Equibles

6-K

Oculis Holding AG (OCS)

6-K 2025-05-08 For: 2025-05-08
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Added on April 07, 2026

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 May 2025

(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 May 8, 2025, Oculis Holding AG (the “Registrant”) announced its unaudited financial results for the three-month period ended March 31, 2025, which are further described in the Registrant’s Unaudited Condensed Consolidated Interim Financial Statements, Management’s Discussion and Analysis of Financial Condition and Results of Operations and press release, copies of which are attached hereto as Exhibits 99.1, 99.2 and 99.3, respectively, and are incorporated by reference herein.

The information contained in this Form 6-K, including Exhibits 99.1 and 99.2 but excluding Exhibit 99.3, is hereby incorporated by reference into the Registrant’s Registration Statements on Form S-8 (File No. 333-271938) and Form F-3 (333-271063, 333-281798 and 333-278409).

EXHIBIT INDEX

Exhibit Description
99.1 Unaudited Condensed Consolidated Interim Financial Statements for the Three Months Ended March 31, 2025
99.2 Management’s Discussion and Analysis of Financial Condition and Results of Operations for the Three Months Ended March 31, 2025
99.3 Press release dated May 8, 2025

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: May 8, 2025 By: /s/ Sylvia Cheung
Sylvia Cheung<br><br>Chief Financial Officer

EX-99.1

Exhibit 99.1

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Oculis Holding AG

Unaudited Condensed Consolidated Interim Financial Statements

Table of Contents
Unaudited Condensed Consolidated Interim:
Statements of Financial Position as of March 31, 2025 and December 31, 2024 3
Statements of Loss for the three months ended March 31, 2025 and 2024 4
Statements of Comprehensive Loss for the three months ended March 31, 2025 and 2024 5
Statements of Changes in Equity for the three months ended March 31, 2025 and 2024 6
Statements of Cash Flows for the three months ended March 31, 2025 and 2024 7
Notes to the Unaudited Condensed Consolidated Interim Financial Statements 8

Oculis Holding AG

Unaudited Condensed Consolidated Interim Statements of Financial Position

(in CHF thousands)

As of March 31, As of December 31,
Note 2025 2024
ASSETS
Non-current assets
Property and equipment 364 385
Intangible assets 6 13,292 13,292
Right-of-use assets 1,218 1,303
Other non-current assets 508 476
Total non-current assets 15,382 15,456
Current assets
Other current assets 8 5,931 5,605
Accrued income 8 930 629
Short-term financial assets 10 122,055 70,955
Cash and cash equivalents 10 59,873 27,708
Total current assets 188,789 104,897
TOTAL ASSETS 204,171 120,353
EQUITY AND LIABILITIES
Shareholders' equity
Share capital 555 446
Share premium 464,190 344,946
Reserve for share-based payment 9 18,642 16,062
Actuarial loss on post-employment benefit obligations (1,646 ) (2,233 )
Treasury shares 13 (35 ) (10 )
Cumulative translation adjustments (310 ) (271 )
Accumulated losses (318,770 ) (285,557 )
Total equity 162,626 73,383
Non-current liabilities
Long-term lease liabilities 799 865
Defined benefit pension liabilities 1,294 1,870
Total non-current liabilities 2,093 2,735
Current liabilities
Trade payables 4,351 5,871
Accrued expenses and other payables 12 19,860 18,198
Short-term lease liabilities 304 315
Warrant liabilities 11 14,937 19,851
Total current liabilities 39,452 44,235
Total liabilities 41,545 46,970
TOTAL EQUITY AND LIABILITIES 204,171 120,353

The accompanying notes form an integral part of the Unaudited Condensed Consolidated Interim Financial Statements.

Oculis Holding AG

Unaudited Condensed Consolidated Interim Statements of Loss

(in CHF thousands, except loss per share data)

For the three months ended March 31,
Note 2025 2024
Grant income 7. (A) 285 222
Operating income 285 222
Research and development expenses 7. (B) (14,771 ) (10,856 )
General and administrative expenses 7. (B) (5,488 ) (4,694 )
Operating expenses (20,259 ) (15,550 )
Operating loss (19,974 ) (15,328 )
Finance income 7. (C) 493 581
Finance expense 7. (C) (247 ) (41 )
Fair value adjustment on warrant liabilities 7. (C) / 11 (11,911 ) (3,069 )
Foreign currency exchange gain (loss) 7. (C) (1,567 ) 1,794
Finance result (13,232 ) (735 )
Loss before tax for the period (33,206 ) (16,063 )
Income tax expense (7 ) (30 )
Loss for the period (33,213 ) (16,093 )
Loss per share:
Basic and diluted loss attributable to equity holders 14 (0.69 ) (0.44 )

The accompanying notes form an integral part of the Unaudited Condensed Consolidated Interim Financial Statements.

Oculis Holding AG

Unaudited Condensed Consolidated Interim Statements of Comprehensive Loss

(in CHF thousands)

For the three months ended March 31,
Note 2025 2024
Loss for the period (33,213) (16,093)
Other comprehensive (loss) income:
Items that will not be reclassified to Statements of Loss:
Actuarial gain on post-employment benefit obligations 587 -
Items that may be reclassified subsequently to (loss) income:
Foreign currency translation differences 7. (C) (39) 31
Other comprehensive (loss) income for the period 548 31
Total comprehensive loss for the period (32,665) (16,062)

The accompanying notes form an integral part of the Unaudited Condensed Consolidated Interim Financial Statements.

Oculis Holding AG

Unaudited Condensed Consolidated Interim Statements of Changes in Equity

(in CHF thousands, except share numbers)

Share capital Treasury shares
Note Shares Share capital Shares Treasury shares Share premium Reserve for share-based payment Cumulative translation adjustment Actuarial loss on post-employment benefit obligations Accumulated losses Total
Balance as of January 1, 2024 36,649,705 366 - - 288,162 6,379 (327) (1,072) (199,780) 93,728
Loss for the period - - - - - - - - (16,093) (16,093)
Other comprehensive income:
Foreign currency translation differences - - - - - - 31 - - 31
Total comprehensive (loss) income for the period - - - - - - 31 - (16,093) (16,062)
Share-based compensation expense 9 - - - - - 1,141 - - - 1,141
Stock options exercised 9 90,590 1 - - 225 - - - - 226
Balance as of March 31, 2024 36,740,295 367 - - 288,387 7,520 (296) (1,072) (215,873) 79,033
Balance as of January 1, 2025 44,662,402 446 (1,000,000) (10) 344,946 16,062 (271) (2,233) (285,557) 73,383
Loss for the period - - - - - - - - (33,213) (33,213)
Other comprehensive (loss) income:
Actuarial gain on post-employment benefit obligations - - - - - - - 587 - 587
Foreign currency translation differences - - - - - - (39) - - (39)
Total comprehensive (loss) income for the period - - - - - - (39) 587 (33,213) (32,665)
Share-based compensation expense 9 - - - - - 2,630 - - - 2,630
Issuance of ordinary shares 4 5,000,000 50 - - 90,177 - - - - 90,227
Transaction costs related to the issuance of ordinary shares 4 - - - - (6,763) - - - - (6,763)
Vesting of earnout shares 9 1,422,723 14 - - (14) - - - - -
Issuance of shares held as treasury shares 13 2,500,000 25 (2,500,000) (25) - - - - -
Warrants exercised 11 1,806,297 18 - - 35,701 - - - - 35,719
Transaction costs related to the exercise of warrants - - - - (219) - - - - (219)
Share-based award settled in equity 9 169,078 2 - - 362 (50) - - - 314
Balance as of March 31, 2025 55,560,500 555 (3,500,000) (35) 464,190 18,642 (310) (1,646) (318,770) 162,626

The accompanying notes form an integral part of the Unaudited Condensed Consolidated Interim Financial Statements.

