SecProbe.io

<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 May 2, 2025

Karina Fedasz
Interim Chief Executive Officer
Onconetix, Inc.
201 E. Fifth Street, Suite 1900
Cincinnati, OH 45202

 Re: Onconetix, Inc.
 Preliminary Proxy Statement on Schedule 14A
 Filed April 18, 2025
 File No. 001-41294
Dear Karina Fedasz:

 We have completed our review of your filing. 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.

 Sincerely,

 Division of Corporation
Finance
 Office of Life Sciences
cc: Jessica Yuan
</TEXT>
</DOCUMENT>

CORRESP
1
filename1.htm

Onconetix, Inc.

201 E. Fifth Street, Suite 1900

Cincinnati, OH 45202

VIA EDGAR

February 10, 2025

U.S. Securities and Exchange Commission

Office of Life Sciences

Washington, D.C. 20549

Attn: Jessica Dickerson

    Re:

    Onconetix, Inc.

    Registration Statement on Form S-1

    Filed January 27, 2025

    File No. 333-284507

Ladies and Gentleman,

Pursuant to Rule 461 under the
Securities Act of 1933, as amended, Onconetix, Inc. hereby requests acceleration of effectiveness of the above referenced Registration
Statement so that it will become effective at 5:00 p.m. EST on Tuesday, February 11, 2025, or as soon as thereafter practicable.

    Very truly yours,

    /s/ Karina Fedasz

    By: Karina Fedasz

    Title: Interim Chief Financial Officer

    cc:

    Ellenoff Grossman & Schole LLP

February 3, 2025
Karina Fedasz
Interim Chief Financial Officer
Onconetix, Inc.
201 E. Fifth Street, Suite 1900
Cincinnati, OH 45202
Re:Onconetix, Inc.
Registration Statement on Form S-1
Filed January 27, 2025
File No. 333-284507
Dear Karina Fedasz:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration. 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.
            Please contact Jessica Dickerson at 202-551-8013 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Jessica Yuan, Esq.

CORRESP
1
filename1.htm

ONCONETIX, INC.

201 E. Fifth Street, Suite 1900

Cincinnati, OH

December 11, 2024

VIA EDGAR

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street, N.E.

Washington, DC 20549

    Re:
    Onconetix, Inc.

    Registration Statement on Form S-1

    File No. 333-282958

Ladies and
Gentlemen:

Pursuant to Rule 461 under
the Securities Act of 1933, as amended, Onconetix, Inc. hereby requests acceleration of effectiveness of the above referenced Registration
Statement so that it will become effective at 5:00 p.m. EST on Thursday, December 12, 2024, or as soon as practicable thereafter.

    Very truly yours,

    /s/ Karina M. Fedasz

    Karina M. Fedasz

    Interim Chief Financial Officer

cc:   Ellenoff Grossman & Schole LLP

CORRESP
1
filename1.htm

Onconetix, Inc.

201 E. Fifth Street, Suite 1900

Cincinnati, OH 45202

VIA EDGAR

November 12, 2024

U.S. Securities and Exchange Commission

Office of Life Sciences

Washington, D.C. 20549

Attn: Joshua Gorsky, Tim Buchmiller

    Re:

    Onconetix, Inc.

    Registration Statement on Form S-1

    Filed November 1, 2024

    File No. 333-282958

Ladies and Gentleman,

Pursuant to Rule 461 under the
Securities Act of 1933, as amended, Onconetix, Inc. hereby requests acceleration of effectiveness of the above referenced Registration
Statement so that it will become effective at 4:00 p.m. EST on Tuesday, November 12, 2024, or as soon as thereafter practicable.

    Very truly yours,

    /s/ Ralph Schiess

    By: Ralph Schiess

    Title: Interim Chief Executive Officer

    cc:

    Ellenoff Grossman & Schole LLP

CORRESP
1
filename1.htm

Onconetix, Inc.

201 E. Fifth Street, Suite 1900

Cincinnati, OH 45202

VIA EDGAR

November 12, 2024

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

Washington, D.C. 20549

    Attention:
    Joshua Gorsky

    Tim Buchmiller

    Re:
    Onconetix, Inc.

    Registration Statement on Form S-1

    Filed November 1, 2024

    File No. 333-282958

Ladies and Gentlemen:

Onconetix, Inc. (the “Company,”
“we,” “our” or “us”) hereby transmits its response to the comment letter received from the staff
(the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) on November 7, 2024,
regarding the Registration Statement on Form S-1 filed with the Commission on November 1, 2024 (the “Registration Statement”).

For the Staff’s convenience,
we have repeated below the Staff’s comments in bold, and have followed each comment with the Company’s response. Disclosure
changes made in response to the Staff’s comments have been made in Amendment No. 1 to the Registration Statement (the “Amendment”)
which is being submitted to the Commission contemporaneously with the submission of this letter.

Registration Statement on Form S-1

General

 1. We note you have entered into the ELOC Purchase Agreement
and are registering the shares that will be issued for resale. This appears to be an equity line financing. As such, please identify
the equity line investor as an underwriter for the resale of those shares, or advise. Additionally, please file the executed version
of the ELOC Purchase Agreement as an exhibit to the registration statement. Refer to Securities Act Sections Compliance and Disclosure
Interpretation 139.13 for guidance.

Response: The Company respectfully acknowledges
the Staff’s comment and advises the Staff that it has amended the cover page and page 28 of the Amendment, and has filed the ELOC
Purchase Agreement as Exhibit 10.66 to the Amendment.

* * *

We thank the Staff for its review
of this response. Should you have any questions or require any additional information, please do not hesitate to contact our legal counsel,
Jessica Yuan, Esq. of Ellenoff Grossman & Schole LLP, at jyuan@egsllp.com or by telephone at (212) 370-1300.

    Very truly yours,

    Onconetix, Inc.

    By:
    /s/ Karina M. Fedasz

    Name:
    Karina M. Fedasz

    Title:
    Interim Chief Financial Officer

    cc:
    Ellenoff Grossman & Schole LLP

CORRESP
1
filename1.htm

Onconetix, Inc.

201 E. Fifth Street, Suite 1900

Cincinnati, OH 45202

VIA EDGAR

November 12, 2024

U.S. Securities and Exchange Commission

Office of Life Sciences

Washington, D.C. 20549

Attn: Joshua Gorsky, Tim Buchmiller

    Re:

    Onconetix, Inc.

    Registration Statement on Form S-1

    Filed November 1, 2024

    File No. 333-282959

Ladies and Gentleman,

Pursuant to Rule 461 under
the Securities Act of 1933, as amended, Onconetix, Inc. hereby requests acceleration of effectiveness of the above referenced Registration
Statement so that it will become effective at 5:00 p.m. EST on Tuesday, November 12, 2024, or as soon as thereafter practicable.

    Very truly yours,

    /s/ Karina M. Fedasz

    By: Karina M. Fedasz

    Title: Interim Chief Financial Officer

    cc:

    Ellenoff Grossman & Schole LLP

CORRESP
1
filename1.htm

November 12, 2024

VIA EDGAR

U.S. Securities and Exchange Commission

Office of Life Sciences

Washington, D.C. 20549

Attn: Joshua Gorsky, Tim Buchmiller

    Re:

    Onconetix, Inc.

    Registration Statement on Form S-1

    Filed November 1, 2024

    File No. 333-282958

Ladies and Gentleman,

Reference is made to our
letter, filed as correspondence via EDGAR on November 12, 2024, in which we requested the acceleration of the effective date of the above-referenced
Registration Statement for Tuesday, November 12, 2024, at 4:00 p.m., Eastern Time, in accordance with Rule 461 under the Securities Act
of 1933, as amended. We are no longer requesting that such Registration Statement be declared effective at this time and we hereby formally
withdraw our request for acceleration of the effective date.

Please call Jessica Yuan of Ellenoff Grossman
& Schole LLP at 212-370-1300 with any questions.

* * *

    Very truly yours,

    /s/ Ralph Schiess

    By: Ralph Schiess

    Title: Interim Chief Executive Officer

    cc:

    Ellenoff Grossman & Schole LLP

November 7, 2024
Karina M. Fedasz
Interim Chief Financial Officer
Onconetix, Inc.
201 E. Fifth Street, Suite 1900
Cincinnati, Ohio 45202
Re:Onconetix, Inc.
Registration Statement on Form S-1
Filed November 1, 2024
File No. 333-282958
Dear Karina M. Fedasz:
            We have conducted a limited review of your registration statement and have the
following comments.
            Please respond to this letter by amending your registration statement and providing
the requested information. If you do not believe a comment applies 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 this letter, we may have additional comments.
Registration Statement on Form S-1
General
1.We note you have entered into the ELOC Purchase Agreement and are registering the
shares that will be issued for resale. This appears to be an equity line financing. As
such, please identify the equity line investor as an underwriter for the resale of those
shares, or advise. Additionally, please file the executed version of the ELOC Purchase
Agreement as an exhibit to the registration statement. Refer to Securities Act Sections
Compliance and Disclosure Interpretation 139.13 for guidance.
            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.

November 7, 2024
Page 2
            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.
            Please contact Joshua Gorsky at 202-551-7836 or Tim Buchmiller at 202-551-3635
with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Jessica Yuan, Esq.

CORRESP
1
filename1.htm

ONCONETIX, INC.

201 E. Fifth Street, Suite 1900

Cincinnati, OH

June 28, 2024

VIA EDGAR

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street, N.E.

Washington, DC 20549

    Re:

    Onconetix, Inc.

    Registration Statement on Form S-1

    File No. 333-277066

Ladies and Gentlemen:

Pursuant to Rule 461 under the
Securities Act of 1933, as amended, Onconetix, Inc. hereby requests acceleration of effectiveness of the above referenced Registration
Statement so that it will become effective at 5:00 p.m. EST on Monday, July 1, 2024, or as soon as practicable thereafter.

    Very truly yours,

    /s/ Karina M. Fedasz

    Karina M. Fedasz

    Interim Chief Financial Officer

    cc:

    Ellenoff Grossman & Schole LLP

CORRESP
1
filename1.htm

Onconetix, Inc.

201 E. Fifth Street, Suite 1900

Cincinnati, OH 45202

VIA EDGAR

June 24, 2024

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

Washington, D.C. 20549

    Attention:
    Tara Harkins

    Angela Connell

    Jimmy McNamara

    Jason Drory

    Re:
    Onconetix, Inc.

    Amendment No. 2 to Registration Statement on Form S-1

    Filed June 5, 2024

    File No. 333-277066

Ladies and Gentlemen:

Onconetix, Inc. (the “Company”)
hereby transmits its response to the comment letter received from the staff (the “Staff”) of the U.S. Securities and
Exchange Commission (the “Commission”) on June 14, 2024 relating to the Amendment No. 2 to Registration Statement on
Form S-1, submitted by the Company to the Commission on June 5, 2024 (the “Registration Statement”).

For the Staff’s convenience,
we have repeated below the Staff’s comments in bold and have followed each comment with the Company’s response. Disclosure
changes made in response to the Staff’s comments have been made in Amendment No. 3 to the Registration Statement, which is being
submitted to the Commission contemporaneously with the submission of this letter.

