Item 9A. Controls and Procedures
Item 9A. Controls and Procedures.
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.
We, under the supervision of and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer,
have evaluated the effectiveness of our disclosure controls and procedures. Based on that evaluation, our Chief Executive Officer and
Chief Financial Officer concluded that the design and operation of our disclosure controls and procedures were not effective because of
material weaknesses in our internal control over financial reporting, which are further described below in Material Weaknesses in Internal
Control Over Financial Reporting .
Material Weaknesses in Internal Control Over
Financial Reporting
In connection with the audit
of our financial statements for the year ended December 31, 2021 and 2020, we and our independent registered public accounting firm identified
material weaknesses in our internal control over financial reporting. A material weakness is a deficiency, or a combination of deficiencies,
in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or
interim financial statements will not be prevented or detected on a timely basis. 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.
The
above 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 .
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. Further, we have designed an approval policy and certain controls surrounding the identification,
approval and reporting of related party transactions, that we expect to implement during 2022. 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.
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 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 a report of management’s assessment regarding internal control over financial reporting or an attestation
report of our independent registered public accounting firm due to a transition period established by rules of the SEC for newly public
companies. Additionally, 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
Reporting
There was no change in
our internal control over financial reporting during the three months ended December 31, 2021 that has materially affected, or is reasonably
likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information.
None.
Item 9C. Disclosure Regarding Foreign Jurisdictions
that Prevent Inspections.
Not applicable.
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PART III
Item 10. Directors, Executive Officers and
Corporate Governance.
Directors and Executive Officers
The following table provides information regarding
our executive officers and directors as of March 15, 2022:
Name
Age
Position(s)
Executive Officers and Directors
Joseph Hernandez
49
Chief Executive Officer and Director
Jon Garfield
56
Chief Financial Officer
Erin Henderson
48
Chief Business Officer and Corporate Secretary
Non-Employee Directors
Kimberly Murphy
58
Director
James Sapirstein
60
Director
Allan Shaw
57
Director
Michael Venerable
58
Director
Executive Officers and Directors
Executive Officers and Directors
Joseph Hernandez
Joseph Hernandez has been the Chief Executive Officer &
Chairman for Blue Water Vaccines Inc. since October 2018. 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 2009. Later, Mr. 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. In 2018, Mr. Hernandez founded Blue Water Vaccines Inc. He has served as Chairman of Blue Water Vaccines Inc.
since 2018. Most recently, 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 2021, Mr. 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, Blue Water Acquisition Corp. consummated a business combination with
Clarus Therapeutics Holdings Inc. (Nasdaq:CRXT) (“Clarus”). Mr. Hernandez currently serves as a director of the post-combination
entity, Clarus, where he serves as a member of the Audit and Compensation Committees. He completed his undergraduate studies in Neuroscience,
M.Sc. in Molecular Genetics and Microbiology, M.B.A. all at the University of Florida and is completing his M.Sc. in Chronic Disease Epidemiology
and Biostatistics at Yale University. In addition to his extensive experience developing early-stage biotechnology companies, Mr. Hernandez
brings strong leadership to the Company, which will be invaluable to the Company’s asset development and success.
Jon Garfield
Jon Garfield served as our
interim Chief Financial Officer since September 2021 until the consummation of our initial public offering, February 2022,
upon which he became our full-time Chief Financial Officer. Mr. Garfield has over 20 years of financial leadership
experience, including with healthcare companies. Mr. Garfield regularly provides consulting services to private equity funds
and privately held companies. Mr. Garfield has served as the CEO of Unity MSK since February 2021. 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. Mr. 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. Mr. Garfield was the Chief Financial Officer of BWAC
from December 2020 until it completed a business combination with Clarus in September 2021. Mr. Garfield received a
B.B.A. in accounting from the University of Texas.
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Erin Henderson
Erin Henderson has been the Chief Business Officer
for Blue Water Vaccines Inc. since September 2020 and our Corporate Secretary since the closing of our initial public offering, 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 2019. Prior to joining Blue Water Vaccines Inc.,
since 2010, Ms. Henderson was the Founder and Managing Partner for 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
Dr. Ronald R. Cobb, Ph.D.
Ron Cobb, Head of Science and Discovery for Blue
Water Vaccines Inc. since August 2021, is a Geneticist and Molecular Biologist with 25 years of pharmaceutical R&D and manufacturing
experience. Dr. Cobb began his career at Research Triangle Institute in 1985 where he had the unique opportunity to work with Drs.
Wall and Wani, who discovered Camptothecin and Taxol. At Tanabe Research Laboratories, Dr. Cobb initiated discovery programs seeking
small molecule inhibitors of inflammatory diseases both while supporting all internal drug discovery screening efforts with protein expression
services. In 1999 Dr. Cobb was recruited to Berlex Biosciences (US Division of Schering AG) to head up the protein expression section
of the Protein Expression and Gene Therapy Group, where he supported gene expression for both research and clinical development phase
project and was a member of the Scientific Advisory Committee and Worldwide Antibody Development Committee for Schering. At the end of
2005, Dr. Cobb joined the Research and Development Group at RTI Biologics where he was named the Director of Research, then to the
Director of Research and Development. Under his guidance, 21 new products were released in 2009. Dr. Cobb joined Nanotherapeutics,
Inc. (now National Resilience) as Vice President of Biologics in January 2011 and was Chief Scientific Officer in 2014 through 2021
and was PI for over $200M in drug development contracts. He has co-authored over 60 peer-reviewed manuscripts and is currently working
with BioDeals, LLC as Managing Director. Dr. Cobb received a BA in Biology at Wake Forest University and a Ph.D. in Biochemistry
from the Medical College of Georgia.
Andrew Skibo, Ph.D.
Mr. Skibo has been the Head of Biologics Operations
for Blue Water Vaccines Inc. since June 2021. Mr. 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
production. He has a broad understanding of many enterprise operations having held roles in Research and Process Development, Commercial/Business
Development, Engineering and Strategic Planning.
Mr. 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 the FDA. 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.
Mr. 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.
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Brian Price, Ph.D.
Brian Price has been Blue Water Vaccines Inc.’s
Head of Technology Strategy since September 2020 after being the Chief Compliance Officer from August 2019 to September 2020.
Mr. Price is an experienced professional in FDA-regulated industries with a focus in CMC Development, regulatory compliance and QC
analytical method development and validation. He has a successful track record of Business Development Growth with Government and Commercial
funded toxicology, therapeutic and vaccine development, and analytical clientele. Brian’s expertise is with molecular biology, microbiology,
infectious disease, immunology, vaccines and drug discovery and development, and FDA compliance. His prior experience includes, from August 2018
to March 2019, as Vice-President of Pharmaceutical Development at Myonexus Therapeutics, Inc. and multiple positions with Battelle
from November 2011 to August 2018, including his most recent role as Vice President of Business Development for the Health Business
Unit. At Battelle, Brian supported sales for, directed and oversaw basic and applied research projects for a number of commercial and
government clients in the areas of toxicology, vaccine and therapeutic efficacy evaluation, medical device development, environmental
microbiology, assay development and validation, and vaccine production, including participating in the development of pre-clinical trial
material for the next generation Anthrax vaccine based on recombinant Protective Antigen for VaxGen, Inc. Mr. Price completed is
undergraduate studies in Microbiology and Ph.D. in Microbiology at The Ohio State University.
Non-Executive Directors
Allan
L. Shaw , one of our directors since January 2020, brings more than two decades of public company financial, operational, and strategic
global business leadership. Mr. Shaw is a highly regarded biopharma executive and board member with extensive senior global strategic,
financial, M&A, operational, capital markets and governance experience. Mr. Shaw’s notable accomplishments include raising more
than $4 billion in public/private financings (including 2 IPOs), scaling a company from $20 million to $750 million in revenue as well
as being involved with the sourcing/development/commercialization of various drug products in numerous therapeutic areas. Mr. Shaw has
been the chief financial officer of Portage Biotech Inc. (PBT.U: CSE, PTGEF: OTC Markets) since May 2020. Mr. Shaw is the founder and
since 2005, has served as senior managing director, of Shaw Strategic Capital LLC, an international financial advisory firm focused on
providing strategic financial counsel on a wide variety of issues such as general corporate finance, mergers and acquisitions, capital
structuring, licensing and capital markets, and serving as financial consultant to private and public companies. Mr. Shaw was the Chief
Financial Officer and Treasurer of Syndax Pharmaceuticals, Inc. from January 2016 to February 2017 and from December 2011 to September
2015, was Managing Director of Alvarez & Marsal LLC, a global professional services firm, where he led their biopharmaceutical consulting
practice. Mr. Shaw has served on five public boards including chairing two audit committees, two compensation committees, and is currently
involved with a portfolio of healthcare-related business endeavors. Mr. Shaw served as the Chief Financial Officer of Serono S.A. from
November 2002 to May 2004; NewLead Holdings Ltd from October 2009 to July 2011; and Viatel, Inc. from November 1994 to June 2002. He currently
serves on the board of directors of Edith & Carl Marks JCH of Bensonhurst, a non-profit organization, and chairs their finance committee.
Mr. Shaw is a certified public accountant in the State of New York as well as a Chartered Global Management Accountant (CGMA). Mr. Shaw
received a B.S. from the State University of New York at Oswego College. Mr. Shaw brings to our Board over twenty-five years
of experience in the finance and accounting fields. In addition, Mr. Shaw also has experience serving as a director of public companies.
Kimberly
Murphy , one of our directors since January 2020, has more than 25 years of experience at leading pharmaceutical companies
including Novartis (NYSE: NVS) and Merck & Co (NYSE: MRK). In her distinguished career at Merck, she rose through various
public affairs and business roles to leadership positions as Region Marketer for U.S. Commercial Operations, U.S. Marketing
Leader for Adult Vaccines and Director of the HPV/Gardasil Franchise. Most recently, Ms. Murphy served as currently the Vice President
of Global Vaccines Commercialization Leader, Influenza Franchise, at GlaxoSmithKline (NYSE: GSK). Ms. Murphy has been with GSK since
2011, initially serving as VP of US Vaccines Customer Strategy from October 2012 to June 2014, then VP of the North America
Vaccines Integration Planning from June 2014 to May 2015, followed by VP and Global Marketing Head for the Shingles Vaccines
from May 2015 to February 2016, before transitioning to the Global Vaccines Commercialization Leader for the Influenza Franchise.
Kim has Board and Advisory experience that includes serving on the boards of Oragenics, Inc. (NYSE: OGEN) as well as the GSK Representative
to the Biotechnology Industry Organization’s Biodefense Advisory Council, and on the St. Joseph’s University Pharmaceutical &
Healthcare Marketing MBA Program’s Advisory Board. Additionally, Ms. Murphy was a director of BWAC from December 2020 to September 2021,
and since BWAC’s business combination with Clarus Therapeutics Holdings Inc. (Nasdaq:CRXT), has continued to serve as chair of the
post-combination entity’s board of directors, and also she serves as a member of the Compensation and Nominating and Corporate Governance
Committees. Ms. Murphy received a B.A. in English from Old Dominion University, a M.B.A. in Marketing from St. Joseph’s University,
and the Marketing Excellence Program from the Wharton School of University of Pennsylvania. She is well qualified to serve on our Board
due to her extensive experience in the healthcare industry. Ms. Murphy brings to the Company’s
Board a wealth of experience in the commercialization and marketing of development-stage vaccine candidates, particularly those created
by public companies. Ms. Murphy’s skill will be vital to the Company’s development of all of our vaccines candidates .
115
Mike
Venerable has been one of Blue Water Vaccines Inc.’s directors since April 2020. As CEO and managing director of CincyTech,
Mike Venerable leads with experience from both sides of the table: as a software industry entrepreneur and executive, and a seasoned investment
and venture capital professional. Mike joined CincyTech in 2006, helping to raise its inaugural fund. He served as managing director for
a decade, evaluating investment opportunities, advising startup companies, and helping to build a network of investors and strategic partners
and raise CincyTech Funds II- IV. Previously, Mike was co-founder and CEO of Talus, a leading data warehouse consultancy,
which was acquired by Sagent Technology. Mike led the company’s services organization through the company’s successful IPO
in 1999. He has specific experience in raising angel and venture capital, software business design and operation, software product management,
business valuation, financial analysis and intellectual property. As an industry practitioner, Mike is an expert on data warehouse design,
business intelligence and analytic applications and software development processes. He has consulted on strategic product development
initiatives for leading technology companies, including Siebel, Advent and Micros. Mike served in the US Army as a Korean linguist after
graduating from the University of Dayton. Mr. Venerable brings to our Board an extensive array of business and industry experience
as well as experience as a director of private and public companies. Mr Venerable’s background provides a foundation for leadership
and consensus-building.
James Sapirstein ,
who has been one of Blue Water Vaccines Inc.’s directors since February 2022, has over 35 years of experience leading,
founding, growing, and selling healthcare companies, specifically in the pharmaceutical space. Mr. Sapirstein is currently the President
and CEO of AzurRx BioPharma (Nasdaq: AZRX), 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. (Nasdaq: 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 (Nasdaq: TBRA), then a private company,
and later acquired by Allergan (NYSE: AGN). 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. Additionally, Mr. Sapirstein holds board positions on Marizyme (OTCMKTS:MRZM)
(Executive Chairman) since December 2018 Enochian Biosciences (Nasdaq: ENOB) since April 2018 and Leading Biosciences since
March 2016. He previously served as a director of BioNJ from February 2017 to February 2019, 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. (NYSE: 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. Mr. Sapirstein received a B.S. 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. Mr.
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 .
116
Directors and Executive Officers Qualifications
Although we have not formally
established any specific minimum qualifications that must be met by each of our officers, we generally evaluate the following qualities:
educational background, diversity of professional experience, including whether the person is a current or was a former chief executive
officer or chief financial officer of a public company or the head of a division of a prominent international organization, knowledge
of our business, integrity, professional reputation, independence, wisdom, and ability to represent the best interests of our shareholders.
The nominating and corporate
governance committee of the board of directors prepare policies regarding director qualification requirements and the process for identifying
and evaluating director candidates for adoption by the board of directors. The above-mentioned attributes, along with the leadership skills
and other experiences of our officers and board of directors members described above, provide us with a diverse range of perspectives
and judgment necessary to facilitate our goals of shareholder value appreciation through organic and acquisition growth.
Director Independence
Our board of directors has
reviewed the composition of our board of directors and its committees and the independence of each director. Based upon information requested
from and provided by each director concerning his background, employment and affiliations, including family relationships, our board of
directors has determined that each of Messrs. Allan Shaw and James Sapirstein as well as Ms. Kimberly Murphy, is an “independent
director” as defined under Rule 5605(a)(2) of the Nasdaq Marketplace Rules. Our board of directors also determined that Messrs.
Allan Shaw and James Sapirstein as well as Ms. Kimberly Murphy, who comprise our audit committee and our compensation committee, and Messrs.
Allan Shaw and James Sapirstein as well as Ms. Kimberly Murphy, members of our nominating and corporate governance committee, satisfy
the independence standards for such committees established by the SEC and the Nasdaq Marketplace Rules, as applicable. In making such
determinations, our board of directors considered the relationships that each such non-employee director has with our company and all
other facts and circumstances our board of directors deemed relevant in determining independence, including the beneficial ownership of
our capital stock by each non-employee director.
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. Three of
our 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.
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. 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.
117
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.
