Greenwich LifeSciences(GLSI) - 2025 Q1 - Quarterly Report

PART I. FINANCIAL INFORMATION This section presents the unaudited interim financial statements and management's discussion and analysis for Greenwich LifeSciences, Inc. Item 1. Financial Statements (unaudited) Presents unaudited interim financial statements including Balance Sheets, Statements of Operations, Stockholders' Equity, and Cash Flows, with accompanying notes. Balance Sheets as of March 31, 2025 (Unaudited) and December 31, 2024 Provides a comparative overview of the company's financial position at the end of Q1 2025 and FY 2024. | Metric | March 31, 2025 | December 31, 2024 | Change | | :-------------------------------- | :------------- | :---------------- | :----- | | Cash | $2,749,959 | $4,091,990 | $(1,342,031) | | Total assets | $2,750,835 | $4,093,769 | $(1,342,934) | | Total current liabilities | $1,438,524 | $1,559,733 | $(121,209) | | Total stockholders' equity | $1,312,311 | $2,534,036 | $(1,221,725) | | Accumulated deficit | $(69,411,740) | $(66,153,378) | $(3,258,362) | Statements of Operations for the Three Months Ended March 31, 2025 and 2024 (Unaudited) Details the company's financial performance, including revenues, expenses, and net loss for the first quarter of 2025 and 2024. | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | YoY Change | | :------------------------------------ | :-------------------------------- | :-------------------------------- | :--------- | | Revenue | $— | $— | N/A | | Research and development expenses | $2,601,122 | $2,194,513 | 18.5% | | General and administrative expenses | $681,210 | $342,688 | 98.8% | | Total operating expenses | $3,282,332 | $2,537,201 | 29.4% | | Loss from operations | $(3,282,332) | $(2,537,201) | 29.4% | | Interest income | $23,970 | $64,006 | (62.5%) | | Net loss | $(3,258,362) | $(2,473,195) | 31.7% | | Net loss per common share, basic and diluted | $(0.25) | $(0.19) | 31.6% | | Weighted average common shares outstanding | 13,171,555 | 12,859,685 | 2.4% | Statements of Stockholders' Equity for the Three Months Ended March 31, 2025 and 2024 (Unaudited) Outlines changes in stockholders' equity, including common stock, additional paid-in capital, and accumulated deficit. | Metric | Balances, Dec 31, 2024 | Stock-based Compensation | ATM Sales (net) | Net Loss | Balances, Mar 31, 2025 | | :----------------------- | :--------------------- | :----------------------- | :-------------- | :--------- | :--------------------- | | Common Stock (Par Amount) | $13,153 | $— | $40 | $— | $13,193 | | Additional Paid-in Capital | $68,674,261 | $1,544,214 | $492,383 | $— | $70,710,858 | | Accumulated Deficit | $(66,153,378) | $— | $— | $(3,258,362) | $(69,411,740) | | Total Stockholders' Equity | $2,534,036 | $1,544,214 | $492,423 | $(3,258,362) | $1,312,311 | Statements of Cash Flows for the Three Months Ended March 31, 2025 and 2024 (Unaudited) Presents the cash inflows and outflows from operating, investing, and financing activities for the first quarter of 2025 and 2024. | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | YoY Change | | :------------------------------------ | :-------------------------------- | :-------------------------------- | :--------- | | Net loss | $(3,258,362) | $(2,473,195) | 31.7% | | Stock-based compensation | $1,544,214 | $594,522 | 159.7% | | Net cash used in operating activities | $(1,834,454) | $(1,782,565) | 2.9% | | Net cash provided by financing activities | $492,423 | $299,116 | 64.6% | | Net increase (decrease) in cash | $(1,342,031) | $(1,483,449) | (9.5%) | | Cash, end of period | $2,749,959 | $5,505,975 | (50.0%) | Notes to Financial Statements (Unaudited) Provides detailed explanations and disclosures supporting the interim financial statements. 