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United States securities and exchange commission logo
September 17, 2021
Joseph Hernandez
Chief Executive Officer
Blue Water Vaccines Inc.
201 E. Fifth Street, Suite 1900
Cincinnati, OH 45202
Re: Blue Water Vaccines
Inc.
Draft Registration
Statement on Form S-1
Submitted on August
23, 2021
CIK No. 000178210
Dear Mr. Hernandez:
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 Submitted on August 23, 2021
Prospectus Summary, page 1
1. Please tell us your
consideration of including summary risk and Risk Factor disclosure
concerning the clinical
trial risks associated with pediatric trials. We note that based on
your disclosures at
least two of your vaccine programs, specifically your your universal
influenza vaccine
candidates being developed in collaboration with Cincinnati Children's
Hospital and your S.
pneumoniae vaccine candidate being developed in collaboration with
St. Jude Children's
Hospital, are intended for use in pediatric populations.
2. We note the following
unqualified statements regarding vaccines on page 1 and page
74 of the prospectus:
"Vaccination is an
effective method of protecting individuals against harmful
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diseases by utilizing the body s natural defense system to
develop resistance or
immunity to infections;" and
"Vaccines introduce or present these foreign pathogens in a
safe manner, prompting
the body s immune system produce a response protective against
the pathogen
without exposing the body to the relevant lethal or harmful
infection."
We also note the following conclusory statements with respect to your
particular vaccine
candidates and platforms:
"We have bioengineered these nanoparticles to be stable and
effective . . ." (pages 2
and 77)
"Unlike traditional live-attenuated and inactivated virus vaccines
that need cultivation
of infectious virions and are associated with certain safety
concerns, the
nonreplicating VLP vaccines derived from bioengineered viral
capsid proteins do not
involve an infectious agent and, therefore, are safer and have
lower manufacturing
costs than traditional vaccines." (page 77)
"Such VLPs and capsid-like nanoparticles are excellent vaccine
candidates against
corresponding viral pathogens..." (page 78)
"[T]he natures of self-formation, high stability, polyvalence, and
high
immunogenicity of the nanoparticles and polymers make them potent
platforms..."
(page 78)
As safety and efficacy determinations are solely within the authority
of the FDA and
comparable regulatory bodies, it is inappropriate to make a conclusory
statement about
vaccines, generally, or your products, specifically, that could imply
that your vaccines
will be determined to be safe or effective. Please revise these
statements and any similar
statements throughout your prospectus that may suggest the safety and
efficacy of your
candidates, platforms, or technologies.
Key Elements of our Platform, page 2
3. Given the early pre-clinical stage of development of each of your
vaccine candidates,
please provide the basis for the following claims on pages 2 and 77 in
the summary
prospectus and business section, respectively, or revise:
"We are able to design and create novel vaccines that are stable
and scalable for
broad spectrum prophylactics."
"We are able to significantly reduce the cost and time to market
of traditional
vaccines."
"We have bioengineered these nanoparticles to be stable and
effective using E.coli
expression, which provides cost savings and efficiency."
Pipeline, page 2
4. With respect to your pipeline table on page 2 and 75:
Please revise your chart to indicate the material stages you will
need to complete
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before marketing your products (i.e., show all phases of the FDA
approval process).
For instance, please add Phase I, II and III to your chart.
Please combine the "Discovery" and "Optimization" columns, as
both relate to pre-
clinical development and are not sufficiently distinct, and may
give the impression
that your product candidates are further along in the clinical
process than they
actually are. Note that we will not object to pre-clinical stage
columns labeled as
"Discovery" and/or "IND Enabling."
Please revise to delete the rows for any preclinical product
candidate that is not
currently material to your business. In this regard, we note your
disclosure on page 3
that your strategic plan is "to advance [your] main vaccine
programs: influenza,
norovirus-rotavirus, and S. pneumoniae induced AOM" and it
appears that there is
only minimal discussion of this program in one paragraph in the
prospectus summary
but no discussion of your BWV-302 vaccine program in the Business
section of your
prospectus. As such, it appears that BWV-302 is not currently
sufficiently material to
your operations to warrant inclusion in the pipeline table and
should be removed.
We further note 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. It appears that this statement is
speculative and
premature, particularly in light of your disclosure on page 68
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 sales of your securities in this offering.
Our Vaccine Candidates, page 3
5. We note that you have included limited discussion of BWV-302, your
Norovirus-Malaria
vaccine program, in one paragraph in the prospectus summary on page 3.
This appears to
be the only discussion of BWV-302 in the prospectus, as there is no
discussion of this
program in the Business section or elsewhere. If BWV-302 is
sufficiently material to your
business to warrant discussion, please either revise your Business
section to include a
complete description of this program, or remove references to BWV-302
in the prospectus
summary.
