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, 2020, 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
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, 2020 that has materially
affected, or is reasonably likely to materially affect, our internal control over financial reporting.
ITEM
9B. OTHER INFORMATION
None.
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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
15, 2021. 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
57
Chief
Executive Officer, Chief Financial Officer and Director
F.
Joseph Daugherty
70
Chief
Medical Officer and Director
Jaye
Thompson
55
Vice
President Clinical & Regulatory Affairs
David
McWilliams
77
Chairman
of the Board
Eric
Rothe
45
Director
Kenneth
Hallock
72
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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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 15, 2021, none of our directors or executive officers
had pledged any shares of our common stock.
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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, 2020.
Name and Principal Position
Year
Salary
($)
Bonus
($)
Stock
awards
($) (1)
Option
awards
($)
Nonequity incentive plan
compensation
($)
Nonqualified
deferred compensation
earnings ($)
All other compensation
($) (2)
Total
($)
Snehal Patel, Chief Executive Officer
2020
114,966
392,516
491,589
—
—
—
—
999,071
2019
—
—
122,750
—
—
—
16,423
139,173
(1)
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.
For 2019 fiscal year, Mr. Patel received 148,254 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 2019 fiscal year.
(2)
For
fiscal year 2019, Mr. Patel received (i) 4,494,383 shares of our common stock in exchange for related party payables for the
periods from January 1, 2010 through September 30, 2019 and (ii) 1,656,607 shares of our common stock in exchange for warrants
to purchase shares of our common stock.
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, 2020.
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
382,326 (1)
860,234
(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, 273,105 vested between October 1 2019 and December 31, 2020 over the 15 month period, and the balance, or 382,347 shares
of common stock vest over 21 equal monthly installments commencing on January 1, 2021.
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, 2020. 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 2020.
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, 2020. Mr. McWilliams did not receive
any options or warrants during the 2020 fiscal year.
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(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, 2020. Mr. Rothe did not receive any options or warrants during
the 2020 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, 2020. Mr. Hallock did not receive any options or warrants during
the 2020 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.
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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 15, 2021
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 15, 2021, 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 12,846,897 shares of common stock issued and outstanding as of March 15, 2021.
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
7,488,467
(1)
58.13
%
F.
Joseph Daugherty
57,886
(2)
*
David
McWilliams
607,631
(3)
4.73
%
Eric
Rothe
304,919
(4)
2.37
%
Kenneth
Hallock
388,697
(5)
3.03
%
All
current named executive officers and directors as a group (5 persons)
8,847,600
68.64
%
*
Represents
beneficial ownership of less than 1%.
(1)
Consists
of (i) 895,548 shares of common stock owned by Snehal Patel, (ii) 1,408,033 shares of common stock owned by Snehal
Patel IRA, (iii) 2,405,670 shares of common stock owned by Patel Family Trust 1, (iv) 1,320,226 shares of common stock owned
by Patel Family Trust 2, (v) 1,329,590 shares of common stock owned by Patel Family Trust 3, and (vi) 129,400 shares of common
stock owned by Kinnary Patel IRA. Excludes 291,291 shares of common stock held by Snehal Patel which vest in 16
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
29,124 shares of common stock which vest in 16 equal monthly installments.
(3)
Excludes
12,470 shares of common stock which vest in 16 equal installments.
(4)
Excludes
8,307 shares of common stock which vest in 16 equal monthly installments.
(5)
Excludes
8,307 shares of common stock which vest in 16 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 2020, all filing requirements applicable to our officers,
directors and greater than ten percent beneficial owners were complied with.
ITEM
13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The
following includes a summary of transactions since January 1, 2020 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.
On
October 9, 2019, Eric Rothe, a director, loaned us $15,000 which is payable on demand, is not secured, and does not incur interest,
all of which was repaid on November 20, 2020.
On May 30, 2018 and October 2, 2019, the Kenneth
and Annette Hallock Revocable Trust loaned us $100,000 and $200,000, respectively, which is payable on demand, is not secured,
and does not incur interest, of which $120,000 remained outstanding as of December 31, 2020 and was subsequently fully paid
off as of March 15, 2021. Kenneth Hallock, a director, is one of the Trustees of the Hallock Trust.