Oculis Holding AG

Unaudited Condensed Consolidated Interim Statements of Cash Flows

(in CHF thousands)

For the three months ended March 31,
Note 2025 2024 (as recast)
Operating activities
Loss before tax for the period (33,206) (16,063)
Non-cash adjustments:
- Financial result 215 (1,662)
- Depreciation of property and equipment and right-of-use assets 123 73
- Share-based compensation expense 9 2,630 1,141
- Post-employment loss 20 10
- Fair value adjustment on warrant liabilities 11 11,911 3,069
Working capital adjustments:
- (Increase)/Decrease in other current assets 8 (8) 4,135
- (Increase) in accrued income 8 (301) (262)
- (Decrease) in payables and accrued liabilities 12 (301) (4,151)
- (Decrease) in other operating assets/liabilities (32) -
Taxes paid (14) (10)
Net cash outflow for operating activities (18,963) (13,720)
Investing activities
Payment for purchase of property and equipment (13) -
Payment for short-term financial assets, net 10 (50,605) (2,047)
Interest received 200 535
Intangible assets acquisition cost (1,087) -
Net cash outflow for investing activities (51,505) (1,512)
Financing activities
Proceeds from sale of ordinary shares 4 90,227 -
Transaction costs related to the issuance of ordinary shares 4 (5,528) -
Proceeds from exercise of warrants, net 11 18,918 -
Proceeds from stock options exercised 9 314 226
Principal payment of lease obligations (88) (45)
Interest paid (12) (10)
Net cash inflow from financing activities 103,831 171
(Decrease) increase in cash and cash equivalents 33,363 (15,061)
Cash and cash equivalents, beginning of period 10 27,708 38,327
Effect of foreign exchange rate changes (1,198) 1,095
Cash and cash equivalents, end of period 10 59,873 24,361
Net cash and cash equivalents variation 33,363 (15,061)
Supplemental non-cash investing information
Interest receivable recorded in other current assets 293 14
Supplemental non-cash financing information
Transaction costs recorded in accrued expenses and other payables 1,506 435

The accompanying notes form an integral part of the Unaudited Condensed Consolidated Interim Financial Statements.

Oculis Holding AG

Notes to the Unaudited Condensed Consolidated Interim Financial Statements

(All amounts presented in CHF thousands, except share numbers, unless otherwise noted)

  • CORPORATE INFORMATION

Oculis Holding AG (“the Company” or “Oculis”) is a stock corporation (Aktiengesellschaft) with its registered office at Bahnhofstrasse 20, CH-6300, Zug, Switzerland. It was incorporated under the laws of Switzerland on October 31, 2022.

The Company controls five wholly-owned subsidiaries: Oculis Operations Sàrl ("Oculis Operations") with its registered office in Lausanne, Switzerland, which was incorporated in Zug, Switzerland on December 27, 2022, Oculis ehf ("Oculis Iceland"), which was incorporated in Reykjavik, Iceland on October 28, 2003, Oculis France Sàrl ("Oculis France"), which was incorporated in Paris, France on March 27, 2020, Oculis US, Inc. ("Oculis US"), with its registered office in Newton MA, USA, which was incorporated in Delaware, USA, on May 26, 2020, and Oculis HK, Limited ("Oculis HK"), which was incorporated in Hong Kong, China on June 1, 2021. The Company and its wholly-owned subsidiaries form the Oculis Group (the "Group").

Oculis is a global late clinical-stage biopharmaceutical company with substantial expertise in therapeutics for the treatment of ophthalmic and neuro-ophthalmic diseases. Oculis is engaged in the development of innovative drug candidates which embrace the potential to address significant unmet medical needs for many conditions. The Company’s focus is on advancing therapeutic candidates intended to treat significant and prevalent ophthalmic diseases which result in vision loss, blindness or reduced quality of life. Its mission is to improve patients’ health and quality of life worldwide by developing medicines that save sight and improve eye care for patients, and it intends to become a global leader in the field.

  1. BASIS OF PREPARATION AND CHANGES TO THE GROUP’S ACCOUNTING POLICIES
  • Going concern

The Group's accounts are prepared on a going concern basis. The Board of Directors believes that based on the Group’s current cash, cash equivalents and investments, including proceeds from the February 2025 underwritten offering described in Note 4 below, the Group has the ability to meet its financial obligations for at least the next 12 months.

The Company is a late clinical stage company and is exposed to all the risks inherent to establishing a business. Inherent to the Company’s business are various risks and uncertainties, including the substantial uncertainty as to whether current projects will succeed. The Company’s success may depend in part upon its ability to (i) establish and maintain a strong patent position and protection, (ii) enter into collaborations with partners in the biotech and pharmaceutical industry, (iii) successfully move its product candidates through preclinical and clinical development, (iv) successfully obtain regulatory approval and commercialize its products, and (v) attract and retain key personnel. The Company’s success is subject to its ability to be able to raise capital to support its operations. To date, the Company has financed its cash requirements primarily through the sale of preferred and ordinary shares. Shareholders should note that the long-term viability of the Company is dependent on its ability to raise additional capital to finance its future operations. The Company will continue to evaluate additional funding through public or private financings, debt financing or collaboration agreements. The Company cannot be certain that additional funding will be available on acceptable terms, or at all. If the Company is unable to raise additional capital when required or on acceptable terms, it may have to (i) significantly delay, scale back or discontinue the development of one or more of its product candidates; (ii) seek collaborators for product candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available; or (iii) relinquish or otherwise dispose of rights to product candidates that the Company would otherwise seek to develop itself, on unfavorable terms.

  • Material accounting policies

There have been no material changes to the accounting policies that were applied by the Group in its audited consolidated financial statements as of and for the year ended December 31, 2024, included in Form 20-F filed with the U.S. Securities and Exchange Commission (“SEC”) on March 11, 2025 and available at www.sec.gov, except as follows:

Presentation of interest in the statement of cash flows

Effective January 1, 2025, the Company revised its accounting policy regarding the classification of interest paid and interest received in the statement of cash flows. Interest paid was reclassified from “net cash flows used in operating activities” to “net cash flows used in financing activities”, and interest received was reclassified from “net cash flows used in operating activities” to “net cash flows used in investing activities”. The Company assessed the change in accounting policy under IAS 8, in accordance with the guidance regarding a voluntary change in accounting policy.

The reclassification of interest paid was elected to provide a more cohesive presentation of payments related to the Company’s office leases. Prior to the change in accounting policy, interest paid on lease liabilities was classified as operating cash flows,

while payments of the principal portion of lease liabilities were classified as financing cash flows. The change aligns the interest paid with the associated financial liability giving rise to the interest.

In addition, the Company reclassified interest received to investing activities, as the majority of interest received relates to interest earned on cash and cash equivalents and short-term investments. The Company believes the updated classification better reflects the nature and source of the cash inflows.

The Company applied the change in accounting policy retrospectively and has recast prior period comparative information within the statement of cash flows to ensure consistency and comparability with the current period presentation. As part of the retrospective application, net cash used in operating activities for the three months ended March 31, 2024 increased by CHF 0.5 million, net cash flow used in investing activities decreased by CHF 0.5 million, and net cash flow inflow from financing activities decreased by CHF 10 thousand.

  • Statement of compliance

These unaudited condensed consolidated interim financial statements as of March 31, 2025 and for the three months ended March 31, 2025 and 2024, have been prepared in accordance with International Accounting Standard ("IAS"), specifically IAS 34 - Interim Financial Reporting. They do not include all of the information required for a complete set of financial statements prepared in accordance with IFRS Accounting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”). In the opinion of the Company, the accompanying unaudited condensed consolidated interim financial statements present a fair statement of its financial information for the interim periods reported.

  • Functional currency

The unaudited condensed consolidated interim financial statements of the Group are expressed in Swiss Francs (“CHF”), which is the Company’s functional and the Group’s presentation currency. The functional currency of the Company's subsidiaries is the local currency except for Oculis Iceland whose functional currency is CHF.

Assets and liabilities of foreign operations are translated into CHF at the rate of exchange prevailing at the reporting date and their statements of profit or loss are translated at average monthly exchange rates. The exchange differences arising on translation for consolidation are recognized in other comprehensive income.

  • Out of period adjustment

During the three months ended June 30, 2024, the Company recorded a CHF 1.8 million out-of-period adjustment to increase research and development expenses and decrease other current assets to account for an understatement and overstatement of such balances, respectively, of which CHF 1.3 million related to the three months ended March 31, 2024. The Company evaluated the impact of the uncorrected prior period balances, and concluded that the uncorrected balances were not material to previously reported financial statements, including for the three months ended March 31, 2024.

  1. SUMMARY OF MATERIAL ACCOUNTING POLICIES, CRITICAL JUDGMENTS AND ACCOUNTING ESTIMATES
  • Critical judgments and accounting estimates

In preparing these unaudited condensed consolidated interim financial statements, the critical accounting estimates, assumptions and judgments made by management in applying the Company’s accounting policies and the key sources of estimation uncertainty were the same as those applied and discussed in the audited consolidated financial statements for the year ended December 31, 2024.

  • New accounting standards, interpretations, and amendments adopted by the Group

The accounting policies adopted in the preparation of the unaudited condensed consolidated interim financial statements are consistent with those followed in the preparation of the Company’s annual consolidated financial statements for the year ended December 31, 2024.

There are no new IFRS Accounting Standards, amendments to standards or interpretations that are mandatory for the financial year beginning on January 1, 2025, that have a material impact in the interim period. In April 2024, the IASB issued IFRS 18, Presentation and Disclosure in Financial Statements, which provides requirements for the presentation and disclosure of information in general purpose financial statements. The standard is effective for periods beginning on or after January 1, 2027. The Company is in the process of evaluating whether IFRS 18 will have a material effect on the consolidated financial statements. New standards, amendments to standards and interpretations that are not yet effective, which have been deemed by the Group as currently not relevant, are not listed here.

