Greenwich LifeSciences, Inc. 10-K

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, 2022, 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, 2022, 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, 2022, our internal control over financial reporting had material weaknesses that lack 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, 2022 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. 54 Table of Contents 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, 2023. 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 59 Chief Executive Officer, Chief Financial Officer and Director F. Joseph Daugherty 72 Chief Medical Officer and Director Jaye Thompson 57 Vice President Clinical & Regulatory Affairs David McWilliams 79 Chairman of the Board Eric Rothe 47 Director Kenneth Hallock 74 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. 55 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. 56 Table of Contents 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 . 57 Table of Contents 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, 2023, none of our directors or executive officers had pledged any shares of our common stock. 58 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, 2022. Name and Principal Position Year Salary ($) Bonus ($) Stock awards ($) (1) Total ($) Snehal Patel, Chief Executive Officer 2022 506,250 503,125 1,201,050 2,210,425 2021 450,000 475,000 491,589 1,416.589 (1) For 2022 fiscal year, Mr. Patel received 163,863 shares of our common stock and options to purchase 131,900 shares of common stock for services rendered and as incentive for services to be rendered. The options may or may not vest based on certain additional performance milestones. For 2021 fiscal year, Mr. Patel received 218,484 shares of our common stock and no options or warrants for services rendered and as incentive for services to be rendered. 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, 2022. Option Awards(1) Name Number of Securities Underlying Unexercised Options (#) Exercisable Number of Securities Underlying Unexercised Options (#) Unexercisable Option Exercise Price ($) Option Expiration Date +Snehal Patel 26,219 1,022,504 7.63 June 21, 2032 (1) On June 22, 2022, we granted Mr. Patel options to purchase shares of common stock for compensation and incentives to be earned in equal installments over 48 months. Between the 6 month period, June, 22, 2022 to December 31, 2022, Mr. Patel earned 131,900 options which may or may not vest based on certain additional performance milestones and of which 20% is currently vested and exercisable, totaling 26,219 shares, and the balance, or 1,022,504 options, may or may not vest over the 42 month period commencing on January 1, 2023 or thereafter. (2) We granted Mr. Patel shares of common stock on September 30, 2019 for compensation and incentives of which 93,633 vested immediately upon grant and 655,452 vested between October 1, 2019 and September 30, 2022 in 36 equal installments over the 36 month period. Non-Employee Director Compensation The following table presents the total compensation for each person who served as a non-employee member of our Board and received compensation for such service during the fiscal year ended December 31, 2022. Other than as set forth in the table and described more fully below, we did not pay any compensation, make any equity awards or non-equity awards to, or pay any other compensation to any of the non-employee members of our Board in 2022. Name Fees Earned or Paid in Cash ($) Stock and Option Awards ($) All Other Compensation ($) Total ($) David McWilliams (1) 65,011 65,011 Eric Rothe (2) 43,368 43,368 Kenneth Hallock (3) 43,368 43,368 (1) We granted Mr. McWilliams options to purchase shares of common stock on June 22, 2022 for compensation and incentives of which 7,748 options vested between June, 22, 2022 and December 31, 2022 over the 6 month period, and the balance, or 54,236 options, vest over 42 equal monthly installments commencing on January 1, 2023. We granted Mr. McWilliams shares of common stock on September 30, 2019 for compensation and incentives of which 28,116 shares vested between October 1, 2019 and September 30, 2022 in 36 equal installments over the 36 month period. 59 Table of Contents (2) We granted Mr. Rothe options to purchase shares of common stock on June 22, 2022 for compensation and incentives of which 5,169 options vested between June, 22, 2022 and December 31, 2022 over the 6 month period, and the balance, or 36,180 options, vest over 42 equal monthly installments commencing on January 1, 2023. We granted Mr. Rothe shares of common stock on September 30, 2019 for compensation and incentives of which 18,756 shares vested between October 1, 2019 and September 30, 2022 in 36 equal installments over the 36 month period. (3) We granted Mr. Hallock options to purchase shares of common stock on June 22, 2022 for compensation and incentives of which 5,169 options vested between June, 22, 2022 and December 31, 2022 over the 6 month period, and the balance, or 36,180 options, vest over 42 equal monthly installments commencing on January 1, 2023. We granted Mr. Hallock shares of common stock on September 30, 2019 for compensation and incentives of which 18,756 shares vested between October 1, 2019 and September 30, 2022 in 36 equal installments over the 36 month period. 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 15, 2023 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, 2023, 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 12,848,165 shares of common stock issued and outstanding as of March 15, 2023. 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. 