Item 9A. Controls and Procedures
ITEM
9A. CONTROLS AND PROCEDURES
Disclosure
Controls and Procedures
We
maintain “disclosure controls and procedures,” as defined in Rule 13a-15(e) and Rule 15d-15(e) under the Exchange Act that
are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange
Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure
controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed
by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to our management, including
our principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.
Our
management, with the participation of our principal executive officer and principal accounting and financial officer, has evaluated the
effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act), as of the
end of the period covered by this Annual Report on Form 10-K. Based on such evaluation, our principal executive officer and principal
accounting and financial officer has concluded that as of December 31, 2021, our disclosure controls and procedures were not effective
as of such date as a result of material weaknesses in our internal control over financial reporting due to inadequate segregation of
duties within account processes due to limited personnel and insufficient written policies and procedures for accounting, IT and financial
reporting and record keeping. Under the direction of our principal executive officer and principal financial and accounting officer,
we are developing a plan to remediate the material weaknesses.
Management’s
Report on Internal Control Over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal control over financial reporting as such term is defined
in Exchange Act Rule 13a-15(f). Internal control over financial reporting is a process designed under the supervision and
with the participation of our management, including our principal executive officer and principal financial officer, to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance
with accounting principles generally accepted in the U.S.. All internal control systems, no matter how well designed,
have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect
to financial statement preparation and presentation.
As
of December 31, 2021, under the supervision and with the participation of our management, including our principal executive officer and
principal financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on
the framework in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway
Commission. Based on this assessment, our management concluded that, as of December 31, 2021, our internal control over financial reporting
lacks adequate segregation of duties within account processes due to limited personnel and insufficient written policies and procedures
for accounting, IT and financial reporting and record keeping and we are implementing plans to improve such internal control.
Changes
in Internal Control Over Financial Reporting
There
has been no change in our internal control over financial reporting during the quarter 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
Executive
Officers, Directors and Key Employees
The
following table sets forth the name, age and position of each of our executive officers, key employees and directors as of March 21,
2022. All directors hold office until the next annual meeting of stockholders and the election and qualification of their successors.
Officers serve at the discretion of the board.
Name
Age
Position
Snehal
Patel
58
Chief
Executive Officer, Chief Financial Officer and Director
F.
Joseph Daugherty
71
Chief
Medical Officer and Director
Jaye
Thompson
56
Vice
President Clinical & Regulatory Affairs
David
McWilliams
78
Chairman
of the Board
Eric
Rothe
47
Director
Kenneth
Hallock
73
Director
Biographies
The
principal occupations for the past five years (and, in some instances, for prior years) of each of our directors and executive officers
are as follows:
Snehal
Patel. Snehal Patel has over 30 years of experience in executive management, corporate development, operations, and investment banking
in the healthcare industry. Mr. Patel has served as our Chief Executive Officer since June 2016 and our Chief Financial Officer and a
member of our board of directors since February 2010. In addition, since 2009, Mr. Patel has served as a consultant, manager, and advisor
at various levels in multiple private start-up biotech companies helping to develop clinical and pre-clinical assets in cancer and other
therapeutic areas. Prior to 2010, Mr. Patel served as a consultant to public and private companies focused on stem cell therapy, multiple
sclerosis t-cell therapy, oncolytic viruses, and disposable biotech manufacturing equipment. In addition, Mr. Patel previously served
as an investment banker at Sanders Morris Harris, Ferghana Partners, and JP Morgan Chase focusing on healthcare and biotech financing
and strategic transactions. Mr. Patel also previously worked in operations and business development at Bayer Corporation and in design
and operations consulting firms. Mr. Patel received a Bachelor of Science degree in chemical engineering and a Master of Science degree
in biochemical engineering from the Massachusetts Institute of Technology and a Masters of Business Administration degree from the University
of Chicago. We believe Mr. Patel is qualified to serve as a member of our board of directors because of his executive and management
experience working with biotech companies.
F.
Joseph Daugherty. F. Joseph Daugherty has over 35 years of experience in managing and overseeing biotechnology and biomedical projects.
Dr. Daugherty has served as our Chief Medical Officer since September 2019 and a member of our board of directors since September 2019.
In addition, since 2002, Dr. Daugherty has served as the Managing Partner of Phenolics, LLC and PharmaPrint, LLC which was spun off from
Phenolics, LLC, both of which are nutraceutical companies. From 2002 until 2018, he served first as President, and since 2008 as Chief
Executive Officer, Chief Medical Officer and the Chairman of the board of directors of Eleos Inc., a clinical stage private biotech company
focused on anti-sense technology in cancer. Dr. Daugherty also served in various other capacities as a management consultant as well
as an officer and director to over 20 public and private biomedical companies including Dupont. In addition, Dr. Daugherty was President
of ConAgra’s biotech division. Dr. Daugherty received a Bachelor of Arts degree in biology from Washington University, a Doctor
of Medicine degree from the University of Nebraska Medical Center and a Masters of Science in Industrial Administration from Carnegie-Mellon
University (Tepper). We believe Dr. Daugherty is qualified to serve as a member of our board of directors because of his executive and
management experience, including his experience working with biotech companies.
Jaye
Thompson. Jaye Thompson has over 30 years of experience in pharmaceutical and device product development. Dr. Thompson has served
as our Vice President Clinical & Regulatory Affairs since September 2019. Since December 2017, Dr. Thompson has served as a co-founder
and Chief Operating Officer of Proxima Clinical Research, Inc., a clinical research service provider. Dr. Thompson previously served
as Senior Vice President of Clinical and Regulatory Affairs of Repros Therapeutics, a reproductive health company, from March 2013 to
May 2017 and as a member of the board of directors of Repros Therapeutics from November 2009 to March 2013. Dr. Thompson previously served
as Senior Vice President of Clinical Development and Regulatory Affairs of Opexa Therapeutics, a multiple sclerosis cell therapy company,
from September 2009 to March 2013. In addition, Dr. Thompson has served at clinical stage biotech companies, in various senior clinical
and regulatory roles and at inVentiv Clinical Solutions, a clinical research service provider. Dr. Thompson was the president and founder
of SYNERGOS, Inc., a clinical research service provider, which was founded in 1991, and acquired by inVentiv Health, as a wholly-owned
subsidiary in 2006. Dr. Thompson has advised several of the region’s leading life science companies on strategic and regulatory
planning as well as clinical product development. She has directed and managed statistical analysis, data management, report writing,
and the conduct of clinical trials for a wide variety of indications. Dr. Thompson has been actively involved in over 200 clinical trials
for drugs, biologics and devices, and has been associated with numerous FDA regulatory submissions. Dr. Thompson has often represented
sponsor companies at FDA meetings and advisory committee meetings, and she was appointed to the Governor’s Texas Emerging Technology
Fund Advisory Committee. Dr. Thompson received a BS in applied mathematics from Texas A&M University and an MS and a PhD in biostatistics
from the University of Texas Health Science Center in Houston.
