Financial Losses and Funding - The company has incurred substantial losses since inception and anticipates continuing to incur significant losses for the foreseeable future[16] - The company needs significant additional financing to fund operations and complete the development of its product candidate[16] - The company must raise substantial additional capital to fund operations, which could delay or reduce product development programs[16] - The company requires significant additional financing to fund operations and complete product candidate development and commercialization[16] Clinical Trials and Regulatory Approval - The success, cost, and timing of clinical trials are critical factors for the company's future[11] - The company relies on third parties for conducting preclinical studies and clinical trials, which poses risks to obtaining regulatory approval[23] - The results of preclinical studies or earlier clinical trials may not predict future results, and regulatory approval is uncertain[18] - The company’s future success is dependent on obtaining regulatory approval for its product candidate[21] Market Acceptance and Competition - Market acceptance of the product candidate is essential for commercial success, with significant competition in the industry[25] - The commercial success of the company depends on achieving significant market acceptance among healthcare providers and payors[25] - The company may face substantial competition, which could hinder its ability to successfully commercialize products[26] Operational Risks - The company faces substantial risks related to intellectual property rights, including potential infringement claims[11] - The company has limited manufacturing and distribution capabilities, relying on third parties, which could affect supply and costs[22] - The company relies on third parties for manufacturing, sales, marketing, and distribution, which introduces risks that could increase costs and limit supply[22] - The potential impact of health epidemics, such as the coronavirus pandemic, on business operations and clinical trials is a significant concern[11] Patient Enrollment Challenges - The company faces challenges in enrolling patients for clinical trials due to the limited number of patients with the targeted diseases[17] Stock Price Volatility - The price of the company's common stock may fluctuate significantly due to stockholder control over a substantial number of shares[27]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER 001-39555 GREENWICH LIFESCIENCES, INC. (Exact Name of registrant as specified in its charter) (State or other jurisdiction of incorporation or ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the transition period from to COMMISSION FILE NUMBER 001-39555 GREENWICH LIFESCIENCES, INC. (Exact Name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT ...

[Business and Risk Overview](index=8&type=section&id=Part%20I) This section provides an overview of Greenwich LifeSciences' core business, its lead product candidate GP2, clinical development progress, market strategy, intellectual property, and a comprehensive analysis of associated risks [Business](index=8&type=section&id=Item%201.%20Business) Greenwich LifeSciences is a clinical-stage biopharmaceutical company developing GP2 immunotherapy for breast cancer recurrence prevention, planning a pivotal Phase III trial [Product Candidate and Technology](index=8&type=section&id=Product%20Candidate%20and%20Technology) The company's sole product candidate, GP2, is a HER2/neu-derived peptide immunotherapy (GLSI-100) for breast cancer recurrence, relying on a single GM-CSF manufacturer - The lead product candidate, **GP2**, is a peptide from the HER2/neu protein, expressed in **75% of breast cancers**, forming **GLSI-100** when combined with GM-CSF[31](index=31&type=chunk) - **GP2** is administered via **11 intradermal injections** over years 2-4 post-surgery, following the first year of Herceptin treatment[41](index=41&type=chunk) - The company relies on a **single manufacturer** for the supply of **GM-CSF**, a critical component of GLSI-100 immunotherapy[34](index=34&type=chunk) [Clinical Trials and Data](index=11&type=section&id=Clinical%20Trials%20and%20Data) Four clinical trials of GP2 have treated 146 patients without serious adverse events, leading to a planned pivotal Phase III trial (Flamingo-01) based on promising Phase IIb results Clinical Trial Status | Clinical Trial | Status | |---|---| | GP2 Phase III Clinical Trial – Flamingo-01 | Planned | | GP2 Phase IIb Clinical Trial | Trial Completed | | GP2 Phase I Clinical Trial — Combination with AE37 | Trial Completed | | GP2 Phase I Clinical Trial — Combination with Trastuzumab | Trial Completed | | First GP2 Phase I Clinical Trial | Trial Completed | - In the Phase IIb trial, **HER2/neu 3+ patients** treated with GLSI-100 showed a **0% recurrence rate** after 5 years, compared to an **11% recurrence rate** in the placebo group (p=0.0338)[51](index=51&type=chunk)[55](index=55&type=chunk) - The planned Phase III trial, **Flamingo-01**, will evaluate GLSI-100 in high-risk HER2/neu positive breast cancer patients post-standard therapy[58](index=58&type=chunk)[59](index=59&type=chunk) [Market, Competition, and Strategy](index=15&type=section&id=Market%2C%20Competition%2C%20and%20Strategy) The company targets an initial U.S. market of 6% of breast cancer patients, faces