Core Viewpoint - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial, FLAMINGO-01, to Belgium, which aims to evaluate GLSI-100, an immunotherapy for preventing breast cancer recurrences [1][2]. Group 1: Clinical Trial Expansion - The FLAMINGO-01 trial has received formal approval from European regulators to include Belgium, adding to its existing sites in Spain, France, Germany, Italy, Poland, Romania, Ireland, Portugal, and the US [2]. - The trial is led by Baylor College of Medicine and plans to open up to 150 sites globally, with a focus on university-based hospitals and academic networks [5]. Group 2: Breast Cancer Statistics in Belgium - In 2022, Belgium reported 11,366 new cases of breast cancer, making it the most common cancer among women, accounting for approximately 33% of all female cancers [3]. - Breast cancer was the leading cause of cancer-related deaths in women in Belgium, with 2,324 deaths recorded in 2022 [3]. Group 3: Principal Investigator and Collaboration - The company is collaborating with Dr. Patrick Neven, a prominent figure in breast oncology, who will serve as the national principal investigator for FLAMINGO-01 in Belgium [4]. - Dr. Neven has extensive experience in clinical trials and has published over 300 peer-reviewed papers, contributing significantly to breast cancer research [4]. Group 4: Trial Design and Objectives - FLAMINGO-01 is designed to evaluate the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who have completed neoadjuvant and postoperative adjuvant trastuzumab-based treatment [5]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis, with an interim analysis planned after 14 events [5].

Core Insights - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial, FLAMINGO-01, to Portugal, focusing on GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][2] Group 1: Clinical Trial Expansion - The FLAMINGO-01 trial has received formal approval from European regulators to include Portugal, joining other countries such as Spain, France, Germany, Italy, Poland, Romania, Ireland, and the US [2] - The trial is designed to evaluate the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who have completed neoadjuvant and postoperative adjuvant trastuzumab-based treatment [5] Group 2: Breast Cancer Statistics in Portugal - In 2022, there were 9,065 new cases of breast cancer diagnosed in Portugal, making it the most common cancer among women, accounting for approximately 30% of all cancers in this demographic [3] - Breast cancer was the leading cause of cancer-related deaths in women in Portugal, with 2,211 deaths reported in 2022 [3] Group 3: Principal Investigator and Collaboration - Dr. Luís António Marques da Costa has been appointed as the national principal investigator for FLAMINGO-01 in Portugal, bringing extensive experience in oncology and clinical trials [4] - The CEO of Greenwich LifeSciences expressed enthusiasm for collaborating with Dr. Costa and his team, indicating ongoing efforts to activate clinical trial sites in Lisbon and other regions of Portugal [5] Group 4: Trial Design and Objectives - FLAMINGO-01 aims to randomize approximately 500 HLA-A*02 patients to receive either GLSI-100 or a placebo, with an additional arm for up to 250 patients of other HLA types [5] - The trial is designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis, with an interim analysis planned once 14 events have occurred [5]

Core Viewpoint - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial FLAMINGO-01 to Ireland, which aims to evaluate GLSI-100, an immunotherapy for preventing breast cancer recurrences [1][2]. Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy designed to prevent breast cancer recurrences in patients who have previously undergone surgery [7][8]. Clinical Trial Details - FLAMINGO-01 (NCT05232916) is a Phase III clinical trial assessing the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery [5]. - The trial is led by Baylor College of Medicine and includes clinical sites in the US and Europe, with plans to open up to 150 sites globally [5]. - Approximately 500 HLA-A*02 patients will be randomized to receive GLSI-100 or placebo, with an additional 250 patients of other HLA types treated with GLSI-100 [5]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [5]. Expansion to Ireland - The application to European regulators for including Ireland in the FLAMINGO-01 trial has been formally approved, adding to existing sites in Spain, France, Germany, Italy, Poland, Romania, and the US [2]. - Dr. Janice Walshe will serve as the national principal investigator in Ireland, collaborating with Cancer Trials Ireland to provide access to novel agents for Irish women affected by breast cancer [4]. Breast Cancer Statistics - In 2022, Ireland reported 3,723 new cases of breast cancer, making it the most common cancer diagnosed in women, accounting for approximately 30% of all cancers in women [3]. - Breast cancer is the second leading cause of cancer-related deaths among women in Ireland, with 883 deaths recorded in 2022 [3].