1. Organization and Description of the Business Describes the company's core business as a clinical-stage biopharmaceutical firm developing a breast cancer immunotherapy. - Greenwich LifeSciences, Inc. is a clinical-stage biopharmaceutical company focused on developing a breast cancer immunotherapy (GLSI-100) to prevent recurrence[17] - A wholly-owned subsidiary, Greenwich LifeSciences Europe Limited, was incorporated in Ireland in February 2023[17] 2. Going Concern Addresses the company's ability to continue operations given historical net losses and negative cash flows, highlighting the need for additional capital. - The company has incurred net losses since inception and has negative operating cash flows, raising substantial doubt about its ability to continue as a going concern[18] - As of March 31, 2025, cash was $2,749,959, and continued operations depend on obtaining additional capital[19] 3. Significant Accounting Policies Details the key accounting principles and estimates used in preparing the interim financial statements, including GAAP compliance and ASU adoptions. - Interim financial statements are prepared in accordance with U.S. GAAP and SEC rules, with management's opinion that all necessary adjustments for fair presentation have been reflected[20][21] - The company adopted ASU No. 2016-02-Leases (Topic 842) using the modified retrospective transition method; the impact is nominal due to a month-to-month sub-lease[22] - Basic and diluted net loss per share calculations include common stock equivalents related to warrants (20,174 shares) and options (3,126,065 shares in 2025, 1,498,128 in 2024)[23] 4. Related Party Transactions Discloses financial transactions and balances involving management and other related parties. - Unreimbursed expenses accrued by management totaled $84,362 as of March 31, 2025, up from $75,916 at December 31, 2024[27] - Deferred bonus compensation for senior management for 2024 services is $306,281[27] 5. Commitments and Contingencies Outlines the company's contractual obligations, including accounts payable and licensing agreements. - Accounts payable totaled $1,047,881 as of March 31, 2025, down from $1,177,536 at December 31, 2024[28] - The company has an exclusive license agreement with The Henry M. Jackson Foundation (HJF) for its product candidate GP2, requiring annual maintenance fees, milestone payments, royalties, and patent expense reimbursements[29] - Accrued interest owed to HJF is $220,845 as of March 31, 2025, and December 31, 2024[30] 6. Stockholders' Equity Provides details on common stock, stock-based compensation, ATM sales, and outstanding warrants and options. - As of March 31, 2025, 893,181 shares of common stock grants had vested (approx. $2,009,657 value), with 15,181 shares remaining unvested (approx. $34,157 value); no shares vested in Q1 2025 or Q1 2024[33] - The board extended the lock-up period for shares owned by directors, officers, and pre-IPO investors to March 31, 2026[35] - Between January 1 and March 31, 2025, the company sold 39,918 shares via ATM offerings, generating net proceeds of $492,423[36] - Outstanding warrants as of March 31, 2025, allow purchase of 20,174 shares at an exercise price of $7.1875, expiring September 24, 2025[38] - On December 24, 2024, 1,627,937 shares were granted as stock options under the Amended 2024 Equity Incentive Plan at an exercise price of $12.16 per share, with a grant date fair value of $16,190,565[40] 7. Segment Information Explains that the company operates as a single segment, focusing on clinical development programs. - The company operates as a single operating segment, focused on its clinical development programs, as evaluated by the Chief Executive Officer (CODM)[41] - Performance is assessed through analysis of segment expense information, cash, cash equivalents, and net cash used in operations, as the company currently generates no revenue or profit[42] 8. Subsequent Events Reports significant events that occurred after the balance sheet date, specifically additional ATM offerings. - Between April 1 and May 9, 2025, the company completed ATM offerings, selling 175,657 shares for net proceeds of $1,635,498[43] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Provides management's perspective on the company's financial condition, operational results, liquidity, and critical accounting policies. Forward-Looking Statements Cautions readers about statements regarding future financial position and operational plans, which are subject to risks and uncertainties. - The report contains forward-looking statements regarding future financial position, business strategy, and operational plans, identified by words like "believe," "may," "will," "estimate," etc[44] - These statements are based on current expectations and projections and are subject to risks, uncertainties, and assumptions, including those discussed in the Annual Report on Form 10-K[45] - Readers are cautioned not to rely on forward-looking statements as predictions of future events due to inherent