Okyo Pharma Limited · NASDAQ:OKYO
Okyo Pharma — Investor Presentation (May 2022)
22 slides from Okyo Pharma's investor presentation, May 2022
Slide 1: Targeting Dry Eye with OK-101
Targeting Dry Eye with OK-101 Corporate Presentation
Slide 2: Disclaimer
Disclaimer • This presentation has been prepared by OKYO Pharma Limited (the "Company") solely for your information and for use at a presentation for the purpose of providing background information on the Company, its business and the industry in which it operates, and has not been approved by the U
Slide 3: OKYO Pipeline
OKYO Pipeline Major OKYO focus: OK-101 to treat Dry Eye Disease *IND-Enabling Asset Indication Pre-Clinical Phase 1 Phase 2 Phase 3 Studies **Not Anticipated start Dry Eye Required date Q1-2023 Uveitis OK-101 Allergic Conjunctivitis Ocular Pain Discovery OK-201 Program *Anticipated IND Submission da
Slide 4: Investment Highlights
Investment Highlights Topically Delivered Rapid Clinical Capital Efficient OK-101 Drug Candidate Development Program • Novel mechanism of action: anti- • IND planned for Q4 2022 • Able to skip Phase 1 safety trial inflammatory & pain reducing and go directly to Phase 2 safety • First human trial pla
Slide 5: Drug Candidate OK-101 to Treat Dry Eye Disease
Drug Candidate OK-101 to Treat Dry Eye Disease OK-101: A lipid-conjugated chemerin peptide that targets a *GPCR receptor located on ocular immune cells involved in inflammation • Novel mechanism-of-action – In vitro and animal studies indicate OK-101 exhibits both anti-inflammatory and ocular pain r
Slide 6: Chemerin - A Potential Regulator of Inflammation & Pain
Chemerin- A Potential Regulator of Inflammation & Pain OK-101 • Chemerin, endogenous agonist of Stable, Protease Resistant chemerin receptor ChemR23, Chemerin Chemerin Peptide fragment activates immune cells at the Linker inflammation site CHEMR23 Anchored Lipid • Smaller chemerin derived peptides c
Slide 7: Proprietary MAP platform
Proprietary MAP platform Chemerin Peptide fragment CHEMR23 / Novel membrane-anchored peptide CMKLR1 Linker Anchored (MAP) technology* enhances Lipid potency and increases drug residual time on the ocular surface Cell membrane *OKYO has exclusive license for OK-101, a novel membrane-anchored chemerin
Slide 8: Membrane Anchoring Improves Potency, and Durability
Membrane Anchoring Improves Potency, and Durability *In-vitro studies Enhanced Potency Increased Durability Human Chemerin Receptor Human Chemerin Receptor (Wash Resistant) 125 125 (Maxsoluble unwashed=100%) (Maxsoluble unwashed=100%) 100 100 OK-101 OK-101 Luciferase activity Luciferase activity 75
Slide 9: Validation, Dry Eye Mouse Model
Validation, Dry Eye Mouse Model OK-101 had efficacy Stain 1600 equivalent to cyclosporine* 1400 Corneal Permeability 1200 • OK-101 and cyclosporine were 1000 administered topically twice a day 800 • Corneal permeability significantly 600 reduced with OK-101 vs phosphate buffer (vehicle) alone 400 20
Slide 10: OK-101 Normalized Goblet Cells & Reduced Inflammatory CD4 T Cells
OK-101 Normalized Goblet Cells & Reduced Inflammatory CD4 T Cells Increased mucin-secreting goblet cells* Reduced Inflammatory Biomarkers* OK-101: (0.04%) normalized goblet cell density OK-101: (0.04%) reduced count of CD4+ T cells, (OK-101 was administered topically twice a day) which are known bio
Slide 11: OK-101: Potential Modulator of Ocular Pain
OK-101: Potential Modulator of Ocular Pain A significant proportion of dry eye patients OK-1011 reduced corneal pain response suffer from “neuropathic ocular pain” with similar to gabapentin2 (GBP), a commonly moderate to greater pain intensity. used drug for neuropathic pain 70 * Ciliary Nerve 60 L
Slide 12: Dry Eye Disease: Overview