Management and History, page 4
6. Based on your risk factor disclosure on page 34 and your management
disclosures
beginning on page 111, we note that your CEO, Joseph Hernandez, also
holds certain
management positions and directorships of other companies and may
allocate his time to
other businesses. Please balance your prospectus summary disclosures
regarding Mr.
Hernandez' experience and qualifications in the Management and History
section of the
prospectus summary with disclosure in that section and the Summary of
Risks Related to
Our Business section regarding Mr. Hernandez' outside employment or
business
relationships, including specifying the amount of time he devotes to
your business
activities and the nature of any material conflicts of interest that
may exist as a result of
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him working for your company on a part-time basis. Please also make
conforming
revisions to your Risk Factor disclosure as appropriate.
Strategy, page 4
7. We note statements such as the following throughout your prospectus:
Disclosure on pages 2 and 77 that states: "We are able to
significantly reduce the
cost and time to market of traditional vaccines."
Disclosure on page 4 regarding your strategy to "leverage the
pre-clinical and clinical
experience from the development of BWV-102, H1 vaccine candidate,
to accelerate
the development of the of BWV-101 program;"
Disclosure on page 75 regarding your strategy to "leverage the
learnings from the
development of BMW-102[sic], H1 vaccine candidate, to accelerate
the development
of the of BWV-101 universal influenza vaccine program;" and
Disclosure on page 83 regarding your proprietary epitopes, which
you state "are able
to be formulated into a vaccine using our VLP platform technologies
and may be
evaluated using other vaccine technologies through partnerships in
order to accelerate
development of vaccines or to explore adjunct therapies." Please
revise these and any
similar disclosures throughout the prospectus to remove any
implication that you or
your collaborators will be successful in developing vaccines that
obtain necessary
regulatory approvals or commercializing your product candidates in
a rapid or
accelerated manner, as such statements are speculative.
Summary of Risks Related to Our Business, page 5
8. We note that in the summary risk factors and Risk Factors section, you
disclose that there
is substantial doubt about your ability to continue as a going
concern. You also note in
the Risk Factors that your auditors have issued a going concern
opinion regarding your
operations. Please revise your disclosure throughout your prospectus
as follows:
Expand and balance your disclosure in your Prospectus Summary by
including discussion regarding your company's recurring operating
losses, negative
cash flows from operating activities, and the auditor's going
concern opinion.
Disclose in the Risk Factors Summary, if true, that you currently
have cash on hand
sufficient to fund your operations only into Q2 2022, and that
your ability to continue
as a going concern beyond that point is contingent upon obtaining
funding from sales
of your securities in this offering. State, if true, your belief
that your existing cash
position, together with the net proceeds from this offering, will
fund your current
operating plans through at least 12 months from the date of this
offering, and further
disclose that you will also need to raise additional capital
beyond this offering to
commence pivotal trails for any of your vaccine candidates as you
have on page
68. Disclose that if you cannot continue as a viable entity, your
stockholders may
lose some or all of their investment in your company. Similarly,
please make
conforming revision to your going concern risk factor on page 14.
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Risk Factors
Risks Related to Owning our Common Stock and this Offering
We have broad discretion in the use of the net proceeds from this offering...,
page 49
9. We note the following statement in a risk factor on page 49: "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 use the proceeds
in ways that differ
from the anticipated uses set forth in this prospectus." We direct
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. Please revise your risk factor
and Use of
Proceeds disclosures accordingly.
Industry and Market Data, page 56
10. We note your statement that certain information contained in the
prospectus involves a
number of assumptions and limitations, and investors are cautioned not
to give undue
weight to such estimates. Please revise to remove any implication that
investors are not
entitled to rely on the disclosure in your registration statement.
Use of Proceeds, page 57
11. We note your statement on page 57 that you intend to use the net
proceeds from this
offering to: (i) Fund your research and development activities; (ii)
Fund clinical trials and
the regulatory review process for your products; and (iii) Use the
remained for working
capital and other general corporate purposes. We also refer to your
statements on pages 6
and 14, respectively, that "[d]ue to the significant resources
required for the development
of vaccine candidates, and depending on [your] ability to access
capital, [you] must
prioritize the development of certain vaccine candidates" and "[you]
must decide which
vaccine candidates to pursue and advance and the amount of resources
to allocate to
each." In this regard, please revise your Use Of Proceeds disclosure
to provide your best
reasonable estimate regarding: (1) the specific vaccine candidate(s)
for which you intend
to fund R&D activities using proceeds from this offering; and (2) the
specific vaccine
candidate(s) you expect to advance into clinical trials, and how far
into development
and/or the regulatory review process you expect such programs to reach
using the offering
proceeds, including the specific phases of clinical trials.
