Okyo Pharma Limited · NASDAQ:OKYO
Okyo Pharma — Investor Presentation (June 2025)
23 slides from Okyo Pharma's investor presentation, June 2025
Slide 1: Clinical Development of Urcosimod to Treat Neuropathic Corneal Pain
Clinical Development of Urcosimod to Treat Neuropathic Corneal Nasdaq: OKYO Pain Corporate Presentation JUNE 2025
Slide 2: Disclaimer
Disclaimer By accepting and using this presentation, you will be deemed to agree not to disclose any information contained herein except as may be required by law. Additionally, certain information contained in this presentation has been obtained from published sources prepared by other parties, whi
Slide 3: Urcosimod: A Lipid-Conjugated Chemerin Peptide
Urcosimod: A Lipid-Conjugated Chemerin Peptide Chemerin Peptide Drug candidate with anti-inflammatory and CMKLR1 Receptor ocular pain reducing properties Linker (ChemR23) Lipid conjugated peptide chemistry minimizes drug washout and enhances the potency Modulates Anchored Lipid Inflammation Urcosimo
Slide 4: Establishing USAN (e.g., Generic) Name for OK-101
ESTABLISHING USAN (e.g., GENERIC) NAME FOR OK-101 Hydrophilic region USAN COUNCIL CONFIRMED NAME: urcosimod Peptide NAME OFFICIAL ON JANUARY 29, 2025 Pegylated Transitioned to urcosimod for all future communications linker Lipid and on website with language to acclimate the reader [e.g., “urcosimod
Slide 5: Pipeline Focus: Urcosimod to Treat Ocular Diseases
Pipeline Focus: Urcosimod to Treat Ocular Diseases Indication Pre-clinical Phase 1 Phase 2 Phase 3 OK-101 Dry Eye Disease (“DED”) Phase 2 Trial Completed Neuropathic Corneal Pain (“NCP”) Phase 2 Trial Initiated in Q4 2024 Allergic Conjunctivitis Uveitis 5
Slide 6: Urcosimod Nonclinical Studies
Urcosimod Nonclinical Studies
Slide 7: Chemerin Derived Peptide: A Potential Regulator of Inflammation & Pain
Chemerin Derived Peptide: A Potential Regulator of Inflammation & Pain Pro-inflammatory chemerin Urcosimod 1 activates immune cells at the 1 Stable, Protease Resistant inflammation site Chemerin Peptide Fragment Chemerin 3 Linker CHEMR23 Peptides derived from chemerin 2 Anchored Lipid 2 physiologica
Slide 8: Urcosimod: Targeting ChemR23 Receptors
Urcosimod: Targeting ChemR23 Receptors ChemR23 Receptors Urcosimod micelle “Velcro Effect” Anti-inflammatory and Urcosimod peptide units analgesic response on exterior of micelle Neuron or white blood cell membrane 8
Slide 9: Urcosimod Reduced NCP in Mouse Model
Urcosimod Reduced Neuropathic Corneal Pain (NCP) in Mouse Model* Ciliary Ligation Model* Illustrates Urcosimod’s Potential Urcosimod** Reduced Corneal Pain Response to Reduce Ocular Pain. Ciliary nerve ligation surgery to Comparable to Gabapentin*** (GBP) create the neuropathic corneal pain (NCP) mo
Slide 10: Neuropathic Corneal Pain (NCP) in Dry Eye Disease
Neuropathic Corneal Pain (NCP) in Dry Eye Disease DED patients suffer from neuropathic corneal pain, making their condition more resistant to anti-inflammatory drugs No Current FDA approved topical treatment for neuropathic corneal pain ChemR23 receptor on leukocytes targeted by urcosimod is also ex
Slide 11: Urcosimod to Treat Neuropathic Corneal Pain (NCP)
Urcosimod to Treat Neuropathic Corneal Pain (NCP)
Slide 12: Urcosimod to Treat Neuropathic Corneal Pain (NCP)
Urcosimod to Treat Neuropathic Corneal Pain (NCP) Agreement with Tufts Medical Center for NCP Phase 2 Trial Announced in July 2023 NCP Trial Conducted by Pedram Hamrah, MD, Professor, at Tufts Medical Center IND Cleared by FDA for OK-101 to Treat NCP Announced on Feb. 9, 2024 Phase 2 Randomized, Pla
