OKYO Pharma Limited’s SEC filings document foreign-private-issuer reports on Form 6-K for a clinical-stage biopharmaceutical company with ordinary shares listed on Nasdaq. The disclosures cover urcosimod clinical and regulatory updates for neuropathic corneal pain, scientific-meeting materials, and descriptions of the company’s focus on inflammatory eye diseases and other ocular disorders.
The filing record also includes capital-structure and financing disclosures tied to Form F-3 registration statements, ordinary-share offerings, underwriter option exercises, and insider share purchases. These records present formal updates on the company’s securities, ownership activity, incorporated exhibits, and material announcements furnished under Exchange Act Rule 13a-16.
OKYO Pharma Ltd. has established an at the market offering program allowing it to sell up to $50,000,000 of ordinary shares through Leerink Partners LLC as sales agent or principal.
The shares will be issued under OKYO’s effective Form F-3 shelf registration and a related prospectus supplement. Leerink Partners will receive a 3.0% cash commission on gross sales and reimbursement of specified expenses. OKYO is not required to sell any minimum amount and either party can suspend the program, so the total capital ultimately raised and commissions paid are not yet determinable.
OKYO Pharma Limited is establishing an at-the-market program to sell up to $50 million of ordinary shares through Leerink Partners on Nasdaq under the symbol OKYO.
Leerink Partners will act as sales agent or principal and earn a 3% commission on gross proceeds. Based on an illustrative price of $1.99, the company shows a scenario where shares outstanding could rise from 40,555,197 to up to 65,680,825, highlighting potential dilution for new and existing holders.
OKYO plans to use any net proceeds for clinical development, general corporate purposes and working capital, with a primary focus on advancing its lead drug candidate urcosimod for neuropathic corneal pain, an indication with no FDA‑approved therapies. Urcosimod has Fast Track designation and encouraging Phase 2a and dry eye disease data, but the company notes significant risks, including ongoing losses, future financing needs, and the possibility of Nasdaq delisting.
OKYO Pharma has appointed Flavio Mantelli, MD, PhD as Chief Medical Officer, adding a seasoned ophthalmology leader to its executive team. He previously led the clinical development, FDA approval and global strategy of Oxervate, an orphan corneal therapy that achieved blockbuster status with sales topping $1 billion in 2024.
At OKYO, Dr. Mantelli will oversee clinical and regulatory strategy, focusing on advancing urcosimod for neuropathic corneal pain and additional orphan indications. Urcosimod has FDA Fast Track designation, the first IND for NCP, compassionate use authorization, positive Phase 2 pain‑reduction data in NCP and earlier efficacy data in dry eye disease. OKYO plans a ~150‑subject Phase 2b/3 multiple‑dose NCP study in the first half of this year.
OKYO Pharma Limited has filed a shelf registration statement on Form F-3 to offer up to $200,000,000 of ordinary shares, warrants and units from time to time. This flexible structure lets the company raise capital in multiple offerings as it advances its clinical pipeline.
OKYO is a clinical-stage biopharmaceutical company developing urcosimod for neuropathic corneal pain and dry eye disease, with FDA Fast Track status for neuropathic corneal pain. The company highlights substantial ongoing losses, limited cash resources, and a going-concern warning, underscoring its dependence on future financings and successful trial outcomes.
OKYO Pharma reported interim results for the six months ended 30 September 2025, highlighting progress on its lead drug urcosimod for neuropathic corneal pain (NCP). The company secured FDA Fast Track Designation for urcosimod in NCP and reported strong Phase 2 proof-of-concept data in 18 patients, with 75% of per-protocol patients achieving more than 80% pain reduction on the Visual Analogue Scale after 12 weeks.
OKYO also strengthened its leadership by appointing Robert J. Dempsey as Chief Executive Officer and transitioning former CEO Gary S. Jacob to Chief Development Officer. Following a successful FDA Type C meeting, the agency confirmed alignment on the proposed 150-patient Phase 2b/3 trial design, including a primary endpoint of VAS pain reduction at Week 12.
Financially, total assets were $4.6 million as of 31 March 2025, with cash on hand of $4.2 million, up from $1.6 million. The company recorded a total comprehensive loss of $3.0 million, slightly improved from a $3.2 million loss for the comparable prior-year period.
OKYO Pharma Limited filed a Form 6-K to share that an abstract on its lead drug candidate urcosimod (formerly OK-101) has been accepted for presentation at the 2026 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting. The paper will present proof-of-concept Phase 2 efficacy and safety results in neuropathic corneal pain during the Ocular Surface Disease II session on April 11, 2026, in Washington, DC.
The company highlights positive efficacy signals from the completed Phase 2 trial, including meaningful pain reduction and encouraging corneal nerve health trends, and describes urcosimod as a potential first-in-class therapy for neuropathic corneal pain, which currently has no FDA-approved treatments. OKYO reiterates prior FDA fast track designation and the first IND for NCP, and states it plans to initiate a 150-patient Phase 2b/3 multiple-dose study of urcosimod in the first half of 2026.
OKYO Pharma reports that the FDA held a successful Type C meeting with the company on the Phase 2b/3 clinical trial of urcosimod for neuropathic corneal pain (NCP). The FDA confirmed the planned trial design, including the primary endpoint, sample size, and overall development approach.
Urcosimod already has the first IND for NCP and fast track designation, and OKYO recently completed a positive Phase 2 NCP trial and an earlier 240-patient Phase 2 dry eye disease study with statistically significant results. The company plans to start a 120-patient Phase 2b/3 multiple-dose study for NCP in the first half of the year, aiming to address a condition with no FDA-approved treatments.
OKYO Pharma Limited reports that the U.S. Food and Drug Administration has authorized a single-patient expanded access (compassionate use) IND for its drug candidate urcosimod (0.05%) to treat a patient with severe neuropathic corneal pain who has limited options and no FDA-approved treatments available. The IND was submitted by Pedram Hamrah, MD, at the University of South Florida, and urcosimod is being provided by OKYO under this authorization.
The company notes that urcosimod previously received the first IND to treat neuropathic corneal pain and was granted FDA fast track designation. OKYO recently reported positive pain-reduction data in an 18-patient Phase 2 trial in neuropathic corneal pain and earlier statistically significant results in a 240-patient Phase 2 trial in dry eye disease. It plans to start a 120-patient Phase 2b/3 multiple-dose study of urcosimod for neuropathic corneal pain this year.
OKYO Pharma LTD disclosed that Panetta Partners Limited, an entity in which Executive Chairman Gabriele Cerrone has a beneficial interest, acquired 24,551 of the company’s ordinary shares on Nasdaq on December 15, 2025.
This purchase brings Cerrone’s total holding to 10,516,297 shares of OKYO Pharma. The company has furnished a detailed news announcement about the transaction as Exhibit 99.1 to this report.
OKYO Pharma (OKYO) reported that Panetta Partners Limited, an entity in which Executive Chairman Gabriele Cerrone has a beneficial interest, purchased 82,018 of the company’s ordinary shares on NASDAQ on November 21, 2025.
This additional purchase increases Cerrone’s total beneficial holding to 10,464,695 shares. The disclosure is informational in nature and does not change the company’s capital structure or operations, but it highlights further share accumulation by a key insider.