[PART I](index=8&type=section&id=PART%20I) [Item 1. Business](index=8&type=section&id=Item%201.%20Business) Greenwich LifeSciences, Inc. is a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, Flamingo-01, evaluating GLSI-100 (GP2 + GM-CSF) as an immunotherapy to prevent breast cancer recurrences in HER2/neu positive patients. [Overview](index=8&type=section&id=Overview) GLSI-100 (GP2 + GM-CSF) is an immunotherapy for preventing breast cancer recurrences. - GLSI-100 (GP2 + GM-CSF) is an immunotherapy for preventing breast cancer recurrences[30](index=30&type=chunk) - Flamingo-01 is a Phase III clinical trial evaluating GLSI-100 in HER2/neu positive patients with residual disease or high-risk pCR after trastuzumab-based treatment[30](index=30&type=chunk) - GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein, expressed in **75% of breast cancers**[30](index=30&type=chunk) [Our Product Candidate](index=8&type=section&id=Our%20Product%20Candidate) GP2 is a HER2/neu transmembrane peptide that targets HER2/neu-expressing cancers. - GP2 is a HER2/neu transmembrane peptide that targets HER2/neu-expressing cancers[31](index=31&type=chunk) - GLSI-100 combines GP2 with GM-CSF (sargramostim, Leukine®) to enhance immune response[33](index=33&type=chunk) - GM-CSF is exclusively available from one manufacturer, creating supply dependency[34](index=34&type=chunk) [Cancer Immunotherapy](index=8&type=section&id=Cancer%20Immunotherapy) Cancer immunotherapy stimulates the immune system to attack cancer cells by recognizing tumor antigens. - Cancer immunotherapy stimulates the immune system to attack cancer cells by recognizing tumor antigens[35](index=35&type=chunk)[37](index=37&type=chunk) - GP2 immunotherapy, with GM-CSF, induces CD8+ cytotoxic T lymphocytes to destroy HER2/neu-expressing cancer cells[39](index=39&type=chunk) - GP2 may be effective in patients who do not respond to Herceptin or Kadcyla, potentially reducing recurrence rates[40](index=40&type=chunk) - GLSI-100 is administered in **11 intradermal injections over 2.5 years**, following the first year of Herceptin treatment[41](index=41&type=chunk) [GP2 Clinical Data & Phase III Clinical Trial (Flamingo-01)](index=11&type=section&id=GP2%20Clinical%20Data%20%26%20Phase%20III%20Clinical%20Trial%20(Flamingo-01)) Clinical trials for GP2 have shown promising results, with a Phase III trial currently enrolling patients. Clinical Trial Description | Clinical Trial Description | Status | | :----------------------- | :----- | | GP2 Phase III Clinical Trial – Flamingo-01 | Enrolling in US and Europe | | 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 | - No serious adverse events (SAEs) were observed in **146 patients** across Phase I and IIb trials related to GLSI-100[46](index=46&type=chunk)[66](index=66&type=chunk) - Phase IIb trial in HER2/neu 3+ patients showed a substantial reduction in cancer recurrences after **5 years of follow-up**, with **100% disease-free survival** in the efficacy population[58](index=58&type=chunk)[62](index=62&type=chunk) - Flamingo-01 (Phase III) is a randomized, multicenter, placebo-controlled study evaluating GLSI-100 in high-risk HER2/neu positive breast cancer patients who completed trastuzumab-based therapy[69](index=69&type=chunk) [U.S. and European Breast Cancer Market](index=16&type=section&id=U.S.%20and%20European%20Breast%20Cancer%20Market) The breast cancer market in the U.S. and Europe represents a significant patient population for GP2. - Estimated **700,000 new breast cancer patients per year** and **9.5 million survivors** in the U.S. and Europe by 2025[72](index=72&type=chunk) - HER2/neu 3+ patients comprise **~25% of all breast cancer patients**[72](index=72&type=chunk) - HLA-A*02 allele is present in **~40-50% of the U.S. and European population**[72](index=72&type=chunk) - The U.S. market for GP2's first indication is estimated to be **~6.25% of breast cancer patients** undergoing surgery[72](index=72&type=chunk) [Competition](index=17&type=section&id=Competition) The company faces competition from large pharmaceutical companies and existing HER2-targeted therapies. - Competitors include large pharmaceutical companies (e.g., Bristol-Myers Squibb, Merck, Roche/Genentech) and smaller niche players[73](index=73&type=chunk) - Existing HER2-targeted therapies include Herceptin, Perjeta, Kadcyla, Nerlynx, Enhertu, and Tukysa[74](index=74&type=chunk)[75](index=75&type=chunk) - Approved trastuzumab biosimilars also exist (e.g., Ogivri, Herzuma, Ontruzant, Trazimera, Kanjinti)[75](index=75&type=chunk) - Immune checkpoint inhibitors like Keytruda and Tecentriq are approved or under review for breast cancer[75](index=75&type=chunk) [Manufacturing](index=18&type=section&id=Manufacturing) The company relies on third-party contract manufacturers for all raw materials and product candidates. - Company does not own or operate manufacturing facilities and depends on third-party contract manufacturers[81](index=81&type=chunk) - Active pharmaceutical ingredient (API) for GP2 is sourced from Polypeptide Laboratories[89](index=89&type=chunk) - GM-CSF, administered with GP2, is exclusively available from one manufacturer, creating supply dependency[34](index=34&type=chunk)[192](index=192&type=chunk) [Exclusive License](index=18&type=section&id=Exclusive%20License) The company holds exclusive worldwide rights to GP2 patents licensed from HJF, with protection extending to 2032. - Exclusive worldwide rights to GP2 patents and applications licensed from HJF since **April 2009**[83](index=83&type=chunk) - Consideration included **202,619 shares of common stock** to HJF[83](index=83&type=chunk) - Obligations include annual maintenance fees, milestone payments (up to **$5.7 million aggregate**), and **2.5-5% royalties** on GP2 sales[83](index=83&type=chunk) - GP2 issued patents provide protection from **2026 through 2032** in major markets[88](index=88&type=chunk)[92](index=92&type=chunk) [Intellectual Property Portfolio](index=19&type=section&id=Intellectual%20Property%20Portfolio) Intellectual property protection includes patents, trade secrets, and regulatory exclusivity for GP2. - Protection methods include patents, trade secrets, and regulatory exclusivity (e.g., data exclusivity)[85](index=85&type=chunk) Patent Family Expiration Dates | Patent Family | Expiration Dates | | :-------------------------- | :--------------- | | GP2 + GM-CSF Patent Family | U.S.: 2029-2032; International: 2029 | | GP2 + Herceptin Patent Family | U.S. & International: 2026-2028 | - Plans to register GP2 as a biologic, potentially granting **10-12 years of market exclusivity** in the U.S. upon approval[88](index=88&type=chunk)[92](index=92&type=chunk) [Corporate Strategy](index=20&type=section&id=Corporate%20Strategy) The corporate strategy focuses on advancing GP2 into global Phase III trials and securing financing. - No current sales, marketing, or distribution strategy as GP2 is in clinical development[91](index=91&type=chunk) - Future commercial strategy may involve strategic partners, distributors, contract sales force, or establishing own sales force[91](index=91&type=chunk) - Plans to advance GP2 into Phase III clinical trials in the U.S. and globally[92](index=92&type=chunk) - Considering financing and/or strategic transactions to fund Phase III trials[92](index=92&type=chunk) [Pipeline Strategy — Including GP2 In Other HER2/neu-Expressing Cancers](index=20&type=section&id=Pipeline%20Strategy%20%E2%80%94%20Including%20GP2%20In%20Other%20HER2/neu-Expressing%20Cancers) The company plans to expand GP2 indications to other HER2/neu-expressing cancers and patient populations. - Developing follow-on indications for GP2[93](index=93&type=chunk) - Plans for additional clinical trials to expand breast cancer patient population and target other HER2/neu-expressing