Oculis Reports Q4 and Full Year 2025 Financial Results and Provides Company Update

Rhea-AI Summary

Oculis (Nasdaq: OCS) reported strong 2025 progress with CHF 213.0M ($268.7M) cash and short-term investments as of Dec 31, 2025, providing a runway into 2029. Key clinical milestones: DIAMOND Phase 3 topline for OCS-01 expected Q2 2026; FDA Breakthrough Therapy granted for Privosegtor; PIONEER and PREDICT-1 registrational programs launched.

Financials: 2025 net loss CHF 98.96M ($119.1M); increased R&D and G&A driven by late-stage trials; 2.0M new treasury shares issued under ATM program.

Positive

• Cash balance CHF 213.0M ($268.7M) provides runway into 2029
• DIAMOND Phase 3 trials enrolled >800 patients; topline Q2 2026
• FDA Breakthrough Therapy designation for Privosegtor in optic neuritis
• PIONEER registrational program initiated; PIONEER-1 started Q4 2025
• Licaminlimab PREDICT-1 genotype-based registrational trial initiated

Negative

• Year-to-date net loss CHF 98.96M ($119.1M) for 2025
• Operating expenses rose to CHF 82.9M in 2025 driven by Phase 3 work
• Share count increased; 2,000,000 new treasury shares issued

News Market Reaction – OCS

+0.54%

1 alert

+0.54% News Effect

+$9M Valuation Impact

$1.66B Market Cap

0.1x Rel. Volume

On the day this news was published, OCS gained 0.54%, reflecting a mild positive market reaction. This price movement added approximately $9M to the company's valuation, bringing the market cap to $1.66B at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Cash & investments: $268.7 million Cash (CHF): CHF 213.0 million Equity financings: $210.0 million +5 more

8 metrics

Cash & investments $268.7 million Cash, cash equivalents and short-term investments as of Dec 31, 2025

Cash (CHF) CHF 213.0 million Cash, cash equivalents and short-term investments as of Dec 31, 2025

Equity financings $210.0 million Aggregate gross proceeds from February and November 2025 financings

Net loss 2025 $119.1 million Year-to-date net loss for year ended Dec 31, 2025

New treasury shares 2,000,000 shares Registered ordinary shares issued into treasury for potential ATM use

Total registered shares 59,169,475 shares Total registered shares after issuance of new treasury shares

DME diagnosed population 1.8 million people People diagnosed with diabetic macular edema in the U.S.

Underserved DME patients 1.3 million patients DME patients underserved by current standard of care in the U.S.

Market Reality Check

Price: $27.72 Vol: Volume 439,401 is 1.38x t...

normal vol

$27.72 Last Close

Volume Volume 439,401 is 1.38x the 20-day average of 318,991 shares. normal

Technical Price $28.61 is above the 200-day MA at $20.46 and 6.75% below the 52-week high.

Peers on Argus

OCS traded down 2.72% while key biotech peers like EYPT (+6.75%) and QURE (+14.2...

1 Up 1 Down

OCS traded down 2.72% while key biotech peers like EYPT (+6.75%) and QURE (+14.25%) gained, suggesting stock-specific dynamics rather than a sector-wide move.

Previous Earnings Reports

5 past events · Latest: Nov 10 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 10	Q3 2025 earnings	Positive	-0.1%	Q3 2025 results, cash near $300M and runway into 2029 highlighted.
Nov 04	Research award news	Positive	-1.1%	Retina research award reinforcing retinal science collaboration and scientific profile.
Aug 21	Q2 2025 earnings	Neutral	+0.3%	Q2 2025 results, $201.3M cash, larger YTD loss and R&D spend.
May 08	Q1 2025 earnings	Negative	-0.6%	Q1 2025 results with higher net loss as trials advanced.
May 08	Q1 2025 earnings	Negative	-0.6%	Detailed Q1 2025 loss and R&D increase alongside pipeline progress.

Pattern Detected

Earnings/day financial updates have typically led to small moves, with slight downside bias despite generally strengthening cash and pipeline positions.