Committees of the Board of Directors
Our board of directors 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 of directors. Copies of each committee’s charter are posted on the Investor Relations
section of our website, which is located at www.bluewatervaccines.com . Each committee has the composition and responsibilities
described below. Our board of directors may from time to time establish other committees.
Audit Committee
Our audit committee consists of Allan Shaw, who
is the chair of the committee, Kimberly Murphy and James Sapirstein. Our board of directors 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 our major financial risk exposures, including the
guidelines and policies to govern the process by which risk assessment and risk management is implemented; and
● reviewing and evaluating on an annual basis the performance
of the audit committee, including compliance of the audit committee with its charter.
Our board of directors has determined that Allan
Shaw 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, our board has considered Mr. Shaw’s extensive
financial experience and business background. Both our independent registered public accounting firm and management periodically meet
privately with our audit committee. During the fiscal year ended December 31, 2021, our audit committee had not yet been established and
as such our audit committee members did not attend any audit committee meetings. Our audit committee was formed upon the consummation
of our initial public offering.
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Compensation Committee
Our compensation committee consists of James Sapirstein,
who is the chair of the committee, Kimberly Murphy and Allan Shaw. 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;
and
● preparing the report that the SEC requires in our annual
proxy statement.
During the fiscal year ended December 31, 2021,
our compensation committee had not yet been established and as such our audit committee members did not attend any compensation committee
meetings. Our compensation committee was formed upon the consummation of our initial public offering.
Nominating and Corporate Governance Committee
Our nominating and corporate governance committee
consists of Kimberly Murphy, who is the chair of the committee, Allan Shaw and James Sapirstein. Our board of directors 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; and
● evaluating nominations by stockholders of candidates for
election to our board of directors.
During the fiscal year ended December 31, 2021,
our nominating and corporate governance committee had not yet been established and as such our audit committee members did not attend
any nominating and corporate governance committee meetings. Our nominating and corporate governance committee was formed upon the consummation
of our initial public offering.
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;
● David Zarley, Ph.D., with more than 30 years of experience
in vaccine research and development, including former leadership roles at Pfizer and Wyeth; and,
● John Rice, Ph.D., Managing Director at CincyTech with more
than 30 years of biotechnology advising experience.
119
Compensation Committee Interlocks and Insider
Participation
None of the members of our
Compensation Committee, at any time, has been one of our officers or employees, or, during the last fiscal year, was a participant in
a related-party transaction that is required to be disclosed. None of our executive officers currently serves, or in the past year has
served, as a member of the Board of Directors or Compensation Committee of any entity that has one or more executive officers on our Board
of Directors or Compensation Committee.
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.
Item 11. Executive Compensation.
Summary Compensation Table
The following table sets forth total compensation
paid to our named executive officers for the years ended December 31, 2021 and 2020. Individuals we refer to as our “named
executive officers” include our Chief Executive Officer and our one additional most highly compensated executive officer whose salary
and bonus for services rendered in all capacities exceeded $100,000 during the fiscal year ended December 31, 2021.
Name and Principal Position
Year
Salary
($)
Bonus
($)
Option
Awards
($) (1)
Non-Equity
Incentive
Plan Compensation
($)
Nonqualified
Deferred
Compensation
Earnings
($)
All
Other
Compensation
($)
Total
($)
Joseph Hernandez
2021
420,000
210,000
—
—
—
—
630,000
Chief Executive Officer
2020
420,000
—
—
—
—
—
420,000
Erin Henderson
2021
120,000
51,173
—
—
—
—
171,173
Chief Business Officer and Corporate Secretary
2020
80,849
—
31,535
—
—
—
112,384
(1) 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.
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.
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
bonus. Pursuant to the employment agreement, following the completion of our initial public offering, Mr. Hernandez’s base
salary is $595,000. 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.
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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. Hernandez 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 applicable); (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 occurred, assuming Mr. Hernandez 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
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. Hernandez 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.
121
Jon Garfield
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 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 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 “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. Garfield 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 applicable); (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. Garfield is terminated without cause or he resigns for good
reason, Mr. Garfield 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 occurred, assuming Mr. Garfield 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 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. Garfield 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. Garfield 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 Inc. or otherwise interfere
with any transaction, agreement, business relationship, and/or business opportunity between Blue Water Vaccines Inc. 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. Garfield 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.
122
Erin Henderson — Employment Agreement
Effective upon the closing of our initial public
offering, we entered into an employment agreement with Ms. Henderson, pursuant to which she is employed as the Chief Business Officer
of 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 bonus. Pursuant to the employment agreement, following the completion of our initial
public offering, Ms. Henderson’s base salary is $325,000. The annual performance bonus will be up to 40% 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 Ms. Henderson’s employment
is terminated by the Company without cause (as defined in the employment agreement), or if Ms. Henderson’s terminates her employment
for “Good Reason” (as defined in the employment agreement), in addition to accrued unpaid salary, reimbursements and vacation days,
she 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
Ms. Henderson 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 applicable); (iii) a payment equal to nine (9) months of her 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 her 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, Ms. Henderson is terminated without cause or resigns for good reason,
Ms. Henderson 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 occurred, assuming Ms. Henderson 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 applicable); (iii) severance
of 12 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 nine months following her termination. Additionally,
any unvested portion of the equity awards held subject to time-vesting held by Ms. Henderson 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, Ms. Henderson 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 Inc. or otherwise interfere
with any transaction, agreement, business relationship, and/or business opportunity between Blue Water Vaccines Inc. 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”), Ms. Henderson 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.
123
Potential Payments Upon Termination or Change-in-Control
See “Employment Agreements of Named Executive
Officers” above.
Outstanding Equity Awards at Fiscal Year-End
The following table summarizes
the number of shares of common stock underlying outstanding equity incentive plan awards for each named executive officer as of December
31, 2021.
Name
Grant Date
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
Option
Exercise
Price ($)
Option
Expiration
Date
Joseph Hernandez
-
-
-
-
-
Erin Henderson (1)
04/2/20
22,952
22,968
0.01
03/2/30
(1) This option vests over 45 months from the vesting commencement
date, with 1/4 vesting December 31, 2020, and the remainder vesting in 36 equal monthly installments, subject to continued service through
each such vesting date.
Director Compensation
Historically, our directors
have not received cash compensation for their service. We plan to adopt a new director compensation program recommended by our corporate
governance committee and/or compensation committee pursuant to which we pay cash compensation or equity compensation or both. Our corporate
governance committee will continue to review and make recommendations to the board regarding compensation of directors, including equity-based
plans. We will reimburse our non-employee directors for reasonable travel expenses incurred in attending board and committee meetings.
We also intend to allow our non-employee directors to participate in our equity compensation plans.
Director Compensation Table
The following table sets forth
information concerning the compensation of our directors for the fiscal year ended December 31, 2021:
Fees
Earned
or Paid In
Cash
Stock Awards
Option
Awards
Total
Name
($)
($)
($) (1)
($)
Kimberly Murphy (2)
—
—
31,566
31,566
James Sapirstein
—
—
—
—
Allan Shaw (3)
—
—
31,566
31,566
Michael Venerable
—
—
—
—
(1)
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.
(2)
Ms. Murphy has 45,920 outstanding stock options as of December 31, 2021.
(3)
Mr. Shaw has 45,920 outstanding stock options as of December 31, 2021.
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Securities Authorized for Issuance under Equity
Compensation Plans
The following table provides
information as of December 31, 2021, regarding our common stock that may be issued under the Company’s 2019 equity incentive plan
(the “2019 Plan”).
Plan category:
Number of
Securities to be
issued Upon
Exercise of
Outstanding
Options,
Warrants, and
Rights (a)
Weighted
Average
Exercise Price
of Outstanding
Options (b)
Number of
Securities
Remaining
Available for
Future Issuance
Under Equity
Compensation
Plans
(Excluding
Securities
Reflected in
column (a)) (c)
Equity compensation plans approved by stockholders
2019 Plan (1)
780,640
$ 0.01
619,360
Total
780,640
$ 0.01
619,360
(1)
The 2019 Plan permits grants of equity awards to employees, directors, consultants and other independent contractors. Our board of directors and stockholders have approved a total reserve of 1,400,000 shares for issuance under the 2019 Plan.
2022 Equity Incentive Plan
Our board of directors adopted our 2022 Plan effective
upon the completion of our initial public offering, and our stockholders approved our 2022 Plan effective upon the completion of the initial
public offering. Our 2022 Plan is a successor to and continuation of our 2019 Plan. Our 2022 Plan will become effective on the date of
the completion of our initial public. Once the 2022 Plan became effective, no further grants will be made under the 2019 Plan.
Awards. Our 2022 Plan
provides for the grant of incentive stock options, or ISOs, within the meaning of Section 422 of the Internal Revenue Code, or the
Code, to employees, including employees of any parent or subsidiary, and for the grant of nonstatutory stock options, or NSOs, stock appreciation
rights, restricted stock awards, restricted stock unit awards, performance awards and other forms of awards to employees, directors and
consultants, including employees and consultants of our affiliates.
Authorized Shares. Initially,
the maximum number of shares of our common stock that may be issued under our 2022 Plan after it becomes effective will not exceed 1,600,000 shares
of our common stock, which is the sum of (i) 200,000 new shares, plus (ii) an additional number of shares not to exceed 1,400,000
(calculated after giving effect to the Pre-IPO Stock Split), consisting of (A) shares that remain available for the issuance
of awards under our 2019 Plan as of immediately prior to the time our 2022 Plan becomes effective and (B) shares of our common stock
subject to outstanding stock options or other stock awards granted under our 2019 Plan that, on or after the 2022 Plan becomes effective,
terminate or expire prior to exercise or settlement; are not issued because the award is settled in cash; are forfeited because of the
failure to vest; or are reacquired or withheld (or not issued) to satisfy a tax withholding obligation or the purchase or exercise price,
if any, as such shares become available from time to time. The number of shares of common stock available for issuance under our 2022
Plan will be reduced by: one share for each share of common stock issued pursuant to a stock option or stock appreciation right with respect
to which the exercise or strike price is at least 100% of the Fair Market Value of the Common Stock subject to the stock option or appreciation
right on the grant date; and (ii) 1.20 shares for each share of common stock issued pursuant to any restricted stock unit or other
“full value award.” The maximum number of shares of our common stock that may be issued on the exercise of ISOs under our
2022 Plan is 250,000 shares.
125
Shares subject to stock awards granted under our
2022 Plan that expire or terminate without being exercised in full or that are paid out in cash rather than in shares do not reduce the
number of shares available for issuance under our 2022 Plan. Shares withheld under a stock award to satisfy the exercise, strike or purchase
price of a stock award or to satisfy a tax withholding obligation do not reduce the number of shares available for issuance under our
2022 Plan. If any shares of our common stock issued pursuant to a stock award are forfeited back to or repurchased or reacquired by us
(i) because of a failure to meet a contingency or condition required for the vesting of such shares, (ii) to satisfy the exercise,
strike or purchase price of an award or (iii) to satisfy a tax withholding obligation in connection with an award, the shares that
are forfeited or repurchased or reacquired will revert to and again become available for issuance under the 2022 Plan. Any shares previously
issued which are reacquired in satisfaction of tax withholding obligations or as consideration for the exercise or purchase price of a
stock award will again become available for issuance under the 2022 Plan. The number of shares available for issuance under our 2022 Plan
will increase by 1.20 shares for each share subject to restricted stock units or other full value awards (not including stock options
or stock appreciation rights) which are forfeited or reacquired for the reasons described in the preceding two sentences.
Plan Administration. Our
Board of Directors has assigned the authority to administer the 2022 Plan to our Compensation Committee, but may, at any time, re-vest in
itself some or all of the power delegated to our Compensation Committee. The Compensation Committee may delegate to one or more of our
officers the authority to (i) designate employees (other than officers) to receive specified stock awards and (ii) determine
the number of shares subject to such stock awards. Under our 2022 Plan, our Compensation Committee has the authority to determine award
recipients, grant dates, the numbers and types of stock awards to be granted, the applicable fair market value, and the provisions of
each stock award, including the period of exercisability and the vesting schedule applicable to a stock award.
Stock Options. ISOs
and NSOs are granted under stock option agreements in a form approved by the Compensation Committee. The Compensation Committee determines
the exercise price for stock options, within the terms and conditions of the 2022 Plan, provided that the exercise price of a stock option
generally cannot be less than 100% of the fair market value of our common stock on the date of grant. Options granted under the 2022 Plan
vest at the rate specified in the stock option agreement as determined by the Compensation Committee.
The Compensation Committee determines the term of
stock options granted under the 2022 Plan, up to a maximum of 10 years. Unless the terms of an option holder’s stock option
agreement, or other written agreement between us and the recipient approved by the Compensation Committee, provide otherwise, if an option
holder’s service relationship with us or any of our affiliates ceases for any reason other than disability, death or cause, the
option holder may generally exercise any vested options for a period of three months following the cessation of service. This period may
be extended in the event that exercise of the option is prohibited by applicable securities laws. If an option holder’s service
relationship with us or any of our affiliates ceases due to death, or an option holder dies within a certain period following cessation
of service, the option holder or a beneficiary may generally exercise any vested options for a period of 18 months following the
date of death. If an option holder’s service relationship with us or any of our affiliates ceases due to disability, the option
holder may generally exercise any vested options for a period of 12 months following the cessation of service. In the event of a
termination for cause, options generally terminate upon the termination date. In no event may an option be exercised beyond the expiration
of its term.
Acceptable consideration for the purchase of common
stock issued upon the exercise of a stock option will be determined by the Compensation Committee and may include (i) cash, check,
bank draft or money order, (ii) a broker-assisted cashless exercise, (iii) the tender of shares of our common stock previously
owned by the option holder, (iv) a net exercise of the option if it is an NSO or (v) other legal consideration approved by the
Board of Directors.
126
Unless the Compensation Committee provides otherwise,
options or stock appreciation rights generally are not transferable except by will or the laws of descent and distribution. Subject to
approval of the Compensation Committee or a duly authorized officer, an option may be transferred pursuant to a domestic relations order,
official marital settlement agreement or other divorce or separation instrument.
Tax Limitations on ISOs. The
aggregate fair market value, determined at the time of grant, of our common stock with respect to ISOs that are exercisable for the first
time by an award holder during any calendar year under all of our stock plans may not exceed $100,000. Options or portions thereof that
exceed such limit will generally be treated as NSOs. No ISO may be granted to any person who, at the time of the grant, owns or is deemed
to own stock possessing more than 10% of our total combined voting power or that of any of our parent or subsidiary corporations unless
(i) the option exercise price is at least 110% of the fair market value of the stock subject to the option on the date of grant and
(ii) the term of the ISO does not exceed five years from the date of grant.
Restricted Stock Unit Awards. Restricted
stock unit awards are granted under restricted stock unit award agreements in a form approved by the Compensation Committee. Restricted
stock unit awards may be granted in consideration for any form of legal consideration that may be acceptable to our board of directors
and permissible under applicable law. A restricted stock unit award may be settled by cash, delivery of stock, a combination of cash and
stock as deemed appropriate by the Compensation Committee or in any other form of consideration set forth in the restricted stock unit
award agreement. Additionally, dividend equivalents may be credited in respect of shares covered by a restricted stock unit award. Except
as otherwise provided in the applicable award agreement, or other written agreement between us and the recipient approved by the Compensation
Committee, restricted stock unit awards that have not vested will be forfeited once the participant’s continuous service ends for
any reason.
