Oculis Holding (NasdaqGM:OCS) FY Conference Transcript

Summary of Oculis Holding FY Conference Call Company Overview - Company: Oculis Holding AG - Ticker: NasdaqGM: OCS - Date of Conference: September 08, 2025 Key Clinical Programs 1. OCS-01 for Diabetic Macular Edema (DME) - First eye drop treatment for DME, currently in Phase 3 with enrollment completed - Expected readout in Q2 2026 - Market potential in the U.S. is estimated at $3 billion, targeting a patient pool twice the size of current treatments [3][4] - Primary endpoint: mean change of Best Corrected Visual Acuity (BCVA) compared to placebo [10] - Secondary endpoint: percentage of patients gaining 15 letters in BCVA [10] - Positioned as a first-line treatment for DME [13] 2. OCS-02 (Licaminlimab) for Dry Eye Disease - Utilizing a genotype-based approach to identify patients likely to respond to treatment - Current market for dry eye is underserved, with a low renewal rate of first prescriptions at 14% [6][7] - Expected initiation of trials this year, with readout in the second half of next year [40] 3. OCS-05 (Privosergtor) for Acute Optic Neuritis (AON) - Phase 2 data showed significant functional improvement, with an 18-letter difference in vision [5] - Plans to consult with the FDA regarding registration for AON and initiate new programs for NAION and MS relapse [6][21] - AON will be the lead indication for Phase 3 trials [23] Market Position and Competitive Landscape - Oculis aims to address unmet medical needs in DME, with over 60% of diagnosed patients currently untreated [11] - OCS-01 shows comparable or superior efficacy to existing treatments like Lucentis and Ozurdex [12] - The company is focused on execution and has clear regulatory support from the FDA [18] Financial Overview - Current cash runway extends to early 2028, financing DME and dry eye trials until NDA submission [42] - The company is exploring potential licensing or co-development opportunities but cannot disclose specifics [41] Upcoming Catalysts - Regulatory clarifications for Privosergtor in AON and IND submissions for NAION and MS relapse [43] - Phase 3 readout for DME expected in the first half of next year and for dry eye in the second half [43] Additional Insights - The company emphasizes the importance of execution in clinical trials, acknowledging inherent risks [18] - The genotype-based approach in ophthalmology is a novel strategy, potentially leading to more efficient trials [37][38] This summary encapsulates the critical points discussed during the conference call, highlighting Oculis Holding's strategic focus on its clinical programs, market positioning, financial health, and upcoming milestones.