OKYO Pharma Limited · NASDAQ:OKYO
OKYO Pharma — Investor Presentation (January 2023)
25 slides from OKYO Pharma's investor presentation, January 2023
Slide 1: Overcoming Limitations of Current Dry Eye Therapies: OK-101 Corporate Presentation
Targeting Overcoming Dry of Limitations Eye Disease Current with Dry Eye Therapies OK-101 Corporate Presentation January 2023 Nasdaq: OKYO LSE: OKYO
Slide 2: Disclaimer
Disclaimer This institutional presentation document has been prepared by OKYO Pharma Limited ("OKYO") for information purposes only in relation to the proposed placing of American Depositary Shares (ADSs) representing ordinary shares of no par value each in the capital of OKYO (the "Offering"). For
Slide 3: OK-101: New Chemical Entity Targeting Inflammation and Ocular Pain in Dry Eye Disease
OK-101 New Chemical Entity Targeting both Inflammation and Ocular Pain in Dry Eye Disease
Slide 4: Pipeline Focus: OK-101 to Treat Dry Eye Disease
Pipeline Focus: OK-101 to Treat Dry Eye Disease *IND Cleared in Indication Pre-clinical Phase 1 Phase 2 Phase 3 Dec 2022 Planned for Dry Eye **Skip over Q1 2023 Uveitis OK-101 Allergic Conjunctivitis Ocular Pain *IND Submitted to FDA on November 18, 2022 **Pre-IND Meeting confirmed FDA concurs with
Slide 5: Dry Eye Disease: Overview
Dry Eye Disease: Overview Ocular Surface Damage Inadequate or unstable tears resulting in lack of moisture and progressive damage to the ocular surface Inflammation & Pain: Key Symptoms of Dry Eye Tear film instability triggers chronic inflammation which leads to symptoms of pain, itchiness, burning
Slide 6: Limits of Current Standard of Care
Limits of Current Standard of Care 5 FDA Approved Drugs on Market With Inadequate Efficacy, Slow Onset of Action, and Numerous Side Effects API 1Limitations Delayed response, up to 6 months to improve symptoms, burning sensation Restasis 0.05% when instilled Allergan cyclosporine 2 70% patients do n
Slide 7: Global DED Market Expected to Reach ~$6.5 Billion by 2027
Global DED* Market Expected to Reach ~$6.5 Billion by 2027 $3.8 Billion Annual Healthcare Costs* ~$50 Billion Annual Healthcare Costs † Current Treatment Options Inadequate More Effective Treatment May Increase Market Size *Market Research Report, Dry Eye Syndrome Market, FBI102413, Dec. 2020 7 †Yu
Slide 8: OK-101: A Lipid-Conjugated Chemerin Peptide
OK-101: A Lipid-Conjugated Chemerin Peptide First-in-class drug candidate with anti- inflammatory and ocular pain reducing property Lipid conjugated peptide chemistry minimizes drug washout and enhances the potency Preservative free, EDTA free Simple, stable formulation OKYO has exclusive license fo
Slide 9: Development of OK-101 Using Proprietary MAP Technology
Development of OK-101 Using Proprietary MAP* Technology Serial Add Stabilization Truncation Synthetic Anchor Full Length 9 aa C-terminal Amino Acid OK-101 Active protein Peptide Protease Alterations Sensitive Protease Resistant Lower potency 149 157 157 21 9 * Membrane Anchored Peptide
Slide 10: Chemerin Derived Peptide: A Potential Regulator of Inflammation & Pain
Chemerin Derived Peptide: A Potential Regulator of Inflammation & Pain 1 OK-101 Stable, Protease Resistant 1. Pro-inflammatory chemerin Chemerin Peptide Fragment activates immune cells at the Chemerin 3 Linker inflammation site CHEMR23 Anchored 2 Lipid 2. Peptides derived from chemerin 4 physiologic
Slide 11: OK-101: Targeting Chemerin Receptor
OK-101: Targeting Chemerin Receptor Chemerin Peptide Chemerin Receptor Linker Anchored Lipid Immune Cells Anti-inflammatory Response 11
Slide 12: Membrane Anchoring Improves Potency, Durability
Membrane Anchoring Improves Potency, Durability *In-vitro studies Enhanced Potency Increased Durability Human Chemerin Receptor Human Chemerin Receptor (Wash Resistant) 125 125 (Maxsoluble unwashed =100%) 100 (Maxsoluble unwashed =100%) Luciferase activity 100 75 Luciferase activity OK-101 Anchored
Slide 13: Validation: OK-101 Efficacy in Dry Eye Mouse Model