Restricted Stock Awards. Restricted
stock awards are granted under restricted stock award agreements in a form approved by the Compensation Committee. A restricted stock
award may be awarded in consideration for cash, check, bank draft or money order, past or future services to us or any other form of legal
consideration that may be acceptable to our board of directors and permissible under applicable law. The Compensation Committee determines
the terms and conditions of restricted stock awards, including vesting and forfeiture terms. If a participant’s service relationship
with us ends for any reason, we may receive any or all of the shares of common stock held by the participant that have not vested as of
the date the participant terminates service with us through a forfeiture condition or a repurchase right.
Stock Appreciation Rights. Stock
appreciation rights are granted under stock appreciation right agreements in a form approved by the Compensation Committee. The Compensation
Committee determines the strike price for a stock appreciation right, which generally cannot be less than 100% of the fair market value
of our common stock on the date of grant. A stock appreciation right granted under the 2022 Plan vests at the rate specified in the stock
appreciation right agreement as determined by the Compensation Committee. Stock appreciation rights may be settled in cash or shares of
common stock or in any other form of payment as determined by the Board and specified in the stock appreciation right agreement.
The Compensation Committee determines the term of
stock appreciation rights granted under the 2022 Plan, up to a maximum of 10 years. If a participant’s service relationship
with us or any of our affiliates ceases for any reason other than cause, disability or death, the participant may generally exercise any
vested stock appreciation right for a period of three months following the cessation of service. This period may be further extended in
the event that exercise of the stock appreciation right following such a termination of service is prohibited by applicable securities
laws. If a participant’s service relationship with us, or any of our affiliates, ceases due to disability or death, or a participant
dies within a certain period following cessation of service, the participant or a beneficiary may generally exercise any vested stock
appreciation right for a period of 12 months in the event of disability and 18 months in the event of death. In the event of
a termination for cause, stock appreciation rights generally terminate immediately upon the occurrence of the event giving rise to the
termination of the individual for cause. In no event may a stock appreciation right be exercised beyond the expiration of its term.
Performance Awards. The
2022 Plan permits the grant of performance awards that may be settled in stock, cash or other property. Performance awards may be structured
so that the stock or cash will be issued or paid only following the achievement of certain pre-established performance goals
during a designated performance period. Performance awards that are settled in cash or other property are not required to be valued in
whole or in part by reference to, or otherwise based on, the common stock.
127
The
performance goals may be based on any measure of performance selected by the board of directors or the Compensation Committee. The performance
goals may be based on company-wide performance or performance of one or more business units, divisions, affiliates or business segments,
and may be either absolute or relative to the performance of one or more comparable companies or the performance of one or more relevant
indices. Unless specified otherwise by the board of directors at the time the performance award is granted, the board or Compensation
Committee will appropriately make adjustments in the method of calculating the attainment of performance goals as follows: (i) to
exclude restructuring and/or other nonrecurring charges; (ii) to exclude exchange rate effects; (iii) to exclude the effects
of changes to generally accepted accounting principles; (iv) to exclude the effects of any statutory adjustments to corporate tax
rates; (v) to exclude the effects of items that are “unusual” in nature or occur “infrequently” as determined
under generally accepted accounting principles; (vi) to exclude the dilutive effects of acquisitions or joint ventures; (vii) to
assume that any portion of our business which is divested achieved performance objectives at targeted levels during the balance of a
performance period following such divestiture; (viii) to exclude the effect of any change in the outstanding shares of our common
stock by reason of any stock dividend or split, stock repurchase, reorganization, recapitalization, merger, consolidation, spin-off, combination
or exchange of shares or other similar corporate change or any distributions to common stockholders other than regular cash dividends;
(ix) to exclude the effects of stock based compensation and the award of bonuses under our bonus plans; (x) to exclude costs
incurred in connection with potential acquisitions or divestitures that are required to be expensed under generally accepted accounting
principles; (xi) to exclude the goodwill and intangible asset impairment charges that are required to be recorded under generally
accepted accounting principles; and (xi) to exclude the effects of the timing of acceptance for review and/or approval of submissions
to the U.S. Food and Drug Administration or any other regulatory body.
Other
Stock Awards. The Compensation Committee may grant other awards based in whole or in part by reference to
our common stock. The Compensation Committee will set the number of shares under the stock award (or cash equivalent) and all other terms
and conditions of such awards.
Non-Employee Director
Compensation Limit. The aggregate value of all compensation granted or paid to any non-employee director
with respect to any calendar year, including awards granted and cash fees paid by us to such non-employee director, will not
exceed $150,000 in total value; provided that such amount will increase to $200,000 for the first year for newly appointed or elected non-employee directors.
Changes
to Capital Structure. In the event there is a specified type of change in our capital structure, such as a
stock split, reverse stock split or recapitalization, appropriate adjustments will be made to (i) the class and maximum number of
shares reserved for issuance under the 2022 Plan, (ii) the class and maximum number of shares by which the share reserve may increase
automatically each year, (iii) the class and maximum number of shares that may be issued on the exercise of ISOs and (iv) the
class and number of shares and exercise price, strike price or purchase price, if applicable, of all outstanding stock awards.
Corporate
Transactions. The following applies to stock awards under the 2022 Plan in the event of a corporate transaction
(as defined in the 2022 Plan), unless otherwise provided in a participant’s stock award agreement or other written agreement with
us or one of our affiliates or unless otherwise expressly provided by the Board of Directors or Compensation Committee at the time of
grant.
In
the event of a corporate transaction, any stock awards outstanding under the 2022 Plan may be assumed, continued or substituted for by
any surviving or acquiring corporation (or its parent company), and any reacquisition or repurchase rights held by us with respect to
the stock award may be assigned to the successor (or its parent company). If the surviving or acquiring corporation (or its parent company)
does not assume, continue or substitute for such stock awards, then (i) with respect to any such stock awards that are held by participants
whose continuous service has not terminated prior to the effective time of the corporate transaction, or current participants, the vesting
(and exercisability, if applicable) of such stock awards will be accelerated in full to a date prior to the effective time of the corporate
transaction (contingent upon the effectiveness of the corporate transaction), and such stock awards will terminate if not exercised (if
applicable) at or prior to the effective time of the corporate transaction, and any reacquisition or repurchase rights held by us with
respect to such stock awards will lapse (contingent upon the effectiveness of the corporate transaction), and (ii) any such stock
awards that are held by persons other than current participants will terminate if not exercised (if applicable) prior to the effective
time of the corporate transaction, except that any reacquisition or repurchase rights held by us with respect to such stock awards will
not terminate and may continue to be exercised notwithstanding the corporate transaction.
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In
the event a stock award will terminate if not exercised prior to the effective time of a corporate transaction, the board of directors
may provide, in its sole discretion, that the holder of such stock award may not exercise such stock award but instead will receive a
payment equal in value to the excess (if any) of (i) the per share amount payable to holders of common stock in connection with
the corporate transaction over (ii) any per share exercise price payable by such holder, if applicable. In addition, any escrow,
holdback, earn out or similar provisions in the definitive agreement for the corporate transaction may apply to such payment to the same
extent and in the same manner as such provisions apply to the holders of common stock.
Plan
Amendment or Termination. Our board of directors has the authority to amend, suspend or terminate our 2022
Plan, provided that such action does not materially impair the existing rights of any participant without such participant’s written
consent. Certain material amendments also require the approval of our stockholders. No ISOs may be granted after the tenth anniversary
of the date our board of directors adopts our 2022 Plan. No stock awards may be granted under our 2022 Plan while it is suspended or
after it is terminated.
2019
Equity Incentive Plan
Our
board of directors adopted and our stockholders approved our 2019 Equity Incentive Plan (the “2019 Plan”) in July 2019 for
grants of awards to employees, directors, officers and consultants of us or any of our subsidiaries. Once the 2022 Plan became effective,
no further grants will be made under the 2019 Plan. However, the 2019 Plan will continue to govern the terms and conditions of the outstanding
awards previously granted under the 2019 Plan.
Awards. Our
2019 Plan provides for the grant of stock awards (collectively, “Stock Awards”) to employees, directors, officers and consultants
of us or any of our subsidiaries, consisting of (i) incentive stock options, (“ISOs”), within the meaning of Section 422
of the Internal Revenue Code (the “Code”); (ii) nonstatutory stock options (“NSOs”); (iii) stock appreciation
rights; (iv) restricted stock awards; (v) restricted stock unit awards, and (vi) other forms of awards.
Authorized
Shares. As of March 1, 2022, stock options covering 780,640 shares, each with an exercise price of $0.01
per share were the only outstanding Stock Awards outstanding under our 2019 Plan, and 619,360 shares of our common stock remained available
for the future grant of awards under our 2019 Plan, which upon the adoption of the 2022 Plan, became issuable under the 2022 Plan.
Plan
Administration. The 2019 Plan may be administered by our board of directors, and our board of directors may
delegate such administration to a committee of the board of directors (as applicable, the “Administrator”). The Administrator,
in its discretion, selects the individuals to whom awards may be granted, the time or times at which such awards are granted and the
terms and conditions of such awards.
Stock
Options. Stock options entitle the holder to purchase a specified number of shares of common stock at a specified
price (the exercise price), subject to the terms and conditions of the stock option grant. Our board of directors may grant either incentive
stock options, which must comply with Code Section 422, or nonqualified stock options. ISO’s may only be granted to employees
of the Company or a “parent corporation” or “subsidiary corporation” thereof (as such terms are defined in Sections
424(e) and 424(f) of the Code). Our Administrator sets exercise prices and terms and conditions, except that stock options
must be granted with an exercise price not less than 100% of the fair market value of our common stock on the date of grant. Unless our
Administrator determines otherwise, fair market value means, as of a given date, the closing price of our common stock. At the time of
grant, our board of directors determines the terms and conditions of stock options, including the quantity, exercise price, vesting periods,
term (which may not exceed 10 years) and other conditions on exercise. Pursuant to the 2019 Plan, we may only issue 1,400,000 ISO’s.
Eligibility. Awards
may be granted under the 2019 Plan to officers, employees, directors, officers and of us and our subsidiaries. Incentive stock options
may be granted only to employees of us or our subsidiaries.
Restricted
Stock, Restricted Stock Units and Other Stock-Based Awards. Our board of directors may grant awards of restricted stock, which
are shares of common stock subject to specified restrictions, and restricted stock units, or RSUs, which represent the right to receive
shares of our common stock in the future. These awards may be made subject to repurchase, forfeiture or vesting restrictions at the discretion
of our board of directors discretion. The restrictions may be based on continuous service with us or the attainment of specified performance
goals, as determined by the board of directors. Stock units may be paid in stock or cash or a combination of stock and cash, as determined
by the board of directors. Other stock awards valued in whole or in part by reference to, or otherwise based on, Common Stock, including
the appreciation in value thereof (e.g., options or stock rights with an exercise price or strike price less than one hundred percent
(100%) of the fair market value of the common stock at the time of grant) may be granted either alone or in addition to stock awards
provided for under the 2019 Plan.
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Stock
Appreciation Rights. Upon exercise, SARs entitle the holder to receive payment per share in stock or cash,
or in a combination of stock and cash, equal to the excess of the share’s fair market value on the date of exercise over the aggregate
strike price of the number of Common Stock equivalents with respect to which the Participant is exercising the SAR on such date (the
“grant price”. Exercise of a SAR issued in tandem with a stock option will reduce the number of shares underlying the related
stock option to the extent of the SAR exercised. The term of a SAR cannot exceed 10 years.
Changes
to Capital Structure. In the event there is a specified type of change in our capital structure, such as a
stock split, reverse stock split or recapitalization, appropriate adjustments will be made to (i) the class and maximum number of
shares subject to the 2019 Plan, (ii) the class and maximum number of shares that may be issued on the exercise of ISOs and (iii) the
class and number of shares and exercise price, strike price or purchase price, if applicable, of all outstanding stock awards.
Corporate
Transactions. The following applies to Stock Awards under the 2019 Plan in the event of a corporate transaction
(as defined in the 2019 Plan), unless otherwise provided in a participant’s stock award agreement or other written agreement with
us or one of our affiliates or unless otherwise expressly provided by the Board of Directors at the time of grant.
In
the event of a corporate transaction, the board of directors may take one of the following actions, contingent on the completion of the
corporate transaction: (i) arrange for the surviving or acquiring corporation (or its parent company) to assume, continue or substitute
the Stock Award for a similar stock award; (ii) arrange for the assignment of any reacquisition or repurchase rights held by the
Company in respect of common stock issued pursuant to the Stock Award to the surviving or acquiring corporation (or its parent company);
(iii) accelerate the vesting (in whole or in part) of the Stock Award; (iv) arrange for the lapse, in whole or in part, of
any reacquisition or repurchase rights held by the Company with respect to the Stock Award; (v) cancel or arrange for the cancellation
of the Stock Award, to the extent not vested or not exercised prior to the effective time of the corporate transaction, in exchange for
such cash consideration that the Board of Directors; and (vi) make a payment equal to the excess, if any, of (A) the value
of the property the participant would have received upon the exercise of the Stock Award immediately prior to the effective time of the
corporate transaction, over (B) any exercise price payable by such holder in connection with such exercise The Board of Directors
need not take the same action or actions with respect to all Stock Awards or portions thereof or with respect to all participants. The
Board of Directors may also take different actions with respect to the vested and unvested portions of a Stock Award.
Additionally,
under the 2019 Plan, a Stock Award may be subject to additional acceleration of vesting and exercisability upon or after a Change in
Control (as defined in the 2019 Plan) as may be provided in the Grant Agreement for such Stock Award or as may be provided in any other
written agreement between the participant and the Company or any of its subsidiaries which may employ the participant, but in the absence
of such provision, no such acceleration will occur.
Plan
Amendment or Termination. Our board of directors has the authority to amend, suspend or terminate our 2019
Plan, subject to certain conditions, including that such action does not materially impair the existing rights of any participant without
such participant’s written consent. Certain material amendments also require the approval of our stockholders. No ISOs may be granted
after the tenth anniversary of the date our board of directors adopted our 2019 Plan.
Item
12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The
following table sets forth certain information concerning the ownership of our common stock, with respect to: (i) each person, or
group of affiliated persons, known to us to be the beneficial owner of more than five percent of our common stock; (ii) each of
our directors; (iii) each of our named executive officers; and (iv) all of our current directors and executive officers as
a group.
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Applicable
percentage ownership is based on 11,048,587 shares of common stock outstanding as of March 1, 2022.
We
have determined beneficial ownership in accordance with the rules of the SEC. These rules generally attribute beneficial ownership
of securities to persons who possess sole or shared voting or investment power with respect to such securities. In addition, pursuant
to such rules, we deemed outstanding shares of common stock subject to options or warrants held by that person that are currently exercisable
or exercisable within 60 days of March 1, 2022. We did not deem such shares outstanding, however, for the purpose of computing
the percentage ownership of any other person. Except as indicated by the footnotes below, we believe, based on the information furnished
to us, that the beneficial owners named in the table below have sole voting and investment power with respect to all shares of our common
stock that they beneficially own, subject to applicable community property laws.
Shares of Common Stock Owned
Name and Address of Beneficial Owner (1)
Number of Shares
Percentage
5% Stockholders
Cincinnati Cornerstone Investors BWV I, LLC
3,611,201 (1)
32.68 %
CincyTech Fund IV, LLC
832,836 (2)
7.54 %
Named Executive Officers and Directors
Joseph Hernandez
3,200,000
28.96 %
Kimberly Murphy
26,768 (3)
*
Allan L. Shaw.