Group 1 - Greenwich LifeSciences (NASDAQ:GLSI) experienced a ~32% increase in premarket trading following the U.S. FDA's Fast Track designation for its lead asset GLSI-100, aimed at treating a specific subset of breast cancer patients [4] - The Fast Track status granted by the FDA is significant as it facilitates the development and expedites the review of drugs intended to treat serious conditions and fill an unmet medical need [4] - GLSI-100 is positioned to potentially improve treatment options for breast cancer patients, indicating a positive outlook for the company's future performance in the oncology sector [4]

Core Viewpoint - Greenwich LifeSciences, Inc. has received Fast Track designation from the FDA for its immunotherapy GLSI-100, aimed at preventing breast cancer recurrences in HLA-A*02 positive patients who have completed standard HER2/neu targeted therapy [1][2] Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy designed to prevent breast cancer recurrences in patients post-surgery [9][11] - The company is currently conducting a Phase III clinical trial named FLAMINGO-01, which evaluates the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients [7][11] Fast Track Designation - The Fast Track designation allows for more frequent communication between the FDA and the company, potentially leading to earlier drug approval and the ability to submit parts of the Biologic License Application (BLA) as they are completed [2][5] - The designation is granted to drugs that address serious conditions and fill unmet medical needs, with GLSI-100 showing potential to improve invasive breast cancer-free survival [2][4] Clinical Trial Details - FLAMINGO-01 is designed to include approximately 500 HLA-A*02 patients randomized to receive GLSI-100 or placebo, with an interim analysis planned after 14 events of invasive breast cancer [7] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, providing 80% power if the annual event rate in placebo-treated subjects is 2.4% or greater [7] Previous Clinical Data - In a Phase IIb trial, GLSI-100 demonstrated an 80% or greater reduction in cancer recurrences over five years in HER2/neu 3+ patients, with no serious adverse events reported [6][10] - The immunotherapy was well tolerated, and booster injections every six months prolonged the immune response, indicating a strong safety profile [6][10]

Core Viewpoint - Greenwich LifeSciences, Inc. has announced the initiation of company-sponsored equity research coverage by Noble Capital Markets, focusing on its Phase III clinical trial, FLAMINGO-01, which evaluates GLSI-100 as an immunotherapy for preventing breast cancer recurrences [1] Group 1: Clinical Trial Details - FLAMINGO-01 is a Phase III clinical trial assessing the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients with residual disease or high-risk pathologic complete response after surgery [2] - The trial will involve approximately 500 HLA-A*02 patients randomized to receive either GLSI-100 or a placebo, with an additional arm for up to 250 patients of other HLA types receiving GLSI-100 [2] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis, with an interim analysis planned after 14 events [2] Group 2: Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy aimed at preventing breast cancer recurrences in patients post-surgery [4] - GP2 is a 9 amino acid transmembrane peptide derived from the HER2 protein, which is expressed in 75% of breast cancers at varying levels [4] - The company is actively conducting the FLAMINGO-01 trial, with plans to expand to 150 clinical sites globally [2][4] Group 3: Breast Cancer Statistics - One in eight U.S. women will develop invasive breast cancer in their lifetime, with around 300,000 new cases and 4 million survivors annually [3] - HER2 protein is expressed in 75% of breast cancers, indicating its significance in treatment strategies [3][4]

Core Viewpoint - Greenwich LifeSciences, Inc. is enhancing its internal clinical trial management by hiring dedicated staff for the FLAMINGO-01 trial, aiming to reduce costs and improve efficiency in the evaluation of GLSI-100, an immunotherapy for breast cancer recurrence [1][2][4]. Group 1: Company Strategy - The company is transitioning from reliance on Clinical Research Organizations (CROs) to an in-house team to manage the FLAMINGO-01 trial, which is expected to lower operational costs and enhance trial quality [2][4]. - By building an internal clinical operations team, the company aims to conduct multiple trials simultaneously and respond more effectively to the needs of FLAMINGO-01 and potential new drug candidates [3][4]. Group 2: Clinical Trial Details - FLAMINGO-01 is a Phase III clinical trial assessing the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients, with plans to open up to 150 sites globally [5]. - The trial will randomize approximately 500 HLA-A*02 patients to receive either GLSI-100 or a placebo, with an additional arm for up to 250 patients of other HLA types [5]. - The trial is designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis, with an interim analysis planned after 14 events [5]. Group 3: Market Context - One in eight U.S. women will develop invasive breast cancer, with around 300,000 new cases annually and 4 million survivors, highlighting the significant market potential for effective therapies like GLSI-100 [6]. - HER2 protein is expressed in 75% of breast cancers, indicating a broad patient population for the company's immunotherapy approach [6][8].