Capitalization, page 59
12. Please address the following:
Tell us why it is appropriate to include the Accounts payable and
accrued expenses in
your Capitalization table.
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Place a double line beneath the Cash line item in the table.
You state below the table that the number of shares of your
common stock to be
outstanding after this offering is based on 2,136,8555 shares of
common stock as of
August 1, 2021 (after giving effect to the conversion of all
outstanding shares of
preferred stock into an aggregate of 1,336,855 shares). If you
believe the preferred
stock will convert upon the offering, please tell us why. In this
regard, we note the
conversion requirements disclosed in Note 5 on page F-15. If the
preferred stock will
convert upon the IPO, revise your discussion above the table to
include the
conversion in the pro forma basis column and elsewhere in the
filing as applicable.
Business
S60 nanoparticles may serve as a polyvalent potent vaccine platform, page 80
13. We note your conclusion in this section and elsewhere in your
prospectus that certain
nanoparticles are "potent platforms" or "potent vaccine
platforms." Given that you
do not appear to have presented any data as to potency, please
tell us the basis for
these claims or revise.
Please also provide the basis for the following statements
within this section. Where
appropriate, you may revise to state that a claim reflects
management's belief:
o "Importantly, our S60 nanoparticles maintained the native
conformation with
authentic antigenicity; thus, our NoV S60 nanoparticle
technology represents a
significant bioengineering advancement."
o "The self-assembled, polyvalent S60 nanoparticle with 60
flexibly exposed S
domain C-termini is an ideal vaccine platform..."
We refer you to the final three bullets in this section, where
you appear to present
certain research findings without context. Please revise your
disclosure to include a
description of the research studies you refer to, including who
performed such
studies, how the tests were conducted, the number of animal
models or human
subjects used, the number of tests conducted, the range of
results or effects observed
in these tests, and how such results were measured. Expand your
descriptions of any
resulting data to include whether or not statistical analysis was
performed, and if so,
revise to indicate whether the results from each test were
statistically significant and
provide the relevant p and n values.
The P24 Nanoparticle as a versatile platform, page 81
14. We refer you to the final bullet in this section. As it is unclear to
what studies
demonstrating immune response you refer, please identify the relevant
research studies.
Antigenic Drift Hypothesis Illustration, page 84
15. We refer you to the second, third, and fourth paragraphs in this
section where you
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discuss prior work conducted by "scientists" including "laboratory
assays"
and "vaccination of mice" and prior "research findings" that have
informed the basis for
your influenza vaccine candidates. As it is unclear to what scientists
or research you refer,
please identify the relevant studies. Please make similar changes
where you discuss the
prior scientific work of others on which you rely elsewhere in the
prospectus.
BWV-101: Universal Influenza Vaccine, page 84
16. We refer to the final paragraph of this section, in which you state
that you "have identified
naturally immunogenic epitopes for H1, H3 and influenza B" through
bioinformatics
studies and wet lab studies that "suggest that these epitopes,
especially H1N1, and the
chimeric scaffold configuration of our vaccine induce immunity..."For
this and each of
your other vaccine candidates, please expand your disclosure of any
referenced pre-
clinical studies or early research data to provide appropriate context
with which investors
can evaluate your findings. To that end, please revise to include more
detailed
descriptions of each pre-clinical study conducted, including who
conducted the study, the
type and number of tests conducted, how the tests were conducted, the
number of animal
models or subjects used, the number of tests conducted, the range of
results or effects
observed in these tests, and how such results were measured. Expand
your descriptions of
any resulting data to include whether or not statistical analysis was
performed, and if so,
revise to indicate whether the results from each test were
statistically significant and
provide the relevant p and n values.
BVW-201: Streptococcus pneumoniae (S. pneumoniae) Vaccine, page 85
17. On page 85, we note that you have provided a bulleted list of
"additional statistics
supporting the need for a novel preventive vaccine" for AOM.
Please expand your
disclosure to include the source or sources you used or otherwise
describe how you
arrived at the statistics you include.
Beginning on page 86, we note your discussion of pre-clinical
results from the animal
model research and development of BWV-201 for treatment of AOM.
In that
discussion, you compare the S. pneumoniae ftsY deletion strain
from which your
vaccine candidate is derived, BHN97ftsY, with alternative
treatments such as
currently approved pneumococcal vaccines. As you have not
conducted head-to-head
clinical trials, please tell us why you believe it is appropriate
to include these
comparisons. Include in your response whether you expect to be
able to rely on this
data to support an IND application for BWV-201 from the FDA.
