Oculis Announces Q2 Financial Results and Company Update

Oculis Holding AG, a global biopharmaceutical company focused on innovative eye care solutions, reported significant progress in its clinical and corporate activities for the quarter ending June 30, 2024. The company has achieved major milestones in its clinical trials and financial standing, reinforcing its commitment to advancing treatments for various eye conditions.

Clinical Developments:

Oculis announced positive topline results for its Phase 2b RELIEF trial of OCS-02 (licaminlimab) targeted at treating Dry Eye Disease (DED). The trial demonstrated improvements in multiple regulatory endpoints, particularly in patients with the TNFR1 genetic biomarker, suggesting the potential for OCS-02 to be the first precision medicine for DED.

The Phase 3 DIAMOND trials of OCS-01, an eye drop for Diabetic Macular Edema (DME), are progressing well. Patient enrollment has exceeded expectations, with 35% and 23% of patients randomized for DIAMOND-1 and DIAMOND-2 trials, respectively. This positions Oculis to potentially offer the first eye drop treatment for DME.

Additionally, the Phase 2 ACUITY trial of OCS-05, aimed at treating Acute Optic Neuritis (AON), has completed patient enrollment. The topline readout for this neuroprotective candidate is anticipated in the fourth quarter of 2024. OCS-05 could play a critical role in treating neuro-ophthalmic diseases and is currently undergoing evaluation as a potential treatment for AON, a condition marked by acute inflammation and demyelination of the optic nerve.

Oculis also held 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. The FDA has confirmed that the data from completed trials are sufficient to support an NDA submission in the first quarter of 2025.

Corporate Achievements:

Oculis successfully raised $59 million through an oversubscribed registered direct offering, which included participation from new Icelandic institutional and existing investors. This funding will support the company's ongoing and future clinical trials.

The company strengthened its leadership by appointing Snehal Shah, Pharm. D., as President of Research & Development. This addition enhances Oculis’s R&D capabilities. Furthermore, Robert K. Warner, M.B.A., and Arshad M. Khanani, M.D., M.A., FASRS joined the Board of Directors, bringing extensive development and commercial expertise. Additionally, Baruch D. Kuppermann, M.D., Ph.D., and Frank G. Holz, M.D., Ph.D., were appointed to the Scientific Advisory Board to support the advancement of the DIAMOND trials.

Presentations and Recognitions:

Oculis presented positive results from the Phase 3 OPTIMIZE-1 trial of OCS-01 for treating inflammation and pain following cataract surgery at the 2024 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting. The company also established the Ramin Tadayoni Award with EURETINA, honoring the late Chief Scientific Officer and renowned retina expert.

Financial Highlights:

As of June 30, 2024, Oculis reported a solid cash position with cash, cash equivalents, and short-term investments totaling $131.2 million. This financial stability is expected to fund operations into the second half of 2026.

The company's research and development expenses increased to $18.2 million for the quarter, largely driven by the ongoing clinical trials for OCS-01, OCS-02, and OCS-05. General and administrative expenses were $6.9 million, reflecting higher personnel costs and non-recurring transaction costs linked to the recent fundraising activity.

Oculis reported a net loss of $23.0 million for the second quarter of 2024, primarily due to increased clinical development expenses. However, the year-to-date net loss decreased compared to the previous year, attributed to the non-recurring merger and listing expense recorded in 2023.

Conclusion:

Oculis Holding AG continues to make significant strides in developing innovative treatments for various eye diseases. With promising clinical trial results, strategic corporate moves, and a strong financial foundation, Oculis is well-positioned to advance its mission of improving eye care globally.

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