cancers[93](index=93&type=chunk) - Potential new indications include: immediate post-diagnosis, other HLA patients, HER2/neu 1-2+ breast cancer, and ovarian, gastrointestinal, and colon cancers[93](index=93&type=chunk) [Government Regulations](index=20&type=section&id=Government%20Regulations) Extensive government regulations govern all stages of product development, approval, and marketing. - Extensive regulation by FDA and foreign authorities covering research, development, testing, manufacturing, approval, and marketing[94](index=94&type=chunk) - U.S. approval process involves preclinical studies (GLP), IND submission, clinical trials (GCP, IRB approval), BLA submission, FDA review, and manufacturing facility inspection (cGMP)[95](index=95&type=chunk)[96](index=96&type=chunk)[97](index=97&type=chunk)[99](index=99&type=chunk)[102](index=102&type=chunk) - Clinical trials typically proceed in **three phases** (Phase 1, 2, 3) to assess safety, efficacy, and optimal dosage[98](index=98&type=chunk)[104](index=104&type=chunk) - Accelerated approval pathways include Fast Track, Priority Review, and Breakthrough Therapy designations, which can expedite development and review but do not change approval standards[106](index=106&type=chunk)[107](index=107&type=chunk)[108](index=108&type=chunk)[109](index=109&type=chunk) - Post-approval, products are subject to ongoing requirements, including safety monitoring, labeling changes, and potential post-marketing trials[105](index=105&type=chunk) [Other Healthcare Laws and Compliance Requirements](index=23&type=section&id=Other%20Healthcare%20Laws%20and%20Compliance%20Requirements) Post-approval activities are subject to federal and state healthcare laws, including anti-kickback and false claims statutes. - Post-approval activities are subject to federal and state laws like the Anti-Kickback Statute, False Claims Act (FCA), and HIPAA[110](index=110&type=chunk)[111](index=111&type=chunk)[112](index=112&type=chunk)[114](index=114&type=chunk) - The Anti-Kickback Statute prohibits remuneration to induce referrals or product use covered by federal healthcare programs[111](index=111&type=chunk) - The FCA imposes liability for false or fraudulent claims to federal healthcare programs[112](index=112&type=chunk) - HIPAA and HITECH impose privacy and security requirements for individually identifiable health information[114](index=114&type=chunk) - Violations can result in civil and criminal penalties, fines, operational restructuring, and exclusion from healthcare programs[116](index=116&type=chunk) [Coverage and Reimbursement](index=25&type=section&id=Coverage%20and%20Reimbursement) Product sales depend on third-party coverage and reimbursement, which can be challenging to obtain. - Sales depend on third-party coverage and reimbursement from government and private payors[118](index=118&type=chunk) - Payors challenge prices and examine cost-effectiveness, leading to uncertainty in reimbursement status[118](index=118&type=chunk) - Obtaining coverage and adequate reimbursement can be time-consuming and expensive, potentially requiring additional clinical trials[118](index=118&type=chunk) [Foreign Regulation](index=25&type=section&id=Foreign%20Regulation) Separate regulatory approvals are required from foreign authorities for clinical trials and marketing outside the U.S. - Requires separate regulatory approvals from foreign authorities for clinical trials and marketing outside the U.S.[119](index=119&type=chunk)[120](index=120&type=chunk) - Clinical trials must comply with GCP and local regulatory requirements[121](index=121&type=chunk)[129](index=129&type=chunk) - EU approval involves marketing authorization applications, with options like the Centralized Procedure (for biotech products, orphan drugs, etc.) and Mutual Recognition Procedure[122](index=122&type=chunk)[123](index=123&type=chunk)[125](index=125&type=chunk) - Non-compliance can lead to fines, suspension of trials, withdrawal of approvals, and other penalties[130](index=130&type=chunk) [Human Capital Management](index=27&type=section&id=Human%20Capital%20Management) The company's success relies on attracting and retaining key personnel and maintaining its organizational culture. - As of **April 11, 2025**, the company has **4 full-time and 4 part-time employees**[132](index=132&type=chunk) - Future success depends on attracting, developing, and retaining key personnel, maintaining culture, and ensuring diversity and inclusion[132](index=132&type=chunk) [Item 1A. Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks across its financial position, product development, manufacturing, third-party dependencies, intellectual property, commercialization, healthcare compliance, and business operations. - An investment in the company's securities involves a **high degree of risk**[133](index=133&type=chunk) [Risks Relating to Our Financial Position and Capital Needs](index=27&type=section&id=Risks%20Relating%20to%20Our%20Financial%20Position%20and%20Capital%20Needs) The company faces substantial losses, requires significant additional financing, and may never achieve profitability. Net Loss and Accumulated Deficit | Metric | 2024 | 2023 | | :------------------ | :----------- | :---------- | | Net Loss | $(15.8) million | $(8.9) million | | Accumulated Deficit | $(66.2) million | N/A | - Existing cash as of **December 31, 2024**, is expected to fund operations for at least **12 months** from the 10-K filing date, but is insufficient to complete product development and obtain regulatory approval[136](index=136&type=chunk) - Total cost to complete interim analysis and file a BLA could exceed **$30 million**[138](index=138&type=chunk) - Raising additional capital through equity or convertible debt will dilute existing stockholders[142](index=142&type=chunk) - The company currently has no revenue and may never achieve profitability[143](index=143&type=chunk) - Federal net operating loss (NOL) carryforwards of approximately **$30.0 million** as of **December 31, 2024**, may be subject to limitations under Section 382 of the Internal Revenue Code[148](index=148&type=chunk)[480](index=480&type=chunk)[481](index=481&type=chunk) [Risks Related to the Development and Regulatory Approval of Our Product Candidate](index=32&type=section&id=Risks%20Related%20to%20the%20Development%20and%20Regulatory%20Approval%20of%20Our%20Product%20Candidate) Product development is subject to uncertainties in clinical trial outcomes, patient enrollment, and regulatory approvals. - Success depends on successfully completing preclinical and clinical trials, obtaining regulatory approvals, and manufacturing[149](index=149&type=chunk) - Difficulties in patient enrollment due to limited patient numbers could delay clinical trials[151](index=151&type=chunk) - Preclinical and early clinical trial results are not necessarily predictive of future results[154](index=154&type=chunk) - Flamingo-01 was previously placed on clinical hold by the FDA due to manufacturing information, but the hold was removed on **July 11, 2022**[159](index=159&type=chunk) - Undesirable side effects could delay or prevent regulatory approval, limit commercial profile, or lead to withdrawal of approval[167](index=167&type=chunk)[170](index=170&type=chunk) - Failure to successfully validate and develop a companion diagnostic could harm drug development[172](index=172&type=chunk)[173](index=173&type=chunk) - Regulatory approval is essential for commercialization, but the process is unpredictable and subject to substantial discretion by authorities[174](index=174&type=chunk)[175](index=175&type=chunk) [Risks Related to Our Manufacturing](index=45&type=section&id=Risks%20Related%20to%20Our%20Manufacturing) Reliance on single-source third-party manufacturers poses risks of supply disruptions