Amendment No. 2 to Registration Statement
on Form S-1

About the Company

Clinical Studies, page 69

 1. We
note your response to comment 16. Please clearly describe the secondary endpoint referenced on page 70.

Response: The Company respectfully acknowledges
the Staff’s comment and advises the Staff that it has amended its disclosure on page 70 of the Registration Statement to include
the requested information.

Proclarix patents, page 89

 2. We
note your response to comment 22 and re-issue in part. Please provide the expected expiration dates of the pending applications referenced
in Tables 3, 4, and 5.

Response: The Company respectfully acknowledges
the Staff’s comment and advises the Staff that it has amended its disclosure on pages 90–94 of the Registration Statement
to include the requested information.

General

 3. We
note your response to comment 29 and re-issue. At first use, please define abbreviations throughout your registration statement. For
example only, we continue to note “BPH” on page 1 and “DRE” on page 69, which do not appear to be defined.

Response: The Company respectfully acknowledges
the Staff’s comment and advises the Staff that it has amended its disclosure throughout the Registration Statement to define abbreviations
on first use, including the definitions of “BPH” and “DRE”.

* * *

We thank the Staff for its
review of this response. Should you have any questions or require any additional information, please do not hesitate to contact our legal
counsel, Jessica Yuan, Esq. of Ellenoff Grossman & Schole LLP, at jyuan@egsllp.com or by telephone at (212) 370-1300.

    Very truly yours,

    Onconetix, Inc.

    By:
    /s/ Ralph Schiess

    Name:
    Ralph Sciess

    Title:
    Interim Chief Executive Officer

    cc:
    Ellenoff Grossman & Schole LLP

United States securities and exchange commission logo
June 14, 2024
Ralph Schiess
Interim Chief Executive Officer
Onconetix, Inc.
201 E. Fifth Street, Suite 1900
Cincinnati, OH 45202
Re:Onconetix, Inc.
Amendment No. 2 to Registration Statement on Form S-1
Filed June 5, 2024
File No. 333-277066
Dear Ralph Schiess:
            We have reviewed your amended registration statement and have the following
comments.
            Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a comment applies 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 this letter, we may have additional comments. Unless we note otherwise,
any references to prior comments are to comments in our May 10, 2024 letter.
Amendment No. 2 to Registration Statement on Form S-1
About the Company
Clinical Studies, page 69
1.We note your response to comment 16. Please clearly describe the secondary endpoint
referenced on page 70.
Proclarix patents, page 89
2.We note your response to comment 22 and re-issue in part. Please provide the expected
expiration dates of the pending applications referenced in Tables 3, 4, and 5.

 FirstName LastNameRalph Schiess
 Comapany NameOnconetix, Inc.
 June 14, 2024 Page 2
 FirstName LastName
Ralph Schiess
Onconetix, Inc.
June 14, 2024
Page 2
General
3.We note your response to comment 29 and re-issue. At first use, please define
abbreviations throughout your registration statement. For example only, we continue
to note “BPH” on page 1 and “DRE” on page 69, which do not appear to be defined.
            Please contact Tara Harkins at 202-551-3639 or Angela Connell at 202-551-3426 if you
have questions regarding comments on the financial statements and related matters. Please
contact Jimmy McNamara at 202-551-7349 or Jason Drory at 202-551-8342 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Jessica Yuan

CORRESP
1
filename1.htm

Onconetix, Inc.

201 E. Fifth Street, Suite 1900

Cincinnati, OH 45202

VIA EDGAR

June 13, 2024

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

Washington, D.C. 20549

    Attention:
    Tara Harkins

    Angela Connell

    Jimmy McNamara

    Jason Drory

    Re:
    Onconetix, Inc.

    Amendment No. 1 Registration Statement on Form S-1

    Filed February 14, 2024

    File No. 333-277066

Ladies and Gentlemen:

Onconetix, Inc. (the “Company”)
hereby transmits its response to the comment letter received from the staff (the “Staff”) of the U.S. Securities and
Exchange Commission (the “Commission”) on May 10, 2024, relating to Amendment No. 1 to the Registration Statement on
Form S-1, submitted by the Company to the Commission on February 14, 2024 (the “Registration Statement”).

For the Staff’s convenience,
we have repeated below the Staff’s comments in bold and have followed each comment with the Company’s response. Disclosure
changes made in response to the Staff’s comments have been made in Amendment No. 2 to the Registration Statement (the “Amended
Registration Statement”), which is being submitted to the Commission contemporaneously with the submission of this letter.

Amendment No. 1 to Registration Statement on Form S-1 Prospectus
Summary

Our Company, page 1

1. We note your response to comment 4 and re-issue. Please revise the prospectus summary to clarify when the diagnostic was approved
and describe the specific target market for Proclarix or otherwise advise. We note your disclosure on page 74 that “Proclarix is
intended for use in diagnosing [“grey zone”] patients where it is difficult to decide if a biopsy is necessary to verify a potential
clinically significant cancer diagnosis.”

The Company respectfully acknowledges the Staff’s comment
and advises the Staff that it has amended its disclosure on pages 1-2 of the Registration Statement to include the requested information.

2. Consistent with your disclosure on page 60, please update your disclosure here to quantify the approximate percentage ownership
stake Proteomedix shareholders will have in Onconetix if the Series B Convertible Preferred Stock are converted into shares of common
stock.

The Company respectfully acknowledges the Staff’s comment
and advises the Staff that it has amended its disclosure on page 2 of the Registration Statement to include the requested information

About this Offering Risk Factors, page 4

3. We note your reference to “Incorporation of Certain Information by Reference,” but this section appears to have been
removed from this amendment. Please revise or otherwise advise.

The Company respectfully acknowledges the Staff’s comment
and advises the Staff that it has amended its disclosure on page 157 of the Registration Statement to include the requested information.

Risk Factors, page 5

4. Please provide concise, bulleted or numbered statements that is no more than two pages summarizing your principal risk factors.
Refer to Item 105(b) of Regulation S-K.

The Company respectfully acknowledges the Staff’s comment
and advises the Staff that it has amended its disclosure on page v of the Registration Statement to include the requested information.

There is substantial doubt about our ability to continue
as a “going concern,” and we will require substantial additional funding..., page 6

5. Please update your risk factor disclosure to highlight how the Forbearance Agreement with Veru may impact your future capital requirements
or otherwise advise.

The Company respectfully acknowledges the Staff’s
comment and advises the Staff that it has amended its disclosure on page 6 of the Registration Statement to include the requested information.

Our current liabilities are significant, and if those to
whom we owe accounts payable, such as Veru, IQVIA or other creditors or vendors..., page 7

6. We note your disclosure that you have accounts payable to IQVIA; however, we do not note disclosure elsewhere related to any agreement
with IQVIA. Please revise your disclosure to clarify whether IQVIA is currently providing any material services to you or otherwise advise.

The Company respectfully acknowledges the Staff’s comment
and advises the Staff that it has amended its disclosure on page 7 of the Registration Statement to include the requested information.

We owe a significant amount of money to Veru, which funds
we do not have. Veru may take action..., page 7

7. Please update your risk factor to disclose the material “certain forbearance terms.”

The Company respectfully acknowledges the Staff’s comment
and advises the Staff that it has amended its disclosure on page 7 of the Registration Statement to provide a reference to the requested
information.

The life of patent protection is limited, and third parties
could develop and commercialize methods, products, and technologies..., page 35

8. We note your disclosure on page 36 that licensed patents and pending patent applications are “expected” to expire on
various dates. We also not your disclosure on page 89 that one patent has already expired and another was set to expire on May 3, 2024.
If material, please revise to disclose what effect you expect the expiration of these patents to have on your patent portfolio and your
business and if you intend to take any action to mitigate such effect.

The Company respectfully acknowledges the Staff’s comment
and advises the Staff that it has amended its disclosure on pages 35 and 89 of the Registration Statement to include the requested information.

    2

ENTADFI, page 65

9. We note your disclosure on page 66 that you agreed to pay Veru “15% of (i) the monthly cash receipts of Proteomedix for the
licensing or sale of any products or services, (ii) monthly cash receipts of the Company or any of its subsidiaries for the sales of Proclarix
anywhere in the world, and (iii) monthly cash receipts of the Company or any of its subsidiaries for milestone payments or royalties from
Labcorp” as consideration for Veru’s entrance into the Forbearance Agreement. Please revise your disclosure to clarify the term of
the potential payments to Veru.

The Company respectfully acknowledges the Staff’s comment
and advises the Staff that it has amended its disclosure on pages 65 and 105 of the Registration Statement to include the requested information.

About the Company

Products

Proclarix, page 69

10. For each diagnostic test and decision support system described in this section, please revise to discuss in greater detail the
technical development of each test including the remaining stages of technical development, regulatory filings or other requirements (i.e.
the necessity of clinical studies, trials or other clearance or approvals) and associated costs and timelines. To the extent clinical
studies or trials will be required, please discuss these requirements and any plans, costs and timelines to complete these studies or
trials. Please include enough details so investors can clearly appreciate where each test resides in your development pipeline and the
steps, costs and timelines necessary to obtain final regulatory approval.

The Company respectfully acknowledges the Staff’s comment
and advises the Staff that it has amended its disclosure on pages 70-71 of the Registration Statement to include the requested information,
and remove disclosure regarding programs that are not currently material.

11. We note your disclosure elsewhere that you entered into an exclusive partnership with Labcorp in 2023 pursuant to which Labcorp
has the exclusive right to develop and commercialize Proclarix in the United States. Please update your product pipeline figure and introductory
disclosure to clarify this partnership.

The Company respectfully acknowledges the Staff’s comment
and advises the Staff that it has amended its disclosure on page 68 of the Registration Statement to include the requested information.

12. We note the inclusion of certain diagnostic candidates and decision support systems in your pipeline table, including Prediction
(Rx), Prosgard Software and Prostate Cancer Decision Support. Given the limited disclosure related to these programs, please explain why
they are sufficiently material to your business to warrant inclusion in your pipeline table. If they are material, please expand your
disclosure in the Business section to provide a more fulsome discussion of these programs, including a description of development activities
conducted. Alternatively, remove any programs that are not currently material from your pipeline table.

The Company respectfully acknowledges the Staff’s comment
and advises the Staff that it has amended its disclosure on pages 68-71 of the Registration Statement to remove disclosure regarding programs
that are not currently material.

13. We note your reference to a “Cockpit” in your pipeline table. Please clarify what this means or otherwise advise.

The Company respectfully acknowledges the Staff’s comment
and advises the Staff that it has amended its disclosure on page 68 of the Registration Statement to remove disclosure regarding this
program, as it is not currently material.

    3

14. We note your pipeline table appears to depict Proclarix twice in the graphic, as a Decision Support System and a Diagnostic. However,
your disclosure elsewhere appears to indicate that “Proclarix already consists of a decision support system integrating different
values in a risk score” and appears to be one “Proclarix diagnostic program.” Please revise your table or otherwise advise
if the decision support system is separate from the diagnostic test.