  1. FINANCING ACTIVITIES

Underwritten offering of ordinary shares

On February 18, 2025, the Company closed an underwritten follow-on offering pursuant to an underwriting agreement with BofA Securities Inc. and Leerink Partners LLC, as a representatives of the several underwriters, of 5,000,000 ordinary shares, CHF 0.01 nominal value per share, 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. In connection with this offering, the Company incurred approximately CHF 6.8 million or $7.5 million of transaction costs during the three months ended March 31, 2025 that are presented as a reduction of share premium within the statement of changes in equity.

Loan facility

On May 29, 2024, the Company entered into an agreement for a loan facility with Kreos Capital VII (UK) Limited (the “Lender”), which are funds and accounts managed by Blackrock, Inc. (the “Loan Agreement”). The Loan Agreement is structured to provide the EUR equivalent of up to CHF 50.0 million in borrowing capacity (which may be increased to up to CHF 65.0 million), comprising tranches 1, 2 and 3, in the amounts of the EUR equivalents of CHF 20.0 million (“Loan 1”), CHF 20.0 million (“Loan 2”) and CHF 10.0 million (“Loan 3”), respectively, as well as an additional loan of the EUR equivalent of up to CHF 15.0 million, which may be made available by the Lender to the Company if mutually agreed in writing by the Lender and the Company (the “Loan”). Upon each tranche becoming available for draw down as well as upon the Company drawing down the loan tranches, certain associated transaction costs become payable by the Company. No amounts were drawn under the Loan Agreement during the three months ended March 31, 2025.

In conjunction with the Loan, the Company entered into a warrant agreement (the “Blackrock Warrant”) with Kreos Capital VII Aggregator SCSp, an affiliate of the Lender (the “Holder”), under which the Holder can purchase up to 361,011 of the Company’s ordinary shares at a price per ordinary share equal to $12.17 (CHF 10.73). At signing the Blackrock Warrant was immediately exercisable for 43,321 ordinary shares and, following the drawdown of each of Loans 1, 2 and 3, the Blackrock Warrant will become exercisable for additional amounts of ordinary shares ratably based on the amounts of Loans 1, 2 and 3 that are drawn. Each tranche of the Blackrock Warrant in connection with Loans 1, 2 and 3, is exercisable for a period of up to seven years from the date of eligibility and will terminate at the earliest of (i) December 31, 2032, (ii) such earlier date on which the Blackrock Warrant is no longer exercisable for any warrant share in accordance with its terms and (iii) the acceptance by the shareholders of the Company of a third-party bona fide offer for all outstanding shares of the Company (subject to any prior exercise by the Holder, if applicable). The Blackrock Warrant had not been exercised in part or in full as of March 31, 2025. Refer to Note 11 - Warrant Liabilities.

In connection with this transaction, the Company incurred CHF 0.8 million of transaction related costs which were capitalized as a prepayment for liquidity services and are being amortized over the period during which the loan is available.

At-the-Market offering program

On May 8, 2024, the Company entered into a sales agreement with Leerink Partners, LLC (“Leerink Partners”) with respect to an at-the-market offering program (the “ATM Offering Program”) under which the Company may offer and sell, from time to time at its sole discretion, ordinary shares of the Company having an aggregate offering price of up to $100.0 million (CHF 88.2 million) through Leerink Partners as its sales agent. Any such sales, made through the sales agent, can be made by any method that is deemed an “at-the-market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, or in other transactions pursuant to an effective shelf registration statement on Form F-3. The Company agreed to pay Leerink Partners a commission of up to 3.0% of the gross proceeds of any sales of ordinary shares sold pursuant to the sales agreement. Following the execution of the agreement, the Company issued 1,000,000 ordinary shares during the three months ended September 30, 2024 and 2,500,000 ordinary shares during the three months ended March 31, 2025 out of its existing capital band to be held as treasury shares, each with a nominal value of CHF 0.01. There were no sales under the ATM Offering Program through March 31, 2025.

Life to date transaction costs incurred in connection with the establishment and maintenance of the ATM program amounted to CHF 0.3 million as of March 31, 2025, which were capitalized within other current assets.

Registered direct offering and Nasdaq Iceland Main Market listing

On April 22, 2024, the Company closed a registered direct offering with gross proceeds of CHF 53.5 million, or $58.8 million, through the issuance and sale of 5,000,000 of its ordinary shares, nominal value CHF 0.01 per share, at a purchase price of CHF 10.70, or $11.75, per share to investors (the “Registered Direct Offering”), and commenced trading of its ordinary shares on the Nasdaq Iceland Main Market under the ticker symbol “OCS” on April 23, 2024. In connection with the Registered Direct Offering and Nasdaq Iceland Main Market listing, the Company incurred approximately CHF 2.5 million of transaction related costs, of which CHF 1.9 million were recorded as a reduction of share premium within the statement of changes in equity.

  • SEGMENT INFORMATION

The Company is managed and operated as one business. A single management team that reports to the Chief Executive Officer comprehensively manages the entire business and accordingly, the Company has one reportable segment.

The table below provides the carrying amount of certain non-current assets, by geographic area:

Switzerland Iceland Others Total
As of March 31, 2025 As of December 31, 2024 As of March 31, 2025 As of December 31, 2024 As of March 31, 2025 As of December 31, 2024 As of March 31, 2025 As of December 31, 2024
Intangible assets 13,292 13,292 - - - - 13,292 13,292
Property and equipment 188 200 160 173 16 12 364 385
Right-of-use assets 660 699 558 589 - 15 1,218 1,303
Total 14,140 14,191 718 762 16 27 14,874 14,980
  • INTANGIBLE ASSETS

Intangible assets as of March 31, 2025 and December 31, 2024 were CHF 13.3 million, and represented licenses purchased under license agreements with Novartis Technology LLC (“Novartis”) and Accure Therapeutics SL (“Accure”). The Novartis license agreement, dated as of December 19, 2018, between Oculis and Novartis relates to a novel topical anti-TNFα antibody, renamed Licaminlimab (OCS-02), licensed by Oculis for ophthalmic indications. The license agreement between Oculis and Accure, dated as of January 29, 2022, relates to Oculis’ exclusive global licensing of Privosegtor (OCS-05) (formerly ACT-01) from Accure. During the fourth quarter of 2024, the Company completed the Phase 2 ACUITY trial of Privosegtor (OCS-05) in acute optic neuritis and received investigational new drug (“IND”) clearance from the U.S. Food and Drug Administration (“FDA”). These events triggered milestone payments to Accure totaling CHF 1.1 million ($1.2 million) which were capitalized during the fourth quarter of 2024, increasing the value of the intangible asset. The milestones were paid during the three months ended March 31, 2025.

  • INCOME AND EXPENSES

  • Grant income

Grant income reflects reimbursement of research and development expenses, and income from certain research projects managed by Icelandic governmental institutions. Certain expenses qualify for incentives from the Icelandic government in the form of tax credits or cash reimbursements. Icelandic government grant income for the three months ended March 31, 2025, was CHF 0.3 million, compared to CHF 0.2 million for the same period in 2024.

  • Operating expenses

The tables below show the breakdown of the operating expenses by category:

For the three months ended March 31,
Research and development <br>expenses General and administrative <br>expenses Total operating <br>expenses
2025 2024 2025 2024 2025 2024
Personnel expense 4,349 1,736 2,857 2,236 7,206 3,972
Payroll 2,448 1,285 2,128 1,546 4,576 2,831
Share-based compensation 1,901 451 729 690 2,630 1,141
Operating expenses 10,422 9,120 2,631 2,458 13,053 11,578
External service providers 10,187 8,971 2,068 1,816 12,255 10,787
Other operating expenses 159 94 516 624 675 718
Depreciation expense 76 55 47 18 123 73
Total 14,771 10,856 5,488 4,694 20,259 15,550

The increased spending for external service providers for research and development expenses primarily reflects clinical trial related expenses as a result of the Company's active and completed clinical trials during the respective periods, mainly the ongoing Phase 3 Stage 2 DIAMOND-1 and DIAMOND-2 clinical trials of OCS-01 in diabetic macular edema (“DME”). These trials began enrollment in December 2023 and February 2024, respectively, and completed enrollment in April 2025. The increase in personnel expense in both research and development and general and administrative expenses is due to increased headcount and CHF 0.4 million of infrequent personnel related costs. The increase in share-based compensation expense is primarily due to awards granted during the three months ended March 31, 2025.

