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United States securities and exchange commission logo
October 21, 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 October 8,
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.
Form S-1 filed on October 8, 2021
Pipeline, page 2
1. We note your response
to prior comment 4. With respect to your pipeline table on pages
2, 63 and 77, we
previously noted that the status column for the Norovirus/Malaria row
of the pipeline table
indicates that you plan to start IND-enabling studies for this candidate
in the second half of
2022, and that such statement appears speculative and premature,
particularly in light
of your disclosure that your current cash position is sufficient to fund
your operations only
until Q2 2022 and that your ability to continue as a going concern
beyond that point is
contingent upon obtaining funding from this offering.
In your response, you
point out that your revisions on page 4 of prospectus summary state
your expectation that
your existing cash along with the proceeds of the offering will be
Joseph Hernandez
FirstName
Blue WaterLastNameJoseph
Vaccines Inc. Hernandez
Comapany
October 21,NameBlue
2021 Water Vaccines Inc.
October
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sufficient for at least 12 months following the closing of this
offering. You further state:
"As such, [the] pipeline projections included in the S-1 assume the
obtaining of funding
from the offering." Particularly since your pipeline table first
appears on page 2 of the S-1
and precedes the revised disclosure on page 4 that you reference in
your response, please
further revise your pipeline table to indicate, by footnote including
a cross-reference or
otherwise, that your disclosures in the "status" column of the table
assume you will obtain
critical funding from this offering that, in combination with your
current cash position,
you expect will allow you to continue to operate for at least 12
months following the
closing.
We have broad discretion in the use of the net proceeds from this offering...,
page 51
2. We note your response to prior comment 9 and your revised risk factor
disclosure on page
51, which appears to attempt to reserve the right of management to
change the use of
proceeds from this offering. The disclosure now states: "While we set
forth our
anticipated use for the net proceeds from this offering in the section
titled 'Use of
Proceeds,' our management will have broad discretion on how to use and
spend any
proceeds that we receive from this offering and may, depending on the
outcomes of our
preclinical studies and other research, use the proceeds in ways that
differ from the
anticipated uses set forth in this prospectus."
We redirect your attention to Instruction 7 to Item 504 of Regulation
S-K, which allows
your company to reserve the right to change the use of proceeds,
provided such
reservation is due to certain contingencies that are discussed
specifically and the
alternatives to such use in the event of such contingencies are
indicated. Here, your
revisions to your risk factor disclosure do not address the specific
"outcomes of [your]
preclinical studies and other research" that could cause management to
use and spend any
proceeds from the offering differently than stated in Use of Proceeds.
Further, the revised
disclosure does not indicate management's intended alternative uses
for the offering
proceeds in the event certain outcomes of preclinical studies and
other research occur.
Therefore, please revise both your risk factor and Use of Proceeds
disclosures
accordingly. In so doing, please ensure that the disclosures in both
sections of your
registration statement are consistent with each other. We note that as
drafted your Use of
Proceeds section appears to describe management's broad discretion
with respect to the
"amounts and timing" of expenditures from the proceeds, whereas your
risk factor
disclosure appears to more broadly describe management's discretion
with respect to the
"use and spending" of any proceeds.
Capitalization, page 60
3. We note your response to prior comment 9 and that you will have
2,172,371 shares of
common stock outstanding as of September 30, 2021 (after giving effect
to the conversion
of all outstanding shares of preferred stock into an aggregate of
1,372,371 shares). Please
Joseph Hernandez
FirstName
Blue WaterLastNameJoseph
Vaccines Inc. Hernandez
Comapany
October 21,NameBlue
2021 Water Vaccines Inc.
October
Page 3 21, 2021 Page 3
FirstName LastName
explain to us how you calculated the conversion of the 1,146,138
outstanding preferred
stock into 1,372,271 shares considering the issuance price and
conversion are the same.
4. We note on page F-15 that each Series Seed is automatically converted
into common
stock of the company, at a conversion price of $6.09 per share,
subject to adjustment,
upon the closing a firmly underwritten public offering netting
proceeds of at least
$50 million with an offering price of at least three hundred percent
(300%) of the Original
Issue Price of the Series Seed. Please explain to us how you will meet
the conversion
requirements for the Series Seed preferred stock to convert upon your
IPO.