Dry Eye Disease: Overview ~700,000,000 Ocular Surface Damage Worldwide patients Lack of moisture and lubrication resulting in progressive damage to the ocular surface ~20,000,000 US patients Inflammation & Hyperpermeability Inflammation and hyperpermeability leads to chronic symptoms of pain, itchin
Slide 13: Dry Eye Disease (DED) Market Opportunity
Dry Eye Disease (DED) Market Opportunity • Global DED*market approximately $5.22 billion in 2019 and expected to reach $6.54 billion by 2027. • DED causes approximately $3.8 billion annually in healthcare costs and represents a major economic burden to public healthcare, accounting for more than $50
Slide 14: Dry Eye: Standard of Care & Short Comings of Current Treatments
Dry Eye: Standard of Care & Short Comings of Current Treatments 5 FDA approved drugs on market Short Comings of Current Drugs 1 Comments Restasis Delayed response, up to 6 months to improve • Inadequate efficacy symptoms, burning sensation when instilled (0.05% cyclosporine) 70.8% patients do not re
Slide 15: Investment Highlights
Investment Highlights Topically Delivered Rapid Clinical Capital Efficient OK-101 Drug Candidate Development Program • Novel mechanism of action: anti- • IND planned for Q4 2022 • Able to skip Phase 1 safety trial inflammatory & pain reducing and go directly to Phase 2 safety • First human trial pla
Slide 16: Drug Development Timelines
Drug Development Timelines *Average time from drug discovery through clinical development to FDA approval: >10 years Standard development: IND Phase 1 Phase 2a/2b Phase 3 NDA FDA Approval Orals/injectables (volunteers) safety/efficacy 2 registration trials FILING ~ 1 year after NDA Standard developm
Slide 17: February 15, 2022 - OKYO Press Release
FEBRUARY 15, 2022 - OKYO PRESS RELEASE OKYO Pharma announces Successful Completion of a Pre-IND Meeting with the FDA on the Development of OK-101 to Treat Dry Eye Disease OK-101 First-in-Human Trial planned as Phase 2 Trial incorporating Primary Efficacy Endpoints covering Signs and Symptoms of Dry
Slide 18: OK-101 Development Timeline
OK-101 Development Timeline • Skipping Phase 1 • Designing Phase 2 effectively as a Phase 3 registration trial 2022 2023 2024 IND Submission Dry Eye Disease Phase 3 Study #1 N = 300-600 10-12 months Pre-IND studies -- formulation IND Filing Phase 2 Start: -- GLP safety / tox Dry Eye Disease 6-8 mont
Slide 19: Investment Highlights
Investment Highlights Topically Delivered Rapid Clinical Capital Efficient OK-101 Drug Candidate Development Program • Unique mechanism of action: • IND planned for Q4 2022 • Able to skip Phase 1 safety trial anti-inflammatory & pain reducing and go directly to Phase 2 safety activity • First human
Slide 20: Intellectual Property Portfolio
Intellectual Property Portfolio OK-101 Technology: OK-201 Technology: Comp. of Matter: US10,233,219 Comp. of Matter: US 10,899,796 • Issued in US to 2034 with potential patent • Issued in US to 2036 (+70 days of *PTA) term extension up to 2039 with potential patent term extension up to 2042 Dry Eye
Slide 21: Experienced Team With Considerable Drug Development Expertise
Experienced Team With Considerable Drug Development Expertise Management Board Gabriele Cerrone Bernard Denoyer Gary S. Jacob, PhD Chairman, Founder Non-Executive Director Extensive experience founding, financing, Extensive financial management Chief Executive Officer and Director restructuring, and
Slide 22: Dry Eye Disease and Ocular Pain
OKYO Pharma Ltd. OKYO Pharma U.S. Inc. Dry Eye Disease 55 Park Lane London W1K1NA 420 Lexington Avenue, Suite 1402 New York, NY, 10170 USA and Ocular Pain Tel: +44 (0) 207 495 237 Tel: +1 (917) 225- 9646 Nasdaq: OKYO LSE: OKYO info@okyopharma.com 22