The Company respectfully acknowledges the Staff’s comment
and advises the Staff that it has amended its disclosure on page 68 of the Registration Statement to make clearer that Proclarix is a
single diagnostic program.

Clinical Studies, page 70

15. At first use, please provide a brief explanation of the disclosed p-value and how it is used to measure statistical significance.

The Company respectfully acknowledges the Staff’s comment
and advises the Staff that it has amended its disclosure on pages 69-70 of the Registration Statement to include the requested information.

16. With respect to the clinical studies, please clearly describe the primary endpoints, and whether these endpoints were met. To the
extent that there were secondary endpoints, please clearly describe, and disclose whether such endpoints were met, or otherwise advise.

The Company respectfully acknowledges the Staff’s comment
and advises the Staff that it has amended its disclosure on page 69-71 of the Registration Statement to include the requested information.

17. Please provide the basis or data for the statement on page 71 that Proclarix was more accurate when compared to PSA density and
online calculators, as well as the conclusion that Proclarix outperformed PSA density in the selection of candidates for prostate biopsy.
You may provide an objective summary of the data that you used to draw such conclusions.

The Company respectfully acknowledges the Staff’s comment
and advises the Staff that it has amended its disclosure on page 70 of the Registration Statement to include the requested information.

A novel serum biomarker quintet that improves disease prognosis
in men with confirmed prostate cancer, page 72

18. Please provide the basis or quantify your analysis showing that the proposed model had a better prediction for disease progression
than the “CAPRA” score. In addition, please clarify, if true, that you conducted the clinical evaluation, or otherwise advise.

The Company respectfully acknowledges the Staff’s comment
and advises the Staff that it has amended its disclosure on page 71 of the Registration Statement to include the requested information.

Market
Opportunity

Proclarix, page 74

19. We note your disclosure that the “worldwide market for in vitro diagnostic (“IVD”) products was valued at $117.8
billion in 2022.” However, we note that “Proclarix has been validated and approved for use in men with elevated total PSA (2.0
to 10.0 ng/mL), a normal DRE not suspicious for cancer and an elevated prostate volume (35 mL).” Please add balancing disclosure
to clarify the addressable market for your specific product of product candidate.

The Company respectfully acknowledges the Staff’s comment
and advises the Staff that it has amended its disclosure on page 73 of the Registration Statement to include the requested information.

    4

Competition

Competitive Advantages of Proclarix, page 78

20. With respect to referencing the insurance company as a “Payer,” please disclose, if true, that this is a potential or
desired stakeholder. In this regard, we note your disclosures on pages 60 and 73 that Proclarix is currently not reimbursed in Europe,
and therefore patients pay for Proclarix out of pocket.

The Company respectfully acknowledges the Staff’s comment
and advises the Staff that it has amended its disclosure on page 77 of the Registration Statement to include the requested information.

Intellectual Property, page 88

21. We note your disclosure here that you partnered with New Horizon Health Limited and Immunovia AB. Please revise your disclosure
to discuss the material terms of your partnerships. Please file these agreements as exhibits or advise. Refer to Item 601(b)(10)(ii)(A)
of Regulation S-K.

The Company respectfully acknowledges the Staff’s comment
and advises the Staff that it has amended its disclosure on page 88 of the Registration Statement to include the requested information,
and filed these agreements as Exhibits 10.60, 10.61 and 10.62.

Patents, page 89

22. Please revise your discussion of your intellectual property to clarify and disclose the specific material product, product groups
and technologies to which such patents relate, whether they are owned or licensed, the type of patent protection you have, the expiration
dates and the applicable material jurisdictions.

The Company respectfully acknowledges the Staff’s comment
and advises the Staff that it has amended its disclosure on page 89-92 of the Registration Statement to include the requested information.

Certain Significant Relationships

Ology Agreement (which was later acquired by National Resilience,
Inc.), page 104

23. We note your disclosure that you are “obligated to pay Ology an aggregate amount of approximately $2.8 million, plus reimbursement
for materials and outsourced testing, which will be billed at cost plus 15%.” Please revise your disclosure to (i) clarify the type
of project or services Ology is performing under the agreement, (ii) disclose the aggregate potential payment remaining and (iii) disclose
the term and termination provision of the project.

The Company respectfully acknowledges the Staff’s
comment and advises the Staff that it has amended its disclosure on page 106 of the Registration Statement to include the requested
information.

Onconetix’s Management’s Discussion and Analysis
of Financial Condition and Results of Operations

Overview, page 104

24. We note your response to comment 17 and re-issue in part. With respect to the license agreement with Laboratory Corporation of America
Holdings, please revise to (i) disclose the aggregate amounts paid to date and the aggregate amount of remaining potential milestone payments;
(ii) quantify the royalty payments on the net sales, or provide a range no greater than 10 percentage points; (iii) disclose when the
royalty provisions expire; (iv) disclose the expiration date; and (v) describe any termination provisions.

The Company respectfully acknowledges the Staff’s
comment and advises the Staff that it has amended its disclosure on page 106 of the Registration Statement to include the requested information.

    5

Services Agreement, page 105

25. Please identify the Vendor referenced in the Services Agreement.

The Company respect

United States securities and exchange commission logo
May 10, 2024
Ralph Schiess
Interim Chief Executive Officer
Onconetix, Inc.
201 E. Fifth Street, Suite 1900
Cincinnati, OH 45202
Re:Onconetix, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed April 26, 2024
File No. 333-277066
Dear Ralph Schiess:
            We have reviewed your amended registration statement and have the following
comments.
            Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a comment applies 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 this letter, we may have additional comments. Unless we note otherwise,
any references to prior comments are to comments in our March 12, 2024 letter.
Amendment No. 1 to Registration Statement on Form S-1
Prospectus Summary
Our Company, page 1
1.We note your response to comment 4 and re-issue. Please revise the prospectus summary
to clarify when the diagnostic was approved and describe the specific target market for
Proclarix or otherwise advise. We note your disclosure on page 74 that "Proclarix is
intended for use in diagnosing ["grey zone"] patients where it is difficult to decide if a
biopsy is necessary to verify a potential clinically significant cancer diagnosis."
2.Consistent with your disclosure on page 60, please update your disclosure here to quantify
the approximate percentage ownership stake Proteomedix shareholders will have in
Onconetix if the Series B Convertible Preferred Stock are converted into shares of
common stock.

 FirstName LastNameRalph Schiess
 Comapany NameOnconetix, Inc.
 May 10, 2024 Page 2
 FirstName LastNameRalph Schiess
Onconetix, Inc.
May 10, 2024
Page 2
About this Offering
Risk Factors, page 4
3.We note your reference to “Incorporation of Certain Information by Reference,” but this
section appears to have been removed from this amendment. Please revise or otherwise
advise.
Risk Factors, page 5
4.Please provide concise, bulleted or numbered statements that is no more than two pages
summarizing your principal risk factors. Refer to Item 105(b) of Regulation S-K.
There is substantial doubt about our ability to continue as a "going concern," and we will require
substantial additional funding..., page 6
5.Please update your risk factor disclosure to highlight how the Forbearance Agreement
with Veru may impact your future capital requirements or otherwise advise.
Our current liabilities are significant, and if those to whom we owe accounts payable, such as
Veru, IQVIA or other creditors or vendors..., page 7
6.We note your disclosure that you have accounts payable to IQVIA; however, we do not
note disclosure elsewhere related to any agreement with IQVIA. Please revise your
disclosure to clarify whether IQVIA is currently providing any material services to you or
otherwise advise.
We owe a significant amount of money to Veru, which funds we do not have. Veru may take
action..., page 7
7.Please update your risk factor to disclose the material "certain forbearance terms."
The life of patent protection is limited, and third parties could develop and commercialize
methods, products, and technologies..., page 35
8.We note your disclosure on page 36 that licensed patents and pending patent applications
are “expected” to expire on various dates. We also not your disclosure on page 89 that one
patent has already expired and another was set to expire on May 3, 2024. If material,
please revise to disclose what effect you expect the expiration of these patents to have on
your patent portfolio and your business and if you intend to take any action to mitigate
such effect.
ENTADFI, page 65
9.We note your disclosure on page 66 that you agreed to pay Veru "15% of (i) the monthly
cash receipts of Proteomedix for the licensing or sale of any products or services, (ii)
monthly cash receipts of the Company or any of its subsidiaries for the sales of Proclarix
anywhere in the world, and (iii) monthly cash receipts of the Company or any of its

 FirstName LastNameRalph Schiess
 Comapany NameOnconetix, Inc.
 May 10, 2024 Page 3
 FirstName LastNameRalph Schiess
Onconetix, Inc.
May 10, 2024
Page 3
subsidiaries for milestone payments or royalties from Labcorp" as consideration for Veru's
entrance into the Forbearance Agreement. Please revise your disclosure to clarify the term
of the potential payments to Veru.
About the Company
Products
Proclarix, page 69
10.For each diagnostic test and decision support system described in this section, please
revise to discuss in greater detail the technical development of each test including the
remaining stages of technical development, regulatory filings or other requirements (i.e.
the necessity of clinical studies, trials or other clearance or approvals) and associated costs
and timelines. To the extent clinical studies or trials will be required, please discuss these
requirements and any plans, costs and timelines to complete these studies or trials. Please
include enough details so investors can clearly appreciate where each test resides in your
development pipeline and the steps, costs and timelines necessary to obtain final
regulatory approval.
11.We note your disclosure elsewhere that you entered into an exclusive partnership with
Labcorp in 2023 pursuant to which Labcorp has the exclusive right to develop and
commercialize Proclarix in the United States. Please update your product pipeline figure
and introductory disclosure to clarify this partnership.
12.We note the inclusion of certain diagnostic candidates and decision support systems in
your pipeline table, including Prediction (Rx), Prosgard Software and Prostate Cancer
Decision Support. Given the limited disclosure related to these programs, please explain
why they are sufficiently material to your business to warrant inclusion in your pipeline
table. If they are material, please expand your disclosure in the Business section to
provide a more fulsome discussion of these programs, including a description of
development activities conducted. Alternatively, remove any programs that are not
currently material from your pipeline table.
13.We note your reference to a "Cockpit" in your pipeline table. Please clarify what this
means or otherwise advise.
14.We note your pipeline table appears to depict Proclarix twice in the graphic, as a Decision
Support System and a Diagnostic. However, your disclosure elsewhere appears to indicate
that "Proclarix already consists of a decision support system integrating different values in
a risk score" and appears to be one "Proclarix diagnostic program." Please revise your
table or otherwise advise if the decision support system is separate from the diagnostic
test.
Clinical Studies, page 70
15.At first use, please provide a brief explanation of the disclosed p-value and how it is used
to measure statistical significance.

