Skye Bioscience, Inc. · NASDAQ:SKYE
Skye Bioscience — Investor Presentation (October 2021)
25 slides from Skye Bioscience's investor presentation, October 2021
Slide 1: Unlocking the Pharmaceutical Potential of Cannabinoids
Unlocking the Pharmaceutical Potential of Cannabinoids Corporate Presentation OTCQB: SKYE
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
§ Transformative new class of therapeutics INVESTMENT HIGHLIGHTS § Endocannabinoid system (ECS) shown to play a significant role in health § ECS-mediated signaling plays a role in multiple ocular indications § Solid clinical and preclinical foundation for glaucoma § Multiple human clinical trials ha
Slide 4: Building a Cannabinoid Platform in Ophthalmology
BUILDING A CANNABINOID PLATFORM IN OPHTHALMOLOGY The endocannabinoid system (ECS) is a complex signaling system which exists in all tissues and plays pivotal role in human health. ECS receptors in the eye CB1 CB2 Ocular Pathologies • Intraocular pressure • Nociception (pain) • Inflammation PPAR-ɣ •
Slide 5: Glaucoma Presents a Significant Unmet Need
GLAUCOMA PRESENTS A SIGNIFICANT UNMET NEED § 80M patients worldwide -> 110M by 2026 MARKET SHARE OF IOP-LOWERING DRUGS BY CLASS § $7B addressable market § 80% represent by generic prostaglandin analogs (latanoprost) or beta blockers (timolol) Rock Inhibitor Carbonic Anhydrase Inhibitor Alpha Agonist
Slide 6: Pathophysiology of Glaucoma
PATHOPHYSIOLOGY OF GLAUCOMA • Disease that leads to the progressive damage of retinal ganglion cells (RGCs) that make up the optic nerve, resulting in irreversible vision loss • Key risk factor in disease progression is elevated intraocular pressure • Current available therapies aim to control IOP •
Slide 7: Scientific Evidence Shows Utility of Cannabinoids for Glaucoma
SCIENTIFIC EVIDENCE SHOWS UTILITY OF CANNABINOIDS FOR GLAUCOMA • ECS receptors, specifically CB1 receptors, are found in the tissues responsible for both fluid production (ciliary body) and drainage (trabecular meshwork, Schlemm’s canal) • THC and the CB1 receptor, specifically, have been shown to b
Slide 8: SBI-100 Advantage – Proprietary Molecule and Formulation
SBI-100 ADVANTAGE – PROPRIETARY MOLECULE AND FORMULATION Skye has developed a prodrug that allows local delivery into the eye, limiting systemic exposure and delivering THC to ocular tissue responsible for regulating IOP • Systemic administration of THC pose PK/PD challenges and other adverse effect
Slide 9: SBI-100 Has 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 netarsudil 19 15 latanoprost 18 SBI-100 SBI-100 + netarsudil timilol 17 netarsudil + 14 latanoprost latanoprost 16 latanoprost + SBI- 100 13 15 0 60 120 180 240 300
Slide 10: Multi-Factorial Mechanism of Action Directly Targets Disease
MULTI-FACTORIAL MECHANISM OF ACTION DIRECTLY TARGETS DISEASE • In a 3D model of human trabecular meshwork (TM) tissues (responsible for fluid drainage), THC significantly lowered pressure and increased drainage in both healthy and disease-simulated tissue • 10 •
Slide 11: Multi-Factorial Mechanism of Action Directly Targets Disease
MULTI-FACTORIAL MECHANISM OF ACTION DIRECTLY TARGETS DISEASE • 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
Slide 12: SBI-100 – Addresses Multiple Issues with Current Treatment Options
SBI-100 – 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 • THC directly targets the TM and increases flow through the eye, as well as uveoscleral pathwa
Slide 13: SBI-100 – Opportunity to Transform the Treatment of Glaucoma