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Table of Contents
David
McWilliams . David McWilliams has over 40 years of experience in building biopharmaceutical and healthcare companies. Mr. McWilliams
has served as a member of our board of directors since February 2009. He previously served as the Chief Executive Officer from February
2010 to June 2016 and Chairman of the board of directors of the Company since February 2009. In addition, since 2008, Mr. McWilliams
has served as a consultant and an advisor at various levels in multiple private start-up biotech companies to help develop clinical and
pre-clinical assets in cancer and other therapeutic areas. Mr. McWilliams previously served as the Chief Executive Officer and a member
of the board of directors of Opexa Therapeutics, Inc., a multiple sclerosis cell therapy company, from 2004 until 2008. Mr. McWilliams
also previously served as the Chief Executive Officer, President and a member of the board of directors of Bacterial Barcodes, Inc.,
a bacteria and fungi diagnostic company, and the Chief Executive Officer and a member of the board of directors of Signase, Inc., a cancer
therapeutics company. Mr. McWilliams has also served in various other capacities including Chief Executive Officer, President and a member
of the board of directors of both Encysive Pharmaceuticals, Inc. and Repros Therapeutics Inc.; Chief Executive Officer and President
of Kallestad Diagnostics (Erbamont); President of Harleco Diagnostics Division (EM Industries); General Manager and Program Manager of
Abbott Laboratories; and Management Consultant at McKinsey & Company. In addition to the foregoing, Mr. McWilliams currently serves
as the Chairman of the board of directors of BioHouston, an advocate of the life sciences industry in Houston. Mr. McWilliams received
a Bachelor of Arts degree in chemistry from Washington and Jefferson College and a Master of Business Administration degree from the
University of Chicago. We believe Mr. McWilliams is qualified to serve as a member of our board of directors because of his executive
experience, management experience and experience working with biotech companies.
Eric
Rothe . Eric Rothe is the founder of the Company and has over 12 years of industry and academic experience in gene-based therapies
and vaccines, including six years of laboratory experience. Mr. Rothe previously served as President of the Company from October 2006
to February 2010, Chief Executive Officer of the Company from October 2007 to February 2010 and Chairman of the Company’s board
of directors from October 2006 to February 2009. In addition, Mr. Rothe has served as a member of the Company’s board of directors
since August 2006. Since August 2017, Mr. Rothe has served as the Global Product Line Leader at Baker Hughes, an energy technology company.
Previously, from September 2014 until its acquisition by GE Oil & Gas’ acquisition of Baker Hughes in July 2017, Mr. Rothe
served as Vice President of Mid-Continent and NE US Geomarket and Global Product Line Leader of GE Oil & Gas. From 2012 to 2014,
Mr. Rothe served as the International Sales and Operations Director at National Oilwell Varco, one of the world’s largest oil field
equipment providers. Before joining the oil & gas sector, Mr. Rothe was Director of the Clinical Cancer Genetics program at U.T.
M.D. Anderson Cancer Center, Project Manager at Introgen, a developer of cancer products in advanced clinical trials, and provided consulting
services for start-up/small biotechnology companies in Texas. Mr. Rothe received a Bachelor of Arts degree in molecular and cell biology
from the University of California at Berkeley and a Master of Business Administration degree from Rice University. We believe Mr. Rothe
is qualified to serve as a member of our board of directors because of his expertise in cancer immunology, GMP manufacturing, and clinical
research, and his experience in various senior management positions in global commercial operations at large corporations.
Kenneth
Hallock . Kenneth Hallock has over 40 years of experience in general management and new venture start-ups and is a major investor
in our Company. Mr. Hallock has served as a member of our board of directors since September 2019. Mr. Hallock is currently a senior
manager and partner in a private start-up equipment manufacturing company and has been in this role for over 10 years. Previously, Mr.
Hallock worked in large industrial corporations such as NL Industries and Anderson Clayton, which were subsequently acquired. Mr. Hallock
received a Bachelor of Engineering degree in chemical engineering from Princeton University and a Master of Business Administration degree
from Harvard Business School. We believe Mr. Hallock is qualified to serve as a member of our board of directors because of his experience
in various management positions for several Fortune 500 companies.
Family
Relationships and Other Arrangements
There
are no family relationships among our directors and executive officers. There are no arrangements or understandings between or among
our executive officers and directors pursuant to which any director or executive officer was or is to be selected as a director or executive
officer.
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Board
Leadership Structure and Role in Risk Oversight
We
have historically separated the roles of Chairman of the Board (“Chairman”) and Chief Executive Officer. Although the separation
of roles has been appropriate for us, in the view of the Board, the advisability of the separation of these roles depends upon the specific
circumstances and dynamics of our leadership.
The
Board, as a unified body and through committee participation, organizes the execution of its monitoring and oversight roles and does
not expect its Chairman to organize those functions.
The
Board has three standing committees-Audit, Compensation and Corporate Governance/Nominating. The membership of each of the committees
of the Board is comprised of independent directors, with each of the committees having a chairman, each of whom is an independent director.
Our non-management members of the Board meet in executive session at each regular Board meeting.
Risk
is inherent with every business, and how well a business manages risk can ultimately determine its success. Management is responsible
for the day-to-day management of the risks we face, while the Board, as a whole and through its committees, has responsibility for the
oversight of risk management. In its risk oversight role, the Board is responsible for satisfying itself that the risk management processes
designed and implemented by management are adequate and functioning as designed.
The
Board believes that establishing the right “tone at the top” and that full and open communication between executive management
and the Board are essential for effective risk management and oversight. Our CEO communicates frequently with members of the Board to
discuss strategy and challenges facing our company. Senior management usually attends our regular quarterly Board meetings and is available
to address any questions or concerns raised by the Board on risk management-related and any other matters. Each quarter, the Board receives
presentations from senior management on matters involving our key areas of operations.
Committees
of Our Board of Directors
Our
Board directs the management of our business and affairs, as provided by Delaware law, and conducts its business through meetings of
the Board and its standing committees. We have a standing audit committee and compensation committee. Our entire Board serves in place
of a nominating and corporate governance committee. In addition, from time to time, special committees may be established under the direction
of the Board when necessary to address specific issues.
Audit
Committee
Our
audit committee is responsible for, among other things:
●
approving
and retaining the independent auditors to conduct the annual audit of our financial statements;
●
reviewing
the proposed scope and results of the audit;
●
reviewing
and pre-approving audit and non-audit fees and services;
●
reviewing
accounting and financial controls with the independent auditors and our financial and accounting staff;
●
reviewing
and approving transactions between us and our directors, officers and affiliates;
●
establishing
procedures for complaints received by us regarding accounting matters;
●
overseeing
internal audit functions, if any; and
●
preparing
the report of the audit committee that the rules of the SEC require to be included in our annual meeting proxy statement.
Our
audit committee consists of David McWilliams, Eric Rothe and Kenneth Hallock, with David McWilliams serving as chair. Our board of directors
has affirmatively determined that David McWilliams, Eric Rothe and Kenneth Hallock each meet the definition of “independent director”
under the Nasdaq rules, and that they meet the independence standards under Rule 10A-3. Each member of our audit committee meets the
financial literacy requirements of the Nasdaq rules. In addition, our board of directors has determined that David McWilliams qualifies
as an “audit committee financial expert,” as such term is defined in Item 407(d)(5) of Regulation S-K. Our board of directors
adopted a written charter for the audit committee, which is available on our principal corporate website at www.greenwichlifesciences.com .
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Compensation
Committee
Our
compensation committee is responsible for, among other things:
●
reviewing
and recommending the compensation arrangements for management, including the compensation for our president and chief executive officer;
●
establishing
and reviewing general compensation policies with the objective to attract and retain superior talent, to reward individual performance
and to achieve our financial goals;
●
administering
our stock incentive plans; and
●
preparing
the report of the compensation committee that the rules of the SEC require to be included in our annual meeting proxy statement.
Our
compensation committee consists of David McWilliams, Eric Rothe and Kenneth Hallock, with David McWilliams serving as chair. Our board
has determined that David McWilliams, Eric Rothe and Kenneth Hallock are independent directors under Nasdaq rules. Our board of directors
adopted a written charter for the compensation committee, which is available on our principal corporate website at www.greenwichlifesciences.com .
