Oculis Reports Q2 2025 Financial Results and Provides Company Update
Focused execution in Q2 2025 to advance Oculis' pipeline in ophthalmology and neuro-ophthalmology
OCS-01: Both pivotal Ph3 DIAMOND trials are fully enrolled, with topline results expected in Q2 2026 for the first potential eye drop to treat diabetic macular edema (DME)
Privosegtor (OCS-05): Preparing to initiate Phase 2/3 trial in acute optic neuritis (AON) in 1H 2026 following positive Ph2 ACUITY results, and expanding clinical development into two new indications as the first potential neuroprotective treatment for non-arteritic anterior ischemic optic neuropathy (NAION) and multiple sclerosis relapses
Licaminlimab (OCS-02): Preparing for first genotype-based Phase 2/3 trial in 2H 2025 to drive personalized medicine in dry eye disease (DED)
Cash, cash equivalents and short-term investments of $201.3 million as of June 30, 2025, providing cash runway into early 2028; excludes the recently announced upsized loan facility with BlackRock, providing access up to $123.7 million
ZUG, Switzerland, Aug. 21, 2025 (GLOBE NEWSWIRE) -- Oculis Holding AG (NASDAQ:OCS) ("Oculis"), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in ophthalmology and neuro-ophthalmology, today announced results for the second quarter ended June 30, 2025 and provided an overview of the Company's progress.
Riad Sherif, M.D., Chief Executive Officer of Oculis, states: "We maintain a strong focus on execution to advance our portfolio of highly differentiated assets in areas with significant unmet medical needs. The rapid enrollment in both Phase 3 DIAMOND trials highlights strong support from the medical community for OCS-01, which aims to become the first eye drop treatment for diabetic macular edema, with topline results expected in Q2 2026. We are also preparing Licaminlimab's (OCS-02) genotype-based Phase 2/3 trial in 2H 2025 to deliver a first personalized medicine treatment in dry eye disease. Moreover, encouraging Phase 2 ACUITY trial results for Privosegtor (OCS-05) in acute optic neuritis, which showed significant improvement in visual function as well as anatomical and biological neuroprotective benefits, are unlocking a new era of potential therapies targeting neuronal and axonal preservation, and addressing a long-standing gap in neuroprotection for the first time. These strong efficacy signals open opportunities across ophthalmology, neuro-ophthalmology, and neurology."
Recent Clinical Highlights and Upcoming Milestones:
OCS-01:
Phase 3 DIAMOND trials completed enrollment with over 800 patients across 119 global sites; if approved, OCS-01 has the potential to be the first topical treatment for DME.
DME affects approximately 37 million people worldwide and represents a ~$5 billion market opportunity with high unmet medical needs for early intervention and for patients with inadequate response to standard of care.
Topline results from both trials are expected in Q2 2026 with NDA submission planned for 2H 2026.
Privosegtor (OCS-05):
Privosegtor is a neuroprotective candidate with the potential to become a first-in-class therapy for AON, an acute inflammation of the optic nerve that can lead to permanent visual impairment and may be the first sign of multiple sclerosis.
Phase 2 ACUITY trial results showed significant improvement in visual function as well as anatomical and biological neuroprotective benefits.
FDA interactions are planned for Q3 2025 to discuss the development program for Privosegtor, including a Phase 2/3 trial for AON, expected to initiate in 1H 2026.
Privosegtor's neuroprotective benefit opens broad potential clinical applications for multiple neuro-ophthalmology and neurology indications with high unmet need, including in the two new indications to be investigated: NAION and multiple sclerosis relapses.
Licaminlimab (OCS-02):
Genotype-based development plan in dry eye disease aligned with FDA to deliver a first personalized medicine treatment in dry eye disease; Phase 2/3 trial to be initiated in 2H 2025 following three positive Phase 2 studies previously completed.
Second Half 2025 Financial Results
As of June 30, 2025, Oculis held cash, cash equivalents and short-term investments of CHF 160.3 million or $201.3 million. Research and development expenses were CHF 14.9 million or $18.1 million for the three-months ended June 30, 2025, compared to CHF 16.5 million or $18.2 million in the same period in 2024. The decrease was primarily due to the timing of two completed trials in 2024, partially offset by ongoing trials and increased R&D personnel-related costs. General and administrative expenses were CHF 6.1 million or $7.4 million for the three-months ended June 30, 2025, compared to CHF 6.3 million or $6.9 million in the same period in 2024. The decrease was primarily driven by a reduction in external professional services costs incurred in the prior year period. Year-to-date net loss was CHF 58.6 million or $67.9 million for the six months ended June 30, 2025, compared to CHF 36.9 million or $41.5 million for the same period in 2024. The increase was primarily driven by advancements in clinical development programs and a CHF 10.4 million or $12.1 million increase in the non-cash fair value adjustment on warrant liabilities as a result of appreciation of underlying warrant fair value.
Upcoming Events:
Medical Conferences and Industry Events
Ophthalmology Futures Retina Forum; Sep. 3, Paris, France
EURETINA Innovation Spotlight; Sep. 3, Paris, France
EURETINA Annual Meeting; Sep. 4 - 7, Paris, France
Retina Society Annual Meeting; Sep. 10 - 13, Chicago, IL, US
Ophthalmology Futures European Forum; Sep. 11, Copenhagen, Denmark
ESCRS Annual Congress; Sept. 12 - 16, Copenhagen, Denmark
ECTRIMS Annual Meeting; Sep. 24 - 26, Barcelona, Spain
Investor Conferences
Wells Fargo Healthcare Conference; Sep. 3 - 5, Boston, MA, US
HCW 27th Annual Global Investment Conference; Sep. 8 - 10, New York City, NY, US
Baird 2025 Global Healthcare Conference; Sep. 9 - 10, New York City, NY, US
Pareto Securities Healthcare Conference; Sep. 16, Stockholm, Sweden
Leerink Biopharma Summit; Sep. 17 - 19, Healdsburg, CA, US
Condensed Consolidated Statements of Financial Position (Unaudited)
(Amounts in CHF thousands)
As of June 30,
As of December 31,
2025
2024
ASSETS
Non-current assets
Property and equipment
441
385
Intangible assets
13,292
13,292
Right-of-use assets
1,155
1,303
Other non-current assets
533
476
Total non-current assets
15,421
15,456
Current assets
Other current assets
4,721
5,605
Accrued income
1,179
629
Short-term financial assets
96,035
70,955
Cash and cash equivalents
64,265
