Okyo Pharma Limited · NASDAQ:OKYO
Okyo Pharma — Investor Presentation (September 2023)
21 slides from Okyo Pharma's investor presentation, September 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 September 2023 Nasdaq: OKYO
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: 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 Disease Tear film instability triggers chronic inflammation which leads to symptoms of pain, itchiness,
Slide 4: Limits of Current Standard of Care
Limits of Current Standard of Care 6 FDA-Approved Drugs in the Market with Significant Limitations, Slow Onset of Action, and Numerous Side Effects API Limitations* Restasis 0.05% Delayed response, up to 6 months to improve symptoms, burning sensation when instilled Allergan cyclosporine 70% patient
Slide 5: Global DED Market Expected to Reach ~$11 Billion by 2030
Global DED Market Expected to Reach ~$11 Billion by 2030* ~$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 for $2.5 Bill
Slide 6: 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 Disease Fully enrolled; Plan to release top-line data in Q4 2023 (“DED”) Neuropathic Corneal Pain Plan to open trial in Q4 2023 (“NCP”) OK-101 Allergic Conjunctivitis Uveitis 6
Slide 7: 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 Completed Full Enrollme
Slide 8: OK-101 DED Development Timeline
OK-101 DED Development Timeline Phase 2 Phase 3 • 240 Subjects; 80 per arm • 12 Week Dosing • 6-8 Months Duration • Potential Registration Trial 2022 2023 2024 2025 Trial Start Announced Anticipated CRO Partner on May 2, 2023 Top-Line Data in December 2023 Completed Full Enrollment of 240 Patients 8
Slide 9: 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 10: OK-101: A Lipid-Conjugated Chemerin Peptide
OK-101: A Lipid-Conjugated Chemerin Peptide Potential novel 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 f
Slide 11: 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 12: OK-101: Targeting Chemerin Receptor
OK-101: Targeting Chemerin Receptor Chemerin Peptide Chemerin Receptor Linker Anchored Lipid Immune Cells Anti-inflammatory Response 12
Slide 13: 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 bi
Slide 14: Corneal Neuropathic Pain in Dry Eye Disease (DED)
Corneal Neuropathic Pain in Dry Eye Disease (DED) DED patients suffer from corneal neuropathic pain, making their condition more resistant to anti-inflammatory drugs No Current FDA approved topical treatment for ocular pain ChemR23 receptor on leukocytes targeted by OK-101 is also expressed on neuro
Slide 15: OK-101 Reduced Neuropathic Corneal Pain in Mouse Model
OK-101 Reduced Neuropathic Corneal Pain (“NCP”) in Mouse Model OK-101** Reduced Corneal Pain Response Ciliary Ligation Model* Illustrates OK-101 Comparable to Gabapentin*** (GBP) Potential to Reduce Ocular Pain Ciliary nerve ligation surgery to create the 70 Vehicle corneal neuropathic pain (CNP) mo
Slide 16: OK-101 Addresses Inflammation and Pain Components of Dry Eye in Mouse Models
OK-101 Addresses Inflammation and Pain Components of Dry Eye in Mouse Models 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
Slide 17: 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 18: Planned Single-Center 40-Patient Open-Label NCP Trial
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 19: Patent Protection through at least 2037
Patent Protection through at least 2037 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
Slide 20: Experienced Team With Considerable Drug Development Expertise
Experienced Team With Considerable Drug Development Expertise Management Board Gary S. Jacob, PhD William Clementi, PhD Gabriele Cerrone Bernard Denoyer Chairman, Founder Non-Executive Director Chief Executive Officer and Director Chief Operating Officer Extensive experience founding, Extensive fina
Slide 21: Investment Highlights
Investment Highlights Novel Molecule Targets Both Ocular Inflammation and Pain, Two Major Symptoms Underserved by Current Dry Eye Therapies Potential to Address Unmet Need in ~$6.6 Billion Market in Dry Eye Disease* Phase 2 Trial in DED Currently Underway, with anticipated Top-Line Data in Q4 2023.