Our Vaccine Platform
Structure, page 80
5. We note your response to prior comment 13. While you have removed one
reference to
"potent" and replaced it with the word "strong" at the top of page 81,
we note that a new
reference to "potent platforms" has been added on page 80. Further, we
note that the
reference to "potent" remains in a sub-section heading on page 82
("S60 nanoparticles
may serve as a polyvalent potent vaccine platform"). While you have
insert a citation to a
published study in this sub-section heading, it is unclear whether the
results of such cited
study related to the potency of the vaccine platform that S60
nanoparticles "may"
provide. In relation to these references to "potent" platforms, we
reissue the prior
comment.
6. We refer to the second bullet on page 80 which states: "There are
several preclinical
animal studies have showed P24/S60 chimeric vaccine candidates have
high protective
effects against viral pathogens or diseases. As set forth below in
Table 1."
Please revise Table 1 and any other tables or graphics throughout
your filing to
ensure that the text in each, including subscript or other
notations are clearly legible.
Please revise your disclosure and/or your table to clarify what
Table 1 on page 81 is
intended to reflect. We note that the items shown in the table
should be easily
identifiable from and tie to the description of those items in the
disclosure above.
While your bulleted disclosure on page 80 references references
"several preclinical
animal studies," it is not clear which studies are being referred
to and how they may
relate to information in Table 1. Further, the bulleted disclosure
preceding the table
indicates that such animal studies "showed that P24/S60 chimeric
vaccine candidates
have high protective effects against viral pathogens or diseases,"
but the level or
degree of protective effect does not appear to shown in Table 1.
Please also revise to clarify what the numbers in the column
labeled "Reference" in
Table 1 on page 81 mean.
Additionally, we note that another table captioned "Table 1" has been
added in this section
on page 82.
To aid investor understanding and for the avoidance of confusion,
please renumber
the second table on page 82.
The same comment given with respect to the Table 1 included on
page 81 applies.
Joseph Hernandez
FirstName
Blue WaterLastNameJoseph
Vaccines Inc. Hernandez
Comapany
October 21,NameBlue
2021 Water Vaccines Inc.
October
Page 4 21, 2021 Page 4
FirstName LastName
Please revise to clearly tie the information presented in the
table to your disclosure.
We note that you appear to have included footnote citations
(a) through "(e)" in the
column labeled "epitope/antigen," and there appears to be a
footnote citation "(f)" in
the heading for the column labeled "significant immune
enhancement in mice."
However, in each case there is no corresponding footnote
disclosure under the table.
Please revise as appropriate. Additionally, please indicate, by
footnote or otherwise,
what the acronyms or abbreviations in the "epitope/antigen"
column mean as you did
in the table included on page 81.
It is unclear what "ND" in the column labeled "significant
immune enhancement in
mice" means. Please revise to provide explanatory disclosure in
order for an investor
to understand the table.
BWV-201 Streptococcus pneumoniae (S. pneumoniae) Vaccine, page 88
7. We note your response to second part of prior comment 17. Please
revise your disclosure
and/or Figure A on page 90 to help investors better understand the
preclinical head-to-
head results your response notes you have included to compare your
vaccine strain to
Prevnar 7, Prevnar 13 and Pneumovax. For example, the names of the
vaccines and
strains shown on the x-axis in the graph should be easily identifiable
from and tie to the
description of those items in the narrative disclosure above the
graph. Explain what
"Percent" on the y-axis measures.
BWV-302: Norovirus-malaria vaccine program, page 95
8. We acknowledge the addition of disclosure beginning on page 95
regarding your BWV-
302 vaccine program for Norovirus-Malaria in response to prior comment
5. We have the
following additional comments:
In the first paragraph in this section captioned "Our Vaccine,"
please revise to
provide additional context for the following statement: "The
researchers, Xi Jason
Jiang, Ph.D., and Ming Tan, Ph.D., demonstrated that S60 VLPs
could be used to
present foreign antigens on the surface of the S60 VLP. Further,
it has also
demonstrated that foreign antigens could also be expressed on the
surface of the P24
VLP." Please explain how the co-researchers for your
norovirus-malaria
combination vaccine "demonstrated" these findings by briefly
describing the
researchers' relevant work or studies.
