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Item 9A. Controls and Procedures

2024-04-11 compared with 2023-03-09 · 3689 added, 2812 removed, 311 unchanged (95% of the section changed)

This section is long enough that the comparison stopped early. What follows is partial, and the remainder is not necessarily unchanged.

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Evaluation of Disclosure Controls and Procedures

The Sarbanes-Oxley Act requires, among other things,

that we maintain effective disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)) that are designed to ensure

that information required to be disclosed by us in reports we file or submit under the Securities Exchange Act of 1934, as amended, is

recorded, processed, summarized and reported within the appropriate time periods, and that such information is accumulated and communicated

to the Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely discussions regarding required disclosure.

Management’s Annual Report on Internal Control Over Financial Reporting

The Sarbanes-Oxley Act requires,

among other things, that we maintain effective disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)) that are

designed to ensure that information required to be disclosed by us in reports we file or submit under the Securities Exchange Act of 1934,

as amended, is recorded, processed, summarized and reported within the appropriate time periods, and that such information is accumulated

and communicated to the Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely discussions regarding required

Our management, with the participation of our Chief Executive Officer and Chief

Financial Officer has evaluated the effectiveness of our disclosure controls and procedures.

Management recognizes that any controls and

procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management

necessarily applies its judgment in evaluating the cost benefit relationship of possible controls and procedures.

Based on that evaluation,

our Chief Executive Officer and Chief Financial Officer have concluded that the Company’s disclosure controls and procedures were

not effective as of December 31, 2023, as a result of the material weaknesses described below.

Management’s Annual Report on Internal

Control Over Financial Reporting

Our management is responsible

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in Internal Control-Integrated Framework (2013 framework).

Based on our assessment

under the framework in Internal Control—Integrated Framework (2013 framework), our management concluded that our internal control

over financial reporting was not effective as of December 31, 2022 due to the existence of material weaknesses described below.

A material weakness in

internal control is a deficiency in internal control, or combination of control deficiencies, that adversely affects the Company’s

ability to initiate, authorize, record, process, or report external financial data reliably in accordance with GAAP such that there is

more than a remote likelihood that a material misstatement of the Company’s annual or interim financial statements will not be prevented

Material Weaknesses in Internal Control Over Financial Reporting

In connection with the audit of our financial statements

for the year ended December 31, 2022 and 2021, we and our independent registered public accounting firm identified material weaknesses

in our internal control over financial reporting.

The material weaknesses identified are as follows:

We failed to employ a sufficient number of staff to maintain optimal segregation of duties and to provide optimal levels of oversight in order to process financial information in a timely manner, analyze and account for complex, non-routine transactions, and prepare financial statements.

We do not yet have adequate internal controls in place for the timely identification, approval or reporting of related party transactions.

material weaknesses did not result in a material misstatement of our previously issued financial statements, however, it could result

in a misstatement of our account balances or disclosures that would result in a material misstatement of our annual or interim financial

statements that would not be prevented or detected.

We have developed a remediation plan for these material weaknesses which is

described below in Remediation of Material Weaknesses .

Based on our assessment under

the framework in Internal Control-Integrated Framework (2013 framework), our management concluded that our internal control over financial

reporting was not effective as of December 31, 2023, due to the existence of the material weaknesses described below.

A material weakness in internal

control is a deficiency in internal control, or combination of control deficiencies, that adversely affects the Company’s ability

to initiate, authorize, record, process, or report external financial data reliably in accordance with GAAP such that there is more than

a remote likelihood that a material misstatement of the Company’s annual or interim financial statements will not be prevented or

Material Weaknesses

in Internal Control Over Financial Reporting

In September 2023,

after a review completed by the Audit Committee, it was determined that our former CEO and an accounting employee charged certain personal

expenses on their corporate credit cards that were not recorded as related party receivables.

The aggregate amount of such unauthorized

charges ranged from approximately (i) $257,000 to $405,000 for all of 2022, (ii) $86,000 to $122,000 for the quarter ended March 31, 2023,

and (iii) $79,000 to $150,000 for the quarter ended June 30, 2023.

These unauthorized charges, in addition to personal charges that were

identified as such in previous reporting periods, may have constituted personal loans that are not permissible under Section 402 of the

Sarbanes-Oxley Act of 2002.

The accounting employee was also the CEO’s assistant and had roles in the Company’s system of

internal control over financial reporting, including controls relating to the Company’s corporate credit cards.

We determined that

this credit card misuse arose from the following control deficiencies, which we have determined to be material weaknesses as of December

● We did not maintain an effective

control environment as there was an inadequate segregation of duties with respect to certain cash disbursements.

The processing and the

approval for payment of credit card transactions and certain bank wires were being handled by the CEO and an accounting employee, and

the accounting employee was responsible for the reconciliation of credit card statements and bank statements.

This allowed these individuals

to submit unauthorized payments to unauthorized third parties.

do not have an effective risk assessment process and effective monitoring of compliance with established accounting policies and procedures,

and do not demonstrate a sufficient level of precision in the application of our controls.

● Our controls over the approval

and reporting of expenses paid with the Company’s credit cards and certain bank wires were not designed and maintained to achieve

the Company’s objectives.

have insufficient accounting resources to maintain adequate segregation of duties, maintain adequate controls over the approval and posting

of journal entries, and to provide optimal levels of oversight in order to process financial information in a timely manner, analyze

and account for complex, non-routine transactions, and prepare financial statements.

● We do not yet have adequate

internal controls in place for the timely identification, approval or reporting of related party transactions.

The Company did not design, implement and maintain

effective controls to ensure information technology (“IT”) policies and procedures set the tone at the top, to mitigate the

risks to the achievement of IT objectives and ITGCs in the change management, logical security and computer operations domains.

Specifically,

the design and implementation of user authentication, user access privileges, data backup and data recovery controls as well as the monitoring

controls of excessive user access and elevated privileged access to financial applications and data were not appropriately designed and

In addition, these inadequate ITGC controls combined with the use of personal devices to conduct business, can lead to an

IT control environment vulnerable to breaches and social engineering persuasion.

Individually, these deficiencies were evaluated as

representing a more than remote likelihood that a misstatement that is more than inconsequential, but, less than material, could occur.

However, each of these deficiencies affects the same set of accounts.

Taken together, these deficiencies represent a more than remote

likelihood that a material misstatement could occur and not be prevented or detected.

Therefore, in combination and on the aggregate,

these deficiencies represent a material weakness.

The above material weaknesses

did not result in a material misstatement of our previously issued financial statements but could have resulted in material misstatements

of our account balances or disclosures of our annual or interim financial statements that would not be prevented or detected.

developed a remediation plan for these material weaknesses which is described below in Remediation of Material Weaknesses .

Remediation of Material Weaknesses

We are committed to maintaining a strong internal control environment

and implementing measures designed to help ensure that the material weaknesses are remediated as soon as possible.

We believe we have

made progress towards remediation and continue to implement our remediation plan for the material weaknesses, which includes steps to

increase dedicated qualified personnel including financial consultants, improve reporting processes, and design and implement new controls.

We have also implemented a related party transactions approval policy which our Board of Directors approved on June 24, 2022.

we have designed certain controls surrounding the identification, approval and reporting of related party transactions, which we expect

to implement in 2023.

We will consider the material weaknesses remediated after the applicable controls operate for a sufficient period

of time, and management has concluded, through testing, that the controls are operating effectively.

The process of designing and implementing an effective

accounting and financial reporting system is a continuous effort that requires us to anticipate and react to changes in our business and

the economic and regulatory environments and to expend significant resources to maintain an accounting and financial reporting system

that is adequate to satisfy our reporting obligations.

As we continue to evaluate and take actions to improve our internal control over

financial reporting, we may determine to take additional actions to address control deficiencies or determine to modify certain of the

remediation measures described above.

We cannot assure you that the measures we have taken to date, or any measures we may take in the

future, will be sufficient to remediate the material weakness we have identified or avoid potential future material weaknesses.

We are committed to maintaining

a strong internal control environment and implementing measures designed to help ensure that the material weaknesses are remediated as

soon as possible.

We believe we have made progress towards remediation and continue to implement our remediation plan for the material

weaknesses, which includes steps to increase dedicated qualified personnel including financial consultants, improve reporting processes,

and design and implement new controls.

Further, following the credit card misuse discussed above, management has designed and begun to

implement the following remediation plan:

● Terminated the accounting employee

involved in the misuse and reassigned such employee’s roles and responsibilities regarding impacted control activities.

● Implemented a travel, entertainment,

and gift policy, which our Board approved on August 31, 2023.

● Implement a formal information

security policy.

● Review and update, as necessary,

the design and operation of our process level and transaction level controls for cash disbursements, credit card transactions, and journal

Implement enhanced approval policies.

We will consider the

material weaknesses remediated after the applicable controls operate for a sufficient period of time, and management has concluded, through

testing, that the controls are operating effectively.