Validation: OK-101 Efficacy in Dry Eye Mouse Model 1600 1400 OK-101 and cyclosporine were 1200 administered topically twice a day Corneal Permeability 1000 Corneal permeability significantly reduced with OK-101 vs phosphate 800 buffer alone 600 Potency of OK-101 was 400 comparable to cyclosporine, a
Slide 14: 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 15: Corneal Neuropathic Pain in Dry Eye Disease
Corneal Neuropathic Pain in Dry Eye Disease Dry-eye patients suffer from corneal neuropathic pain, making their condition more resistant to anti-inflammatory drugs No FDA approved topical treatment for ocular pain ChemR23 receptor on leukocytes targeted by OK-101 is also expressed on neurons and gli
Slide 16: OK-101 Reduced Corneal Neuropathic Pain in Mouse Model
OK-101 Reduced Corneal Neuropathic Pain in Mouse Model OK-1011 Reduced Corneal Pain Response Ciliary Ligation Model* Illustrates OK-101 Similar to Gabapentin2 (GBP) Potential to Reduce Ocular Pain Ciliary nerve ligation surgery to create the 70 Vehicle corneal neuropathic pain (CNP) model Gabapentin
Slide 17: OK-101 Addresses Inflammation and Pain Components of Dry Eye
OK-101 Addresses Inflammation and Pain Components of Dry Eye Dry Eye Cycle Extrinsic Factors: OK-101 Reduces Contact lens Inflammatory Markers Inflammation Loss of Digital screen time of Ocular Goblet Cells Surface Allergies Surgery Inflammation OK-101 Blepharitis C Normalizes Goblet Cell Loss Tear
Slide 18: Overcoming Limitations of Current Dry Eye Therapies OK-101 Clinical Development
Overcoming Limitations of Current Dry Eye Therapies OK-101 Clinical Development
Slide 19: Successful Pre-IND Meeting with FDA
Successful Pre-IND Meeting with FDA OK-101 IND Clearance for DED Announced on 22 December 2022 Pre-IND Meeting Held February 2022 FDA Concurs First In-human Trial to be Phase 2 FDA Agrees on Pre-Specified Co-primary Endpoints (Signs and Symptoms) in Planned Phase 2 Trial OK-101 IND Clearance announc
Slide 20: OK-101 Development Timeline
OK-101 Development Timeline Phase 2 Phase 3 • Q1 2023 Initiation • 240 subjects/ 80 per arm • 12 Week Dosing • 6-9 months Duration • Potential Registration Trial 2022 2023 2024 2025 IND Anticipated CRO Partner Clearance Phase 2 (Announced 22 Dec 2022) Top-Line Data 20
Slide 21: Phase 2 Trial Design
Phase 2 Trial Design Primary Objective: Compare safety and efficacy of OK-101 to placebo for the treatment of the signs and symptoms of dry eye 6 visits over the course of 12 weeks ENDPOINTS N=240 subjects Primary Endpoints OK-101 (Low Dose) (through Day 85) 12 Weeks Dosing • Total Corneal Staining
Slide 22: Patent Protection up to 2039
Patent Protection up to 2039 OK-101 Technology: OK-201 Technology: Composition of Matter: US 10,233,219 Composition of Matter: US 10,899,796 Issued in US to 2034 with potential patent term extension up Issued in US to 2036 (+70 days of *PTA) with potential to 2039 patent term extension up to 2042 Dr
Slide 23: Experienced Team With Considerable Drug Development Expertise
Experienced Team With Considerable Drug Development Expertise Management Board Gabriele Cerrone Chairman, Founder Bernard Denoyer Gary S. Jacob, PhD Extensive experience founding, Non-Executive Director Chief Executive Officer and Director financing, restructuring, and listing Extensive financial ma
Slide 24: Investment Highlights
Investment Highlights Novel Molecule Targets Both Ocular Inflammation and Pain, Two Major Symptoms Underserved by Current Dry Eye Therapies Addressing Unmet Need in ~$6.5 Billion Market in Dry Eye Disease Q1 2023 Phase 2 Trial Initiation. Anticipated Top Line Data in Q4 2023, with Potential for Acce
Slide 25: Dry Eye Disease and Ocular Pain
OKYO Pharma Ltd. OKYO Pharma U.S. Inc. 14-15 Conduit Street 420 Lexington Avenue, London W1S 2XJ Suite 1402 Tel: +44 (0) 207 495 237 New York, NY, 10170 USA Tel: +1 (917) 225- 9646 Nasdaq OKYO LSE OKYO Dry Eye Disease info@okyopharma.com and Ocular Pain 25