  • Finance result

The table below shows the breakdown of the finance result by category:

For the three months ended March 31,
2025 2024
Finance income 493 581
Finance expense (247 ) (41 )
Fair value adjustment on warrant liabilities (11,911 ) (3,069 )
Foreign currency exchange gain (loss) (1,567 ) 1,794
Finance result (13,232 ) (735 )

Refer to Note 11 for further discussions of the fair value adjustment on warrant liabilities.

Foreign currency exchange gains (losses) primarily reflect fluctuations in the U.S. dollar and Euro against the Swiss Franc, impacting the valuation of the Company’s cash and short-term financial asset balances. In 2025, the U.S. dollar weakened against the Swiss Franc, resulting in foreign exchange losses on U.S. dollar-denominated cash and financial assets. Conversely, in 2024, the Company recognized foreign exchange gains, primarily due to the strengthening of the U.S. dollar relative to the Swiss Franc.

  • OTHER CURRENT ASSETS AND ACCRUED INCOME

The table below shows the breakdown of other current assets by category:

As of<br>March 31, 2025 As of <br>December 31, 2024
Prepaid clinical and technical development expenses 392 2,615
Prepaid general and administrative expenses 3,906 2,842
VAT and other withholdings receivable 1,633 148
Total 5,931 5,605

The decrease in prepaid clinical and technical development expenses as of March 31, 2025 compared to prior year end was due to advancements of clinical trials, primarily the OCS-01 DIAMOND-1 and DIAMOND-2 trials in DME which started in December 2023 and February 2024, respectively, and completed enrollment in April 2025. The increase in prepaid general and administrative expenses as of March 31, 2025 compared to prior year end is due to corporate insurances policies renewed in the first quarter, resulting in prepaid balances.

The table below shows the movement of accrued income for the three months ended March 31, 2025 and 2024:

2025 2024
Balance as of January 1, 629 876
Accrued income recognized during the period 285 222
Foreign exchange revaluation 16 40
Balance as of March 31, 930 1,138

Accrued income is generated by incentives for research and development offered by the Icelandic government in the form of tax credits for innovation companies. These tax credits are either used to reduce the company’s income tax liability or, if the credits exceed the tax due, they are paid out in cash. The tax credit is subject to companies having a research project approved as eligible for tax credit by the Icelandic Centre for Research (Rannís).

  • SHARE-BASED COMPENSATION

Option awards and SARs

The following table summarizes stock option and stock appreciation right (“SAR”) activities under the Company’s Stock Option and Incentive Plan Regulation 2023 (“2023 Plan”) for the three months ended March 31, 2025 and 2024:

For the three months ended March 31, 2025 For the three months ended March 31, 2024
Number of awards Weighted average exercise price (CHF) Range of expiration dates Number of awards (1) Weighted average exercise price (1) (CHF) Range of expiration dates
Outstanding as of January 1, 4,687,054 6.82 2028 - 2034 3,466,210 4.50 2027 - 2033
Options granted 973,931 16.82 2035 270,582 10.63 2034
Forfeited(1) (278,821) 10.94 2033 - 2034 (55,928) 6.80 2032 - 2033
Exercised(1) (164,363) 1.88 2033 (90,590) 2.50 2027 - 2032
Outstanding as of March 31, 5,217,801 8.76 2028 - 2035 3,590,274 4.96 2028 - 2034

(1) Forfeited and exercised amount includes earnout options forfeited and exercised during the three month periods ended March 31, 2025 and 2024. No SARs had been exercised or forfeited during the three months ended March 31, 2025 and 2024.

The number of options and SARs that were exercisable at March 31, 2025 and 2024 were 1,989,163 and 1,482,230, respectively. Excluding earnout options, which have an exercise price of CHF 0.01, options outstanding as of March 31, 2025 have exercise prices ranging from CHF 1.76 to CHF 16.82. The weighted average remaining contractual life of options and SARs outstanding as of March 31, 2025 and December 31, 2024 was eight years.

The following assumptions were used in the Black-Scholes option pricing model for determining the value of options and SARs granted during the three months ended March 31, 2025 and 2024:

For the three months ended March 31,
2025 2024
Weighted average share price at the date of grant 18.71 (CHF 16.82) 12.16 (CHF 10.63)
Expected volatilities (%) (1)
Expected term (years) (2) 6.25 6.25
Range of risk-free interest rates (%) (3) 4.06-4.14 3.91-4.30
Dividend yield (%)

All values are in US Dollars.

(1) The expected volatility was derived from the historical stock volatilities of comparable peer public companies within the Company’s industry.

(2) The expected term represents the period that share-based awards are expected to be outstanding.

(3) The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the measurement date with maturities approximately equal to the expected terms.

The fair value of option awards and SARs is determined using the Black-Scholes option-pricing model. The weighted average grant date fair value for options granted during the three months ended March 31, 2025 was CHF 13.02 or $14.48 per share. The weighted average grant date fair value for options granted during the three months ended March 31, 2024 was CHF 8.36 or $9.56 per share. No SARs were granted during either period.

Restricted stock units

Each restricted stock unit (“RSU”) granted under the 2023 Plan entitles the grantee to one ordinary share upon vesting of the RSU. The Company intends to settle all RSUs granted in equity. The fair value of RSUs is determined by the closing stock price on the date of grant and the related compensation cost is amortized over the vesting period of the award using the graded method. RSUs have time-based vesting conditions ranging from one to four years. Certain RSUs also include a performance condition for which the Company has evaluated the probability of achievement. Expense is only recorded for awards with vesting criteria linked to performance conditions that are deemed probable of achievement. No RSUs were granted or outstanding during the three month period ending March 31, 2024. The following is a summary of RSU activity for the three months ended March 31, 2025:

For the three months ended March 31, 2025
Number of awards Weighted average grant date fair value (CHF) Range of expiration dates
Outstanding as of January 1, 2025 467,478 9.81 2034
RSUs granted 594,524 16.82 2035
RSUs vested/settled (4,715) 10.73 2034
Outstanding as of March 31, 2025 1,057,287 14.15 2034 - 2035

Share-based compensation expense

The total share-based compensation expense recognized in the statement of loss amounted to CHF 2.6 million for the three months ended March 31, 2025, including CHF 0.9 million recognized during the three months ended March 31, 2025 related to RSUs outstanding. Total share-based compensation recognized in the statement of loss was CHF 1.1 million for the three months ended March 31, 2024. The reserve for share-based payment increased from CHF 16.1 million as of December 31, 2024 to CHF 18.6 million as of March 31, 2025.

Earnout options

As a result of the Company’s 2023 business combination with European Biotech Acquisition Corp, certain pre-business combination Oculis equity holders received an aggregate of 369,737 earnout options with an exercise price of CHF 0.01. Vesting of these options are based on the achievement of post-acquisition-closing volume weighted average share price (“VWAP”) targets of Oculis of $15.00, $20.00 and $25.00, respectively, in each case, for any 20 trading days within any consecutive 30 trading day period commencing after the acquisition closing date and ending on or prior to March 2, 2028 (the “earnout period”). The first two price targets of $15.00 and $20.00 were met in November 2024 and February 2025, respectively, resulting in an aggregate of 168,571 earnout options becoming exercisable.

  • CASH AND CASH EQUIVALENTS, AND SHORT-TERM FINANCIAL ASSETS

The table below shows the breakdown of the cash, cash equivalents and short-term financial assets by currencies:

Cash and cash equivalents Short-term financial assets
by currency As of<br>March 31, 2025 As of<br>December 31, 2024 As of<br>March 31, 2025 As of<br>December 31, 2024
Swiss Franc 1,831 2,810 115,000 61,000
US Dollar 49,677 15,234 7,055 9,955
Euro 8,213 8,960 - -
Iceland Krona 145 648 - -
Other 7 56 - -
Total 59,873 27,708 122,055 70,955

Short-term financial assets consist of fixed term bank deposits with maturities between three and six months.

  • WARRANT LIABILITIES

The following table summarizes the Company’s outstanding warrant liabilities by warrant type as of March 31, 2025 and 2024:

2025 2024
BCA Warrants Blackrock Warrant Total Warrant Liabilities BCA Warrants Blackrock Warrant Total Warrant Liabilities
Balance as of January 1, 19,390 461 19,851 5,370 5,370
Fair value loss on warrant liabilities 11,867 44 11,911 3,069 - 3,069
Exercise of public and private warrants (16,825) - (16,825) - - -
Balance as of March 31, 14,432 505 14,937 8,439 - 8,439

The BCA warrants represent public and private placement warrants assumed from European Biotech Acquisition Corp. as part of the 2023 business combination agreement (“BCA Warrants”). The fair value of the public BCA Warrants, which are traded on Nasdaq, is based on the quoted Nasdaq market prices at the end of the reporting period for such warrants. Since the private placement BCA Warrants have identical terms to the public BCA Warrants, the Company determined that the fair value of each private placement BCA Warrant is equivalent to that of each public BCA Warrant. The public BCA Warrants are included in Level 1 and the private placement BCA Warrants in Level 2 of the fair value hierarchy. BCA Warrants are classified as short-term liabilities given that the Company cannot defer the settlement for at least 12 months.

