomolgus mo
Slide 17: Competitive Landscape – 2nd Gen CB1 Inhibitors
COMPETITIVE LANDSCAPE – 2nd GEN CB1 INHIBITORS Nimacimab sets itself apart from other CB1 peripherally-targeted agents GOLDFINCH CORBUS INVERSAGO SKYE GFB-024 CRB-913 INV-202 NIMACIMAB Molecule Type Antibody Small Molecule Small Molecule Antibody Allosteric Modulator Inverse Agonist Favorable Safety
Slide 18: Nimacimab: New Novel CB1-Targeting mAb Therapeutic
NIMACIMAB: NEW NOVEL CB1-TARGETING mAb THERAPEUTIC MOA Disease R&D Phase 1 Phase 2 CB1 Cardio- NIMACIMAB Receptor Inhibitor Metabolic Indication Sub-cutaneous • Phase 2 ready molecule with three open INDs. Best–in-class and • Only CB1 negative allosteric modulating humanized monoclonal antibody (mAB
Slide 19: SBI-100 Ophthalmic Emulsion Glaucoma Program
SBI-100 Ophthalmic Emulsion Glaucoma Program skyebioscience.com • 19
Slide 20: SBI-100 OE: Improving CB1-Targeting Drug Design for Glaucoma
SBI-100 OE: IMPROVING CB1-TARGETING DRUG DESIGN FOR GLAUCOMA MOA Disease R&D Phase 1 Phase 2 SBI-100 OE CB1 Receptor Glaucoma Agonist Topical Best–in-class and Only-in-class First/only prodrug of THC developed and currently in the clinic for glaucoma. Molecules Clear Clinical Lowering intraocular pr
Slide 21: Targeting Glaucoma: Large Market, Unmet Needs
TARGETING GLAUCOMA: LARGE MARKET, UNMET NEEDS World’s leading cause of irreversible blindness Market lacks innovation ― predominantly using legacy classes of drugs and generic compounds. $7B drug market ROCK Inhibitor Carbonic Anhydrase Inhibitor Alpha Agonist Fixed Combo Beta Blockers Prostaglandin
Slide 22: Current Treatment Paradigm
CURRENT TREATMENT PARADIGM Once ocular hypertension progresses to the point of requiring treatment, PGA IOP-lowering monotherapy Treatment Paradigm becomes the dominant 1L treatment option • First-line treatment can either be a PGA Selective Laser Prostaglandin monotherapy regimen or SLT; use of SLT
Slide 23: SBI-100 OE: Potential to Fulfill Clinical Unmet Needs
SBI-100 OE: POTENTIAL TO FULFILL CLINICAL UNMET NEEDS Key Unmet Needs in Glaucoma Patient Adherence: Patient adherence is a significant hurdle KOLs face Following initial approval of ✓ when providing effective long-term care; greater adherence with current pharmacologic options would allow KOLs to p
Slide 24: 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 agonist
Slide 25: 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 25 24 18 23 22 17 IOP (mmHg) IOP (mmHg) 21 16 20 SBI-100 Netarsudil 19 15 Latanoprost 18 SBI-100 SBI-100 + Netarsudil timolol 17 14 Netarsudil + Latanoprost latanoprost
Slide 26: 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 27: Potential Neuroprotective Benefits
POTENTIAL NEUROPROTECTIVE BENEFITS Glaucoma: Without Introduction of THC Research has identified key processes that lead to Glutamate release Vasoconstriction Inflammation neurodegeneration and death of retinal ganglion cells (RGC): Neurodegeneration/RGC Death • Destructive glutamate release1 • vaso
Slide 28: 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 § Open IND for glaucoma with FDA COHORT COHORT 3 § Randomized, double-masked, placebo- 3
Slide 29: 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 30: Capitalization
CAPITALIZATION Cap Table (proforma unaudited1) Top Holders 5 AM Ventures 37% Common shares o/s 12.3 M Versant Ventures 16% Options and RSUs 0.5 M GSK 6% Warrants 3.3 M Apposite Healthcare Fund LP 6% Convertible note (as-converted basis) 1.0 M Other Inst./Corp. 9% Total Life Science VC 66% Common sha
Slide 31: Skye Next Steps
SKYE NEXT STEPS • Advance nimacimab clinical trials with longer-term view toward franchise expansion • Achieve SBI-100 OE/glaucoma proof-of-concept milestone • Maintain focused operational and clinical development strategy • Selectively evaluate business development opportunities to advance product
Slide 32: Investment Highlights
INVESTMENT HIGHLIGHTS • Two clinical stage Phase 2 first- and only-in class pharmaceuticals in development, targeting the endocannabinoid system, a renewed area of interest through next ENDOCANNABINOIDS generation engineering. • Lead-asset acquired through transformational Bird Rock Bio acquisition,
Slide 33: Thank You
THANK YOU To learn more, please contact: Punit Dhillon Chief Executive Officer & Chair [email protected] +1 (858) 410-0266 skyebioscience.com • 33
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