Oculis Surges Ahead with Groundbreaking Ophthalmic AdvancementsOculis Holding AG, a global biopharmaceutical company, has announced significant progress in its product portfolio, including the enrollment of the OCS-01 DIAMOND Phase 3 program in diabetic macular edema (DME) and the OCS-05 Phase 2 ACUITY trial in acute optic neuritis (AON). The company has also bolstered its leadership team with extensive experience in key areas, positioning it for continued success as it advances its late-stage pipeline and prepares for the commercial phase.

Unlocking the Future of Eye Care with Oculis' Innovative Pipeline

Pioneering Treatments for Diabetic Macular Edema

Oculis has made substantial enrollment progress in its Phase 3 DIAMOND-1 and DIAMOND-2 trials for OCS-01, an OPTIREACH® formulation of high-concentration dexamethasone eye drop, in the treatment of DME. The company has achieved approximately 70% enrollment in the DIAMOND-1 trial and 40% enrollment in the DIAMOND-2 trial, demonstrating the strong momentum in its clinical development efforts.The DIAMOND program has been further strengthened by the expansion of its committees with leading retina experts. These renowned specialists will provide invaluable insights and guidance as Oculis continues to advance the development of OCS-01, which has the potential to become the first non-invasive therapy for DME. This innovative treatment aims to address the unmet medical needs for early intervention and patients who are inadequately controlled with current therapies.

Exploring the Neuroprotective Potential of OCS-05 in Acute Optic Neuritis

Oculis is also eagerly anticipating the topline readout from the Phase 2 ACUITY trial for OCS-05, a peptidomimetic serum glucocorticoid kinase-2 (SGK-2) activator, in the treatment of AON. This randomized, double-blind, placebo-controlled, multi-center trial in France is designed to evaluate the safety and tolerability of OCS-05, as well as explore its potential neuroprotective benefits.AON is a rare condition characterized by acute inflammation of the optic nerve, which can lead to permanent visual impairment. While corticosteroids are currently used to treat the inflammation, there remains a critical unmet need for therapies that can preserve vision or provide neuroprotection after an acute episode of optic neuritis.In preclinical studies, OCS-05 has demonstrated promising neuroprotective activity, including the prevention of retinal ganglion cell damage in models of neuroinflammation, neurodegeneration, and AON. The upcoming topline readout from the ACUITY trial will provide valuable insights into the safety and potential of OCS-05 as a novel therapeutic approach for AON and other neuro-ophthalmic diseases.

Strengthening the Leadership Team for Continued Success

Oculis has further bolstered its leadership team with the appointments of Sharon Klier, M.D. as Chief Development Officer and Daniel S. Char as Chief Legal Officer. These experienced professionals bring a wealth of expertise in key areas, strengthening the company's capabilities as it advances its late-stage pipeline and prepares for the commercial phase.The addition of these seasoned leaders, coupled with Oculis' solid financial position, positions the company well to drive the execution of its pipeline development and create value for its stakeholders.

Robust Financial Footing to Fuel Continued Growth

As of September 30, 2024, Oculis reported a strong cash position, with total cash, cash equivalents, and short-term investments of CHF 105.5 million (approximately $125.0 million). This represents an increase from the CHF 91.7 million (approximately $109.0 million) reported as of December 31, 2023, reflecting the proceeds from a registered direct offering in the second quarter of 2024.Based on the company's current development plans, the cash balances are expected to fund operations into the second half of 2026, providing Oculis with the financial resources to continue advancing its pipeline and preparing for the commercial phase.The company's research and development expenses for the third quarter of 2024 were CHF 13.0 million (approximately $15.0 million), up from CHF 8.9 million (approximately $10.0 million) in the same period in 2023. This increase was primarily driven by higher clinical trial expenses related to the ongoing OCS-01 DIAMOND trials and the OCS-05 ACUITY trial.Oculis' commitment to transparency is evident in its reporting, which includes the presentation of non-IFRS financial measures. These measures, which exclude the impact of one-time and non-cash items, provide investors with a clearer understanding of the company's underlying business performance and financial outlook.