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United States securities and exchange commission logo
November 18, 2021
Joseph Hernandez
Chief Executive Officer
Blue Water Vaccines Inc.
201 E. Fifth Street, Suite 1900
Cincinnati, OH 45202
Re: Blue Water Vaccines
Inc.
Registration
Statement on Form S-1
Filed November 5,
2021
File No. 333-260137
Dear Mr. Hernandez:
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.
Amendment 1 to Form S-1 filed on November 5, 2021
Prospectus Summary, page 1
1. We note you disclosed
that you adjusted all share and per share numbers in your
filing, other than your
historical financial statements and related notes including your
summary financial data
on page 11, for a stock split of the outstanding shares of your
common stock (following
the conversion of your preferred stock) at a ratio of 4:1 to be
effected immediately
prior to the pricing of this offering. Prior to going effective, please
revise your historical
financial statements to reflect the reverse stock split based upon the
guidance in ASC
260-10-55-12 and SAB Topic 4(C) or alternatively, please tell us how
you complied with this
guidance.
2. Please have your
independent auditors tell us their consideration of the need for them to
reference and dual-date
their audit opinion related to the aforementioned stock split.
Joseph Hernandez
FirstName
Blue WaterLastNameJoseph
Vaccines Inc. Hernandez
Comapany 18,
November NameBlue
2021 Water Vaccines Inc.
November
Page 2 18, 2021 Page 2
FirstName LastName
Our Vaccine Program
Structure, page 83
3. We note your response to prior comment 6, which we reissue in part.
You state that you
have revised disclosure throughout the prospectus to ensure tables and
graphics included
are legible. However, we observe that there are still numerous
instances where the
revisions are not sufficient to render your disclosures easily
readable. By way of example
and not limitation, we refer you to Table 2 on page 85 and the first
paragraph following
Table 2 on page 86. The subscript used to identify the footnotes in
Table 2, as well as the
revisions on page 86 intended to provide the citations for these
footnotes, is too small to
be clear. Accordingly, please further review and revise as appropriate
throughout the
prospectus.
BWV-201 Streptococcus pneumoniae (S. pneumoniae) Vaccine, page 92
4. We note your response to prior comment 7, which we reissue with
respect to Figure 7
(formerly Figure A). Please further revise your disclosure and/or
Figure 7 on page page
95 to help investors better understand the preclinical head-to head
results you are
including to compare your vaccine strain to Prevnar 7, Prevnar 13 and
Pneumovax. To
this end, please clarify how each vaccine strain listed on the x-axis
corresponds to the
vaccine names used in your narrative disclosure. For example, if true,
revise Figure 7 to
indicate whether "PCV7" corresponds to Prevnar 7, whether BHN97DftsY
corresponds to
BWV-201, and so on.
Additionally, with respect to graphs A and B in Figure 8, revise to
clarify whether the x-
axis references to "vaccine" are to BHN97DftsY, and if true, whether
this is the strain
corresponding to BWV-201.
Intellectual Property, page 119
5. We note your responses to comment 19 from the staff's initial comment
letter dated
October 8, 2021, and to prior comment 10. Please note that we consider
the information
requested in the prior comments to be material to investors and
therefore it is our position
that providing a range rather than quantifying the dollar amounts as
requested is not
appropriate. As such, we again reissue the comment in relevant part.
Revise your
disclosures regarding each of your license and option agreements to
include a discussion
of all material payment terms, including quantification of the
following:
Up-front, deferred, or execution payments paid or received. In
this regard, we refer
you by way of example and not limitation to phrases such as a
one-time low ten-
thousands initial license fee" or "a low hundred-thousands
deferred license fee" on
page 120.
Annual maintenance fees. In this regard, we refer you by way of
example and not
limitation to phrases such as "an annual maintenance fee in the
low tens of
thousands" on page 123.
Joseph Hernandez
Blue Water Vaccines Inc.
November 18, 2021
Page 3
Aggregate amounts paid or received. In this regard, we refer you
by way of example
and not limitation to statements such as the following: "The Company
is obligated to
pay, and has paid, a low 5-digit number of British pounds to OUI for
any past patent
expenses that were incurred prior to the execution of the OUI
Agreement."
6. We also note that a portion of prior comment 10, which we reissue here,
was not
addressed in either your disclosure or your response letter. With respect
to the OUI
license agreement, please revise your disclosure on page 123 to state the
highest
minimum sum of royalties that must be paid to OUI in any year
before application of
the step down. Please disclose the period of years over which the
step-down will apply
before the minimum sum is reduced to zero.
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 Tara Harkins at 202-551-3639 or Mary Mast at
202-551-3613 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Lauren Hamill at 303-844-1008 or Celeste Murphy at 202-551-3257 with
any other
questions.
Sincerely,
FirstName LastNameJoseph Hernandez
Division of
Corporation Finance
Comapany NameBlue Water Vaccines Inc.
Office of Life
Sciences
November 18, 2021 Page 3
cc: Jessica Yuan
FirstName LastName