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August 21, 2019
Jeffrey Nau
Chief Executive Officer
Oyster Point Pharma, Inc.
202 Carnegie Center, Suite 109
Princeton, NJ 08540
Re: Oyster Point Pharma, Inc.
Draft Registration Statement on Form S-1
Submitted July 25, 2019
CIK No. 0001720725
Dear Dr. Nau:
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
Prospectus Summary
Overview, page 1
1. To the extent comparisons are not based on head-to-head trials, please
revise here and
throughout to remove statements that compare your drug candidate to
other drug
candidates, products and treatments. For example, we note your
disclosure on page 1 that
OC-01 is the first and only therapy to demonstrate statistically
significant improvements
in both signs and symptoms of DED in a single registrational clinical
trial and your
disclosure on page 86 that OC-01 is the only therapy to demonstrate
rapid onset of action
to significantly improved signs and symptoms of DED. In addition, please
revise here and
throughout to eliminate any suggestions that your product candidates
have been or will
Jeffrey Nau
FirstName LastNameJeffrey Nau
Oyster Point Pharma, Inc.
Comapany NameOyster Point Pharma, Inc.
August 21, 2019
August 21, 2019 Page 2
Page 2
FirstName LastName
ultimately be determined to be safe or effective, as only the FDA and
foreign government
equivalent regulations have the authority to make those
determinations.. For example, we
note your disclosure on page 1 that, based on OC-01's safety and
efficacy results, you
believe that OC-01 has the potential to become the new standard of
care and redefine
how DED is treated for millions of patients. Similarly, remove your
statements regarding
the efficacy of other products. For example, we note your discussion
of the "suboptimal
efficacy" of Restasis and Xiidra.
2. Please balance your disclosure regarding the consideration paid for
Xiiadra and the sales
of Restasis and Xiiadra in the second paragraph of this section and
throughout to clarify
that there is no guarantee that OS-01 or any of your other product
candidates will be
approved by the FDA and that, even if they are approved, there is no
guarantee that you
will earn revenues comparable to either Restasis or Xiidra. Similarly,
balance your
disclosure on page 89 that ONSET-1's endpoints are consistent with
other FDA-approved
products for DED, including Restasis an Xiidra.
3. We note your disclosure regarding a survey of eye care practitioners
on page 1. Please
describe how this survey was conducted, including how many
practitioners were surveyed
and how they were selected. In addition, clarify what you mean by
"successfully" treat
dry eye patients.
Our Clincial Trial Results, page 2
4. Please disclose the nominal p-value used in ONSET-1 here and on page
82 in your
business section.
Implications of Being an Emerging Growth Company, page 6
5. Please 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 Intellectual Property
Third-party claims or litigation alleging infringement of patents, page 28
6. We note your disclosure on page 28 that Pfizer owns three U.S. patents
covering Chantix,
its varenicline tartrate product. Please expand your discussion in
this risk factor or a
separate risk factor to describe in detail how Pfizer's patents may
limit the type of patent
protection you are able to receive for OC-01, and provide a summary of
this risk in your
prospectus summary section. Alternatively, tell us why this is not
necessary.
Jeffrey Nau
FirstName LastNameJeffrey Nau
Oyster Point Pharma, Inc.
Comapany NameOyster Point Pharma, Inc.
August 21, 2019
August 21, 2019 Page 3
Page 3
FirstName LastName
Risks Related to our Common Stock and to this Offering
Our amended and restated bylaws that will become effective, page 54
7. We note your disclosure on page 54 that the exclusive forum provision
in your bylaws
does not preclude stockholders from bringing claims under the
Securities Act or the
Exchange Act in state or federal court, and we note your disclosure on
page 144 that your
certificate of incorporation has an exclusive forum provision. Please
revise your
disclosure on pages 54 and 144 to clarify, if true, that your bylaws
and certificate of
incorporation have exclusive forum provisions, and clarify your
disclosure, if true, that
both provisions do not apply to claims brought under the Securities or
Exchange
Act. Please ensure that the exclusive forum provision in your bylaws
and certificate of
incorporation state this clearly or tell us how you will inform
investors in future filings
that the provisions do not apply to any actions arising under the
Securities Act or
Exchange Act. Please file a copy of your bylaws and certificate of
incorporation with
your next amendment or tell us when you plan to do so. Note that we
may have further
comment after review of these documents.
Use of Proceeds, page 59
8. Please provide an estimate of how far in each of the proposed purposes
you will be able to
reach using the allocated proceeds from this offering, and disclose an
estimate of the
amount and sources of other funds needed if the anticipated proceeds
will not be sufficient
to fully fund all of the proposed purposes.
Managements Discussion and Analysis of Financial Condition and Results of
Operations
Components of Results of Operations
Operating Expenses
Research and Development Expenses, page 69
9. You state that you do not allocate research and development costs by
product candidate.
However, it appears that you do track such costs by other
classifications, such as payroll
and other personnel expenses, laboratory supplies, and fees paid to
third parties to conduct
R&D activities on your behalf. Please revise to disclose the costs
incurred by the types of
costs classified as research and development for each period
presented.
Management's Discussion and Analysis of Financial Condition and Results of
Operatoin
Contractual Obligations and Commitments, page 74
10. Please describe the material terms of your asset purchase agreement
for OC-02 in your
business section and file the agreement as an exhibit to your
registration statement if
required by Item 601 of Regulation S-K.
Jeffrey Nau
FirstName LastNameJeffrey Nau
Oyster Point Pharma, Inc.
Comapany NameOyster Point Pharma, Inc.
August 21, 2019
August 21, 2019 Page 4
Page 4
FirstName LastName
Critical Accounting Policies, Significant Judgments and Use of Estimates
Stock-Based Compensation, page 75
11. 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
Our Strategy, page 83
12. We note your disclosure on page 84 that you have identified several
indications outside of
ophthalmology where OC-02 could advance directly into a Phase 2 proof
of concept
study. Please disclose whether the FDA has given you any indication
that OC-02 could
advance directly into a Phase 2 study for these indications.
Our Product Candidates
Our development program for OC-01
ONSET-1: Phase 2b clinical trial results, page 88
13. Please describe the differences in testing between the 0.12mg/ml dose,
which you describe
as "not formally tested," and the testing of the other doses. In
addition, it does not appear
that all of the patients in the 0.6mg/ml group and in the 1.2mg/ml
group completed the
study. If material, please explain why some of the participants left
prior to week 4 of the
study.
Manufacturing, page 102
14. Please expand your discussion of the facilities used for the
manufacturing, storage,
distribution and testing to include OC-02. In this regard, we note
your disclosure on page
98 that your Phase 2b clinical trial of OC-02 was limited by the
amount of available OC-
02.
Employment Arrangements with Our Named Executive Officers
Mark Murray, page 124
15. Please disclose the material terms of your consulting agreement with
FLG Partners and
file the agreement as an exhibit to your registration statement.
Jeffrey Nau
Oyster Point Pharma, Inc.
August 21, 2019
Page 5
You may contact Sasha Parikh at 202-551-3627 or Angela Connell at
202-551-3426 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Sonia Bednarowski at 202-551-3666 or Justin Dobbie at 202-551-3469 with
any other
questions.
FirstName LastNameJeffrey Nau Sincerely,
Comapany NameOyster Point Pharma, Inc.
Division of
Corporation Finance
August 21, 2019 Page 5 Office of Healthcare
& Insurance
FirstName LastName