Greenwich LifeSciences, Inc.

Previous wording

We are a clinical-stage biopharmaceutical company focused on our Phase III clinical trial, Flamingo-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. We have commenced Flamingo-01, a Phase III clinical trial, with plans to expand into Europe and to open up to 150 sites globally. Flamingo-01 is designed to evaluate the safety and efficacy of GLSI-100 in HER2*/neu*positive patients with residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment.

Current wording

We are a clinical-stage biopharmaceutical company focused on our Phase III clinical trial, Flamingo-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. The combination of GP2 + GM-CSF is called GLSI-100. We are currently expanding Flamingo-01 into Europe with plans to open up to 150 sites globally. Flamingo-01 is designed to evaluate the safety and efficacy of GLSI-100 in HER2*/neu*positive patients with residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment.

Previous wording

To date, we have not generated any revenue and we have incurred net losses. Our net losses were approximately $8.9 million and $7.8 million for the years ended December 31, 2023 and 2022, respectively.

Current wording

To date, we have not generated any revenue and we have incurred net losses. Our net losses were approximately $15.8 million and $8.9 million for the years ended December 31, 2024 and 2023, respectively.

Previous wording

Research and development expenses increased by $1,222,954, or approximately 19%, to $7,698,622 for the year ended December 31, 2023 from $6,475,668 for the year ended December 31, 2022. The increase was primarily the result of increases in clinical expenses for the Phase III clinical trial.

Current wording

Research and development expenses increased by $5,253,407, or approximately 68%, to $12,952,029 for the year ended December 31, 2024 from $7,698,622 for the year ended December 31, 2023. The increase was primarily the result of increases in clinical expenses for the Phase III clinical trial and the one-time upfront vesting of 25% of an options grant to employees, management and the board of directors.

Previous wording

General and administrative expenses increased by $64,658, or approximately 4% to $1,629,244 for the year ended December 31, 2023 from $1,564,586 for the year ended December 31, 2022. The increase was primarily the result of increases in stock-based compensation expense.

Current wording

General and administrative expenses increased by $1,430,544, or approximately 88% to $3,059,788 for the year ended December 31, 2024 from $1,629,244 for the year ended December 31, 2023. The increase was primarily the result of the one-time upfront vesting of 25% of an options grant to employees, management and the board of directors.

Previous wording

We will require additional capital to meet our long-term operating requirements. We expect to raise additional capital through the sale of equity and/or debt securities; however, there is no assurance that we will be successful at raising additional capital in the future. If our plans are not achieved and/or if significant unanticipated events occur, we may have to further modify our business plan, which may require us to raise additional capital. As of December 31, 2023 and December 31, 2022, our principal source of liquidity was our cash, which totaled $6,989,424 and $13,468,026, respectively, and additional loans and accrued unreimbursed expenses from related parties. Historically, our principal sources of cash have included proceeds from the sale of common stock and preferred stock and related party loans. Our principal uses of cash have included cash used in operations. We expect that the principal uses of cash in the future will be for continuing operations, funding of research and development, including our clinical trials, and general working capital requirements.

Current wording

We will require additional capital to meet our long-term operating requirements. We expect to raise additional capital through the sale of equity and/or debt securities; however, there is no assurance that we will be successful at raising additional capital in the future. If our plans are not achieved and/or if significant unanticipated events occur, we may have to further modify our business plan, which may require us to raise additional capital. As of December 31, 2024 and December 31, 2023, our principal source of liquidity was our cash, which totaled $4,091,990 and $6,989,424, respectively, and additional loans and accrued unreimbursed expenses from related parties. Historically, our principal sources of cash have included proceeds from the sale of common stock and preferred stock and related party loans. Our principal uses of cash have included cash used in operations. We expect that the principal uses of cash in the future will be for continuing operations, funding of research and development, including our clinical trials, and general working capital requirements.

Previous wording

Between January 1, 2024 and April 10, 2024, the Company completed At The Market (“ATM”) offerings pursuant to its ATM agreement with Jefferies, in which it issued and sold a total of 30,244 shares of its common stock at an average offering price of $12.81 per share for gross proceeds of $387,490 and net proceeds of $348,741, after deducting underwriting discounts and commissions and offering expenses borne by the Company, which totaled$38,749.

Current wording

Between January 1, 2025 and April 11, 2025, the Company completed At The Market (“ATM”) offerings pursuant to its ATM agreement with H. C. Wainwright, in which it issued and sold a total of 120,810 shares of its common stock at an average offering price of $10.42 per share for gross proceeds of $1,259,198 and net proceeds of $1,232,026, after deducting underwriting discounts and commissions and offering expenses borne by the Company, which totaled $27,172.

Previous wording

We incurred net losses of $8,891,803 and $7,825,237 during the years ended December 31, 2023 and 2022, respectively, and the increase was primarily the result of increases in clinical expenses for the Phase III clinical trial and increases in stock-based compensation expense. Cash was $6,989,424 at December 31, 2023 and $13,468,026 at December 31, 2022 and decreased due to the following reasons:

Current wording

We incurred net losses of $15,788,809 and $8,891,803 during the years ended December 31, 2024 and 2023, respectively, and the increase was primarily the result of increases in clinical expenses for the Phase III clinical trial and the one-time upfront vesting of 25% of an options grant to employees, management and the board of directors. Cash was $4,091,990 at December 31, 2024 and $6,989,424 at December 31, 2023 and decreased due to the following reasons:

Previous wording

Net cash used in operating activities was $6,478,602 for the year ended December 31, 2023 and $6,200,027 for the year ended December 31, 2022. The increase was primarily the result of increases in clinical expenses for the Phase III clinical trial.

Current wording

Net cash used in operating activities was $7,266,543 for the year ended December 31, 2024 and $6,478,602 for the year ended December 31, 2023. The increase was primarily the result of increases in clinical expenses for the Phase III clinical trial.

Previous wording

There was no net cash provided by or used in financing activities during the year ended December 31, 2023. Net cash used in financing activities was $7,536,216 during the year ended December 31, 2022, attributable to the repurchase of common stock pursuant to the Company’s stock repurchase program.

Current wording

Net cash provided by financing activities was $4,369,109 during the year ended December 31, 2024, attributable to the sale of common stock via the ATM program and a private placement. There was no net cash provided by or used in financing activities during the year ended December 31, 2023.