26,768 (3)
*
Michael Venerable
James Sapirstein
Erin Henderson
26,776 (4)
*
Jon Garfield
All directors and named executive officers as a group (7 persons)
29.69 %
* Represents
beneficial ownership of less than 1%.
(1) Consists
of 3,611,201 shares of common stock (following the conversion of the preferred stock) held of record by Cincinnati Cornerstone Investors
BWV I. Cincinnati Cornerstone Capital, LLC holds voting and dispositive power with respect to the shares of common stock held
by Cincinnati Cornerstone Investors BWV I. The address for these entities is 2900 Reading Rd., Suite 410, Cincinnati, OH 45206.
(2) Consists
of (i) 806,068 shares of common stock (following the conversion of preferred stock) held of record by CincyTech Fund IV, LLC
and (ii) 26,768 shares of common stock underlying options that are currently exercisable within 60 days of March 1, 2022.
CincyTech, LLC holds voting and dispositive power with respect to the shares of common stock held by CincyTech Fund IV, LLC. The
address for these entities is 2900 Reading Rd., Suite 410, Cincinnati, OH 45206.
(3) Consists
of 26,768 shares of common stock underlying options that are currently exercisable within 60 days of March 1, 2022.
(4) Consists
of 26,776 shares of common stock underlying options that are currently exercisable within 60 days of March 1, 2022.
Item
13. Certain Relationships and Related Transactions, and Director Independence.
The
following is a description of transactions since January 1, 2020 to which we were a party in which (i) the amount involved
exceeded or will exceed the lesser of $120,000 of one percent (1%) of our average total assets at year-end for the last two completed
fiscal years and (ii) any of our directors, executive officers or holders of more than 5% of our capital stock, or any member
of the immediate family of, or person sharing the household with, any of the foregoing persons, who had or will have a direct or indirect
material interest, other than equity and other compensation, termination, change in control and other similar arrangements, which are
described under “Executive and Director Compensation.”
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Agreement
with Blue Water Real Estate Holdings
We leased office space in November 28, 2018
from an affiliate of our chief executive officer, Blue Water Real Estate Holdings, Inc. Rental expense recorded for the years ended
December 31, 2020 and 2021 was approximately $66,000, and $26,000, respectively. This lease was terminated on March 31, 2021;
however, the company did not vacate the premises until May 26, 2021. As of the date hereof, we have no outstanding obligations under
this agreement.
Consulting
Agreement with Joseph Hernandez
On
October 22, 2018, we entered into a Consulting Agreement with Joseph Hernandez, the Chief Executive Officer of Blue Water Vaccines
Inc. Consulting expense recorded for the years ended December 31, 2021 and 2020, was $420,000. Pursuant to the Consulting Agreement,
Joseph Hernandez provides us with consulting services, and we are required to pay him an aggregate amount of $1.68 million during
the term of the agreement, in monthly payments of $35,000. The Consulting Agreement was to be effective through November 1, 2022
and cancellable by either party with 90 days written notice. As of December 31, 2021, we have prepaid $140,000 on this Consulting
Agreement and the remaining monthly payments through the end of the contract term total $210,000. The Consulting Agreement became null
and void upon the consummation of our initial public offering.
Indemnification
of Officers and Directors
Our
Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws provide that we will indemnify each of our directors
and officers to the fullest extent permitted by the DGCL. Further, we have entered into indemnification agreements with each of
our directors and officers, and we have purchased a policy of directors’ and officers’ liability insurance that insures our
directors and officers against the cost of defense, settlement or payment of a judgment under certain circumstances. For further information,
see “Executive and Director Compensation — Limitations of Liability and Indemnification Matters.”
Policies
and Procedures for Related Party Transactions
All
future transactions between us and our officers, directors or five percent stockholders, and respective affiliates will be on terms no
less favorable than could be obtained from unaffiliated third parties and will be approved by a majority of our independent directors
who do not have an interest in the transactions and who had access, at our expense, to our legal counsel or independent legal counsel.
To
the best of our knowledge, during the past two fiscal years, other than as set forth above, there were no material transactions,
or series of similar transactions, or any currently proposed transactions, or series of similar transactions, to which we were or are
to be a party, in which the amount involved exceeds $120,000, and in which any director or executive officer, or any security holder
who is known by us to own of record or beneficially more than 5% of any class of our common stock, or any member of the immediate family
of any of the foregoing persons, has an interest (other than compensation to our officers and directors in the ordinary course of business).
Anti-Takeover
Provisions of Delaware Law and Our Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws
Section 203
of the Delaware General Corporation Law
We
are subject to Section 203 of the DGCL, which prohibits a Delaware corporation from engaging in any business combination with any
interested stockholder for a period of three years after the date that such stockholder became an interested stockholder, with the
following exceptions:
● before
such date, the board of directors of the corporation approved either the business combination or the transaction that resulted in the
stockholder becoming an interested stockholder;
● upon
completion of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at
least 85% of the voting stock of the corporation outstanding at the time the transaction began, excluding for purposes of determining
the voting stock outstanding (but not the outstanding voting stock owned by the interested stockholder) those shares owned (i) by
persons who are directors and also officers and (ii) employee stock plans in which employee participants do not have the right to
determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or
132
● on
or after such date, the business combination is approved by the board of directors and authorized at an annual or special meeting of
the stockholders, and not by written consent, by the affirmative vote of at least 66 2 / 3 % of the outstanding voting
stock that is not owned by the interested stockholder.
Section 203
defines a “business combination” to include the following:
● any
merger or consolidation involving the corporation and the interested stockholder;
● any
sale, transfer, pledge or other disposition of 10% or more of the assets of the corporation involving the interested stockholder;
● subject
to certain exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to
the interested stockholder;
● any
transaction involving the corporation that has the effect of increasing the proportionate share of the stock or any class or series of
the corporation beneficially owned by the interested stockholder; and
● the
receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits by or through
the corporation.
In
general, Section 203 defines an “interested stockholder” as an entity or person who, together with the person’s
affiliates and associates, beneficially owns, or within three years prior to the time of determination of interested stockholder
status did own, 15% or more of the outstanding voting stock of the corporation.
The
statute could prohibit or delay mergers or other takeover or change in control attempts and, accordingly, may discourage attempts to
acquire us even though such a transaction may offer our stockholders the opportunity to sell their stock at a price above the prevailing
market price.
Amended
and Restated Certificate of Incorporation and Amended and Restated Bylaws
Among
other things, our Amended and Restated Certificate of Incorporation and our Amended and Restated Bylaws:
● permit
our board of directors to issue up to 10,000,000 shares of preferred stock, with any rights, preferences and privileges as
they may designate, including the right to approve an acquisition or other change in control;
● provide
that the authorized number of directors may be changed only by resolution of our board of directors;
● provide
that our board of directors will be classified into three classes of directors;
● provide
that, subject to the rights of any series of preferred stock to elect directors, directors may only be removed for cause, which removal
may be effected, subject to any limitation imposed by law, by the holders of at least 66 2 / 3 % of the voting power
of all of our then-outstanding shares of the capital stock entitled to vote generally at an election of directors;
● provide
that all vacancies, including newly created directorships, may, except as otherwise required by law, be filled by the affirmative vote
of a majority of directors then in office, even if less than a quorum;
● require
that any action to be taken by our stockholders must be effected at a duly called annual or special meeting of stockholders and not be
taken by written consent or electronic transmission;
● provide
that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at
a meeting of stockholders must provide advance notice in writing, and also specify requirements as to the form and content of a stockholder’s
notice;
133
● provide
that special meetings of our stockholders may be called only by the chairman of our board of directors, our chief executive officer or
president or by our board of directors pursuant to a resolution adopted by a majority of the total number of authorized directors, and
not by our stockholders; and
● not
provide for cumulative voting rights, therefore allowing the holders of a majority of the shares of common stock entitled to vote in
any election of directors to elect all of the directors standing for election, if they should so choose.
The
amendment of any of these provisions would require approval by the holders of at least 66 2 / 3 % of the voting power
of all of our then-outstanding common stock entitled to vote generally in the election of directors, voting together as a single class.
The
combination of these provisions will make it more difficult for our existing stockholders to replace our board of directors as well as
for another party to obtain control of us by replacing our board of directors. Because our board of directors has the power to retain
and discharge our officers, these provisions could also make it more difficult for existing stockholders or another party to effect a
change in management. In addition, the authorization of undesignated preferred stock makes it possible for our board of directors to
issue preferred stock with voting or other rights or preferences that could impede the success of any attempt to change our control.
These
provisions are intended to enhance the likelihood of continued stability in the composition of our board of directors and its policies
and to discourage coercive takeover practices and inadequate takeover bids. These provisions are also designed to reduce our vulnerability
to hostile takeovers and to discourage certain tactics that may be used in proxy fights. However, such provisions could have the effect
of discouraging others from making tender offers for our shares and may have the effect of delaying changes in our control or management.
As a consequence, these provisions may also inhibit fluctuations in the market price of our stock that could result from actual or rumored
takeover attempts. We believe that the benefits of these provisions, including increased protection of our potential ability to negotiate
with the proponent of an unfriendly or unsolicited proposal to acquire or restructure our company, outweigh the disadvantages of discouraging
takeover proposals, because negotiation of takeover proposals could result in an improvement of their terms.
Choice
of Forum
Our
Amended and Restated Certificate of Incorporation requires, to the fullest extent permitted by law, that derivative actions brought in
our name, actions against directors, officers and employees for breach of fiduciary duty and certain other actions may be brought only
in the Court of Chancery in the State of Delaware, except any action (A) as to which the Court of Chancery in the State of Delaware
determines that there is an indispensable party not subject to the jurisdiction of the Court of Chancery (and the indispensable party
does not consent to the personal jurisdiction of the Court of Chancery within ten days following such determination), (B) which
is vested in the exclusive jurisdiction of a court or forum other than the Court of Chancery or (C) for which the Court of Chancery
does not have subject matter jurisdiction. If an action is brought outside of Delaware, the stockholder bringing the suit will be deemed
to have consented to service of process on such stockholder’s counsel. Although we believe this provision benefits us by providing
increased consistency in the application of law in the types of lawsuits to which it applies, a court may determine that this provision
is unenforceable, and to the extent it is enforceable, the provision may have the effect of discouraging lawsuits against our directors
and officers.
Our
Amended and Restated Certificate of Incorporation provides that the exclusive forum provision will be applicable to the fullest extent
permitted by applicable law, subject to certain exceptions. Section 27 of the Exchange Act creates exclusive federal jurisdiction
over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder. As
a result, the exclusive forum provision will not apply to suits brought to enforce any duty or liability created by the Exchange Act
or any other claim for which the federal courts have exclusive jurisdiction. In addition, our Amended and Restated Certificate of Incorporation
provides that, unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States
of America shall, to the fullest extent permitted by law, be the exclusive forum for the resolution of any complaint asserting a
cause of action arising under the Securities Act or the rules and regulations promulgated thereunder. We note, however, that there is
uncertainty as to whether a court would enforce this provision and that investors cannot waive compliance with the federal securities
laws and the rules and regulations thereunder. Section 22 of the Securities Act creates concurrent jurisdiction for state and federal
courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder.
134
Limitation
on Liability and Indemnification
See
the section titled “Management — Limitation on Liability and Indemnification Matters.”
Listing
Our
common stock is listed on The Nasdaq Capital Market under the trading symbol “BWV.”
Transfer
Agent and Registrar
The
transfer agent and registrar for our common stock is Continental Stock Transfer & Trust Company. The Transfer Agent’s
address is 1 State Street, 30 th Floor, New York, New York 10004.
Item
14. Principal Accounting Fees and Services.
Audit
and Non-Audit Fees
Mayer
Hoffman McCann P.C. (“MHM”) served as the independent registered public accounting firm to audit our books and accounts for
the fiscal years ending December 31, 2021 and 2020. Substantially all of MHM’s personnel, who work under the control of MHM shareholders,
are employees of wholly-owned subsidiaries of CBIZ, Inc., which provides personnel and various services to MHM in an alternative practice
structure.
The
table below presents the aggregate fees billed for professional services rendered by MHM for the years ended December 31, 2021 and 2020.
2021
2020
Audit fees
$ 460,673
$ 135,640
Audit-related fees
—
—
All other fees
—
—
Total fess
$ 460,673
$ 135,640
In
the above table, “audit fees” are fees billed for services provided related to the audit of our annual financial statements,
quarterly reviews of our interim financial statements, and services normally provided by the independent accountant in connection with
regulatory filings or engagements for those fiscal periods. “Audit-related fees” are fees not included in audit fees that
are billed by the independent accountant for assurance and related services that are reasonably related to the performance of the audit
or review of our financial statements. “All other fees” are fees billed by the independent accountant for products and services
not included in the foregoing categories. For the year ended December 31, 2021, the audit fees included professional services rendered
related to our initial public offering.
Pre-Approval
Policy
It
is the Audit Committee’s policy to approve in advance the types and amounts of audit, audit-related, tax, and any other services
to be provided by our independent registered public accounting firm. In situations where it is not practicable to obtain full Audit Committee
approval, the Audit Committee has delegated authority to the Chair of the Audit Committee to grant pre-approval of audit and permissible
non-audit services and any associated fees,. Any pre-approved decisions by the Chair are required to be reviewed with the Audit Committee
at its next scheduled meeting.
Our
Audit Committee was formed upon the consummation of our initial public offering. As a result, the audit committee did not pre-approve
all of the foregoing services, although any services rendered prior to the formation of our audit committee were approved by our board
of directors. Since the formation of our Audit Committee, and on a going-forward basis, the Audit Committee has and will pre-approve
all auditing services and permitted non-audit services to be performed for us by our auditors, including the fees and terms thereof (subject
to the de minimis exceptions for non-audit services described in the Exchange Act which are approved by the audit committee prior to
the completion of the audit).
135
PART
IV
Item
15. Exhibit and Financial Statement Schedules.
(a)
List of documents filed as part of this Annual Report on Form 10-K:
(1)
Financial Statements
Page
Financial Statements
Report of Independent Registered Public Accounting Firm
F-2
Balance Sheets as of December 31, 2021 and 2020
F-3
Statements of Operations for the years ended December 31, 2021 and 2020
F-4
Statements of Stockholders’ Equity for the years ended December 31, 2021 and 2020
F-5
Statements of Cash Flows for the years ended December 31, 2021 and 2020
F-6
Notes to Financial Statements
F-7
(2)
Financial Statement Schedules
All
financial statement schedules are omitted because they are not applicable or the amounts are immaterial or the required information is
presented in the financial statements and notes thereto beginning on page F-2 of this Report.
(3)
Exhibits
We
hereby file as part of this Report the exhibits listed in the attached Exhibit Index. Exhibits which are incorporated herein by reference
can be accessed on the SEC website at www.sec.gov.
Item
16. Form 10-K Summary.
We
have elected not to include a summary pursuant to this Item 16.
136
BLUE
WATER VACCINES INC.
INDEX
TO FINANCIAL STATEMENTS
Page
Financial Statements
Report of Independent Registered Public Accounting Firm
F-2
Balance Sheets as of December 31, 2021 and 2020
F-3
Statements of Operations for the years ended December 31, 2021 and 2020
F-4
Statements of Stockholders’ Equity for the years ended December 31, 2021 and 2020
F-5
Statements of Cash Flows for the years ended December 31, 2021 and 2020
F-6
Notes to Financial Statements
F-7
F- 1
Report
of Independent Registered Public Accounting Firm
To
the Board of Directors and Stockholders of
Blue Water Vaccines Inc.