Between November 2014 and August 2017, Snehal
Patel, our Chief Executive Officer and director, loaned us an aggregate of $320,154, which is payable on demand, is not secured,
and does not incur interest, of which $155,154 remained outstanding, as of December 31, 2020 and was subsequently fully
paid off as of March 15, 2021. In addition, as of December 31, 2020, Snehal Patel is owed $59,367 for reimbursable expenses.
64
Table of Contents
As
of September 30, 2019, related party payables to our officers and directors since January 1, 2010 totaled $12 million. As of September
30, 2019, our officers and directors owned outstanding warrants to acquire 2,565,521 shares of our common stock. On September
30, 2019, the officers and directors exchanged all related party payables and outstanding warrants for an aggregate of 7,902,603
shares of our common stock, leaving us with no related party payables and no outstanding warrants on September 30, 2019.
On
December 15, 2020, we announced we had entered into an option agreement with Westport Bio to in-license a pre-clinical coronavirus
vaccine program that is currently at the stage of pre-clinical animal testing. The option is exercisable at our discretion. In
exchange for the option, we have agreed to sponsor research with Westport Bio in an aggregate amount of up to $250,000, plus additional
license and assignment fees. The founder of Westport Bio is our Chief Executive Officer and director, Snehal Patel
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.
65
Table of Contents
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:
2020
2019
Audit fees (1)
$ 69,000
$ 15,000
(1)
Audit
fees consist of fees for professional services performed by MaloneBailey for the audit and review of our financial statements,
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.
66
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.
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
XBRL
Instance Document.
101.SCH
XBRL
Taxonomy Extension Schema.
101.CAL
XBRL
Taxonomy Extension Calculation Linkbase.
101.LAB
XBRL
Taxonomy Extension Labels Linkbase.
101.PRE
XBRL
Taxonomy Extension Presentation Linkbase.
101.DEF
XBRL
Taxonomy Extension Definition Linkbase.
+
Indicates
a management contract or compensatory plan or arrangement.
ITEM
16. FORM 10-K SUMMARY
None.
67
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
31, 2021
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
31, 2021
Snehal
Patel
(Principal
Executive Officer and Principal Accounting and Financial Officer)
/s/
F. Joseph Daugherty
Chief
Medical Officer and Director
March 31, 2021
F.
Joseph Daugherty
/s/
David McWilliams
Director
March 31, 2021
David
McWilliams
/s/
Eric Rothe
Director
March 31, 2021
Eric
Rothe
/s/
Kenneth Hallock
Director
March 31, 2021
Kenneth
Hallock
68
Table of Contents
GREENWICH
LIFESCIENCES, INC.
Index
to Financial Statements
Report of Independent Registered Public Accounting Firm
F-2
Balance Sheets
F-3
Statements of Operations
F-4
Statement
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, 2020
and 2019, and the related statements of operations, stockholders’ equity (deficit), 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, 2020 and 2019, 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
www.malonebailey.com
We
have served as the Company’s auditor since 2019.
Houston,
Texas
March 31, 2021
F- 2
Table of Contents
GREENWICH
LIFESCIENCES, INC.
BALANCE
SHEETS
AS
OF DECEMBER 31, 2020 AND 2019
December
31, 2020
December
31, 2019
Assets
Current assets
Cash
$ 28,660,375
$ 6,835
Total current assets
28,660,375
6,835
Acquired patents, net
16,227
19,836
Total assets
$ 28,676,602
$ 26,671
Liabilities and stockholders’
deficit
Current liabilities
Accounts payable & accrued interest
$ 710,971
$ 730,309
Unreimbursed expenses
59,367
11,626
Advance from related party/shareholder
275,154
635,154
Total current liabilities
1,045,492
1,377,089
Total liabilities
1,045,492
1,377,089
Stockholders’ equity (deficit)
Common stock, $0.001 par value; 100,000,000
shares authorized; 12,703,541 and 8,458,048 shares issued and outstanding as of December 31, 2020 and 2019, respectively
12,704
8,458
Preferred stock, $0.001 par value; 10,000,000 shares authorized;
Series A preferred stock: No shares as of December 31, 2020 and
1,520,937 shares issued and outstanding as of December 31, 2019
—
1,521
Series B preferred stock: No shares as of December 31, 2020 and
129,267 shares issued and outstanding as of December 31, 2019
—
129
Series C preferred stock: No shares as of December 31, 2020 and
66,575 shares issued and outstanding as of December 31, 2019
—
67
Series D preferred stock: No shares as of December 31, 2020 and
263,586 shares issued and outstanding as December 31, 2019
—
264
Additional paid-in capital
56,695,359
25,853,134
Accumulated deficit
(29,076,953 )
(27,213,991 )
Total stockholders’
equity (deficit)
27,631,110
(1,350,418 )
Total
liabilities and stockholders’ equity (deficit)
$ 28,676,602
$ 26,671
See
accompanied notes to financial statements.
