Exhibit 99.2

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

The Unaudited Condensed Consolidated Interim Financial Statements as of and for the three months ended March 31, 2026 are included as Exhibit 99.1 to this Report on Form 6-K submitted to the Securities and Exchange Commission (“SEC”). We also recommend that you read our discussion and analysis of financial condition and results of operations together with the audited financial statements and notes thereto for the year ended December 31, 2025 and the section entitled “Risk Factors” included in our Annual Report on Form 20-F for the year ended December 31, 2025 filed on March 4, 2026 and our subsequent filings with the SEC. The following discussion and analysis contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Exchange Act, including, without limitation, statements regarding our expectations, beliefs, intentions or future strategies that are signified by the words “expect,” “anticipate,” “intend,” “believe,” or similar language. As discussed in the below section titled “Cautionary Note Regarding Forward Looking Statements,” all forward looking statements included in this discussion and analysis are based on information available to us on the date hereof, and we assume no obligation to update any such forward looking statements. The terms “Company,” “Oculis,” “we,” “our” or “us” as used herein refer to Oculis Holding AG and its consolidated subsidiaries unless otherwise stated or indicated by context.

 

The Unaudited Condensed Consolidated Interim Financial Statements as of and for the three months ended March 31, 2026 were prepared in accordance with IFRS Accounting Standards (“IFRS”), specifically International Accounting Standard (“IAS”) 34, Interim Financial Reporting, as issued by the International Accounting Standards Board (“IASB”) and are presented in Swiss Francs (CHF) unless otherwise indicated. Amounts, aside from share data, are also presented in thousands unless otherwise indicated.

 

Company Overview

 

We are a global late clinical-stage biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology, headquartered in Switzerland with operations in Switzerland, the U.S. and Iceland. Our highly differentiated late-stage clinical pipeline includes three core product candidates: OCS-01, an eye drop in pivotal registration studies, aiming to become the first non-invasive topical treatment for diabetic macular edema (“DME”); 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”), and 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.

Our pipeline currently includes three clinical-stage therapeutic candidates: OCS-01, Licaminlimab (OCS-02) and Privosegtor (OCS-05). OCS-01 is an eye drop candidate which aims to be the first non-invasive topical treatment for DME. In April 2026, the last patient visits were completed in the two Phase 3 clinical trials for DME, with topline results expected in June 2026. Licaminlimab is a product candidate for the treatment of keratoconjunctivitis sicca, or DED, which we are advancing with a precision medicine approach. After a successful FDA meeting in the first quarter of 2025, we initiated the PREDICT-1 registrational Phase 2/3 trial with a genotype-based approach to investigate Licaminlimab in DED in the fourth quarter of 2025 for which topline results are expected around the end of 2026. Privosegtor is a neuroprotective candidate that has the potential to become a novel therapy for ON and NAION, with broad potential for other neuro-ophthalmic diseases, neurological diseases and beyond. Following a successful meeting with the FDA in the third quarter of 2025, we advanced Privosegtor into the PIONEER registrational program for ON and NAION. PIONEER-1 was initiated in the fourth quarter of 2025, with PIONEER-2 planned to follow later in the year. The third trial in the PIONEER program, PIONEER-3, will evaluate Privosegtor after the acute onset of NAION and is expected to follow after PIONEER-1 and -2. Privosegtor was granted PRIME (PRIority MEdicines) designation by the European Medicines Agency, a highly selective process to provide early and proactive support to developers of promising medicines that may offer a major therapeutic advantage over existing treatments or provide benefits to patients without treatment options. This follows the recent granting of Breakthrough Therapy designation for Privosegtor for the treatment of ON by the FDA, reinforcing global regulatory support for this unique neuroprotective asset.