The process of designing

and implementing an effective accounting and financial reporting system is a continuous effort that requires us to anticipate and react

to changes in our business and the economic and regulatory environments and to expend significant resources to maintain an accounting

and financial reporting system that is adequate to satisfy our reporting obligations.

As we continue to evaluate and take actions to improve

our internal control over financial reporting, we may determine to take additional actions to address control deficiencies or determine

to modify certain of the remediation measures described above.

We cannot assure you that the measures we have taken to date, or any measures

we may take in the future, will be sufficient to remediate the material weakness we have identified or avoid potential future material

Inherent Limitation

on the Effectiveness of Internal Control Processes

Our management, including our Chief Executive Officer

and Chief Financial Officer, does not expect that our disclosure controls or our internal control over financial reporting will prevent

all errors and all fraud.

A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance

that the objectives of the control system are met.

Because of the inherent limitations in all control systems, no evaluation of controls

can provide absolute assurance that all control issues and instances of fraud, if any, have been detected.

These inherent limitations

include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake.

Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management

override of the controls.

The design of any system of controls is also based in part upon certain assumptions about the likelihood of

future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions;

over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may

Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and

not be detected.

Our management, including

our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls or our internal control over financial

reporting will prevent all errors and all fraud.

A control system, no matter how well designed and operated, can provide only reasonable,

not absolute, assurance that the objectives of the control system are met.

Because of the inherent limitations in all control systems,

no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected.

inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a

simple error or mistake.

Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more

people or by management override of the controls.

The design of any system of controls is also based in part upon certain assumptions

about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under

all potential future conditions;

over time, controls may become inadequate because of changes in conditions, or the degree of compliance

with policies or procedures may deteriorate.

Because of the inherent limitations in a cost-effective control system, misstatements due

to error or fraud may occur and not be detected.

Management’s Report on Internal Control over Financial Reporting

This Annual Report on Form 10-K does not include

an attestation report of our registered public accounting firm regarding internal control over financial reporting.

Our auditors will

not be required to formally opine on the effectiveness of our internal control over financial reporting pursuant to Section 404 until

we are no longer an “emerging growth company” as defined in the JOBS Act.

This Annual Report on Form

10-K does not include an attestation report of our registered public accounting firm regarding internal control over financial reporting.

Our auditors will not be required to formally opine on the effectiveness of our internal control over financial reporting pursuant to

Section 404 until we are no longer an “emerging growth company” as defined in the JOBS Act.

Changes in Internal Control over Financial

There was no change in our internal control over

financial reporting during the three months ended December 31, 2022 that has materially affected, or is reasonably likely to materially

affect, our internal control over financial reporting.

During the year ended December

31, 2023, the Company implemented enhanced approval controls over cash disbursements and journal entries.

There were no other changes

in our internal control over financial reporting during the year ended December 31, 2023, that have materially affected, or is reasonably

likely to materially affect, our internal control over financial reporting.

Other Information.

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Directors and Executive Officers

The following table provides information regarding our executive officers

and directors as of March 6, 2023:

The following table provides information regarding

our executive officers and directors as of April 5, 2024:

Executive Officers and Directors

Joseph Hernandez

Chief Executive Officer and Director

Ralph Schiess

Interim Chief Executive Officer and Chief Science Officer

Chief Financial Officer

Erin Henderson

Chief Business Officer and Corporate Secretary

Christian Brühlmann

Chief Strategy Officer

Non-Employee Directors

James Sapirstein

Lead Independent Director

Timothy Ramdeen

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Executive Officers and Directors

Joseph Hernandez

Joseph Hernandez founded Blue Water Vaccines, Inc.

in October 2018 and has been the Chief Executive Officer & Executive Chairman of the Company since inception.

He has a background

in company creation, early stage technology development, as well as private and public market financing.

He brings leadership to the team,

backed by a strong educational foundation in biology, medicine, molecular genetics, microbiology, epidemiology, marketing, and finance.

Over the course of his career, he has founded or led eight entrepreneurial companies in cutting edge areas of healthcare and pharmaceuticals.

After years of building his career at Merck & Co.

(NYSE:MRK) from December 1998 to January 2001 and Digene from 2005 to 2009 (acquired

by Qiagen (NYSE:QGEN)) from 2005 to 2009, Mr.

Hernandez founded and became the President and CEO of Innovative Biosensors from 2004 to

Hernandez served as the Founder and Chairman of Microlin Bio Inc.

from August 2013 to January 2017 and as Chairman of

the Board of Ember Therapeutics (OTCMKTS:EMBT) from April 2014 to January 2019.

He was also the Chairman of Sydys Corporation from May

2016 to January 2019.

Hernandez founded Blue Water Vaccines, an early stage biotechnology company focused on manufacturing

a universal influenza vaccine in partnership with the University of Oxford in England.

Additionally, in January 2020, he founded and in

May 2020 sold Noachis Terra, Inc.

(acquired by Oragenics (NYSE:OGEN)), a company developing a vaccine for COVID-19.

From May 2020 to September

Hernandez was also the chairman and chief executive officer of Blue Water Acquisition Corp.

(“BWAC”), a special

purpose acquisition company which completed its initial public offering in December 2020.

On September 9, 2021, BWAC consummated a business

combination with Clarus Therapeutics Holdings Inc.

(OTCPink:CRXT) (“Clarus”).

Hernandez served as a director of the post-combination

entity, Clarus, until August 2022.

He completed his undergraduate studies in Neuroscience, M.Sc.

in Molecular Genetics and Microbiology,

all at the University of Florida and is completing his M.Sc.

in Chronic Disease Epidemiology and Biostatistics at Yale University.

Jon Garfield served as our interim Chief Financial

Officer since September 2021 until the consummation of our initial public offering, in February 2022, upon which he became our full-time

Chief Financial Officer.

Garfield has over 20 years of financial leadership experience, including with healthcare companies.

regularly provides consulting services to private equity funds and privately held companies.

Garfield served as the CEO of Unity MSK

from February 2021 to January 2023.

He has served as a consultant of Bay State Physical Therapy from June 2018 to February 2019 and also

as a director beginning in February 2019.

From 2016 to 2017, Mr.

Garfield was the CFO of Pyramid Healthcare, also a private equity based

healthcare company.

Prior to Pyramid Healthcare, Mr.

Garfield joined Monte Nido as CFO in 2012 until 2016.

Before Monte Nido, he served

as CFO of Clearant, Inc., a publicly-traded medical device company, and Network IP and Simplified Development, where he oversaw the finance

and treasury functions, implemented systems upgrades, and pursued a number of growth initiatives.

Garfield was previously a Co-Founder

and Vice President of Acquisitions for Coach USA, a consolidator of ground transportation entities throughout North America, and was heavily

involved in over 50 acquisitions and the eventual IPO of the company.

Earlier in his career, he held positions with PricewaterhouseCoopers

and Arthur Andersen.

Garfield was the Chief Financial Officer of BWAC from December 2020 until it completed a business combination

with Clarus in September 2021.

Garfield received a B.B.A.

in accounting from the University of Texas.

Erin Henderson

Erin Henderson has been the Chief Business Officer

for Blue Water Vaccines, Inc.

since September 2020 and has extensive experience in program and project management, business operational

management, marketing, fundraising and public-private partnership development and implementation.

She joined the company in September

Prior to joining Blue Water Vaccines, since 2010, Ms.

Henderson was the Founder and Managing Principal at The Aetos Group, a management

consulting company working with public, private, governmental and non-governmental organizations focused on operational efficiency, Lean

Six Sigma implementation, revenue development strategy and real estate acquisition strategy.

Erin began her career at Lockwood Greene

Engineers, followed by The Facility Group.

She led local, state and federal governmental relations for the University of West Georgia

and was responsible for identifying and securing financial support from both the public and private sector.

Erin completed her undergraduate

studies in Chemical Engineering from Auburn University.

Erin serves on the Board of the Greater Gainesville Chamber of Commerce and the

Board of Danscompany of Gainesville.

Significant Employees and Consultants

Ali Fattom, Ph.D.

Ali Fattom, Head of Science and Discovery since

September 2022, is a vaccinologist and microbiologist with nearly 40 years of experience in vaccine programs ranging from preclinical

to late-stage clinical development.

Fattom is an author of over 70 peer-reviewed publications and holds over 20 patents in the field

of vaccinology.

Currently, since March 2012, Dr.

Fattom has been an Adjunct Professor at the University of Michigan and since September

2022, has served as an independent consultant for Blue Water Vaccines, providing expertise to advance BWV’s vaccine pipeline and

progress towards clinical development of vaccine candidates.

Fattom joined NanoBio Corporation, which was eventually renamed

Bluewillow Biologics Inc, and he was ultimately named Chief Scientific Officer, where he led their efforts to develop viral vaccines for

various infectious diseases, including HSV, RSV, and influenza.