Nominating
and Governance Committee
Although
our entire board of directors serves in place of a nominating and corporate governance committee, our independent directors on the board
are responsible for, among other things:
●
nominating
members of the board of directors;
●
developing
a set of corporate governance principles applicable to our company; and
●
overseeing
the evaluation of our board of directors.
Our
entire board of directors serves in place of a nominating and corporate governance committee. Our board of directors adopted resolutions
addressing, among other things, the nomination process.
Code
of Business Conduct and Ethics
We
have adopted a formal Code of Business Conduct and Ethics applicable to all Board members, officers and employees. Our Code of Business
Conduct and Ethics can be found on our website (www.greenwichlifesciences.com). A copy of our Code of Business Conduct and Ethics may
be obtained without charge upon written request to Secretary, Greenwich LifeSciences, Inc., 3992 Bluebonnet Dr., Building 14, Stafford,
TX 77477. If we make any substantive amendments to our Code of Business Conduct and Ethics or grant any waiver from a provision of the
Code of Business Conduct and Ethics to any executive officer or director, we will promptly disclose the nature of the amendment or waiver
on our website (www.greenwichlifesciences.com) and/or in our public filings with the SEC.
Hedging
and Pledging Policies
As
part of our Insider Trading Policy, all of our officers, all of our directors, certain of our employees and consultants and family members
or others sharing a household with any of the foregoing are prohibited from engaging in short sales of our securities, any hedging or
monetization transactions involving our securities and in transactions involving puts, calls or other derivative securities based on
our securities. Our Insider Trading Policy further prohibits such persons from purchasing our securities on margin, borrowing against
any account in which our securities are held or pledging our securities as collateral for a loan unless pre-cleared by our Insider Trading
Compliance Officer. As of March 21, 2022, none of our directors or executive officers had pledged any shares of our common stock.
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Table of Contents
ITEM
11. EXECUTIVE COMPENSATION
Summary
Compensation Table
The
following table presents the compensation awarded to, earned by or paid to each of our named executive officers for the year ended December
31, 2021.
Name and Principal Position
Year
Salary
($)
Bonus
($)
Stock
awards
($) (1)
Total
($)
Snehal Patel, Chief Executive Officer
2021
450,000
475,000
491,589
1,416,589
2020
114,966
392,516
491,589
999,071
(1)
For
2021 fiscal year, Mr. Patel received 218,484 shares of our common stock for services rendered and as incentive for services to be
rendered. Mr. Patel did not receive any options or warrants for the 2021 fiscal year. For 2020 fiscal year, Mr. Patel received 218,484
shares of our common stock for services rendered and as incentive for services to be rendered. Mr. Patel did not receive any options
or warrants for the 2020 fiscal year.
Outstanding
Equity Awards at Fiscal Year-End
The
following table provides information regarding awards held by each of our named executive officers that were outstanding as of December
31, 2021.
Option Awards (1)
Stock Awards
Name
Number of Securities
Underlying Unexercised Options (#)
Exercisable
Number of Securities
Underlying Unexercised Options (#)
Unexercisable
Option
Exercise Price ($)
Option
Expiration Date
Number of
shares or units of
stock that
have not vested (#)
Market value of
shares or units of
stock that
have not vested ($)
Snehal Patel
163,863 (1)
368,692
(1)
We
granted Mr. Patel shares of common stock on September 30, 2019 for compensation and incentives of which 93,633 vested immediately
upon grant, 491,589 vested between October 1 2019 and December 31, 2021 over the 27 month period, and the balance, or 163,863
shares of common stock vest over 9 equal monthly installments commencing on January 1, 2022.
Non-Employee
Director Compensation
The
following table presents the total compensation for each person who served as a non-employee member of our Board and received compensation
for such service during the fiscal year ended December 31, 2021. Other than as set forth in the table and described more fully below,
we did not pay any compensation, make any equity awards or non-equity awards to, or pay any other compensation to any of the non-employee
members of our Board in 2021.
Name
Fees Earned or
Paid in Cash
($)
Stock Awards
($)
All Other
Compensation
($) (4)
Total
($)
David McWilliams (1)
21,087
21,087
Eric Rothe (2)
14,067
14,067
Kenneth Hallock (3)
14,067
14,067
(1)
On
September 30, 2019, we authorized the issuance of 28,090 shares of its common stock to Mr. McWilliams. The shares vest in 36 equal
monthly installments with the first installment vesting on October 1, 2019. Of such shares, 9,372 shares of common stock vested during
the fiscal year ended December 31, 2021. Mr. McWilliams did not receive any options or warrants during the 2021 fiscal year.
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Table of Contents
(2)
On
September 30, 2019, we authorized the issuance of 18,727 shares of its common stock to Mr. Rothe. The shares vest in 36 equal monthly
installments with the first installment vesting on October 1, 2019. Of such shares, 6,252 shares of common stock vested during the
fiscal year ended December 31, 2021. Mr. Rothe did not receive any options or warrants during the 2021 fiscal year.
(3)
On
September 30, 2019, we authorized the issuance of 18,727 shares of its common stock to Mr. Hallock. The shares vest in 36 equal monthly
installments with the first installment vesting on October 1, 2019. Of such shares, 6,252 shares of common stock vested during the
fiscal year ended December 31, 2021. Mr. Hallock did not receive any options or warrants during the 2021 fiscal year.
Employment
Agreements
Snehal
Patel Employment Agreement
On
September 29, 2020, we entered into an employment agreement (the “Employment Agreement”) with Snehal Patel, our Chief Executive
Officer in connection with our initial public offering (the “IPO”). The term of the Employment Agreement will continue until
December 31, 2021 and automatically renews for successive one year periods at the end of each term until either party delivers written
notice of their intent not to renew at least 60 days prior to the expiration of the then effective term. Pursuant to the terms of the
Employment Agreement, Mr. Patel shall, among other things, (i) receive a base salary of $450,000, subject to increase, (ii) shall be
eligible to receive equity grants, (iii) shall be eligible to receive an annual bonus of up to 50% of his then base salary and (iv) shall
be eligible to receive a strategic transaction bonus. In addition, Mr. Patel shall also be eligible to participate in all employee welfare
and benefit plans and shall receive such other fringe benefits as we offer to our senior executives and directors.
In
the event Mr. Patel’s employment is terminated by us for Cause (as defined in the Employment Agreement), as a result of Mr. Patel’s
death or Disability (as defined in the Employment Agreement), voluntarily by Mr. Patel without Good Reason (as defined in the Employment
Agreement), or upon expiration of the term, we shall pay Mr. Patel (i) a lump sum amount equal to (A) any unpaid base salary and equity
grants then due plus (B) any bonus earned but not paid and (ii) any unpaid expenses (collectively, the “Patel Compensation”).
