-- 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
------------------ ------------------
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
Total non-current
liabilities 3,146 2,735
------------------ ------------------
Current liabilities
Trade payables 1,800 5,871
Accrued expenses and
other payables 19,967 18,198
Short-term lease
liabilities 502 315
Warrant liabilities 14,478 19,851
Total current
liabilities 36,747 44,235
------------------ ------------------
Total liabilities 39,893 46,970
------------------ ------------------
TOTAL EQUITY AND
LIABILITIES 235,963 120,353
================== ==================
Consolidated Statements of Loss (Unaudited)
(Amounts in CHF
thousands, except For the three months For the twelve months
per share data) ended December 31, ended December 31,
2025 2024 2025 2024
Grant income 411 3 1,199 686
Operating income 411 3 1,199 686
----------- ---------- ----------- ----------
Research and
development
expenses (13,288) (11,763) (57,085) (52,083)
General and
administrative
expenses (7,756) (5,500) (25,786) (21,807)
Operating expenses (21,044) (17,263) (82,871) (73,890)
----------- ---------- ----------- ----------
Operating loss (20,633) (17,260) (81,672) (73,204)
----------- ---------- ----------- ----------
Finance income 319 371 1,770 2,168
Finance expense (241) (247) (833) (639)
Fair value
adjustment on
warrant
liabilities (3,238) (13,387) (12,294) (15,531)
Foreign currency
exchange gain
(loss) 97 1,630 (6,114) 1,269
Finance result (3,063) (11,633) (17,471) (12,733)
----------- ---------- ----------- ----------
Loss before tax for
the period (23,696) (28,893) (99,143) (85,937)
Income tax benefit
(expense) 182 238 186 160
Loss for the period (23,514) (28,655) (98,957) (85,777)
=========== ========== =========== ==========
Loss per share:
Basic and diluted
loss attributable
to equity holders (0.42) (0.67) (1.89) (2.12)
- ENDS-
About Oculis
Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology. Oculis' highly differentiated late-stage clinical pipeline includes three core product candidates: Privosegtor, a breakthrough neuroprotective candidate in the PIONEER program which consists of studies intended to support registration plans for treatment in optic neuropathies like optic neuritis (ON) and non-arteritic anterior ischemic optic neuropathy (NAION), with potentially broad clinical applications in various other neuro-ophthalmic and neurological diseases; OCS-01, an eye drop in pivotal registration studies, aiming to become the first non-invasive topical treatment for diabetic macular edema (DME); and Licaminlimab, a novel, topical anti-TNF<ALPHA> in registrational trial, which is being developed with a genotype-based approach to drive precision medicine in dry eye disease (DED). Headquartered in Switzerland with operations in the U.S. and Iceland, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors.
For more information, please visit: www.oculis.com
Oculis Contact
Ms. Sylvia Cheung, CFO
sylvia.cheung@oculis.com
Investor Relations
LifeSci Advisors
Corey Davis, Ph.D.
cdavis@lifesciadvisors.com
Media Relations
ICR Healthcare
Amber Fennell / David Daley / Sean Leous
oculis@icrhealthcare.com
Cautionary Statement Regarding Forward Looking Statements
This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of the Company's product candidates, the initiation, timing, progress and results of current and future clinical trials, Oculis' research and development programs, regulatory and business strategy; Oculis' future development plans; the timing or likelihood of regulatory filings and approvals; statements about market opportunity, and the Company's expected financial position and cash runway, are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Oculis' control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis' annual report on Form 20-F and any other documents filed with the SEC. Copies of these documents are available on the SEC's website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
References:
1. Decision Resources Group: DME -- DR Landscape Forecast -- Disease
Landscape Forecast 2020
2. Iris Registry -- Baseline characteristics and demographics of treatment
naïve patients at diagnosis (Table S1)
3. Gonzalez 2016 Early and Long-term Responses to VEGF Therapy in DME:
Analysis of protocol I data
(END) Dow Jones Newswires
March 03, 2026 16:05 ET (21:05 GMT)