60 Table of Contents Name of Beneficial Owner Shares of Common Stock Beneficially Owned Percentage Executive officers and directors: Snehal Patel 5,324,974 (1) 40.68 % F. Joseph Daugherty 96,142 (2) * David McWilliams 634,532 (3) 4.93 % Eric Rothe 322,731 (4) 2.51 % Kenneth Hallock 406,809 (5) 3.16 % All current named executive officers and directors as a group (5) persons 6,785,188 51.62 % * Represents beneficial ownership of less than 1% (1) Consists of (i) 1,255,074 shares of common stock owned by Snehal Patel, (ii) 1,474,568 shares of common stock owned by Snehal Patel IRA, (iii) 919,234 shares of common stock owned by Patel Family Trust 1, (iv) 743,218 shares of common stock owned by Patel Family Trust 2, (v) 743,218 shares of common stock owned by Patel Family Trust 3, and (vi) 135,865 shares of common stock owned by Kinnary Patel IRA. Includes 53,797 shares of common stock exercisable upon exercise of vested stock options and stock options that vest within 60 days. 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) Includes 6,009 shares of common stock exercisable upon exercise of vested stock options and stock options that vest within 60 days. (3) Includes 14,205 shares of common stock exercisable upon exercise of vested stock options and stock options that vest within 60 days. (4) Includes 9,476 shares of common stock exercisable upon exercise of vested stock options and stock options that vest within 60 days. (5) Includes 9,476 shares of common stock exercisable upon exercise of vested stock options and stock options that vest within 60 days. 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 2022, 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, 2022 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: 2022 2021 Audit fees (1) $ 60,000 $ 54,000 Audit-related fees $ 30,000 $ 8,940 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, 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 1.1 Open Market Sale Agreement, dated July 12, 2022 by and between the Company and Jefferies LLC (incorporated by reference to Exhibit 1.1 to Form 8-K filed on July 12, 2022) 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) 23.1 Consent of MaloneBailey LLP 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 31, 2023 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, 2023 Snehal Patel (Principal Executive Officer and Principal Accounting and Financial Officer) /s/ F. Joseph Daugherty Chief Medical Officer and Director March 31, 2023 F. Joseph Daugherty /s/ David McWilliams Director March 31, 2023 David McWilliams /s/ Eric Rothe Director March 31, 2023 Eric Rothe /s/ Kenneth Hallock Director March 31, 2023 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 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, 2022 and 2021, 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, 2022 and 2021, 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, 2023 F- 2 Table of Contents GREENWICH LIFESCIENCES, INC. BALANCE SHEETS AS OF DECEMBER 31, 2022 AND 2021 2022 2021 Assets Current assets Cash $ 13,468,026 $ 27,204,269 Acquired patents, net 9,003 12,615 Total assets $ 13,477,029 $ 27,216,884 Liabilities and stockholders’ deficit Current liabilities Accounts payable & accrued interest $ 220,845 $ 220,845 Unreimbursed expenses 42,060 164,327 Total current liabilities 262,905 385,172 Total liabilities 262,905 385,172 Stockholders’ equity Common stock, $ 0.001 par value; 100,000,000 shares authorized; 12,848,165 and 13,147,829 shares issued and outstanding as of December 31, 2022 and 2021, respectively 12,848 13,148 Additional paid-in capital 54,674,042 60,466,093 Accumulated deficit ( 41,472,766 ) ( 33,647,529 ) Total stockholders’ equity 13,214,124 26,831,712 Total liabilities and stockholders’ equity $ 13,477,029 $ 27,216,884 See accompanying notes to financial statements. F- 3 Table of Contents GREENWICH LIFESCIENCES, INC. STATEMENTS OF OPERATIONS FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021 2022 2021 2022 2021 Revenue $ — $ — Operating expenses Research and development 6,475,668 3,559,515 General and administrative 1,564,586 1,038,428 Total operating expenses 8,040,254 4,597,943 Loss from operations ( 8,040,254 ) ( 4,597,943 ) Interest income 215,017 27,367 Net loss $ ( 7,825,237 ) $ ( 4,570,576 ) Per share information: Net loss per common share, basic and diluted $ ( 0.61 ) $ ( 0.35 ) Weighted average common shares outstanding, basic and diluted 12,913,848 12,944,134 See accompanying notes to financial statements. F- 4 Table of Contents GREENWICH LIFESCIENCES, INC. STATEMENTS OF STOCKHOLDERS’ EQUITY FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021 Shares Par Amount Shares Par Amount Paid-in Capital Accumulated Deficit Equity (Deficit) Common Stock Preferred Stock Additional Total Shares Par Amount Shares Par Amount Paid-in Capital Accumulated Deficit Stockholders’ Equity Balances, December 31, 2020 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 Beginning balance 13,147,829 $ 13,148 — $ — $ 60,466,093 $ ( 33,647,529 ) $ 26,831,712 Stock-based compensation 220,164 220 — — 1,743,645 — 1,743,865 Repurchase of common stock via stock repurchase program, net of costs ( 519,828 ) ( 520 ) — — ( 7,535,696 ) — ( 7,536,216 ) Net loss ( 7,825,237 ) ( 7,825,237 ) Balances, December 31, 2022 12,848,165 $ 12,848 — $ — $ 54,674,042 $ ( 41,472,766 ) $ 13,214,124 Ending balance 12,848,165 $ 12,848 — $ — $ 54,674,042 $ ( 41,472,766 ) $ 13,214,124 See accompanying notes to financial statements. F- 5 Table of Contents GREENWICH LIFESCIENCES, INC. STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021 2022 2021 2022 2021 Operating activities: Net loss $ ( 7,825,237 ) $ ( 4,570,576 ) Adjustments required to reconcile net loss to net cash used in operating activities: Amortization 3,612 3,612 Stock-based compensation 1,743,865 660,582 Changes in operating assets and liabilities: Accounts payable — ( 526,732 ) Accrued interest — 36,606 Unreimbursed expenses (accrued) ( 122,267 ) 104,960 Net cash used in operating activities ( 6,200,027 ) ( 4,291,548 ) Investing activities: Financing activities: Net proceeds from exercise of Green Shoe from follow-on offering and exercise of underwriter warrants — 3,110,596 Repurchase of common stock via stock repurchase program, net of costs ( 7,536,216 ) — Advance from related party/shareholder — ( 275,154 ) Net cash provided by (used in) financing activities ( 7,536,216 ) 2,835,442 Net increase (decrease) in cash ( 13,736,243 ) ( 1,456,106 ) Cash, beginning of period 27,204,269 28,660,375 Cash, end of period $ 13,468,026 $ 27,204,269 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. In February 2023, Greenwich LifeSciences Europe Limited was incorporated as a wholly owned subsidiary in Ireland. 