Recent Company History

Across the last five earnings/financial updates from May 2025 through November 2025, Oculis repeatedly highlighted growing cash balances, extended runway into 2028–2029, and steady advancement of Privosegtor, OCS-01, and Licaminlimab into late-stage or registrational trials. Price reactions to these updates clustered around modest moves (near flat to low single digits), often slightly negative even when cash and pipeline news were constructive. Today’s Q4/FY 2025 report continues that theme with higher cash, larger losses, and late-stage clinical milestones.

Historical Comparison

-0.4% avg move · Over five prior earnings-style updates, OCS moved an average of -0.44%. Today’s -2.72% pre-news move...

earnings

-0.4%

Average Historical Move earnings

Over five prior earnings-style updates, OCS moved an average of -0.44%. Today’s -2.72% pre-news move is more negative than the typical reaction to similar financial updates.

Earnings updates have traced a progression from early 2025 through late 2025: steadily rising cash balances and extended runway into 2028–2029, while Privosegtor, OCS-01, and Licaminlimab advanced from Phase 2 into pivotal and registrational programs.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-11-10

An effective Form F-3 dated Nov 10, 2025 registers the resale of up to 494,259 ordinary shares issuable under a warrant. Oculis is not selling shares in this prospectus and would only receive up to $6,877,246.59 if the warrant is fully exercised for cash.

Market Pulse Summary

This announcement combines Q4/FY 2025 results with a detailed clinical roadmap. Oculis reported $268...

Analysis

This announcement combines Q4/FY 2025 results with a detailed clinical roadmap. Oculis reported $268.7 million in cash, cash equivalents and short-term investments and a full-year net loss of $119.1 million, while advancing OCS-01, Privosegtor, and Licaminlimab toward Phase 3 and registrational milestones. Investors may watch upcoming DIAMOND and PREDICT-1 readouts, the pace of PIONEER enrollment, and any use of the 2,000,000 treasury shares under the ATM program.

Key Terms

diabetic macular edema, breakthrough therapy designation, optic neuritis, non-arteritic anterior ischemic optic neuropathy, +4 more

8 terms

diabetic macular edema medical

"OCS-01 eye drops in diabetic macular edema (DME) in Q2 2026"

Diabetic macular edema is an eye condition in which fluid leaks into and swells the macula, the part of the retina used for sharp, central vision, often as a complication of diabetes. For investors it matters because it drives demand for medicines, medical devices and eye-care services, influences clinical trial and regulatory outcomes, and can affect healthcare costs and revenue forecasts—think of the macula as the camera’s central lens that becomes blurred when it soaks up excess fluid.

breakthrough therapy designation regulatory

"Breakthrough Therapy designation granted to Privosegtor, propelling the PIONEER"

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

optic neuritis medical

"Breakthrough Therapy designation recently granted by the FDA for treatment of optic neuritis (ON)"

Inflammation of the optic nerve that can cause sudden vision loss, blurring, or eye pain, often like a camera lens fogging or an electrical wire briefly losing connection. It matters to investors because optic neuritis can signal safety issues for drugs or devices, affect regulatory approval, drive legal or clinical costs, and influence demand for treatments and diagnostic services—so reports of cases can move stock prices in healthcare and biotech names.

non-arteritic anterior ischemic optic neuropathy medical

"three pivotal trials in ON and non-arteritic anterior ischemic optic neuropathy (NAION)"

Non-arteritic anterior ischemic optic neuropathy is a sudden loss of vision caused by reduced blood flow to the front portion of the optic nerve, not by inflammation of blood vessels. Think of the optic nerve as an electrical cable whose power supply is briefly cut; the result is patchy or complete vision loss in one eye that can be permanent. It matters to investors because it defines a clear medical need, shapes the size of potential markets for treatments, affects the design and outcomes of clinical trials, and can influence regulatory decisions, reimbursement and liability risks for healthcare companies.

nda submission regulatory

"Topline results are expected in Q2 2026, and, if positive, a subsequent NDA submission"

An NDA submission is the formal application a drug developer files with a medicines regulator seeking permission to market a new prescription drug. Think of it as the final product pitch that compiles all clinical trial results, safety data and manufacturing details so the regulator can decide whether the drug can be sold. For investors, an NDA submission is a major milestone because acceptance or approval can unlock sales and revenue, while delays or rejections create uncertainty and financial risk.