and increased costs. - Reliance on third-party contract manufacturers for all raw materials, APIs, and finished product candidate[188](index=188&type=chunk) - Single source for active pharmaceutical ingredient (Polypeptide Laboratories) and exclusive manufacturer for GM-CSF[189](index=189&type=chunk)[192](index=192&type=chunk) - Manufacturing risks include cost overruns, scale-up problems, stability issues, and timely availability of raw materials[190](index=190&type=chunk) - Adverse developments in manufacturing could lead to shipment delays, inventory shortages, product recalls, and increased costs[191](index=191&type=chunk) - Damage or destruction of CMO facilities could severely impact business and prospects[195](index=195&type=chunk) [Risks Related to Our Dependence on Third Parties and Our License Agreements](index=47&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties%20and%20Our%20License%20Agreements) The company heavily depends on third-party CROs and an exclusive license, with risks of non-performance or termination. - Heavy reliance on third-party CROs, vendors, and contractors for preclinical studies and clinical trials[197](index=197&type=chunk)[198](index=198&type=chunk) - Limited influence over third-party performance, but company remains responsible for regulatory compliance[199](index=199&type=chunk) - Dependent on an exclusive license from HJF for GP2 technology; failure to meet obligations could lead to license termination[203](index=203&type=chunk) - Operations may be affected by natural disasters, pandemics (e.g., COVID-19), war, or other catastrophic events impacting employees, CMOs, CROs, or regulatory agencies[204](index=204&type=chunk) - May not realize benefits from future strategic alliances due to competition, early development stage, or perceived risks[205](index=205&type=chunk) - Inability to establish or maintain third-party relationships could prevent clinical development, manufacturing, or commercialization[207](index=207&type=chunk) [Risks Related to Our Intellectual Property](index=49&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Intellectual property protection is complex and uncertain, with risks of infringement, litigation, and loss of exclusivity. - Relies on an exclusive license from HJF for GP2; HJF's failure to adequately defend the license could harm the business[209](index=209&type=chunk) - Patent positions in biotechnology are uncertain and involve complex legal questions[212](index=212&type=chunk) - Risk of third parties filing similar patent applications or having priority over HJF's applications[213](index=213&type=chunk)[225](index=225&type=chunk) - Failure to comply with license obligations could lead to termination or loss of exclusivity[214](index=214&type=chunk) - Litigation to enforce or defend intellectual property rights is costly and diverts resources[220](index=220&type=chunk) - Risk of infringing third-party intellectual property rights, leading to development delays, commercialization halts, or damages[221](index=221&type=chunk)[222](index=222&type=chunk) - Difficulty in preventing disclosure of trade secrets could diminish technology value[227](index=227&type=chunk) - Changes to patent law (e.g., Leahy-Smith America Invents Act) may affect patent protection[234](index=234&type=chunk) [Risks Related to Commercialization of Our Current Product Candidate and Future Product Candidates](index=57&type=section&id=Risks%20Related%20to%20Commercialization%20of%20Our%20Current%20Product%20Candidate%20and%20Future%20Product%20Candidates) Commercial success depends on market acceptance, adequate reimbursement, and navigating healthcare legislative measures. - Market acceptance depends on efficacy, safety, clinical indications, physician and patient acceptance, and cost-effectiveness[236](index=236&type=chunk) - Commercial success depends on coverage and adequate reimbursement from third-party payors[239](index=239&type=chunk) - Third-party payors are challenging prices and requiring cost-effectiveness data, leading to potential delays or insufficient reimbursement[240](index=240&type=chunk)[241](index=241&type=chunk) - Healthcare legislative measures (e.g., ACA, Budget Control Act of 2011) aim to reduce healthcare costs, potentially lowering product prices and reimbursement[242](index=242&type=chunk)[243](index=243&type=chunk)[245](index=245&type=chunk) - Foreign markets may impose price controls, affecting profitability[246](index=246&type=chunk)[247](index=247&type=chunk) - Product candidates are expected to be regulated as biologics, potentially subject to biosimilar competition after **12 years of exclusivity**, which could be shortened[255](index=255&type=chunk)[256](index=256&type=chunk) [Risks Related to Healthcare Compliance Regulations](index=63&type=section&id=Risks%20Related%20to%20Healthcare%20Compliance%20Regulations) Relationships with healthcare providers and payors are subject to stringent anti-kickback and fraud laws. - Relationships with healthcare providers and payors are subject to federal and state anti-kickback, fraud and abuse laws (e.g., Anti-Kickback Statute, False Claims Act)[257](index=257&type=chunk)[258](index=258&type=chunk) - HIPAA and HITECH impose privacy and security obligations for health information[258](index=258&type=chunk) - Non-compliance can lead to criminal sanctions, civil penalties, exclusion from government programs, and reputational damage[260](index=260&type=chunk) - Risk of employee fraud or misconduct, including non-compliance with regulatory standards, leading to significant liability[261](index=261&type=chunk) - Product liability lawsuits from clinical trials or commercial sales could result in substantial liabilities, regardless of merit[262](index=262&type=chunk)[264](index=264&type=chunk) - International operations are subject to laws like the Foreign Corrupt Practices Act (FCPA), prohibiting improper payments to foreign officials[266](index=266&type=chunk) [Risks Related to our Business Operations](index=67&type=section&id=Risks%20Related%20to%20our%20Business%20Operations) The company faces substantial competition, operational challenges, cybersecurity threats, and economic risks. - Faces substantial competition from numerous pharmaceutical and biotechnology enterprises with greater resources and experience[270](index=270&type=chunk)[272](index=272&type=chunk) - COVID-19 pandemic continues to pose risks to clinical trial activities, manufacturing, supply chain, and global economic stability[274](index=274&type=chunk)[275](index=275&type=chunk) - Subject to stringent data privacy regulations, including GDPR (EU), UK GDPR, and CCPA (California), which impose complex compliance requirements and potential fines[277](index=277&type=chunk)[278](index=278&type=chunk)[280](index=280&type=chunk)[282](index=282&type=chunk)[283](index=283&type=chunk) - Relies on sophisticated information technology systems, making it vulnerable to cybersecurity threats, system failures, or breaches, which could disrupt drug development and lead to loss of confidential information[285](index=285&type=chunk)[286](index=286&type=chunk) - Future growth requires expanding the organization, managing clinical trials, recruiting personnel, and improving systems, which presents management challenges[287](index=287&type=chunk)[288](index=288&type=chunk) - Success depends on retaining executive officers (e.g., Snehal Patel) and attracting qualified personnel[289](index=289&type=chunk) - Inadequate funding for regulatory agencies (FDA, SEC) could delay product review/approval and impact business operations[290](index=290&type=chunk)[291](index=291&type=chunk) - Periodically involved in litigation/regulatory proceedings that could be costly and divert management attention[292](index=292&type=chunk) - May hold cash in foreign