In 1991, he moved to industry and joined Nabi Biopharmaceuticals and ultimately

became Vice President for Research and Development in 2007.

While at Nabi, he was responsible for advancing vaccine programs from discovery

stage to advanced clinical stages, including Staphylococcal pentavalent vaccine and NicVAX, a vaccine to treat nicotine addiction and

aid in smoking cessation.

During the period of 1982 and 1986 he was an Assistant Professor in microbiology at Beir-Zeit University, West

Bank, Palestine.

In 1986, he joined the NIH and worked on a conjugate vaccine against bacterial infectious diseases, with a focus on pneumococcal

and staphylococcal vaccines, under Dr John Robbins of the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

Prior to this, Dr.

Fattom spent 5 years at John Robbins lab at the National Institutes of Health (“NIH”) working on polysaccharide

conjugate pneumococcal vaccines, providing him with a strong background and expertise in pneumococcal disease

Andrew Skibo, Ph.D.

Skibo has been the Head of Biologics Operations

for Blue Water Vaccines Inc.

since June 2021.

Skibo is a seasoned biopharmaceutical operations executive with deep cross-functional

experience in international biopharmaceutical manufacturing, process scale-up, internal and external supply chain network design strategy

and major capital project expansions.

He has extensive international experience having been responsible for the design and startup of

major pharmaceutical manufacturing facilities in USA, UK, Europe, Russia, Singapore and China.

He is deeply familiar with all aspects

of biotechnology product scale up and launch, having held related roles since the founding days of large-scale biotechnology commercial

He has a broad understanding of many enterprise operations having held roles in Research and Process Development, Commercial/Business

Development, Engineering and Strategic Planning.

Skibo served as EVP Operations at Medimmune,

and Head of Biologics Operations at Astra Zeneca for eleven years.

He retired from that full time role in April 2019, but continues to

serve as Technical Advisor to EVP Operations, AstraZeneca.

In his role, he was responsible for the development and improvement of AstraZeneca’s

mono-clonal antibody operations and influenza seasonal and pandemic LAIV Flu operations.

He developed the network strategy for these operations

and implemented them in ten plants across eight sites (including two new sites) in the USA, UK, Europe and China.

He transformed a previously

challenging regulatory quality environment (warning letter) to best in class status.

He oversaw the development of four BLA’s and

biologics product launches in 2017 to 2019, and has held related roles for nine product launches in his career.

In both his role with MedImmune/AstraZeneca and

his role on the Board of ISPE, Mr.

Skibo routinely interfaced with leadership levels of major international regulatory agencies, especially

He was instrumental in resolving a dead-locked product approval/cGMP regulatory issue, involving multiple firms, with the FDA

associated with the recent launch of one of AstraZeneca’s most significant oncology products.

Skibo received his B.S.

degree in Chemistry

and his M.S degree in Chemical Engineering from MIT.

He holds patents in polymer film extrusion from his original career at Monsanto.

He has served as a member of the Mayor’s Fiscal Advisory Committee in San Francisco and has been a member and chairman of the Board

of Supervisors in Birmingham/Chester County, PA.

Ralph Schiess

Schiess co-founded Proteomedix

in March 2010 and served as its Chief Executive Officer from its inception until December 2019.

Schiess then served as Proteomedix’s

Chief Scientific Officer from January 2020 to May 2023.

Schiess returned to his role as Chief Executive Officer of Proteomedix in

June 2023 and upon consummation of the Share Exchange between the Company and Proteomedix became the Chief Science Officer of the Company.

Schiess was appointed Interim Chief Executive Officer of the Company by the Board of Directors on January 12, 2024.

Harmon has more than 40

years of experience in financial positions with life sciences companies and various other industries.

Harmon has served in a variety

of roles, including chief financial officer, controller, chief executive officer, and audit committee chairman.

He has been an independent

consultant since 2008 through his business, Lakeport Business Services, Inc., and served in the outsourced CFO capacity for multiple publicly

traded companies.

During this time, Mr.

Harmon was CFO of Marizyme Inc.

from 2020 to 2021, CFO of bioAffinity Technologies Inc.

a director of Dale Biotech LLC since 2017, and a director of Patriax Industries since 2023.

He has extensive experience with fundraising,

public offerings, mergers and acquisitions, and turnarounds.

Earlier in his career, he was a member of a team that, at the invitation

of the Environmental Programmé, presented a green building product to delegates at the United Nations.

He earned a Bachelor of

Science degree in accounting from Missouri State University.

Christian Brühlmann

Brühlmann has been

Chief Strategy Officer since December 2023.

He was Chief Business Officer and co-founder of Proteomedix, which was acquired by the Company

in December 2023.

Brühlmann co-founded Proteomedix and served as its Chief Financial and Operations Officer from March 2010 until

November 2018.

Beginning in December 2018, Mr.

Brühlmann served as Proteomedix’s Chief Business Officer.

gained 20 years of experience in public and private companies in the life sciences, information and communications and financial industries.

Being responsible for product management, business development, operations and finance, he was instrumental in Proteomedix’s development

from inception to the market introduction of Proclarix.

Previously, he worked for Swisscom, Switzerland’s telecom market leader

in several strategic and leadership roles in the area of digitalization.

Brühlmann received his Bachelor and Master’s in Business

Administration from University of Zurich, Switzerland and completed executive professional trainings at the Babson College, USA and at

the University of St.

Gallen, Switzerland.

Non-Executive Directors

James Sapirstein , one of our directors since

February 2022, has over 35 years of experience leading, founding, growing, and selling healthcare companies, specifically in the pharmaceutical

Sapirstein is currently the President, CEO and Chairman of First Wave BioPharma, Inc.

FWBI), where he has been since

October 2019.

His career began in sales at Eli Lilly, eventually rising to Director of International Marketing at Bristol Myers Squibb

from July 1996 to June 2000, and later led the launch of Viread (tenofovir) at Gilead Sciences, Inc.

GILD), where he served as

Global Marketing Lead from June 2020 to June 2002.

From November 2006 to January 2011, he served as founding CEO of Tobira Therapeutics

TBRA), then a private company, and later acquired by Allergan (NYSE:

Since then, he has served as CEO of Alliqua Biomedical

ALQA) from September 2012 to February 2014 and CEO of Contravir Pharmaceuticals (Nasdaq:

Sapirstein , one of our directors since February 2022 and our Lead Independent Director since October 2023, has over 35 years of experience leading, founding, growing, and selling

healthcare companies, specifically in the pharmaceutical space.

Sapirstein is currently the President, CEO and Chairman of First

Wave BioPharma, Inc.

FWBI), where he has been since October 2019.

His career began in sales at Eli Lilly, eventually rising

to Director of International Marketing at Bristol Myers Squibb from July 1996 to June 2000, and later led the launch of Viread

(tenofovir) at Gilead Sciences, Inc.

GILD), where he served as Global Marketing Lead from June 2020 to June 2002.

November 2006 to January 2011, he served as founding CEO of Tobira Therapeutics (Nasdaq:

TBRA), then a private company, and later

acquired by Allergan (NYSE:

Since then, he has served as CEO of Alliqua Biomedical (Nasdaq:

ALQA) from September 2012 to

February 2014 and CEO of Contravir Pharmaceuticals (Nasdaq:

CTRV) from March 2014 to October 2018.

He has been part of almost two dozen drug product launches and specifically either led or has been a key member of several HIV product

launches into different new classes of therapeutics at the time.

He has been part of almost two

dozen drug product launches and specifically either led or has been a key member of several HIV product launches into different new

classes of therapeutics at the time.

Additionally, Mr.

Sapirstein has held board positions on ZyVersa Therapeitics,

Sapirstein has held board positions on ZyVersa Therapeutics, Inc.

ZVSA) since January 2023 and Enochian Biosciences (Nasdaq:

ENOB) since April 2018.

He previously served as a director of

Marizyme (OTCMKTS:MRZM) (Executive Chairman) from December 2018 to June 2021, Leading Biosciences from 2016 to 2021, BioNJ, an association

of biopharma industries in New Jersey, from February 2017 to February 2019, RespireRX (OTCBB:RSPI) from April 2014 to January 2020, NanoViricides

NNVC) from November 2018 to January 2020, and BWAC from December 2020 until its business combination with Clarus in September

He is also a Board Director for BIO, the leading Biopharma Industries Organization promoting public policy and networking in the

healthcare space, where he sits on both the Health Section and Emerging Companies Section Governing Boards.

Sapirstein received a

in Pharmacy from Rutgers University and his MBA from Fairleigh Dickinson University.

He is well qualified to serve on our Board due

to his extensive network from decades in the healthcare industry.

Sapirstein brings to our Board a significant depth of experience

in the pharmaceutical and biotechnology industries that will be invaluable to the Company as we continue to develop biotechnology assets.

Simon Tarsh , one of our directors since August 2022, has more

than 40 years of financial experience, working in both the UK and the USA.

