October 10,
2019
Jeffrey Nau
Chief Executive Officer
Oyster Point Pharma, Inc.
202 Carnegie Center, Suite 109
Princeton, NJ 08540
Re: Oyster Point Pharma, Inc.
Registration Statement on Form S-1
Filed October 4, 2019
File No. 333-234104
Dear Dr. Nau:
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. Unless
we note
otherwise, our references to prior comments are to comments in our September
16, 2019 letter.
Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1. We note your response to comment 1. Throughout your registration
statement you state
that you are not aware of any other therapy that has demonstrated
statistically significant
improvements in both signs and symptoms of DED in a single
registrational clinical trial.
Please revise to clarify, if true, that you did not test any other
products or therapies in this
specific trial and that there are no head-to-head results providing
support that another
product candidate, product or therapy could not have shown similar
results in the specific
clinical trial you reference.
2. We note your response to comment 4 that you do not expect to continue to
pursue FDA
Jeffrey Nau
Oyster Point Pharma, Inc.
October 10, 2019
Page 2
approval of OC-02 for the treatment of dry eye disease. If true,
please revise throughout
to clarify that you do not intend to pursue FDA approval for OC-02 for
the treatment of
dry eye disease.
Business
Our Product Candidates, page 89
3. Please revise your pipeline chart to indicate the therapeutic area for
OC-02. In addition,
please tell us what you mean by "oral indication" in the chart as your
disclosure on page
99 states that OC-02 was studied as a nasal spray in a Phase 2b
clinical study, the PEARL
study, for dry eye disease. To the extent that you intend to file an
IND for OC-02 in a
different indication, please revise the chart to indicate that OC-02
is still in the preclinical
stage for that indication. Similarly, please revise to chart to
clarify, if true, that you have
not yet filed an IND for Neurotrophic Keratitis and that OC-01 for
this indication is still in
the preclinical phase.
Certain Relationships and Related Party Transactions
Consulting Agreement, page 144
4. We note your revised disclosure on page 144 in response to comment 5.
Please provide
the required disclosure pursuant to Item 404 of Regulation S-K
regarding the amended
consulting agreement with FLG Partners, LLC under which Mr. Murray
provides general
financial advisory services.
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.
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, Legal Branch Chief,
at 202-551-
3469 with any other questions.
FirstName LastNameJeffrey Nau Sincerely,
Comapany NameOyster Point Pharma, Inc.
Division of
Corporation Finance
October 10, 2019 Page 2 Office of Life
Sciences
FirstName LastName