 

Recent Developments

OCS-01 is an innovative high concentration eye drop candidate to treat DME. Following the positive Phase 3 DIAMOND Stage 1 trial outcome, we advanced the OCS-01 DME DIAMOND program into Stage 2, which includes two global pivotal Phase 3 clinical trials, DIAMOND-1 and DIAMOND-2, for the treatment of DME. The last patient visit was completed in the DIAMOND program during April 2026. The topline results from the DIAMOND trials are expected in June 2026. If the results are positive, we plan to submit a new drug application (“NDA”) to the FDA for OCS-01 for the treatment of DME in the fourth quarter of 2026.

 

Privosegtor is a novel small molecule peptoid that penetrates blood-brain and retinal barriers and was selected by high-throughput screening for neurotrophic and neuroprotective properties. Following a successful meeting with the FDA in the third quarter of 2025, we advanced Privosegtor into the PIONEER registrational program for ON and NAION. PIONEER-1 was initiated in the fourth quarter of 2025, with PIONEER-2 planned to follow later in the year. The third trial in the PIONEER program, PIONEER-3, will evaluate Privosegtor after the acute onset of NAION and is expected to follow after PIONEER-1 and -2. Privosegtor was granted PRIME (PRIority MEdicines) designation by the European Medicines Agency, a highly selective process to provide early and proactive support to developers of promising medicines that may offer a major therapeutic advantage over existing treatments or provide benefits to patients without treatment options. This follows the recent granting of Breakthrough Therapy designation for Privosegtor for the treatment of ON by the FDA, reinforcing global regulatory support for this unique neuroprotective asset. In May 2026, we received written agreement from the FDA under a Special Protocol Assessment (SPA) regarding PIONEER-1 to confirm that the design and planned analysis of the PIONEER-1 study are adequate to address the objectives necessary to support a future NDA submission, subject to a successful trial outcome and FDA review of the complete submission.

 

Components of Results of Operations

 

Revenue

 

We have not generated any revenue from product sales since our inception and do not expect to generate any revenue from the sale of products in the near future. If our development efforts for our product candidates are successful and result in regulatory approval or if we enter into collaboration or licensing agreements with third parties, we may generate revenue in the future from a combination of product sales and payments from such collaboration or licensing agreements. However, there can be no assurance as to when we will generate such revenue, if at all.


 

Grant income

 

Grant income reflects reimbursement of research and development expenses and income from certain research projects managed by Icelandic governmental institutions. We maintain a subsidiary in Iceland that provides research and development for our product candidates. Certain expenses qualify for incentives from the Icelandic government in the form of tax credits or cash reimbursements. We do not anticipate generating significant grant income in the near future.

 

Operating Expenses

 

Research and development expenses

 

Research and development expenses consist primarily of costs incurred in connection with the research and development of our product candidates and programs. We expense research and development costs and the cost of acquired intangible assets used in research and development activities as incurred. Research and development expenditures are capitalized only if they meet the recognition criteria of IAS 38 (“Intangible Assets”). Capitalization does not result in amortization until the related product is approved for commercialization, where a finite useful economic life can be more reliably determined. To date, all capitalized research and development intangible assets remain unamortized.

 

Research and development expenses include:

personnel-related expenses, including salaries, related benefits and equity-based compensation expense, for employees and third-party consultants engaged in research and development functions;
expenses incurred in connection with the preclinical and clinical development of our product candidates and programs, including under agreements with clinical research organizations (“CROs”), as well as clinical trial investigative sites and consultants that conduct our clinical trials;
costs related to contract manufacturing organizations that are primarily engaged to provide drug substance and product for our clinical trials, research and development programs, as well as costs of acquiring and manufacturing non-clinical and clinical trial materials, including manufacturing registration and validation batches;
costs related to non-clinical studies and other scientific development services;
costs related to compliance with quality and regulatory requirements; and
costs related to formulation research, intellectual property expenses, facilities, overhead, depreciation and amortization of laboratory equipment and other expenses.

 

For the three months ended March 31, 2026 and 2025, no research and development costs were capitalized by the Company.

 

Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect that our research and development expenses will increase substantially in connection with our ongoing and planned clinical development activities in the near term and in the future. At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the clinical development of any current or future product candidates.