He has recently retired from Deloitte Consulting LLP, where

he was a Senior Managing Director in the Finance and Enterprise Performance Practice, where he had served global clients since 2007.

led a growing global practice focused around Operational Transformation, including supporting Carve Out transactions, joint ventures and

hybrid structures, both in the US and in international locations, such as India, China, Eastern Europe and Latin America.

high growth companies with their finance operations as they globalized, and was able to advise them on their expansion, while balancing

growth with appropriate controls.

He previously served as a director of Marizyme,

(OTCMKTS:MRZM) (Executive Chairman) from December 2018 to June 2021, Leading Biosciences from 2016 to 2021, BioNJ, an

association of biopharma industries in New Jersey, from February 2017 to February 2019, RespireRX (OTCBB:RSPI) from April 2014 to

January 2020, NanoViricides Inc.

NNVC) from November 2018 to January 2020, and BWAC from December 2020 until its business

combination with Clarus in September 2021.

He is also a Board Director for BIO, the leading Biopharma Industries Organization

promoting public policy and networking in the healthcare space, where he sits on both the Health Section and Emerging Companies

Section Governing Boards.

Sapirstein received a B.S.

in Pharmacy from Rutgers University and his MBA from Fairleigh Dickinson

He is well qualified to serve on our Board due to his extensive network from decades in the healthcare industry.

Sapirstein brings to our Board a significant depth of experience in the pharmaceutical and biotechnology industries that will be

invaluable to the Company as we continue to develop biotechnology assets.

Simon Tarsh , one of

our directors since August 2022, has more than 40 years of financial experience, working in both the UK and the U.S.

He has recently retired

from Deloitte Consulting LLP, where he was a Senior Managing Director in the Finance and Enterprise Performance Practice, where he had

served global clients since 2007.

He led a growing global practice focused around Operational Transformation, including supporting Carve

Out transactions, joint ventures and hybrid structures, both in the US and in international locations, such as India, China, Eastern Europe

and Latin America.

He supported high growth companies with their finance operations as they globalized, and was able to advise them on

their expansion, while balancing growth with appropriate controls.

Prior to moving to the United States in 2007, Mr.

Tarsh’s consulting career began with PA Consulting

Group, London in 1988, where he was elected as a Partner in 1997, and he built ISG’s business process outsourcing advisory practice

in Europe between 2001 and 2006.

Tarsh’s early career was in finance, working with Marathon Oil and Dow Chemical, and during

this period, he qualified as a Chartered Accountant.

Tarsh received a Bachelor of Science undergraduate degree in Business and Administration

from the University of Salford, Manchester, UK in 1981, and an MBA from City University Business School, London, UK in 1988.

He is a Fellow

of the Chartered Institute of Management Accountants (1984), which is considered as a CPA equivalent.

Tarsh’s deep financial

experience at Deloitte Consulting LLP for fifteen years offers valuable insights to our Board, particularly given the enhanced accounting

rules and regulations affecting public companies.

Vuk Jeremić , one of our Directors

since November 2022, brings decades of experience in operational and strategy advisement on a global scale for both private and public

Currently, Mr.

Jeremić is the President of the Center for International Relations and Sustainable Development (CIRSD),

a global public policy think-tank, and Editor-in-Chief of the quarterly magazine “Horizons – Journal of International Relations

and Sustainable Development.” Since 2013, Mr.

Jeremić has operated Vuk Jeremić ent Consulting Agency Belgrade, through

which he currently serves as a senior advisor to a leading global private equity firm and to one of the largest cryptocurrency exchanges.

He also serves on the Advisory Board of the NYSE-listed technology special purpose acquisition company, Adit Edtech Acquisition Corp.

In addition, he has lectured around the world at major universities, think-tanks, and institutes, as well as published opinion

pieces in leading outlets including The New York Times, The Washington Post, The Wall Street Journal, The Financial Times, and Le Monde.

Prior to his experience in company advisement, Mr.

Jeremić held multiple key positions in global public policy development nationally

and internationally.

In 2007, he chaired the Council of Europe’s Committee of Ministers and, from 2007 to 2012, he served as Serbia’s

Minister of Foreign Affairs.

In June 2012, Mr.

Jeremić was directly elected by the majority of world’s nations to be the

President of the 67th session of the United Nations (UN) General Assembly.

During his term in office, he played a leading role in steering

the UN towards the establishment of the Sustainable Development Goals (SDGs).

Jeremić was named a Young Global Leader by the

World Economic Forum in 2013 and appointed to the Leadership Council of the UN Sustainable Development Solutions Network (UN SDSN) in

Jeremić served as the President of the Serbian Tennis Federation from 2011 to 2015.

Jeremić holds a bachelor’s

degree in Theoretical and Experimental Physics from Cambridge University and a master’s degree in Public Administration in International

Development from Harvard University’s John F.

Kennedy School of Government.

Jeremić’s impressive resume, operational

advisement experience and global public policy development offer a unique prospective to our Board in as we continue to grow the Company

and progress our vaccine candidates towards commercialization.

Timothy Ramdeen , one of our directors since

January 2023 nearly a decade of experience in private equity and hedge fund investing, capital markets, and company formation.

Ramdeen has been founder and managing partner of Dharma Capital Advisors, an investment and advisory firm focused on early-stage

private and public companies.

Tarsh’s consulting

career began with PA Consulting Group, London in 1988, where he was elected as a Partner in 1997, and he built ISG’s business process

outsourcing advisory practice in Europe between 2001 and 2006.

Tarsh’s early career was in finance, working with Marathon Oil

and Dow Chemical, and during this period, he qualified as a Chartered Accountant.

Tarsh received a Bachelor of Science undergraduate

degree in Business and Administration from the University of Salford, Manchester, UK in 1981, and an MBA from City University Business

School, London, UK in 1988.

He is a Fellow of the Chartered Institute of Management Accountants (1984), which is considered as a CPA equivalent.

Tarsh’s deep financial experience at Deloitte Consulting LLP for fifteen years offers valuable insights to our Board, particularly

given the enhanced accounting rules and regulations affecting public companies.

Timothy Ramdeen , one

of our directors since January 2023, has nearly a decade of experience in private equity and hedge fund investing, capital markets, and

company formation.

Since June 2022, Mr.

Ramdeen has been founder and managing partner of Dharma Capital Advisors, an investment and advisory

firm focused on early-stage private and public companies.

From March 2021 to March 2022, Mr.

Ramdeen was co-founder, chief investment officer, and portfolio manager

at Sixth Borough Capital Management, a multi-stage, event-driven hedge fund focused on both private and public equities.

Ramdeen was co-founder, chief investment

officer, and portfolio manager at Sixth Borough Capital Management, a multi-stage, event-driven hedge fund focused on both private and

public equities.

Since 2022, Mr.

Ramdeen has been the co-founder of Amplexd Therapeutics, which is a women’s health/biotechnology company focused on providing low-cost,

effective, safe and accessible treatments for early cervical and HPV-related cancers worldwide.

Ramdeen also serves as a corporate

advisor/board member to multiple early-stage companies and investment funds.

Ramdeen has been the co-founder of Amplexd Therapeutics, which is a women’s health/biotechnology

company focused on providing low-cost, effective, safe and accessible treatments for early cervical and HPV-related cancers worldwide.

Ramdeen also serves as a corporate advisor/board member to multiple early-stage companies and investment funds.

Previously, Mr.

Ramdeen was the fifth hire at Altium Capital

Management (“Altium”), a healthcare-focused investment firm, where from July 2019 to March 2021 he served as the sole investment

analyst on the private capital markets/special situations desk (privately-negotiated financings, direct investments, event-driven long/short,

and private to public investments in micro and small-cap companies).

During his tenure at Altium, Mr.

Ramdeen was instrumental in co-creating

the firm’s SPAC and reverse merger investment efforts and establishing extensive relationships with sell-side constituents, buy-side

counterparts, and hundreds of private and publicly traded companies across biotechnology, therapeutics, healthcare services, medical devices

was the fifth hire at Altium Capital Management (“Altium”), a healthcare-focused investment firm, where from July 2019 to

March 2021 he served as the sole investment analyst on the private capital markets/special situations desk (privately-negotiated financings,

direct investments, event-driven long/short, and private to public investments in micro and small-cap companies).

During his tenure at

Ramdeen was instrumental in co-creating the firm’s SPAC and reverse merger investment efforts and establishing extensive

relationships with sell-side constituents, buy-side counterparts, and hundreds of private and publicly traded companies across biotechnology,

therapeutics, healthcare services, medical devices and medtech.

From 2017 to 2018, Mr.

Ramdeen worked for Brio Capital Management, an event-driven hedge fund focused on small and micro

cap equities.

Ramdeen worked for Brio Capital Management, an

event-driven hedge fund focused on small and micro cap equities.