F- 3
Table of Contents
GREENWICH
LIFESCIENCES, INC.
STATEMENTS
OF OPERATIONS
FOR
THE YEARS ENDED DECEMBER 31, 2020 AND 2019
Year
Ended December 31,
2020
2019
Revenue
$ —
$ —
Operating expenses
Research and development
1,057,606
2,606,420
General and administrative
806,188
818,887
Total
operating expenses
1,863,794
3,425,307
Loss from operations
(1,863,794 )
(3,425,307 )
Interest income
832
Net loss
$ (1,862,962 )
$ (3,425,307 )
Per share information:
Net loss per common share, basic and
diluted
$ (0.20 )
$ (1.52 )
Weighted average common shares outstanding,
basic and diluted
9,499,155
2,257,979
See
accompanied notes to financial statements.
F- 4
Table of Contents
GREENWICH
LIFESCIENCES, INC.
STATEMENTS
OF STOCKHOLDERS’ EQUITY (DEFICIT )
FOR
THE YEARS ENDED DECEMBER 31, 2020 AND 2019
Common
Stock
Preferred
Stock
Additional
Total
Stockholders’
Shares
Par
Amount
Shares
Par
Amount
Paid-in
Capital
Accumulated
Deficit
Equity
(Deficit )
Balances, December 31, 2018
202,996
$ 203
1,980,365
$ 1,981
$ 13,666,446
$ (23,788,684 )
$ (10,120,054 )
Exchange of related party payables and
warrants for common stock
8,012,684
8,013
—
—
11,991,987
—
12,000,000
Stock-based compensation
242,368
242
—
—
194,701
—
194,943
Net loss
(3,425,307 )
(3,425,307 )
Balances, December 31, 2019
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
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
See
accompanied notes to financial statements.
F- 5
Table of Contents
GREENWICH
LIFESCIENCES, INC.
STATEMENTS
OF CASH FLOWS
FOR
THE YEARS ENDED DECEMBER 31, 2020 AND 2019
Year
Ended December 31,
2020
2019
Operating activities:
Net loss
$ (1,862,962 )
$ (3,425,307 )
Adjustments required to reconcile net
loss to net cash used in operating activities:
Amortization
3,609
3,607
Stock-based compensation
677,988
194,943
Changes in operating assets and liabilities:
Accounts payable
(92,550 )
393,402
Accrued interest
73,212
59,353
Unreimbursed expenses (accrued)
47,741
(19,263 )
Related party payable
—
2,500,000
Net cash used in operating activities
(1,152,962 )
(293,267 )
Investing activities:
Financing activities:
Net proceeds from initial public offering
and follow-on offering of common stock
30,166,502
—
Repayment to related party/shareholder
(360,000 )
—
Advance from related party/shareholder
—
215,000
Net cash provided by (used in) financing
activities
29,806,502
215,000
Net increase (decrease) in cash
28,653,540
(78,267
Cash, beginning of period
6,835
85,102
Cash, end of period
$ 28,660,375
$ 6,835
Non-cash investing and financing activities:
Common stock to settle related party
payable
—
12,000,000
Conversion of preferred stock to common
2,023
—
Issuance of preferred stock due to antidilution
42
—
See
accompanied 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.