 

General and administrative expenses

 

General and administrative expenses consist primarily of internal and external costs related to executive management, finance and accounting functions, legal, business development, corporate insurance, corporate and investor communications, pre-commercial and other administrative functions and operating costs.

 

Finance income (expense)

 

Finance income (expense) consists primarily of interest income on fixed term deposits.

 

Fair value adjustment on warrant liabilities

 

Fair value adjustment on warrant liabilities reflects the changes in fair value of the Company’s warrant instruments. The fair value is dependent on the change in the underlying market price of the public and private placement warrants, the change in the Black-Scholes fair value of the warrant issued to Kreos Capital VII Aggregator SCSp (the “Amended BlackRock Warrant”), and the number of outstanding warrants at the reporting date. The fair value of the public and private placement warrants is, in general, directly correlated with the market price of our warrants. Assuming the number of outstanding warrants remains constant, we would expect a fair value loss due to an increase in the market price of the warrants, and a fair value gain due to a decrease in the market price of the warrants. The fair value of the Amended BlackRock Warrant is dependent on the change in the Black-Scholes fair value and the number of outstanding warrants at the reporting date.

 

Foreign currency exchange gain (loss)

 

Foreign currency exchange gains and losses consist of currency exchange differences that arise from transactions denominated in currencies other than Swiss Francs.

 


Income tax benefit (expense)

 

We are subject to corporate Swiss federal, cantonal and communal taxation, respectively, in Switzerland, Canton of Zug, and Commune of Zug, as well as in the Canton of Vaud and Commune of Lausanne. We are also subject to taxation in other jurisdictions in which we operate, in particular the United States, France, Hong Kong and Iceland where our wholly owned subsidiaries are incorporated.

 

We are entitled under Swiss laws to carry forward any losses incurred for a period of seven years and can offset our losses carried forward against future taxes owed. As of December 31, 2025, we had tax loss carry-forwards totaling CHF 106.9 million. There is no certainty that we will make sufficient profits to be able to utilize tax loss carry-forwards in full and no deferred tax assets have been recognized in the financial statements.

A. Operating Results

 

Comparison of the Three Months Ended March 31, 2026 and 2025

The following table summarizes our results of operations for the periods presented:

 

 

For the three months ended March 31,

 

 

 

 

 

 

 

 

2026

 

 

2025

 

 

Change

 

 

% Change

 

Grant income

 

209

 

 

 

285

 

 

 

(76

)

 

 

(27

%)

Operating income

 

209

 

 

 

285

 

 

 

(76

)

 

 

(27

%)

Research and development expenses

 

(14,046

)

 

 

(14,771

)

 

 

725

 

 

 

(5

%)

General and administrative expenses

 

(7,891

)

 

 

(5,488

)

 

 

(2,403

)

 

 

44

%

Operating expenses

 

(21,937

)

 

 

(20,259

)

 

 

(1,678

)

 

 

8

%

Operating loss

 

(21,728

)

 

 

(19,974

)

 

 

(1,754

)

 

 

9

%

Finance income

 

367

 

 

 

493

 

 

 

(126

)

 

 

(26

%)

Finance expense

 

(173

)

 

 

(247

)

 

 

74

 

 

 

(30

%)

Fair value adjustment on warrant liabilities

 

(7,983

)

 

 

(11,911

)

 

 

3,928

 

 

 

(33

%)

Foreign currency exchange gain (loss)

 

567

 

 

 

(1,567

)

 

 

2,134

 

 

 

136

%

Finance result

 

(7,222

)

 

 

(13,232

)

 

 

6,010

 

 

 

45

%

Loss before tax for the period

 

(28,950

)

 

 

(33,206

)

 

 

4,256

 

 

 

(13

%)

Income tax benefit (expense)

 

98

 

 

 

(7

)

 

 

105

 

 

 

(1500

%)

Loss for the period

 

(28,852

)

 

 

(33,213

)

 

 

4,361

 

 

 

(13

%)

 

Grant income

 

Grant income for the three months ended March 31, 2026 and 2025 was CHF 0.2 million and CHF 0.3 million, respectively. The grant income is dependent upon the Icelandic government making such reimbursement available for qualified research and development activities. While certain of our research and development expenses have historically qualified for reimbursement and we anticipate incurring a similar level of costs in the future, there is no assurance that the Icelandic government will continue with the tax reimbursement program.

