Oculis Reports Q2 2024 Financial Results and Provides Recent Company Update

Core Insights - Oculis Holding AG reported positive topline results for the Phase 2b RELIEF trial of OCS-02 (licaminlimab), indicating potential for the first precision medicine in Dry Eye Disease (DED) [1][3] - The Phase 2 ACUITY trial of OCS-05 in acute optic neuritis (AON) is on track for topline readout in Q4 2024 [1][4] - A pre-NDA meeting with the FDA was completed in August for OCS-01, with NDA submission anticipated in Q1 2025 [1][6] Clinical Highlights - OCS-01 for DME: Patient enrollment in Phase 3 DIAMOND trials exceeded expectations, reaching 35% for DIAMOND-1 and 23% for DIAMOND-2 by the end of June 2024 [4] - OCS-02 (licaminlimab) in DED: Positive results from the Phase 2b RELIEF trial showed improvements in multiple regulatory efficacy endpoints, particularly in patients with the TNFR1 genetic biomarker [4][3] - OCS-05 in AON: Enrollment in the Phase 2 ACUITY trial is complete, with topline readout expected in Q4 2024 [4][6] Financial Highlights - As of June 30, 2024, the company had cash, cash equivalents, and short-term investments totaling $131.2 million, an increase from $109.0 million as of December 31, 2023 [7] - Research and development expenses for Q2 2024 were $18.2 million, up from $6.9 million in Q2 2023, primarily due to increased clinical trial expenses [7][8] - The net loss for Q2 2024 was $23.0 million, compared to $14.3 million in Q2 2023, driven by higher clinical development costs [7][8] Corporate Developments - The company raised $59 million in an oversubscribed registered direct offering and listed on the Nasdaq Iceland Main Market [5] - New appointments to the Board of Directors and Scientific Advisory Board aim to strengthen the company's development and commercial expertise [5] - The company plans to consult with the FDA in Q1 2025 regarding the OCS-02 (licaminlimab) program in DED [6]