The Blackrock Warrant, described in Note 4, is classified as a liability because its exercise price is fixed in USD, which is not the functional currency of the Company and therefore it does not meet the requirements to be classified as equity under IFRS. The fair value of the Blackrock Warrant is determined using the Black-Scholes option-pricing model and is included in Level 3 of the fair value hierarchy.

The following assumptions were used in the Black-Scholes option-pricing model for determining the fair value of the Blackrock Warrant as of March 31, 2025 and December 31, 2024 as indicated:

March 31, 2025 December 31, 2024
Share price on valuation date $19.03 (CHF 16.78) $17.00 (CHF 15.38)
Expected volatility (%) (1) 90.50 94.32
Expected term (years) (2) 3.08 3.21
Risk-free interest rate (%) (3) 3.89 4.28
Dividend yield (%) 0.00 0.00

(1) The expected volatility was derived from the historical stock volatilities of comparable peer public companies within the Company’s industry.

(2) The expected term represents the period that the Blackrock Warrant is expected to be outstanding.

(4) The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the measurement date with maturities approximately equal to the expected terms

For the three months ended March 31, 2025, the Company recognized fair value loss of CHF 11.9 million, primarily due to an increase in the trading price of public warrants as well as exercise activity during the quarter. Warrant exercises contributed to a decrease in warrant liabilities to CHF 14.9 million as of March 31, 2025, compared to CHF 19.9 million as of December 31, 2024. There were exercises of 1,806,297 warrant shares during the three months ended March 31, 2025 at a price of CHF 10.34 or $11.50 per share. For the three months ended March 31, 2024, the Company recognized a fair value loss of CHF 3.1 million, leading to an increase of warrant liabilities to CHF 8.4 million as of March 31, 2024. There were no warrant exercises during the three months ended March 31, 2024.

The movement of the warrant liabilities during the three months ended March 31, 2025 and 2024 is illustrated below:

2025 2024
Warrant liabilities<br>(in CHF thousands) Number of outstanding warrants Warrant liabilities<br>(in CHF thousands) Number of outstanding warrants
Balance as of January 1, 19,851 4,018,384 5,370 4,254,096
Fair value loss on warrant liabilities 11,911 - 3,069 -
Exercise of public and private warrants (16,825 ) (1,806,297 ) - -
Balance as of March 31, 14,937 2,212,087 8,439 4,254,096

The exercise of warrants during the first quarter of 2025 resulted in cash proceeds of CHF 18.9 million.

  • ACCRUED EXPENSES AND OTHER PAYABLES

The table below shows the breakdown of the accrued expenses and other payables by category:

As of<br>March 31, 2025 As of <br>December 31, 2024
Product development related expenses 15,354 13,702
Personnel related expenses 2,199 3,696
General and administration related expenses 2,249 749
Other payables 58 51
Total 19,860 18,198

The increase in product development-related accrued expenses as of March 31, 2025 relative to the prior year-end primarily reflects continued advancement of the Company’s development pipeline, notably the two Phase 3 clinical trials under the OCS-01 DIAMOND program. The decrease in accrued personnel related expenses during the quarter was primarily related to the payout of bonus amounts accrued as of December 31, 2024. Accrued general and administrative related expenses increased due to transaction costs incurred related to the February 2025 underwritten offering.

  • SHAREHOLDERS’ EQUITY
  • Conditional capital

The conditional capital at March 31, 2025 amounts to a maximum of CHF 209,405.43 split into 20,940,543 ordinary shares, in connection with the potential future issuances of:

  • Conditional share capital for new bonds and similar debt instruments:

CHF 67,500.00 through the issuance of a maximum of 6,750,000 fully paid up registered shares, each with a par value of CHF 0.01 (ordinary shares), in connection with the exercise of convertible rights and/or option rights or warrants, new bonds and similar debt instruments.

  • Conditional share capital in connection with employee benefit plans:

CHF 95,663.02 through the issuance of a maximum of 9,566,302 fully paid up registered shares, each with a par value of CHF 0.01 (ordinary shares), in connection with the exercise of option rights or other equity-linked instruments granted to any employee, consultant or member of the Board of Directors of Oculis.

During the three months ended March 31, 2025, 169,078 shares have been issued in connection with option exercises and vested RSU settlements using the conditional share capital for employee benefit plans (refer to Note 9). These shares were not registered yet in the commercial register as of balance sheet date.

  • Conditional share capital for Business Combination Agreement (“BCA”) public and private warrants:

CHF 42,541.38 through the issuance of a maximum of 4,254,138 fully paid up registered shares, each with a par value of CHF 0.01 (ordinary shares), in connection with the exercise of warrants.

As of March 31, 2025, 2,234,486 warrants have been exercised and associated ordinary shares have been issued using the conditional share capital for BCA public and private warrants. 1,806,297 of these shares were not registered yet in the commercial register as of the balance sheet date.

  • Conditional share capital for earnout options:

CHF 3,701.03 through the issuance of a maximum of 370,103 fully paid up registered shares, each with a par value of CHF 0.01 (ordinary shares), in connection with the exercise of option rights or other equity-linked instruments granted to any employee, consultant or member of the Board of Directors of Oculis.

(B) Capital band

The Company has a capital band between CHF 464,437.00 (lower limit) and CHF 691,655.50 (upper limit). The Company may effect an increase of the Company’s share capital in a maximum amount of CHF 227,218.50 by issuing up to 22,721,850 ordinary shares with a par value of CHF 0.01 each out of the Company’s capital band. The Board of Directors is authorized to increase the share capital to the upper limit at any time and as often as required until May 29, 2029. The Company had 52,060,500 ordinary shares issued and outstanding as of March 31, 2025 with a share price of $19.03 or CHF 16.78.

(C) Treasury shares

In connection with the establishment of the ATM Offering Program described in Note 4 - Financing Activities, the Company has issued 1,000,000 ordinary shares during the three months ended September 30, 2024 and 2,500,000 ordinary shares during the three months ended March 31, 2025 out of its capital band with a par value of CHF 0.01 each. The shares are to be held in treasury and exclusively reserved for future settlement of any sales under the sales agreement with Leerink Partners.

(D) Earnout consideration

As a result of the Company’s 2023 business combination with European Biotech Acquisition Corp, certain pre-business combination Oculis equity holders received consideration in the form of 3,793,995 earnout shares.

The earnout shares are subject to forfeiture in the event of a failure to achieve the price targets during the earnout period defined as follows: (i) 1,500,000, (ii) 1,500,000 and (iii) 1,000,000 earned based on the achievement of post-acquisition-closing volume weighted average share price (“VWAP”) targets of Oculis of $15.00, $20.00 and $25.00, respectively, in each case, for any 20 trading days within any consecutive 30 trading day period commencing after the acquisition closing date and ending on or prior to March 2, 2028 (the “earnout period”). The first two price targets of $15.00 and $20.00 were met in November 2024 and February 2025, respectively, resulting in the immediate vesting of 1,422,723 shares on each date.

  • LOSS PER SHARE

The following table sets forth the loss per share calculations for the three months ended March 31, 2025 compared to the three months ended March 31, 2024.

For the three months ended March 31,
2025 2024
Net loss for the period attributable to Oculis shareholders - in CHF thousands (33,213 ) (16,093 )
Loss per share
Weighted-average number of shares used to compute basic and diluted loss per share 48,263,134 36,621,162
Basic and diluted net loss per share for the period, ordinary shares (0.69 ) (0.44 )

Since the Company has a loss for all periods presented, basic net loss per share is the same as diluted net loss per share. Potentially dilutive securities that were not included in the diluted loss per share calculations because they would be anti-dilutive were as follows:

As of March 31, 2025 As of March 31, 2024
Share options issued and outstanding 4,989,191 3,220,537
Earnout options 228,610 369,737
Share and earnout options issued and outstanding 5,217,801 3,590,274
Restricted stock units subject to future vesting 1,057,287 -
Restricted shares subject to repurchase - 61,308
Earnout shares 948,549 3,793,995
Public BCA Warrants 2,017,067 4,102,397
Private BCA Warrants 151,699 151,699
Blackrock Warrant 43,321 -
Total 9,435,724 11,699,673
  • RELATED PARTY DISCLOSURES

Key management, including the Board of Directors and the executive management team, compensation were:

For the three months ended March 31,
2025 2024
Salaries, cash compensation and other short-term benefits 1,755 966
Pension 105 92
Share-based compensation expense 1,522 915
Total 3,382 1,973

Salaries, cash compensation and other short-term benefits include social security and board member fees.

