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[6-K] Oculis Holding AG Current Report (Foreign Issuer)

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Rhea-AI Filing Summary

Oculis Holding reported a 2025 net loss of CHF 99.0 million (vs. CHF 85.8 million in 2024) as it stepped up investment in its late‑stage pipeline. Cash, cash equivalents and short‑term investments rose to CHF 213.0 million, or $268.7 million, helped by $210.0 million of equity financings in February and November 2025, giving a cash runway into 2029.

During 2025, the company obtained FDA Breakthrough Therapy designation for Privosegtor in optic neuritis and initiated the PIONEER‑1 registrational trial. Both Phase 3 DIAMOND trials of OCS‑01 in diabetic macular edema enrolled over 800 patients, with topline data expected in Q2 2026 and a possible NDA in Q4 2026 if results are positive. Oculis also launched the genotype‑based PREDICT‑1 registrational trial of Licaminlimab in dry eye disease, with topline results targeted for Q4 2026.

Positive

  • Strengthened cash position and extended runway: Cash, cash equivalents and short‑term investments increased to CHF 213.0 million (or $268.7 million) as of December 31, 2025, supported by $210.0 million of equity financings, giving a stated cash runway into 2029.
  • Multiple late‑stage clinical value drivers: FDA Breakthrough Therapy designation for Privosegtor, ongoing Phase 3 DIAMOND trials for OCS‑01 with Q2 2026 topline, and the PREDICT‑1 registrational trial for Licaminlimab with Q4 2026 topline create several potential 2026 inflection points.

Negative

  • Rising operating loss and net loss: Year‑to‑date net loss widened to CHF 99.0 million (or $119.1 million) from CHF 85.8 million (or $97.4 million) in 2024, driven by higher research and development and general and administrative expenses and increased foreign exchange revaluation loss.

Insights

Oculis strengthens its balance sheet while advancing three late‑stage ophthalmology programs toward key 2026 readouts.

Oculis ended 2025 with cash, cash equivalents and short‑term investments of CHF 213.0 million (or $268.7 million), up from CHF 98.7 million, mainly from $210.0 million of equity financings. Management indicates this supports a cash runway into 2029 while multiple registrational programs progress in parallel.

On the pipeline side, FDA Breakthrough Therapy designation for Privosegtor in optic neuritis and initiation of the PIONEER‑1 registrational trial mark a notable expansion into neuro‑ophthalmology. Both Phase 3 DIAMOND trials of OCS‑01 in diabetic macular edema and the PREDICT‑1 precision‑medicine trial for Licaminlimab in dry eye disease are designed to deliver topline results in Q2 2026 and Q4 2026, respectively. Subsequent disclosures around these milestones and any planned NDA submission for OCS‑01 in Q4 2026 will be central to assessing future value.

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 6-K

 

 

REPORT OF FOREIGN ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

OF THE SECURITIES EXCHANGE ACT OF 1934

For the Month of March 2026

(Commission File No. 001-41636)

 

 

Oculis Holding AG

(Translation of registrant's name into English)

 

 

Bahnhofstrasse 20

CH-6300

Zug, Switzerland

(Address of registrant’s principal executive office)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒

Form 40-F ☐

 

 

 


INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K

 

On March 3, 2026, Oculis Holding AG (the “Registrant”) issued a press release announcing its financial results for the fiscal year ended December 31, 2025. The press release is furnished as Exhibit 99.1 to this Report on Form 6-K.

 

 

 

EXHIBIT INDEX

 

Exhibit

Description

99.1

 

Press Release dated March 3, 2026

 


SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

 

OCULIS HOLDING AG

 

 

 

 

Date: March 3, 2026

 

By:

/s/ Sylvia Cheung

 

 

 

Chief Financial Officer

 


Exhibit 99.1

img187686630_0.gif

 

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.

 

 

 

 


Exhibit 99.1

img187686630_0.gif

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

 

 

 

 


Exhibit 99.1

img187686630_0.gif

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

 

 

 

 

 


Exhibit 99.1

img187686630_0.gif

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

 

 

 

 

 

 

 

 

 


Exhibit 99.1

img187686630_0.gif

Consolidated Statements of Loss (Unaudited)

 

 

 

For the three months
ended December 31,

 

 

For the twelve months
ended December 31,

 

(Amounts in CHF thousands, except per share data)

 

 

 

 

 

 

 

 

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-

 

 

 

 


Exhibit 99.1

img187686630_0.gif

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,

 

 

 

 


Exhibit 99.1

img187686630_0.gif

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

 

 

 

 

 


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