Oculis Holding (NasdaqGM:OCS) 2025 Conference Transcript

Financial Data and Key Metrics Changes - The company has a cash runway that extends to the beginning of 2028, which will support the completion of the DME program and the first phase three trial for acute optic neuritis [68] - The company expects readout for the Diamond studies in Q2 next year, with over 800 patients enrolled [8][10] Business Line Data and Key Metrics Changes - OCS-01 is in phase three for DME, showing a 7.26 letter gain at week 12 in BCVA, with over 27% of patients gaining more than 15 letters [8][11] - OCS-02 (Licaminlimab) targets dry eye disease with a unique genotype-based development approach, aiming to address the unmet need where 86% of patients are dissatisfied with current treatments [50][53] - OCS-05 (Privosegtor) has shown significant results in acute optic neuritis, with an 18-letter gain in LCVA at the primary endpoint [32][34] Market Data and Key Metrics Changes - In the U.S., 60% of diagnosed DME patients are untreated, representing a significant market opportunity [10] - The potential patient population for OCS-01 includes 1.3 million diagnosed but untreated patients in the U.S. [11] - The dry eye market has around 30 to 35 million patients in the U.S., with 2 million being TNFR1 positive and moderate to severe [54] Company Strategy and Development Direction - The company aims to leverage its unique technologies to address significant unmet medical needs in ophthalmology and neuro-ophthalmology [70] - The strategy includes focusing on early treatment for DME and addressing patients who do not respond to anti-VEGF therapies [23][25] - The company plans to broaden its neuro-ophthalmic programs beyond acute optic neuritis to include other relapses of multiple sclerosis [43] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing trials and the unique positioning of their products in the market [9][70] - The company is optimistic about the upcoming discussions with the FDA regarding the registrational trial for Privosegtor [38] - Management highlighted the importance of patient compliance, noting an 85% compliance rate in phase two trials for OCS-01 [20] Other Important Information - The company has a clear plan for the development of Licaminlimab, with a focus on a genotype-based approach to improve the probability of success in clinical trials [53] - The company is preparing for the launch of DME and subsequent trials for dry eye and multiple sclerosis relapses, pending FDA feedback [68] Q&A Session Summary Question: Can you discuss the results of the Diamond stage one? - The Diamond stage one showed a 7.26 letter gain in BCVA at week 12, with 27% of patients gaining more than 15 letters, consistent with anti-VEGF results [8][11] Question: What is the expected compliance for the eye drop regimen? - Compliance was measured at 85% in phase two trials, and management is confident it will remain high in real-world applications [20] Question: How does the company plan to address the unmet need in dry eye disease? - The company aims to leverage a genetic biomarker to identify patients who will respond well to Licaminlimab, addressing the dissatisfaction of 86% of current dry eye patients [50][53] Question: What is the expected timeline for the registrational trial for Privosegtor? - The company plans to clarify next steps with the FDA and hopes to initiate phase three trials as soon as possible [38] Question: How many patients are affected by acute optic neuritis? - There are approximately 30,000 to 35,000 new cases of acute optic neuritis in the U.S. each year, primarily affecting young patients [40]