Opinion
on the Financial Statements
We
have audited the accompanying balance sheets of Blue Water Vaccines Inc. (the “Company”) as of December 31, 2021
and 2020, and the related statements of operations, stockholders’ equity, and cash flows for each of the two years in the
period ended December 31, 2021, and the related notes (collectively referred to as the “financial statements”). In our
opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31,
2021 and 2020, and the results of its operations and its cash flows for each of the two years in the period ended December 31,
2021, in conformity with accounting principles generally accepted in the United States of America.
Basis
for Opinion
These
financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s
financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board
(United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal
securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We
conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits
to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.
The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part
of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing
an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error
or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding
the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant
estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits
provide a reasonable basis for our opinion.
We
have served as the Company’s auditor since 2021.
/s/
Mayer Hoffman McCann P.C.
Los
Angeles, California
March 18, 2022
F- 2
BLUE
WATER VACCINES INC.
Balance Sheets
December 31,
2021
December 31,
2020
ASSETS
Current
assets
Cash
$ 1,928,474
$ 4,308,821
Prepaid
expenses
234,551
242,853
Deferred
offering costs
757,646
—
Receivable
from related parties
152,524
44,805
Total
current assets
3,073,195
4,596,479
Prepaid
expenses, long-term
—
184,934
Property
and equipment, net
11,502
15,667
Deposit
—
15,000
Total
assets
$ 3,084,697
$ 4,812,080
LIABILITIES
AND STOCKHOLDERS’ EQUITY
Current
liabilities
Accounts
payable
$ 582,605
$ 68,668
Accrued
expenses
1,055,515
—
Total
current liabilities
1,638,120
68,668
Deferred
rent
—
9,642
Total
liabilities
1,638,120
78,310
Commitments
and Contingencies (see Note 7)
Stockholders’
equity
Preferred
stock, $0.00001 par value, 10,000,000 and 1,150,000 shares authorized at December 31, 2021 and 2020, respectively;
Series Seed:
1,150,000 shares designated; 1,146,138 shares issued and outstanding at December 31, 2021 and December 31, 2020; $15.4 million
and $7.8 million aggregate liquidation preference of Series Seed cumulative preferred stock at December 31, 2021
and
December 31, 2020, respectively
11
11
Common
stock, $0.00001 par value, 250,000,000 and 2,300,000 shares authorized at December 31, 2021 and 2020, respectively; 3,200,000
shares outstanding at December 31, 2021 and 2020
32
32
Additional
paid-in-capital
7,403,204
7,273,063
Accumulated
deficit
(5,956,670 )
(2,539,336 )
Total
stockholders’ equity
1,446,577
4,733,770
Total
liabilities and stockholders’ equity
$ 3,084,697
$ 4,812,080
The
accompanying notes are an integral part of these financial statements.
F- 3
BLUE
WATER VACCINES INC.
Statements of Operations
Year
Ended December 31, 2021
Year
Ended December 31, 2020
Operating costs and expenses
General and administrative
$ 2,092,304
$ 1,097,161
Research
and development
1,325,030
524,908
Total
operating expenses
3,417,334
1,622,069
Loss
from operations
(3,417,334 )
(1,622,069 )
Other income
Interest
income
—
22,603
Total
other income
—
22,603
Net
loss
$ (3,417,334 )
$ (1,599,466 )
Cumulative
preferred stock dividends
627,391
559,928
Net loss
applicable to common stockholder
(4,044,725 )
(2,159,394 )
Net loss per share attributable
to common stockholder, basic and diluted
$ (1.26 )
$ (0.67 )
Weighted average number of
common shares outstanding, basic and diluted
3,200,000
3,200,000
The
accompanying notes are an integral part of these financial statements.
F- 4
BLUE
WATER VACCINES INC.
Statements of Stockholders’ Equity
For
the Years Ended December 31, 2021 and 2020
Preferred
Stock
Common
Stock
Additional
Paid-in
Accumulated
Total
Stockholders’
Shares
Amount
Shares
Amount
Capital
Deficit
Equity
Balance
at December 31, 2019
1,146,138
$ 11
3,200,000
$ 32
$ 6,938,226
$ (939,870 )
$ 5,998,399
Stock-based
compensation
—
—
—
—
334,837
—
334,837
Net
loss
—
—
—
—
—
(1,599,466 )
(1,599,466 )
Balance
at December 31, 2020
1,146,138
$ 11
3,200,000
$ 32
$ 7,273,063
$ (2,539,336 )
$ 4,733,770
Stock-based
compensation
—
—
—
—
130,141
—
130,141
Net
loss
—
—
—
—
—
(3,417,334 )
(3,417,334 )
Balance
at December 31, 2021
1,146,138
$ 11
3,200,000
$ 32
$ 7,403,204
$ (5,956,670 )
$ 1,446,577
The
accompanying notes are an integral part of these financial statements.
F- 5
BLUE
WATER VACCINES INC.
Statements of Cash Flows
Year
Ended
December 31,
2021
Year
Ended
December 31,
2020
Cash flows from operating
activities
Net loss
$ (3,417,334 )
$ (1,599,466 )
Adjustments to reconcile net
loss to net cash used in operating activities:
Depreciation expense
4,890
3,056
Stock-based compensation
130,141
334,837
Write off of receivable from
related party
22,242
—
Loss on disposal of property
and equipment
1,199
—
Changes in assets and liabilities:
Prepaid
expenses
8,302
(242,845 )
Receivable
from related parties
(114,961 )
(36,475 )
Prepaid
expenses, long-term
184,934
(184,934 )
Accrued
expenses
809,279
(57,385 )
Accounts
payable
336,715
50,291
Deferred
rent
(9,642 )
2,783
Net
cash used in operating activities
(2,044,235 )
(1,730,138 )
Cash flows
from investing activities
Purchase
of property and equipment
(1,924 )
(11,792 )
Net
cash used in investing activities
(1,924 )
(11,792 )
Cash flows
from financing activities
Payments
of deferred offering costs
(334,188 )
—
Net
cash used in financing activities
(334,188 )
—
Net decrease in cash
(2,380,347 )
(1,741,930 )
Cash, beginning of period
4,308,821
6,050,751
Cash, end of period
$ 1,928,474
$ 4,308,821
Noncash
investing and financing activities:
Deferred offering costs included
in accounts payable and accrued expenses
$ 423,458
$ —
The
accompanying notes are an integral part of these financial statements.
F- 6
BLUE
WATER VACCINES INC.
Notes to Financial Statements
Note 1
— Organization, Plan of Business Operations
Blue
Water Vaccines Inc. (the “Company”) was formed on October 26, 2018, to focus on the research and development of transformational
vaccines to prevent infectious diseases worldwide. The Company’s lead vaccine candidates, BWV-101 and BWV-102, are being investigated
as a universal influenza vaccine with the potential against all influenza strains and may provide a first-in-class long-term global vaccine
that protects millions. The Company’s proprietary, immunogenic, multi-purpose platform enables the Company to bioengineer viral
nanoparticles to deliver antigens, enhancing immunity, in an array of infectious disease agents, including influenza. All of the Company’s
vaccine candidates are in the pre-clinical developmental stage.
Note 2
— Liquidity and Financial Condition
The
Company has had limited operating activities to date, substantially all of which have been devoted to seeking licenses and engaging in
research and development activities. The Company’s product candidates currently under development will require significant additional
research and development efforts prior to commercialization. The Company has financed its operations since inception primarily using
proceeds received from seed investors.
The
Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the
foreseeable future. As of December 31, 2021, the Company had cash of approximately $1.9 million, working capital of approximately
$1.4 million and an accumulated deficit of approximately $6.0 million.
On
February 23, 2022, the Company completed its initial public offering (“IPO”) in which the Company received approximately
$17.2 million in net proceeds, after deducting the underwriting discount, and estimated offering expenses, see Note 10. The
Company believes the existing cash at December 31, 2021, together with the net proceeds received upon the close of its IPO, will
be sufficient to continue operations, satisfy its obligations and fund the future expenditures that will be required to conduct the clinical
and regulatory work to develop its product candidates into the second quarter of 2023. As such, the Company determined that it is not
probable based on projected cash flows that substantial doubt about the Company’s ability to continue as a going concern exists
for the one-year period following the date that the financial statements for the year ended December 31, 2021 were issued.
The
Company will require significant additional capital to make the investments it needs to execute its longer-term business plan. The Company
expects a significant increase in cash outflows as compared to its historical spend for its planned pre-clinical development and clinical
trial activities, and as such, it will need to raise additional capital to sustain operations and meet its long-term operating requirements
beyond the one year period following the issuance of these financial statements. The Company expects to seek additional funding through
additional debt or equity financings; however, there are currently no commitments in place for further financing nor is there any assurance
that such financing will be available to the Company on favorable terms, if at all. If the Company is unable to secure additional capital,
it may be required to curtail any clinical trials and development of products and take additional measures to reduce expenses in order
to conserve its cash in amounts sufficient to sustain operations and meet its obligations in the long-term.
Note 3
— Summary of Significant Accounting Policies
Basis
of Presentation
The
Company’s financial statements have been prepared in conformity with accounting principles generally accepted in the United States
of America (“U.S. GAAP”).
F- 7
BLUE
WATER VACCINES INC.
Notes
to Financial Statements
Note 3
— Summary of Significant Accounting Policies (cont.)
Stock
Split
On
November 24, 2021, the Company’s board of directors approved a 4-for-1 (4:1) stock split (the “Stock Split”) of
the Company’s common stock without any change to its par value, which became effective on November 24, 2021, see Note 6.
All references to share and per share amounts for all periods presented in these financial statements have been retrospectively restated
to reflect the Stock Split and proportional adjustment of the preferred stock conversion ratio. Par values were not adjusted.
Immaterial
Correction to Previously Issued Financial Statements
During
the preparation of the financial statements for the nine months ended September 30, 2021, the Company identified an error in
the disclosures related to the Series Seed liquidation preference, see Note 6 for related disclosures and defined terms. In
previously issued financial statements, the Liquidation Preference Amount was incorrectly calculated and disclosed in the balance sheet
at one times the Original Issue Price per share, plus unpaid cumulative dividends. As discussed in Note 6, the Liquidation Preference
Amount has been two times the Original Issue Price per share, plus unpaid cumulative dividends. The Company evaluated this disclosure
error based on the guidance provided by the SEC’s Staff Accounting Bulletin 99, Materiality , and determined that its impact
was not material to its previously issued annual and interim financial statements, and accordingly, no prior period financial statements
have been restated. The Company corrected the disclosure amount prospectively in the balance sheet as of September 30, 2021, and
corrected the related disclosure in Note 6, to accurately describe the existing liquidation preference.
Use
of Estimates
The
preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect
the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements
and the reported amounts of expenses during the reporting periods. The most significant estimates in the Company’s financial statements
relate to the valuation of common stock, stock-based compensation, accrued research and development expenses and the valuation allowance
of deferred tax assets resulting from net operating losses. These estimates and assumptions are based on current facts, historical experience
and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments
about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual
results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates
and actual results, the Company’s future results of operations will be affected.
Concentration
of Credit Risk
Financial
instruments that potentially subject the Company to concentrations of credit risk consist of cash accounts in a financial institution,
which, at times, may exceed the Federal Depository Insurance Coverage limit of $250,000. As of December 31, 2021 and 2020, the Company
has not experienced losses on these accounts and management believes the Company is not exposed to significant risks on such accounts.
Property
and Equipment
Property
and equipment consists of computers and office furniture and fixtures, all of which are recorded at cost. Depreciation is recorded using
the straight-line method over the respective useful lives of the assets ranging from three to seven years. Long-lived assets are
reviewed for impairment whenever events or circumstances indicate that the carrying amount of these assets may not be recoverable.
F- 8
BLUE
WATER VACCINES INC.
Notes
to Financial Statements
Note 3
— Summary of Significant Accounting Policies (cont.)
Fair
Value of Financial Instruments
Financial
instruments, including cash, accounts payable and accrued liabilities are carried at cost, which management believes approximates fair
value due to the short-term nature of these instruments. The fair value of the Company’s assets and liabilities, which qualify
as financial instruments under the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”)
Topic 820, Fair Value Measurements , approximates the carrying amounts represented in the balance sheet.
Fair
Value Measurements
Fair
value is defined as the price that would be received for sale of an asset or paid for transfer of a liability, in an orderly transaction
between market participants at the measurement date. U.S. GAAP establishes a three-tier fair value hierarchy, which prioritizes
the inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical
assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). These tiers include:
● Level
1, defined as observable inputs such as quoted prices (unadjusted) for identical instruments
in active markets;
● Level
2, defined as inputs other than quoted prices in active markets that are either directly
or indirectly observable such as quoted prices for similar instruments in active markets
or quoted prices for identical or similar instruments in markets that are not active; and
● Level
3, defined as unobservable inputs in which little or no market data exists, therefore requiring
an entity to develop its own assumptions, such as valuations derived from valuation techniques
in which one or more significant inputs or significant value drivers are unobservable.
In
some circumstances, the inputs used to measure fair value might be categorized within different levels of the fair value hierarchy. In
those instances, the fair value measurement is categorized in its entirety in the fair value hierarchy based on the lowest level input
that is significant to the fair value measurement.
Deferred
Offering Costs
Deferred
offering costs consist of legal, accounting, and other costs incurred through the balance sheet date that are directly related to the
Company’s initial public offering and that will be charged to stockholders’ equity upon the completion of the IPO.
Research
and Development
The
Company expenses the cost of research and development as incurred. Research and development expenses include costs incurred in funding
research and development activities, license fees, and other external costs. Advance payments for goods and services that will be used
in future research and development activities are expensed when the activity has been performed or when the goods have been received
rather than when the payment is made. Upfront and milestone payments due to third parties that perform research and development services
on the Company’s behalf will be expensed as services are rendered or when the milestone is achieved. When billing terms under research
and development contracts do not coincide with the timing of when the work is performed, the Company is required to make estimates of
outstanding obligations as of period end to those third parties. Accrual estimates are based on several factors, including the Company’s
knowledge of the progress towards completion of the research and development activities, invoicing to date under the contracts, communication
from the research institution or other companies of any actual costs incurred during the period that have not yet been invoiced, and
the costs included in the contracts. Significant judgments and estimates may be made in determining the accrued balances at the end of
any reporting period. Actual results could differ from the estimates made by the Company. The historical accrual estimates made by the
Company have not been materially different from the actual costs. See Notes 5 and 7.
F- 9
BLUE
WATER VACCINES INC.
Notes
to Financial Statements
Note 3
— Summary of Significant Accounting Policies (cont.)
In
accordance with FASB ASC Topic 730-10-25-1, Research and Development, costs incurred in obtaining licenses and patent
rights are charged to research and development expense if the technology licensed has not reached commercial feasibility and has no alternative
future use. The licenses purchased by the Company (see Note 5) require substantial completion of research and development, regulatory
and marketing approval efforts to reach commercial feasibility and have no alternative future use. Accordingly, the total purchase price
for the licenses acquired is reflected as research and development on the Company’s statements of operations.
Stock-Based
Compensation
The
Company expensed stock-based compensation to employees and non-employees over the requisite service period based on the estimated grant-date
fair value of the awards. Stock-based awards to employees with graded-vesting schedules are recognized, using the accelerated attribution
method, on a straight-line basis over the requisite service period for each separately vesting portion of the award.