Ramdeen received his B.S.

in Biology from Temple University, where he conducted scientific research across neurology,

oncology, and developmental biology.

in Biology from Temple University, where

he conducted scientific research across neurology, oncology, and developmental biology.

In addition, Mr.

Ramdeen earned his MBA in Finance from NYU Stern School of Business.

brings to our Board extensive experience in capital advisement and company development, specifically within the life science industry

and for publicly traded companies.

Ramdeen earned his MBA in Finance

from NYU Stern School of Business.

Ramdeen brings to our Board extensive experience in capital advisement and company development,

specifically within the life science industry and for publicly traded companies.

Thomas Meier , one

of our directors since February 1, 2024, has close to 25 years’ experience as a life-science and biotech entrepreneur, executive

manager, and board member.

Since June 2022, Dr.

Meier has served as Chairman of, and member of the Audit and Compensation Committees of,

Santhera Pharmaceuticals Holding AG (SIX:

SANN), a publicly listed Swiss specialty pharmaceutical company focused on the development and

commercialization of innovative medicines for rare neuromuscular and pulmonary diseases.

Meier has served on the board of Santhera

since 2017 and stepped down as the company’s CEO in November 2019 after having served 15 years as executive manager, the last 8

years as CEO.

Meier became managing partner of Viopas Venture Consulting GmbH, a Swiss consultancy and advisory firm for

the healthcare industry.

Since 2020, Dr.

Meier has served as a board member of Novaremed AG, a privately held Swiss company developing

innovative treatment options for the management of chronic pain and alternatives to opioids.

Meier has served on Novaremed’s

Audit Committee since October 2021 and became Executive Chairman of the company in January 2024.

Since January 2022, Dr.

Meier also serves

on the board of Visgenx Inc.

In September 2021, he co-founded SEAL Therapeutics AG, a privately owned Swiss gene therapy company

for which he also serves as Chairman.

Between July 2020 and November 2021, he served as Chairman of privately held Pharmabiome AG (Switzerland).

Meier has a PhD in Biology and qualified as lecturer in neurosciences at the Biozentrum, University of Basel (Switzerland).

brings to our board experience as an internationally recognized scientist with track record in clinical research of orphan diseases.

Ajit Singh, one

of our directors since February 7, 2024, is a Partner at Silicon Valley based Artiman Ventures, focused on early-stage technology and

life science investments, with over $1 billion in assets under management.

Besides serving on the board of directors of Artiman portfolio

companies, he has served on the boards of Sofie Biosciences, a PET radiopharmaceuticals company focused on Oncology and Neurology, Leo

Cancer Care, focused on radiation oncology since 2013, Artidis, an oncology diagnostics company with nanomechanical biomarkers for cancer,

and Chronus Health, in the area of Point-of-Care diagnostics since 2023.

He also serves on the Board of Trustees of American Association

for Cancer Research (AACR) Foundation, the oldest and the largest cancer research organization globally.

Singh is an Adjunct Professor

in the School of Medicine at Stanford where he teaches clinical diagnostics and entrepreneurship.

In the past, Dr.

Singh has served as

a Lead Director on the Board of Directors of Max Healthcare, and as a Senior Advisor to the Tata Trusts Cancer program, which developed

a “plan centrally, deliver locally” platform for cancer care, and delivered it via comprehensive cancer centers built bespoke

with funding from the Tata Group.

Until 2023, he also served on the board of directors of Cadila Pharmaceuticals.

Prior to joining Artiman,

Singh was the President and CEO of BioImagene, a company specializing in AI-based Cancer Diagnostics, based in California.

was acquired by Roche Pharmaceuticals in September 2010.

Before BioImagene, Dr.

Singh spent nearly twenty years at Siemens in various

roles, in the United States and Germany, most recently as the global CEO of Siemens Oncology, and Siemens Digital Imaging Systems.

transitioning to these executive responsibilities, Dr.

Singh spent several years in R&D at Siemens Research in Princeton, responsible

for research in the areas of artificial intelligence and robotics.

During this time, he concurrently served as an adjunct faculty at Princeton

Singh has a Ph.D.

in Computer Science from Columbia University, a Master’s degree in Computer Engineering from Syracuse

University, and a Bachelor’s in Electrical Engineering from Indian Institute of Technology (IIT) in Varanasi, India.

He has published

two books and numerous refereed articles and holds five patents.

His Top-10 Book Review is carried by various blogs and reading journals

in December every year.

Singh brings to our board significant experience in the biotech industry and diagnostic field, particularly

in a commercial execution capacity.

Board of Directors and Corporate Governance

Our business and affairs are organized under the

direction of our board of directors (“ Board ”), which currently consists of five members.

Our Board is divided into

three classes, Class I, Class II and Class III, with members of each class serving staggered three-year terms.

Our directors are divided

among the three classes as follows:

● the Class I directors are Simon Tarsh and Vuk Jeremić,

and their terms will expire at our 2023 annual meeting of stockholders;

● the Class II director is James Sapirstein, and his term will

expire at our 2024 annual meeting of stockholders;

● the Class III directors are Joseph Hernandez and Timothy

Ramdeen, and their terms will expire at our 2025 annual meeting of stockholders.

Our Amended and Restated Certificate of Incorporation

and our Amended and Restated Bylaws provide that the authorized number of directors may be changed only by resolution of the Board.

directors hold office until the earlier of their death, resignation, removal or disqualification, or until their successors have been

elected and qualified.

Our board of directors does not have a formal policy on whether the roles of Chief Executive Officer and Chairman

of our Board should be separate.

The primary responsibilities of our Board are to provide oversight, strategic guidance, counselling and

direction to our management.

We have no formal policy regarding board diversity.

Our priority in selection of board members is identification of members who will further the interests of our stockholders through his

or her established record of professional accomplishment, the ability to contribute positively to the collaborative culture among board

members, knowledge of our business and understanding of the competitive landscape.

Our business and affairs are

organized under the direction of our board of directors (“ Board ”), which currently consists of five members.

is divided into three classes, Class I, Class II and Class III, with members of each class serving staggered three-year terms.

Our directors

are divided among the three classes as follows:

● the Class I directors are Simon

Tarsh and Thomas Meier, and their term will expire at our 2025 annual meeting of stockholders;

● the Class II director is James

Sapirstein, and his term will expire at our 2026 annual meeting of stockholders;

● the Class III directors are

Timothy Ramdeen and Ajit Singh, and their term will expire at our 2024 annual meeting of stockholders.

Our Amended and Restated Certificate

of Incorporation and our Amended and Restated Bylaws provide that the authorized number of directors may be changed only by resolution

of the Board.

Our directors hold office until the earlier of their death, resignation, removal, or disqualification, or until their successors

have been elected and qualified.

Our board of directors does not have a formal policy on whether the roles of Chief Executive Officer

and Chairman of our Board should be separate.

The primary responsibilities of our Board are to provide oversight, strategic guidance,

counselling, and direction to our management.

We have no formal policy regarding

board diversity.

Our priority in selection of board members is identification of members who will further the interests of our stockholders

through his or her established record of professional accomplishment, the ability to contribute positively to the collaborative culture

among board members, knowledge of our business and understanding of the competitive landscape.

Directors and Executive Officers Qualifications

We believe that the collective skills, experiences

and qualifications of our directors provide our Board with the expertise and experience necessary to advance the interests of our stockholders.

In selecting directors, the Board considers candidates that possess qualifications and expertise that will enhance the composition of

Nominees for director will be selected on the basis of, among other things, leadership experience, knowledge, skills, expertise,

integrity, diversity, ability to make independent analytical inquiries, understanding of the Company’s business environment and willingness

to devote adequate time and effort to Board responsibilities.

The Nominating & Corporate Governance Committee may require certain

skills or attributes, such as financial or accounting experience, to meet specific board needs that arise from time to time and will also

consider the overall experience and makeup of its members to obtain a broad and diverse mix of board members.

We believe that our directors

should have the highest professional and personal ethics and values, consistent with our longstanding values and standards.

have broad experience at the policy-making level in business, exhibit commitment to enhancing stockholder value and have sufficient time

to carry out their duties and to provide insight and practical wisdom based on their past experience.

Director Independence

The Board has evaluated each of its directors’

independence from the Company based on the definition of “independence” established by Nasdaq and has determined that each

of Vuk Jeremić, Simon Tarsh, Timothy Ramdeen and James Sapirstein are independent directors, constituting a majority of the Board.

The Board has further determined that each member of our audit committee, compensation committee and nominating and corporate governance

committee is “independent” under applicable Nasdaq rules.

The Board has also determined that each member of

our audit committee is “independent” for purposes of Section 10A(m)(3) of the Securities Exchange Act of 1934, as amended

(“ Exchange Act ”).

In its evaluation of each director’s or nominee’s

independence from the Company, the Board reviewed whether any transactions or relationships currently exist or existed during the past

year between each director or nominee and the Company and its subsidiaries, affiliates, equity investors, or independent registered public

accounting firm, and whether there were any transactions or relationships between each director or nominee and members of the senior management

of the Company or their affiliates.