intense competition, and plans to advance GP2 through Phase III, seeking global approvals and partnerships - The estimated U.S. market for GP2's initial indication comprises approximately **6% of breast cancer patients** undergoing surgery[60](index=60&type=chunk) - Key competitors include Genentech/Roche, Puma, Daiichi Sankyo, and Merck, offering products like Herceptin, Perjeta, Kadcyla, Nerlynx, Enhertu, and Keytruda[62](index=62&type=chunk)[63](index=63&type=chunk) - The company's strategy involves advancing **GP2** into a Phase III trial, seeking global registration, and pursuing strategic collaborations for funding and commercialization[81](index=81&type=chunk) [Intellectual Property and Regulation](index=17&type=section&id=Intellectual%20Property%20and%20Regulation) The company's IP relies on an exclusive HJF license for GP2 patents (2026-2032), operating under strict FDA and global regulations for clinical trials and BLA submission - The company holds an exclusive worldwide license from HJF for GP2 patents, requiring annual fees, milestone payments up to **$5.7 million**, and **2.5-5% royalties** on sales[71](index=71&type=chunk) - Licensed patents protect **GP2** from **2026 through 2032** in major markets, with plans for **12 years of market exclusivity** as a biologic in the U.S[77](index=77&type=chunk)[81](index=81&type=chunk) - Drug development is heavily regulated by the FDA, requiring successful preclinical studies and phased clinical trials (Phase 1, 2, 3) before BLA submission[84](index=84&type=chunk)[88](index=88&type=chunk)[91](index=91&type=chunk) [Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including substantial financial losses, high capital needs, clinical development uncertainties, regulatory approval challenges, third-party dependencies, intense competition, and internal control weaknesses - **Financial Risk:** The company has a history of substantial losses, including **$4.6 million in 2021**, with an accumulated deficit of **$33.6 million**, requiring significant additional funding (estimated **>$30 million** for Phase III) to continue operations[123](index=123&type=chunk)[128](index=128&type=chunk) - **Clinical & Regulatory Risk:** Success depends on lengthy, expensive clinical trials with no guarantee of regulatory approval from the FDA or other authorities[149](index=149&type=chunk)[160](index=160&type=chunk) - **Dependency Risk:** The company relies on third parties for manufacturing its product candidate and GM-CSF, and its platform is based on an exclusive HJF license that could be terminated if obligations are not met[174](index=174&type=chunk)[178](index=178&type=chunk)[189](index=189&type=chunk) - **Ownership & Control Risk:** As of March 2022, insiders beneficially owned approximately **70%** of the company's stock, granting them effective control over stockholder matters[295](index=295&type=chunk) - **Internal Control Risk:** A material weakness in internal control over financial reporting was identified due to inadequate segregation of duties, potentially affecting financial reporting accuracy[312](index=312&type=chunk) [Financial Performance and Condition](index=79&type=section&id=Part%20II) This section provides management's discussion and analysis of the company's financial condition and results of operations, including detailed financial statements and disclosures on internal controls [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=79&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company reported no revenue and a **$4.6 million** net loss in 2021, driven by a **237%** increase in R&D expenses, holding **$27.2 million** cash but requiring future capital for full development MD&A Financial Highlights | Metric | 2021 | 2020 | | :--- | :--- | :--- | | **Net Loss** | **$4.6 million** | **$1.9 million** | | Research & Development Expenses | $3.56 million | $1.06 million | | General & Administrative Expenses | $1.04 million | $0.81 million | - The **237% increase** in R&D expenses was primarily due to costs for planned Phase III clinical trial preparations[327](index=327&type=chunk) - As of December 31, 2021, the company's cash balance was **$27.2 million**, down from **$28.7 million** at the end of 2020[330](index=330&type=chunk) - Net cash used in operating activities increased to **$4.3 million** in 2021 from **$1.2 million** in 2020, reflecting increased clinical trial preparation spending[331](index=331&type=chunk) [Financial Statements](index=97&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The audited financial statements for 2021 and 2020 show the company's pre-revenue status, with **$27.2 million** in cash assets and a **$4.6 million** net loss, detailed further in notes regarding license obligations and a suspended stock repurchase program [Balance Sheets](index=99&type=section&id=Balance%20Sheets) As of December 31, 2021, the company reported **$27.2 million** in total assets, primarily cash, with minimal liabilities of **$385,172** and stockholders' equity of **$26.8 million** Balance Sheet Highlights | Balance Sheet Highlights | Dec 31, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Cash | $27,204,269 | $28,660,375 | | Total Assets | $27,216,884 | $28,676,602 | | Total Liabilities | $385,172 | $1,045,492 | | Total Stockholders' Equity | $26,831,712 | $27,631,110 | [Statements of Operations](index=100&type=section&id=Statements%20of%20Operations) For