Oculis Q2 2024 Financial Results and Company Update

Oculis Holding AG, a global biopharmaceutical company dedicated to enhancing eye care, recently announced its financial results for the quarter ending June 30, 2024, and highlighted significant advancements in its clinical programs.

The Swiss-based company reported positive topline results from the Phase 2b RELIEF trial of OCS-02 (licaminlimab), a promising treatment for Dry Eye Disease (DED). This trial demonstrated significant improvements in regulatory efficacy endpoints, particularly in patients with the TNFR1 genetic biomarker. If approved, OCS-02 could become the first precision medicine for this condition, which has traditionally relied on a trial-and-error treatment approach.

Oculis has also made substantial progress with its lead asset, OCS-01, a topical eye drop under evaluation for diabetic macular edema (DME). The company is conducting two Phase 3 trials, DIAMOND-1 and DIAMOND-2, in which patient enrollment has surpassed initial expectations, reaching 35% for DIAMOND-1 and 23% for DIAMOND-2 as of June. Furthermore, Oculis completed a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for OCS-01, aimed at treating post-operative inflammation and pain following ocular surgery. With FDA guidance, the company plans to submit an NDA in the first quarter of 2025.

In addition to these advancements, Oculis is progressing with its Phase 2 ACUITY trial of OCS-05, a novel neuroprotective candidate for acute optic neuritis (AON). The trial has completed patient enrollment, and topline results are anticipated in the fourth quarter of 2024. OCS-05 could potentially address unmet needs in neuro-ophthalmic diseases by offering neuroprotection in conditions like glaucoma, geographic atrophy, and diabetic retinopathy.

On the financial front, Oculis reported cash, cash equivalents, and short-term investments totaling $131.2 million as of June 30, 2024, sufficient to fund operations into the second half of 2026. The company raised $59 million in a recent oversubscribed registered direct offering, which included participation from new Icelandic institutional and existing investors. As part of its growth strategy, Oculis also listed on the Nasdaq Iceland Main Market in addition to the Nasdaq Global Market in the U.S.

Oculis strengthened its leadership team with the appointment of Snehal Shah as President of Research & Development and elected Robert K. Warner and Arshad M. Khanani to its Board of Directors. Additionally, Baruch D. Kuppermann and Frank G. Holz joined the Scientific Advisory Board, further bolstering the company’s expertise as it advances its Phase 3 DIAMOND trials.

The company reported increased research and development expenses of $18.2 million for the quarter, a rise primarily driven by ongoing clinical trials for OCS-01, OCS-02, and OCS-05. General and administrative expenses also increased to $6.9 million, reflecting higher personnel costs and transaction expenses from the recent offering. Consequently, Oculis reported a net loss of $23.0 million for the second quarter, up from $14.3 million in the same period in 2023.

Despite the financial losses, Oculis remains focused on its mission to advance innovative treatments for eye diseases. The company is poised for several upcoming milestones, including the NDA submission for OCS-01 and the topline readout for the Phase 2 ACUITY trial.

In summary, Oculis Holding AG is making significant strides in the development of treatments for various eye conditions. With robust clinical progress, strategic financial moves, and a strengthened leadership team, the company is well-positioned to achieve its goal of improving eye care and patient outcomes worldwide.