 FirstName LastNameRalph Schiess
 Comapany NameOnconetix, Inc.
 May 10, 2024 Page 4
 FirstName LastName
Ralph Schiess
Onconetix, Inc.
May 10, 2024
Page 4
16.With respect to the clinical studies, please clearly describe the primary endpoints, and
whether these endpoints were met. To the extent that there were secondary endpoints,
please clearly describe, and disclose whether such endpoints were met, or otherwise
advise.
17.Please provide the basis or data for the statement on page 71 that Proclarix was more
accurate when compared to PSA density and online calculators, as well as the conclusion
that Proclarix outperformed PSA density in the selection of candidates for prostate biopsy.
You may provide an objective summary of the data that you used to draw such
conclusions.
A novel serum biomarker quintet that improves disease prognosis in men with confirmed
prostate cancer, page 72
18.Please provide the basis or quantify your analysis showing that the proposed model had a
better prediction for disease progression than the “CAPRA” score. In addition, please
clarify, if true, that you conducted the clinical evaluation, or otherwise advise.
Market Opportunity
Proclarix, page 74
19.We note your disclosure that the "worldwide market for in vitro diagnostic (“IVD”)
products was valued at $117.8 billion in 2022." However, we note that "Proclarix has been
validated and approved for use in men with elevated total PSA (2.0 to 10.0 ng/mL), a
normal DRE not suspicious for cancer and an elevated prostate volume (35 mL)." Please
add balancing disclosure to clarify the addressable market for your specific product of
product candidate.
Competition
Competitive Advantages of Proclarix, page 78
20.With respect to referencing the insurance company as a "Payer," please disclose, if true,
that this is a potential or desired stakeholder. In this regard, we note your disclosures on
pages 60 and 73 that Proclarix is currently not reimbursed in Europe, and therefore
patients pay for Proclarix out of pocket.
Intellectual Property, page 88
21.We note your disclosure here that you partnered with New Horizon Health Limited and
Immunovia AB. Please revise your disclosure to discuss the material terms of your
partnerships. Please file these agreements as exhibits or advise. Refer to Item
601(b)(10)(ii)(A) of Regulation S-K.

 FirstName LastNameRalph Schiess
 Comapany NameOnconetix, Inc.
 May 10, 2024 Page 5
 FirstName LastName
Ralph Schiess
Onconetix, Inc.
May 10, 2024
Page 5
Patents, page 89
22.Please revise your discussion of your intellectual property to clarify and disclose the
specific material product, product groups and technologies to which such patents relate,
whether they are owned or licensed, the type of patent protection you have, the expiration
dates and the applicable material jurisdictions.
Certain Significant Relationships
Ology Agreement (which was later acquired by National Resilience, Inc.), page 104
23.We note your disclosure that you are "obligated to pay Ology an aggregate amount of
approximately $2.8 million, plus reimbursement for materials and outsourced testing,
which will be billed at cost plus 15%." Please revise your disclosure to (i) clarify the
type of project or services Ology is performing under the agreement, (ii) disclose the
aggregate potential payment remaining and (iii) disclose the term and termination
provision of the project.
Onconetix’s Management’s Discussion and Analysis of Financial Condition and Results of
Operations
Overview, page 104
24.We note your response to comment 17 and re-issue in part. With respect to the license
agreement with Laboratory Corporation of America Holdings, please revise to (i) disclose
the aggregate amounts paid to date and the aggregate amount of remaining potential
milestone payments; (ii) quantify the royalty payments on the net sales, or provide a range
no greater than 10 percentage points; (iii) disclose when the royalty provisions expire; (iv)
disclose the expiration date; and (v) describe any termination provisions.
Services Agreement, page 105
25.Please identify the Vendor referenced in the Services Agreement.
Selling Stockholders, page 153
26.We note your disclosure that the second column lists the number of shares of Common
Stock beneficially owned by each Selling Stockholder, based on its ownership of the
shares of Common Stock, PIOs, as of April 1, 2024. Please update this section to provide
all required information in Item 507 of Regulation S-K, including the amount of securities
held by the security holders prior to the offering, and the amount and (if one percent or
more) percentage of the class to be owned by the security holders after completion of the
offering.

 FirstName LastNameRalph Schiess
 Comapany NameOnconetix, Inc.
 May 10, 2024 Page 6
 FirstName LastName
Ralph Schiess
Onconetix, Inc.
May 10, 2024
Page 6
Onconetix, Inc.
Consolidated Balance Sheet, page F-4
27.Please revise to clearly identify any related party amounts on the face of your financial
statements as required by Rule 4-08(k) of Regulation S-X.  In this regard, we note that
the PMX Investor, which is a party to your Subscription Agreement, is a 5% stockholder
of the company.
ProteoMedix AG
Notes to Condensed Financial Statements
Note 3 - Summary of Significant Accounting Policies
Revenue Recognition, page F-87
28.We note your tabular disclosure on page F-88 which disaggregates ProteoMedix revenues
by type for the periods ended September 30, 2023 and 2022.  Please revise to clarify
whether product sales are derived from sales of Proclarix in the European Union.  If not,
please clarify from where such product sales are derived. Please also revise to provide the
customer concentration disclosures required by ASC 275-10-50-18.  In this regard, we
note your disclosure on page 122 that development services revenue was attributable to a
contract with a single customer while license revenue was attributable to a one-time
licensing contract.  Please also revise your revenue throughout your
document accordingly.
General
29.At first use, please define abbreviations throughout your registration statement. For
example only, we note “BPH” on page 1, “DRE” on page 70, which do not appear to be
defined.
30.Many of your tables and graphics include print that is not legible. For example only, your
Figure 4 and 5 contains text that is too small to be legible. Please revise your graphics
throughout your prospectus as applicable to ensure that the text is legible.
31.We note your disclosure throughout your registration statement that Proclarix is "expected
to be available in the United States (“U.S.”) in the near future." We also note, pursuant to
your license agreement with Labcorp, "Labcorp is wholly responsible for the cost, if any,
of research, development and commercialization of Licensed Products in the
United States." Please revise your disclosure to clarify the current regulatory status of
Proclarix in the United States or otherwise advise.
            Please contact Tara Harkins at 202-551-3639 or Angela Connell at 202-551-3426 if you
have questions regarding comments on the financial statements and related matters. Please
contact Jimmy McNamara at 202-551-7349 or Jason Drory at 202-551-8342 with any other
questions.

 FirstName LastNameRalph Schiess
 Comapany NameOnconetix, Inc.
 May 10, 2024 Page 7
 FirstName LastName
Ralph Schiess
Onconetix, Inc.
May 10, 2024
Page 7
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Jessica Yuan

CORRESP
1
filename1.htm

Onconetix, Inc.

201 E. Fifth Street, Suite 1900

Cincinnati, OH 45202

VIA EDGAR

April 26, 2024

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

Washington, D.C. 20549

    Attention:
    Tara Harkins

    Angela Connell

    Jimmy McNamara

    Jason Drory

    Re:
    Onconetix, Inc.

    Registration Statement on Form S-1

    Filed February 14, 2024

    File No. 333-277066

Ladies and Gentlemen:

Onconetix, Inc. (the “Company”)
hereby transmits its response to the comment letter received from the staff (the “Staff”) of the U.S. Securities and
Exchange Commission (the “Commission”) on March 12, 2024, relating to the Registration Statement on Form S-1, submitted
by the Company to the Commission on February 14, 2024 (the “Registration Statement”).

For the Staff’s convenience,
we have repeated below the Staff’s comments in bold and have followed each comment with the Company’s response. Disclosure
changes made in response to the Staff’s comments have been made in Amendment No. 1 to the Registration Statement (the “Amended
Registration Statement”), which is being submitted to the Commission contemporaneously with the submission of this letter.

Registration Statement on Form S-1

Prospectus Summary, page 1

 1. We
note your disclosure that local diagnostic laboratories can easily add Proclarix, an affordable multiparametric test, to their existing
infrastructure. Please provide balancing disclosure with your statement on page 17 that Proclarix is complicated and expensive to manufacture
or otherwise advise.

Response: The Company respectfully acknowledges
the Staff’s comment and advises the Staff that it has amended its disclosure on pages 2-3 of the Registration Statement to include
the requested information.

    2.
    We note your disclosure that “ENTADFI will become the inaugural therapeutic drug in [your] expanding portfolio of oncology therapeutics once launched.” However, we note that ENTADFI appears to be approved for an indication outside of the field of oncology and you do not describe any other oncology therapeutics approved or under development. Please update your disclosure to describe your “expanding portfolio of oncology therapeutics” or otherwise revise.

Response: The Company respectfully acknowledges
the Staff’s comment and advises the Staff that it has amended its disclosure on page 1 of the Registration Statement.

Overview of Company, page 5

    3.
    We note your disclosure that “In Europe, Proteomedix has begun marketing Proclarix to pilot laboratories in selected markets that are open to self-pay to show initial adoption.” Please expand your disclosure to clarify and describe the material details of the marketing of Proclarix to date. For example only, please revise your disclosure to describe when you launched Proclarix and quantify how it has been accepted to date. In addition, please clarify what “self-pay” means.

Response: The Company respectfully acknowledges
the Staff’s comment and advises the Staff that it has amended its disclosure on pages 59-60 of the Registration Statement to include
the requested information and to clarify what “self-pay” means.

    4.
    We note your disclosure that “Proclarix is approved for sale in the European Union under the IVDR.” Please revise your disclosure to clarify when the diagnostic was approved and describe the specific target market for Proclarix or otherwise advise.

Response: The Company respectfully acknowledges
the Staff’s comment and advises the Staff that it has amended its disclosure on page 59 of the Registration Statement to include
the requested information.

Recent Acquisitions

Proteomedix, page 5

    5.
    We note that you acquired Proteomedix AG on December 15, 2023 in a share exchange transaction whereby the aggregate value of your exchange shares at closing was equal to approximately $75 million less the value of the Proteomedix Shares. Please revise your filing to include Proteomedix’s audited and unaudited financial statements and related pro forma financial statements pursuant to Rule 8-04 and Rule 8-05 of Regulation S-X similar to those included within your amended Form 8-K filed on February 27, 2024.

Response: The Company respectfully acknowledges the Staff’s comment and advises
the Staff that it has included Proteomedix’s audited and unaudited financial statements and related pro forma financial statements
in the Amended Registration Statement on pages 97-101.

    6.
    The pro forma financial information included as Exhibit 99.3 to your amended Form 8-K filed on February 27, 2024 indicates that Onconetix was determined to be the accounting acquirer in the share exchange agreement with Proteomedix. Please provide to us your detailed analysis of the guidance at ASC 805-10-55-10 through 15 for this transaction to explain how you determined that Onconetix is the accounting acquirer under U.S. GAAP. Please also revise to provide expanded disclosures as to how you determined Onconetix is the acquiring entity. In this regard, we note that upon consummation of this transaction, as well as the related Conversion and Subscription transactions, Proteomedix shareholders were to own 87.2% of the combined company.

Response: The Company respectfully acknowledges
the Staff’s comment and advises the Staff that it has amended its disclosure of page F-28 of the Registration Statement to include
the requested information.

    2

    7.
    We note that you issued 3,675,414 shares of common stock and 2,696,729 shares of series B convertible preferred stock and that you determined that the purchase price was $62.5 million. Please revise your filing to explain how you determined that the fair value of the shares exchanged in this transaction were $62.5 million. In this regard, you indicate that the 3,675,414 shares of common stock issued were valued at $1.1 million based on a per share price of $0.30. Please explain how this per share price was determined in relation to your quoted market price. Please also explain how you determined that the 2,696,729 shares of series B convertible preferred stock issued were valued at $61.3 million.

