Oculis Announces Q1 2024 Financial Results and Company Updates

Oculis Holding AG, a biopharmaceutical company listed on both Nasdaq and the Nasdaq Iceland Main Market, has announced its first-quarter results for 2024, highlighting significant progress in its clinical programs and corporate developments.

Clinical Program Progress:

Oculis has initiated the second Phase 3 DIAMOND-2 trial for OCS-01 in diabetic macular edema (DME). OCS-01, formulated as a high-concentration dexamethasone eye drop, is under investigation in two ongoing Phase 3 trials, DIAMOND-1 and DIAMOND-2, which started in December 2023 and February 2024, respectively.

Additionally, Oculis rapidly completed patient enrollment for the Phase 2b RELIEF trial of OCS-02 (licaminlimab) for dry eye disease (DED). Licaminlimab, a TNFα inhibitor eye drop developed through proprietary antibody fragment technology, aims to address ocular inflammations. The trial, initiated in November 2023, evaluates the efficacy and safety of OCS-02 against a vehicle and explores its potential benefits for patients with specific genotypes.

Corporate Developments:

In April 2024, Oculis secured $59 million through an oversubscribed registered direct equity offering, with strong participation from new Icelandic institutional and existing investors. Concurrently, the company completed a dual listing on the Nasdaq Iceland Main Market alongside its existing Nasdaq Global Market listing in the U.S. This financing extends Oculis' cash runway into the second half of 2026.

The company also strengthened its executive leadership with the appointments of Snehal Shah, Pharm. D., as President of Research & Development, and Virginia R. Dean as Chief Human Resources Officer. Both are seasoned professionals with extensive experience in their respective fields.

Key Highlights and Events:

Oculis hosted an R&D Day on February 28, 2024, which featured discussions on pivotal clinical programs, including the DIAMOND and RELIEF trials, and presentations from ten leading experts in retina and anterior segments. The event attracted over 100 participants.

At the 2024 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting, Oculis presented positive results from the Phase 3 OPTIMIZE-1 trial, demonstrating the efficacy of OCS-01 in treating inflammation and pain post-cataract surgery.

Upcoming Milestones:

Oculis continues to advance its pipeline with several anticipated milestones. Topline results for the Phase 2b RELIEF trial of OCS-02 in DED are expected in the second quarter of 2024. The second Phase 3 OPTIMIZE-2 trial evaluating OCS-01 for inflammation and pain following cataract surgery is set to report topline results in the fourth quarter of 2024. Positive outcomes from this trial and the prior OPTIMIZE-1 trial could support the company's first NDA submission.

The Phase 2 ACUITY trial, assessing the safety and tolerability of OCS-05, a serum glucocorticoid kinase-2 (SGK-2) activator with potential neuroprotective benefits for acute optic neuritis (AON), is also expected to deliver topline results by the fourth quarter of 2024. Oculis plans to complete an IND submission for OCS-05 in the U.S. in 2024.

Financial Overview:

As of March 31, 2024, Oculis reported total cash, cash equivalents, and short-term investments of CHF 79.9 million ($88.7 million), down from CHF 91.7 million ($108.9 million) at the end of 2023. The decrease reflects planned development activities and routine operations. However, the recent $59 million equity offering bolsters the company's financial position, ensuring sufficient funds into the latter half of 2026.

Research and development expenses rose to CHF 10.9 million ($12.4 million) for the quarter, compared to CHF 6.1 million ($6.6 million) in the same period in 2023, largely due to increased clinical trial costs. General and administrative expenses also increased to CHF 4.7 million ($5.4 million) from CHF 4.0 million ($4.4 million), driven by higher public company operating costs and personnel expenses.

The net loss for the first quarter was CHF 16.1 million ($18.4 million), down from CHF 46.0 million ($49.7 million) in the first quarter of 2023, primarily due to non-recurring merger and listing expenses in the previous year, offset by increased R&D expenses and non-cash fair value adjustments on outstanding warrants.

Oculis remains committed to its mission of saving sight and improving eye care, with a robust pipeline of innovative product candidates. The company’s strategic initiatives and financial stewardship position it well for future growth and success.