subsidiaries, which may not be readily available or may incur additional tax burdens for repatriation[293](index=293&type=chunk) - Adversely affected by inflation and potential recession, increasing costs and impacting financial condition[294](index=294&type=chunk)[295](index=295&type=chunk) [Risks Related to Owning our Common Stock](index=74&type=section&id=Risks%20Related%20to%20Owning%20our%20Common%20Stock) Stock price volatility, dilution from future issuances, and control by principal stockholders pose risks to investors. - Stock price is subject to substantial fluctuation due to factors like clinical trial results, regulatory approvals, and market conditions[296](index=296&type=chunk)[301](index=301&type=chunk) - Certain stockholders (directors, executive officers, principal stockholders) beneficially own approximately **52% of outstanding common stock**, giving them effective control over stockholder approval matters[303](index=303&type=chunk) - Future sales and issuances of common stock will result in additional dilution for existing stockholders[304](index=304&type=chunk) - No intention to pay cash dividends; returns are limited to share price appreciation[305](index=305&type=chunk) - As an 'emerging growth company,' it avails itself of reduced disclosure requirements, which may make common stock less attractive to some investors[306](index=306&type=chunk) - Risk of securities class action litigation due to stock price volatility common in the biotechnology industry[307](index=307&type=chunk) - Failure to maintain listing on Nasdaq or other exchanges could adversely affect stock price and liquidity[309](index=309&type=chunk)[310](index=310&type=chunk) - Amended and Restated Certificate of Incorporation and Bylaws, and Delaware law, may have anti-takeover effects[311](index=311&type=chunk)[312](index=312&type=chunk) - Financial reporting obligations as a public company are expensive and time-consuming, requiring substantial management time[313](index=313&type=chunk)[316](index=316&type=chunk) - Bylaws designate Delaware Court of Chancery as exclusive forum for certain disputes, potentially limiting stockholder's judicial forum choice[317](index=317&type=chunk)[319](index=319&type=chunk) - Failure to maintain an effective system of internal control over financial reporting could lead to inaccurate financial reporting[320](index=320&type=chunk)[321](index=321&type=chunk) [Item 1B. Unresolved Staff Comments](index=81&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) There are no unresolved staff comments. - No unresolved staff comments[322](index=322&type=chunk) [Item 1C. Cybersecurity](index=81&type=section&id=Item%201C.%20Cybersecurity) The company considers cybersecurity critical, implementing third-party evaluations, awareness training, and an incident response plan to manage threats. [Risk Management](index=81&type=section&id=Risk%20Management) Cybersecurity is critical, with third-party evaluations, awareness training, and an incident response plan in place. - Cybersecurity is critical due to various threats, including ransomware and denial-of-service attacks[323](index=323&type=chunk) - Engages third-party services for security control evaluations (penetration testing, audits, consulting)[324](index=324&type=chunk) - Has established cybersecurity awareness training and ongoing monitoring[324](index=324&type=chunk) - Follows a cybersecurity incident response plan and contracts with external IT firms[325](index=325&type=chunk) - Complies with FDA requirements for patient information and SEC requirements for incident reporting[325](index=325&type=chunk) [Governance](index=81&type=section&id=Governance) The Audit Committee oversees cybersecurity risks, with regular discussions with senior management. - Audit Committee has oversight responsibility for cybersecurity threats and incidents[326](index=326&type=chunk) - Senior management regularly discusses cyber risks and material incidents with the Audit Committee[326](index=326&type=chunk) - No material cybersecurity threats or incidents experienced in recent years, but future incidents are possible[327](index=327&type=chunk) [Item 2. Properties](index=81&type=section&id=Item%202.%20Properties) The company subleases a facility to support its clinical trial operations and research and development activities. - Subleases a facility for clinical trial operations and R&D[328](index=328&type=chunk) [Item 3. Legal Proceedings](index=81&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings and is unaware of any pending or threatened litigation that would have a material adverse effect on its operations or finances. - Not currently a party to any material legal proceedings[330](index=330&type=chunk) - No awareness of pending or threatened litigation that would materially affect operations or finances[330](index=330&type=chunk) [Item 4. Mine Safety Disclosures](index=82&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company. - Not applicable[331](index=331&type=chunk) [PART II](index=83&type=section&id=PART%20II) [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=83&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock has traded on The Nasdaq Capital Market under 'GLSI' since September 25, 2020. [Market information](index=83&type=section&id=Market%20information) Common stock trades on The Nasdaq Capital Market under 'GLSI' since September 25, 2020. - Common stock trades on The Nasdaq Capital Market under 'GLSI' since **September 25, 2020**[333](index=333&type=chunk) [Number of Stockholders](index=83&type=section&id=Number%20of%20Stockholders) As of April 11, 2025, there were approximately 16 stockholders of record. - Approximately **16 stockholders of record** as of **April 11, 2025**[334](index=334&type=chunk) [Dividend Policy](index=83&type=section&id=Dividend%20Policy) The company has not paid dividends historically and does not expect to in the foreseeable future. - No historical dividends paid on common stock[335](index=335&type=chunk) - Does not expect to pay cash dividends in the foreseeable future; will retain earnings for business development[335](index=335&type=chunk) [Item 6. [Reserved]](index=83&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved and contains no information. - Item is reserved[336](index=336&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=83&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company, a clinical-stage biopharmaceutical firm, reported net losses of $15.8 million in 2024 and $8.9 million in 2023, with an accumulated deficit, and expects continued losses due to R&D and commercialization efforts. [Overview](index=83&type=section&id=Overview) The company is a clinical-stage biopharmaceutical firm focused on its Phase III trial, expecting continued losses. - Clinical-stage biopharmaceutical company focused on Phase III trial Flamingo-01 for GLSI-100[336](index=336&type=chunk) Net Losses | Year | Net Loss | | :--- | :----------- | | 2024 | $(15.8) million | | 2023 | $(8.9) million | - Expects to continue incurring significant expenses and operating losses due to R&D, clinical trials, regulatory approval, and commercialization infrastructure[338](index=338&type=chunk) [Basis of Presentation](index=84&type=section&id=Basis%20of%20Presentation) Financial statements conform to U.S. GAAP and SEC rules. - Financial statements conform to U.S. GAAP and SEC rules[339](index=339&type=chunk) [Results of Operations For the Years Ended December 31, 2024 and 2023](index=84&type=section&id=Results%20of%20Operations%20For%20the%20Years%20Ended%20December%2031%2C%202024%20and%202023) Operating expenses, particularly R&D, increased significantly in 2024, contributing to higher net losses. Operating Expenses (2024 vs. 2023) | Expense Category | 2024 | 2023 | Change (%) | | :----------------------- | :----------- | :----------- | :--------- | | Research