Going Concern
On August 27, 2014, the Financial Accounting
Standards Board issued Accounting Standards Update (“ASU”) 2014-05, Disclosure of Uncertainties about an Entity’s
ability to Continue as a Going Concern (“ASU 2014-05”), which requires management to assess a company’s ability
to continue as a going concern within one year from financial statement issuance and to provide related footnote disclosures in
certain circumstances.
The accompanying financial statements and
notes have been prepared assuming the Company will continue as a going concern. During the year ended December 31, 2019, the Company
suffered from recurring losses from operations and negative cash flows from operations, resulting in a need for, among other things,
capital resources. As of December 31, 2019, the Company had cash of $6,835 and disclosed that its ability to continue as a going
concern was predicated on the Company’s ability to raise capital and to sustain adequate working capital to finance its
operations. In September 2020, the Company completed its initial public offering and raised $7,250,002 in gross proceeds and $6,207,502
in net proceeds, after deducting underwriting discounts and commissions and other offering expenses. In December 2020, the Company
completed a follow-on offering and raised $26,400,000 in gross proceeds and $23,959,000 in net proceeds, after deducting underwriting
discounts and commissions and other offering expenses. The Company met and exceeded those predications thus mitigating any substantial
doubt about the Company’s ability to continue as a going concern as defined by ASU 2014-05 and its ability to satisfy the
estimated liquidity needs for the twelve months from the issuance of the financial statements.
As
of December 31, 2020, the Company had cash of $28,660,375.
3.
Significant Accounting Policies
Basis
of Presentation
The
accompanying financial statements are presented in conformity with accounting principles generally accepted in the United States
of America (“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, 2020.
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
3.
Significant Accounting Policies (cont.)
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, 2020, the Company has common stock equivalents related to warrants outstanding to acquire 100,869 shares of the
Company’s common stock. As of December 31, 2019, the Company had no warrants.
As
of December 31, 2020, the Company has no common stock equivalents related to convertible preferred stock issued and outstanding.
As of December 31, 2019, the Company had common stock equivalents related to 1,520,937 shares of the Company’s common stock
issuable upon conversion of the Company’s Series A Preferred Stock, 129,267 shares of the Company’s common stock issuable
upon conversion of the Company’s Series B Preferred Stock, 66,575 shares of the Company’s common stock issuable upon
conversion of the Company’s Series C Preferred Stock, and 263,586 shares of the Company’s common stock issuable upon
conversion of the Company’s Series D Preferred Stock issued and outstanding.
Recent
Accounting Pronouncements
The
Company has evaluated the following recent accounting pronouncements through the date the financial statements were issued and
filed with the SEC and believes that none of them will have a material effect on the Company’s financial statements:
In
February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”)
No. 2016-02, “Leases: Topic 842 (ASU 2016-02)”, to supersede nearly all existing lease guidance under GAAP. The guidance
would require lessees to recognize most leases on their balance sheets as lease liabilities with corresponding right-of-use assets.
ASU 2016-02 is effective for the Company in the first quarter of its fiscal year ending December 31, 2019 using a modified retrospective
approach with the option to elect certain practical expedients. The Company has no material leases, thus the adoption of
ASU 2016-02 will have no material impact on the Company’s financial statements.
In
May 2016, the FASB issued ASU 2016-12, Revenue from Contracts from Customers (Topic 606): Narrow-Scope Improvements and Practical
Expedients. The amendments in this update affect the guidance in ASU 2014-09. The core principle of the guidance in Topic 606
is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that
reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The amendments
in ASU 2016-12 do not change the core principle of the guidance in Topic 606, but instead affect only the narrow aspects noted
in Topic 606. Topic 606 became effective for the Company on December 1, 2018. The Company has no revenue, thus the adoption of
ASU 2016-12 will have no material impact on the Company’s financial statements.
F- 8
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GREENWICH
LIFESCIENCES, INC.
NOTES
TO FINANCIAL STATEMENTS
3.
Significant Accounting Policies (cont.)