In addition, if Mr. Patel’s employment is terminated for death, Disability or as a result of the expiration of the term of the
Employment Agreement as a result of the non-renewal of such term by us, we shall pay Mr. Patel any pro-rated bonus for the target year
in which the termination occurs. In the event Mr. Patel’s employment is terminated by us without Cause or by Mr. Patel for Good
Reason, we shall pay Mr. Patel (i) the Patel Compensation, (ii) any pro-rated bonus for the target year in which the termination occurs
and (iii) provided that Mr. Patel executes the Release (as defined in the Employment Agreement), (A) the Severance Payment (as defined
in the Employment Agreement) and (B) COBRA premiums for twelve months from the date of termination. In the event of Mr. Patel’s
termination (i) by us without Cause or by Mr. Patel for Good Reason within six months prior to the consummation of a Change of Control
(as defined in the Employment Agreement) transaction, if, prior to or as of such termination, a Change of Control transaction was Pending
(as defined in the Employment Agreement), at any time during such six month period, (ii) by Mr. Patel for Good Reason at any time within
twelve months after the consummation of a Change of Control, or (iii) by us without Cause at any time within twelve months after the
consummation of a Change of Control, Mr. Patel shall receive (A) the Patel Compensation, (B) any pro-rated bonus for the target year
in which the termination occurs and (C) provided that Mr. Patel executes the Release, (a) a lump sum amount equal to twelve months of
Mr. Patel’s then base salary and equity grants at the rate in effect as of the date of termination and (b) COBRA premiums for six
months from the date of termination. Furthermore, all of the shares that are then unvested shall immediately vest and, all options, warrants
and other convertible securities beneficially held by Mr. Patel shall become fully exercisable for (i) a period of six months following
the date of termination only if at the time of such termination there is a Change of Control transaction Pending but in no event beyond
expiration of the original term of the award or (ii) if clause (i) does not apply, then such period of time set forth in the agreement
evidencing the security. The Employment Agreement also contains covenants restricting Mr. Patel from: (i) engaging in any activity competitive
with our business during the term of the Employment Agreement and for a period of one year thereafter; and (ii) soliciting our customers,
suppliers or employees during the term of the Employment Agreement and for a period of one year thereafter.
ITEM
12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The
following table sets forth certain information regarding the beneficial ownership of our common stock as of March 21, 2022
by:
●
each
of our named executive officers;
●
each
of our directors;
●
all
of our current directors and executive officers as a group; and
●
each
stockholder known by us to own beneficially more than 5% of our common stock.
Beneficial
ownership is determined in accordance with the rules of the SEC and includes voting or investment power with respect to the securities.
Shares of common stock that may be acquired by an individual or group within 60 days of March 21, 2022, pursuant to the exercise
of options or warrants, vesting of common stock or conversion of preferred stock or convertible debt, are deemed to be outstanding for
the purpose of computing the percentage ownership of such individual or group, but are not deemed to be outstanding for the purpose of
computing the percentage ownership of any other person shown in the table. Percentage of ownership is based on 12,951,453 shares
of common stock issued and outstanding as of March 21, 2022.
Except
as indicated in footnotes to this table, we believe that the stockholders named in this table have sole voting and investment power with
respect to all shares of common stock shown to be beneficially owned by them, based on information provided to us by such stockholders.
Unless otherwise indicated, the address for each director and executive officer listed is: c/o Greenwich LifeSciences, Inc., 3992 Bluebonnet
Dr, Building 14, Stafford, TX 77477.
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Table of Contents
Number of Shares
Percentage of Common Stock
Name of Beneficial Owner
Beneficially Owned
Beneficially Owned
Directors and Named Executive Officers
Snehal Patel
7,725,041 (1)
59.48 %
F. Joseph Daugherty
81,849 (2)
*
David McWilliams
617,203 (3)
4.76 %
Eric Rothe
311,171 (4)
2.40 %
Kenneth Hallock
395,249 (5)
3.05 %
All current named executive officers and directors as a group (5 persons)
9,130,513
70.26 %
*
Represents
beneficial ownership of less than 1%.
(1)
Consists
of (i) 944,604 shares of common stock owned by Snehal Patel, (ii) 1,408,033 shares of common stock owned by Snehal Patel IRA,
(iii) 919,234 shares of common stock owned by Patel Family Trust 1, (iv) 2,063,444 shares of common stock owned by
Patel Family Trust 2, (v) 2,072,808 shares of common stock owned by Patel Family Trust 3, and (vi) 129,400 shares of common
stock owned by Kinnary Patel IRA. Excludes 72,807 shares of common stock held by Snehal Patel which vest in 4 equal
monthly installments. Snehal Patel and Kinnary Patel, the spouse of Snehal Patel, are the Trustees of the Patel Family Trust 1, Patel
Family Trust 2 and Patel Family Trust 3. Snehal Patel is the Trustee of the Snehal Patel IRA. Kinnary Patel is the Trustee of the
Kinnary Patel IRA. In such capacities, Snehal Patel is deemed to hold voting and dispositive power over the securities held by such
entities.
(2)
Excludes
7,272 shares of common stock which vest in 4 equal monthly installments.
(3)
Excludes
10,401 shares of common stock which vest in 4 equal installments.
(4)
Excludes
2,055 shares of common stock which vest in 4 equal monthly installments.
(5)
Excludes
2,055 shares of common stock which vest in 4 equal monthly installments. Kenneth Hallock and Annette Hallock are the
Trustees of the Hallock Trust and in such capacities share voting and dispositive power over the securities held by such entity.
Section
16(A) Beneficial Ownership Reporting Compliance
Section
16(a) of the Exchange Act requires our officers and directors, and persons who own more than ten percent of a registered class of our
equity securities, to file reports of ownership and changes in ownership with the SEC. Officers, directors and greater than ten percent
stockholders are required by SEC regulations to furnish us with copies of all Section 16(a) forms they file.
Based
on a review of the copies of such forms received, we believe that during 2021, all filing requirements applicable to our officers,
directors and greater than ten percent beneficial owners were complied with, except that Jaye Thompson filed a Form 3 after its due date.
ITEM
13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The
following includes a summary of transactions since January 1, 2021 to which we have been a party, including transactions in which the
amount involved in the transaction exceeds the lesser of $120,000 or 1% of the average of our total assets at year-end for the last two
completed fiscal years, and in which any of our directors, executive officers or, to our knowledge, beneficial owners of more than 5%
of our capital stock or any member of the immediate family of any of the foregoing persons had or will have a direct or indirect material
interest, other than equity and other compensation, termination, change in control and other arrangements, which are described elsewhere
in this Annual Report on Form 10-K. We are not otherwise a party to a current related party transaction, and no transaction is currently
proposed, in which the amount of the transaction exceeds the lesser of $120,000 or 1% of the average of our total assets at year-end
for the last two completed fiscal years and in which a related person had or will have a direct or indirect material interest.
61
Table of Contents
Related
Person Transaction Policy
We
adopted a related person transaction policy that sets forth our procedures for the identification, review, consideration and approval
or ratification of related person transactions. For purposes of our policy only, a related person transaction is a transaction, arrangement
or relationship, or any series of similar transactions, arrangements or relationships, in which we and any related person are, were or
will be participants in which the amount involved exceeds the lesser of $120,000 or 1% of the average of our total assets at year-end.
Transactions involving compensation for services provided to us as an employee or director are not covered by this policy. A related
person is any executive officer, director or beneficial owner of more than 5% of any class of our voting securities, including any of
their immediate family members and any entity owned or controlled by such persons.
Under
the policy, if a transaction has been identified as a related person transaction, including any transaction that was not a related person
transaction when originally consummated or any transaction that was not initially identified as a related person transaction prior to
consummation, our management must present information regarding the related person transaction to our audit committee, or, if audit committee
approval would be inappropriate, to another independent body of our board of directors, for review, consideration and approval or ratification.
The presentation must include a description of, among other things, the material facts, the interests, direct and indirect, of the related
persons, the benefits to us of the transaction and whether the transaction is on terms that are comparable to the terms available to
or from, as the case may be, an unrelated third party or to or from employees generally. Under the policy, we will collect information
that we deem reasonably necessary from each director, executive officer and, to the extent feasible, significant stockholder to enable
us to identify any existing or potential related-person transactions and to effectuate the terms of the policy. In addition, under our
code of business conduct and ethics, our employees and directors have an affirmative responsibility to disclose any transaction or relationship
that reasonably could be expected to give rise to a conflict of interest. In considering related person transactions, our audit committee,
or other independent body of our board of directors, will take into account the relevant available facts and circumstances including,
but not limited to:
●
the
risks, costs and benefits to us;
●
the
impact on a director’s independence in the event that the related person is a director, immediate family member of a director
or an entity with which a director is affiliated;
●
the
availability of other sources for comparable services or products; and
●
the
terms available to or from, as the case may be, unrelated third parties or to or from employees generally.