Financial Performance - The company reported net losses of approximately $15.8 million and $8.9 million for the years ended December 31, 2024 and 2023, respectively, and $7.3 million and $5.1 million for the six months ended June 30, 2025 and 2024, respectively [52]. - The company incurred net losses of $7,283,640 and $5,079,877 during the six-month periods ended June 30, 2025 and 2024, respectively [60]. - The company has not yet generated any revenue and expects to continue incurring significant expenses as it develops its pipeline [53]. Expenses - Research and development expenses increased by $1,200,033 or 52%, to $3,507,906 for the three months ended June 30, 2025, compared to $2,307,873 for the same period in 2024 [54]. - General and administrative expenses rose by $184,516, or 52%, to $538,047 for the three months ended June 30, 2025, from $353,531 for the same period in 2024 [55]. - Research and development expenses increased by $1,606,642, or 36%, to $6,109,028 for the six months ended June 30, 2025, compared to $4,502,386 for the same period in 2024 [56]. - General and administrative expenses increased by $523,038, or 75%, to $1,219,257 for the six months ended June 30, 2025, from $696,219 for the same period in 2024 [57]. Cash Position - As of June 30, 2025, the company's cash totaled $3,125,101, down from $4,091,990 as of December 31, 2024 [59]. Capital Raising - The company completed At The Market ("ATM") offerings, issuing 320,210 shares at an average price of $9.95 per share for gross proceeds of $3,185,661 between January 1, 2025, and June 30, 2025 [64]. Clinical Development - The company plans to expand its Phase III clinical trial, Flamingo-01, into Europe with plans to open up to 150 sites globally [51].

Core Viewpoint - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial, FLAMINGO-01, into Romania to evaluate GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][2]. Group 1: Clinical Trial Expansion - The European regulators have formally approved the addition of Romanian clinical sites to the FLAMINGO-01 trial, which already includes approximately 150 sites across several countries including Spain, France, Germany, Italy, Poland, and the US [2]. - Currently, there are about 123 actively enrolling sites globally for the FLAMINGO-01 trial [2]. Group 2: Breast Cancer Statistics in Romania - In 2022, Romania reported 12,861 new cases of breast cancer, making it the most common cancer among women, accounting for approximately 28% of all cancers in women [3]. - Breast cancer was the leading cause of cancer-related deaths in women in Romania, with 3,877 deaths recorded in 2022 [3]. Group 3: Collaboration and Leadership - The company is collaborating with Dr. Nicoleta Antone, who leads a major academic breast cancer center in Cluj Napoca, Romania, and is supported by colleagues from at least three other sites in the country [4][5]. - Dr. Antone will serve as the national principal investigator for FLAMINGO-01 in Romania [5]. Group 4: Future Plans and Expectations - The CEO of Greenwich LifeSciences indicated that Romania is the first of several additional European countries planned for inclusion in the FLAMINGO-01 trial, focusing on mid-sized population countries with significant population centers [6]. - The company has conducted multiple site visits in Romania to assess feasibility and provide training, with plans to potentially start screening and enrolling Romanian patients in the coming months [6]. Group 5: Trial Design and Objectives - FLAMINGO-01 is designed to evaluate the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who have residual disease or high-risk pathologic complete response after surgery [7]. - The trial aims to randomize approximately 500 HLA-A*02 patients to receive either GLSI-100 or a placebo, with an additional arm for up to 250 patients of other HLA types [7]. - The trial is structured to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [7].