Research and development expenses

 

 

For the three months ended March 31,

 

 

 

 

 

 

 

 

2026

 

 

2025

 

 

Change

 

 

% Change

 

Personnel expenses

 

5,379

 

 

 

4,349

 

 

 

1,030

 

 

 

24

%

  Payroll and related expenses

 

2,706

 

 

 

2,448

 

 

 

258

 

 

 

11

%

  Share-based compensation

 

2,673

 

 

 

1,901

 

 

 

772

 

 

 

41

%

Other operating expenses

 

8,667

 

 

 

10,422

 

 

 

(1,755

)

 

 

(17

%)

  External service providers

 

8,142

 

 

 

10,187

 

 

 

(2,045

)

 

 

(20

%)

  Other operating expenses

 

435

 

 

 

159

 

 

 

276

 

 

 

174

%

  Depreciation expense

 

90

 

 

 

76

 

 

 

14

 

 

 

18

%

Total research and development expenses

 

14,046

 

 

 

14,771

 

 

 

(725

)

 

 

(5

%)

 

Research and development expense was CHF 14.0 million for the three months ended March 31, 2026, compared to CHF 14.8 million for the three months ended March 31, 2025. The decrease of CHF 0.7 million, or 5%, was primarily due to a CHF 2.0 million decrease in external service providers driven by the DIAMOND-1 and DIAMOND-2 trials of OCS-01 in DME, which are expected to readout during the second quarter of 2026. This decrease was offset by increased personnel costs primarily due to share-based compensation expense resulting from new equity grants and increased grant value for awards granted in 2026.

 

The table below represents the breakdown of research and development expenses by project:

 


 

For the three months ended March 31,

 

 

 

 

 

2026

 

2025

 

Change

 

% Change

OCS-01

6,736

 

10,712

 

(3,976)

 

(37%)

Privosegtor (OCS-05)

5,469

 

1,823

 

3,646

 

200%

Licaminlimab (OCS-02)

1,107

 

1,457

 

(350)

 

(24%)

Other development projects

734

 

779

 

(45)

 

(6%)

Total

14,046

 

14,771

 

(725)

 

(5%)

 

During the three months ended March 31, 2026 and 2025, the decrease in research and development expenses was primarily due to a decrease in external service provider expense driven by the impending conclusion of the DIAMOND-1 and DIAMOND-2 trials in DME, with topline results expected in June 2026.

General and administrative expenses

 

 

For the three months ended March 31,

 

 

 

 

 

 

 

 

2026

 

 

2025

 

 

Change

 

 

% Change

 

Personnel expenses

 

4,652

 

 

 

2,857

 

 

 

1,795

 

 

 

63

%

  Payroll and related expenses

 

2,324

 

 

 

2,128

 

 

 

196

 

 

 

9

%

  Share-based compensation

 

2,328

 

 

 

729

 

 

 

1,599

 

 

 

219

%

Other operating expenses

 

3,239

 

 

 

2,631

 

 

 

608

 

 

 

23

%

  External service providers

 

2,530

 

 

 

2,068

 

 

 

462

 

 

 

22

%

  Other operating expenses

 

645

 

 

 

516

 

 

 

129

 

 

 

25

%

  Depreciation expense

 

64

 

 

 

47

 

 

 

17

 

 

 

36

%

Total general and administrative expenses

 

7,891

 

 

 

5,488

 

 

 

2,403

 

 

 

44

%

 

General and administrative expenses were CHF 7.9 million for the three months ended March 31, 2026, compared to CHF 5.5 million for the three months ended March 31, 2025. The increase of CHF 2.4 million, or 44%, was primarily driven by an increase in share-based compensation expense due to new equity grants and increased grant value for equity awards granted in 2026.

