Press Release: Oculis Reports Q4 and Full Year 2025 Financial Results and Provides Company Update
-- Significant achievements in 2025, enabling multiple near-term clinical milestones across late-stage portfolio, starting with the forthcoming topline results from DIAMOND Phase 3 trials with OCS-01 eye drops in diabetic macular edema (DME) in Q2 2026 -- Key expansion in neuro-ophthalmology with Breakthrough Therapy designation granted to Privosegtor, propelling the PIONEER registrational program in optic neuropathies with a potential U.S. market opportunity of over $7 billion -- Cash, cash equivalents, and short-term investments of $268.7 million as of December 31, 2025, providing cash runway into 2029
ZUG, Switzerland, March 3, 2026 -- Oculis Holding AG (Nasdaq: OCS / XICE: 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 fourth quarter and full year ended December 31, 2025, and provided an overview of the Company's progress.
Riad Sherif, M.D., Chief Executive Officer of Oculis, stated "Oculis has delivered a transformative 2025, marked by significant clinical progress across our late-stage portfolio and a strategic expansion into neuro-ophthalmology. The compelling Phase 2 ACUITY results for Privosegtor in optic neuritis led to a pivotal FDA Breakthrough Therapy designation and anchored the launch of our global PIONEER registrational program. We believe Privosegtor holds immense potential as a first-in-class neuroprotective platform for a range of neuro-axonal diseases. 2026 is positioned to be a landmark year for the company with a roadmap featuring three major expected registrational milestones: the DIAMOND-1 and DIAMOND-2 trials readout with OCS-01, a potential first-in-class eye drop in DME, anticipated in Q2, the PREDICT-1 trial results for Licaminlimab with a precision medicine approach in dry eye disease planned in Q4, and the commencement of three registrational trials with Privosegtor as part of the PIONEER program. The operational excellence and significant milestones we achieved in 2025 have uniquely positioned Oculis to drive innovation in areas of high unmet medical need, a potential market opportunity of over $30 billion, with the aim of redefining the standard of care in ophthalmology and neuro-ophthalmology."
Recent Clinical Highlights and Upcoming Milestones:
Privosegtor:
-- Breakthrough Therapy designation recently granted by the FDA for treatment of optic neuritis (ON), a sight-threatening neuro-ophthalmic condition that is often the first clinical manifestation of multiple sclerosis. Designation is supported by the Phase 2 ACUITY trial results, in which Privosegtor + steroid showed substantial improvements in vision and consistent anatomical and biological neuroprotective benefits compared with placebo + steroid. These novel findings reinforced Privosegtor's potential as a neuroprotective treatment across both neuro-ophthalmic and neurological diseases. -- Following a successful meeting with the FDA in the fall of 2025, Oculis launched the PIONEER program, which includes three pivotal trials in ON and non-arteritic anterior ischemic optic neuropathy (NAION). These two optic neuropathies represent a market opportunity estimated at $7+ billion in the U.S. alone. The first registrational trial in the program, PIONEER-1 in ON, was initiated in Q4 of 2025, with clinical sites activation progressing as planned.
OCS-01:
-- Both Phase 3 DIAMOND trials with OCS-01, which aims to be the first eye drop therapy for DME, have enrolled over 800 patients and are nearing completion. Topline results are expected in Q2 2026, and, if positive, a subsequent NDA submission to the FDA is planned for Q4 2026. -- While the U.S. DME market is currently valued at approximately $3 billion, only a fraction of the 1.8 million people diagnosed1,2,3 with the disease are successfully managed. This leaves a staggering 1.3 million patients underserved by the current standard of care1,2,3. OCS-01 is intended to be strategically positioned to capture this 'lost' majority by providing a non-invasive, topical eye drop for those requiring early intervention and a versatile option for patients who do not respond to existing injections.
