Urcosimod advances as OKYO Pharma (NASDAQ: OKYO) gains Fast Track and Phase 2b/3 plan
Rhea-AI Filing Summary
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.
Positive
- Regulatory acceleration: Urcosimod received FDA Fast Track Designation for neuropathic corneal pain, a serious condition with no FDA-approved therapies, potentially enabling expedited development and review.
- Compelling Phase 2 signal: In the 18-patient Phase 2 proof-of-concept trial, 75% of per-protocol patients achieved over 80% pain reduction on the Visual Analogue Scale after 12 weeks.
- Regulatory alignment for pivotal trial: A successful FDA Type C meeting confirmed alignment on the 150-patient Phase 2b/3 design, including primary endpoint, powering, OPAS usage, and CMC with no material issues noted.
- Strengthened leadership: Appointment of industry veteran Robert J. Dempsey as CEO, with the former CEO moving to Chief Development Officer, adds commercialization and transaction experience while maintaining development continuity.
- Improved liquidity: Cash on hand rose to $4.2 million from $1.6 million, supported by $1.9 million in non-dilutive funding, while the total comprehensive loss narrowed slightly versus the prior-year interim period.
Negative
- None.
Insights
Urcosimod advances with FDA Fast Track, strong Phase 2 data, and defined pivotal trial path.
OKYO Pharma is focused on neuropathic corneal pain, a condition described as having no FDA-approved therapies. Urcosimod received FDA Fast Track Designation, which is intended to expedite development and review for serious conditions with unmet medical need.
The Phase 2 proof-of-concept trial in 18 NCP patients showed that 75% of per-protocol patients achieved more than 80% pain reduction on the Visual Analogue Scale at 12 weeks. A successful FDA Type C meeting established alignment on a 150-patient Phase 2b/3 design, including the primary pain endpoint and use of OPAS as supportive evidence.
Financially, cash on hand increased to $4.2 million from $1.6 million, and the interim total comprehensive loss narrowed slightly to $3.0 million. The company plans to initiate the Phase 2b/3 multiple-dose study in the first half of 2026, with future disclosures likely to provide further detail on execution and funding.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
January 2026
Commission File Number: 001-41386
OKYO Pharma LTD
(Exact Name of Registrant as Specified in Its Charter)
9th Floor
107 Cheapside
London
EC2V 6DN
(Address of registrant’s principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On January 30, 2026, OKYO Pharma LTD (the “Company”) issued this 6K filing its interim results for the six months ended 30 September 2025.
The Interim results are furnished herewith as Exhibit 99.1 and Exhibit 99.2 to this Report on Form 6-K. The information in the attached Exhibits 99.1 and 99.2 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that Section. Exhibit 99.2 of this Form 6-K is hereby incorporated by reference into the Company’s Registration Statement on Form F-3 (Reg. No. 333-272516).
| 2 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| OKYO Pharma LTD | |||
| Date: | January 30, 2026 | By: | /s/ Keeren Shah |
| Name: | Keeren Shah | ||
| Title: | Chief Financial Officer | ||
| 3 |
EXHIBIT INDEX
| Exhibit No. | Description | |
| 99.1 | Interim results cover page | |
| 99.2 | Interim Results, dated January 30, 2026 |
| 4 |
Exhibit 99.1
OKYO Pharma Interim Results for the Six Months Ended 30 September 2025
London and New York, NY, January 30, 2026 – OKYO Pharma Limited (Nasdaq: OKYO), a clinical-stage biopharmaceutical company developing investigational therapies for the treatment of neuropathic corneal pain (NCP) and for inflammatory eye diseases, has today filed its interim results for the six months ended 30 September 2025.
During the 6 months to September 30, 2025, OKYO Pharma achieved key clinical and regulatory milestones that strengthened the foundation for urcosimod’s development in treating NCP, a debilitating condition with no FDA-approved therapies. Highlights included:
| ● | Positive long-term stability data for urcosimod, enabling accelerated clinical progression. | |
| ● | FDA Fast Track Designation granted for urcosimod in NCP, expediting development and review. | |
| ● | Strong topline results from the Phase 2 proof-of-concept trial in 18 NCP patients, where 75% of per-protocol patients achieved >80% pain reduction on the Visual Analogue Scale (VAS) after 12 weeks. | |
| ● | $1.9 million in non-dilutive funding secured (July 2025) to support accelerated development. | |
| ● | Outlining a registration pathway, including plans for a 150-patient multi-center Phase 2b/3 trial. |
These achievements underscore urcosimod’s potential to address a significant unmet need in ophthalmology, supported by a solid financial position and efficient resource allocation during the period.
Recent Leadership and Regulatory Momentum in 2026
Building on this progress, OKYO Pharma has strengthened both its executive team and regulatory path:
| ● | On January 5, 2026, the Company appointed Robert J. Dempsey as Chief Executive Officer. Mr. Dempsey, is an industry veteran with over two decades of global ophthalmology experience, including leadership positions in the successful launches of Xiidra® and Restasis® at Shire (now part of Takeda). He brings deep expertise in drug development, commercialization, and strategic transactions. | |
| ● | Former CEO Gary S. Jacob, Ph.D., transitioned to Chief Development Officer while remaining on the Board, ensuring seamless continuity. | |
| ● | On January 28, 2026, OKYO Pharma announced a successful Type C meeting with the U.S. Food and Drug Administration (FDA). The FDA confirmed alignment on the proposed Phase 2b/3 clinical trial design for urcosimod in NCP, including: |
| ○ | Primary endpoint of VAS pain reduction at Week 12 (with ≥2-point improvement deemed clinically meaningful). | |
| ○ | Sample size, powering assumptions, and use of the Ocular Pain Assessment Survey (OPAS) as supportive quality-of-life evidence. | |
| ○ | Chemistry, manufacturing, and controls (CMC) strategy with no material issues. |
This alignment significantly de-risks the pathway to pivotal trials, with OKYO planning to initiate a 150-patient multiple-dose Phase 2b/3 study in the first half of 2026.
OKYO Pharma continues to accelerate its pipeline in inflammatory eye diseases, including neuropathic corneal pain, while maintaining disciplined financial management.
Financial Highlights:
| ● | Total assets of $4.6 million (31 March 2025: $3.7 million) | |
| ● | Cash on hand of $4.2 million (31 March 2025: $1.6 million) | |
| ● | During the financial period under review, the Company reported a total comprehensive loss of $3.0 million (compared to total comprehensive loss of $3.2 million for the six months ending September 30, 2024) |
About OKYO Pharma
OKYO Pharma Limited (Nasdaq: OKYO) is a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain (NCP) and inflammatory eye diseases, with ordinary shares listed for trading on the Nasdaq Capital Market. OKYO is focused on the discovery and development of novel molecules to treat neuropathic corneal pain and other ocular diseases. OKYO recently completed a successful phase 2 trial of its flagship drug urcosimod in patients with NCP and plans to initiate a 150-patient Phase 2b/3 multiple-dose study of urcosimod to treat NCP in the first half of this year.
For further information, please visit www.okyopharma.com.
Enquiries:
| OKYO Pharma Limited | Robert Dempsey, Chief Executive Officer | +44 (0)20 7495 2379 |
| Business Development & Investor Relations | Paul Spencer | +44 (0)20 7495 2379 |