fiscal year 2021, the company reported no revenue and a net loss of **$4,570,576**, or **($0.35)** per share, reflecting a significant increase in loss due to higher operating expenses Statements of Operations Summary | Statement of Operations | Year Ended Dec 31, 2021 | Year Ended Dec 31, 2020 | | :--- | :--- | :--- | | Revenue | $0 | $0 | | Research and Development | $3,559,515 | $1,057,606 | | General and Administrative | $1,038,428 | $806,188 | | **Net Loss** | **($4,570,576)** | **($1,862,962)** | | Net Loss Per Share | ($0.35) | ($0.20) | [Notes to Financial Statements](index=103&type=section&id=Notes%20to%20Financial%20Statements) Notes disclose **$434,732** in HJF license payments, **$8.8 million** in federal NOL carryforwards, and a **$10 million** stock repurchase program initiated and then suspended in early 2022 after **$5.5 million** in buybacks - The company paid HJF an aggregate of **$434,732** in July 2021 for annual maintenance fees and patent expense reimbursements under its exclusive license agreement[457](index=457&type=chunk) - As of December 31, 2021, the company had federal net operating loss (NOL) carryforwards of approximately **$8.8 million** available to offset future taxable income[453](index=453&type=chunk) - In early 2022, the company initiated a **$10 million** stock repurchase program, repurchased approximately **269,828 shares** for about **$5.5 million**, and then suspended the program indefinitely on March 15, 2022[475](index=475&type=chunk)[476](index=476&type=chunk) [Controls and Procedures](index=82&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were ineffective as of December 31, 2021, due to a material weakness in internal control over financial reporting from inadequate segregation of duties - Management concluded that disclosure controls and procedures were **not effective** as of December 31, 2021[347](index=347&type=chunk) - A material weakness was identified in internal control over financial reporting due to inadequate segregation of duties from limited personnel and insufficient written policies[347](index=347&type=chunk)[349](index=349&type=chunk) [Corporate Governance and Ownership](index=84&type=section&id=Part%20III) This section outlines the company's corporate governance structure, including its directors, executive compensation, and the concentrated nature of its security ownership [Directors, Executive Officers, and Corporate Governance](index=84&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) The company's leadership includes CEO Snehal Patel and Chairman David McWilliams, with separate roles, three independent directors on Audit and Compensation committees, and a Code of Business Conduct and Ethics - The company's leadership includes **Snehal Patel** as CEO & CFO, **F. Joseph Daugherty** as CMO, and **David McWilliams** as Chairman of the Board[357](index=357&type=chunk) - The Board has **three independent directors** (David McWilliams, Eric Rothe, Kenneth Hallock) who comprise the Audit and Compensation committees[373](index=373&type=chunk)[374](index=374&type=chunk)[400](index=400&type=chunk) - The company has separated the roles of Chairman of the Board and Chief Executive Officer[367](index=367&type=chunk) [Executive Compensation](index=89&type=section&id=Item%2011.%20Executive%20Compensation) In 2021, CEO Snehal Patel's total compensation was approximately **$1.42 million**, comprising salary, bonus, and stock awards, while non-employee directors received stock awards Executive Compensation Summary | Named Executive Officer | Year | Salary | Bonus | Stock Awards | Total Compensation | | :--- | :--- | :--- | :--- | :--- | :--- | | Snehal Patel, CEO | 2021 | $450,000 | $475,000 | $491,589 | $1,416,589 | | Snehal Patel, CEO | 2020 | $114,966 | $392,516 | $491,589 | $999,071 | - CEO Snehal Patel's employment agreement provides for a base salary of **$450,000** and eligibility for an annual bonus of up to **50%** of his base salary[386](index=386&type=chunk) - Non-employee directors received compensation in the form of stock awards, with shares vesting monthly over a **36-month period**[384](index=384&type=chunk) [Security Ownership](index=90&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management) As of March 21, 2022, the company's ownership is highly concentrated, with directors and executive officers, including CEO Snehal Patel, beneficially owning **70.26%** of common stock, granting them effective control Beneficial Ownership Summary | Name of Beneficial Owner | Percentage of Common Stock Beneficially Owned | | :--- | :--- | | Snehal Patel (CEO) | 59.48% | | All current named executive officers and directors as a group (5 persons) | 70.26% |

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER 001-39555 GREENWICH LIFESCIENCES, INC. (Exact Name of registrant as specified in its charter) (State or other jurisdiction of incorporation or ...

GREENWICH LIFESCIENCES Planned GP2 Phase III Clinical Trial A Breakthrough Targeted Immunotherapy to Prevent Breast Cancer Recurrences NASDAQ: GLSI Snehal Patel, CEO David McWilliams, Chairman © 2020 GLSI Image: T-cells targeting cancer cell Safe Harbor Statement This document is the property of Greenwich LifeSciences, Inc., (the "Company" or "Greenwich LifeSciences"). This document is non-directive in nature (contains no recommendations regarding financial actions related to the Company). This document is ...