and development | $12,952,029 | $7,698,622 | 68% increase | | General and administrative | $3,059,788 | $1,629,244 | 88% increase | - Increases primarily due to clinical expenses for Phase III trial and one-time upfront vesting of **25% of an options grant**[340](index=340&type=chunk)[341](index=341&type=chunk) [Liquidity and Capital Resources](index=84&type=section&id=Liquidity%20and%20Capital%20Resources) Cash decreased to $4.09 million by year-end 2024, necessitating additional capital for long-term operations. - Cumulative net loss and negative operating cash flows since inception[342](index=342&type=chunk) Cash Position | Date | Cash | | :----------------- | :----------- | | December 31, 2024 | $4,091,990 | | December 31, 2023 | $6,989,424 | - Requires additional capital for long-term operating requirements, to be raised through equity and/or debt[343](index=343&type=chunk) - Between **Jan 1, 2025 and April 11, 2025**, raised **$1,232,026 net proceeds** from ATM offerings[344](index=344&type=chunk) [Cash Flow Activities for the Years Ended December 31, 2024 and 2023](index=84&type=section&id=Cash%20Flow%20Activities%20for%20the%20Years%20Ended%20December%2031%2C%202024%20and%202023) Net cash used in operating activities increased in 2024, partially offset by cash provided by financing activities. Cash Flow Summary | Activity | 2024 | 2023 | | :-------------------------------- | :----------- | :----------- | | Net cash used in operating activities | $(7,266,543) | $(6,478,602) | | Net cash provided by financing activities | $4,369,109 | $0 | - Increase in cash used in operating activities primarily due to increased clinical expenses for Phase III trial[346](index=346&type=chunk) - Financing activities in 2024 included sales of common stock via ATM program and a private placement[348](index=348&type=chunk) [Contractual Obligations and Commitments](index=86&type=section&id=Contractual%20Obligations%20and%20Commitments) No material contractual obligations as of December 31, 2024, except for employment/shareholder agreements and the HJF license. - No material contractual obligations as of **December 31, 2024**, except for employment/shareholder agreements and HJF license[349](index=349&type=chunk) [Off-Balance Sheet Arrangements](index=86&type=section&id=Off-Balance%20Sheet%20Arrangements) There are no off-balance sheet arrangements as of December 31, 2024. - No off-balance sheet arrangements as of **December 31, 2024**[350](index=350&type=chunk) [Critical Accounting Policies and Estimates](index=86&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Financial statements require estimates and judgments for accrued expenses and stock-based compensation. - Financial statements require estimates and judgments for accrued expenses and stock-based compensation[351](index=351&type=chunk)[352](index=352&type=chunk) - Estimates are based on historical experience and assumptions, subject to inherent uncertainty[352](index=352&type=chunk) [Recent Adopted Accounting Pronouncements](index=86&type=section&id=Recent%20Adopted%20Accounting%20Pronouncements) The company adopted ASU 2016-13 (Credit Losses) on January 1, 2023, with no material effect. - Adopted ASU 2016-13 (Credit Losses) on **January 1, 2023**[353](index=353&type=chunk) - Adoption of ASU 2016-13 did not have a material effect on financial statements[353](index=353&type=chunk) [Recently Issued Accounting Pronouncements Not Yet Adopted](index=86&type=section&id=Recently%20Issued%20Accounting%20Pronouncements%20Not%20Yet%20Adopted) The company is evaluating ASU 2023-06 (Codification Amendments) and does not expect a material impact. - Evaluating ASU 2023-06 (Codification Amendments) issued in **October 2023**[354](index=354&type=chunk) - Does not expect ASU 2023-03 to have a material impact[474](index=474&type=chunk) [JOBS Act](index=86&type=section&id=JOBS%20Act) As an 'emerging growth company,' the company utilizes JOBS Act exemptions for accounting standards and auditor attestation. - Qualifies as an 'emerging growth company' under the JOBS Act[355](index=355&type=chunk) - Utilizes extended transition periods for new accounting standards, potentially affecting comparability[356](index=356&type=chunk) - Relies on exemptions from auditor attestation (Section 404(b)) and PCAOB requirements[357](index=357&type=chunk) [Item 7A. Quantitative and Qualitative Disclosures About Market Risk](index=88&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the registrant is not required to provide the information for this item. - Not required to provide information as a smaller reporting company[359](index=359&type=chunk) [Item 8. Financial Statements and Supplementary Data](index=88&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) All required financial information is attached at the end of the report, starting on page F-1. - Financial statements are incorporated by reference, starting on page F-1[360](index=360&type=chunk) [Item 9. Changes In and Disagreements with Accountants on Accounting and Financial Disclosure](index=88&type=section&id=Item%209.%20Changes%20In%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) There are no changes in or disagreements with accountants on accounting and financial disclosure. - None[361](index=361&type=chunk) [Item 9A. Controls and Procedures](index=88&type=section&id=Item%209A.%20Controls%20and%20Procedures) As of December 31, 2024, the company's disclosure controls and internal control over financial reporting were deemed ineffective due to material weaknesses. [Disclosure Controls and Procedures](index=88&type=section&id=Disclosure%20Controls%20and%20Procedures) Disclosure controls and procedures were ineffective as of December 31, 2024, due to material weaknesses. - Disclosure controls and procedures were **not effective** as of **December 31, 2024**[363](index=363&type=chunk) - Material weaknesses identified: inadequate segregation of duties and insufficient written policies for accounting, IT, and financial reporting[363](index=363&type=chunk) - A plan to remediate material weaknesses is under development[363](index=363&type=chunk) [Management's Report on Internal Control Over Financial Reporting](index=88&type=section&id=Management%27s%20Report%20on%20Internal%20Control%20Over%20Financial%20Reporting) Management concluded material weaknesses in internal control over financial reporting as of December 31, 2024. - Management concluded material weaknesses in internal control over financial reporting as of **December 31, 2024**[365](index=365&type=chunk) - Weaknesses include inadequate segregation of duties and insufficient written policies[365](index=365&type=chunk) - Plans are being implemented to improve internal controls[365](index=365&type=chunk) [Changes in Internal Control Over Financial Reporting](index=88&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) No material changes in internal control over financial reporting occurred during Q4 2024. - No material changes in internal control over financial reporting during **Q4 2024**[366](index=366&type=chunk) [Item 9B. Other Information](index=88&type=section&id=Item%209B.