Okyo Pharma Limited · NASDAQ:OKYO
Okyo Pharma — Investor Presentation (July 2023)
27 slides from Okyo Pharma's investor presentation, July 2023
Slide 1: Targeting Dry Eye Disease and Neuropathic Corneal Pain
Targeting Dry Eye Disease Overcoming& Limitations of Current Dry Eye Therapies Neuropathic Corporate Presentation Corneal Pain JULY 2023 Nasdaq: OKYO 1
Slide 2: OK-101: New Chemical Entity Targeting Inflammation and Ocular Pain
OK-101 New Chemical Entity Targeting both Inflammation and Ocular Pain in Dry Eye Disease 2
Slide 3: Pipeline Focus: OK-101 to Treat Ocular Diseases
Pipeline Focus: OK-101 to Treat Ocular Diseases Indication Pre-clinical Phase 1 Phase 2 Phase 3 Dry Eye (“DED”) Skipped Phase 1; Phase 2 Commenced May 2, 2023 Neuropathic Corneal Pain Plan to open trial in Q4 2023 (“NCP”) OK-101 Allergic Conjunctivitis Uveitis 3
Slide 4: OK-101 Phase 2 Trial in DED Patients Began on May 2, 2023
OK-101 Phase 2 Trial in DED* Patients Began on May 2, 2023 Pre-IND Meeting Held February 2022; FDA Concurs First-in-human Trial to be Phase 2 FDA Agrees on Pre-Specified Co-primary Endpoints for Phase 2 Trial IND on OK-101 to treat DED patients cleared by FDA in December 2022 OK-101 Phase 2 Trial To
Slide 5: July 28, 2023 – Announced Plans for OK-101 to Treat NCP
July 28, 2023 – Announced Plans for OK-101 to Treat NCP* Announced Clinical Trial Agreement with Tufts Medical Center for Trial on NCP NCP Trial to be Conducted by Pedram Hamrah, MD, Professor, at Tufts Medical Center Plan to File IND on OK-101 to Treat NCP in Q4 2023 Open Label Trial Planned to be
Slide 6: 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 7: 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 8: 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 Costs of Managing DED to US Economy† Current Treatment Options Inadequate; More Effective Treatment May Increase Market Size Bausch & Lomb Recent Acquisition of Xiidra $2.5 Billion 8
Slide 9: 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 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 (Max soluble unwashed =100%) 100 (Max soluble unwashed =100%) Luciferase activity 100 75 Luciferase activity OK-101 Anchore
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 a
Slide 16: OK-101 Reduced Neuropathic Corneal Pain in Mouse Model
OK-101 Reduced Neuropathic Corneal Pain (“NCP”) 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 Ga
Slide 17: OK-101 Addresses Inflammation and Pain Components of Dry Eye
OK-101 Addresses Inflammation and Pain Components of Dry Eye Extrinsic Factors: Dry Eye Cycle 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 OK-101 Current Dry Eye Therapies Clinical Development 18
Slide 19: OK-101 DED Development Timeline
OK-101 DED Development Timeline Phase 2 • 240 subjects/ 80 per arm • 12 Week Dosing • 6-8 months Duration Phase 3 • Potential Registration Trial Expected to start in Q2 2024 2022 2023 2024 2025 Phase 2 Trial Initiation Anticipated CRO Partner Announced Phase 2 on May 2, 2023 Top-Line Data in Q4 2023
Slide 20: Phase 2 DED Trial Design
Phase 2 DED 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 14 weeks ENDPOINTS N=240 subjects Primary Endpoints OK-101 (0.05%) (Through Day 85) 12 Weeks Dosing • Total Corneal Staining
Slide 21: Neuropathic Corneal Pain (NCP)
Neuropathic Corneal Pain (NCP) • Debilitating condition characterized by chronic and severe eye discomfort, leading to decreased quality of life for affected individuals. • NCP occurs through changes in both peripheral and central neurons leading to allodynia and hyperalgesia. • NCP can be caused by
Slide 22: July 28, 2023 – Announced Plans for OK-101 to Treat NCP
July 28, 2023 – Announced Plans for OK-101 to Treat NCP Planned Single-Center 40-Patient Open-Label Trial • Pedram Hamrah, MD, Principal Investigator, Tufts Medical Center • Evaluate safety and efficacy of OK-101 to treat symptoms of NCP • Four visits over the course of 16 weeks • Study duration: 6-
Slide 23: 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 24: Comparable Companies
Comparable Companies M&A Transactions Target Acquirer Date Purchase Price Target’s Drug Candidates • ROCKLATAN® and RHOPRESSA® for glaucoma Transaction closed on Aerie Pharmaceuticals Alcon (ALC) • $770 million in cash • AR-15512 – Ph3 candidate for DED 11/22/2022 • Additional pipeline of ophthalmic
Slide 25: 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 26: 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 ~$5.5 Billion Market in Dry Eye Disease Phase 2 Trial in DED currently underway, with anticipated Top-Line Data in Q4 2023. Phase 2 Tri
Slide 27: 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 info@okyopharma.com Dry Eye Disease and Ocular Pain 27