Response: The Company respectfully acknowledges
the Staff’s comment and advises the Staff that it has amended its disclosure of page 60 of the Registration Statement to include
the requested information.

    8.
    We note that you allocated $51.1 million of the purchase price to internally-developed technology with a useful life of 15 years. Please tell us and revise your filing to explain the nature of this technology, how you determined the fair value of this technology and determined its useful life.

Response: The Company respectfully
acknowledges the Staff’s comment and advises the Staff that it has amended its disclosure of page 101 of the Registration
Statement to include the requested information.

    9.
    Please identify the “Investor”  referenced in this section.

Response: The Company respectfully acknowledges
the Staff’s comment and advises the Staff that it has amended its disclosure on page 59 of the Registration Statement to include
the requested information.

    10.
    It appears that you are attempting to rely on Instruction VII to Form S-1 to incorporate by reference previously filed and future filings of Exchange Act reports. Because you have not yet filed your Form 10-K for your most recently completed fiscal year, December 31, 2023, it appears that you have not satisfied the requirements of paragraph C of that instruction. Please revise your filing to include all disclosures required by Form S-1.

Response: The Company respectfully acknowledges
the Staff’s comment and advises the Staff that the Company filed its Annual Report on Form 10-K for its most recently completed
fiscal year ended December 31, 2023 on April 11, 2024, and as such, the Company believes that the Amended Registration Statement satisfies
paragraph C of Instruction VII to Form S-1.

ENTADFI, page 9

    11.
    We note your disclosure that “[p]ursuant to the Amendment, [you] agreed to use commercially reasonable efforts to obtain such shareholder approval by December 31, 2023.” Please revise your disclosure to clarify whether or not you received shareholder approval for the issuance of shares of Common Stock upon conversion of your Series A Preferred Stock or otherwise advise. In addition, if applicable, describe any ramifications if such shareholder approval is not obtained or otherwise advise.

Response: The Company respectfully acknowledges
the Staff’s comment and advises the Staff that it has amended its disclosure on page 66 of the Registration Statement to include
the requested information.

    12.
    We note you “purchased substantially all of the assets related to Veru ENTADFI business and assumed certain liabilities of Veru.” Please revise your disclosure to describe the “certain liabilities” you assumed.

Response: The Company respectfully
acknowledges the Staff’s comment and advises the Staff that it has amended its disclosure on page 65 to remove the reference
to “certain liabilities”.

    3

 13. We
note your transaction with Veru for ENTADFI closed in April 2023. Please update your disclosure here to clarify that you have not generated
any revenue from product sales of ENTADFI consistent with your disclosure elsewhere. In addition, please update your disclosure to clarify
and quantify where you are at in “building out [y]our commercial capabilities to launch ENTADFI” or otherwise advise.

Response: The Company respectfully acknowledges
the Staff’s comment and advises the Staff that it has amended its disclosure on pages 2, 57 and 102 of the Registration Statement
to include the requested information.

Risk Factors

There is substantial doubt about our ability to continue as a
“going concern.”, page 14

    14.
    We note your disclosure that you do not currently have sufficient cash to redeem the shares of Series B Convertible Preferred Stock. Please quantify the amount of cash required to redeem the shares of Series B Convertible Preferred Stock as of a recent date.

Response: The Company respectfully acknowledges
the Staff’s comment and advises the Staff that it has amended its disclosure on page 6 of the Registration Statement to include
the requested information.

We may have violated, as amended (the “Exchange Act”)
implementing Section 402 of the Sarbanes-Oxley Act of 2002)..., page 15

    15.

    Please specify the “certain expenses”
you paid to your former CEO and Chairman, and disclose the material terms of such loans.

Response: The Company respectfully acknowledges
the Staff’s comment and advises the Staff that it has amended its disclosure on page 44 of the Registration Statement to include
the requested information.

General

    16.
    We note your acquisitions of substantially all of the assets related to Veru ENTADFI on April 19, 2023 and your acquisition of Proteomedix on December 15, 2023, as well as your disclosures that you are currently focusing your efforts on building out your commercial capabilities to launch ENTADFI in the marketplace and commercializing Proclarix. Please provide a description of your business that addresses the requirements of Item 101 of Regulation S-K.

Response: The Company respectfully acknowledges
the Staff’s comment and advises the Staff that it has amended its disclosure in the section titled “About the Company”
beginning on page 56 of the Registration Statement to include additional disclosure required by Item 101 of Regulation S-K.

    17.
    We note the reference on page 6 to your exclusive license agreement with Laboratory Corporation of America Holdings. Please describe the material terms of the agreement and file the agreement as an exhibit to the registration statement or tell us why you believe it is not a material contract. Refer to Item 601(b)(10) of Regulation S-K.

Response: The Company respectfully acknowledges
the Staff’s comment and advises the Staff that it has amended its disclosure on page 104 of the Registration Statement to include
the requested information and has filed the exclusive license agreement with Laboratory Corporation of American Holdings as Exhibit 10.55
to the Amended Registration Statement.

    18.
    Please file the employment agreement with Ralph Schiess and the severance agreements with Jon Garfield and Dr. Neil Campbell as exhibits to your registration statement or otherwise advise. Refer to Item 601(b)(10) of Regulation S-K.

Response: The Company respectfully acknowledges
the Staff’s comment and advises the Staff that it has filed the employment agreements with Ralph Schiess and the severance agreements
with Jon Garfield and Dr. Neil Campbell as Exhibits 10.21 through 10.28 to the Amended Registration Statement.

* * *

    4

We thank the Staff for its
review of this response. Should you have any questions or require any additional information, please do not hesitate to contact our legal
counsel, Jessica Yuan, Esq. of Ellenoff Grossman & Schole LLP, at jyuan@egsllp.com or by telephone at (212) 370-1300.

    Very truly yours,

    Onconetix, Inc.

    By:
    /s/ Bruce Harmon

    Name:
    Bruce Harmon

    Title:
    Chief Financial Officer

cc:     Ellenoff
Grossman & Schole LLP

5

United States securities and exchange commission logo
March 12, 2024
Ralph Schiess
Interim Chief Executive Officer
Onconetix, Inc.
201 E. Fifth Street, Suite 1900
Cincinnati, OH 45202
Re:Onconetix, Inc.
Registration Statement on Form S-1
Filed February 14, 2024
File No. 333-277066
Dear Ralph Schiess:
            We have reviewed your registration statement and have the following comments.
            Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a comment applies 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 this letter, we may have additional comments.
Registration Statement on Form S-1
Prospectus Summary, page 1
1.We note your disclosure that local diagnostic laboratories can easily add Proclarix, an
affordable multiparametric test, to their existing infrastructure. Please provide balancing
disclosure with your statement on page 17 that Proclarix is complicated and expensive to
manufacture or otherwise advise.
2.We note your disclosure that “ENTADFI will become the inaugural therapeutic drug in
[your] expanding portfolio of oncology therapeutics once launched.” However, we note
that ENTADFI appears to be approved for an indication outside of the field of oncology
and you do not describe any other oncology therapeutics approved or under development.
Please update your disclosure to describe your “expanding portfolio of oncology
therapeutics” or otherwise revise.

 FirstName LastNameRalph Schiess
 Comapany NameOnconetix, Inc.
 March 12, 2024 Page 2
 FirstName LastName
Ralph Schiess
Onconetix, Inc.
March 12, 2024
Page 2
Overview of Company, page 5
3.We note your disclosure that "In Europe, Proteomedix has begun marketing Proclarix to
pilot laboratories in selected markets that are open to self-pay to show initial adoption."
Please expand your disclosure to clarify and describe the material details of the marketing
of Proclarix to date. For example only, please revise your disclosure to describe when you
launched Proclarix and quantify how it has been accepted to date. In addition, please
clarify what "self-pay" means.
4.We note your disclosure that "Proclarix is approved for sale in the European Union under
the IVDR." Please revise your disclosure to clarify when the diagnostic was approved and
describe the specific target market for Proclarix or otherwise advise.
Recent Acquisitions:
Proteomedix, page 5
5.We note that you acquired Proteomedix AG on December 15, 2023 in a share exchange
transaction whereby the aggregate value of your exchange shares at closing was equal to
approximately $75 million less the value of the Proteomedix Shares. Please revise your
filing to include Proteomedix's audited and unaudited financial statements and related pro
forma financial statements pursuant to Rule 8-04 and Rule 8-05 of Regulation S-X similar
to those included within your amended Form 8-K filed on February 27, 2024.
6.The pro forma financial information included as Exhibit 99.3 to your amended Form 8-K
filed on February 27, 2024 indicates that that Onconetix was determined to be the
accounting acquirer in the share exchange agreement with Proteomedix. Please provide to
us your detailed analysis of the guidance at ASC 805-10-55-10 through 15 for this
transaction to explain how you determined that Onconetix is the accounting
acquirer under U.S. GAAP. Please also revise to provide expanded disclosures as to how
you determined Onconetix is the acquiring entity. In this regard, we note that upon
consummation of this transaction, as well as the related Conversion and Subscription
transactions, Proteomedix shareholders were to own 87.2% of the combined company.
7.We note that you issued 3,675,414 shares of common stock and 2,696,729 shares of series
B convertible preferred stock and that you determined that the purchase price was $62.5
million. Please revise your filing to explain how you determined that the fair value of the
shares exchanged in this transaction were $62.5 million. In this regard, you indicate that
the 3,675,414 shares of common stock issued were valued at $1.1 million based on a per
share price of $0.30. Please explain how this per share price was determined in relation to
your quoted market price. Please also explain how you determined that the 2,696,729
shares of series B convertible preferred stock issued were valued at $61.3 million.

 FirstName LastNameRalph Schiess
 Comapany NameOnconetix, Inc.
 March 12, 2024 Page 3
 FirstName LastName
Ralph Schiess
Onconetix, Inc.
March 12, 2024
Page 3
8.We note that you allocated $51.1 million of the purchase price to internally-developed
technology with a useful life of 15 years. Please tell us and revise your filing to explain
the nature of this technology, how you determined the fair value of this technology and
determined its useful life.
9.Please identify the "Investor" referenced in this section.
10.It appears that you are attempting to rely on Instruction VII to Form S-1 to incorporate by
reference previously filed and future filings of Exchange Act reports. Because you have
not yet filed your Form 10-K for your most recently completed fiscal year, December 31,
2023, it appears that you have not satisfied the requirements of paragraph C of that
instruction. Please revise your filing to include all disclosures required by Form S-1.
ENTADFI, page 9
11.We note your disclosure that "[p]ursuant to the Amendment, [you] agreed to use
commercially reasonable efforts to obtain such shareholder approval by December 31,
2023." Please revise your disclosure to clarify whether or not you received shareholder
approval for the issuance of shares of Common Stock upon conversion of your Series A
Preferred Stock or otherwise advise. In addition, if applicable, describe any ramifications
if such shareholder approval is not obtained or otherwise advise.
12.We note you "purchased substantially all of the assets related to Veru ENTADFI business
and assumed certain liabilities of Veru." Please revise your disclosure to describe the
"certain liabilities" you assumed.
13.We note your transaction with Veru for ENTADFI closed in April 2023. Please update
your disclosure here to clarify that you have not generated any revenue from product sales
of ENTADFI consistent with your disclosure elsewhere. In addition, please update your
disclosure to clarify and quantify where you are at in "building out [y]our commercial
capabilities to launch ENTADFI" or otherwise advise.
Risk Factors
There is substantial doubt about our ability to continue as a "going concern.", page 14
14.We note your disclosure that you do not currently have sufficient cash to redeem the
shares of Series B Convertible Preferred Stock. Please quantify the amount of cash
required to redeem the shares of Series B Convertible Preferred Stock as of a recent date.
We may have violated, as amended (the "Exchange Act") implementing Section 402 of the
Sarbanes-Oxley Act of 2002)..., page 15
15.Please specify the “certain expenses” you paid to your former CEO and Chairman, and
disclose the material terms of such loans.

