Oculis (OCS) Study result summary

Phase III/DIAMOND Study Results for OCS-01 in DME

• Both DIAMOND-1 and DIAMOND-2 phase III trials for OCS-01 in diabetic macular edema did not meet their primary endpoint of change in BCVA at week 52, nor the key secondary endpoint of ≥15 letter gain in BCVA.

• Objective measures showed rapid and sustained reduction in retinal thickness in the active arm versus vehicle through week 52, replicating earlier stage results.

• OCS-01 was well-tolerated with no unexpected safety findings or adverse events; elevated IOP and cataract rates were consistent with chronic steroid use.

• Over 800 patients were enrolled across 119 sites in the US and other countries, with over 80% completing the 52-week study and high compliance.

• No material differences were observed between phakic and pseudophakic patients, and trial execution quality was confirmed.

Strategic Focus and Financial Position

• No FDA regulatory filing will be pursued for OCS-01 in DME; focus shifts to advancing late-stage portfolio assets.

• Developmental efforts and resources will shift to the Privosegtor PIONEER program in optic neuropathies and the licaminlimab PREDICT-1 trial in dry eye disease.

• Cash runway extends into the second half of 2029, with $278 million in cash and equivalents as of March 31, 2026.

• Routine site closeout costs for DIAMOND studies are expected in Q2 and early Q3; no licensing fees are due for OCS-01.

• Analyst and investor call scheduled to review results and provide a pipeline update.

Updates on Ongoing and Future Studies

• PREDICT-1 is a registrational trial for licaminlimab in dry eye, enrolling 160 patients with primary endpoint at day 29; updates expected end of year or early next year.

• Approximately 70% of planned sites for PREDICT-1 are in active screening; randomization updates to be provided in Q3.

• PIONEER program for Privosegtor includes three trials for optic neuropathies, with PIONEER-1 and -2 for optic neuritis and PIONEER-3 for NAION; over 70 sites are in various stages of activation.

• PIONEER-1 trial design is aligned with FDA under SPA, with first patient treatment expected soon.

• PIONEER-2 will begin after randomization starts in PIONEER-1; focus remains on quality execution and protocol adherence.