Derek Dostal

+1 212 450 4322

derek.dostal@davispolk.com    

Davis Polk & Wardwell LLP

450 Lexington Avenue
New York, NY 10017

davispolk.com

Oculis Holding AG

Registration Statement on Form F-4

Filed November 7, 2022

File No. 333-268201

Li Xiao

Daniel Gordon

Daniel Crawford

Ada D. Sarmento

Please disclose the sponsor and its affiliates’ total potential ownership interest in the combined company, assuming exercise and conversion of all securities.

Please highlight the risk that the sponsor will benefit from the completion of a business combination and may be incentivized to complete an acquisition of a less favorable target company or on terms less favorable to shareholders rather than liquidate.

Revise your disclosure to show the potential impact of redemptions on the per share value of the shares owned by non-redeeming shareholders by including a sensitivity analysis showing a range of redemption scenarios, including minimum, maximum and interim redemption levels.

Please revise to disclose all possible sources and extent of dilution that shareholders who elect not to redeem their shares may experience in connection with the business combination. Provide disclosure of the impact of each significant source of dilution, including the amount of equity held by founders, convertible securities, including warrants retained by redeeming shareholders, at each of the redemption levels detailed in your sensitivity analysis, including any needed assumptions.

It appears that underwriting fees remain constant and are not adjusted based on redemptions. Revise your disclosure to disclose the effective underwriting fee on a percentage basis for shares at each redemption level presented in your sensitivity analysis related to dilution.

With respect to the 4,251,595 Public Warrants and 151,699 Private Warrants issued by EBAC in connection with its IPO, please tell us whether you anticipate any change in classification between liabilities and equity upon consummation of the business combination. If so, please revise your pro forma financial statements accordingly.

In Note 4 related party transaction of EBAC financial statement at page F-15, you disclosed EBAC founder shares are subject to share based compensation accounting upon occurrence of a business combination as a performance condition under ASC 718. Please tell us whether you anticipate such accounting under IFRS as issued by the IASB. If so, please revise your pro forma financial statements accordingly.

We note several statements that if your product candidates were approved today, they would be the first and only such treatment for certain indications. These statements are speculative and are inappropriate given the length of time and uncertainty with respect to securing marketing approval. If your intention is to convey your belief that your product candidates utilize a novel technology or approach, you may discuss how your technology differs from technology used by competitors or that you are not aware of competing products that are further along in the development process. Statements such as these should be accompanied by cautionary language that the statements are not intended to give any indication that your product candidates have been proven effective or will receive regulatory approval.

Please revise where appropriate to provide the data and assumptions relied on for your estimated indication populations and estimated addressable market of your product candidates for each indication.

We note the inclusion of the glaucoma, geographic atrophy, diabetic retinopathy, and neurotrophic keratitis indications for OCS-05, and the OCS-03 and OCS-04 programs in your pipeline table on page 193. Please explain why each program is sufficiently material to your business to warrant inclusion in your pipeline table and revise to provide additional disclosure about these programs in your Business of Oculis and Certain Information about Oculis section including, without limitation, the current status of program development and future development plans. Alternatively, remove the programs from your pipeline table.

Given the early stage and lack of disclosure regarding the undisclosed product candidate, please remove the undisclosed product candidate row from the pipeline table.

Please revise your statements on pages 194 and 204 that topical ocular administration of OCS-02 showed efficacy as efficacy determinations are solely within the authority of the FDA or similar regulatory body. You may provide a summary of the objective data from your trials without including conclusions related to efficacy. Similarly, please revise the statement on page 196 that you are conducting a Phase 3 clinical trial of OCS-01 to “confirm its efficacy” in treating inflammation and pain following ocular surgery and remove the reference to “positive” Phase 2 clinical trial results achieved with OCS-01 in treating DME on page 201.

We note your disclosure on page 82 that OCS-05 has been subject to a clinical hold by the FDA since 2016. Please revise your discussion of OCS-05 on pages 193, 195 and 208, and your pipeline table to discuss the clinical hold and the steps that you must take to clear the hold. Please also include in your discussion the fact that if you are unable to clear the clinical hold, OCS-05 may not receive clearance from the FDA to proceed with human clinical trials, may never receive regulatory approval from the FDA, and you may be unable to market and commercialize OCS-05 in the United States.

Please limit the disclosure of specific investors to those identified in the Principal Shareholder table on page 320. Additionally, indicate that prospective investors should not rely on the named investors’ investment decision, that these investors may have different risk tolerances and that the investors acquired their shares at a significant discount to the market price, if true.

Please revise to disclose the jurisdiction of your DIAMOND trial.

Please revise page 199 to provide the basis for your belief that approximately 40% of patients have a suboptimal response to therapy after 12 weeks of anti-VEGF treatment.

Please revise your disclosure of the tiered royalties percentage for both license agreements to further define a “low double-digit percentage” to a range within 10% percentage points of mid-single digit. Please also revise the disclosure of the royalty term for both agreements to specify the number of years following the first commercial sale that royalties are payable.

Please revise to further disclose the costs incurred on each of your key research and development projects. If you do not track your research and development costs by project, please disclose that fact and explain why you do not maintain and evaluate research and development costs by project.