In
June 2018, the FASB issued ASU 2018-07, “Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based
Payment Accounting,” which modifies the accounting for share-based payment awards issued to nonemployees to largely align
it with the accounting for share-based payment awards issued to employees. ASU 2018-07 is effective for us for annual periods
beginning January 1, 2019. The Company evaluated ASU 2018-07 and determined that the adoption of this new accounting standard
did not have a material impact on the Company’s financial statements.
4.
Related Party Transactions
Unreimbursed
expenses have been accrued and incurred by management, which total $59,367 as of December 31, 2020 and $11,626 as of December
31, 2019. 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.
F- 9
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GREENWICH
LIFESCIENCES, INC.
NOTES
TO FINANCIAL STATEMENTS
4.
Related Party Transactions (cont.)
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.
5.
Income Taxes
Significant
components of the Company’s deferred tax assets and liabilities were as follows:
December
31,
2020
2019
Deferred tax assets:
Net operating loss carryforwards
1,039,177
790,333
Valuation allowance
(1,039,177 )
(790,333 )
Total deferred tax
assets
—
—
The
federal income tax rate used for 2020 and 2019 was 21%. At December 31, 2020, the Company had federal net operating loss (“NOL”)
carryforwards of approximately $4.9 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.
6.
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.
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 through purchase orders with Polypeptide Laboratories and Stratum Medical,
and legal expenses with Sheppard Mullin, which total $710,971 as of December 31, 2020 and $730,309 as of December 31,
2019.
F- 10
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GREENWICH
LIFESCIENCES, INC.
NOTES
TO FINANCIAL STATEMENTS
6.
Commitments and Contingencies (cont.)
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.
7.
Stockholders’ Equity
In
2019, an aggregate total of 8,255,052 shares of the Company’s common stock were issued to retire all related party payables,
to cancel all warrants, and to compensate and incentivize management, directors, and consultants.
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. In addition, on September 30, 2019, the Board authorized the Company to enter into a lock-up/leak-out
agreement with its shareholders, the size of the Board was increased from three to five members, two new members were appointed
to the Board, $12 million of related party payables and 2,675,602 warrants were exchanged for 8,012,684 shares of the Company’s
common stock, and 155,433 shares of the Company’s common stock were issued upfront at no value in consideration for services
and 908,242 shares of the Company’s common stock were authorized to be issued at $2,037,000 value based on various vesting
schedules that start monthly vesting on October 1, 2019 and on the first day of each subsequent month.
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
December 30, 2019, the Company issued a consultant 9,364 shares of the Company’s common stock for services rendered at approximately
$21,000 value.
Pursuant
to ASU 2018-07, “Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting,”
the Company’s warrants were valued using the Black-Scholes option pricing model. Assumptions used in the valuation include
the following: a) market value of stock on measurement date of $0.00; b) risk-free rate of 0.49%; c) volatility factor of 109%;
d) dividend yield of 0.00%. Based on the valuation, the warrants had no value on the grant date of September 30, 2019.
In
addition, the Company modified the exercise price of all 2,675,602 warrants to $0 on the modification date of September 30, 2019,
and thus the Company exchanged the 2,675,602 warrants for 2,675,602 shares of the Company’s common stock at no value on
the modification date. The warrants were valued using the Black-Scholes option pricing model. Assumptions used in the valuation
include the following: a) market value of stock on measurement date of $0.00; b) risk-free rate of 0.49%; c) volatility factor
of 109%; d) dividend yield of 0.00%. Based on the valuation, the modified warrants had no value on the modification date of September
30, 2019. Therefore, no incremental expense was recorded due to the modification.
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- 11
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GREENWICH
LIFESCIENCES, INC.
NOTES
TO FINANCIAL STATEMENTS
No
new equity was raised in 2019.
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.
F- 12
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.
At
December 31, 2020, 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, 2020 of $2,953,726 based on the December 31, 2020 closing
share price of $36.47:
Shares
Underlying
Outstanding
Exercise
Expiration
Warrants
Price (1)
Date (1)
100,870
$ 7.1875
September 24, 2025
100,870
(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.
8.
Subsequent Events
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.
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.
An
aggregate of 73,356 shares of common stock were vested in January, February, and March 2021 in consideration for services rendered.
F- 13
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.