SBI-100 – OPPORTUNITY TO TRANSFORM THE TREATMENT OF GLAUCOMA Phase 3 commercial- enabling Initiate Phase 2 Efficacy Study IND Clearance Impact AUS Ethics Approval Complete Phase 1 - FDA Pre-IND Meeting for Phase 1 - Neuroprotection Study Initiate - GLP Toxicology Phase 1 Studies Q421 Q122 Q222 Q322
Slide 14: Upcoming Catalysts to Advance Our Growth
UPCOMING CATALYSTS TO SBI-100 INVESTMENT HIGHLIGHTS ADVANCE OUR GROWTH q Neuroprotection study to provide early evidence that SBI-100 has potential to spare vision loss q Completion of GLP toxicology studies demonstrating safety of topical delivery of SBI-100 and minimal systemic exposure to THC q P
Slide 15: Cannabinoid Pharmaceutical Innovation Program
CANNABINOID PHARMACEUTICAL INNOVATION PROGRAM Expanding the reach of cannabinoid-based therapies
Slide 16: Unlocking the Potential of Pharmaceutical Cannabinoids
UNLOCKING THE POTENTIAL OF PHARMACEUTICAL CANNABINOIDS Decades of cannabinoid science advancements are merging Skye CPI Program: expanding novel cannabinoid with modern biotechnology techniques, creating an opportunity pharmaceutical research and development to to develop novel, valuable, clinically
Slide 17: Validation of Pharmaceutical Cannabinoid Approach
VALIDATION OF PHARMACEUTICAL CANNABINOID APPROACH GW Pharma Overview – Plant-Based Cannabinoid Therapies • GW demonstrated that cannabinoids are a viable and marketable class of drugs • Company’s lead product, Epidiolex, is first plant-derived cannabinoid approved in the US • Has since generated sal
Slide 18: Management Team
skKze MANAGEMENT TEAM
Slide 19: Senior Management
SENIOR MANAGEMENT Punit Dhillon Kaitlyn Arsenault, CPA Tu Diep, MSc Chief Executive Officer & Chair Chief Financial Officer SVP, Development • Co-founded and led OncoSec (NASDAQ: • Over 14 years of experience in • Over 15 years of experience in research, ONCS), a cancer immunotherapy company, accoun
Slide 20: Board of Directors
BOARD OF DIRECTORS Punit Dhillon James Heppell, LLB Chair Director • Co-founded and led OncoSec (NASDAQ: ONCS), a • Former Founder, CEO, Director of BC Advantage cancer immunotherapy company, through early Life Sciences venture fund. Director of multiple life development and a partnership with Merck
Slide 21: Advisors
vADVISORS CLINICAL SCIENTIFIC Robert Ritch, MD Louis Pasquale, MD Giovanni Appendino, PhD Professor of Ophthalmology, Mt. Sinai Professor of Ophthalmology, Mt. Sinai Professor of Organic Chemistry, U. Piedmont • Shelley and Steven Einhorn • Professor Ophthalmology, Icahn School • Over 40 years of re
Slide 22: 2020-2021 Key Accomplishments
2020-2021 KEY ACCOMPLISHMENTS Objective Achievements Strengthen new product development - Cannabinoid pharmaceutical innovation program; expanded team and capability budget - Pipeline expansion focused on novel cannabinoid pharmaceuticals addressing unmet needs beyond ophthalmology Develop Clear Str
Slide 23: Investment Highlights: Finance Dashboard
\INVESTMENT HIGHLIGHTS 1 1 FINANCE DASHBOARD 475.3M 136.1M Common Shares Outstanding Options & Warrants 2 $30.9M Market Cap 1 1 611.4M $11.0M Fully Diluted Cash Position 1 Based on 10-Q filed 9/28/21 2 Based on 10/21/21 OTCQB closing price $0.065 • 23 •
Slide 24: Investment Highlights: Skye Summary
INVESTMENT HIGHLIGHTS SKYE SUMMARY • Near-term initiation of SBI-100 Phase 1 safety and tolerability study • Key nonclinical studies have established mechanism of q Building organization action and efficacy of SBI-100 in glaucoma q Finalizing nonclinical studies q Initiating Phase 1 • Skye’s near-te
Slide 25: Thank You
THANK YOU To learn more please contact: Karam Takhar VP, Corporate Development & Investor Relations ir@skyebioscience.com 1 (858) 410-0266
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