The
Company estimates the fair value of stock option grants using the Black-Scholes option pricing model and the assumptions used in calculating
the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application
of management’s judgment.
Expected
Term — The expected term of options represents the period that the Company’s stock-based awards are expected
to be outstanding based on the simplified method, which is the half-life from vesting to the end of its contractual term.
Expected
Volatility — The Company computes stock price volatility over expected terms based on comparable companies historical
common stock trading prices.
Common
Stock Fair Value — The fair value of the common stock underlying the Company’s stock options was estimated
at each grant date and was determined with the assistance of an independent third-party valuation expert. The assumptions underlying
these valuations represented management’s best estimates, which involved inherent uncertainties and the application of significant
levels of management judgment.
Risk-Free
Interest Rate — The Company bases the risk-free interest rate on the implied yield available on U.S. Treasury
securities with a remaining term commensurate with the estimated expected term.
Expected
Dividend — The Company has never declared or paid any cash dividends on its common shares and does not plan to pay
cash dividends in the foreseeable future, and, therefore, uses an expected dividend yield of zero in its valuation models.
The
Company recognizes forfeitures of equity awards as they occur.
Fair
Value of Common Stock
In
order to determine the fair value of shares of common stock of the Company when issuing stock options and computing their estimated stock-based
compensation expense, its board of directors considered with input from third party valuations, among other things, contemporaneous valuations
of the Company’s common stock. Given the absence of a public trading market of the Company’s capital stock to date, its board
of directors has exercised reasonable judgment and considered a number of objective and subjective factors to determine the best estimate
of the fair value of the Company common and preferred stock, including:
● the
prices, rights, preferences and privileges of our preferred stock relative to our common stock;
● our
business, financial condition and results of operations, including related industry trends affecting our operations;
F- 10
BLUE
WATER VACCINES INC.
Notes
to Financial Statements
Note 3
— Summary of Significant Accounting Policies (cont.)
● the
likelihood of achieving a liquidity event, such as an IPO, or sale of our company, given prevailing market conditions;
● the
lack of marketability of our common stock;
● the
market performance of comparable publicly traded companies;
● U.S. and
global economic and capital market conditions and outlook; and
● Common
stock valuation methodology.
In
estimating the fair market value of common stock of the Company, its board of directors first determined the equity value of its business
using accepted valuation methods.
The
Company engaged a third-party valuation specialist to conduct a valuation, which used its recent preferred stock financing as a starting
point and determined the equity value of the Company based on the Backsolve method using an Option Pricing Method (OPM) to calculate
the implied value based on a market approach. The Company’s equity value was allocated using OPM to estimate the fair market value
of the Company’s classes of equity.
Income
Taxes
Income
taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for future tax consequences
attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective
tax bases and operating loss and tax credit carryforwards.
Deferred
tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those
temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rate
is recognized in operations in the period that includes the enactment date. Deferred tax assets are reduced to estimated amounts expected
to be realized by the use of a valuation allowance.
Comprehensive
Income (Loss)
The
Company is required to report all components of comprehensive income (loss), including net income (loss), in the accompanying financial
statements in the period in which they are recognized. Comprehensive income (loss) is defined as the change in equity during a period
from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on investments and
foreign currency translation adjustments. Net loss and comprehensive loss were the same for all periods presented.
Net
Loss Per Share
Basic
loss per share is computed by dividing the net income or loss applicable to common shares by the weighted average number of common shares
outstanding during the period. Diluted earnings per share is computed using the weighted average number of common shares and, if dilutive,
potential common shares outstanding during the period. Potential common shares consist of the Company’s preferred stock and options.
Diluted loss per share excludes the shares issuable upon the conversion of preferred stock, as well as common stock options, from the
calculation of net loss per share if their effect would be anti-dilutive.
F- 11
BLUE
WATER VACCINES INC.
Notes
to Financial Statements
Note 3
— Summary of Significant Accounting Policies (cont.)
The
two-class method is used to determine earnings per share based on participation rights of participating securities in any undistributed
earnings. Each preferred stock that includes rights to participate in distributed earnings is considered a participating security and
the Company uses the two-class method to calculate net income available to the Company’s common stockholder per common share — basic
and diluted.
The
following were excluded from the computation of diluted shares outstanding due to the losses since inception, as they would have had
an anti-dilutive impact on the Company’s net loss:
Years Ended
December 31,
2021
2020
Options to purchase shares of common stock
780,640
780,640
Series Seed Preferred Stock
4,584,552
4,584,552
Total
5,365,192
5,365,192
New
Accounting Pronouncement s
In
April 2012, the Jump-Start Our Business Startups Act (the “JOBS Act”) was signed into law. The JOBS Act contains provisions
that, among other things, reduce certain reporting requirements for an emerging growth company. As an emerging growth company, the Company
may elect to adopt new or revised accounting standards when they become effective for non-public companies, which typically is later
than when public companies must adopt the standards. The Company has elected to take advantage of the extended transition period afforded
by the JOBS Act and, as a result, unless the Company elects early adoption of any standards, will adopt the new or revised accounting
standards on the relevant dates on which adoption of such standards is required for non-public companies.
On
February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) .
Under the new guidance, lessees will be required to recognize all leases (with the exception of short-term leases) on the balance sheet
as a lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis
and a right-of-use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset
for the lease term. This guidance was effective for public business entities for fiscal years beginning after December 15,
2018, including interim periods within those fiscal years. For all other entities, after certain effective date deferrals, this
guidance is effective for fiscal years beginning after December 15, 2021, and interim periods within fiscal years beginning
after December 15, 2022. Early adoption was permitted. On January 1, 2021, the Company adopted ASU No. 2016-02, and the
adoption of this standard did not have an impact on the Company’s financial statements as the Company is currently not subject
to any lease agreements with terms in excess of 12 months.
In
December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes
(“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12
removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent
application. This guidance is effective for public business entities for fiscal years, and interim periods within those fiscal years,
beginning after December 15, 2020. For all other entities, the standard will be effective for fiscal years beginning after
December 15, 2021, and interim periods within fiscal years beginning after December 15, 2022. Early adoption is permitted.
The Company adopted ASU 2019-12 on January 1, 2021 on a prospective basis. Adoption of the ASU did not impact the Company’s
financial position, results of operations or cash flows.
In
August 2020, the FASB issued ASU No. 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20)
and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible
Instruments and Contracts in an Entity’s Own Equity , which simplifies accounting for convertible instruments by removing major
separation models required under current GAAP. The ASU also removes certain
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WATER VACCINES INC.
Notes
to Financial Statements
Note 3
— Summary of Significant Accounting Policies (cont.)
settlement
conditions that are required for equity contracts to qualify for the derivative scope exception and it also simplifies the diluted earnings
per share calculation in certain areas. This guidance is effective for public business entities except for smaller reporting companies
for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2021. For all other entities,
the standard will be effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years.
Early adoption is permitted. The Company adopted ASU 2020-06 on January 1, 2022, and the adoption of the ASU did not impact
the Company’s financial position, results of operations or cash flows.
In
May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt — Modifications and Extinguishments
(Subtopic 470-50), Compensation — Stock Compensation (Topic 718), and Derivatives and Hedging — Contracts
in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding
Equity-Classified Written Call Options (a consensus of the FASB Emerging Issues Task Force). The ASU clarifies and reduces diversity
in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants)
that remain equity classified after modification or exchange. The ASU provides guidance that will clarify whether an issuer should account
for a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification
or exchange as (1) an adjustment to equity and, if so, the related earnings per share (EPS) effects, if any, or (2) an expense
and, if so, the manner and pattern of recognition. The new guidance is effective for all entities for annual and interim periods beginning
after December 15, 2021, and early adoption is permitted, including adoption in an interim period. The Company is currently evaluating
the impact that this new guidance will have on its financial statements.
The
Company’s management does not believe that any other recently issued, but not yet effective, accounting standards if currently
adopted would have a material effect on the accompanying financial statements.
Reclassification
Certain
amounts in the accompanying financial statements have been reclassified to conform to the current period’s presentation. The amounts
reclassified were those related to consulting fee prepayments to our Chief Executive Officer (see Note 8), which were previously
included in prepaid expenses in the historical balance sheet as of December 31, 2020, and were reclassified to receivable from related
parties in the accompanying financial statements. The reclassification did not have any effect on the prior period net loss or cash flows
from operations.
Note 4
— Balance Sheet Details
Prepaid
Expenses
Prepaid
expenses consisted of the following as of December 31, 2021 and 2020:
As of
December 31,
2021
As of
December 31,
2020
Prepaid research and development
$ 203,910
$ 233,532
Prepaid insurance
4,842
4,321
Prepaid other
25,799
5,000
Total
$ 234,551
$ 242,853
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WATER VACCINES INC.
Notes
to Financial Statements
Note 4
— Balance Sheet Details (cont.)
Accrued
Expenses
Accrued
expenses consisted of the following as of December 31, 2021 and 2020:
As of
December 31,
2021
As of
December 31,
2020
Accrued license fees
$ 225,000
$ —
Accrued research and development
300,182
—
Accrued deferred offering costs
246,236
—
Accrued compensation
234,265
—
Accrued other
49,832
—
Total
$ 1,055,515
$ —
Note 5
— Significant Agreements
Oxford
University Innovation Limited
In
December 2018, the Company entered into an option agreement Oxford University Innovation (“OUI”), which was a precursor
to a license agreement (the “OUI Agreement”), dated July 16, 2019. Under the terms of the OUI Agreement, the Company
holds an exclusive, worldwide license to certain specified patent rights and biological materials relating to the use of epitopes of
limited variability and virus-like particle products and practice processes that are covered by the licensed patent rights and biological
materials for the purpose of developing and commercializing a vaccine product candidate for influenza. The Company is obligated to use
its best efforts to develop and market Licensed Products, as defined in the OUI Agreement, in accordance with its development plan, report
to OUI on progress, achieve the following milestones and must pay OUI nonrefundable milestone fees when it achieves them: initiation
of first Phase I study; initiation of first Phase II study; initiation of first Phase III/pivotal registration studies;
first submission of application for regulatory approval (BLA/NDA); marketing authorization in the United States; marketing authorization
in any EU country; marketing authorization in Japan; first marketing authorization in any other country; first commercial sale in Japan;
first commercial sale in any ROW country; first year that annual sales equal or exceed certain thresholds. See Note 7 for additional
information on the milestone payments as well as royalty obligations required under the OUI Agreement. The OUI Agreement will expire
upon ten (10) years from the expiration of the last patent contained in the licensed patent rights, unless terminated earlier. None
of the applications included in the OUI licensed patent rights have been issued as of December 31, 2020. During the year ended December 31,
2021, the U.S. Patent related to immunogenic composition was issued to OUI. This patent expires in August 2037. Either
party may terminate the OUI Agreement for an uncured material breach. The Company may terminate the OUI Agreement for any reason at any
time upon six months’ written notice expiring after the third anniversary of the OUI Agreement. OUI may terminate immediately
if the Company has a petition presented for its winding-up or passes a resolution for winding up other than for a bona fide amalgamation
or reconstruction or compounds with its creditors or has a receiver or administrator appointed. OUI may also terminate if the Company
opposes or challenges the validity of any of the patents or applications in the Licensed Technology, as defined in the OUI Agreement;
raises the claim that the know-how of the Licensed Technology is not necessary to develop and market Licensed Products; or in OUI’s
reasonable opinion, is taking inadequate or insufficient steps to develop or market Licensed Products and does not take any further steps
that OUI requests by written notice within a reasonable time.
For
the years ended December 31, 2021 and 2020, the Company did not incur any licensing fee payments for intellectual property
licenses. See Note 7.
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WATER VACCINES INC.
Notes
to Financial Statements
Note 5
— Significant Agreements (cont.)
St.
Jude Children’s Hospital
The
Company entered into a license agreement (the “St. Jude Agreement”), dated January 27, 2020, with St. Jude Children’s
Research Hospital (“St. Jude”). Under the terms of the St. Jude Agreement, the Company holds an exclusive, worldwide license
to certain specified patent rights and biological materials relating to the use of live attenuated streptococcus pneumoniae and practice
processes that are covered by the licensed patent rights and biological materials for the purpose of developing and commercializing a
vaccine product candidate for streptococcus pneumoniae. The St. Jude Agreement will expire upon the expiration of the last valid claim
contained in the licensed patent rights, unless terminated earlier. The Company is obligated to use commercially reasonable efforts to
develop and commercialize the licensed product(s). The milestones include the following events: (i) complete IND enabling study;
(ii) initiate animal toxicology study; (iii) file IND; (iv) complete Phase I Clinical Trial; (v) commence Phase II
Clinical Trial; (vi) commence Phase III Clinical Trial; and, (vii) regulatory approval, U.S. or foreign equivalent.
If the Company fails to achieve the development milestones contained in the St. Jude Agreement, and if the Company and St. Jude fail
to agree upon a mutually satisfactory revised timeline, St. Jude will have the right to terminate the St. Jude Agreement. Either party
may terminate the St. Jude Agreement in the event the other party (a) files or has filed against it a petition under the Bankruptcy
Act (among other things) or (b) fails to perform or otherwise breaches its obligations under the St. Jude Agreement, and has not
cured such failure or breach within sixty (60) days. The Company may terminate for any reason on thirty (30) days written notice.
For
the years ended December 31, 2021 and 2020, the Company recognized $11,000 and $15,000, respectively, for intellectual property
licenses, which is recorded as research and development expenses. See Note 7 for additional information on the milestone payments
as well as royalty obligations required under the St. Jude Agreement.
Cincinnati
Children’s Hospital Medical Center
The
Company entered into a license agreement (the “CHMC Agreement”), dated June 1, 2021, with Children’s Hospital
Medical Center, d/b/a Cincinnati Children’s Hospital Medical Center (“CHMC”). Under the terms of the CHMC
Agreement, the Company holds an exclusive, worldwide license (other than the excluded field of immunization against, and prevention,
control, or reduction in the severity of gastroenteritis caused by rotavirus and norovirus in China and Hong Kong) to certain
specified patent and biological materials relating to the use of norovirus nanoparticles and practice processes that are covered by
the licensed patent rights and biological materials for the purpose of developing and commercializing CHMC patents and related
technology directed to a virus-like particle vaccine platform that utilizes nanoparticle delivery technology that may have potential
broad application to develop vaccines for multiple infectious diseases. The term of the CHMC Agreement begins on the effective date
and extends on a jurisdiction by jurisdiction and product by product basis until the later of: (i) the last to expire licensed
patent; (ii) ten (10) years after the first commercial sale; or, (iii) entrance onto the market of a biosimilar or
interchangeable product. The Company is obligated to use commercially reasonable efforts to bring licensed products to market
through diligent research and development, testing, manufacturing and commercialization, to use best efforts to make all necessary
regulatory filings and obtain all necessary regulatory approvals, to achieve milestones relating to development and sales, and
report to CHMC on progress. The Company will also be obligated to pay the agreed upon development milestone payments to CHMC, as
well as royalty payments, see Note 7 for additional information. The Company may terminate the CHMC Agreement for convenience,
at any time prior to first commercial sale of a product or process by providing one hundred and eighty (180) days’
written notice to CHMC. It may also terminate for a CHMC uncured material breach. CHMC may terminate the CHMC Agreement for an
uncured Company material breach or insolvency or bankruptcy. Pursuant to the terms of the CHMC Agreement, if the Company fails to
achieve the milestones, and cannot mutually agree with CHMC on an amendment to the milestones, then CHMC will have the option of
converting any and all of such exclusive licenses to nonexclusive licenses, to continue developing indications that have already
entered development at any stage or in which the Company has invested in developing. CHMC may also terminate the CHMC Agreement to
the fullest extent permitted by law in the countries of the worldwide territory, in the event the Company or its affiliates challenge
or induce others set up challenges to the validity or enforceability of any of the Licensed Patents, as defined in the CHMC Agreement,
and the Company will be obligated reimburse CHMC for its costs, including reasonable attorneys’ fees.