The number of key management individuals reported as receiving compensation in the table above was increased from 8 to 9 for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024. The number of individuals receiving compensation for service on the Board of Directors as reported in the table above decreased from 6 to 4 for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024.

  • SUBSEQUENT EVENTS

There are no material subsequent events.

EX-99.2

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, 2025 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, 2024 and the section entitled “Risk Factors” included in our Annual Report on Form 20-F for the year ended December 31, 2024 filed on March 11, 2025 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, 2025 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, headquartered in Switzerland with operations in the U.S. and Iceland. We have substantial expertise in therapeutics for the treatment of ophthalmic and neuro-ophthalmic disease. We are engaged in developing innovative drug candidates that embrace the potential to address significant unmet medical needs for many eye-related and neuro-ophthalmic conditions. Our mission is to save sight and improve eye care of patients worldwide. We intend to become a global leader in ophthalmic and neuro-ophthalmic therapeutics to realize this mission.

Our pipeline currently includes three clinical-stage therapeutic candidates: OCS-01, Privosegtor and Licaminlimab. Our lead product candidate, OCS-01, is presently being evaluated in two ongoing Phase 3 clinical trials for DME. Our second clinical candidate is Privosegtor (OCS-05), a neuroprotective candidate. We completed a Phase 2 proof-of-concept trial evaluating Privosegtor (OCS-05) as a potential treatment for acute optic neuritis, for which there is currently no approved neuroprotective treatment, and announced positive results in January 2025. In April 2025, we announced that the company will meet with the FDA to discuss the development plan in acute optic neuritis and it will initiate two new programs evaluating Privosegtor as a potential neuroprotective treatment for an orphan condition, non-arteritic anterior ischemic optic neuropathy (“NAION”), and for the acute treatment of relapses in multiple sclerosis (“MS”). Our third clinical candidate is Licaminlimab (OCS-02) for the treatment of keratoconjunctivitis sicca, or dry eye disease (“DED”), after a successful FDA meeting in Q1 2025, the company intends to advance it with a genotype-based development approach to deliver a potentially first in class precision medicine treatment in ophthalmology. We plan to initiate a Phase 2/3 trial in the second half of 2025.

Recent Developments

Clinical Development Update

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. We completed enrollment for both trials in April 2025 with over 800 patients in 119 clinical sites globally. The topline results from the DIAMOND trials are expected in Q2 2026 with the NDA submission to the FDA for OCS-01 for the treatment of DME planned for 2026. NDA submission to the FDA for the treatment of inflammation and pain following ocular surgery is expected to follow thereafter.

Our second product candidate, Privosegtor (OCS-05), is a novel peptidomimetic small molecule in development as a potential neuroprotective agent. We are initially developing Privosegtor (OCS-05) as a potential therapy to treat acute optic neuritis, a rare disease with high unmet medical need. Currently there is no specific neuroprotective treatment which is approved by the FDA or European Commission for acute optic neuritis. We conducted a first-in-patient clinical trial of Privosegtor (OCS-05) in acute optic neuritis to test the candidate’s safety, tolerability and efficacy, for which we announced positive topline results in January 2025. The results showed, in patients suffering from acute optic neuritis, an improvement of visual function with Privosegtor (OCS-05) as well as a neuroprotective effect as observed in the better preservation of the thickness of the retina, a biomarker of axonal and retinal ganglion cells protection, consistent with the pre-clinical study results. Additionally, the FDA cleared our IND application for Privosegtor (OCS-05), enabling the initiation of clinical development in the United States. We plan to meet with the FDA in Q3 2025 to discuss the development program for OCS-05, including a registrational study program for acute optic neuritis, which is expected to initiate in 2026.

In April 2025, we announced the initiation two new programs utilizing Privosegtor as a potential neuroprotective treatment for NAION, and for the acute treatment of relapses in MS. Pre-IND interactions with the FDA are planned for the second half of 2025 to support applications relying on existing Privosegtor data.

Components of Results of Operations

Revenue

We have not generated any revenue from the sale of products 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 generated by incentives for research and development offered by the Icelandic government in the form of tax reimbursement for innovation companies. 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.

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:

  • employee-related expenses, including salaries, related benefits and equity-based compensation expense, for employees 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 (“CMOs”) that are primarily engaged to provide drug substance and product for our clinical trials and research and development programs;

  • 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.

During the three months ended March 31, 2025 and 2024, 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 development of our product candidates.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and related costs for personnel in executive management, finance and accounting, legal, business development, corporate communications, pre-commercial and other administrative functions. General and administrative expenses also include legal fees pertaining to certain intellectual properties expenses, corporate insurance expenses, professional fees for accounting, auditing, investor communication, and other 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 agreement with Kreos Capital VII Aggregator SCSp, 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.

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 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 law 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, 2024, we had tax loss carry-forwards totaling CHF 233.8 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

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

For the three months ended March 31,
2025 2024 Change % Change
Grant income 285 222 63 28 %
Operating income 285 222 63 28 %
Research and development expenses (14,771 ) (10,856 ) (3,915 ) 36 %
General and administrative expenses (5,488 ) (4,694 ) (794 ) 17 %
Operating expenses (20,259 ) (15,550 ) (4,709 ) 30 %
Operating loss (19,974 ) (15,328 ) (4,646 ) 30 %
Finance income 493 581 (88 ) (15 %)
Finance expense (247 ) (41 ) (206 ) 502 %
Fair value adjustment on warrant liabilities (11,911 ) (3,069 ) (8,842 ) 288 %
Foreign currency exchange gain (loss) (1,567 ) 1,794 (3,361 ) (187 %)
Finance result (13,232 ) (735 ) (12,497 ) 1700 %
Loss before tax for the period (33,206 ) (16,063 ) (17,143 ) 107 %
Income tax expense (7 ) (30 ) 23 (77 %)
Loss for the period (33,213 ) (16,093 ) (17,120 ) 106 %

Comparison of the Three Months Ended March 31, 2025 and 2024

Grant Income

Grant income for the three months ended March 31, 2025 was CHF 0.3 million, compared to CHF 0.2 million for the three months ended March 31, 2024. The increase is driven by increased spending on qualifying research and development activities. The grant income is dependent upon the Icelandic government making such reimbursement available for research and development activities. While certain of our research and development expenses have historically qualified for reimbursement, 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,
2025 2024 Change % Change
Personnel expenses 4,349 1,736 2,613 151 %
Payroll 2,448 1,285 1,163 91 %
Share-based compensation 1,901 451 1,450 322 %
Operating expenses 10,422 9,120 1,302 14 %
External service providers 10,187 8,971 1,216 14 %
Other operating expenses 159 94 65 69 %
Depreciation expense 76 55 21 38 %
Total research and development expense 14,771 10,856 3,915 36 %

Research and development expenses were CHF 14.8 million for the three months ended March 31, 2025, compared to CHF 10.9 million for the three months ended March 31, 2024. The increase of CHF 3.9 million, or 36%, was primarily due to an increase in research and development personnel-related costs, as well as an increase in external service providers as a result of our active clinical trials and technical development activities. Increased development expenses reflect mainly the ongoing Phase 3 Stage 2 DIAMOND-1 and DIAMOND-2 clinical trials of OCS-01 in DME, which began enrolling in December 2023 and February 2024, respectively, and completed enrollment in April 2025.

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

For the three months ended March 31,
2025 2024 Change % Change
OCS-01 10,712 4,949 5,763 116%
OCS-02 (Licaminlimab) 1,823 4,362 (2,539) (58%)
OCS-05 (Privosegtor) 1,457 809 648 80%
Other development projects 779 736 43 6%
Total 14,771 10,856 3,915 36%

General and Administrative Expenses

For the three months ended March 31,
2025 2024 Change % Change
Personnel expenses 2,857 2,236 621 28 %
Payroll 2,128 1,546 582 38 %
Share-based compensation 729 690 39 6 %
Operating expenses 2,631 2,458 173 7 %
External service providers 2,068 1,816 252 14 %
Other operating expenses 516 624 (108 ) (17 %)
Depreciation expense 47 18 29 161 %
Total 5,488 4,694 794 17 %

General and administrative expenses were CHF 5.5 million for the three months ended March 31, 2025, compared to CHF 4.7 million for the three months ended March 31, 2024. The increase of CHF 0.8 million, or 17%, was primarily due to increased personnel-related costs.

Finance Income and Finance Expense

For the three months ended March 31,
2025 2024 Change % Change
Finance income 493 581 (88 ) (15 %)
Finance expense (247 ) (41 ) (206 ) 502 %
Total finance income (expense) 246 540 (294 ) (54 %)

We recorded finance income of CHF 0.5 million for the three months ended March 31, 2025 and CHF 0.6 million for the three months ended March 31, 2024, which was comprised of interest income earned on our cash equivalents and short term financial assets. Finance expense during the three months ended March 31, 2025 primarily related to the amortization of transaction costs associated with the Loan Agreement, discussed further in “B. Liquidity and Capital Resources” below.