 

Finance income and Finance expense

 

For the three months ended March 31,

 

 

 

 

 

 

 

 

2026

 

 

2025

 

 

Change

 

 

% Change

 

Finance income

 

367

 

 

 

493

 

 

 

(126

)

 

 

(26

%)

Finance expense

 

(173

)

 

 

(247

)

 

 

74

 

 

 

(30

%)

Total finance income

 

194

 

 

 

246

 

 

 

(52

)

 

 

(21

%)

 

We realized net finance income of CHF 0.2 million for the three months ended March 31, 2026 and 2025, which is primarily comprised of interest income from our short-term bank deposits, offset by amortization of prior period financing transaction costs.

 

Fair value adjustment on warrant liabilities

 

 

For the three months ended March 31,

 

 

 

 

 

 

 

 

2026

 

 

2025

 

 

Change

 

 

% Change

 

Fair value adjustment on warrant liabilities

 

(7,983

)

 

 

(11,911

)

 

 

3,928

 

 

 

(33

%)

 

We realized fair value losses on warrant liabilities of CHF 8.0 million and CHF 11.9 million for the three months ended March 31, 2026 and 2025, respectively, primarily due to increases in the market price of the public warrants during the periods presented. The public and private placement warrants were assumed from European Biotech Acquisition Corp. as part of the 2023 business combination agreement (“BCA Warrants”).

 

Foreign currency exchange gain (loss)

 

For the three months ended March 31,

 

 

 

 

 

 

 

 

2026

 

 

2025

 

 

Change

 

 

% Change

 

Foreign currency exchange gain (loss)

 

567

 

 

 

(1,567

)

 

 

2,134

 

 

 

(136

%)

 

We recognized a foreign currency exchange gain of CHF 0.6 million for the three months ended March 31, 2026, compared to a loss of CHF 1.6 million for the three months ended March 31, 2025. The foreign currency exchange gain (loss) reflects fluctuations of the U.S. dollar against the


Swiss Franc impacting our cash and short-term financial assets balances and currency transaction activities, which were favorable in 2026 due to a strengthening U.S. dollar as compared to the same period in 2025.

 

B. Liquidity and Capital Resources

 

Overview

 

Since our inception, we have incurred significant operating losses. We have not yet commercialized any products and we do not expect to generate revenue from sales of products in the near future. We incurred a loss of CHF 28.9 million and a cash outflow from operations of CHF 15.3 million for the three months ended March 31, 2026. We had a total of CHF 222.0 million, or $277.6 million, in cash, cash equivalents and short-term financial assets as of March 31, 2026.

On March 4, 2026, we entered into an amended and restated sales agreement with Leerink Partners LLC with respect to an at-the-market offering program (the “ATM Program”) under which we may offer and sell, from time to time at our sole discretion, ordinary shares having an aggregate offering price of up to $100.0 million (CHF 79.6 million) through Leerink Partners LLC as our sales agent. In the first quarter of 2026, we issued 1,050,000 ordinary shares under the ATM Program for gross proceeds of CHF 22.4 million, or $28.8 million. We have recognized CHF 1.3 million of transaction costs that were offset against the proceeds and recorded as a reduction of share premium for the three month period ended March 31, 2026.

 

On November 3, 2025, we closed concurrent underwritten and registered direct offerings for the issuance and sale of an aggregate of 5,432,098 ordinary shares at a price per share of $20.25 (CHF 16.33) for total gross proceeds of $110.0 million (CHF 88.7 million) before deducting underwriting discounts and commissions and offering expenses.

 

On July 31, 2025 we amended our existing loan facility with Kreos Capital VII (UK) Limited (the “Lender”), which are funds and accounts managed by BlackRock, Inc. (the “Amended Loan Agreement”). The Amended Loan Agreement is structured to provide the EUR equivalent of up to CHF 75.0 million in borrowing capacity (which may be increased to up to CHF 100.0 million), comprising tranches 1, 2 and 3, in the amounts of the EUR equivalents of CHF 25.0 million each, as well as an additional loan of the EUR equivalent of up to CHF 25.0 million, which may be made available by the Lender to us if mutually agreed in writing between us and the Lender.