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WATER VACCINES INC.
Notes
to Financial Statements
Note 5
— Significant Agreements (cont.)
For
the year ended December 31, 2021, the Company accrued licensing fee payments for intellectual property licenses and patent reimbursements,
which are recorded as research and development expenses, in aggregate of $402,104. See Notes 4 and 7.
Ology
Bioservices, Inc. (which was later acquired by National Resilience, Inc.)
The
Company entered into a Master Services Agreement (“Ology MSA”), dated July 19, 2019, with Ology, Inc. (“Ology”)
to provide services from time to time, including but not limited to technology transfer, process development, analytical method optimization,
cGMP manufacture, regulatory affairs, and stability studies of biologic products. Pursuant to the Ology MSA, the Company and Ology shall enter
into a Project Addendum for each project to be governed by the terms and conditions of the Ology MSA. The Company
has entered into two Project Addendums as of December 31, 2021. The initial Project Addendum was executed on October 18,
2019 and the Company was required to pay Ology an aggregate of approximately $4 million. Due to unforeseen
delays associated with COVID-19, the Company and Ology entered into a letter agreement dated January 9, 2020 to stop work on the
project. The Company paid Ology $100,000 for services, of which $48,600 remained as a prepaid expense as of December 31, 2020. The
second Project Addendum was executed on May 21, 2021 and the Company is 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%. This
project began during the year ended December 31, 2021, and the Company has incurred related research and development expenses of
approximately $328,000 of which approximately $164,000 and $115,000 was recorded as accounts payable and accrued expenses, respectively,
at December 31, 2021. See Note 4.
Note 6
— Stockholders’ Equity
Authorized
Capital and Stock Split
On
November 24, 2021, in connection with the filing of the amended registration statement for an IPO, the Company’s board of
directors approved a 4-for-1 (4:1) stock split of the Company’s common stock without any change to its par value, which became
effective on November 24, 2021. No fractional shares will be issued in connection with the Stock Split as all fractional shares
will be rounded down to the next whole share. All references to share and per share amounts for all periods presented in these financial
statements have been retrospectively restated to reflect the Stock Split and proportional adjustment of the preferred stock conversion
ratio. Par values were not adjusted. Additionally, the Company’s board of directors approved for the increase in authorized shares
of common stock and preferred stock to 250,000,000 shares and 10,000,000 shares, respectively. There was no change to the number of shares
designated as Series Seed Preferred Stock, which is 1,150,000. Prior to this amendment, the Company was authorized to issue up to
2,300,000 shares of common stock and 1,150,000 shares of preferred stock, both with par value $0.00001 per share.
Common
Stock
As
of December 31, 2021 and 2020, there were 3,200,000 shares of common stock issued and outstanding.
The
holder of the Company’s common stock is entitled to one vote for each share held of record, and is entitled upon liquidation of
the Company to share ratably in the net assets of the Company available for distribution after payment of all obligations of the Company
and after provision has been made with respect to each class of stock, if any, having preference over the common stock, currently including
the Company’s preferred stock. The shares of common stock are not redeemable and have no preemptive or similar rights.
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WATER VACCINES INC.
Notes
to Financial Statements
Note 6
— Stockholders’ Equity (cont.)
Preferred
Stock
The
Company has authorized 1,150,000 shares of preferred stock as Series Seed Preferred Stock (“Series Seed”), with
an original issue price of $6.09 per share (the “Original Issue Price”). As of December 31, 2021 and 2020, there were
1,146,138 shares issued and outstanding.
Conversion
Each
share of the Series Seed is convertible, at the option of the holder, at any time and from time to time, and without the payment
of additional consideration by the holder, at a conversion price of $1.52 per share, subject to certain adjustments for stock splits,
stock dividends, recapitalizations, and similar corporate transactions, into fully paid and non-assessable shares of the Company’s
common stock. Each Series Seed is automatically converted into common stock of the Company, at the then-effective conversion price,
upon the closing of 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. On October 7, 2021, the majority of the
holders of the Series Seed approved the automatic conversion of the outstanding shares of the Series Seed and all related accrued
and unpaid dividends, upon the close of the IPO. The number of conversion shares to be issued upon the close of the IPO will be
calculated in accordance with the original conversion terms provided by the Company’s Amended and Restated Certificate of Incorporation
(“COI”) dated July 1, 2019. This conversion occurred on February 23, 2022, upon the close of the Company’s
IPO, see Note 10.
Dividends
Holders
of the Series Seed are entitled to receive cumulative dividends at a per share rate of 8% per annum, compounded annually, on the
initial investment amount commencing on the date of issue. Dividends are payable only when, as, and if declared by the Board of Directors
or upon a Liquidation Event, as described below. Dividends on Series Seed are in preference to any dividend on the Company’s
common stock. As of December 31, 2021, aggregate cumulative dividends total $1,489,803 or $1.30 per Series Seed share.
Liquidation
Preference
In
the event of certain voluntary or involuntary acquisition or sale transactions or upon the liquidation, dissolution or winding up of
the Company (each, a “Liquidation Event”), the holders of Series Seed shall be entitled to receive out of the proceeds
or assets of the Company legally available for distribution to its stockholders (the “Proceeds”), prior and in preference
to any distribution of the Proceeds of such Liquidation Event to the holders of common shares by reason of their ownership thereof, an
amount (“the Liquidation Preference Amount”) determined based on the provisions of the Company’s COI. The COI
provides that the Liquidation Preference Amount be calculated upon the occurrence of a Liquidation Event, based on the Company’s
achievement of a Pre-Clinical Milestone and a Qualified Financing, both as defined in the COI. Per the provisions of the COI, if
a Liquidation Event occurs before a Pre-Clinical Milestone is achieved, the Liquidation Preference Amount would be equal to two times
the Series Seed Original Issue price per share, plus unpaid cumulative dividends. If a Liquidation Event occurs after a Pre-Clinical
Milestone is achieved, and after a Qualified Financing is completed, then the Liquidation Preference Amount would be equal to one times
the Series Seed Original Issue price, plus unpaid cumulative dividends. If a Liquidation Event occurs after a Pre-Clinical Milestone
is achieved and before a Qualified Financing is completed, the Liquidation Preference Amount would be equal to the greater of (a) such
amount per share as such holder would have been entitled to receive after a Qualified Financing or (b) two times the Series Seed
Original Issue price, plus unpaid cumulative dividends.
As
of December 31, 2021, and all other historical periods, the Liquidation Preference Amount is equal to two times the Series Seed
Original Issue Price per share, plus unpaid cumulative dividends. In the event that the Proceeds shall be insufficient to enable the
distribution in full of the Liquidation Preference Amount to the holders of the Series Seed for all of the preferred shares held
by them, all of the Proceeds shall be distributed among the
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WATER VACCINES INC.
Notes
to Financial Statements
Note 6
— Stockholders’ Equity (cont.)
holders
of Series Seed on a pro rata basis. Upon completion of the distribution required to the holders of Series Seed, all of the
remaining Proceeds available for distribution to stockholders shall be distributed among the holders of common shares and preferred shares,
on an as-converted basis, pro rata based on the number of common shares held by each such holder. However, if upon the occurrence of
a Liquidation Event, the Liquidation Preference Amount the Series Seed stockholders are entitled to receive is two times the Original
Issue Price per share, plus unpaid cumulative dividends, after such distribution is made, then the remaining Proceeds available for distribution
to stockholders shall be distributed among the holders of common shares, pro rata based on the number of common shares held by each such
holder.
Voting
On
any matter presented to the stockholders of the Company for their action or consideration at any meeting of stockholders of the Company
(or by written consent of stockholders in lieu of meeting), each holder of outstanding shares of Series Seed will be entitled to
cast the number of votes equal to the number of whole shares of common stock into which the shares of Series Seed held by such holder
are convertible as of the record date for determining stockholders entitled to vote on such matter. Holders of Series Seed will
vote together with the holder of common stock as a single class. Holders of Series Seed are entitled to nominate two out of five
of the Company’s directors.
Stock
Transactions
On
July 1, 2019, the Company entered into a Series Seed Preferred Stock Purchase Agreement (“Purchase Agreement”)
with five qualified investors. The investors agreed to purchase and the Company agreed to sell and issue to investors a total of 1,146,138
shares of Series Seed Preferred Stock, $0.00001 par value per share, at a purchase price of $6.09 per share. On July 1, 2019,
the Company received approximately $6.9 million (net of offering costs of approximately $45,000) in cash from investors in
exchange for the issuance of 1,146,138 shares of Series Seed Preferred Stock.
2019
Equity Incentive Plan
The
Company’s 2019 Equity Incentive Plan (the “2019 Plan”) was adopted by its board of directors and by its stockholders
on July 1, 2019. The Company has reserved 1,400,000 shares of common stock for issuance pursuant to the 2019 Plan.
Stock
Options
During
the year ended December 31, 2020, the Company granted options to purchase up to 688,800 shares of the Company’s common stock
to its board members and employees pursuant to the 2019 Plan. The aggregate grant date fair value of these options was approximately
$0.5 million. No stock options have been granted during the year ended December 31, 2021.
The
fair value of options granted in 2020 was estimated using the following assumptions:
For the
Year Ended
December 31,
2020
Exercise price
$ 0.01
Term (years)
5.03 – 6.98
Expected stock price volatility
112.2% – 115.2 %
Risk-free rate of interest
0.37% – 1.76 %
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WATER VACCINES INC.
Notes
to Financial Statements
Note 6
— Stockholders’ Equity (cont.)
A
summary of stock option information for the year ended December 31, 2021 is presented below:
Number of
Shares
Weighted
Average
Exercise
Price
Total
Intrinsic
Value
Weighted
Average
Remaining
Contractual
Life
(in years)
Outstanding as of December 31, 2020
780,640
$ 0.01
$ 532,787
9.1
Outstanding as of December 31, 2021
780,640
$ 0.01
$ 532,787
8.1
Options vested and exercisable as of December 31, 2021
438,096
$ 0.01
$ 299,001
8.1
Stock-Based
Compensation
Stock-based
compensation expense for the years ended December 31, 2021 and 2020 was as follows:
For the Years Ended
December 31,
2021
2020
General and administrative
$ 41,061
$ 89,555
Research and development
89,080
245,282
Total
$ 130,141
$ 334,837
As
of December 31, 2021, future stock-based compensation expense relating to outstanding stock options is approximately $68,000 and
will be recorded through December 2023.
Note 7
— Commitments and Contingencies
Office
lease
The
Company leased office space for approximately $5,500 a month from a related party. The Company paid a $15,000 rental deposit and rent
expense for the years ended December 31, 2021 and 2020 was approximately $26,000 and $66,000, respectively. The Company terminated
the related party lease in May 2021 and entered into a new lease with an unrelated party in April 2021. The Company is not
a party to a lease with a term in excess of 12 months and has a month-to-month lease as of December 31, 2021.
Litigation
From
time to time, the Company may be subject to various legal proceedings and claims that arise in the ordinary course of its business activities.
The Company is not a party to any material legal proceedings and is not aware of any pending or threatened claims.
Significant
agreements
Oxford
University Innovation Limited
Pursuant
to the OUI Agreement, as disclosed in Note 5, the Company is obligated to pay certain milestone and royalty payments in the future,
as the related contingent events occur. Specifically, the Company is obligated to pay a 6% royalty on all net sales of licensed products,
as defined in the OUI Agreement, with an annual minimum royalty payment of $250,000 starting post-product launch, until the expiration
of the OUI Agreement or revocation of the last valid claim covering a licensed product, at which point a royalty rate of 3% will apply.
An annual maintenance fee of $10,000 and $20,000 is required in the pre-phase III year and Phase III year, respectively, and
as defined in the OUI Agreement. The Company is also obligated to pay a 25% royalty on any sums received by the Company
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WATER VACCINES INC.
Notes
to Financial Statements
Note 7
— Commitments and Contingencies (cont.)
from
any sublicensee (including all up-front, milestone and other one-off payments received by the Company from any sub-licenses or other
contracts granted by the Company with respect to the licensed technology). In addition, the Company is required to pay OUI milestone
payments of up to an aggregate of $51.25 million; specifically, upon the achievement of specified development milestones of approximately
$2.25 million, regulatory milestones of approximately $9.5 million, and commercial milestones of approximately $39.5 million.
The annual maintenance fee and milestone fees are indexed to the RPI (Retail Prices index for all items which is published in the United
Kingdom by the Office for National Statistics, or any replacement of it) and will be increased or decreased as appropriate as set forth
in the OUI Agreement. As of December 31, 2021, the Company evaluated the likelihood of the Company achieving the specified milestones
and generating product sales, and determined the likelihood is not yet probable and as such no accrual of these payments is required
as of December 31, 2021.
Oxford
University Research Agreement
Pursuant
to the terms of the OUI Agreement, as disclosed in Note 5, the Company entered into a sponsored research agreement dated December 18,
2019 with Oxford University for research related to the OUI Agreement for a period of three years for a total of £420,000.
The Company prepaid the full amount to Oxford of $554,802 for the services in January 2020, of which approximately $0.2 million
and $0.4 million remains as a prepaid expense as of December 31, 2021 and 2020, respectively.
St.
Jude Children’s Hospital
Pursuant
to the St. Jude Agreement, as disclosed in Note 5, the Company is obligated to pay certain milestone and royalty payments in the
future, as the related contingent events occur. Specifically, the Company is obligated to make 4% royalty payments for each licensed
product(s) sold by the Company or its affiliates, based on the net sales for the duration of the St. Jude Agreement, and also pay
15% of consideration received for any sublicenses. The Company is required to pay an annual maintenance fee of $10,000 beginning on the
first anniversary of the Effective Date (which is waived if all of the developmental milestones scheduled for completion before such
annual fee is due have been achieved). In addition, the Company is required to pay St. Jude milestone payments of up to an aggregate
of $1 million; specifically, upon the achievement of specified development milestones of approximately $0.2 million, regulatory
milestones of approximately $0.3 million, and commercial milestones of approximately $0.5 million. As of December 31,
2021, the Company evaluated the likelihood of the Company achieving the specified milestones and generating product sales, and determined
the likelihood is not yet probable and as such no accrual of these payments is required as of December 31, 2021.
St.
Jude Children’s Sponsored Research Agreement
In
addition to the St. Jude Agreement, the Company also entered into a sponsored research agreement dated May 3, 2021 with St. Jude
for research related to the St. Jude Agreement. Pursuant to this research agreement, the Company is obligated to pay St. Jude an aggregate
amount of $73,073 in two parts, Phase I for $57,624 and Phase II for $15,449. This sponsored research project began during
the year ended December 31, 2021, and the Company has incurred related research and development expenses of approximately $65,000
of which approximately $8,000 was recorded as accrued expenses at December 31, 2021.
