Okyo Pharma Limited · NASDAQ:OKYO
Okyo Pharma — Biotech Showcase 2024
22 slides from Okyo Pharma's conference presentation, Jan 9, 2024
Slide 1: Overcoming Limitations of Current Dry Eye Therapies
Targeting Dry Eye Disease Overcoming& Limitations of Current Dry Eye Therapies Neuropathic BIOTECH SHOWCASE Corneal Pain January 9, 2024 Nasdaq: OKYO 1
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: 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 4: 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 (“DED”) Phase 2 Trial Completed Neuropathic Corneal Pain Plan to open trial in Q1 2024 (“NCP”) OK-101 Allergic Conjunctivitis Uveitis 4
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 Disease Tear film instability triggers chronic inflammation which leads to symptoms of pain, itchiness,
Slide 6: 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 Allergan cyclosporine 70% patients do not refill
Slide 7: 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 8: OK-101: Targeting Chemerin Receptor
OK-101: Targeting Chemerin Receptor Chemerin Peptide Chemerin Receptor Linker Anchored Lipid Immune Cells Anti-inflammatory Response 8
Slide 9: 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 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 bi
Slide 11: 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 12: 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 13: 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 14: 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 Top-Line Data CRO Partner on May 2, 2023 Announced Jan 2024 Completed Full Enrollment of 240 Patients 14
Slide 15: 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 16: US Regulatory Requirements for Dry Eye Disease
US Regulatory Requirements for Dry Eye Disease Dry Eye: Developing Drugs for Treatment Guidance for Industry Requirements Acceptable Signs and Symptoms of Dry Eye Sign and Symptoms (co-primaries, p<0.05, no Signs: corneal staining, conjunctival staining, unit difference required) – can be achieved i
Slide 17: Phase 2 Trial Highlights
Phase 2 Trial Highlights Identified statistically significant endpoints that Novel mechanism of action Excellent tolerability include both signs and distinct from currently profile symptoms of Dry Eye marketed drugs Disease to steer design and endpoint selection in future Phase 3 trials 17
Slide 18: OK-101 Phase 2 Trial Highlights - Efficacy
OK-101 Phase 2 Trial Highlights - Efficacy Identified Sign and Symptom Endpoints for Future Phase 3 Trials OK-101 demonstrated superiority when compared to placebo in the sign endpoint of total conjunctival staining as measured by the Ora Calibra© Staining Scale as early as Day 29 (p = 0.034). OK-10
Slide 19: OK-101 Phase 2 Trial Highlights - Safety
OK-101 Phase 2 Trial Highlights - Safety 3.8% Treatment emergent adverse events (TEAEs) were observed to be similar to the placebo-treated group. 2.5% No severe drug related ocular TEAEs were seen. Possible drug-related TEAEs were observed in one patient in the OK-101 0.05% treatment group and 3 pat
Slide 20: 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 21: Patent Protection through at least 2039
Patent Protection through at least 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
Slide 22: 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