We believe that the collective

skills, experiences, and qualifications of our directors provide our Board with the expertise and experience necessary to advance the

interests of our stockholders.

In selecting directors, the Board considers candidates that possess qualifications and expertise that will

enhance the composition of the Board.

Nominees for director will be selected on the basis of, among other things, leadership experience,

knowledge, skills, expertise, integrity, diversity, ability to make independent analytical inquiries, understanding of the Company’s

business environment and willingness to devote adequate time and effort to Board responsibilities.

The Nominating & Corporate Governance

Committee may require certain skills or attributes, such as financial or accounting experience, to meet specific board needs that arise

from time to time and will also consider the overall experience and makeup of its members to obtain a broad and diverse mix of board members.

We believe that our directors should have the highest professional and personal ethics and values, consistent with our longstanding values

and standards.

They should have broad experience at the policy-making level in business, exhibit commitment to enhancing stockholder value

and have sufficient time to carry out their duties and to provide insight and practical wisdom based on their past experience.

Committees of the Board

Our Board has established three standing committees

— audit, compensation and nominating and corporate governance — each of which operates under a charter that has been adopted

by our Board.

Copies of each committee’s charter are posted on the Investor Relations section of our website, which is located at

https://ir.bluewatervaccines.com/corporate-governance/governance-overview .

Each committee has the composition and responsibilities

described below.

Our Board has established three

standing committees—audit, compensation and nominating and corporate governance—each of which operates under a charter that

has been adopted by our Board.

Copies of each committee’s charter are posted on the “Investor Relations” section of

our website, which is located at https://onconetix.com/corporate-governance/governance-overview .

Each committee has the composition

and responsibilities described below.

Our Board may from time to time establish other committees.

Audit Committee

Our audit committee (“ Audit Committee ”)

consists of Simon Tarsh, who is the chair of the committee, Timothy Ramdeen and James Sapirstein.

Our Board has determined that each of

the members of our audit committee satisfies the Nasdaq Marketplace Rules and SEC independence requirements.

The functions of this committee

include, among other things:

● evaluating the performance, independence and qualifications

of our independent auditors and determining whether to retain our existing independent auditors or engage new independent auditors;

● reviewing and approving the engagement of our independent

auditors to perform audit services and any permissible non-audit services;

● reviewing our annual and quarterly financial statements and

reports, including the disclosures contained under the caption “Management’s Discussion and Analysis of Financial Condition

and Results of Operations,” and discussing the statements and reports with our independent auditors and management;

● reviewing with our independent auditors and management significant

issues that arise regarding accounting principles and financial statement presentation and matters concerning the scope, adequacy and

effectiveness of our financial controls;

● reviewing and approving, in accordance with the Company’s

policies, any related party transaction as defined by applicable rules and regulations

● reviewing our major financial risk exposures, including the

guidelines and policies to govern the process by which risk assessment and risk management is implemented;

● reviewing and evaluating on an annual basis the performance

of the audit committee, including compliance of the audit committee with its charter.

The Board has determined that Simon Tarsh qualifies

as an “audit committee financial expert” within the meaning of applicable SEC regulations and meets the financial sophistication

requirements of the Nasdaq Marketplace Rules.

Our audit committee (“ Audit Committee ”) consists

of Simon Tarsh, who is the chair of the committee, Timothy Ramdeen, and James Sapirstein.

Our Board has determined that each of the members

of our Audit Committee satisfies the Nasdaq Marketplace Rules and SEC independence requirements.

The functions of this committee include,

among other things:

● evaluating the performance,

independence and qualifications of our independent auditors and determining whether to retain our existing independent auditors or engage

new independent auditors;

● reviewing and approving the

engagement of our independent auditors to perform audit services and any permissible non-audit services;

● reviewing our annual and quarterly

financial statements and reports, including the disclosures contained under the caption “Management’s Discussion and Analysis

of Financial Condition and Results of Operations” and discussing the statements and reports with our independent auditors and management;

● reviewing with our independent

auditors and management significant issues that arise regarding accounting principles and financial statement presentation and matters

concerning the scope, adequacy, and effectiveness of our financial controls;

● reviewing and approving, in

accordance with the Company’s policies, any related party transaction as defined by applicable rules and regulations

● reviewing our major financial

risk exposures, including the guidelines and policies to govern the process by which risk assessment and risk management is implemented;

● reviewing and evaluating on

an annual basis the performance of the audit committee, including compliance of the audit committee with its charter.

The Board has determined that

Simon Tarsh qualifies as an “audit committee financial expert” within the meaning of applicable SEC regulations and meets

the financial sophistication requirements of the Nasdaq Marketplace Rules.

In making this determination, the Board has considered Mr.

Tarsh’s extensive financial

experience and business background.

Both our independent registered public accounting firm and management periodically meet privately

with our Audit Committee.

Tarsh’s extensive financial experience and business background.

Both our independent registered public accounting firm and management

periodically meet privately with our Audit Committee.

Compensation Committee

Our compensation committee (“ Compensation

Committee ”) consists of James Sapirstein, who is the chair of the committee, Simon Tarsh, Vuk Jeremić and Timothy Ramdeen.

Our board of directors has determined that each of the members of our Compensation Committee is an outside director, as defined pursuant

to Section 162(m) of the Internal Revenue Code of 1986, as amended, or the Code, and satisfies the Nasdaq Marketplace Rules independence

Our compensation committee

(“ Compensation Committee ”) consists of James Sapirstein, who is the chair of the committee, Simon Tarsh, and Timothy

Our board of directors has determined that each of the members of our Compensation Committee is an outside director, as defined

pursuant to Section 162(m) of the Internal Revenue Code of 1986, as amended, or the Code, and satisfies the Nasdaq Marketplace Rules independence

requirements.

The functions of this committee include, among other things:

● reviewing, modifying and approving (or if it deems appropriate,

making recommendations to the full board of directors regarding) our overall compensation strategy and policies;

● reviewing and approving the compensation, the performance

goals and objectives relevant to the compensation, and other terms of employment of our executive officers;

● reviewing and approving (or if it deems appropriate, making

recommendations to the full board of directors regarding) the equity incentive plans, compensation plans and similar programs advisable

for us, as well as modifying, amending or terminating existing plans and programs;

● reviewing and approving the terms of any employment agreements,

severance arrangements, change in control protections and any other compensatory arrangements for our executive officers;

● reviewing with management and approving our disclosures under

the caption “Compensation Discussion and Analysis” in our periodic reports or proxy statements to be filed with the SEC;

● preparing the report that the SEC requires in our annual

proxy statement.

● reviewing, modifying, and approving

(or if it deems appropriate, making recommendations to the full board of directors regarding) our overall compensation strategy and policies;

● reviewing and approving the

compensation, the performance goals, and objectives relevant to the compensation, and other terms of employment of our executive officers;

● reviewing and approving (or

if it deems appropriate, making recommendations to the full board of directors regarding) the equity incentive plans, compensation plans

and similar programs advisable for us, as well as modifying, amending, or terminating existing plans and programs;

● reviewing and approving the

terms of any employment agreements, severance arrangements, change in control protections and any other compensatory arrangements for

our executive officers;

● reviewing with management and

approving our disclosures under the caption “Compensation Discussion and Analysis” in our periodic reports or proxy statements

to be filed with the SEC;

● preparing the report that the

SEC requires in our annual proxy statement.

Nominating and Corporate Governance Committee

Our nominating and corporate governance committee

(“ Nominating Committee ”) consists of Timothy Ramdeen, who is the chair of the committee, James Sapirstein, Simon Tarsh

and Vuk Jeremić.

Our Board has determined that each of the members of this committee satisfies the Nasdaq Marketplace Rules independence

requirements.

Our nominating and corporate

governance committee (“ Nominating Committee ”) consists of Timothy Ramdeen, who is the chair of the committee, James

Sapirstein and Simon Tarsh.

Our Board has determined that each of the members of this committee satisfies the Nasdaq Marketplace Rules

independence requirements.

The functions of this committee include, among other things:

● identifying, reviewing and evaluating candidates to serve

on our board of directors consistent with criteria approved by our board of directors;

● evaluating director performance on the board and applicable

committees of the board and determining whether continued service on our board is appropriate;

● evaluating, nominating and recommending individuals for membership

on our board of directors;

● evaluating nominations by stockholders of candidates for

election to our board of directors.

● identifying, reviewing, and

evaluating candidates to serve on our board of directors consistent with criteria approved by our board of directors;

● evaluating director performance

on the board and applicable committees of the board and determining whether continued service on our board is appropriate;

● evaluating, nominating, and

recommending individuals for membership on our board of directors;

● evaluating nominations by stockholders

of candidates for election to our board of directors.