The
policy requires that, in determining whether to approve, ratify or reject a related person transaction, our audit committee, or other
independent body of our board of directors, must consider, in light of known circumstances, whether the transaction is in, or is not
inconsistent with, our best interests and those of our stockholders, as our audit committee, or other independent body of our board of
directors, determines in the good faith exercise of its discretion.
Director
Independence
Our
board of directors undertook a review of the independence of our directors and considered whether any director has a relationship with
us that could compromise that director’s ability to exercise independent judgment in carrying out that director’s responsibilities.
Our board of directors has affirmatively determined that David McWilliams, Eric Rothe and Kenneth Hallock are each an “independent
director,” as defined under the Nasdaq rules.
ITEM
14. PRINCIPAL ACCOUNTING FEES AND SERVICES
Audit
Fees
The
aggregate fees billed to us by MaloneBailey, LLP, our independent registered public accounting firm, for the indicated services for each
of the last two fiscal years were as follows:
2021
2020
Audit fees (1)
$ 54,000
$ 33,500
Audit-related fees (2)
$ 8,940
$ 40,040
Tax fees
$ -
$ -
All other fees
$ -
$ -
(1)
Audit
fees consist of fees for professional services performed by MaloneBailey for the audit and review of our financial statements.
(2)
Audit
related fees consist of fees for preparation and filing of our registration statements, including issuance of comfort letters.
Policy
on Audit Committee Pre-Approval of Audit and Permissible Non-Audit Services of Independent Auditors
Consistent
with SEC policies and guidelines regarding audit independence, the Audit Committee is responsible for the pre-approval of all audit and
permissible non-audit services provided by our independent registered public accounting firm on a case-by-case basis. Our Audit Committee
has established a policy regarding approval of all audit and permissible non-audit services provided by our principal accountants. Our
Audit Committee pre-approves these services by category and service. Our Audit Committee has pre-approved all of the services provided
by our independent registered public accounting firm.
62
Table of Contents
PART
IV
ITEM
15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
Exhibit
Number
Description
of Exhibit
(a)(1)
Financial Statements
The
financial statements required by this item are submitted in a separate section beginning on page F-1 of this Annual Report on Form
10-K.
(b)
Exhibits
Exhibit
Number
Description
3.1
Second Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to Form 8-K filed on October 1, 2020)
3.2
Second Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to Form 8-K filed on October 1, 2020)
4.1
Form of Underwriter Warrant (incorporated by reference to Exhibit 4.2 to Amendment No. 1 to Form S-1 filed on June 23, 2020)
4.2
Description
of the Registrant’s securities registered pursuant to Section 12 of the Securities Exchange Act of 1934 (incorporated by
reference to Exhibit 4.2 to Form 10-K filed on March 31, 2021).
10.1+
2019 Equity Incentive Plan (incorporated by reference to Exhibit 10.1 to Form S-1 filed on May 29, 2020)
10.2
Form of Indemnification Agreement with directors and executive officers (incorporated by reference to Exhibit 10.1 to Form S-1 filed on May 29, 2020)
10.3
Exclusive License Agreement between The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. and the Company (incorporated by reference to Exhibit 10.3 to Amendment No. 1 to Form S-1 filed on June 23, 2020)
10.4
First Amendment to Exclusive License Agreement between The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. and the Company (incorporated by reference to Exhibit 10.4 to Amendment No. 1 to Form S-1 filed on June 23, 2020)
10.5
Second Amendment to Exclusive License Agreement between The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. and the Company (incorporated by reference to Exhibit 10.5 to Amendment No. 1 to Form S-1 filed on June 23, 2020)
10.6
American Arbitration Association Award of Arbitrators (incorporated by reference to Exhibit 10.6 to Amendment No. 1 to Form S-1 filed on June 23, 2020)
10.7+
Employment Agreement between the Company and Snehal Patel dated September 29, 2020 (incorporated by reference to Exhibit 10.1 to Form 8-K filed on October 1, 2020)
10.8
Registration Rights Agreement (incorporated by reference to Exhibit 10.8 to Amendment No. 1 to Form S-1 filed on June 23, 2020)
24
Power of Attorney (included on signature page hereto).
31.1
Certification of Principal Executive Officer and Principal Financial Officer required under Rule 13a-14(a)/15d-14(a) under the Exchange Act.
32.1
Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS
Inline
XBRL Instance Document.
101.SCH
Inline
XBRL Taxonomy Extension Schema.
101.CAL
Inline
XBRL Taxonomy Extension Calculation Linkbase.
101.LAB
Inline
XBRL Taxonomy Extension Labels Linkbase.
101.PRE
Inline
XBRL Taxonomy Extension Presentation Linkbase.
101.DEF
Inline
XBRL Taxonomy Extension Definition Linkbase.
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
+
Indicates
a management contract or compensatory plan or arrangement.
ITEM
16. FORM 10-K SUMMARY
None.
63
Table of Contents
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.
GREENWICH
LIFESCIENCES, INC.
/s/
Snehal Patel
March
21, 2022
Chief
Executive Officer (Principal Executive Officer and Principal Accounting and Financial Officer)
POWER
OF ATTORNEY
KNOW
ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below hereby constitutes and appoints Snehal Patel as his or
her attorney-in-fact, with full power of substitution and resubstitution, for him or her in any and all capacities, to sign any and all
amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith,
with the Securities and Exchange Commission, granting unto said attorney-in-fact full power and authority to do and perform each and
every act and thing requisite and necessary to be done in connection therewith as fully to all intents and purposes as he might or could
do in person, hereby ratifying and confirming all that said attorney-in-fact, or his substitute or substitutes, may lawfully do or cause
to be done by virtue hereof.
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 and on the dates indicated.
SIGNATURE
TITLE
DATE
/s/
Snehal Patel
Chief
Executive Officer and Director
March
21, 2022
Snehal
Patel
(Principal
Executive Officer and Principal Accounting and Financial Officer)
/s/
F. Joseph Daugherty
Chief
Medical Officer and Director
March
21, 2022
F.
Joseph Daugherty
/s/
David McWilliams
Director
March
21, 2022
David
McWilliams
/s/
Eric Rothe
Director
March
21, 2022
Eric
Rothe
/s/
Kenneth Hallock
Director
March
21, 2022
Kenneth
Hallock
64
Table of Contents
GREENWICH
LIFESCIENCES, INC.
Index
to Financial Statements
Report
of Independent Registered Public Accounting Firm (PCAOB ID: 206 )
F-2
Balance Sheets
F-3
Statements of Operations
F-4
Statements
of Stockholders’ Equity (Deficit)
F-5
Statements of Cash Flows
F-6
Notes to Financial Statements
F-7
F- 1
Table of Contents
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Shareholders and Board of Directors of
Greenwich
Lifesciences, Inc.
Opinion
on the Financial Statements
We
have audited the accompanying balance sheets of Greenwich LifeSciences, Inc. (the “Company”) as of December 31, 2021 and
2020, and the related statements of operations, stockholders’ equity, and cash flows for the years then ended, 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 the years then ended, 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 audit 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.
/s/
MaloneBailey, LLP
PCAOB
ID: 206
www.malonebailey.com
We
have served as the Company’s auditor since 2019.
Houston,
Texas
March 21, 2022
F- 2
Table of Contents
GREENWICH
LIFESCIENCES, INC.