Cincinnati
Children’s Hospital Medical Center
Pursuant
to the CHMC Agreement, as disclosed in Note 5, the Company is obligated to pay certain milestone and royalty payments in the future,
as the related contingent events occur. Specifically, the Company is obligated to pay CHMC a single-digit royalty on net sales, being
5%, 4% or 2% depending on the product, until the last valid claim covering a licensed product exists, at which point the royalty rates
decrease by 50%. The Company is also
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WATER VACCINES INC.
Notes
to Financial Statements
Note 7
— Commitments and Contingencies (cont.)
obligated
to pay up to a 25% royalty on any non-royalty sublicense revenue paid to the Company by any sublicensee. The CHMC Agreement also provides
the Company with an option to license any CHMC or jointly patented modification, alteration or improvement of any invention claimed in
a Licensed Patent (“CHMC Improvement” and “Joint Improvement, respectively”), with a $50,000 option fee for each
Improvement that the Company elects to include in the license grant of the CHMC Agreement. In addition, the Company is required to pay
CHMC milestone payments of up to an aggregate of $59.75 million; specifically, upon the achievement of specified development milestones
of approximately $0.5 million, regulatory milestones of approximately $1.25 million, and commercial milestones of approximately
$58 million. As of December 31, 2021, the Company evaluated the likelihood of the Company achieving the specified milestones
and generating product sales, and determined the likelihood is not yet probable and as such no accrual of these payments is required
as of December 31, 2021.
Ology
Bioservices, Inc. (which was later acquired by National Resilience, Inc.)
Pursuant
to the Ology MSA and the second Project Addendum, as disclosed in Note 5, the Company is 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%. This
project began during the year ended December 31, 2021, and the Company has incurred related research and development expenses of
approximately $328,000 of which approximately $164,000 and $115,000 was recorded as accounts payable and accrued expenses, respectively,
at December 31, 2021. This project is currently expected to be performed through the fourth quarter of 2023.
Indemnification
In
the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties
and provide for general indemnifications. The Company’s exposure under these agreements is unknown because it involves claims that
may be made against the Company in the future but have not yet been made. To date, the Company has not paid any claims or been required
to defend any action related to its indemnification obligations. However, the Company may incur charges in the future as a result of
these indemnification obligations.
Risks
and Uncertainties — COVID-19
Management
continues to evaluate the impact of the COVID-19 pandemic on the industry and has concluded that while it is reasonably possible that
the virus could have a negative effect on the Company’s financial position, results of its operations and/or search for drug candidates,
the specific impact is not readily determinable as of the date of these financial statements. The financial statements do not include
any adjustments that might result from the outcome of this uncertainty.
Note 8
— Related Party Transactions
The
Company has engaged the Chief Executive Officer, who is also the Board Chairman and sole common stockholder of the Company, pursuant
to a consulting agreement commencing October 22, 2018, which calls for the Company to pay for consulting services performed on a
monthly basis. During the years ended December 31, 2021 and 2020, the Company incurred approximately $0.4 million in fees
under the consulting agreement, which are recognized in general and administrative expenses in the statements of operations. In addition,
during the year ended December 31, 2021, the Company paid the Chief Executive Officer a discretionary bonus of $0.2 million,
which is also recognized in general and administrative expenses in the statements of operations. No such bonuses were earned or paid
during the year ended December 31, 2020.
F- 21
BLUE
WATER VACCINES INC.
Notes
to Financial Statements
Note 8
— Related Party Transactions (cont.)
The
Company also leased office space from a related party, through common ownership, and had a rental deposit of $15,000 on the balance sheet
as of December 31, 2020. The lease is further described in Note 7 of these financial statements. The lease was terminated in
May 2021, and the deposit was reclassified to the receivable from related parties balance. During the fourth quarter of 2021, the
amounts due from this related party were determined to be uncollectible and were written off. The total amount written off was approximately
$22,000, is recognized in general and administrative expenses in the accompanying statement of operations, and is related to the lease
deposit, overpaid rent and utility expenses.
As
of December 31, 2021 and 2020, the Company has a receivable from related parties of approximately $153,000 and $45,000, respectively.
The balance consists primarily of consulting fee prepayments to the Company’s CEO, in the amounts of $140,000 and $35,000 as of
December 31, 2021 and 2020, respectively. The remaining balance as of December 31, 2021 consists of miscellaneous payments
made by the Company on the behalf of the CEO. The remaining balance as of December 31, 2020 consists of overpaid rent and utility
expenses.
One
of the Company’s directors serves on the Advisory Board for the Cincinnati Children’s Hospital Medical Center Innovation
Fund, which is affiliated with CHMC. The Company has an exclusive license agreement with CHMC as disclosed in Note 5.
Note 9
— Income Taxes
The
Company’s major tax jurisdictions are the United States, Florida, and Ohio and the Company does not have any pending tax audits.
All of the Company’s tax years are subject to examination by the United States, Florida and Ohio tax authorities.
At
December 31, 2021, the Company had a net operating loss (“NOL”) carryforward for federal and state income tax purposes
totaling approximately $4.9 million and $5.1 million, respectively, available to reduce future taxable income, all of which
are carried forward indefinitely for federal tax purposes under the Tax Cuts and Jobs Act. The Coronavirus Aid, Relief, and Economic
Security Act (“CARES Act”) signed in to law on March 27, 2020, provided that NOLs generated in a taxable year beginning
in 2018 and all subsequent years to date, may now be carried back five years and forward indefinitely. In addition, the limitation
of NOL utilization up to 80% of taxable income limitation is temporarily removed, allowing NOLs to fully offset taxable income. Of the
state net operating losses, approximately $1.4 million follow the Federal Tax Cuts and Jobs Act and are carried over indefinitely,
and approximately $3.7 million will begin to expire in 2024 if not utilized.
The
NOL carry forward is subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. Under the Internal
Revenue Code (“IRC”) Sections 382 and 383, annual use of the Company’s net operating loss carryforwards to offset taxable
income may be limited based on cumulative changes in ownership. The Company has not completed an analysis to determine whether any such
limitations have been triggered as of December 31, 2021. The amount of the annual limitation, if any, will be determined based on
the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in
future years.
F- 22
BLUE
WATER VACCINES INC.
Notes
to Financial Statements
Note 9
— Income Taxes (cont.)
The
tax effects of the temporary differences and carryforwards that give rise to deferred tax assets consist of the following:
As of
December 31,
2021
2020
Deferred tax assets:
Net-operating loss carryforward
$ 1,120,155
$ 554,813
Stock-based compensation
106,171
91,035
License agreement
59,685
20,848
Accrued compensation
55,500
—
Other accrued expenses
14,636
11,247
Gross deferred tax assets
1,356,147
677,943
Valuation allowance
(1,353,673 )
(677,943 )
Deferred tax assets, net of allowance
$ 2,474
$ —
Deferred tax liabilities:
Fixed assets
(2,474 )
—
Total deferred tax liabilities
$ (2,474 )
$ —
Net deferred tax assets
$ —
$ —
The
Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets. Based on the Company’s
history of operating losses since inception, the Company has concluded that it is more likely than not that the benefit of its deferred
tax assets will not be realized. Accordingly, the Company has provided a full valuation allowance for deferred tax assets as of December 31,
2021 and 2020. During the year ended December 31, 2021, the valuation allowance increased by approximately $0.7 million.
The
provision for income taxes on earnings subject to income taxes differs from the statutory Federal rate at December 31, 2021 and
2020, due to the following:
For the Years Ended
December 31,
2021
2020
Expected income tax benefit at Federal statutory tax rate
$ (717,640 )
$ (335,888 )
State and local taxes, net of Federal tax benefit
(91,233 )
(94,768 )
State rate adjustment
119,413
—
Other
13,730
4,884
Change in valuation allowance
675,730
425,772
Provision for income taxes
$ —
$ —
Under
U.S. GAAP, the impact of an uncertain income tax position on the income tax return must be recognized at the largest amount that
is more-likely-than-not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized
if it has less than a 50% likelihood of being sustained. Additionally, U.S. GAAP provides guidance on derecognition, classification,
interest and penalties, accounting for interim periods, disclosure and transition. The Company’s policy is to recognize interest
and penalties related to uncertain tax positions in income tax expense. As of December 31, 2021 and 2020, there were no unrecognized
tax benefits and therefore, no accrual for related interest and penalties.
F- 23
BLUE
WATER VACCINES INC.
Notes
to Financial Statements
Note 10
— Subsequent Events
The
Company has completed an evaluation of all subsequent events through March 18, 2022 to ensure that these financial statements include
appropriate disclosure of events both recognized in the financial statements and events which occurred but were not recognized in the
financial statements. Except as described below, the Company has concluded that no subsequent event has occurred that requires disclosure.
Effective
January 1, 2022, the Company adopted a defined contribution savings plan (“the Plan”) pursuant to Section 401(k) of
the Internal Revenue Code. The Plan is for the benefit of all qualifying employees and permits voluntary contributions by employees of
up to 100% of eligible compensation, subject to the maximum limits imposed by Internal Revenue Service. The terms of the Plan allow for
discretionary employer contributions. Enrolment in the Plan will become available on April 1, 2022.
On
February 7, 2022, the Company and its former underwriter, Maxim Group (“Maxim”), entered into a termination agreement,
whereby the parties agreed to terminate their engagement of Maxim as the Company’s lead managing underwriter and book runner in
connection with the Company’s IPO. Per the terms of the termination agreement, the Company agreed to pay Maxim a termination
fee of $300,000, due upon the close of the Company’s IPO.
On
February 17, 2022, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Boustead Securities,
LLC, acting as representative of the underwriters (“Boustead”), in relation to the Company’s IPO, pursuant to which
the Company agreed to sell to the underwriters an aggregate of 2,222,222 shares of the Company’s common stock, at a price of $9.00
per share. The IPO closed on February 23, 2022, and resulted in net proceeds to the Company, after deducting the underwriting discount,
and estimated offering expenses, of approximately $17.2 million. Pursuant to the Underwriting Agreement, the Company issued to Boustead
warrants to purchase 111,111 shares of common stock. The warrants will be exercisable at a per share exercise price equal to $10.35 and
are exercisable at any time and from time to time, in whole or in part, during the period commencing on February 23, 2022 and terminating
on February 11, 2027. In addition, effective upon the closing of the IPO, all of the shares of the Company’s outstanding Series Seed
Preferred Stock, along with all accrued dividends, converted into 5,626,365 shares of common stock pursuant to a conversion approved
by requisite holders of the Series Seed Preferred Stock.
On
February 23, 2022, the Company filed with the Secretary of State of the State of Delaware an amended and restated certificate of
incorporation (the “A&R COI”), which became effective immediately. The Company’s board of directors and stockholders
approved the A&R COI to be effective upon the closing of the IPO. There was no change to the Company’s authorized shares
of common stock and preferred stock of 250,000,000 shares and 10,000,000 shares, respectively. In addition, on February 23, 2022
and in connection with the closing of the IPO, the Company’s board of directors adopted Amended and Restated Bylaws and the Company’s
2022 Equity Incentive Plan (the “2022 Plan”), which is the successor and continuation of the Company’s 2019 Plan. Under
the 2022 Plan, the Company may grant stock options, restricted stock, restricted stock units, stock appreciation rights, and other forms
of awards to employees, directors and consultants of the Company. Upon its effectiveness, a total of 1,600,000 shares of common
stock were reserved for issuance under the 2022 Plan.
Upon
the close of the Company’s IPO, employment agreements with the Company’s Chief Executive Officer, Chief Financial Officer,
and Chief Business Officer became effective. The employment agreements provide for annual compensation of approximately $1.4 million
in the aggregate for the three officers, as well as annual performance bonuses up to their respective targeted amounts, with the actual
bonuses being based upon the level of achievement of annual Company and individual performance objectives each year, as determined by
the Company’s compensation committee.
F- 24
EXHIBIT
INDEX
Exhibit No.
Description
1.1
Underwriting
Agreement, dated as of February 17, 2022, by and between the Company and Boustead Securities, LLC. (2)
3.1
Second
Amended and Restated Certificate of Incorporation. (2)
3.2
Amended and Restated Bylaws. (2)
4.1
Form of Representative’s Warrant in connection with the Company’s initial public offering. (2)
4.2
Description of Registered Securities.*
10.1
2019 Equity Incentive Plan. (1)
10.2
2022 Equity Incentive Plan. (1)
10.3
2019 Equity Incentive Plan Form of Stock Option Grant Agreement. (1)
10.4
2022 Equity Incentive Plan Form of Incentive Stock Option Agreement (Employee). (1)
10.5
2022 Equity Incentive Plan Form of Nonstatutory Stock Option Agreement (Consultant). (1)
10.6
2022 Equity Incentive Plan Form of Nonstatutory Stock Option Agreement (Non-Employee Director). (1)
10.7
2022 Equity Incentive Plan Form of Nonstatutory Stock Option Agreement (Employee). (1)
10.8
Exclusive License Agreement between the Registrant and Children’s Hospital Medical Center, d/b/a Cincinnati Children’s Hospital Medical Center, effective as of June 1, 2021. (1)
10.9
License Agreement between the Registrant and Oxford
University Innovation Limited, effective as of July 16, 2019. (1)
10.10
Exclusive License Agreement between the Registrant and St. Jude Children’s Research Hospital, Inc., effective as of January 27, 2020. (1)
10.11
Lease Agreement, dated as of April 29, 2021, between the Registrant and Regus Management Group, LLC. (1)
10.12
Master Services Agreement between the Registrant and Ology Bioservices, Inc., effective as of July 19, 2019. (1)
10.13
Project Addendum 1 to Master Services Agreement between the Registrant and Ology Bioservices, Inc., effective as of October 9, 2019. (1)
10.14
Letter Agreement between the Registrant and Ology Bioservices, Inc., dated as of January 9, 2020. (1)
10.15
Project Addendum II to Master Services Agreement between the Registrant and Ology Bioservices, Inc., effective as of May 21, 2021. (1)
10.16
Form of Employment Agreement with Joseph Hernandez. (1)
10.17
Form of Employment Agreement with Erin Henderson. (1)
10.18
Form of Employment Agreement with Jon Garfield. (1)
10.19
Form of Indemnification Agreement for Directors and Officers. (1)
31.1
Certification of the Principal Executive Officer, pursuant to Rules 13a-14(a) and 15d-14(a) under the Exchange Act, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2
Certification of the Principal Financial Officer, pursuant to Rules 13a-14(a) and 15d-14(a) under the Exchange Act, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1
Certification of the Principal Executive Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.**
32.2
Certification of the Principal Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.**
* Filed
herewith.
** Furnished
herewith.
(1) Incorporated
by reference to the Company’s Registration Statement on Form S-1/A, filed with the SEC on February 8, 2022.
(2) Incorporated
by reference to the Company’s Current Report on Form 8-K, filed with the SEC on February 24, 2022.
137
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized.
Blue Water Vaccines Inc.
Date: March 31, 2022
By:
/s/ Joseph Hernandez
Joseph Hernandez
Chairman of the Board and Chief Executive Officer
(principal executive officer)
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the
registrant and in the capacities indicated on March 31, 2022.
Signature
Title
/s/
Joseph Hernandez
Chairman of the Board and Chief Executive Officer (principal
executive officer)
Joseph Hernandez
/s/
Jon Garfield
Chief Financial Officer (principal financial and accounting
officer)
Jon Garfield
/s/
Kimberly Murphy
Director
Kimberly Murphy
/s/
Michael Venerable
Director
Michael Venerable
/s/
Allan Shaw
Director
Allan Shaw
/s/
James Sapirstein
Director
James Sapirstein
138
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.