%20Other%20Information) There is no other information to report under this item. - None[367](index=367&type=chunk) [Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.](index=88&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections.) This item is not applicable. - Not applicable[369](index=369&type=chunk) [PART III](index=90&type=section&id=PART%20III) [Item 10. Directors, Executive Officers, and Corporate Governance](index=90&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%2C%20and%20Corporate%20Governance) The company's leadership includes Snehal Patel (CEO, CFO), F. Joseph Daugherty (CMO), and Jaye Thompson (VP Clinical & Regulatory Affairs), alongside directors David McWilliams (Chairman), Eric Rothe, and Kenneth Hallock, all with extensive industry experience. [Executive Officers, Directors and Key Employees](index=90&type=section&id=Executive%20Officers%2C%20Directors%20and%20Key%20Employees) The company's executive officers and directors include Snehal Patel, F. Joseph Daugherty, Jaye Thompson, David McWilliams, Eric Rothe, and Kenneth Hallock. Executive Officers, Directors and Key Employees (as of April 11, 2025) | Name | Age | Position | | :---------------- | :-- | :--------------------------------------- | | Snehal Patel | 61 | Chief Executive Officer, Chief Financial Officer and Director | | F. Joseph Daugherty | 74 | Chief Medical Officer and Director | | Jaye Thompson | 59 | Vice President Clinical & Regulatory Affairs | | David McWilliams | 81 | Chairman of the Board | | Eric Rothe | 50 | Director | | Kenneth Hallock | 76 | Director | [Biographies](index=90&type=section&id=Biographies) Biographies detail the extensive experience of the company's executive officers and directors in healthcare and biotech. - Snehal Patel: Over **30 years** in healthcare executive management, corporate development, operations, and investment banking; CEO/CFO/Director since **2010/2016**[373](index=373&type=chunk) - F. Joseph Daugherty: Over **35 years** in biotech/biomedical project management; CMO/Director since **2019**[374](index=374&type=chunk) - Jaye Thompson: Over **30 years** in pharmaceutical/device product development; VP Clinical & Regulatory Affairs since **2019**[375](index=375&type=chunk) - David McWilliams: Over **40 years** in building biopharmaceutical/healthcare companies; Chairman since **2009**[377](index=377&type=chunk) - Eric Rothe: Founder, over **12 years** in gene-based therapies/vaccines; Director since **2006**[378](index=378&type=chunk) - Kenneth Hallock: Over **40 years** in general management/new venture start-ups; Director since **2019**[379](index=379&type=chunk) [Family Relationships and Other Arrangements](index=92&type=section&id=Family%20Relationships%20and%20Other%20Arrangements) There are no family relationships among directors and executive officers, nor arrangements for their selection. - No family relationships among directors and executive officers[380](index=380&type=chunk) - No arrangements for selection of directors or executive officers[380](index=380&type=chunk) [Board Leadership Structure and Role in Risk Oversight](index=93&type=section&id=Board%20Leadership%20Structure%20and%20Role%20in%20Risk%20Oversight) The board separates Chairman and CEO roles and oversees risk management through its committees and open communication. - Separates roles of Chairman and Chief Executive Officer[382](index=382&type=chunk) - Board, through committees, oversees risk management and ensures adequacy of management's processes[385](index=385&type=chunk) - Emphasizes full and open communication between executive management and the board for effective risk management[386](index=386&type=chunk) [Committees of Our Board of Directors](index=93&type=section&id=Committees%20of%20Our%20Board%20of%20Directors) The board has Audit, Compensation, and Nominating and Corporate Governance committees, with independent and financially literate members. - Board has Audit, Compensation, and Nominating and Corporate Governance committees[387](index=387&type=chunk) - Audit Committee members (David McWilliams, Eric Rothe, Kenneth Hallock) are independent and financially literate; David McWilliams is an 'audit committee financial expert'[388](index=388&type=chunk) - Compensation Committee members (David McWilliams, Eric Rothe, Kenneth Hallock) are independent[390](index=390&type=chunk) - Entire board serves as the Nominating and Governance Committee[391](index=391&type=chunk) [Code of Business Conduct and Ethics](index=94&type=section&id=Code%20of%20Business%20Conduct%20and%20Ethics) A formal Code of Business Conduct and Ethics has been adopted for all board members, officers, and employees. - Adopted a formal Code of Business Conduct and Ethics for all board members, officers, and employees[392](index=392&type=chunk) - Code is available on the company website[392](index=392&type=chunk) [Hedging and Pledging Policies](index=94&type=section&id=Hedging%20and%20Pledging%20Policies) The Insider Trading Policy prohibits short sales, hedging, and pledging of securities by officers and directors. - Insider Trading Policy prohibits short sales, hedging, and derivative transactions by officers, directors, and certain employees/consultants[393](index=393&type=chunk) - Restricts purchasing securities on margin or pledging them as collateral without pre-clearance[393](index=393&type=chunk) - As of **April 11, 2025**, no directors or executive officers had pledged common stock shares[393](index=393&type=chunk) [Item 11. Executive Compensation](index=95&type=section&id=Item%2011.%20Executive%20Compensation) Executive compensation for 2024 saw a significant increase for CEO Snehal Patel, primarily driven by stock awards. [Summary Compensation Table](index=95&type=section&id=Summary%20Compensation%20Table) The summary compensation table details executive compensation, showing a significant increase for the CEO in 2024. Summary Compensation Table | Name and Principal Position | Year | Salary ($) | Bonus ($) | Stock awards ($) | Total ($) | | :------------------------ | :--- | :--------- | :-------- | :--------------- | :-------- | | Snehal Patel, Chief Executive Officer | 2024 | 612,563 | 306,281 | 5,322,841 | 6,241,685 | | | 2023 | 556,875 | 528,438 | 1,664,716 | 2,750,028 | - Mr. Patel received deferred bonus compensation of **$306,281** and options to purchase **630,000 shares** in 2024[397](index=397&type=chunk) [Outstanding Equity Awards at Fiscal Year-End](index=95&type=section&id=Outstanding%20Equity%20Awards%20at%20Fiscal%20Year-End) Details of outstanding equity awards for Snehal Patel, including options granted and their vesting schedules, are provided. Outstanding Equity Awards for Snehal Patel (as of Dec 31, 2024) | Number of Securities Underlying Unexercised Options () Exercisable | Number of Securities Underlying Unexercised Options () Unexercisable | Option Exercise Price ($) | Option Expiration Date | | :---------------------------------------------------------------- | :------------------------------------------------------------------ | :------------------------ | :--------------------- | | 132,403 | 916,320 | 7.63 | June 21, 2032 | | 100,000 | 1,048,723 | 12.16 | December 23, 2034 | - Options granted on **June 22, 2022**, vest over **48 months** based on time and performance milestones[399](index=399&type=chunk) - Options granted on **December 24, 2024**, include **100,000 immediately vested** and **25% of 1,048,723 earned immediately**, with the remainder vesting over **36 months** based on time and retention milestones[399](index=399&type=chunk) [Non-Employee Director Compensation](index=95&type=section&id=Non-Employee%20Director%20Compensation) Non-employee director compensation primarily consists of stock options granted and vesting over several years. Non-Employee Director Compensation (2024) | Name | Fees Earned or Paid in Cash ($) | Stock and Option Awards ($) | All Other Compensation ($) | Total ($) | | :---------------- | :------------------------------ | :-------------------------- | :------------------------- | :-------- | | David McWilliams | | 255,818 | | 255,818 | | Eric Rothe | | 170,650 | | 170,650 | | Kenneth Hallock | | 170,650 | | 170,650 | - Compensation primarily consists of stock options granted on **June 22, 2022**, and **December 24, 2024**, vesting over **36-48 months**[401](index=401&type=chunk)[403](index=403&type=chunk)[404](index=404&type=chunk) [Employment Agreements](index=97&type=section&id=Employment%20Agreements) Snehal