BALANCE
SHEETS
AS
OF DECEMBER 31, 2021 AND 2020
December 31, 2021
December 31, 2020
Assets
Current assets
Cash
$ 27,204,269
$ 28,660,375
Acquired patents, net
12,615
16,227
Total assets
$ 27,216,884
$ 28,676,602
Liabilities and stockholders’ deficit
Current liabilities
Accounts payable & accrued interest
$ 220,845
$ 710,971
Unreimbursed expenses
164,327
59,367
Advance from related party/shareholder
—
275,154
Total current liabilities
385,172
1,045,492
Total liabilities
385,172
1,045,492
Stockholders’ equity (deficit)
Common stock, $ 0.001 par value; 100,000,000 shares authorized; 13,147,829 and 12,703,541 shares issued and outstanding as of December 31, 2021 and 2020, respectively
13,148
12,704
Additional paid-in capital
60,466,093
56,695,359
Accumulated deficit
( 33,647,529 )
( 29,076,953 )
Total stockholders’ equity
26,831,712
27,631,110
Total liabilities and stockholders’ equity
$ 27,216,884
$ 28,676,602
See accompanying notes to financial statements.
F- 3
Table of Contents
GREENWICH
LIFESCIENCES, INC.
STATEMENTS
OF OPERATIONS
FOR
THE YEARS ENDED DECEMBER 31, 2021 AND 2020
2021
2020
Year Ended December 31,
2021
2020
Revenue
$ —
$ —
Operating expenses
Research and development
3,559,515
1,057,606
General and administrative
1,038,428
806,188
Total operating expenses
4,597,943
1,863,794
Loss from operations
( 4,597,943 )
( 1,863,794 )
Interest income
27,367
832
Net loss
$ ( 4,570,576 )
$ ( 1,862,962 )
Per share information:
Net loss per common share, basic and diluted
$ ( 0.35 )
$ ( 0.20 )
Weighted average common shares outstanding, basic and diluted
12,944,134
9,499,155
See accompanying notes to financial statements.
F- 4
Table of Contents
GREENWICH
LIFESCIENCES, INC.
STATEMENTS
OF STOCKHOLDERS’ EQUITY (DEFICIT )
FOR
THE YEARS ENDED DECEMBER 31, 2021 AND 2020
Shares
Par Amount
Shares
Par Amount
Paid-in Capital
Accumulated Deficit
Equity (Deficit)
Common Stock
Preferred Stock
Additional
Total Stockholders’
Shares
Par Amount
Shares
Par Amount
Paid-in Capital
Accumulated Deficit
Equity (Deficit)
Balances, December 31, 2019
8,458,048
$
8,458
1,980,365
$
1,981
$
25,853,134
$
( 27,213,991
)
$
( 1,350,418
)
Balances
8,458,048
$
8,458
1,980,365
$
1,981
$
25,853,134
$
( 27,213,991
)
$
( 1,350,418
)
Stock-based compensation
301,854
302
—
—
677,686
—
677,988
Issuance of common stock in initial public offering, net of offering costs
1,260,870
1,261
—
—
6,206,241
—
6,207,502
Additional preferred stock issued due to anti-dilution
—
—
42,404
42
( 42
)
—
—
Conversion of preferred to common stock
2,022,769
2,023
( 2,022,769
)
( 2,023
)
—
—
—
Issuance of common stock in follow-on offering, net of offering costs
660,000
660
—
—
23,958,340
—
23,959,000
Issuance of common stock from exercise of Green Shoe of follow-on offering, net of offering costs
Issuance of common stock from exercise of Green Shoe of follow-on offering, net of offering costs, shares
Issuance of common stock through partial exercise of underwriter warrants
Issuance of common stock through partial exercise of underwriter warrants, shares
Net loss
( 1,862,962
)
( 1,862,962
)
Balances, December 31, 2020
12,703,541
$
12,704
—
$
—
$
56,695,359
$
( 29,076,953
)
$
27,631,110
Balances
12,703,541
$
12,704
—
$
—
$
56,695,359
$
( 29,076,953
)
$
27,631,110
Stock-based compensation
293,592
293
—
—
660,289
—
660,582
Issuance of common stock from exercise of Green Shoe of follow-on offering, net of offering costs
70,000
70
—
—
2,547,930
—
2,548,000
Issuance of common stock through partial exercise of underwriter warrants
80,696
81
—
—
562,515
—
562,596
Net loss
( 4,570,576
)
( 4,570,576
)
Balances, December 31, 2021
13,147,829
$
13,148
—
$
—
$
60,466,093
$
( 33,647,529
)
$
26,831,712
Balances
13,147,829
$
13,148
—
$
—
$
60,466,093
$
( 33,647,529
)
$
26,831,712
See accompanying notes to financial statements.
F- 5
Table of Contents
GREENWICH
LIFESCIENCES, INC.
STATEMENTS
OF CASH FLOWS
FOR
THE YEARS ENDED DECEMBER 31, 2021 AND 2020
2021
2020
Year Ended December 31,
2021
2020
Operating activities:
Net loss
$ ( 4,570,576 )
$ ( 1,862,962 )
Adjustments required to reconcile net loss to net cash used in operating activities:
Amortization
3,612
3,609
Stock-based compensation
660,582
677,988
Changes in operating assets and liabilities:
Accounts payable
( 526,732 )
( 92,550 )
Accrued interest
36,606
73,212
Unreimbursed expenses (accrued)
104,960
47,741
Related party payable
—
—
Net cash used in operating activities
( 4,291,548 )
( 1,152,962 )
Investing activities:
Financing activities:
Net proceeds from initial public offering, follow-on offering, exercise of Green Shoe, and exercise of underwriter warrants
3,110,596
30,166,502
Repayment to related party/shareholder
—
( 360,000 )
Advance from related party/shareholder
( 275,154 )
—
Net cash provided by (used in) financing activities
2,835,442
29,806,502
Net increase (decrease) in cash
( 1,456,106 )
28,653,540
Cash, beginning of period
28,660,375
6,835
Cash, end of period
$ 27,204,269
$ 28,660,375
Non-cash investing and financing activities:
Common stock to settle related party payable
—
—
Conversion of preferred stock to common
—
2,023
Issuance of preferred stock due to antidilution
—
42
See accompanying notes to financial statements.
F- 6
Table of Contents
GREENWICH
LIFESCIENCES, INC.
NOTES
TO FINANCIAL STATEMENTS
1.
Organization and Description of the Business
Greenwich
LifeSciences, Inc. (the “Company”) was incorporated in the state of Delaware in 2006 under the name Norwell, Inc. In March
2018, Norwell, Inc. changed its name to Greenwich LifeSciences, Inc. The Company is developing a breast cancer immunotherapy focused
on preventing the recurrence of breast cancer following surgery.
2 .
Significant
Accounting Policies
Basis
of Presentation
The
accompanying financial statements are presented in conformity with accounting principles generally accepted in the U.S. (“GAAP”)
and pursuant to the rules and regulations of US Securities and Exchange Commission (“SEC”).
Use
of Estimates
The
preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the
amounts reported in its financial statements and accompanying notes. On an ongoing basis, management evaluates these estimates and judgments,
which are based on historical and anticipated results and trends and on various other assumptions that management believes to be reasonable
under the circumstances. By their nature, estimates are subject to an inherent degree of uncertainty and, as such, actual results may
differ from management’s estimates.
Cash
Cash
consists primarily of deposits with commercial banks and financial institutions.