 FirstName LastNameRalph Schiess
 Comapany NameOnconetix, Inc.
 March 12, 2024 Page 4
 FirstName LastName
Ralph Schiess
Onconetix, Inc.
March 12, 2024
Page 4
General
16.We note your acquisitions of substantially all of the assets related to Veru ENTADFI on
April 19, 2023 and your acquisition of Proteomedix on December 15, 2023, as well as
your disclosures that you are currently focusing your efforts on building out your
commercial capabilities to launch ENTADFI in the marketplace and commercializing
Proclarix. Please provide a description of your business that addresses the requirements of
Item 101 of Regulation S-K.
17.We note the reference on page 6 to your exclusive license agreement with Laboratory
Corporation of America Holdings. Please describe the material terms of the agreement file
the agreement as an exhibit to the registration statement or tell us why you believe it is not
a material contract. Refer to Item 601(b)(10) of Regulation S-K.
18.Please file the employment agreement with Ralph Schiess and the severance agreements
with Jon Garfield and Dr. Neil Campbell as exhibits to your registration statement or
otherwise advise. Refer to Item 601(b)(10) of Regulation S-K.
            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.
            Please contact Tara Harkins at 202-551-3639 or Angela Connell at 202-551-3426 if you
have questions regarding comments on the financial statements and related matters. Please
contact Jimmy McNamara at 202-551-7349 or Jason Drory at 202-551-8342 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Jessica Yuan

CORRESP
1
filename1.htm

bLUE
WATER VACCINES, Inc.

201 E. Fifth Street, Suite 1900

Cincinnati, Ohio 45202

March 14, 2023

VIA EDGAR

U.S. SECURITIES AND EXCHANGE COMMISSION

Division of Corporation Finance, Office of Life Sciences

100 F Street, N.E.

Washington, DC 20549

Attention: Tim Buchmiller

 Re: Blue Water Vaccines, Inc.

Registration Statement on Form S-3

Originally Filed March 9, 2023

File No. 333- 270383

Dear Mr. Buchmiller:

Pursuant to Rule 461 under the Securities Act of
1933, as amended, Blue Water Vaccines, Inc. (the “Company”) hereby requests acceleration of effectiveness of the above
referenced Registration Statement so that it will become effective at 5:00 p.m. Eastern Time on Thursday, March 16, 2023, or as soon as
thereafter practicable.

    Very truly yours,

    /s/ Joseph Hernandez

    Joseph Hernandez

    Chief Executive Officer

United States securities and exchange commission logo
March 13, 2023
Joseph Hernandez
Chief Executive Officer
Blue Water Vaccines Inc.
201 E. Fifth Street, Suite 1900
Cincinnati, Ohio 45202
Re:Blue Water Vaccines Inc.
Registration Statement on Form S-3
Filed March 9, 2023
File No. 333-270383
Dear Joseph Hernandez:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration.  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.
            Please contact Tim Buchmiller at (202) 551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Jessica Yuan, Esq.

CORRESP
1
filename1.htm

bLUE
WATER VACCINES, Inc.

201 E. Fifth Street, Suite 1900

Cincinnati, Ohio 45202

September 14, 2022

VIA EDGAR

U.S. SECURITIES AND EXCHANGE COMMISSION

Division of Corporation Finance, Office of Life Sciences

100 F Street, N.E.

Washington, DC 20549

Attention: Ms. Sarmento

    Re:
    Blue Water Vaccines, Inc.

Registration Statement on Form S-1

Originally Filed August 29, 2022

File No. 333-267142

Dear Ms. Sarmento:

Pursuant to Rule 461 under the Securities Act of
1933, as amended, Blue Water Vaccines, Inc. (the “Company”) hereby requests acceleration of effectiveness of the above
referenced Registration Statement so that it will become effective at 5:00 p.m. on September, 19, 2022 (the “Effective Time”).
The Company hereby grants to each of Barry I. Grossman, Esq. and Jessica Yuan, Esq. the authority to communicate to the staff of the U.S.
Securities and Exchange Commission one or more requests for any potential deferral of the Effective Time.

    Very truly yours,

    /s/ Joseph Hernandez

    Joseph Hernandez

    Chief Executive Officer

United States securities and exchange commission logo
September 7, 2022
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 August 29, 2022
File No. 333-267142
Dear Mr. Hernandez:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration.  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.
            Please contact Ada D. Sarmento at 202-551-3798 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Jessica Yan, Esq.

CORRESP
1
filename1.htm

February 11, 2022

Securities and Exchange Commission

100 F. Street, NE

Washington, D.C. 20549

    Re:
    Blue Water Vaccines, Inc.

    Registration Statement on Form S-1

    File No. 333-260137

VIA EDGAR

Ladies and Gentlemen:

Pursuant to Rule 461 of the General Rules and Regulations of the U.S.
Securities and Exchange Commission under the Securities Act of 1933, as amended, Boustead Securities, LLC, as representative of the underwriters,
hereby requests acceleration of the effective date of the above-referenced Registration Statement so that it will become effective at
5:00 p.m., Washington D.C. time, on Friday, February 11, 2022, or as soon thereafter as practicable.

Pursuant to Rule 460 under the Act, we wish to
advise you that the underwriters have distributed as many copies of the Preliminary Prospectus dated February 8, 2022 to underwriters,
dealers, institutions and others as appears to be reasonable to secure adequate distribution of the Preliminary Prospectus.

The undersigned confirms that it has complied with and will continue
to comply with, and it has been informed or will be informed by participating dealers that they have complied with or will comply with,
Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection with the above-referenced issue.

[Signature Page Follows]

    Boustead Securities, LLC

    By:
    /s/ Keith Moore

    Name:
    Keith Moore

    Title:
    CEO

CORRESP
1
filename1.htm

bLUE
WATER VACCINES, Inc.

201 E. Fifth Street, Suite 1900

Cincinnati, Ohio 45202

February 11, 2022

VIA EDGAR

U.S. SECURITIES AND EXCHANGE COMMISSION

Division of Corporation Finance

100 F Street, N.E.

Washington, DC 20549

Attention: Ms. Lauren Hamill and Ms. Celeste Murphy

    Re:
    Blue Water Vaccines, Inc.

    Registration Statement on Form S-1

    October 8, 2021

    File No. 333-260137

Dear Ms. Hamill and Ms. Murphy:

Pursuant to Rule 461 under the Securities Act of
1933, as amended, Blue Water Vaccines, Inc. (the “Company”) hereby requests acceleration of effectiveness of the above
referenced Registration Statement so that it will become effective at 5:00 p.m. on Friday, February 11, 2022 (the “Effective
Time”). The Company hereby grants to each of Barry I. Grossman, Esq. and Jessica Yuan, Esq. the authority to communicate to
the staff of the U.S. Securities and Exchange Commission one or more requests for any potential deferral of the Effective Time.

    Very truly yours,

    /s/ Joseph Hernandez

    Joseph Hernandez

    Chief Executive Officer

CORRESP
1
filename1.htm

VIA EDGAR

December 13, 2021

U.S. Securities & Exchange Commission

Division of Corporation Finance

Office of Energy & Transportation

100 F Street, NE

Washington, D.C. 20549

Attn: Ms. Lauren Hamill and Ms. Celeste Murphy

 Re: Blue Water Vaccines Inc.

Amendment No. 2 to Registration Statement
on Form S-1

Filed November 29, 2021

File No. 333-260137

Dear Ms. Hamill and Ms. Murphy:

Blue Water Vaccines Inc. (the
“Company,” “we,” “our” or “us”) hereby transmits the Company’s
response to the comment letter received from the staff (the “Staff”) of the U.S. Securities and Exchange Commission
(the “Commission”) on December 9, 2021, regarding Registration Statement on Form S-1.

For the Staff’s convenience,
we have repeated below the Staff’s comments in bold, and have followed each comment with the Company’s response.

Amendment No. 2 to Form S-1

Our Vaccine Program, page 82

1. We note your responses to both prior comment 3 and to the
first bullet in comment 6 issued in the staff’s letter dated November 4, 2021. We reissue such comments and reiterate that
there are still numerous instances throughout the prospectus, specifically from pages 86-101, where information presented in your
tables and figures appears to be printed in much smaller type than the surrounding text. Even with enhanced pixilation, such text is
not easily legible. Revise the formatting in your graphics to use font size that is clearly readable without the need for
magnification.

In response to the Staff’s comment, we have
revised the information presented in our tables and figures from pages 86-101 of the S-1 to revise the formatting in our graphics to use
font size that is clearly readable without the need for magnification

Participation in this Offering, page 146

2. We note your disclosure on the cover page and here that certain
existing stockholders and their affiliates have indicated an interest to purchase up to a specific amount of common stock in the offering
at the initial public offering price. We also note your disclosure that such stockholders may decide to purchase more than the amount
for which they indicated an interest in buying. We have the following comments:

● With reference to Item 501 of Regulation S-K, please
tell us how you determined that such potential purchase information is so significant to an investment decision that it should be
referenced on the prospectus cover page.

In response to the Staff’s comment, we
have clarified the disclosure to indicate that Great American Insurance Company and its affiliates may purchase up to $1.5 million
in the offering. Because such amount could result in Great American Insurance Company and its affiliates owning over 5% of the
post-closing company, we believe such information is material to a potential investor’s investment decision with respect to
the offering and should be referenced on the prospectus cover page. Pursuant to Item 501 of Regulation S-K, we have also revised the
disclosure on the prospectus cover page to indicate that the underwriters will receive a reduced fee on any sales of common stock to
Great American Insurance Company and its affiliates in this offering.

● In the new section on page 146, please identify the
existing stockholders and their affiliated entities, other than Great American Insurance Company, that have indicated an interest in
purchasing securities in this offering. Also tell us the aggregate dollar amount or the number of offered securities that each
stockholder or affiliated entity has indicated an interest in purchasing.

In response to the Staff’s comment, we have revised the
disclosure on page 146 to clarify that only one existing stockholders and its affiliated entities, Great
American Insurance Company, has indicated an interest in purchasing securities in this offering. We have also indicated the aggregate
dollar amount or the number of offered securities that such stockholder or affiliated entity has indicated an interest in purchasing.