The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 245 and 246 of Amendment No. 1 stating that it does not track research and development costs by project.

The Company respectfully advises the Staff that the Company has, since inception, pursued a number of early-stage research and development projects that, at any given time, involve employees, manufacturing, infrastructure and other internal resources that are not directly tied to a specific product candidate, until such product candidate reaches the clinical trial stage. The Company has historically tracked its research and development costs under its various programs on an aggregate basis and not on a project-by-project basis. Its considerations for doing so are as follows:

•  the Company is a clinical-stage company and recently progressed to have multiple product candidates in late-stage clinical trials.

•  the Company uses cash flow as the primary measure to manage its business and the Company’s management historically has received and reviewed its results of operations as a whole and not on a project-by-project basis when making decisions about allocating resources and assessing performance of the Company’s ability to operate; and

•  for accounting purposes, the Company reports its development programs on an aggregate basis.

Please revise to provide additional detail of how EBAC eliminated the six potential targets other than Oculis from consideration. For example, without limitation, disclose who initiated discussions with each target, describe the negotiations, including when they started and ended, the reasons negotiations ceased, and describe each target’s business.

Here you disclose that Oculis recognized CHF 4,025 thousand as the license was partially acquired from Novartis in a share-based compensation transaction completed in 2019 which increased the amount of share premium for the corresponding value. Please expand your disclosures to describe the share-based compensation transaction and how you have arrived at the CHF 4,025 thousand valuation from that transaction.

The Company respectfully advises the Staff that it considered the disclosure requirements of IFRS 2, Share based payments, most notably IFRS 2.46, which requires that an entity disclose information that “enables users of the financial statements to understand how the fair value of the goods or services received…during the period was determined”, and concluded that those disclosure requirements were no longer relevant to its consolidated financial statements as of and for the years ended December 31, 2021 and 2020 as the license was acquired in 2019. In addition, the Company also considered the disclosure requirements in other standards (i.e. IAS 38, Intangible assets) and concluded that none of them require disclosure on an ongoing basis for transactions consummated in prior periods. Those requirements (or lack thereof) notwithstanding, the Company decided to retain a brief description of the transaction to provide certain background information and context for the origin of its intangible asset to the users of its financial statements.

For the staff’s information, the Company accounted for the share-based payment made to acquire the license in accordance with IFRS 2.10, which requires that an entity “measure the goods or services received, and the corresponding increase in equity, directly, at the fair value of the goods or services received, unless that fair value cannot be estimated reliably.” The Company concluded that the fair value of the good received was reliably estimable. Accordingly, the Company determined the fair value of the license using a discounted cash flow model. The key assumptions used in the valuation model in accordance with an income approach included observable and unobservable key inputs as follows:

•  Anticipated development costs;

•  Anticipated cost of goods sold, and sales, marketing and general costs;

•  Probability of achieving clinical and regulatory development milestones in accordance with certain industry benchmarks;

•  Relevant commercial assumptions, expected patent life and market exclusivity periods; and

•  Other metrics such as the tax rate and estimated working capital.

The Company’s valuation model calculated the net cash flows through the projected period of market exclusivity across target sales regions and discounted those cash flows at a rate of 15%, based on the estimated weighted average cost of capital for the Company over the forecast period.

Please revise your disclosure to identify the natural person or persons who have voting and investment control of the shares held by certain funds managed by Pivotal Partners, Brunnur vaxtarsjóður slhf. and BEYEOTECH.

We note your disclosure in this section regarding granted patents in foreign jurisdictions. Please revise to identify the material foreign jurisdictions for each granted patent.

We note your disclosure that a number of financial institutions have acted as advisors in connection with the Business Combination and PIPE Financing or as underwriters for the EBAC SPAC IPO. We also note press reports that certain financial advisors are ending their involvement in SPAC business combination transactions. Please tell us, with a view to disclosure, whether you have received notice from any of the firms advising on the business combination transaction about them ceasing involvement in your transaction and how that may impact your deal or the deferred underwriting compensation owed to such firms for the SPAC’s initial public offering.

With a view toward disclosure, please tell us whether your sponsor is, is controlled by, has any members who are, or has substantial ties with, a non-U.S. person. Please also tell us whether anyone or any entity associated with or otherwise involved in the transaction, is, is controlled by, or has substantial ties with a non-U.S. person. If so, please revise your filing to include risk factor disclosure that addresses how this fact could impact your ability to complete your initial business combination. For instance, discuss the risk to investors that you may not be able to complete an initial business combination with a target company should the transaction be subject to review by a U.S. government entity, such as the Committee on Foreign Investment in the United States (CFIUS), or ultimately prohibited. Further, disclose that the time necessary for government review of the transaction or a decision to prohibit the transaction could prevent you from completing an initial business combination and require you to liquidate. Disclose the consequences of liquidation to investors, such as the losses of the investment opportunity in a target company, any price appreciation in the combined company, and the warrants, which would expire worthless.

/s/ Derek Dostal

Eduardo Bravo Fernandez de Araoz, Principal Executive Officer

Riad Sherif, Principal Financial and Accounting Officer

Michael Davis, Davis Polk & Wardwell LLP

Michal Berkner, Cooley LLP

Divakar Gupta, Cooley LLP