Oculis Announces Q3 2024 Financials and Company Updates

ZUG, Switzerland, Nov. 07, 2024 – Oculis Holding AG, a global biopharmaceutical company dedicated to improving eye care, has reported its third-quarter results for 2024 and shared its progress. The company has made significant advances in its product pipeline, particularly with its OCS-01 DIAMOND Phase 3 program in diabetic macular edema (DME) and its OCS-05 Phase 2 ACUITY trial in acute optic neuritis (AON), with key results expected in December 2024. Additionally, Oculis has enhanced its leadership team and strengthened its financial position.

CEO Riad Sherif provided an update on the company's achievements, highlighting the accelerated recruitment for both Phase 3 trials of OCS-01 in DME and the anticipated topline results for the OCS-05 Phase 2 ACUITY trial in AON. These results will provide critical insights into the safety and tolerability of OCS-05 and its potential as a neuroprotective therapy in AON and other neuro-ophthalmic diseases. The company's leadership has been bolstered with the appointment of Sharon Klier, M.D. as Chief Development Officer and Daniel S. Char as Chief Legal Officer. Oculis is well-positioned to advance its pipeline and create value for stakeholders, supported by a solid balance sheet with $125.0 million in cash and investments as of September 30, 2024.

Key developments in Q3 2024 include substantial enrollment progress in the Phase 3 DIAMOND-1 and DIAMOND-2 trials for OCS-01 in DME, with about 70% and 40% of patients enrolled, respectively. The DIAMOND program committees have also been expanded with leading retina experts. Notably, David Eichenbaum, M.D., presented updates on the DIAMOND Phase 3 program at the Innovate Retina event, emphasizing the potential of OCS-01 to become the first non-invasive therapy for DME. Additionally, at the 2024 EURETINA congress, the inaugural Ramin Tadayoni Award, supported by Oculis, was presented to Andrea Govetto, M.D., Ph.D., recognizing his work on a computational model of fluid flow and retinal tissue deformation in macular edema.

The company is also preparing for important milestones, including a pre-NDA meeting with the U.S. FDA in August 2024 for OCS-01, which aims for NDA submission readiness by Q1 2025. For OCS-02 (licaminlimab), Oculis plans to consult with the FDA in Q1 2025 to discuss the positive results from the Phase 2b RELIEF trial. OCS-05 is set to provide topline readouts for the Phase 2 ACUITY trial in AON in December 2024. This trial, conducted in France, focuses on evaluating the safety and tolerability of OCS-05. AON, a rare disease causing acute inflammation of the optic nerve, affects up to 8 in 100,000 individuals worldwide and primarily occurs in adults aged 20 to 40. While corticosteroids are the current treatment, there is a pressing need for therapies offering neuroprotection after an acute optic neuritis episode. In animal models, OCS-05 has shown evidence of neuroprotective activity, demonstrating potential benefits in conditions like glaucoma and AON, without reported drug-related side effects in Phase 1 trials.

Financially, Oculis reported a cash position of $125.0 million as of September 30, 2024, reflecting an increase from $109.0 million as of December 31, 2023, due to proceeds from a direct offering in Q2 2024. The company expects this cash reserve to support operations into the second half of 2026. Research and development expenses for Q3 2024 were $15.0 million, up from $10.0 million in Q3 2023, driven by clinical trial expenses for OCS-01 and OCS-05. General and administrative expenses also increased to $6.2 million, primarily due to stock-based compensation. The net loss for Q3 2024 was $23.3 million, compared to $19.7 million in Q3 2023, mainly due to rising clinical development costs. For the nine months ended September 30, 2024, the net loss was $64.8 million, down from $84.5 million in the comparable period of 2023, influenced by non-recurring merger and listing expenses recorded in 2023.

In conclusion, Oculis is making substantial progress in advancing its innovative eye care treatments, supported by a robust financial position and an experienced leadership team, positioning the company for future growth and success in the biopharmaceutical industry.