dry eye disease medical

"precision medicine approach in dry eye disease planned in Q4"

Dry eye disease is a chronic condition where the eyes do not make enough tears or the tears evaporate too quickly, causing irritation, blurred vision and sensitivity to light — imagine having tiny grains of sand or a windshield with streaks that never clear. It matters to investors because it creates steady demand for prescription drugs, medical devices and diagnostic tests; treatments can be long‑term, subject to regulatory approval and insurance coverage, and successful products can capture large, recurring revenue streams.

treasury shares financial

"recorded as treasury shares (the “New Shares”), to enable future sales"

Treasury shares are a company’s own stock that it has repurchased and keeps on its books instead of canceling or leaving in the hands of outside investors. Think of them like coupons a business puts back in a drawer: they don’t vote or receive dividends while held, but they can be reissued later for employee pay or fundraising. For investors this matters because buybacks change the number of shares that count toward earnings and ownership, can boost per‑share metrics, and use corporate cash that might otherwise go to growth or dividends.

at-the-market ("atm") offering program financial

"under the existing sales agreement with Leerink Partners LLC relating to the Company's at-the-market ("ATM") offering program"

An at-the-market (ATM) offering program lets a company sell newly issued shares directly into the public market over time at the current market price through a broker, instead of selling a large block all at once. Investors should care because it provides the company flexible, on-demand funding while causing gradual share dilution and potentially small, repeated impacts on the stock price—like topping off a car’s gas tank bit by bit rather than filling it in one visit.

AI-generated analysis. Not financial advice.

ZUG, Switzerland, March 03, 2026 (GLOBE NEWSWIRE) --

• 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
  
  

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 diagnosed^1,2,3 with the disease are successfully managed. This leaves a staggering 1.3 million patients underserved by the current standard of care^1,2,3. 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.

Issuance of New Treasury Shares

The Company has today issued 2,000,000 registered ordinary shares (nominal value CHF 0.01 per share) out of its existing capital band (Kapitalband), recorded as treasury shares (the “New Shares”), to enable future sales, if any, under the existing sales agreement with Leerink Partners LLC relating to the Company's at-the-market (“ATM”) offering program. The total number of registered shares issued by the Company as per its Articles of Association is now 59,169,475. The New Shares have not been sold under the ATM offering program and will be held in reserve as treasury shares. For more details on the ATM offering program, please refer to the Company's previous press release dated May 17, 2024, and to the Company's SEC filings.

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 per share data)		For the three months ended December 31,				For the twelve months 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-TNFα 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
   
   

FAQ

When will Oculis (OCS) report DIAMOND Phase 3 topline results for OCS-01?

Topline results for the DIAMOND-1 and DIAMOND-2 Phase 3 trials are expected in Q2 2026. According to the company, both trials have enrolled over 800 patients and are nearing completion, with a potential NDA submission planned for Q4 2026 if results are positive.

What does the FDA Breakthrough Therapy designation for Privosegtor mean for OCS (OCS)?

Breakthrough Therapy designation accelerates development and interactions with FDA for optic neuritis. According to the company, designation was based on Phase 2 ACUITY results and supports the PIONEER registrational program in optic neuropathies.

How much cash does Oculis (OCS) have and how long is the runway?

Oculis held CHF 213.0M ($268.7M) in cash and short-term investments as of Dec 31, 2025. According to the company, that balance provides a cash runway into 2029, supported by equity financings completed in 2025 totaling $210.0M gross proceeds.

What are the near-term clinical milestones for Oculis (OCS) in 2026?

Key 2026 milestones include DIAMOND topline readouts in Q2 and PREDICT-1 results in Q4 2026. According to the company, 2026 also includes commencement of three registrational trials with Privosegtor as part of the PIONEER program.

Did Oculis (OCS) change its share count or issue new shares in 2026?

The company issued 2,000,000 registered ordinary shares as treasury shares to enable future ATM sales. According to the company, total registered shares are now 59,169,475 and the new shares remain held in reserve.