Impairment
of Long-Lived Assets
The
Company reviews long-lived assets for impairment when events or changes in circumstances indicate the carrying value of the assets may
not be recoverable. Recoverability is measured by comparison of the book values of the assets to future net undiscounted cash flows that
the assets or the asset groups are expected to generate. If such assets are considered to be impaired, the impairment to be recognized
is measured by the amount by which the book value of the assets exceed their fair value, which is measured based on the estimated discounted
future net cash flows arising from the assets or asset groups. No impairment losses on long-lived assets have been recorded through December
31, 2021.
Stock-Based
Compensation
Compensation
expense related to warrants and stock granted to employees and non-employees is measured at the grant date based on the estimated fair
value of the award and is recognized on a straight-line basis over the requisite service period. Forfeitures are recognized as a reduction
of stock-based compensation expense as they occur. Stock-based compensation expense for an award with a performance condition is recognized
when the achievement of such performance condition is determined to be probable. If the outcome of such performance condition is not
determined to be probable or is not met, no compensation expense is recognized and any previously recognized compensation expense is
reversed.
F- 7
Table of Contents
GREENWICH
LIFESCIENCES, INC.
NOTES
TO FINANCIAL STATEMENTS
Research
and Development Costs
Research
and development expenses are charged to operations as incurred. Research and development expenses include, among other things, salaries,
costs of outside collaborators and outside services, and supplies.
Income
Taxes
The
Company’s income tax returns are based on calculations and assumptions that are subject to examination by the Internal Revenue
Service and other tax authorities. In addition, the calculation of tax liabilities involves dealing with uncertainties in the application
of complex tax regulations.
Basic
and Diluted Loss per Share
The
Company computes loss per share in accordance with Accounting Standards Codification (“ASC”) 260 — Earnings per Share.
ASC 260 requires presentation of both basic and diluted earnings per share (“EPS”) on the face of the statements of operations.
Basic EPS is computed by dividing net loss available to common shareholders (numerator) by the weighted average number of common shares
outstanding (denominator) during the period. Diluted EPS gives effect to all dilutive potential common shares outstanding during the
period using the treasury stock method and convertible notes payable using the if-converted method. Diluted EPS excludes all dilutive
potential shares if their effect is antidilutive. During periods of net loss, all common stock equivalents are excluded from the diluted
EPS calculation because they are antidilutive.
As
of December 31, 2021 and 2020, the Company had common stock equivalents related to warrants outstanding to acquire 20,174 and 100,869
shares of the Company’s common stock, respectively.
As
of December 31, 2021 and 2020, the Company has no common stock equivalents related to convertible preferred stock issued and outstanding.
3 .
Related Party Transactions
Unreimbursed
expenses have been accrued and incurred by management, which total $ 164,327 as of December 31, 2021 and $ 59,367 as of December 31, 2020.
In October 2019, the Kenneth Hallock and Annette Hallock Revocable Trust loaned $ 200,000 to the Company and Eric Rothe, a director of
the Company, loaned $ 15,000 to the Company, both of which are payable on demand, are not secured, and do not incur interest. Kenneth
Hallock, a director of the Company, is one of the Trustees of the Hallock Trust. In 2018, the Kenneth Hallock and Annette Hallock Revocable
Trust loaned $ 100,000 to the Company that is payable on demand, not secured, and does not incur interest. In total, Snehal Patel, Company’s
Chief Executive Officer and director, Eric Rothe, and the Kenneth Hallock and Annette Hallock Revocable Trust have loaned capital to
the Company that is payable on demand, is not secured, and does not incur interest, which in the aggregate totals $ 275,154 as of December
31, 2020 and $ 635,154 as of December 31, 2019. In 2020, an aggregate of $ 360,000 of the outstanding loan balance as of December 31, 2019
was paid off by the Company to the related parties. Between January 1, 2021 and March 15, 2021, the Company paid off the remaining related
party loans of $ 155,154 and $ 120,000 to Snehal Patel and the Kenneth Hallock and Annette Hallock Revocable Trust, respectively.
F- 8
Table of Contents
Related
party payables to the Company’s officers and directors since January 1, 2010 total $ 12.0 million as of September 30, 2019. Related
party payables were decreased from $ 12.0 million to $ 0 and all of the Company’s 2,675,602 warrants were cancelled on September
30, 2019, as all related party payables and all warrants were exchanged for an aggregate of 8,012,684 shares of the Company’s common
stock on September 30, 2019. There are no related party payables as of December 31, 2020 and December 31, 2019.
4.
Income Taxes
Significant
components of the Company’s deferred tax assets and liabilities were as follows:
Schedule
of Components of Deferred Tax Assets and Liabilities
2021
2020
December 31,
2021
2020
Deferred tax assets:
Net operating loss carryforwards
1,860,276
1,039,177
Valuation allowance
( 1,860,276 )
( 1,039,177 )
Total deferred tax assets
—
—
The
federal income tax rate used for 2021 and 2020 was 21 %.
At December 31, 2021, the Company had federal net operating loss (“NOL”) carryforwards of approximately $ 8.8
million that will expire in tax years up
through 2037 .
The NOLs generated in tax years 2018 and forward will carry forward indefinitely, but the deductibility of such federal net operating
losses is limited. The NOL and tax credit carryforwards may be further subject to the application of Section 382 of the Internal Revenue
Code of 1986, as amended (the “Code”), as discussed further below. The Company has provided a valuation allowance to offset
the deferred tax assets due to the uncertainty of realizing the benefits of the net deferred tax asset.
The
Company’s issuances of common and preferred stock have likely resulted in ownership changes as defined by Section 382 of the Code;
however, the Company has not conducted a Section 382 study to date. It is possible that a future analysis may result in the conclusion
that a substantial portion, or perhaps substantially all of the Company’s NOL carryforwards and R&D tax credit carryforwards
will expire due to the limitations of Sections 382 and 383 of the Code. As a result, the utilization of the carryforwards may be limited
and a portion of the carryforwards may expire unused.
The
Company is subject to U.S. federal tax examinations by tax authorities for the years 2010 to 2009 due to the fact that NOL carryforwards
exist going back to 2010 that may be utilized on a current or future year tax return.
5.
Commitments
and Contingencies
License
Obligation, Legal Expenses, and Manufacturing Agreements
The
Company entered into an exclusive license agreement with The Henry M. Jackson Foundation (“HJF”) in April 2009, as amended,
pursuant to which it acquired exclusive marketing rights to GP2, the Company’s product candidate. In consideration for such licensed
rights, the Company issued HJF 202,619 shares of the Company’s common stock valued at $ 0.267 per share, which is amortized over
15 years at $ 3,607 per year. Pursuant to the exclusive license agreement, the Company is required to pay an annual maintenance fee, milestone
payments and royalty payments based on sales of GP2 and to reimburse HJF for patent expenses related to GP2. The Company currently depends
on third-party contract manufacturers for all required raw materials, active pharmaceutical ingredients, and finished product candidate
for the Company’s clinical trials.
The
Company paid HJF an aggregate total of $ 434,732 in July 2021 related to annual maintenance fees and reimbursement of patent expenses.
Accounts payable includes accrued patent and license obligations to HJF, including accrued interest, plus accrued expenses for manufacturing
of GP2 for the upcoming Phase III clinical trial, which total $ 220,845 as of December 31, 2021 and $ 710,971 as of December 31, 2020.
F- 9
Table of Contents
Legal
Proceedings
From
time to time, the Company may be involved in disputes, including litigation, relating to claims arising out of operations in the normal
course of business. Any of these claims could subject the Company to costly legal expenses and, while management generally believes that
there will be adequate insurance to cover different liabilities at such time the Company becomes a public company and commences clinical
trials, the Company’s future insurance carriers may deny coverage or policy limits may be inadequate to fully satisfy any damage
awards or settlements. If this were to happen, the payment of any such awards could have a material adverse effect on the results of
operations and financial position. Additionally, any such claims, whether or not successful, could damage the Company’s reputation
and business. The Company is currently not a party to any legal proceedings, the adverse outcome of which, in management’s opinion,
individually or in the aggregate, could have a material adverse effect on our results of operations or financial position.