 

On February 18, 2025, we closed an underwritten offering for the issuance and sale of 5,000,000 ordinary shares at a price of $20.00 or CHF 18.05 per share, for total gross proceeds of CHF 90.2 million or $100.0 million before deducting underwriting discounts and commissions and offering expenses.

We expect to incur additional operating losses in the near future and our operating expenses will increase as we continue to invest in the development of our product candidates through additional research and development activities, including clinical trials, and prepare for potential commercialization. Based on our current operating plan, we believe that our existing cash, cash equivalents and short-term financial assets will be sufficient to fund our operations and capital expenditures for at least 12 months from the date of this Report without additional capital or drawdown from our loan facility. We have based our estimate on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. We may require additional capital resources due to underestimation of the nature, timing and costs of the efforts that will be necessary to complete the development of our product candidates. We may also need to raise additional funds more quickly if we choose to expand our development activities or our portfolio or if we consider acquisitions or other strategic transactions, including licensing transactions.

Cash Flows

The following table summarizes our sources and uses of cash and cash equivalents for each of the periods presented:

 

For the three months ended March 31,

 

 

 

 

 

 

 

 

2026

 

 

2025

 

 

Change

 

 

% Change

 

Net cash outflow for operating activities

 

(15,337

)

 

 

(18,963

)

 

 

3,626

 

 

 

(19

%)

Net cash outflow for investing activities

 

(25,516

)

 

 

(51,505

)

 

 

25,989

 

 

 

(50

%)

Net cash inflow from financing activities

 

23,603

 

 

 

103,831

 

 

 

(80,228

)

 

 

(77

%)

Increase (decrease) in cash and cash equivalents

 

(17,250

)

 

 

33,363

 

 

 

(50,613

)

 

 

(152

%)

 

Total cash, cash equivalents and short-term investments were CHF 222.0 million as of March 31, 2026, which represents an increase of CHF 9.0 million from CHF 213.0 million at December 31, 2025. The increase was primarily due to proceeds from the ATM sale, partially offset by ongoing operating expenses of the Company.

 

Operating Activities

 

For the three months ended March 31, 2026, operating activities used CHF 15.3 million of cash, primarily consisting of a loss before tax of CHF 29.0 million, partially offset by non-cash adjustments of CHF 12.3 million and working capital adjustments of CHF 1.3 million. Non-cash adjustments primarily consisted of CHF 8.0 million fair value adjustment loss on warrant liabilities, CHF 5.0 million of share-based compensation expense, partially offset by CHF 0.9 million of financial result comprised primarily of foreign exchange losses on U.S. dollar liquid asset balances during the period and interest income. Working capital adjustments consisted of a CHF 0.7 million decrease in other current assets related to a decrease in prepaid general and administrative expenses related to capitalized transaction costs associated with the Company’s ATM Program that were recorded as a reduction of share premium as a result of the ATM sale in the three months ended March 31, 2026, and a CHF 0.9 million timing related increase in payables and accrued liabilities, partially offset by a CHF 0.2 million increase in accrued income related to Icelandic government research and development cost reimbursements.

 


For the three months ended March 31, 2025, operating activities used CHF 19.0 million of cash, primarily consisting of a loss before tax of CHF 33.2 million, partially offset by non-cash adjustments of CHF 14.9 million. Our total operating expense and resulting operating loss was primarily driven by development expenses for our core assets, OCS-01, Licaminlimab and Privosegtor. Non-cash charges primarily consisted of a CHF 11.9 million fair value adjustment loss on warrant liabilities and CHF 2.6 million of share-based compensation expense.

 

Investing Activities

 

For the three months ended March 31, 2026, the Company recorded cash outflow for investing activities of CHF 25.5 million, primarily driven by CHF 25.7 million for investments in current fixed term bank deposits, net of maturities.