Board Leadership Structure

Our board of directors is free to select the Chairman

of the board of directors and the Chief Executive Officer in a manner that it considers to be in the best interests of our company at

the time of selection.

Currently, Mr.

Joseph Hernandez serves as our Chief Executive Officer and executive chairman.

Four of our five

members of our board of directors have been deemed to be “independent” by the board of directors, which we believe provides

Our board of directors is free to select the Chairman of the board

of directors and the Chief Executive Officer in a manner that it considers to be in the best interests of our company at the time of selection.

Currently, Ralph Schiess serves as our Interim Chief Executive Officer and James Sapirstein serves as our non-executive Chairman.

five members of our board of directors have been deemed to be “independent” by the board of directors, which we believe provides

sufficient independent oversight of our management.

Our board of directors, as a whole and also at the

committee level, plays an active role overseeing the overall management of our risks.

Our Audit Committee reviews risks related to financial

and operational items with our management and our independent registered public accounting firm.

Our board of directors is in regular

contact with our Chief Executive Officer, who reports directly to the board of directors and who supervise day-to-day risk management.

Our board of directors, as

a whole and also at the committee level, plays an active role overseeing the overall management of our risks.

Our Audit Committee reviews

risks related to financial and operational items with our management and our independent registered public accounting firm.

of directors is in regular contact with our Chief Executive Officer, who reports directly to the board of directors and supervises

day-to-day risk management.

Role of Board in Risk Oversight Process

We face a number of risks, including those described

under the caption “Risk Factors” contained elsewhere in this Report.

Our board of directors believes that risk management

is an important part of establishing, updating and executing on our business strategy.

Our board of directors has oversight responsibility

relating to risks that could affect the corporate strategy, business objectives, compliance, operations, and the financial condition and

performance of our company.

Our board of directors focuses its oversight on the most significant risks facing us and on our processes

to identify, prioritize, assess, manage and mitigate those risks.

Our board of directors receives regular reports from members of our

senior management on areas of material risk to us, including strategic, operational, financial, legal and regulatory risks.

board of directors has an oversight role, management is principally tasked with direct responsibility for management and assessment of

risks and the implementation of processes and controls to mitigate their effects on us.

Our board is generally responsible for the oversight

of corporate risk in its review and deliberations relating to our activities.

Our principal source of risk falls into two categories,

financial and product commercialization.

We face a number of risks,

including those described under the caption “Risk Factors” contained elsewhere in this Report.

Our board of directors believes

that risk management is an important part of establishing, updating, and executing our business strategy.

Our board of directors has oversight

responsibility relating to risks that could affect the corporate strategy, business objectives, compliance, operations, and the financial

condition and performance of our Company.

Our board of directors focuses its oversight on the most significant risks facing us and, on

our processes to identify, prioritize, assess, manage, and mitigate those risks.

Our board of directors receives regular reports from

members of our senior management on areas of material risk to us, including strategic, operational, financial, legal and regulatory risks.

While our board of directors has an oversight role, management is principally tasked with direct responsibility for management and assessment

of risks and the implementation of processes and controls to mitigate their effects on us.

Our board is generally responsible

for the oversight of corporate risk in its review and deliberations relating to our activities.

Our principal source of risk falls into

two categories, financial and product commercialization.

Our Audit Committee oversees management of financial risks;

our board regularly reviews information

regarding our cash position, liquidity and operations, as well as the risks associated with each.

The board regularly reviews plans, results

and potential risks related to our product offerings, growth, and strategies.

Our Compensation Committee oversees risk management as it

relates to our compensation plans, policies and practices for all employees including executives and directors, particularly whether our

compensation programs may create incentives for our employees to take excessive or inappropriate risks which could have a material adverse

effect on our company.

Scientific Advisory Board

In January 2020, we formally established a Scientific

Advisory Board to advise our management regarding our clinical and regulatory development programs and other customary matters.

Our scientific

advisors are experts in various areas of medicine including theoretical epidemiology, vaccine research and development, and biotechnology.

Our Scientific Advisory Board is comprised of the following individuals:

Sunetra Gupta, Ph.D.

Professor of Theoretical Epidemiology at The University of Oxford, a leading voice in infectious disease globally;

John Rice, Ph.D., Managing Director at CincyTech with more than 30 years of biotechnology advising experience.

our board regularly

reviews information regarding our cash position, liquidity, and operations, as well as the risks associated with each.

The board regularly

reviews plans, results and potential risks related to our product offerings, growth and strategies.

Our Compensation Committee oversees

risk management as it relates to our compensation plans, policies and practices for all employees including executives and directors,

particularly whether our compensation programs may create incentives for our employees to take excessive or inappropriate risks which

could have a material adverse effect on our company.

Code of Business Conduct and Ethics

We have adopted a written code of business conduct

and ethics that applies to our directors, officers and employees, including our principal executive officer, principal financial officer,

principal accounting officer or controller, or persons performing similar functions.

The code of business conduct and ethics is posted

on our website at www.bluewatervaccines.com .

We expect that any amendments or waivers to the code that are required by law or Nasdaq

Marketplace Rules will be disclosed on our website.

Meetings Attended by Directors

the fiscal year ended December 31, 2022, the Board held a total of 10 meetings, our Audit Committee held a total of 6 meetings, our Compensation

Committee held a total of 7 meetings and our Nominating Committee held a total of 6 meeting.

Each of our incumbent directors attended

at least 75% of the aggregate of the total number of meetings of the Board and the total number of meetings held by the committees of

the Board on which such director served during the period in which such director served.

Although we do not maintain a formal policy regarding

director attendance at the annual meeting of stockholders, director attendance at stockholder meetings is encouraged, and in 2022, all

directors and Simon Tarsh, director nominee, attended the 2022 annual meeting of stockholders in person or via teleconference.

We have adopted a written

code of business conduct and ethics that applies to our directors, officers, and employees, including our principal executive officer,

principal financial officer, principal accounting officer or controller, or persons performing similar functions.

The code of business

conduct and ethics is posted on our website at www.onconetix.com .

We expect that any amendments or waivers to the code that are

required by law or Nasdaq Marketplace Rules will be disclosed on our website.

Insider Trading Policy

On December 1, 2023, we adopted

insider trading policies and procedures governing the purchase, sale, and/or other dispositions of our securities by directors, officers,

and employees, which are reasonably designed to promote compliance with insider trading laws, rules and regulations, and applicable Nasdaq

listing standards (the “ Insider Trading Policy ”).

The foregoing description of

the Insider Trading Policy does not purport to be complete and is qualified in its entirety by the terms and conditions of the Insider

Trading Policy, a copy of which is attached hereto as Exhibit 19 and is incorporated herein by reference.

Delinquent Section 16(a) Reports

Section 16(a) of the Exchange Act requires the Company’s directors

and executive officers, and persons who own more than 10% of a registered class of the Company’s equity securities, to file with

the SEC reports of beneficial ownership and reports of changes in beneficial ownership in the Company’s securities.

upon a review of Forms 3, 4 and 5, and amendments thereto, filed electronically with the SEC during the year ended December 31, 2022,

the Company believes that all Section 16(a) filings applicable to its directors, officers, and 10% stockholders were filed on a timely

basis during the year ended December 31, 2022, except that James Sapirstein, Jon Garfield, Joseph Hernandez, Erin Henderson, Allan Shaw,

Michael Venerable and Kimberly Murphy each filed one late Form 4.

Section 16(a) of the Exchange

Act requires the Company’s directors, executive officers, and persons who own more than 10% of a registered class of the Company’s

equity securities, to file with the SEC reports of beneficial ownership and reports of changes in beneficial ownership in the Company’s

Based solely upon a review of Forms 3, 4 and 5, and amendments thereto, filed electronically with the SEC during the year

ended December 31, 2023, the Company believes that all Section 16(a) filings applicable to its directors, officers, and 10% stockholders

were filed on a timely basis during the year ended December 31, 2023, except that Ralph Schiess filed one late Form 3.

Executive Compensation.

Summary Compensation Table

The following table sets forth total compensation

paid to our named executive officers for the years ended December 31, 2022 and 2021.

Individuals we refer to as our “named executive

officers” include our Chief Executive Officer and our two additional most highly compensated executive officers whose salary and

bonus for services rendered in all capacities exceeded $100,000 during the fiscal year ended December 31, 2022 and our one additional

most highly compensated executive officer whose salary and bonus for services rendered in all capacities exceeded $100,000 during the

fiscal year ended December 31, 2021.

and Principal Position

Plan Compensation

The following table sets forth total compensation paid to our named

executive officers for the years ended December 31, 2023 and 2022.