Slide 13: Urcosimod Trial to Treat Neuropathic Corneal Pain
Urcosimod Trial to Treat Neuropathic Corneal Pain Phase 2a, Randomized, Double-Masked, Placebo-Controlled Study Assessing the Safety and Efficacy of Urcosimod in Subjects with Neuropathic Corneal Pain IND Clearance by FDA - February 2024 Primary Endpoint: To evaluate the efficacy of urcosimod compar
Slide 14: OKYO Pharma Announces First Patient Dosed with OK-101
OKYO Pharma Announces First Patient Dosed with OK-101 in the First Clinical Trial to Treat Neuropathic Corneal Pain • OK-101 is the first drug candidate to enroll patients in a clinical trial specifically diagnosed with this disease • The Phase 2 trial is designed as a randomized, placebo-controlled
Slide 15: Phase 2 Trial for Urcosimod to Treat NCP
Phase 2 Trial for Urcosimod (formerly called OK-101) to Treat NCP Phase 2, Randomized, Double masked, Placebo-Controlled Study Assessing Safety and Efficacy of Urcosimod (formerly called OK-101) in Subjects with NCP • Number of subjects to be enrolled: 48 • Number of Cohorts: three (0.05% and 0.1% U
Slide 16: OKYO Pharma Announces Plans to Accelerate Clinical Development of Urcosimod
OKYO Pharma Announces Plans to Accelerate the Clinical Development of Urcosimod to Treat Neuropathic Corneal Pain • Urcosimod phase 2 trial treating Neuropathic Corneal Pain (“NCP”) patients was initiated in October 2024 and designed as a double-masked, randomized, 12-week placebo-controlled trial.
Slide 17: Rationale for Closing the Trial Early
RATIONALE FOR CLOSING THE TRIAL EARLY • Decision to close trial after 17 patients completed the study due to strong desire to access the currently masked data. • Company anticipates analysis of data from these patients should take no longer than 8-10 weeks. • Decision to close the trial enables sign
Slide 18: FDA Grants OKYO Pharma Fast Track Designation to Urcosimod
FDA Grants OKYO Pharma Fast Track Designation to Urcosimod for Neuropathic Corneal Pain • Fast Track designation by the FDA is granted to facilitate development and expedite review of therapies that aim to treat serious conditions and fulfill unmet medical needs. • Designation intended to accelerate
Slide 19: Company Catalysts
Company Catalysts Urcosimod NCP Program 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 2024 2025 2026 APRIL 30: JULY: Plan Top- Announced line Data Release 4Q24: Start of Closing of for Phase 2 NCP Phase 2 NCP Trial Trial with 17 trial Patients Completed 19
Slide 20: Patent Protection Through at Least 2039
Patent Protection Through at Least 2039 Urcosimod Intellectual Property: Method of Use Composition of Matter: Method of Use (Dry Eye): (Neuropathic Pain): US 10,233,219 US 11,197,906 US 11,254,720 Issued in US to 2034 with Issued in US to 2037 with Issued in US to 2034 (+187 potential patent term po
Slide 21: Experienced Team With Considerable Drug Development Expertise
Experienced Team With Considerable Drug Development Expertise Management Board Gary S. Jacob, PhD, Chief Executive Officer and Director Co-inventor and Gabriele Cerrone Chairman, Founder Extensive experience founding, developer of Synergy’s FDA-approved drug Trulance, currently marketed by Bausch fi
Slide 22: Key Takeaways
Key Takeaways • Urcosimod (formerly called OK-101) is a novel topical eye drop that targets both inflammation and ocular pain • Neuropathic corneal pain (NCP) is characterised by heightened experience of pain in response to normally non-painful stimuli, which severely impacts quality of life • No FD
Slide 23: Thank you
Overcoming Limitations of Current Dry Eye Therapies Thank you 23