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This section presents the unaudited interim financial statements and management's discussion and analysis for Greenwich LifeSciences, Inc. [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(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](index=3&type=section&id=Balance%20Sheets%20as%20of%20March%2031%2C%202025%20(Unaudited)%20and%20December%2031%2C%202024) 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)](index=4&type=section&id=Statements%20of%20Operations%20for%20the%20Three%20Months%20Ended%20March%2031%2C%202025%20and%202024%20(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)](index=5&type=section&id=Statements%20of%20Stockholders'%20Equity%20for%20the%20Three%20Months%20Ended%20March%2031%2C%202025%20and%202024%20(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)](index=6&type=section&id=Statements%20of%20Cash%20Flows%20for%20the%20Three%20Months%20Ended%20March%2031%2C%202025%20and%202024%20(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)](index=7&type=section&id=Notes%20to%20Financial%20Statements%20(Unaudited)) Provides detailed explanations and disclosures supporting the interim financial statements. [1. Organization and Description of the Business](index=7&type=section&id=1.%20Organization%20and%20Description%20of%20the%20Business) 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](index=17&type=chunk) - A wholly-owned subsidiary, Greenwich LifeSciences Europe Limited, was incorporated in Ireland in February 2023[17](index=17&type=chunk) [2. Going Concern](index=7&type=section&id=2.%20Going%20Concern) 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](index=18&type=chunk) - As of March 31, 2025, cash was **$2,749,959**, and continued operations depend on obtaining additional capital[19](index=19&type=chunk) [3. Significant Accounting Policies](index=7&type=section&id=3.%20Significant%20Accounting%20Policies) 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](index=20&type=chunk)[21](index=21&type=chunk) - 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](index=22&type=chunk) - 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](index=23&type=chunk) [4. Related Party Transactions](index=9&type=section&id=4.%20Related%20Party%20Transactions) 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](index=27&type=chunk) - Deferred bonus compensation for senior management for 2024 services is **$306,281**[27](index=27&type=chunk) [5. Commitments and Contingencies](index=9&type=section&id=5.%20Commitments%20and%20Contingencies) 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](index=28&type=chunk) - 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](index=29&type=chunk) - Accrued interest owed to HJF is **$220,845** as of March 31, 2025, and December 31, 2024[30](index=30&type=chunk) [6. Stockholders' Equity](index=9&type=section&id=6.%20Stockholders'%20Equity) 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](index=33&type=chunk) - The board extended the lock-up period for shares owned by directors, officers, and pre-IPO investors to March 31, 2026[35](index=35&type=chunk) - Between January 1 and March 31, 2025, the company sold **39,918 shares** via ATM offerings, generating net proceeds of **$492,423**[36](index=36&type=chunk) - 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](index=38&type=chunk) - 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](index=40&type=chunk) [7. Segment Information](index=11&type=section&id=7.%20Segment%20Information) 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](index=41&type=chunk) - 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](index=42&type=chunk) [8. Subsequent Events](index=11&type=section&id=8.%20Subsequent%20Events) 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](index=43&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=12&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Provides management's perspective on the company's financial condition, operational results, liquidity, and critical accounting policies. [Forward-Looking Statements](index=12&type=section&id=Forward-Looking%20Statements) 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](index=44&type=chunk) - 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](index=45&type=chunk) - Readers are cautioned not to rely on forward-looking statements as predictions of future events due to inherent uncertainties[46](index=46&type=chunk) [Overview](index=12&type=section&id=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](index=48&type=chunk) - 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](index=49&type=chunk) - Significant expenses and operating losses are expected to continue due to drug development, clinical trials, regulatory approval, and commercialization efforts[50](index=50&type=chunk) [Results of Operations for the Three Months Ended March 31, 2025 and 2024](index=13&type=section&id=Results%20of%20Operations%20for%20the%20Three%20Months%20Ended%20March%2031%2C%202025%20and%202024) Analyzes the changes in key operating expenses and net loss for the first quarter of 2025 compared to 2024. [Research and Development Expenses](index=13&type=section&id=Research%20and%20Development%20Expenses) 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](index=51&type=chunk) [General and Administrative Expenses](index=13&type=section&id=General%20and%20Administrative%20Expenses) 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](index=52&type=chunk) [Liquidity and Capital Resources](index=13&type=section&id=Liquidity%20and%20Capital%20Resources) 