Fair Value Adjustment on Warrant Liabilities

For the three months ended March 31,
2025 2024 Change % Change
Fair value adjustment on warrant liabilities (11,911 ) (3,069 ) (8,842 ) 288 %

We recorded fair value adjustment losses on warrant liabilities of CHF 11.9 million and CHF 3.1 million for the three months ended March 31, 2025 and 2024, respectively, primarily due to increases in the market price of our public warrants during the respective quarters.

Foreign Currency Exchange Gain (Loss)

For the three months ended March 31,
2025 2024 Change % Change
Foreign currency exchange (loss) gain (1,567 ) 1,794 (3,361 ) (187 %)

We recognized a foreign currency exchange loss of CHF 1.6 million during the three months ended March 31, 2025, compared to a gain of CHF 1.8 million for the three months ended March 31, 2024. For the three months ended March 31, 2025, the unfavorable currency exchange loss was reflective of fluctuations in the U.S. dollar and Euro against the Swiss Franc, impacting the valuation of the Company’s cash and short-term financial assets balances. For the three months ended March 31, 2024, the foreign currency exchange gain was mainly due to the strengthening of the U.S. dollar relative to the Swiss Franc.

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 33.2 million and a cash outflow from operations of CHF 19.0 million for the three months ended March 31, 2025. We had a total of CHF 181.9 million, or $206.3 million, in cash, cash equivalents and short-term financial assets as of March 31, 2025.

On April 22, 2024, we closed a registered direct offering with gross proceeds of CHF 53.5 million or $58.8 million through the issuance of 5,000,000 ordinary shares, nominal value CHF 0.01 per share, at a purchase price of CHF 10.70 or $11.75 per share (the “Registered Direct Offering”), and commenced trading of our ordinary shares on the Nasdaq Iceland Main Market under the ticker symbol “OCS” on April 23, 2024.

On May 8, 2024, we entered into a sales agreement with Leerink Partners LLC with respect to an at-the-market offering program (the “ATM Offering 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 88.2 million) through Leerink Partners LLC as our sales agent. There have been no sales under the ATM Offering Program through March 31, 2025.

On May 29, 2024, we entered into an agreement for a loan facility with Kreos Capital VII (UK) Limited (the “Lender”), which are funds and accounts managed by Blackrock, Inc. (“the Loan Agreement”). The Loan Agreement is structured to provide the EUR equivalent of up to CHF 50.0 million in borrowing capacity (which may be increased to up to CHF 65.0 million), comprising tranches 1, 2 and 3, in the amounts of the EUR equivalents of CHF 20.0 million, CHF 20.0 million and CHF 10.0 million, respectively, as well as an additional loan of the EUR equivalent of up to CHF 15.0 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 follow-on offering for the issuance and sale of 5,000,000 ordinary shares, CHF 0.01 nominal value per share, at a price of $20.00 or CHF 18.05 per share (the “Underwritten Offering”), for total gross proceeds of CHF 90.2 million or $100.0 million.

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 and clinical trials. 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, 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,
2025 2024(1) Change % Change
Net cash outflow for operating activities (18,963) (13,720) (5,243) 38%
Net cash outflow for investing activities (51,505) (1,512) (49,993) 3306%
Net cash inflow from financing activities 103,831 171 103,660 60620%
Increase/(Decrease) in cash and cash equivalents 33,363 (15,061) 48,424 322%

(1) Amounts presented for the three months ended March 31. 2024 reflect the retrospective impact of the change in presentation of interest in the statement cash flows described in Note 2 of our Unaudited Condensed Consolidated Interim Financial Statements.

Total cash, cash equivalents and short-term investments were CHF 181.9 million as of March 31, 2025, which represents an increase of CHF 83.3 million from CHF 98.7 million at December 31, 2024. The increase was primarily due to CHF 90.2 million, or $100.0 million, gross proceeds raised in the February 2025 underwritten offering.

Operating Activities

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, Privosegtor (OCS-05) and Licaminlimab (OCS-02). 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.

For the three months ended March 31, 2024, operating activities used CHF 13.7 million of cash, primarily consisting of a loss before tax of CHF 16.1 million and a decrease in net working capital of CHF 0.3 million, partially offset by non-cash adjustments of CHF 2.6 million. The decrease in net working capital was driven by a decrease of CHF 4.2 million in trade payables and accrued liabilities partially offset by a CHF 4.1 million decrease in other current assets. Non-cash charges primarily consisted of a CHF 3.1 million fair value adjustment loss on warrant liabilities and CHF 1.1 million of share based compensation expense, partially offset by CHF 1.7 million of financial result composed primarily of foreign exchange transactions.

Investing Activities

For the three months ended March 31, 2025 and 2024, CHF 50.6 million and CHF 2.0 million was used for investments in current fixed term bank deposits, net of maturities, respectively. We also paid CHF 1.1 million during the three months ended March 31, 2025 for milestone payments pursuant to our licensing agreement with Accure, increasing the capitalized intangible asset.

Financing Activities

For the three months ended March 31, 2025, net cash inflow from financing activities was CHF 103.8 million, which consisted 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. For the three months ended March 31, 2024, net cash provided by financing activities was CHF 0.2 million, which primarily consisted of proceeds received for 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 expect to incur significant expenses related to developing our commercialization capabilities to support product sales, medical affairs activities, market access activities, marketing and distribution activities, either alone or in collaboration with others. As a result, we will 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 financing. 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 Loan Agreement we entered into in May 2024, 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. 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:

  • advance our clinical-stage product candidates, including as we progress our Phase 3 clinical trials for OCS-01 for DME;

  • advance Privosegtor (OCS-05) in acute optic neuritis into potentially registrational programs in 2026, pending FDA interaction;

  • initiate our two new programs utilizing Privosegtor as a potential neuroprotective treatment for NAION and MS;

  • advance our Licaminlimab (OCS-02) program into Phase 2/3 and related manufacturing development activities;

  • 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, quality assurance and control, medical, scientific and other technical personnel to support our clinical 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 and Accure, each described in Note 6 of the Unaudited Condensed Consolidated Interim Financial Statements, 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 various 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 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, 2024, included in our Annual Report on Form 20-F filed with the SEC on March 11, 2025. Refer to Note 3 to our Unaudited Condensed Consolidated Interim Financial Statements 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 11, 2025.

E. Emerging Growth Company Status

As an emerging growth company, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies. In addition, our independent registered public accounting firm is not required to attest to the effectiveness of our internal control over financial reporting until the date we are no longer an emerging growth company.

We will cease to be an emerging growth company upon the earliest to occur of (i) the last day of the fiscal year in which we have more than $1.235 billion in annual revenue; (ii) the last day of the fiscal year in which we qualify as a “large accelerated filer”; (iii) the date on which we have, during the previous three-year period, issued more than $1.0 billion in non-convertible debt securities; and (iv) the last day of our fiscal year following the fifth anniversary of the date of becoming a public company.

Cautionary Note Regarding Forward-Looking Statements

Some of the statements in this quarterly 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 public 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 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, trade policies and other global events on our business;

  • changes in applicable laws or regulations; 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 quarterly 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.

EX-99.3

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Exhibit 99.3

Oculis Reports Q1 2025 Financial Results and Provides Company Update

  • The recent R&D Day (replay) showcased material progress across all three core assets and highlighted potential first-in-class neuroprotection treatment in neuro-ophthalmology, an area of high unmet medical need, thanks to Privosegtor’s (OCS-05) positive results from the ACUITY trial in Acute Optic Neuritis

  • OCS-01: DIAMOND Ph3 trials enrollment completed with over 800 patients randomized; topline results expected Q2 2026 for the first potential eye drop treatment for diabetic macular edema (DME)

  • Licaminlimab (OCS-02) genotype-based development plan to drive a personalized medicine approach in dry eye disease (DED) aligned with FDA; first registrational trial initiation anticipated in 2H 2025

  • Cash, cash equivalents and short-term investments of $206.3 million as of March 31, 2025, reflects proceeds from the $100.0 million financing in February 2025, providing cash runway into early 2028

ZUG, Switzerland, May 8, 2025 -- Oculis Holding AG (Nasdaq: OCS / ICX: OCS.IC) (“Oculis” or the “Company”), a global biopharmaceutical company focused on innovations addressing ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs, today announced results for the first quarter ended March 31, 2025 and provided an overview of the Company’s progress.