Individuals we refer to as our “named executive officers”

include (i) all individuals serving as our Chief Executive Officer during the fiscal year ended December 31, 2023;

(ii) our two most highly

compensated executive officers other than our Chief Executive Officer who were serving as executive officers at the end of the fiscal

year ended December 31, 2023, whose salary and bonus for services rendered in all capacities exceeded $100,000 during the fiscal year

ended December 31, 2023 and (iii) up to two of our most highly compensated executive officers other than our Chief Executive Officer who

served as executive officers during the fiscal year ended December 31, 2023 but not at the end of the fiscal year ended December 31, 2023

whose salary and bonus for services rendered in all capacities exceeded $100,000 during the fiscal year ended December 31, 2023.

Name and Principal Position

Joseph Hernandez (2)

Chief Executive Officer

Former Chief Executive Officer

Neil Campbell (3)

Former Chief Executive Officer

Jon Garfield (4)

Former Chief Financial Officer

Bruce Harmon (6)

Chief Financial Officer

Erin Henderson (5)

Chief Business Officer and Corporate

This figure represents the aggregate grant date fair value of stock options granted in the fiscal year, computed in accordance with the provisions of FASB ASC 718.

Assumptions used in the calculation of these amounts are included in the notes to our financial statements included elsewhere in this Report.

As required by SEC rules, the amounts shown exclude the impact of estimated forfeitures related to service-based vesting conditions.

Former Chief Business Officer and Corporate Secretary

This figure represents the aggregate grant date fair value of stock-based awards granted in the fiscal year, computed in accordance with the provisions of FASB ASC 718.

Assumptions used in the calculation of these amounts are included in the notes to our consolidated financial statements included elsewhere in this Report.

Hernandez resigned as Chief Executive Officer on August 16, 2023.

Campbell was appointed by the Board to serve as Chief Executive Officer on October 4, 2023, and resigned on January 10, 2024.

Campbell received a sign-on bonus of $75,000.

Garfield resigned as Chief Financial Officer on October 4, 2023.

Garfield received severance of $72,500 upon his resignation.

Henderson resigned as Chief Business Officer on December 21, 2023.

Harmon was appointed by the Board to serve as Chief Financial Officer on October 4, 2023

Employment Agreements of Executive Officers

We have entered into various employment agreements

with certain of our executive officers.

Set forth below is a summary of many of the material provisions of such agreements, which summaries

do not purport to contain all of the material terms and conditions of each such agreement.

Set forth below is a summary

of many of the material provisions of the employment agreements with our named executive officers and other executive officers, which

summaries do not purport to contain all of the material terms and conditions of each such agreement.

Joseph Hernandez

Effective upon the closing of our initial public

offering, we entered into an employment agreement with Mr.

Hernandez, pursuant to which he is employed as the Chief Executive Officer

of the Company, which superseded Mr.

Hernandez’s prior consulting agreement with the Company.

The employment agreement provides

for an annual base salary, subject to annual increases in the discretion of our compensation committee, the Company, and an annual performance

Pursuant to the employment agreement, following the completion of our initial public offering, Mr.

Hernandez’s base salary

The annual performance bonus will be up to 50% of annual base salary (the “Target Annual Bonus”), with the actual

bonus being based upon the level of achievement of annual Company and individual performance objectives for such fiscal year, as determined

by our compensation committee.

Effective upon the closing

of our initial public offering, we entered into an employment agreement with Mr.

Hernandez (the “Hernandez Employment Agreement”),

pursuant to which he was employed as the Chief Executive Officer of the Company, which superseded Mr.

Hernandez’s prior consulting

agreement with the Company.

The Hernandez Employment Agreement provided for an annual base salary, subject to annual increases in the

discretion of our compensation committee, the Company, and an annual performance bonus.

Pursuant to the Hernandez Employment Agreement,

following the completion of our initial public offering, Mr.

Hernandez’s base salary was $595,000.

The annual performance bonus

was up to 50% of annual base salary (the “Target Annual Bonus”), with the actual bonus being based upon the level of achievement

of annual Company and individual performance objectives for such fiscal year, as determined by our compensation committee.

In the event that Mr.

Hernandez’s employment

is terminated by the Company without cause (as defined in the employment agreement), or if Mr.

Hernandez terminates his employment for

“Good Reason” (as defined in the employment agreement), in addition to accrued unpaid salary, reimbursements and vacation

days, he will be entitled to certain severance payments and benefits, including:

(i) any unpaid annual bonus in respect of any completed

fiscal year that has ended prior to the date of such termination;

(ii) subject to certain conditions set forth in the employment agreement,

an amount equal to (A) the Target Annual Bonus otherwise for the fiscal year in which such termination occurred, assuming Mr.

had remained employed through the applicable payment date, multiplied by (B) a fraction, the numerator of which is the number of days

elapsed from the commencement of such fiscal year through the date of such termination and the denominator of which is 365 (or 366, as

(iii) a payment equal to twelve (12) months of his base salary;

and (iv) payment of an amount equal to the difference between

the monthly COBRA premium cost and the monthly contribution paid by active employees for the same coverage for eighteen months following

his termination.

The employment agreement also provides that if a change in control (as defined in the employment agreement) occurs, and

during the period commencing three months prior to a change in control and ending on the eighteen (18)-month anniversary of the change

in control, Mr.

Hernandez is terminated without cause or he resigns for good reason, Mr.

Hernandez will be entitled to (i) any unpaid

annual bonus in respect of any completed fiscal year that has ended prior to the date of such termination;

(ii) subject to certain conditions

set forth in the employment agreement, an amount equal to (A) the Target Annual Bonus otherwise for the fiscal year in which such termination

employment was terminated by the Company without cause (as defined in the Hernandez Employment Agreement), or if Mr.

Hernandez terminated

his employment for “Good Reason” (as defined in the Hernandez Employment Agreement), in addition to accrued unpaid salary,

reimbursements and vacation days, he would be entitled to certain severance payments and benefits, including:

(i) any unpaid annual bonus

in respect of any completed fiscal year that has ended prior to the date of such termination;

(ii) subject to certain conditions set forth

in the Hernandez Employment Agreement, an amount equal to (A) the Target Annual Bonus otherwise for the fiscal year in which such termination

occurred, assuming Mr.

2 unchanged sentences

of which is 365 (or 366, as applicable);

(iii) severance of 18 months’ salary;

and (iv) payment of an amount equal to the difference

between the monthly COBRA premium cost and the monthly contribution paid by active employees for the same coverage for eighteen months

following his termination.

Additionally, any unvested portion of the equity awards held subject to time-vesting held by Mr.

will automatically vest.

The employment agreement is governed by the laws

of the State of Ohio and contains non-solicitation and non-competition covenants (each of which remains in effect during the term of employment

and for six months following termination of employment) and confidentiality, trade secrets and assignment of intellectual property clauses.

Pursuant to the non-solicitation and non-competition

covenants, Mr.

Hernandez has agreed to not directly or indirectly solicit any comparable business from a broad category of customers,

request or advise customers to curtail, cancel, or withdraw its business from Blue Water Vaccines Inc., aid any other entity in obtaining

business from customers that is comparable or similar to any products or services provided by Blue Water Vaccines or otherwise interfere

with any transaction, agreement, business relationship, and/or business opportunity between Blue Water Vaccines and any customer or potential

customer of the Company.

During the term of employment and for a period of

six months after termination (“the Post-Termination Restricted Period”), Mr.

Hernandez is prohibited from recruiting, encouraging,

soliciting, or inducing, or in any manner attempting to recruit, encourage, solicit, or induce, any person employed by or engaged by Blue

Water Vaccines Inc.

or its subsidiaries to terminate such Person’s employment or services (or in the case of a consultant, materially

reducing such services) with Blue Water Vaccines Inc.

or its subsidiaries, hiring, or engaging any individual who was employed by or providing

services to Blue Water Vaccines Inc.

or its subsidiaries within the six (6) month period prior to the date of such hiring or engagement,

or encouraging, soliciting, or inducing, or in any manner attempting to encourage, solicit, or induce, any current or prospective client,

customer, licensee, supplier, or other business relation of Blue Water Vaccines Inc.

or its subsidiaries, or any such relation that was

a client, customer, licensee or other business relationship within the prior six (6) month period to cease doing business with or reduce

the amount of business conducted with Blue Water Vaccines Inc.

or its subsidiaries, or in any way interfering with the relationship between

any such party and Blue Water Vaccines Inc.

or its subsidiaries.

Effective upon the closing of our initial public

offering, we entered into an employment agreement with Mr.

Garfield, pursuant to which he is employed as the Chief Financial Officer of

The employment agreement provides for an annual base salary, subject to annual increases in the discretion of our compensation

committee, the Company, and an annual performance bonus.

Pursuant to the employment agreement, following the completion of our initial

public offering, Mr.

Garfield’s base salary is $435,000.

The annual performance bonus will be up to 50% of annual base salary (the

“Target Annual Bonus”), with the actual bonus being based upon the level of achievement of annual Company and individual performance

objectives for such fiscal year, as determined by our compensation committee.

In the event that Mr.

Garfield’s employment

is terminated by the Company without cause (as defined in the employment agreement), or if Mr.

Garfield terminates his employment for