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March 13, 2018
Victor Perlroth, M.D.
Chairman and Chief Executive Officer
Kodiak Sciences Inc.
2631 Hanover Street
Palo Alto, CA 94304
Re: Kodiak Sciences Inc.
Draft Registration Statement on Form S-1
Filed February 14, 2018
CIK No. 0001468748
Dear Dr. Perlroth:
We have reviewed your draft 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 providing the requested information and
either submitting
an amended draft registration statement or publicly filing your registration
statement on
EDGAR. 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 the information you provide in response to these comments
and your
amended draft registration statement or filed registration statement, we may
have additional
comments.
Draft Registration Statement on Form S-1
Overview, page 1
1. We note your statements that you believe KSI-301 has the potential to be
best-in-class.
This implies an expectation of regulatory approval, which is
inappropriate given the early
stage of development and lack of clinical trial data. Please remove this
statement from the
descriptions of your product candidate.
2. Please revise the first paragraph to disclose that you have not yet
filed an investigational
new drug application, or IND, for KSI-301 and disclose your expected
timing for filing
the IND with the FDA.
Victor Perlroth, M.D.
FirstName LastNameVictor Perlroth, M.D.
Kodiak Sciences Inc.
Comapany2018
March 13, NameKodiak Sciences Inc.
June 16, 2017 Page 2
Page 2
FirstName LastName
Current Standard of Care for Wet AMD and DR, page 1
3. We note your statement that the addressable market in wet AMD and DR
could be
substantially greater than the current market size. Please quantify
the current market size.
It is not clear from the disclosure whether the current market size is
equal to the
worldwide sales for Lucentis and EYLEA or some other figure.
KSI301: Our Lead Product Candidate, page 2
4. We note your statement that KSI-301 contains a proven mechanism of
action. Please
revise your disclosure to eliminate any suggestion that KSI-301 has
been or will
ultimately be determined to be effective or to have demonstrated
efficacy for purposes of
receiving marketing approval by the FDA or comparable agency.
Risks Associated with Our Business, page 4
5. Please revise the first bullet point to clarify that you are in the
pre-clinial stages of drug
development and that you have not initiated clinical studies for any
of your products.
Implications of Being an Emerging Growth Company, page 5
6. Please supplementally provide us with copies of all written
communications, as defined
in Rule 405 under the Securities Act, that you, or anyone authorized
to do so on your
behalf, present to potential investors in reliance on Section 5(d) of
the Securities Act,
whether or not they retain copies of the communications.
Risk Factors
Risks Related to This Offering and Ownership of Our Common Stock, page 50
7. We note your disclosure on page 133 that your certificate of
incorporation and bylaws will
include an exclusive forum provision. Please include a risk factor in
this section to
discuss the effects of such a provision on your shareholders,
including the possibility that
the exclusive forum provision may discourage shareholder lawsuits, or
limit
shareholders' ability to obtain a favorable judicial forum for
disputes with the company, its
officers and directors.
Special Note Regarding Forward-Looking Statements, page 56
8. We note your reference to the Private Securities Litigation Reform Act
in the first
paragraph of this section. The safe harbors for forward-looking
statements provided in the
Private Securities Litigation Reform Act of 1995 do not apply to
statements made by a
registrant that is not subject to the reporting requirements of either
Section 13(a) or
Section 15(d) of the Exchange Act. Accordingly, please either delete
your reference to the
Private Securities Litigation Reform Act, or state that the Private
Securities Litigation
Reform Act does not apply to the statements made in connection with
this offering. Please
refer to Section 27A(a)(1) and (b)(2)(D) of the Securities Act.
Victor Perlroth, M.D.
FirstName LastNameVictor Perlroth, M.D.
Kodiak Sciences Inc.
Comapany2018
March 13, NameKodiak Sciences Inc.
June 16, 2017 Page 3
Page 3
FirstName LastName
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Future Funding Requirements, page 68
9. We note your disclosure that you believe your existing cash and cash
equivalents and your
net proceeds from this offering will enable you to fund your operating
expenses, including
clinical trial expenditure through the KSI-301 Phase 2 trial. With
reference to your
disclosure on pages 3 and 79 that after initiating your Phase 2 trial
in wet AMD, you
intend to conduct a Phase 2 trial in subjects with DR, please revise
your disclosure here
and in the Use of Proceeds section to clarify whether you intend to
use the proceeds of the
offering to complete only the Phase 2 trial in wet AMD or Phase 2
trials in both wet AMD
and DR.
Critical Accounting Policies, Significant Judgments and Use of Estimates
Stock-Based Compensation Expense, page 73
10. Once you have an estimated offering price or range, please explain to
us how you
determined the fair value of the common stock underlying your equity
issuances and the
reasons for any differences between the recent valuations of your
common stock leading
up to the IPO and the estimated offering price. This information will
help facilitate our
review of your accounting for equity issuances including stock
compensation and
beneficial conversion features.
Business
Intellectual Property, page 107
11. Please expand your description of your patent portfolio to
specifically describe the
patent families related to KSI-301 and the ABC platform. Please
disclose the type of
patent protection you have (such as composition of matter, use or
process, etc.)
and specify the expiration dates for of the most significant patents
within each patent
portfolio.
Financial Statements
Note 6. Commitments and Contingencies, page F-14
12. Tell us why the amount of milestones related to the license agreement
on KSI-201
technology are not estimable. If the amounts of milestones are fixed
tell us the amount of
the milestones that may be payable and why you believe the amount
would not be material
to an investor and should be disclosed. Revise the disclosure as
necessary to explain why
the amounts of milestones are not estimable, if true.
General
13. Please provide us proofs of all graphics, visual, or photographic
information you will
provide in the printed prospectus prior to its use, for example in a
preliminary prospectus.
Please note that we may have comments regarding this material.
Victor Perlroth, M.D.
Kodiak Sciences Inc.
March 13, 2018
Page 4
14. We note that you have requested confidential treatment for agreements
that are to be filed
as exhibits to the registration statement. We will send any comments on
your application
for confidential treatment under separate cover.
You may contact Mary Mast at (202) 551-3613 or Lisa Vanjoske at (202)
551-3614 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Chris Edwards at (202) 551-6761 or Irene Paik at (202) 551-6553 with
any other
questions.
FirstName LastNameVictor Perlroth, M.D.
Division of
Corporation Finance
Comapany NameKodiak Sciences Inc.
Office of Healthcare
& Insurance
June 16, 2017 Page 4
cc: Michael Nordtvedt
FirstName LastName