● So that investors will be able to understand the
minimum amount of your shares that will enter the public market through sales to the public, as opposed to the existing
stockholders, please disclose in the new section on page 146 whether there is a ceiling on the amount that may be purchased by
existing stockholders and quantify any ceiling. If not, please disclose the potential material impact on public investors.

In response to the Staff’s comment, we have
revised the disclosed on page 146 to include the ceiling on the amount that may be purchased by existing stockholders and quantify any
ceiling.

● If the existing stockholders and/or their affiliated
entities are reflected in the beneficial ownership table on page 145, please disclose under the Principal Stockholders section the
expected percentage ownership if the stockholder does purchase common stock in this offering as their indication of interest
reflects. Additionally, please tell us whether these indications of interest could result in a stockholder that is not currently
included in the table on page 145 beneficially owning more than 5% of your outstanding shares following the offering.

In response to the Staff’s comment, we
have revised the disclosure in the S-1 to include the expected percentage ownership if Great American Insurance Company and its affiliates does purchase common
stock in this offering as their indication of interest reflects. We have also included these indications of interest could
result in a stockholder that is not currently included in the table on page 145 beneficially owning more than 5% of your outstanding
shares following the offering.

    2

● We note your disclosure that any of the existing
stockholders or their affiliates that have indicated an interest in buying shares in the offering may determine to purchase more,
fewer or no shares in this offering. If material, please revise your risk factors to describe how such developments would relate to
the offering. In this regard, we note the risk factor on page 53 describing the concentration of stock ownership by your principal
stockholders and management of the company.

In response to the Staff’s comment, we have
revised the risk factor on page 53 to describe how such developments would relate to the offering.

Item 16. Exhibits and Financial Statement Schedules, page II-3

3. We note that your exhibit index key to Amendment No. 2 has
been revised to indicate that Exhibit 24.1, Power of Attorney, was “previously filed.” In this regard, it appears your
POA was included on the signature page of your S-1 filed on October 8, 2021. As Applicable, in your next amendment, please revise
your index key to include a reference to the part of the registration statement containing the power of attorney. Refer to Item
601(b)(24) of Regulation S-K.

In response to the Staff’s comment, we have
revised the index key to include a reference to the part of the registration statement containing the power of attorney.

We thank the Staff for its
review of the foregoing. If you have further comments, please feel free to contact our counsel, Jessica Yuan, at jyuan@egsllp.com or by
telephone at (212) 370-1300.

    Sincerely,

    /s/ Joseph Hernandez

    Joseph Hernandez

    Chief Executive Officer

    cc:
    Jessica Yuan, Esq.

3

United States securities and exchange commission logo
December 9, 2021
Joseph Hernandez
Chief Executive Officer
Blue Water Vaccines Inc.
201 E. Fifth Street, Suite 1900
Cincinnati, OH 45202
Re:Blue Water Vaccines Inc.
Amendment No. 2 to Registration Statement on Form S-1
Filed November 29, 2021
File No. 333-260137
Dear Mr. Hernandez:
            We have reviewed your amended 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 November 18, 2021 letter.
Amendment No. 2 to Form S-1
Our Vaccine Program, page 82
1.We note your responses to both prior comment 3 and to the first bullet in comment 6
issued in the staff's letter dated November 4, 2021. We reissue such comments
and reiterate that there are still numerous instances throughout the prospectus, specifically
from pages 86-101, where information presented in your tables and figures appears to
be printed in much smaller type than the surrounding text.   Even with enhanced
pixilation, such text is not easily legible.  Revise the formatting in your graphics to use a
font size that is clearly readable without the need for magnification.
Participation in this Offering, page 146

 FirstName LastNameJoseph Hernandez
 Comapany NameBlue Water Vaccines Inc.
 December 9, 2021 Page 2
 FirstName LastName
Joseph Hernandez
Blue Water Vaccines Inc.
December 9, 2021
Page 2
2.We note your disclosure on the cover page and here that certain existing stockholders and
their affiliates have indicated an interest to purchase up to a specific amount of common
stock in the offering at the initial public offering price. We also note your disclosure that
such stockholders may decide to purchase more than the amount for
which they indicated an interest in buying. We have the following comments:
•With reference to Item 501 of Regulation S-K, please tell us how you determined that
such potential purchase information is so significant to an investment decision that it
should be referenced on the prospectus cover page.
•In the new section on page 146, please identify the existing stockholders and their
affiliated entities, other than Great American Insurance Company, that have indicated
an interest in purchasing securities in this offering.  Also tell us the aggregate dollar
amount or the number of offered securities that each stockholder or affiliated
entity has indicated an interest in purchasing.
•So that investors will be able to understand the minimum amount of your shares that
will enter the public market through sales to the public, as opposed to the existing
stockholders, please disclose in the new section on page 146 whether there is a
ceiling on the amount that may be purchased by existing stockholders and quantify
any ceiling. If not, please disclose the potential material impact on public investors.
•If the existing stockholders and/or their affiliated entities are reflected in the
beneficial ownership table on page 145, please disclose under the Principal
Stockholders section the expected percentage ownership if the stockholder does
purchase common stock in this offering as their indication of interest
reflects. Additionally, please tell us whether these indications of interest could result
in a stockholder that is not currently included in the table on page 145 beneficially
owning more than 5% of your outstanding shares following the offering.
•We note your disclosure that any of the existing stockholders or their affiliates that
have indicated an interest in buying shares in the offering may determine to purchase
more, fewer or no shares in this offering. If material, please revise your risk factors to
describe how such developments would relate to the offering.  In this regard, we note
the risk factor on page 53 describing the concentration of stock ownership by your
principal stockholders and management of the company.
Item 16. Exhibits and Financial Statement Schedules, page II-3
3.We note that your exhibit index key to Amendment No. 2 has been revised to indicate that
Exhibit 24.1, Power of Attorney, was "previously filed."  In this regard, it appears your
POA was included on the signature page of your S-1 filed on October 8, 2021.  As
applicable in your next amendment, please revise your index key to include a reference to
the part of the registration statement containing the power of attorney.  Refer to Item
601(b)(24) of Regulation S-K.

 FirstName LastNameJoseph Hernandez
 Comapany NameBlue Water Vaccines Inc.
 December 9, 2021 Page 3
 FirstName LastName
Joseph Hernandez
Blue Water Vaccines Inc.
December 9, 2021
Page 3
            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,
Division of Corporation Finance
Office of Life Sciences
cc:       Jessica Yuan

CORRESP
1
filename1.htm

VIA EDGAR

November 29, 2021

U.S. Securities & Exchange Commission

Division of Corporation Finance

Office of Energy & Transportation

100 F Street, NE

Washington, D.C. 20549

Attn: Ms. Lauren Hamill and Ms. Celeste Murphy

    Re:
    Blue Water Vaccines Inc.

    Registration Statement on Form S-1

    Filed on November 5, 2021

    File No. 333-260137

Dear Ms. Hamill and Ms. Murphy:

Blue Water Vaccines Inc. (the
“Company,” “we,” “our” or “us”) hereby transmits the Company’s
response to the comment letter received from the staff (the “Staff”) of the U.S. Securities and Exchange Commission
(the “Commission”) on November 18, 2021, regarding Amendment 1 to the Company’s Registration Statement on Form
S-1 (the “Registration Statement”).

For the Staff’s convenience,
we have repeated below the Staff’s comments in bold, and have followed each comment with the Company’s response. Disclosure
changes made in response to the Staff’s comments have been made in Amendment 2 to the Registration Statement (the “Amendment
2”), which is being filed with the Commission contemporaneously with the filing of this letter.

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.

In response to the Staff’s comment, the
Company recognizes the requirement to submit revised financial statements to reflect the stock split prior to effectiveness of the
registration statement.  The Company’s board of directors approved the stock split on November 24, 2021, and the Company
has now retrospectively reflected the stock split in the Company’s historical financial statements, and has revised the
disclosures as requested throughout Amendment No. 2 to Form S-1.

 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.

In response to the Staff’s comment, the Company’s
independent auditor considered the Company’s board of directors’ approval of the stock split, which took place on November
24, 2021, to be the event that required reflecting the stock split in the Company’s historical financial statements and the dual-dating
of their audit opinion.  The Company has revised the financial statements to reflect the stock split, as referenced in Comment #1
above, and the auditors have dual-dated their audit opinion accordingly.

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.

In response to the Staff’s comment, we have
revised the disclosure of the amended S-1 on pages 86 (footnote corresponding to Table 2), 90 and 91 of Amendment 2 to increase the font
size of the corresponding citations.

 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 xaxis references to “vaccine” are to BHN97DftsY, and if true, whether this is the strain
corresponding to BWV-201.

In response to the Staff’s comment, we have
revised the disclosure on pages 94 and 95 of Amendment 2 to further clarify the nomenclature used in Figures 7 and 8 corresponding to
the vaccine names used in the narrative disclosure. Further, we have clarified the nomenclature in the figure descriptions corresponding
to Figures and 7 and 8.

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.

 ● 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.”

In response to the Staff’s comment, we have
revised the disclosure on pages 120 to 125 of Amendment 2 to quantify the above-referenced information.

 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.

In response to the Staff’s comment, we have
revised the disclosure on page 123 of Amendment No. 2 to provide the highest minimum sum of royalties that must be paid to OUI in any
year before application of the “step down” and the number of years over which the step-down will apply.

    2

We thank the Staff for its
review of the foregoing. If you have further comments, please feel free to contact our counsel, Jessica Yuan, at jyuan@egsllp.com or by
telephone at (212) 370-1300.

    Sincerely,

    /s/ Joseph Hernandez

    Joseph Hernandez

    Chief Executive Officer

    cc:
    Jessica Yuan, Esq.

3

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.

 FirstName LastNameJoseph Hernandez
 Comapany NameBlue Water Vaccines Inc.
 November 18, 2021 Page 2
 FirstName LastNameJoseph Hernandez
Blue Water Vaccines Inc.
November 18, 2021
Page 2
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.

 FirstName LastNameJoseph Hernandez
 Comapany NameBlue Water Vaccines Inc.
 November 18, 2021 Page 3
 FirstName LastName
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,
Division of Corporation Finance
Office of Life Sciences
cc:       Jessica Yuan

CORRESP
1
filename1.htm

VIA
EDGAR

November
4, 2021

U.S.
Securities & Exchange Commission

Division
of Corporation Finance

Office
of Energy & Transportation

100
F Street, NE

Washington,
D.C. 20549

Attn:
Ms. Lauren Hamill and Ms. Celeste Murphy

 Re: Blue
Water Vaccines Inc.

Registration
Statement on Form S-1

Filed
October 8, 2021

File
No. 333-260137

Dear
Ms. Hamill and Ms. Murphy:

Blue
Water Vaccines Inc. (the “Company,” “we,” “our” or “us”)
hereby transmits the Company’s response to the comment letter received from the staff (the “Staff”) of the U.S.
Securities and Exchange Commission (the “Commission”) on October 21, 2021, regarding Registration Statement on Form
S-1.

