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United States securities and exchange commission logo
December 2, 2022
Eduardo Bravo Fernandez de Araoz
Principal Executive Officer
Oculis Holding AG
Bahnhofstrasse 7
CH-6300
Zug, Switzerland
Re: Oculis Holding AG
Registration
Statement on Form F-4
Filed November 7,
2022
File No. 333-268201
Dear Eduardo Bravo Fernandez de Araoz:
We have reviewed your registration statement and have the
following comments. In
some of our comments, we may ask you to provide us with information so
we may better
understand your disclosure.
Please respond to this letter by amending your registration
statement and providing the
requested information. If you do not believe our comments apply to your
facts and
circumstances or do not believe an amendment is appropriate, please tell
us why in your
response.
After reviewing any amendment to your registration statement and
the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form F-4
Questions and Answers about the Business Combination and the
Extraordinary General Meeting
of Shareholders
Q: What equity stake will the current holders of public shares of EBAC .
.. . ., page 18
1. Please disclose the
sponsor and its affiliates total potential ownership interest in the
combined company,
assuming exercise and conversion of all securities.
Risk Factors, page 59
2. 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.
Eduardo Bravo Fernandez de Araoz
FirstName LastNameEduardo Bravo Fernandez de Araoz
Oculis Holding AG
Comapany2,
December NameOculis
2022 Holding AG
December
Page 2 2, 2022 Page 2
FirstName LastName
Unaudited Pro Forma Condensed Combined Financial Information, page 176
3. 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.
4. 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.
5. 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.
Unaudited Pro forma Condensed Combined Statement of Financial Position as of
June 30, 2022,
page 181
6. 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.
Unaudited Pro forma Condensed Combined Statement of Operations for the Year
Ended
December 31, 2021, page 184
7. 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.
Business of Oculis and Certain Information about Oculis, page 193
8. 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
Eduardo Bravo Fernandez de Araoz
Oculis Holding AG
December 2, 2022
Page 3
to give any indication that your product candidates have been proven
effective or will
receive regulatory approval.
Company Overview, page 193
9. 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.
10. 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.
11. Given the early stage and lack of disclosure regarding the undisclosed
product candidate,
please remove the undisclosed product candidate row from the pipeline
table.
12. 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.
13. 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.
Our Executive Management Team, page 195
14. Please limit the disclosure of specific investors to those identified in
the Principal
Shareholder table on page 320. Additionally, indicate that prospective
investors should
FirstName LastNameEduardo Bravo Fernandez de Araoz
not rely on the named investors investment decision, that these
investors may have
Comapany NameOculis
different Holding
risk tolerances AG
and that the investors acquired their shares
at a significant
discount
December to the
2, 2022 Pagemarket
3 price, if true.
FirstName LastName
Eduardo Bravo Fernandez de Araoz
FirstName LastNameEduardo Bravo Fernandez de Araoz
Oculis Holding AG
Comapany2,
December NameOculis
2022 Holding AG
December
Page 4 2, 2022 Page 4
FirstName LastName
Our clinical development candidates, page 197
15. Please revise to disclose the jursidiction of your DIAMOND trial.
16. 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.
Material Licenses, Partnerships and Collaborations, page 211
17. 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.
Oculis Management's Discussion and Analysis of Financial Condition and Results
of Operations
Results of Operations
Research and Development Expenses, page 242
18. 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.
Background of the Business Combination, page 349
19. 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.
Oculis SA Consolidated Financial Statements for the Years Ended December 31,
2021 and 2020
Note 8. Intangible Assets, page F-63
20. 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.
Beneficial Ownership of New Parent Securities, page 319
21. 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 vaxtarsj ur slhf. and BEYEOTECH.
Eduardo Bravo Fernandez de Araoz
FirstName LastNameEduardo Bravo Fernandez de Araoz
Oculis Holding AG
Comapany2,
December NameOculis
2022 Holding AG
December
Page 5 2, 2022 Page 5
FirstName LastName
Intellectual Property, page 214
22. 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.
General
23. 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.
24. 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.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.
Eduardo Bravo Fernandez de Araoz
Oculis Holding AG
December 2, 2022
Page 6
You may contact Li Xiao at 202-551-4391 or Daniel Gordon at 202-551-3486
if you have
questions regarding comments on the financial statements and related matters.
Please contact
Daniel Crawford at 202-551-7767 or Ada D. Sarmento at 202-551-3798 with any
other
questions.
Sincerely,
FirstName LastNameEduardo Bravo Fernandez de Araoz
Division of Corporation
Finance
Comapany NameOculis Holding AG
Office of Life Sciences
December 2, 2022 Page 6
cc: Derek Dostal, Esq.
FirstName LastName