OKYO Pharma (OKYO) investor relations material

Urcosimod and clinical evidence

• Urcosimod is a preservative-free, non-opioid eye drop designed to activate ChemR23, targeting neuropathic pain signaling and ocular inflammation.

• In a phase II proof-of-concept study, mean pain improvement was 5.5 points on the 10-point VAS; 75% of per-protocol patients achieved >80% pain reduction after 12 weeks.

• The phase II study showed pain separation from placebo after four weeks and a ~4-point active-versus-placebo delta at study end in patients with moderate-to-severe baseline pain.

• Exploratory findings included increased corneal nerve fiber count and length, suggesting potential nerve restoration; pain relief persisted through the one-month post-treatment observation.

• Prior studies were described as well tolerated, with no serious adverse events; curative potential remains uncertain pending further data.

NEPTUNE phase III trial and milestones

• NEPTUNE began enrolling in early October; the randomized, double-masked, placebo-controlled trial plans ~111 adults, 2:1 randomization, 12 weeks of treatment, and one-month follow-up.

• The FDA-endorsed primary endpoint is change in ocular pain on the 10-point VAS; a ≥2-point improvement versus placebo was described as clinically meaningful and potentially label-enabling.

• Planned enrollment criteria include pain scores of 5 or greater, confocal identification of microneuromas, and a proparacaine challenge to distinguish neuropathic from centralized pain.

• Enrollment is targeted for mid-2027, with top-line data expected in H2 2027; an FDA meeting is planned for late 2027 or early 2028.

• Five European sites were planned alongside eight U.S. sites, with Europe activation targeted by year-end 2026 or early 2027; a separate safety study is needed to support exposure of ~300 subjects.

Regulatory position and funding

• The program has Fast Track designation and an IND; Type C and Type D FDA meetings supported proceeding directly to phase III.

• Intellectual property protection extends through at least 2039.

• A $22 million raise, including the greenshoe, was said to fund the phase III program through top-line data; additional financing may be pursued opportunistically.

• Breakthrough Therapy designation was identified as an opportunity under evaluation.