For
the Staff’s convenience, we have repeated below the Staff’s comments in bold, and have followed each comment with the Company’s
response.

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 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.

In
response to the Staff’s comment, we have revised the pipeline figure on pages 2, 66 and 80 of the amended S-1 to indicate that
all pipeline projections are contingent upon obtaining funding from the contemplated offering.

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.

In
response to the Staff’s comment, we have revised the Risk Factor disclosure on page 52 and Use of Proceeds disclosure on page 58
to further illuminate potential outcomes warranting reallocation of proceeds and clarifying that we expect to use the net proceeds from
this offering, together with our existing cash and cash equivalents, to advance the development of our preclinical product candidates
and to fund working capital, including general operating expenses. Further to your comment, we have edited the referenced sections to
provide consistent disclosure.

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 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.

In
response to the Staff’s comment, we note that the referenced disclosure has been updated to reflect outstanding shares as of October
31, 2021. The number of shares of common stock into which the preferred stock will be converted was determined by multiplying the existing
number of shares of preferred stock (1,146,138) by the conversion ratio, which is obtained by adding the accrued dividends as of October
31, 2021, to the initial issue price of $6.09.

    2

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.

In
response to the Staff’s comment, we have revised the disclosure on pages 10, 53, 63 and 144 of the amended S-1. As mentioned in
our previous communication, pursuant to a consent dated October 7, 2021, holders of all of the outstanding shares of preferred stock
have consented to an optional conversion pursuant to Section 4 of our amended and restated certificate of incorporation which was adopted
on July 1, 2019. The numbers included in the amended S-1 also account for the Pre-IPO Stock Split which is summarized in the Summary
section of the S-1 on page 8 of the amended S-1.

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.

In
response to the Staff’s comment, we have revised the disclosure on pages 86 of the amended S-1. We have removed the word potent
from the disclosure.

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.

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 didin
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.

    3

In
response to the Staff’s comment, we have revised the disclosure on pages 83, 84, 85, 86, 88, 89, 90, 91, 95, 96, 98, and 99 of
the amended S-1 to ensure tables and graphics included in the S-1 are legible.

In
response to the Staff’s comment, we have revised the disclosure page 83 and 84 of the amended S-1 to clarify what Table 1 is intended
to reflect. Further, we have revised the disclosure to tie to the disclosure above Table 1.

In
response to the Staff’s comment, we have revised the disclosure on pages 83, 84, 85, 86, 88, 89, 90, 91, 95, 96, 98, 99, and 102
of the amended S-1 to renumber the tables and figures throughout the disclosure for greater understanding and avoidance of confusion.

In
response to the Staff’s comment, we have revised the disclosure on page 83 and 85 of the amended S-1 to clarify what Table 2 is
intended to reflect. Further, we have revised the disclosure to tie to the disclosure above Table 2.

In
response to the Staff’s comment, we have revised the disclosure on page 86 of the amended S-1 to provide the footnote citations
for Table 2.

In
response to the Staff’s comment, we have revised the disclosure on page 86 of the amended S-1 to provide clarification of the “ND”
column label in the footnote to Table 2.

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.

In
response to the Staff’s comment, we have revised the disclosure on page 95 of the amended S-1. We have added language to Figure
7 (Formerly Figure A) further clarifying the information presented.

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 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

    4

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

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

 FirstName LastNameJoseph Hernandez
 Comapany NameBlue Water Vaccines Inc.
 October 21, 2021 Page 2
 FirstName LastNameJoseph Hernandez
Blue Water Vaccines Inc.
October 21, 2021
Page 2
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

 FirstName LastNameJoseph Hernandez
 Comapany NameBlue Water Vaccines Inc.
 October 21, 2021 Page 3
 FirstName LastNameJoseph Hernandez
Blue Water Vaccines Inc.
October 21, 2021
Page 3
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.

 FirstName LastNameJoseph Hernandez
 Comapany NameBlue Water Vaccines Inc.
 October 21, 2021 Page 4
 FirstName LastNameJoseph Hernandez
Blue Water Vaccines Inc.
October 21, 2021
Page 4
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-

 FirstName LastNameJoseph Hernandez
 Comapany NameBlue Water Vaccines Inc.
 October 21, 2021 Page 5
 FirstName LastNameJoseph Hernandez
Blue Water Vaccines Inc.
October 21, 2021
Page 5
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.

 FirstName LastNameJoseph Hernandez
 Comapany NameBlue Water Vaccines Inc.
 October 21, 2021 Page 6
 FirstName LastName
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

CORRESP
1
filename1.htm

VIA
EDGAR

October
8, 2021

U.S.
Securities & Exchange Commission

Division
of Corporation Finance

Office
of Energy & Transportation

100
F Street, NE

Washington,
D.C. 20549

Attn:
Ms. Mary Mast and Ms. Tara Harkins

 Re: Blue
Water Vaccines Inc.

    Draft Registration Statement on Form
                                            S-1

    Submitted on August 23, 2021

    CIK No. 000178210

Dear
Ms. Mast and Ms. Harkins:

Blue
Water Vaccines Inc. (the “Company,” “we,” “our” or “us”)
hereby transmits the Company’s response to the comment letter received from the staff (the “Staff”) of the U.S.
Securities and Exchange Commission (the “Commission”) on September 17, 2021, regarding Draft Registration Statement
on Form S-1.

For
the Staff’s convenience, we have repeated below the Staff’s comments in bold, and have followed each comment with the Company’s
response. Disclosure changes made in response to the Staff’s comments have been made in the Registration Statement (the “Registration
Statement”), which is being filed with the Commission contemporaneously with the filing of this letter. Page numbers referred
to in the responses reference the applicable pages of the Registration Statement.

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 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.

In response to the Staff’s comment, we have revised the disclosure
on pages 8 and 24 of the updated S-1. We included an additional Risk Factor and updated the summary risk disclosure accordingly. We have
also added disclosure relating to pediatric approval in our discussion of regulatory matters in the Business Section on page 103 of the
updated S-1. We respectfully note to the Staff that our BWV-201 (S. pneumoniae) vaccine platform is currently specifically intended
for pediatrics.

 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 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.

We
respectfully note that the below paragraphs correspond to the bullet notations in the Staff’s comments.

In response to the Staff’s comment, we have revised the disclosure
on pages 1 and 76 of the updated S-1. We revised the unqualified and conclusory statements with more appropriate language and certain
statements to make it clear that the safety and efficacy of our candidates, platforms, or technologies are not determined.

    2

In response to the Staff’s comment,
we have revised the disclosure on pages 1 and 76 of the updated S-1. We revised the unqualified and conclusory statements with more appropriate
language and certain statements to make it clear that the safety and efficacy of our candidates, platforms, or technologies are not determined.

In response to the Staff’s comment,
we have revised the disclosure on pages 3 and 79 of the updated S-1. We revised the language to indicate efficacy on animal subjects and
included reference to a study which supports the statement made.

In response to the Staff’s comment,
we have revised the disclosure on page 80 of the updated S-1. We revised the language to indicate that this practice ‘may’
be safer and have lower manufacturing costs.

In response to the Staff’s comment,
we have revised the disclosure on page 80 of the updated S-1. We revised the language to indicate that such VLPs and capsid-like nanoparticles
‘may’ be excellent vaccine candidates.

In response to the Staff’s comment,
we have revised the disclosure on page 80 of the updated S-1. We revised the language to indicate efficacy on animal subjects.

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.”

In
response to the Staff’s comment, we have revised the disclosure on pages 2 and 79 of the S-1.

We revised the referenced language on
pages 2 and 79 to indicate that the company believes it is able to design and create novel vaccines.

We revised the referenced language on
pages 3 and 79 to indicate that we are potentially able to reduce the cost and time to manufacture a vaccine candidate.

We revised the referenced language on
pages 3 and 79 to indicate efficacy on animal subjects.

    3

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 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 preclinical 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.

In response to the Staff’s comment,
we have revised our pipeline chart on pages 2, 63 and 77 of the updated S-1 to (i) add Phase I, Phase II and Phase III, (ii) combine the
“Discovery” and “Optimization” columns.

In response to the Staff’s comment, we have revised the disclosure
on page 3 of the updated S-1. We included further discussion of BWV-302 in the Business section of the updated S-1, beginning on page
95.

In response to the Staff’s comment, we respectfully note that
as set forth in our prospectus summary on page 4 of the updated S-1, our existing cash and the proceeds of the offering will be sufficient
for at least 12 months following the closing of the offering. As such, our pipeline projections included in the S-1 assume the obtaining
of funding from the offering.

    4

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.

In response to the Staff’s comment, we have revised the disclosure
on page 3 of the updated S-1. We included further discussion of BWV-302 in the Business section of the updated S-1, beginning on page
95.

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 him working for your company on a part-time basis. Please also make
                                            conforming revisions to your Risk Factor disclosure as appropriate.

In response to the Staff’s comment, we have revised the disclosure
on pages 5, 35 and 78 of the updated S-1 to discuss certain conflicts of interest related to Mr. Hernandez’s outside business interests.
We respectfully note that Mr. Hernandez works for us on a full-time basis.

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;”

    5

 ● 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.

In response to the Staff’s comment,
we have revised the disclosure on pages 2 and 79 of the updated S-1. We have included language that states the potential for reducing
cost and time to market traditional vaccines.

In response to the Staff’s comment,
we have revised the disclosure on page 4 and 77 of the updated S-1. We have elaborated on how the Company can leverage pre-clinical and
clinical experience to accelerate the development of BWV-101.

In response to the Staff’s comment,
we have revised the disclosure on page 4 and 77 of the updated S-1. We have elaborated on how the Company can leverage pre-clinical and
clinical experience to accelerate the development of BWV-101.

In response to the Staff’s comment,
we have revised the disclosure on page 85 of the updated S-1. We have included support derived from a study and provided reference to
the study as further substantiation.

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 tru

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

 FirstName LastNameJoseph Hernandez
 Comapany NameBlue Water Vaccines Inc.
 September 17, 2021 Page 2
 FirstName LastNameJoseph Hernandez
Blue Water Vaccines Inc.
September 17, 2021
Page 2
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

 FirstName LastNameJoseph Hernandez
 Comapany NameBlue Water Vaccines Inc.
 September 17, 2021 Page 3
 FirstName LastNameJoseph Hernandez
Blue Water Vaccines Inc.
September 17, 2021
Page 3
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

 FirstName LastNameJoseph Hernandez
 Comapany NameBlue Water Vaccines Inc.
 September 17, 2021 Page 4
 FirstName LastNameJoseph Hernandez
Blue Water Vaccines Inc.
September 17, 2021
Page 4
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.

 FirstName LastNameJoseph Hernandez
 Comapany NameBlue Water Vaccines Inc.
 September 17, 2021 Page 5
 FirstName LastNameJoseph Hernandez
Blue Water Vaccines Inc.
September 17, 2021
Page 5
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.

 FirstName LastNameJoseph Hernandez
 Comapany NameBlue Water Vaccines Inc.
 September 17, 2021 Page 6
 FirstName LastNameJoseph Hernandez
Blue Water Vaccines Inc.
September 17, 2021
Page 6
•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 w