Greenwich LifeSciences, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Greenwich LifeSciences, Inc. has filed its 2023 annual report (10-K) detailing its financial performance and significant corporate events.</b>

AI Summary

Greenwich LifeSciences, Inc. (GLSI) filed a Annual Report (10-K) with the SEC on April 15, 2024. Greenwich LifeSciences, Inc. filed its 2023 Form 10-K on April 15, 2024. The company's fiscal year ends on December 31st. The filing covers the period from January 1, 2023, to December 31, 2023. Key dates include the IPO on September 25, 2020, and a follow-on offering on December 22, 2020. Subsequent events include an At-The-Market Offering on April 10, 2024.

Why It Matters

For investors and stakeholders tracking Greenwich LifeSciences, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of the company's financial health and operational status for the fiscal year 2023, which is crucial for investors to assess its current standing and future prospects. The inclusion of subsequent events, such as the recent At-The-Market Offering, offers timely information on the company's capital-raising activities and strategic financial maneuvers.

Risk Assessment

Risk Level: low — Greenwich LifeSciences, Inc. shows low risk based on this filing. The company is in the pharmaceutical preparations industry, which is subject to extensive regulatory oversight and lengthy development cycles, posing inherent risks to commercialization and profitability.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand the company's current financial position and the potential impact of its ongoing clinical development programs.

Key Numbers

• 2023-12-31 — Fiscal Year End (Period of Report)
• 2024-04-15 — Filing Date (10-K Filing Date)
• 2020-09-25 — IPO Date (Initial Public Offering)
• 2020-12-22 — Follow-on Offering Date (Subsequent Offering)
• 2024-04-10 — At-The-Market Offering Date (Subsequent Event)

Key Players & Entities

• Greenwich LifeSciences, Inc. (company) — Filer
• 2023 (date) — Fiscal Year End
• April 15, 2024 (date) — Filing Date
• December 31, 2023 (date) — Period of Report
• September 25, 2020 (date) — IPO Date
• December 22, 2020 (date) — Follow-on Offering Date
• April 10, 2024 (date) — At-The-Market Offering Date
• Stafford, TX (location) — Business Address

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The company's operations are subject to extensive government regulation, including the FDA, which can impact product development, approval, and marketing.
• Need for Additional Financing [high — financial]: The company has a history of net losses and may require significant additional capital to fund its ongoing operations and clinical trials.
• Clinical Trial Risks [high — operational]: The success of the company's product candidates depends on the outcome of clinical trials, which are inherently uncertain and can be affected by efficacy, safety, and regulatory hurdles.
• Competition [medium — market]: The pharmaceutical market is highly competitive, and the company faces competition from established companies and other emerging biopharmaceutical firms.

Key Financial Figures

• $0.001 — nge on which registered Common Stock, $0.001 par value GLSI The NASDAQ Capital M
• $9.65 — liates based on a closing sale price of $9.65 per share, which was the last sale pric

Filing Documents

• form10-k.htm (10-K) — 1327KB
• ex23-1.htm (EX-23.1) — 6KB
• ex23-2.htm (EX-23.2) — 4KB
• ex31-1.htm (EX-31.1) — 20KB
• ex32-1.htm (EX-32.1) — 4KB
• ex97.htm (EX-97.1) — 73KB
• form10-k_001.jpg (GRAPHIC) — 32KB
• form10-k_002.jpg (GRAPHIC) — 75KB
• form10-k_003.jpg (GRAPHIC) — 61KB
• form10-k_004.jpg (GRAPHIC) — 51KB
• form10-k_005.jpg (GRAPHIC) — 130KB
• form10-k_006.jpg (GRAPHIC) — 98KB
• form10-k_007.jpg (GRAPHIC) — 30KB
• ex23-1_001.jpg (GRAPHIC) — 19KB
• rep_001.jpg (GRAPHIC) — 18KB
• 0001493152-24-014625.txt (&nbsp;) — 4929KB
• glsi-20231231.xsd (EX-101.SCH) — 19KB
• glsi-20231231_cal.xml (EX-101.CAL) — 23KB
• glsi-20231231_def.xml (EX-101.DEF) — 87KB
• glsi-20231231_lab.xml (EX-101.LAB) — 176KB
• glsi-20231231_pre.xml (EX-101.PRE) — 145KB
• form10-k_htm.xml (XML) — 218KB

Business

Business 6 Item 1A

Risk Factors

Risk Factors 22 Item 1B Unresolved Staff Comments 51 Item 1C Cybersecurity 51 Item 2

Properties

Properties 51 Item 3

Legal Proceedings

Legal Proceedings 51 Item 4 Mine Safety Disclosures 51 PART II Item 5 Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 52 Item 6 [Reserved] 52 Item 7

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 52 Item 7A

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 55 Item 8

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 55 Item 9 Changes In and Disagreements with Accountants on Accounting and Financial Disclosure 55 Item 9A

Controls and Procedures

Controls and Procedures 55 Item 9B Other Information 55 Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 55 PART III Item 10 Directors, Executive Officers, and Corporate Governance 56 Item 11

Executive Compensation

Executive Compensation 60 Item 12

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 61 Item 13 Certain Relationship and Related Transactions, and Director Independence 62 Item 14 Principal Accountant Fees and Services 63 PART IV Item 15 Exhibits 64 Item 16 Form 10-K Summary 64

SIGNATURES

SIGNATURES 65 2 Table of Contents Forward-Looking This Annual Report on Form 10-K contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). These statements may be identified by such forward-looking terminology as "may," "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "continue" or the negative of these terms or other comparable terminology. Our forward-looking statements are based on a series of expectations, assumptions, estimates and projections about our company, are not guarantees of future results or performance and involve substantial risks and uncertainty. We may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Our business and our forward-looking statements involve substantial known and unknown risks and uncertainties, including the risks and uncertainties inherent in our statements regarding: our projected financial position and estimated cash burn rate; our estimates regarding expenses, future revenues and capital requirements; our ability to continue as a going concern; our need to raise substantial additional capital to fund our operations; the success, cost and timing of our clinical trials; our dependence on third parties in the conduct of our clinical trial; our ability to obtain the necessary regulatory approvals to market and commercialize our product candidate; the ultimate impact of the current coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole; the

BUSINESS

BUSINESS Overview 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 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. Our Product Candidate GP2 is a HER2/ neu transmembrane peptide that elicits a targeted immune response against HER2/ neu -expressing cancers. Below is an image of a cell surface showing therapeutically relevant cell surface proteins in cancer. Breast cancers and other solid tumors with elevated expression of HER2/ neu protein are highly aggressive with an increased disease recurrence and a worse prognosis. GM-CSF Immunoadjuvant Recombinant human granulocyte macrophage colony-stimulating factor or GM-CSF (sargramostim, Leukine) has been shown to enhance monocyte and neutrophil cytotoxicity against melanoma tumor cells and to enhance activity-dependent cellular cytotoxicity of monocytes and neutrophils against targets coated with the anti-ganglioside antibodies. GP2 will be delivered in combination with GM-CSF to induce GP2 peptide specific immunity. GP2 treatment is administered via an intradermal injection by mixing GP2 peptide and GM-CSF at the time of administration. GM-CSF is available in lyophilized form exclusively from one manufactu

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View this 10-K filing on SEC EDGAR