Oculis (OCS) investor relations material

Pipeline and strategic focus

• Refocused resources on Privosegtor and Licaminlimab after an unexpected setback in the DIAMOND 1 and 2 phase III trials for DME, as top-line results did not meet efficacy endpoints at week 52.

• Privosegtor is being advanced in three trials: PIONEER-1 and PIONEER-2 for optic neuritis, and PIONEER-3 for NAION, with plans to potentially expand into acute MS relapse pending FDA feedback.

• Licaminlimab is in a registrational phase III trial (PREDICT-1) for dry eye disease, leveraging a genotype-based development strategy to target patients with a specific TNF biomarker.

• Both Privosegtor and Licaminlimab are positioned as first-in-class: neuroprotective and precision medicine approaches, respectively.

• The company maintains a pragmatic approach to partnerships, prioritizing execution and value creation but remaining open to strategic collaborations.

Clinical data and development updates

• Privosegtor demonstrated neuroprotection in animal models and phase II trials, showing improved vision and reduced neurofilament release in optic neuritis patients.

• Privosegtor received Breakthrough designation from the FDA and PRIME from the EMEA, with the first patient visit in PIONEER-1 imminent.

• Licaminlimab showed positive results in three clinical trials, with a TNF biomarker enabling more efficient trials and a paradigm shift toward precision treatment in dry eye disease.

• The ongoing PREDICT-1 trial for Licaminlimab uses a qPCR-based saliva swab for genotyping, with data expected around the end of the year or early next year.

• The company is aligning phase III trial designs closely with successful phase II protocols to minimize risk in translation.

Market opportunity and financial position

• Privosegtor targets large unmet needs in optic neuritis and NAION, with a potential $7 billion market opportunity if approved, and possible expansion to 180,000-200,000 MS relapse patients annually in the US.

• Licaminlimab’s biomarker-driven approach could improve patient outcomes and payer value by reducing trial-and-error prescribing.

• Cash runway extends to the second half of 2029, supporting delivery of all planned milestones for both lead assets.

• The portfolio is described as differentiated and innovative, with strong positioning despite recent clinical setbacks.

• Leadership remains committed to maximizing learnings from setbacks and delivering on upcoming clinical milestones.