The last sentence in "Our Vaccine" states as follows with respect
to your mouse
immunization study: "These data demonstrate the potential of our
vaccine candidate
against malaria." Based on your disclosure in the "status" column
of your pipeline
table for BWV-302, which indicates that you intend to begin
IND-enabling studies
for BWV-302 in the second half of 2022, it appears that you do
not expect to be able
to rely on this mouse immunization study data data to support an
IND application.
Please revise your disclosure to briefly explain what additional
pre-IND enabling
studies or steps you expect to have to conduct or take prior to
proceeding with IND-
Joseph Hernandez
FirstName
Blue WaterLastNameJoseph
Vaccines Inc. Hernandez
Comapany
October 21,NameBlue
2021 Water Vaccines Inc.
October
Page 5 21, 2021 Page 5
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enabling studies.
The paragraph in this section captioned "Development" states as
follows: "Following
IND submission, if accepted, we intend to initiate our Phase I
clinical trial in healthy
adults ages 18 to 54 in the first half of 2023." We note that you
disclose your
intended timing of Phase 1 clinical trials for BWV-302 without
having first addressed
when you plan to submit your IND application. Given the early
stage of development
for this candidate, and your statement in your pipeline table
that you do not plan to
initiate IND-enabling studies for this candidate until the second
half of 2022, this
statement regarding clinical trial commencement is premature and
speculative and
should be removed.
Intellectual Property, page 114
9. We note your response to prior comment 18. We have the following
additional comments:
With respect to your pending patent applications, please revise
the disclosure in your
various tabular presentations to disclose the type of patent
protection sought for each
product or technology (composition of matter, use, or process).
We note your disclosure that the CHMC license agreement may end
upon the last-to-
expire patent on a jurisdiction by jurisdiction and product by
product basis. Please
revise your tabular presentation of the issued and pending patents
under
this agreement to clarify when the last of these patents are
expected to expire in both
the U.S. and any foreign jurisdictions.
10. We note your revisions in response to prior comment 19, which we
reissue. 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 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
five-digit initial license
fee" on page 115.
Annual maintenance fees.
Aggregate amounts paid or received.
Aggregate future potential milestone payments to be paid or
received.
Profit or revenue-sharing provisions.
Applicable royalty rates to be paid by each party. In the event a
range is provided in
place of the actual royalty rate, such range should be within ten
percentage points. In
this regard, we refer you to your reference on page 117 to
"double-digit royalties to
be paid on any sums received by the Company from any sublicensee
under the terms
of the OUI Agreement" and on page 119 to the Company's obligation
to pay "a
double-digit percentage of other consideration received for any
sublicenses" under
the St. Jude License Agreement. Also, with respect to the OUI
license agreement,
please revise your disclosure on page 118 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.
Joseph Hernandez
Blue Water Vaccines Inc.
October 21, 2021
Page 6
Additionally, please revise your IP disclosure to define acronyms at
first use. For
instance, we note that in a description of a development milestone on
page 115, you use
the acronym "first commercial sale in ROW" without defining "ROW," which
appears
again later in this section.
11. We note your revisions in response prior comment 20, and that you have
now disclosed
the "minimum" amount of funding the Company provided to Oxford University
in
January 2020 for three years of salary for Dr. Craig Thompson as a
condition of entering
into the OUI license agreement. To the extent known, please revise your
disclosure to
provide the maximum amount that the Company may be required to pay to
fund three
years of salary for Dr. Craig Thompson, and when such additional
payment(s) will be
due. Disclose any factors that will impact the amount of annual salary
for the relevant
three-year period so as to determine the ultimate amount the Company will
be obligated to
pay, or advise.
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
October 21, 2021 Page 6
cc: Jessica Yuan
FirstName LastName