Intellectual Property, page 105
18. In relation to the company's material patents, please further revise
your intellectual
property disclosure to clearly describe on an individual or patent
family basis the type of
patent protection granted for each product or technology (composition
of matter, use, or
process) and the jurisdiction, including any foreign jurisdiction, of
each material pending
or issued patent. Additionally, we note your disclosures that the term
of various license
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agreements may end upon the last-to-expire patent on a jurisdiction by
jurisdiction and
product by product basis. Please revise to clarify when the last of
these patents are
expected to expire.
19. Please 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.
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.
20. With respect to the option agreement between your company and Oxford
University
Innovation Limited, we note that obtaining the license agreement was
conditioned upon
the Company entering into a separate agreement with Oxford University
to provide
funding for three years salary for Dr. Craig Thompson in the
University s Department of
Zoology, which was paid by the Company in January 2020. Please
disclose the aggregate
amount paid pursuant to such separate agreement.
Manufacturing and Supply, page 110
21. We note that you have entered into a development and manufacturing
master services
agreement with Ology. Please expand your disclosure to include the
material terms of the
agreement, including the financial terms and termination provisions.
Additionally, please
file the agreement as an exhibit or advise us why this is not a
material contract. See Item
601(b)(10) of Regulation S-K.
Management, page 111
22. Please revise the discussion of your executive officers' and
directors' business experience
to provide clear disclosure regarding the business experience of each
such officer and
director during the past five years as required by Item 401(e)(1) of
Regulation S-K. By
way of example only, we note that the description of Erin Henderson's
business
experience begins in September 2018 and it is unclear from your
disclosure whether
Ronald Cobb's business experience with Nanotherapeutics beginning in
2011
continued until the start of his employment with Blue Water Vaccines
in August 2021.
23. Based on your Management disclosures beginning on page 111, we note
that several of
your executive officers appear to have outside management, advisory or
directorship
positions with other companies and may allocate their time to other
businesses. Please
revise your prospectus disclosures as follows:
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Include an appropriately captioned risk factor to discuss, if
true, that certain executive
officers serve in their positions on a part-time basis and/or
otherwise clarify the
number of hours they have agreed to dedicate to the business
affairs of your
company. To the extent material, please also identify and
describe any potential
conflicts of interest that exist, or may exist, as a result of
your executive officers'
outside business relationships.
Please balance your prospectus summary disclosures regarding
your executive
officers' experience and qualifications in the Management and
History section of the
prospectus summary with disclosure in that section and the
Summary of Risks
Related to Our Business section regarding their outside
employment or business
relationships, including specifying the amount of time they
devote to your business
activities and the nature of any material conflicts of interest
that may exist as a result
of them working for your company on a part-time basis.
Choice of Forum, page 132
24. We note your choice of forum provision. We refer you to the
penultimate and final
sentences of the Choice of Forum section beginning on page 132, which
pertain to the
provision's intended application to claims arising under the
Securities Act. We note that
these sentences seem to conflict. Please revise your disclosure to
state that investors
cannot waive compliance with the federal securities laws and the rules
and regulations
thereunder, and clarify whether your Amended and Restated Certificate
of Incorporation
will provide for concurrent jurisdiction or whether the federal
district courts of the United
States will be the exclusive forum for asserting any cause of action
under the Securities
Act, unless you consent in writing to an alternative forum. To the
extent the latter will
apply, please revise your disclosure to state that there is
uncertainty as to whether a court
would enforce a provision that limits limits the choice of forum to
federal court. In this
regard, we note that Section 22 of the Securities Act creates
concurrent jurisdiction for
federal and state courts over all suits brought to enforce any duty or
liability created by the
Securities Act or the rules and regulations thereunder. Please also
revise your risk factors
to provide clear and prominent risk factor disclosure of the impact
and risks to
shareholders related to the provision. Such risks may include, but are
not limited to,
increased costs to bring a claim and that these provisions can
discourage claims or limit
investors ability to bring a claim in a judicial forum that they
find favorable.
Notes to Financial Statements
Note 1 - Organization, Plan of Business Operations, page F-7
25. Please clarify that all of your vaccine candidates in the preclinical
developmental stage.
Note 7 - Commitments and Contingencies
Significant Agreements, page F-18
26. Please separately disclose in the filing the amount of milestone
payments you may be
Joseph Hernandez
Blue Water Vaccines Inc.
September 17, 2021
Page 10
required to pay for each type of event (e.g. development, regulatory and
commercial).
General
27. 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.
You may contact Mary Mast at 202-551-3613 or Tara Harkins at
202-551-3639 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
September 17, 2021 Page 10
cc: Jessica Yuan
FirstName LastName