6.
Stockholders’
Equity
On
September 30, 2019, the board of directors (the “Board”) and stockholders of the Company adopted the Greenwich LifeSciences,
Inc. 2019 Equity Incentive Plan setting aside and reserving 1,498,128
shares of common stock without any issuance of
common stock or options under the plan.
As
of December 31, 2021, 673,017 shares of the 908,242 shares of the common stock grant had vested at approximately $ 1,514,288 value and
235,225 shares remain unvested and unrecognized at approximately $ 529,256 value. In 2021, 293,592 shares of the common stock grant vested
at approximately $ 660,582 value.
As of December 31, 2020, 379,425 shares of the
908,242 shares of the common stock grant had vested at approximately $ 853,706 value and 528,817 shares remain unvested and unrecognized
at approximately $ 1,189,838 value. In 2020, 301,854 shares of the common stock grant vested at approximately $ 677,988 value.
On
June 22, 2020, the Company filed an amendment to its Amended and Restated Certificate of Incorporation, as amended (the “Certificate
of Incorporation”), to effectuate a 1-for-2.67 reverse stock split of the Company’s issued and outstanding common and preferred
stock. No fractional shares were issued and any fractional shares resulting from the stock split were rounded up to the nearest whole
share. All common and preferred stock share and per-share data and conversion or exercise price data for applicable common stock equivalents
included in these financial statements have been retroactively adjusted to reflect the reverse stock split.
F- 10
Table of Contents
GREENWICH
LIFESCIENCES, INC.
NOTES
TO FINANCIAL STATEMENTS
Initial
Public Offering (IPO)
On
September 25, 2020, the Company completed its initial public offering (the “IPO”) pursuant to which it issued and sold 1,260,870
shares of its common stock at a public offering price of $ 5.75 per share for gross proceeds of $ 7,250,002 and net proceeds of $ 6,207,502 ,
after deducting underwriting discounts and commissions and offering expenses borne by the Company, which totaled $ 1,042,500 . In addition,
the Company granted the underwriters a 45-day option to purchase up to 189,130 additional shares of common stock at the public offering
price, less offering expenses, to cover over-allotments, if any.
On
September 29, 2020, in connection with the completion of the IPO, the Company converted all of the outstanding shares of Series A Preferred
Stock into an aggregate of 1,520,937 shares of common stock, all of the outstanding shares of Series B Preferred Stock into an aggregate
of 129,267 shares of common stock, all of the outstanding shares of Series C Preferred Stock into an aggregate of 66,575 shares of common
stock and all of the outstanding shares of Series D Preferred Stock into an aggregate of 305,990 shares of common stock upon the closing
of the IPO, which included the issuance of an aggregate of 42,404 additional shares of common stock upon the issuance and conversion
of an additional 42,404 shares of Series D Preferred Stock issuable in connection with the IPO as a result of the anti-dilution protection
set forth in the Company’s Certificate of Incorporation; based upon the IPO price of $ 5.75 per share.
On
September 29, 2020, in connection with the completion of the IPO, the Board and stockholders of the Company approved the Company’s
Second Amended and Restated Bylaws and the filing of the Company’s Second Amended and Restated Certificate of Incorporation with
the Delaware Secretary of State which authorizes the Company to issue 100,000,000 shares of common stock with a par value of $ 0.001 per
share and 10,000,000 shares of preferred stock with a par value of $ 0.001 per share. In addition, on September 29, 2020, the Company
entered into an employment agreement with Snehal Patel pursuant to which Mr. Patel will serve as the Company’s Chief Executive
Officer as described in the Company Current Report on Form 8-K filed with the SEC on October 1, 2020.
Follow-On
Offering
On
December 22, 2020, the Company completed a follow-on offering pursuant to which it issued and sold 660,000 shares of its common stock
at a public offering price of $ 40.00 per share for gross proceeds of $ 26,400,000 and net proceeds of $ 23,959,000 , after deducting underwriting
discounts and commissions and offering expenses borne by the Company, which totaled $ 2,441,000 . In addition, the Company granted the
underwriters a 45-day option to purchase up to 99,000 additional shares of common stock at the public offering price, less offering expenses,
to cover over-allotments, if any.
On
January 29, 2021, the underwriter exercised its option to purchase 70,000 additional shares of common stock at the public offering price
of $ 40.00 per share for gross proceeds of $ 2,800,000 and net proceeds of $ 2,548,000 , after deducting underwriting discounts and commissions
and offering expenses borne by the Company, which totaled $ 252,000 .
F- 11
Table of Contents
Warrants
Prior
to the IPO, there were no outstanding warrants to purchase shares of common stock accounted for as equity or liabilities.
On
September 25, 2020, in connection with the IPO, the underwriter, Aegis Capital Corp., was issued a warrant to purchase 100,870 shares
of common stock, representing 8 % of the number of shares sold in the IPO, excluding the over-allotment option. The warrants will be exercisable
at any time and from time to time, in whole or in part, during a period commencing March 24, 2021 and expiring September 24, 2025 . The
warrants will be exercisable at a price equal to $ 7.1875 per share, which represents 125 % of the public offering price per share of common
stock sold in the IPO. In the event that a registration statement registering the common stock underlying the warrants is not effective,
the warrants may be exercised on a cashless basis. If the warrants are exercised for cash within the first six months of the period in
which they are exercisable, the exercise price will be equal to 97 % of 125% of the public offering price or $ 6.9718 per share.
On
October 19, 2021, the underwriter warrants were partially exercised resulting in the issuance of 80,696 shares of common stock and gross
proceeds to the Company of $ 562,596 .
At
December 31, 2021, outstanding warrants to purchase shares of common stock accounted for as equity or liabilities were as follows with
an aggregate intrinsic value as of December 31, 2021 of $ 345,833 based on the December 31, 2021 closing share price of $ 24.33 :
Schedule of Outstanding Warrants
Shares Underlying
Outstanding
Exercise
Expiration
Warrants
Price (1)
Date (1)
20,174
$ 7.1875
September 24, 2025
20,174
(1)
The
warrants are exercisable at any time and from time to time, in whole or in part, during a period commencing March 24, 2021 and expiring
September 24, 2025 . The exercise price of the warrants is $ 7.1875 per share or $ 6.9718 per share if the warrants are exercised for
cash within the first six months of the period in which they are exercisable.
7.
Subsequent
Events
On
January 23, 2022, the Board of Directors authorized the Company’s management to implement a stock repurchase program for up to
$ 10
million of the Company’s common stock at
any time. The term of the Board of Directors authorization of the repurchase program is until March 31, 2023. The repurchase program
may be suspended or discontinued at any time and will be funded using the company’s working capital. As of March 15, 2022,
approximately 269,828 shares of the Company’s common stock
has been repurchased at a purchase price, including all transactions costs, of approximately $ 5,513,711 .
On
March 15, 2022, the Board of Directors indefinitely suspended the Company’s stock repurchase program.
On
January 23, 2022, the Board of Directors extended the lock-up of the shares owned by the Company’s directors, officers, and existing
pre-IPO investors to March 24, 2023 (30 months from date of the Company’s IPO) from March 24, 2022 (18 months from date of the
Company’s IPO). During this period, current officers, directors and certain shareholders will not be able to sell their shares
of the Company’s common stock unless otherwise modified by the Board of Directors.
F- 12
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.