Riad Sherif M.D., Chief Executive Officer of Oculis: “We began 2025 with an exciting evolution of our portfolio, driven by strong execution and solid science. We’ve made significant advancements on all three of our highly differentiated assets: completing randomization of over 800 patients in both Phase 3 DIAMOND-1 and DIAMOND-2 trials with OCS-01; initiating the first-ever genotype-based development program in ophthalmology with Licaminlimab (OCS-02); and announcing promising neuroprotective data with Privosegtor in the ACUITY trial - a potentially transformative catalyst for our company. The ACUITY readout not only validates our approach in acute optic neuritis, but also allows us the ability to expand into neuro-ophthalmology and beyond, significantly increasing our potential addressable patient population by multiple folds. These advancements, combined with a strengthened financial position, have enabled us to expand our innovative pipeline. With several near-term value inflection points ahead, we are well-positioned to drive value creation, while bringing transformative treatments to those who need them most."

R&D Day Key Highlights:

  • Privosegtor (OCS-05) – A new era in neuroprotection for acute optic neuritis and beyond: Additional analyses from the successful Phase 2 ACUITY trial further supported the previously announced neuroprotective effects on retinal ganglion cells and axons, as well as vision improvement in patients with acute optic neuritis. These analyses also revealed that Privosegtor led to lower neurofilament release, a prominent biomarker of reduced neuro-axonal damage in neurological disorders, including MS. Oculis is planning to pursue a global registration program in acute optic neuritis, and evaluate Privosegtor in NAION and as a treatment of acute MS relapses.

  • OCS-01 – A non-invasive eye drop for DME: The Company has completed enrollment in the Phase 3 DIAMOND-1 and DIAMOND-2 trials of OCS-01 eye drops in DME, with over 800 patients randomized; topline results are expected in Q2 2026.

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  • Licaminlimab (OCS-02) – An innovative TNF inhibitor specifically design for ocular inflammation : An FDA meeting in Q1 2025 confirmed the path forward for genotype-based development with Licaminlimab (OCS-02) to deliver a precision medicine treatment in DED with initiation of the first phase 2/3 activities to start in 2H 2025.

Recent Clinical Highlights and Upcoming Milestones:

  • OCS-01:

  • Phase 3 DIAMOND trials investigating OCS-01 in DME completed enrollment with over 800 patients randomized. DIAMOND is the first ever Phase 3 program investigating a topical, non-invasive treatment for DME.

  • DME is a progressive complication of diabetic retinopathy, estimated to affect around 37 million people worldwide currently representing a ~$5 billion market opportunity and the unmet needs for early intervention and patients with inadequate response to standard of care.

  • The topline results from both DIAMOND Phase 3 trials are expected in Q2 2026 with the NDA submission to the FDA for OCS-01 for the treatment of DME planned for 2H 2026.

  • Licaminlimab (OCS-02):

  • Following three positive Phase 2 trials and a successful meeting with the FDA, a genotype-based development plan investigating Licaminlimab for the treatment of DED has been aligned with the Agency; a phase 2/3 is anticipated to initiate 2H 2025.

  • Privosegtor (OCS-05):

  • Results from Phase 2 ACUITY trial investigating Privosegtor, a novel, first-in-class peptidomimetic small molecule in development for the treatment of acute optic neuritis, showed significant neuroprotective anatomical benefits and functional vision improvement.

  • Plan to meet with the FDA in Q3 2025 to discuss the development program for Privosegtor, including a registrational program for acute optic neuritis, expected to initiate in 1H 2026.

  • Privosegtor’s demonstration of neuroprotection in the ACUITY trial supports its potential for broad applicability in multiple neuro-ophthalmology and neurology indications. Oculis intends to expand its Privosegtor development program into NAION, an orphan indication often leading to permanent vision loss, for which there are no approved therapies and as a treatment of acute MS relapses. Pre-IND discussions with the FDA are planned for 2H 2025, to support applications relying on existing Privosegtor data.

Q1 2025 Financial Highlights

  • Cash position: As of March 31, 2025, the Company had total cash, cash equivalents and short-term investments of CHF 181.9 million or $206.3 million, compared to CHF 98.7 million or $109.0 million as of December 31, 2024. The increase in cash position from December 31, 2024 reflected proceeds from the $100.0 million (CHF 90.2 million) equity financing in February 2025. Based on its current development plans, the Company’s cash balances are expected to fund operations into early 2028.

  • Research and development expenses: The Company’s research and development expenses were CHF 14.8 million or $16.4 million for the three months ended March 31, 2025, compared to CHF 10.9 million or $12.4 million in the same period in 2024. The increase was primarily due

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  • to development costs associated with the Company’s active clinical trials, in particular the two DIAMOND Phase 3 trials, as well as personnel-related costs.

  • General and administrative expenses: The Company’s general and administrative expenses were CHF 5.5 million or $6.1 million for the three months ended March 31, 2025, compared to CHF 4.7 million or $5.4 million in the same period in 2024. The increase was primarily driven by personnel-related costs.

  • Q1 Net loss: The Company’s net loss was CHF 33.2 million or $36.9 million, or CHF 0.69 or $0.77 per share, for the three months ended March 31, 2025, compared to CHF 16.1 million or $18.4 million, or CHF 0.44 or $0.50 per share, for the same period in 2024. The increase was primarily driven by advancements in clinical development programs, G&A expenses, as well as a CHF 8.8 million or $9.8 million increase in the non-cash fair value adjustment on warrant liabilities.

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Condensed Consolidated Statements of Financial Position (Unaudited)

(Amounts in CHF thousands) As of March 31, As of December 31,
2025 2024
ASSETS
Non-current assets
Property and equipment, net 364 385
Intangible assets 13,292 13,292
Right-of-use assets 1,218 1,303
Other non-current assets 508 476
Total non-current assets 15,382 15,456
Current assets
Other current assets 5,931 5,605
Accrued income 930 629
Short-term financial assets 122,055 70,955
Cash and cash equivalents 59,873 27,708
Total current assets 188,789 104,897
TOTAL ASSETS 204,171 120,353
EQUITY AND LIABILITIES
Shareholders' equity
Share capital 555 446
Share premium 464,190 344,946
Reserve for share-based payment 18,642 16,062
Actuarial loss on post-employment benefit obligations (1,646) (2,233)
Treasury shares (35) (10)
Cumulative translation adjustments (310) (271)
Accumulated losses (318,770) (285,557)
Total equity 162,626 73,383
Non-current liabilities
Long-term lease liabilities 799 865
Defined benefit pension liabilities 1,294 1,870
Total non-current liabilities 2,093 2,735
Current liabilities
Trade payables 4,351 5,871
Accrued expenses and other payables 19,860 18,198
Short-term lease liabilities 304 315
Warrant liabilities 14,937 19,851
Total current liabilities 39,452 44,235
Total liabilities 41,545 46,970
TOTAL EQUITY AND LIABILITIES 204,171 120,353

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Condensed Consolidated Statements of Loss (Unaudited)

(Amounts in CHF thousands, except per share data) For the three months ended <br>March 31,
2025 2024
Grant income 285 222
Operating income 285 222
Research and development expenses (14,771) (10,856)
General and administrative expenses (5,488) (4,694)
Operating expenses (20,259) (15,550)
Operating loss (19,974) (15,328)
Finance income 493 581
Finance expense (247) (41)
Fair value adjustment on warrant liabilities (11,911) (3,069)
Foreign currency exchange loss, net (1,567) 1,794
Finance result, net (13,232) (735)
Loss before tax for the period (33,206) (16,063)
Income tax expense (7) (30)
Loss for the period (33,213) (16,093)
Loss per share:
Basic and diluted loss attributable to equity holders (0.69) (0.44)

-ENDS-

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About Oculis

Oculis is a global biopharmaceutical company (Nasdaq: OCS / XICE: OCS) focused on innovations addressing ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs. Oculis’ highly differentiated pipeline of multiple innovative product candidates in clinical development includes: OCS-01, a topical eye drop candidate for diabetic macular edema (DME); Privosegtor (OCS-05), a neuroprotective candidate for acute optic neuritis with potentially broad clinical applications in other neuro-ophthalmic diseases; and Licaminlimab (OCS-02), a topical biologic anti-TNFα eye drop candidate for 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 is supported by leading international healthcare investors.

For more information, please visit: www.oculis.com

Oculis Contacts

Ms. Sylvia Cheung, CFO

sylvia.cheung@oculis.com

Investor & Media Relations

LifeSci Advisors

Corey Davis, Ph.D.

cdavis@lifesciadvisors.com

1-212-915-2577

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 timing, progress and results of current and future clinical trials, Oculis’ research and development programs, regulatory and business strategy, including planned interactions with the FDA; Oculis’ future development plans; the timing or likelihood of regulatory filings and approvals; 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 other documents filed with the U.S. Securities and Exchange Commission (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.

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