 

For the three months ended March 31, 2025, the Company recorded cash outflow for investing activities of CHF 51.5 million, primarily consisting of CHF 50.6 million for investments in current fixed term bank deposits, net of maturities, and a CHF 1.1 million milestone payment pursuant to our licensing agreement with Accure Therapeutics SL (the “Accure Agreement”).

 

Financing Activities

 

For the three months ended March 31, 2026, net cash provided by financing activities was CHF 23.6 million which consisted primarily of CHF 22.0 million of net proceeds received from the issuance and sale of shares from the ATM program, CHF 1.3 million received from the exercise of warrants and CHF 0.5 million of proceeds from the exercise of stock options.

 

For the three months ended March 31, 2025, net cash provided by financing activities was CHF 103.8 million, which consisted primarily of CHF 84.8 million of net proceeds received from the issuance and sale of shares in the February 2025 underwritten offering, CHF 18.9 million received from the exercise of warrants and CHF 0.3 million of proceeds from the exercise of stock options.

 

Future Funding Requirements

 

Product development is expensive and involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. We will not generate revenue from product sales unless and until we successfully complete clinical development and are able to obtain regulatory approval for and successfully commercialize the product candidates we are currently developing or that we may develop.

 

Our product candidates, currently under development or that we may develop, will require significant additional research and development efforts, including extensive clinical testing and regulatory approval prior to commercialization.

If we obtain regulatory approval for one or more of our product candidates, we have the options of seeking strategic partnerships or commercializing such products ourselves. If we decide to pursue direct commercialization, we expect to incur significant expenses to develop our commercialization capabilities to support product sales, medical affairs, market access, and marketing and distribution activities, either alone or in collaboration with others. As a result, we may need substantial additional funding to support our continuing operations and pursue our growth strategy.

Until such time, if ever, when we can generate substantial product revenue, we may finance our operations through a combination of private or public equity offerings, debt financings, collaborations, strategic alliances, marketing, distribution or licensing arrangements or through other sources of funding. Adequate capital may not be available to us when needed or on acceptable terms. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a holder of ordinary shares. Debt financing, such as the Amended Loan Agreement we entered into in July 2025, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures. Debt financing would also result in fixed payment obligations. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts, grant third parties rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves, obtain funds through arrangements with collaborators on terms unfavorable to us or pursue merger or acquisition strategies, all of which could adversely affect the holdings or the rights of our shareholders.

 

We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities, manufacturing and clinical development of our product candidates, and prepare for potential commercialization. In addition, we will continue to incur additional costs associated with operating as a dual-listed public company, including significant legal, accounting, investor relations and other expenses. Our expenses will also increase as we:

 

progress our Phase 3 clinical trials for OCS-01 for DME;
advance our Licaminlimab program into registrational trials starting with the PREDICT-1 for DED and related manufacturing development activities;
advance Privosegtor in ON and NAION into the PIONEER registrational program and explore its potential in other indications;
advance our preclinical stage product candidates into clinical development;
seek to identify, acquire and develop additional product candidates, including through business development efforts to invest in or in-license other technologies or product candidates;
hire additional clinical, regulatory, technical development, quality assurance and control, medical, scientific and other technical personnel to support our product development operations;

expand our operational, financial and management systems and increase personnel to support our operations;
meet the requirements and demands of being a dual-listed public company, including compliance with regulatory regimes and stock exchange rules in both the U.S. and Iceland;
maintain, expand, protect and enforce our intellectual property portfolio;
make milestone, royalty or other payments due under the license agreements with Novartis Technology LLC and Accure Therapeutics SL, each described in Note 9 of our Annual Report on Form 20-F filed with the SEC on March 4, 2026, and any future in-license or collaboration agreements;
seek regulatory approvals for any product candidates that successfully complete clinical trials; and
undertake any pre-commercialization activities to establish sales, medical affairs, market access, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products on our own or jointly with third parties.