uncertainties[46] Overview Summarizes the company's focus on its Phase III clinical trial and highlights historical and expected net losses due to development costs. - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, Flamingo-01, evaluating GLSI-100 for preventing breast cancer recurrences[48] - The company has not generated revenue and incurred net losses of $3.3 million in Q1 2025 (vs. $2.5 million in Q1 2024) and $15.8 million in FY2024 (vs. $8.9 million in FY2023)[49] - Significant expenses and operating losses are expected to continue due to drug development, clinical trials, regulatory approval, and commercialization efforts[50] Results of Operations for the Three Months Ended March 31, 2025 and 2024 Analyzes the changes in key operating expenses and net loss for the first quarter of 2025 compared to 2024. Research and Development Expenses Discusses the increase in R&D expenses, primarily driven by an options grant, for the first quarter of 2025. - R&D expenses increased by $406,609 (19%) to $2,601,122 for Q1 2025 from $2,194,513 for Q1 2024, primarily due to an options grant[51] General and Administrative Expenses Explains the increase in G&A expenses, mainly due to an options grant, for the first quarter of 2025. - G&A expenses increased by $338,522 (99%) to $681,210 for Q1 2025 from $342,688 for Q1 2024, also primarily attributed to an options grant[52] Liquidity and Capital Resources Assesses the company's cash position, historical losses, and future capital requirements, including financing activities. - The company has incurred cumulative net losses since inception and expects to continue incurring losses, requiring additional capital for long-term operating requirements[53][54] - As of March 31, 2025, cash totaled $2,749,959, down from $4,091,990 at December 31, 2024[54] - The company plans to raise additional capital through equity and/or debt securities, but there is no assurance of success[54] Cash Flow Activities for the Three Months Ended March 31, 2025 and 2024 Summarizes the net losses and their primary drivers for the first quarter of 2025 and 2024. - Net losses were $3,258,362 in Q1 2025 and $2,473,195 in Q1 2024, with the increase primarily due to an options grant[55] Operating Activities Details the net cash used in operating activities for the first quarter of 2025 and 2024. - Net cash used in operating activities was $1,834,454 for Q1 2025, a slight increase from $1,782,565 for Q1 2024[56] Investing Activities Confirms no cash was used or generated from investing activities during the first quarters of 2025 and 2024. - No cash was used or generated from investing activities during Q1 2025 and Q1 2024[57] Financing Activities Reports net proceeds raised from ATM offerings during the first quarter of 2025 and 2024, and subsequent events. - From January 1 to March 31, 2025, the company raised net proceeds of $492,423 from ATM offerings (39,918 shares at $12.52/share)[58] - From January 1 to March 31, 2024, the company raised net proceeds of $299,116 from ATM offerings (27,117 shares at $12.26/share)[59] - Subsequent to the quarter, between April 1 and May 9, 2025, an additional $1,635,498 in net proceeds was raised from ATM offerings (175,657 shares at $9.58/share)[60] Contractual Obligations and Commitments States the company's material contractual obligations, primarily employment agreements and a licensing agreement. - As of March 31, 2025, the company had no material contractual obligations other than employment and shareholder agreements and the GP2 license from HJF[61] Off-Balance Sheet Arrangements Confirms the absence of any off-balance sheet arrangements as of March 31, 2025. - As of March 31, 2025, the company had no off-balance sheet arrangements[62] Critical Accounting Policies and Estimates Highlights the key accounting policies and estimates, such as accrued expenses and stock-based compensation, used in financial statement preparation. - Financial statements are prepared using U.S. GAAP, requiring estimates and judgments, particularly for accrued expenses and stock-based compensation[63][64] Recent Adopted Accounting Pronouncements Discusses the adoption of ASU 2016-13 and its immaterial effect on the financial statements. - The company adopted ASU 2016-13, Financial Instruments – Credit Losses (Topic 326), on January 1, 2023, with no material effect on financial statements[65] Recently Issued