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](index=53&type=chunk)[54](index=54&type=chunk) - As of March 31, 2025, cash totaled **$2,749,959**, down from **$4,091,990** at December 31, 2024[54](index=54&type=chunk) - The company plans to raise additional capital through equity and/or debt securities, but there is no assurance of success[54](index=54&type=chunk) [Cash Flow Activities for the Three Months Ended March 31, 2025 and 2024](index=13&type=section&id=Cash%20Flow%20Activities%20for%20the%20Three%20Months%20Ended%20March%2031%2C%202025%20and%202024) 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](index=55&type=chunk) [Operating Activities](index=13&type=section&id=Operating%20Activities) 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](index=56&type=chunk) [Investing Activities](index=13&type=section&id=Investing%20Activities) 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](index=57&type=chunk) [Financing Activities](index=14&type=section&id=Financing%20Activities) 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](index=58&type=chunk) - 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](index=59&type=chunk) - 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](index=60&type=chunk) [Contractual Obligations and Commitments](index=14&type=section&id=Contractual%20Obligations%20and%20Commitments) 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](index=61&type=chunk) [Off-Balance Sheet Arrangements](index=14&type=section&id=Off-Balance%20Sheet%20Arrangements) 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](index=62&type=chunk) [Critical Accounting Policies and Estimates](index=14&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) 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](index=63&type=chunk)[64](index=64&type=chunk) [Recent Adopted Accounting Pronouncements](index=14&type=section&id=Recent%20Adopted%20Accounting%20Pronouncements) 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](index=65&type=chunk) [Recently Issued Accounting Pronouncements Not Yet Adopted](index=14&type=section&id=Recently%20Issued%20Accounting%20Pronouncements%20Not%20Yet%20Adopted) 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](index=66&type=chunk) [JOBS Act](index=14&type=section&id=JOBS%20Act) 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](index=69&type=chunk) - 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](index=70&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=15&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) 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](index=71&type=chunk) [Item 4. Controls and Procedures](index=16&type=section&id=Item%204.%20Controls%20and%20Procedures) Details the company's disclosure controls and internal control over financial reporting, noting material weaknesses in segregation of duties. [Disclosure Controls and Procedures](index=16&type=section&id=Disclosure%20Controls%20and%20Procedures) 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](index=73&type=chunk) - 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](index=73&type=chunk) - A plan is being developed to remediate these material weaknesses[73](index=73&type=chunk) [Changes in Internal Control over Financial Reporting](index=16&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) 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](index=74&type=chunk) [Limitations on Effectiveness of Controls and Procedures](index=16&type=section&id=Limitations%20on%20Effectiveness%20of%20Controls%20and%20Procedures) 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](index=75&type=chunk) [PART II. OTHER INFORMATION](index=16&type=section&id=PART%20II%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and exhibits. [Item 1. Legal Proceedings](index=16&type=section&id=Item%201.%20Legal%20Proceedings) 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](index=77&type=chunk) - No pending or threatened legal proceedings are expected to have a material adverse effect on the company's business or financial condition[77](index=77&type=chunk) [Item 1A. Risk Factors](index=16&type=section&id=Item%201A.%20Risk%20Factors) 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](index=78&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=16&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Reports no unregistered sales of equity securities or use of proceeds during the period. - None[78](index=78&type=chunk) [Item 3. Defaults Upon Senior Securities](index=16&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Reports no defaults upon senior securities during the period. - None[79](index=79&type=chunk) [Item 4. Mine Safety Disclosures](index=16&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) States that this item is not applicable to the company's operations. - Not applicable[80](index=80&type=chunk) [Item 5. Other Information](index=16&type=section&id=Item%205.%20Other%20Information) Reports no other information required under this item. - None[81](index=81&type=chunk) [Item 6. Exhibits](index=18&type=section&id=Item%206.%20Exhibits) 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](index=82&type=chunk) - 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](index=82&type=chunk) - Includes the Cover Page Interactive Data File formatted in Inline XBRL (Exhibit 104)[82](index=82&type=chunk) [SIGNATURES](index=19&type=section&id=SIGNATURES) Provides details of the official signing of the report by the company's executive officers. [Signatures Details](index=19&type=section&id=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](index=85&type=chunk) - Date of signing: May 20, 2025[85](index=85&type=chunk)