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, 2022. Leases In February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02-Leases (Topic 842), which significantly amends the way companies are required to account for leases. Under the updated leasing guidance, some leases that did not have to be reported previously are now required to be presented as an asset and liability on the balance sheet. In addition, for certain leases, what was previously classified as an operating expense must now be allocated between amortization expense and interest expense. The Company elected to adopt this update using the modified retrospective transition method and prior periods have not been restated. The current monthly rent is approximately $ 2,555 . The month-to-month sub-lease is from a related party and the underlying lease expires in May of 2024 . Any right of use asset and liability is deemed to be nominal as of December 31, 2022 and 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, 2022 and 2021, the Company had common stock equivalents related to warrants outstanding to acquire 20,174 shares of the Company’s common stock. As of December 31, 2022 and 2021, the Company has no common stock equivalents related to convertible preferred stock issued and outstanding. Convertible Debt and Convertible Preferred Stock In January 2021, the Company early adopted ASU 2020-06 Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40). ASU 2020-06 simplifies the accounting for convertible debt instruments and convertible preferred stock by reducing the number of accounting models and limiting the number of embedded conversion features separately recognized from the primary contract. The guidance also includes targeted improvements to the disclosures for convertible instruments and earnings per share. ASU 2020-06 is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020. The adoption of ASU 2020-06 did not have a material impact on the Company’s financial statements. 3. Related Party Transactions Unreimbursed expenses have been accrued and incurred by management, which total $ 42,060 as of December 31, 2022 and $ 164,327 as of December 31, 2021. 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 GREENWICH LIFESCIENCES, INC. NOTES TO FINANCIAL STATEMENTS 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 2022 2021 December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards 3,137,364 1,860,276 Valuation allowance ( 3,137,364 ) ( 1,860,276 ) Total deferred tax assets — — The federal income tax rate used for 2022 and 2021 was 21 %. At December 31, 2022, the Company had federal net operating loss (“NOL”) carryforwards of approximately $ 14.9 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. 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 interest which total $ 220,845 as of December 31, 2022 and 2021. F- 9 Table of Contents GREENWICH LIFESCIENCES, INC. NOTES TO FINANCIAL STATEMENTS 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, 2022, 893,181 shares of the 908,362 shares of the common stock grant, which includes an additional grant of 120 shares issued during the vesting period due to rounding up of fractional shares, had vested at approximately $ 2,009,657 value and 15,181 shares remain unvested and unrecognized at approximately $ 34,157 value. In 2022, 220,164 shares of common stock grant vested at approximately $ 495,369 value. 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. 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 December 31, 2022, approximately 519,828 shares of the Company’s common stock has been repurchased and cancelled at an aggregate purchase price, including all transactions costs, of approximately $ 7,536,216 . 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). On November 30, 2022, the Board of Directors further extended the lock-up of the shares owned by the Company’s directors, officers, and existing pre-IPO investors to December 31, 2023 (approximately 39 months from date of the Company’s IPO) from March 24, 2023 (30 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. 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 GREENWICH LIFESCIENCES, INC. NOTES TO FINANCIAL STATEMENTS 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, 2022, 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, 2022 of $ 161,644 based on the December 30, 2022 closing share price of $ 15.20 : 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. Options On June 22, 2022, prior to the close of the Nasdaq market, 1,498,128 shares of common stock were granted to employees, consultants, and directors issuable upon exercise of outstanding stock options under the Company’s 2019 Equity Incentive Plan at an exercise price of $ 7.63 per share, which was the most recent prior closing share price on June 21, 2022. The options had a fair value on the grant date of $ 9,512,356 , based on a risk-free rate of 3.2% and an annualized volatility of 106%, of which $ 1,248,496 was expensed through December 31, 2022 and $ 8,263,860 will be expensed in the future if and as vesting occurs. Vesting will be based on time of service over a four year period and certain additional performance milestones for senior management, primarily related to the Phase III clinical trial. F- 12