Licaminlimab:
-- Oculis recently initiated the first genotype-based registrational trial, PREDICT-1, to drive precision medicine in dry eye disease (DED) with Licaminlimab. In prior Phase 2 studies, Licaminlimab showed a substantially greater treatment effect in patients carrying a specific TNFR1 genotype, with profound improvements ranging from five-fold greater in signs and seven-fold greater in symptoms. Topline results from PREDICT-1 are expected in Q4 2026. -- In the U.S. approximately 10 million patients suffer from moderate to severe DED. Current disease management relies on trial and error, and only 13% of patients experience sustained relief, leading to high discontinuation rates within the first six months, underscoring the strong need for a targeted, effective treatment approach. Licaminlimab has the potential to transform the current treatment paradigm by providing a precision medicine approach with efficacy, rapid onset of action, and a comfort level similar to artificial tears.
Q4 and Full Year 2025 Financial Highlights:
As of December 31, 2025, Oculis held cash, cash equivalents and short-term investments of CHF 213.0 million or $268.7 million, compared to CHF 98.7 million or $109.0 million as of December 31, 2024. The increase in cash, cash equivalents and short-term investments was primarily due to equity financings closed in February and November 2025 for aggregate gross proceeds of $210.0 million (CHF 178.9 million). Research and development expenses were CHF 13.3 million or $16.6 million for the three months ended December 31, 2025, compared to CHF 11.8 million or $13.4 million in the same period in 2024. The increase was primarily due to advancements in clinical development activities of our late-stage portfolio and associated personnel expenses. General and administrative expenses were CHF 7.8 million or $9.7 million for the three months ended December 31, 2025, compared to CHF 5.5 million or $6.3 million in the same period in 2024. The increase was primarily driven by personnel expenses and external professional services costs. Year-to-date net loss was CHF 99.0 million or $119.1 million for the year ended December 31, 2025, compared to CHF 85.8 million or $97.4 million for the same period in 2024. The increase was primarily due to an increase in operating expenses driven by the OCS-01 Phase 3 DIAMOND trials, increased personnel costs and a CHF 7.4 million or $8.9 million increase in foreign exchange revaluation loss, offset by a CHF 3.2 million or $3.9 million decrease in the non-cash fair value adjustment on warrant liabilities resulting from warrant exercises during the year offset by increases in the fair value of outstanding warrants.
Upcoming Events:
Medical Conferences and Industry Events
-- COPHy Annual Congress, Mar. 20-21, Krakow, Poland -- NANOS Annual Meeting, Mar. 20-24, Boston, MA, U.S. -- AAN Annual Meeting, Apr. 18-21, Chicago, IL, U.S. -- Eyecelerator, May 1, Denver, CO, U.S. -- ARVO, May 3-7, Denver, CO, U.S.
Investor Conferences
-- Leerink Partners Global Healthcare Conference, Mar. 8-11, Miami, FL, U.S. -- Leerink Partners Mountain Meeting, Mar. 22-25, Jackson Hole, WY, U.S. -- Needham Healthcare Conference, Apr. 13-16, Virtual -- Van Lanschot Kempen Life Sciences Conference, Apr. 15-16, Amsterdam, Netherlands
Consolidated Statements of Financial Position (Unaudited)
(Amounts in CHF
thousands) As of December 31, As of December 31,
2025 2024
ASSETS
Non-current assets
Property and equipment 534 385
Intangible assets 13,292 13,292
Right-of-use assets 2,463 1,303
Other non-current assets 785 476
Total non-current assets 17,074 15,456
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Current assets
Other current assets 4,883 5,605
Accrued income 993 629
Short-term financial
assets 131,684 70,955
Cash and cash
equivalents 81,329 27,708
Total current assets 218,889 104,897
------------------ ------------------
TOTAL ASSETS 235,963 120,353
================== ==================
EQUITY AND LIABILITIES
Shareholders' equity
Share capital 587 446
Share premium 551,731 344,946
Reserve for share-based
payment 30,387 16,062
Actuarial loss on
post-employment benefit
obligations (1,634) (2,233)
Treasury shares (7) (10)
Cumulative translation
adjustments (480) (271)
Accumulated losses (384,514) (285,557)
Total equity 196,070 73,383
------------------ ------------------
Non-current
liabilities
Long-term lease
liabilities 1,811 865
Defined benefit pension
liabilities 1,335 1,870
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