Skye Bioscience, Inc. · NASDAQ:SKYE
Skye Bioscience — Investor Presentation (March 2021)
22 slides from Skye Bioscience's investor presentation, March 2021
Slide 1: Unlocking the Pharmaceutical Potential of Cannabinoids
Unlocking the Pharmaceutical Potential of Cannabinoids CORPORATE DECK March 2021 • OTCQB: SKYE
Slide 2: Legal Disclaimer
Legal Disclaimer This presentation contains “forward-looking statements”, All information contained in this presentation is provided as of including statements regarding Skye Bioscience, Inc. and its the date of the presentation and is subject to change without subsidiaries, within the meaning of th
Slide 3: Overview
Overview Biopharmaceutical company developing differentiated, synthetic, NOVEL TECHNOLOGY proprietary cannabinoid derivatives Bioengineered, synthetic cannabinoid derivatives designed to treat diseases with significant to significantly enhance therapeutic benefits unmet medical needs COMMERCIAL OPPO
Slide 4: Glaucoma is the leading cause of irreversible blindness
Glaucoma is the leading cause of irreversible blindness Glaucoma is a disease that leads to the progressive damage of retinal ganglion cells, which make up the optic nerve, and without intervention will gradually lead to irreversible blindness Healthy Vision Early Glaucoma Advanced Glaucoma skyebios
Slide 5: Large & growing patient population
Large & growing patient population 78M 100M Current Glaucoma Patients 2040 Predicted Glaucoma Patients $6.6B current global market and expected to reach $11B by 2027 with a growing aging population (CAGR 6.6%) skyebioscience.com • 5
Slide 6: How does glaucoma cause blindness?
How does glaucoma cause blindness? A common trait of glaucoma involves increased pressure in the eye - intraocular pressure (IOP) HEALTHY GLAUCOMA Production/drainage Drainage canal becomes Increased pressure of aqueous humor blocked, fluid builds up and damages optic nerve cells, (fluid) balanced l
Slide 7: Current therapies leave notable unmet needs
Current therapies leave notable unmet needs IOP Class of Medication Generic Example MOA Potential Side Effects Reduction irritation, redness, blurred vision, dry eyes, • Current drugs aim to lower IOP in order Prostaglandins Latanoprost 30-35% ↑ Outflow light sensitivity, headaches, eyelash changes,
Slide 8: Relevance of THC to glaucoma
Relevance of THC to glaucoma • Cannabinoid receptors throughout the body play an important role in managing many vital body functions • Eye is rich with cannabinoid receptors, specifically in tissues involved in managing fluid production and drainage as well as cells responsible for vision • THC and
Slide 9: Multiple independent studies have demonstrated THC's ability to lower IOP
Multiple independent studies have demonstrated THC’s ability to lower IOP Y. Panahi et al. / Biomedicine & Pharmacotherapy 86 (2017) 620–627 skyebioscience.com • 9
Slide 10: Challenges to THC as an effective treatment of glaucoma
Challenges to THC as an effective treatment of glaucoma Systemic Delivery Local Delivery • Requires relatively high dose to achieve • THC is lipophilic - challenging to deliver therapeutic effect in the eye into and penetrate aqueous tissue, like the eye • Variable pharmacokinetics and pharmacodynam
Slide 11: SKYE's approach unlocks therapeutic value of THC
SKYE’s approach unlocks therapeutic value of THC • Rational drug design and bioengineering • Inside the eye, THCVHS is converted back used to develop a synthetic prodrug of THC, into THC by enzymes that cleave VHS arm of called THCVHS the molecule • Valine-hemi-succinate amide ester (VHS) • THCVHS i
Slide 12: THCVHS lowers IOP better than both market leaders
THCVHS lowers IOP better than both market leaders • In a rabbit model, THCVHS achieves Average IOP vs Time profile of Latanoprost (0.005%) vs superior decline in IOP versus THCVHS-NEC (1.0%) vs Timolol (0.25%) latanoprost and timolol • Superior duration of response • Potential for once-daily dosing
Slide 13: Multi-factorial mechanism of action
Multi-factorial mechanism of action • In an ex vivo model of human trabecular meshwork, the tissues responsible for fluid drainage • THC significantly lowered pressure and increased drainage in both healthy and diseased tissue • THC treatment also significantly reduced markers of fibrosis and inflam
Slide 14: Not all glaucoma patients have elevated IOP
Not all glaucoma patients have elevated IOP • Large proportion of glaucoma patients % of glaucoma patients with normal IOP present with normal IOP, but still suffer progressive damage to optic nerve cells and vision loss • Not clear what causes neurodegeneration of optic nerve in these patients • A
Slide 15: Cannabinoids demonstrate neuroprotection
Cannabinoids demonstrate neuroprotection • Multiple studies in different animal species & models of glaucoma have demonstrated ability of cannabinoids to promote health and survival of optic nerve cells • Optic nerve injury model in rats planned in Q2-21 to validate neuroprotection properties of THC
Slide 16: Phase 1 human clinical trial
Phase 1 human clinical trial OBJECTIVES STUDY DESIGN ELIGIBILTY • Assess safety, tolerability, • 64 subjects, double-blinded, 3:1 • Healthy cohorts: IOP ≥ 12 to ≤ 22 mmHg pharmacokinetics of single and randomization • Elevated IOP cohorts: IOP ≥ 18 to ≤ 26 multiple ascending doses in healthy • 5 SAD
Slide 17: Positioned for value creation
Positioned for value creation First human trial will be fast, low cost, and include assessment of intraocular pressure Head-to-head CBDVHS preclinical study with Phase 1 in Australia development plan Rhopressa & Phase 1 data latanoprost Q1 Q2 Q3 Q4 Q1 2021 2022 IND-enabling GLP repeat-dose toxicity
Slide 18: Capitalization
Capitalization 1 1 2 350.0 M 117.6 M 5.1 M Common Shares Outstanding Options & Warrants Convertible Debt Shares (As Converted Basis) 1 3 472.7 M $31.5 M San Diego, CA Fully Diluted Market Cap Base of Operations 1 Based on 10K filed 21/03/01 2 Based on principal balance and accrued interest outstandi
Slide 19: Management: Focused on delivering near-term data outcomes
Management: Focused on delivering near-term data outcomes Punit Dhillon Richard Janney Tu Diep, MSc Chief Executive Officer Principal Accounting Officer Sr Vice President, Development • 30 years of business experience and • Senior leaderships positions at • Co-founded and led OncoSec Medical, a serv
Slide 20: Board Directors & Advisors Offer Expert Guidance
Board Directors & Advisors Offer Expert Guidance Eminent experts in ophthalmology, research, and development applying their knowledge to Emerald’s mission Board of Director Clinical Advisors Scientific Advisors Punit Dhillon Robert Ritch, MD Giovanni Appendino, PhD Chair Professor of Ophthalmology,
Slide 21: Unique competitive position
Unique competitive position Demonstrated greater IOP lowering than market-leading glaucoma therapeutics Potential neuroprotection capabilities would be a game changer Key preclinical data (IOP/neuroprotection) in Q2-2021 First clinical trial: fast; low-cost; will include assessment of intraocular pr
Slide 22: To learn more please contact
To learn more please contact: Punit Dhillon Karam Takhar Chief Executive Officer VP, Corporate Development & Investor Relations [email protected] [email protected] 1 (949) 336-3437 1 (949) 336-3437