 

Material Cash Requirements for Known Contractual Obligations and Commitments

 

We have certain payment obligations under existing license and collaboration agreements. Under these agreements, we are required to pay non-refundable, upfront license fees, predefined development and commercial milestone payments and royalties on net sales of licensed products. The next clinical and regulatory milestone under the Accure Agreement, which we expect to become payable in 2026, would trigger a payment of CHF 2.1 million ($2.6 million).

 

The majority of our near-term cash needs relate to our clinical and chemistry, manufacturing and controls (CMC) projects. We have conducted research and development programs through collaboration arrangements that include, among others, arrangements with universities, CROs and clinical research sites. In addition, we enter into agreements in the normal course of business with CROs for clinical trials and with vendors for preclinical studies, manufacturing services, and other services and products for operating purposes, which are generally cancelable upon written notice.

 

C. Critical Accounting Policies and Accounting Estimates

 

There have been no material changes to the key estimates, assumptions and judgments from those disclosed in our audited financial statements and notes thereto for the year ended December 31, 2025, included in our Annual Report on Form 20-F filed with the SEC on March 4, 2026. Refer to Note 2 to our Unaudited Condensed Consolidated Interim Financial Statements included elsewhere in this Report on Form 6-K for further details on the most material accounting policies applied in the preparation of our consolidated financial statements and our critical accounting estimates and judgments.

 

D. Risk Factors

 

There have been no material changes to the risk factors as set out in our Annual Report on Form 20-F filed with the SEC on March 4, 2026.

 

Cautionary Note Regarding Forward-Looking Statements

 

Some of the statements in this Report on Form 6-K constitute forward-looking statements that do not directly or exclusively relate to historical facts. You should not place undue reliance on such statements because they are subject to numerous uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Forward-looking statements include information concerning our possible or assumed future results of operations, including descriptions of our business strategy. These statements are often, but not always, made through the use of words or phrases such as “believe,” “anticipate,” “could,” “may,” “would,” “should,” “intend,” “plan,” “potential,” “predict,” “will,” “expect,” “estimate,” “project,” “positioned,” “strategy,” “outlook” and similar expressions. All such forward looking statements involve estimates and assumptions that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from the results expressed in the statements. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Among the key factors that could cause actual results to differ materially from those projected in the forward-looking statements are the following:

our financial performance;
the ability to maintain the listing of our ordinary shares and warrants on the Nasdaq Global Market and the Nasdaq Iceland Main Market;
timing and expected outcomes of clinical trials, preclinical studies, regulatory submissions and approvals, as well as commercial outcomes;
timing of expected milestones in connection with our in-licensed assets;
expected benefits of our business and scientific approach and technology;
the potential safety and efficacy of our product candidates;
our ability to successfully develop, advance, and partner or commercialize our pipeline of product candidates;
our ability to establish and maintain arrangements for the manufacture of our product candidates;
the effectiveness and profitability of our collaborations and partnerships, our ability to maintain current collaborations and partnerships and enter into new collaborations and partnerships;
expectations related to future milestone and royalty payments and other economic terms under our collaborations and partnerships;

estimates regarding cash runway, future revenue, expenses, capital requirements, financial condition, and need for additional financing;
estimates of market opportunity for our product candidates;
the effects of increased competition as well as innovations by new and existing competitors in our industry;
our strategic advantages and the impact those advantages may have on future financial and operational results;
our expansion plans and opportunities;
our ability to grow our business in a cost-effective manner;
our expectations regarding our ability to obtain and maintain intellectual property protection and not infringe on the rights of others;
the impact of any macroeconomic factors and other global events on our business;
changes in applicable laws or regulations;
our ability to maintain our status as a “foreign private issuer”; and
the outcome of any known and unknown litigation and regulatory proceedings.

 

These forward-looking statements are based on information available as of the date of this Report, and current expectations, forecasts and assumptions, and involve a number of judgments, risks and uncertainties. Accordingly, forward looking statements should not be relied upon as representing our views as of any subsequent date, and we do not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

 

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based on information available to us as of the date of this Report. And while we believe such information provides a reasonable basis for these statements, such information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely on these statements.