Announcement • Mar 19
Okyo Pharma Limited Reports New Phase 2 Data Demonstrating Meaningful Improvements in Patient-Reported Quality of Life Outcomes with Urcosimod in Neuropathic Corneal Pain OKYO Pharma Limited, a clinical-stage biopharmaceutical company developing investigational therapies for the treatment of neuropathic corneal pain (NCP) and for inflammatory eye diseases, announced new positive findings from an exploratory analysis of patient-reported outcomes in its recently completed Phase 2a trial of urcosimod (0.05%) for the treatment of NCP. This new quality-of-life (QoL) data will be presented at the Association for Research in Vision and Ophthalmology (ARVO) 2026 Annual Meeting. The presentation, titled: “First-in-Human Study of Urcosimod to Treat Neuropathic Corneal Pain (NCP) Shows Clinically Meaningful Pain Reduction and Quality-of-Life Improvement in NCP Patients” will detail the Phase 2a clinical trial results, including reductions in pain as measured by the VAS, improvements in patient-reported QoL measures, as well as signals suggesting potential restoration of corneal nerve structure in NCP patients. In this Phase 2, randomized, double-masked, placebo-controlled study, patients with NCP received either 0.05% urcosimod (n=6) or placebo (n=6) in the Intent-to-Treat (ITT) population. After 12 weeks of treatment, patients receiving urcosimod demonstrated greater improvements across key aspects of emotional well-being and quality of life compared to placebo. These measures were assessed on a 0–10 scale. Notable improvements included: Enjoying life/relationships with other people: mean change from baseline of -4.5 (IQR -6.00 to -0.75) for urcosimod vs. 0 (IQR -4.75 to 1.25) for placebo. Mood: mean change of -1.5 (IQR -5.25 to 0.25) for urcosimod vs. -0.5 (IQR -4.75 to 2.25) for placebo. Time spent thinking about eye pain: mean change of -3.0 (IQR -5.00 to 0.00) for urcosimod vs. -1.5 (IQR -4.00 to 0.00) for placebo. (IQR = Interquartile Range) These secondary findings build on the primary efficacy signals from the trial, where urcosimod previously demonstrated meaningful reductions in pain as measured by the Visual Analogue Scale (VAS). The exploratory patient-reported outcomes data suggest that urcosimod may provide broader therapeutic benefits, contributing to enhanced emotional well-being and overall day-to-day life satisfaction for patients suffering from this debilitating condition. NCP is a severe, chronic ocular pain disorder with no FDA-approved treatments available, representing a major unmet medical need. These results highlight urcosimod's potential holistic profile beyond pain reduction alone. Urcosimod is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response, as well as on neurons and glial cells in the dorsal root ganglion. Urcosimod has been shown to produce anti-inflammatory and pain-reducing activities in a mouse model of dry eye disease and in a neuropathic corneal pain mouse model, respectively. OKYO recently announced positive data on NCP pain reduction in a randomized, placebo-controlled, double-masked Phase 2a trial involving 18 neuropathic corneal pain subjects. Urcosimod has shown significant pain reduction in an earlier 240 subject Phase 2, multi-center, double-masked, placebo-controlled trial in DED, which supports the development rationale in NCP. OKYO recently completed a successful phase 2 trial of its flagship drug urcosimod in subjects with NCP and plans to initiate a ~150 subject Phase 2b/3 multiple-dose study of urcosimod to treat NCP in the first half of this year. New Risk • Feb 13
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 51% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Negative equity (-US$3.4m). Earnings are forecast to decline by an average of 28% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (51% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$27m net loss in 3 years). Share price has been volatile over the past 3 months (16% average weekly change). Announcement • Feb 13
OKYO Pharma Limited has completed a Follow-on Equity Offering in the amount of $20.00775 million. OKYO Pharma Limited has completed a Follow-on Equity Offering in the amount of $20.00775 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 10,815,000
Price\Range: $1.85