Accounting Pronouncements Not Yet Adopted Mentions the ongoing evaluation of ASU 2023-06 and its potential impact. - The company is evaluating the impact of ASU 2023-06—Codification Amendments in Response to the SEC's Disclosure Update and Simplification Initiative, issued in October 2023[66] JOBS Act Explains the company's status as an "emerging growth company" and its election to use extended transition periods for accounting standards. - As an "emerging growth company" under the JOBS Act, the company has elected to use extended transition periods for complying with new or revised accounting standards[69] - The company intends to rely on exemptions, including not providing an auditor's attestation report on internal controls (Section 404(b) of Sarbanes-Oxley Act)[70] Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Greenwich LifeSciences, Inc. is exempt from providing market risk disclosures. - The company is a smaller reporting company and is exempt from providing disclosures required under Item 3[71] Item 4. Controls and Procedures Details the company's disclosure controls and internal control over financial reporting, noting material weaknesses in segregation of duties. Disclosure Controls and Procedures Concludes that disclosure controls were ineffective due to inadequate segregation of duties and insufficient written policies. - Management concluded that disclosure controls and procedures were not effective as of March 31, 2025[73] - Material weaknesses identified include inadequate segregation of duties due to limited personnel and insufficient written policies and procedures for accounting, IT, and financial reporting[73] - A plan is being developed to remediate these material weaknesses[73] Changes in Internal Control over Financial Reporting Reports no material changes in internal control over financial reporting during the most recent fiscal quarter. - No material changes in internal control over financial reporting occurred during the most recent fiscal quarter[74] Limitations on Effectiveness of Controls and Procedures Clarifies that disclosure controls provide reasonable, not absolute, assurance of achieving objectives. - Disclosure controls and procedures are designed to provide reasonable, not absolute, assurance of achieving objectives[75] PART II. OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and exhibits. Item 1. Legal Proceedings States the company is not involved in any material legal proceedings and is unaware of any significant pending actions. - The company is not currently involved in any material legal proceedings[77] - No pending or threatened legal proceedings are expected to have a material adverse effect on the company's business or financial condition[77] Item 1A. Risk Factors Confirms no material changes to the risk factors previously disclosed in the company's Form 10-K. - No material changes to risk factors from the Form 10-K for the year ended December 31, 2024[78] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds Reports no unregistered sales of equity securities or use of proceeds during the period. - None[78] Item 3. Defaults Upon Senior Securities Reports no defaults upon senior securities during the period. - None[79] Item 4. Mine Safety Disclosures States that this item is not applicable to the company's operations. - Not applicable[80] Item 5. Other Information Reports no other information required under this item. - None[81] Item 6. Exhibits Lists the various exhibits filed as part of the Form 10-Q, including certifications and XBRL documents. - Includes certifications from the Chief Executive Officer and Principal Financial and Accounting Officer (Exhibits 31.1, 32.1)[82] - Contains Inline XBRL Instance Document, Taxonomy Extension Schema, Calculation Linkbase, Labels Linkbase, Presentation Linkbase, and Definition Linkbase (Exhibits 101.INS, 101.SCH, 101.CAL, 101.LAB, 101.PRE, 101.DEF)[82] - Includes the Cover Page Interactive Data File formatted in Inline XBRL (Exhibit 104)[82] SIGNATURES Provides details of the official signing of the report by the company's executive officers. Signatures Details Confirms the report was signed by Snehal Patel, CEO and Principal Executive and Financial Officer, on May 20, 2025. - Report signed by Snehal Patel, Chief Executive Officer and Principal Executive Officer and Principal Accounting and Financial Officer[85] - Date of signing: May 20, 2025[85]