Patel's employment agreement outlines his base salary, bonus eligibility, and severance terms, including change of control provisions. - Snehal Patel's employment agreement (**Sept 29, 2020**) includes a base salary of **$450,000** (subject to increase), equity grants, and annual bonus eligibility (up to **50% of base salary**)[405](index=405&type=chunk) - Provides for specific compensation and vesting acceleration upon termination without cause, for good reason, or in connection with a change of control[406](index=406&type=chunk) - Contains non-compete and non-solicitation covenants for **one year** post-employment[406](index=406&type=chunk) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=97&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of April 11, 2025, the company's directors, executive officers, and principal stockholders collectively beneficially own approximately 52.29% of the common stock, giving them significant control. [Beneficial Ownership](index=98&type=section&id=Beneficial%20Ownership) Directors, executive officers, and principal stockholders collectively own a significant percentage of common stock. Beneficial Ownership (as of April 11, 2025) | Name of Beneficial Owner | Shares of Common Stock Beneficially Owned | Percentage | | :------------------------------------------------ | :---------------------------------------- | :--------- | | Snehal Patel | 5,848,646 | 41.58% | | F. Joseph Daugherty | 109,964 | * | | David McWilliams | 690,777 | 5.19% | | Eric Rothe | 360,250 | 2.71% | | Kenneth Hallock | 444,328 | 3.34% | | All current named executive officers and directors as a group (5) persons | 7,453,965 | 52.29% | (* Represents beneficial ownership of less than 1%) - Percentage of ownership is based on **13,273,539 shares outstanding** as of **April 11, 2025**[408](index=408&type=chunk) [Section 16(A) Beneficial Ownership Reporting Compliance](index=99&type=section&id=Section%2016(A)%20Beneficial%20Ownership%20Reporting%20Compliance) All Section 16(a) beneficial ownership reporting requirements were met during 2024. - All Section 16(a) filing requirements were complied with during **2024**[413](index=413&type=chunk) [Item 13. Certain Relationship and Related Transactions, and Director Independence](index=99&type=section&id=Item%2013.%20Certain%20Relationship%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The company has a policy for reviewing and approving related person transactions exceeding specific thresholds, ensuring they are in the company's best interest and on comparable terms to third-party dealings. [Related Person Transaction Policy](index=100&type=section&id=Related%20Person%20Transaction%20Policy) A policy is in place for reviewing and approving related person transactions, ensuring fairness and company benefit. - Policy for related person transactions exceeding **$120,000** or **1% of average total assets**[416](index=416&type=chunk) - Audit Committee or independent board body reviews transactions, considering material facts, related person interests, company benefits, and comparable terms[417](index=417&type=chunk) - Requires directors and employees to disclose potential conflicts of interest[417](index=417&type=chunk) [Director Independence](index=100&type=section&id=Director%20Independence) David McWilliams, Eric Rothe, and Kenneth Hallock are independent directors under Nasdaq rules. - David McWilliams, Eric Rothe, and Kenneth Hallock are independent directors under Nasdaq rules[419](index=419&type=chunk) [Item 14. Principal Accountant Fees and Services](index=100&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) The company incurred $64,000 in audit fees and $88,000 in audit-related fees from MaloneBailey, LLP and RBSM, LLP in 2024. [Audit Fees](index=100&type=section&id=Audit%20Fees) Audit and audit-related fees were incurred from MaloneBailey, LLP and RBSM, LLP in 2024. Principal Accountant Fees | Fee Type | 2024 | 2023 | | :---------------- | :------- | :------- | | Audit fees | $64,000 | $69,000 | | Audit-related fees | $88,000 | $26,000 | | Tax fees | $0 | $0 | | All other fees | $0 | $0 | - Audit fees are for professional services for audit and review of financial statements[420](index=420&type=chunk) - Audit-related fees are for services related to registration statement filings and comfort letters[420](index=420&type=chunk) [Policy on Audit Committee Pre-Approval of Audit and Permissible Non-Audit Services of Independent Auditors](index=100&type=section&id=Policy%20on%20Audit%20Committee%20Pre-Approval%20of%20Audit%20and%20Permissible%20Non-Audit%20Services%20of%20Independent%20Auditors) The Audit Committee pre-approves all audit and permissible non-audit services provided by independent auditors. - Audit Committee pre-approves all audit and permissible non-audit services[423](index=423&type=chunk) - All services provided by independent registered public accounting firm have been pre-approved[423](index=423&type=chunk) [PART IV](index=102&type=section&id=PART%20IV) [Item 15. Exhibits, Financial Statement Schedules](index=102&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists all exhibits and financial statement schedules included in the Annual Report on Form 10-K, with financial statements provided in a separate section starting on page F-1. - Lists all exhibits and financial statement schedules[426](index=426&type=chunk) - Financial statements are in a separate section starting on page F-1[426](index=426&type=chunk) [Item 16. Form 10-K Summary](index=102&type=section&id=Item%2016.%20Form%2010-K%20Summary) This item is not applicable. - None[427](index=427&type=chunk) [SIGNATURES](index=103&type=section&id=SIGNATURES) The report is signed by the registrant's authorized officers and directors, including the Chief Executive Officer and Chief Financial Officer, on April 15, 2025. - Report signed by authorized officers and directors on **April 15, 2025**[430](index=430&type=chunk)[433](index=433&type=chunk) - Snehal Patel signed as Chief Executive Officer, Principal Executive Officer, and Principal Accounting and Financial Officer[430](index=430&type=chunk)[433](index=433&type=chunk) [Index to Financial Statements](index=104&type=section&id=Index%20to%20Financial%20Statements) The index lists the Report of Independent Registered Public Accounting Firm, Balance Sheets, Statements of Operations, Statements of Stockholders' Equity, Statements of Cash Flows, and Notes to Financial Statements. - Index lists Report of Independent Registered Public Accounting Firm, Balance Sheets, Statements of Operations, Statements of Stockholders' Equity, Statements of Cash Flows, and Notes to Financial Statements[435](index=435&type=chunk) [Report of Independent Registered Public Accounting Firm](index=105&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) RBSM LLP provided an unqualified opinion on the financial statements for 2024 and 2023, noting a 'going concern' uncertainty. - RBSM LLP provided an unqualified opinion on the financial statements for **2024 and 2023**[437](index=437&type=chunk) - Noted a 'going concern' uncertainty due to recurring losses, limited cash flow, and accumulated deficit[438](index=438&type=chunk) - The audit did not include an opinion on the effectiveness of internal control over financial reporting[440](index=440&type=chunk) [Financial Statements](index=107&type=section&id=Financial%20Statements) [Balance Sheets](index=107&type=section&id=Balance%20Sheets) The company's financial position as of December 31, 2024, shows a decrease in total assets to $4.09 million from $6.99 million in 2023, primarily due to reduced cash. Balance Sheet Summary | Metric | 2024 | 2023 | | :-------------------------------- | :----------- | :----------- | | Cash | $4,091,990 | $6,989,424 | | Total assets | $4,093,769 | $6,994,815 | | Total current liabilities | $1,559,733 | $294,406 | | Total liabilities | $1,559,733 | $294,406 | | Total stockholders' equity | $2,534,036 | $6,700,409 | - Cash decreased by approximately **$2.9 million** from 2023 to 2024[445](index=445&type=chunk) - Total liabilities increased significantly, driven by accounts payable & accrued interest and deferred compensation[445](index=445&type=chunk) [Statements of Operations](index=108&type=section&id=Statements%20of%20Operations) For the years ended December 31, 2024, and 2023, the company reported no revenue. Its net loss increased to $15.79 million in 2024 from $8.89 million in 2023, primarily due to higher operating expenses, which totaled $16.01 million in 2024. Statements of Operations Summary | Metric | 2024 | 2023 | | :-------------------------- | :----------- | :----------- | | Revenue | $0 | $0 | | Total operating expenses | $16,011,817 | $9,327,866 | | Net loss | $(15,788,809) | $(8,891,803) | | Net loss per common share | $(1.21) | $(0.69) | - Net loss increased by approximately **$6.9 million (77.6%)** from 2023 to 2024[448](index=448&type=chunk) - Operating expenses increased significantly, contributing to the higher net loss[448](index=448&type=chunk) [Statements of Stockholders' Equity](index=109&type=section&id=Statements%20of%20Stockholders%27%20Equity) The company's total stockholders' equity decreased from $6.70 million in 2023 to $2.53 million in 2024. Stockholders' Equity Summary | Metric | 2024 | 2023 | | :----------------------- | :----------- | :----------- | | Additional paid-in capital | $68,674,261 | $57,052,130 | | Accumulated deficit | $(66,153,378) | $(50,364,569) | | Total stockholders' equity | $2,534,036 | $6,700,409 | - Accumulated deficit increased by **$15.79 million** in 2024 due to net loss[451](index=451&type=chunk) - Additional paid-in capital increased by **$11.62 million** in 2024, primarily from stock-based compensation (**$7.25 million**) and common stock sales (**$4.37 million**)[451](index=451&type=chunk) [Statements of Cash Flows](index=110&type=section&id=Statements%20of%20Cash%20Flows) In 2024, net cash used in operating activities increased to $7.27 million, primarily due to higher clinical trial expenses. Cash Flow Activities | Activity | 2024 | 2023 | | :-------------------------------- | :----------- | :----------- | | Net cash used in operating activities | $(7,266,543) | $(6,478,602) | | Net cash provided by financing activities | $4,369,109 | $0 | | Net increase (decrease) in cash | $(2,897,434) | $(6,478,602) | | Cash, end of period | $4,091,990 | $6,989,424 | - Operating cash outflow increased by **$0.79 million** in 2024[454](index=454&type=chunk) - Financing activities in 2024 included **$1.87 million** from ATM program and **$2.50 million** from private placement[454](index=454&type=chunk) [Notes to Financial Statements](index=111&type=section&id=Notes%20to%20Financial%20Statements) The notes provide detailed information on the company's organization, going concern status, significant accounting policies, related party transactions, income taxes, commitments, contingencies, stockholders' equity, segment information, and subsequent events. [1. Organization and Description of the Business](index=111&type=section&id=1.%20Organization%20and%20Description%20of%20the%20Business) The company, incorporated in Delaware in 2006, focuses on developing breast cancer immunotherapy to prevent recurrence. - Incorporated in Delaware in **2006** (as Norwell, Inc.), changed name to Greenwich LifeSciences, Inc. in **2018**[457](index=457&type=chunk) - Established Greenwich LifeSciences Europe Limited in Ireland in **2023**[457](index=457&type=chunk) - Focuses on developing breast cancer immunotherapy to prevent recurrence[457](index=457&type=chunk) [2. Going Concern](index=111&type=section&id=2.%20Going%20Concern) Recurring net losses and negative operating cash flows raise substantial doubt about the company's ability to continue as a going concern. - Financial statements prepared on a going concern basis[458](index=458&type=chunk) - Recurring net losses and negative operating cash flows raise substantial doubt about going concern[458](index=458&type=chunk) - Future operations dependent on obtaining additional capital[459](index=459&type=chunk) [3. Significant Accounting Policies](index=111&type=section&id=3.%20Significant%20Accounting%20Policies) Financial statements conform to U.S. GAAP and SEC rules, relying on estimates for accrued expenses and stock-based compensation. - Financial statements conform to U.S. GAAP and SEC rules[460](index=460&type=chunk) - Uses estimates and assumptions, particularly for accrued expenses and stock-based compensation[461](index=461&type=chunk) - Reviews long-lived assets for impairment; no impairment losses recorded through **Dec 31, 2024**[463](index=463&type=chunk) - Adopted ASU 2016-02 (Leases) using modified retrospective method; elected practical expedient for leases under **12 months**[464](index=464&type=chunk) - Stock-based compensation expense is measured at grant date fair value and recognized over service period[466](index=466&type=chunk) - Research and development expenses are charged to operations as incurred[468](index=468&type=chunk) - Basic and diluted EPS calculations exclude common stock equivalents during net loss periods as they are antidilutive[470](index=470&type=chunk) - Early adopted ASU 2020-06 (Debt with Conversion and Other Options) in **January 2021**, with no material impact[472](index=472&type=chunk) [4. Related Party Transactions](index=114&type=section&id=4.%20Related%20Party%20Transactions) Related party transactions include accrued unreimbursed expenses and deferred bonus compensation for management, and a private placement stock purchase by the CEO. - Accrued unreimbursed expenses from management: **$75,916 (2024)**, **$38,089 (2023)**[476](index=476&type=chunk) - Deferred bonus compensation for senior management: **$306,281 (2024)**[477](index=477&type=chunk) - CEO Snehal Patel purchased **174,825 shares** for **$2,499,998** in a private placement on **June 13, 2024**[477](index=477&type=chunk)[508](index=508&type=chunk) [5. Income Taxes](index=115&type=section&id=5.%20Income%20Taxes) Federal net operating loss carryforwards of approximately $30.0 million as of December 31, 2024, are subject to a full valuation allowance. Deferred Tax Assets (as of Dec 31) | Metric | 2024 | 2023 | | :------------------------ | :----------- | :----------- | | Net operating loss carryforwards | $6,297,696 | $4,505,244 | | Valuation allowance | $(6,297,696) | $(4,505,244) | | Total deferred tax assets | $0 | $0 | - Federal NOL carryforwards of approximately **$30.0 million** as of **December 31, 2024**, expiring through **2037** (post-2017 NOLs carry forward indefinitely)[480](index=480&type=chunk) - Full valuation allowance provided due to uncertainty of realizing benefits[480](index=480&type=chunk) - NOLs may be limited by Section 382 of the Code due to ownership changes[481](index=481&type=chunk) [6. Commitments and Contingencies](index=115&type=section&id=6.%20Commitments%20and%20Contingencies) Commitments include an exclusive license agreement with HJF, and the company is not currently involved in material legal proceedings. - Exclusive license agreement with HJF for GP2 requires annual maintenance fees, milestone payments, and royalties[483](index=483&type=chunk) - Accrued interest in accounts payable: **$220,845 (2024 and 2023)**[484](index=484&type=chunk) - Deferred bonus compensation for senior management: **$306,281 (2024)**[487](index=487&type=chunk) - Not currently a party to any material legal proceedings[488](index=488&type=chunk) [7. Stockholders' Equity](index=116&type=section&id=7.%20Stockholders%27%20Equity) Stockholders' equity details include the 2019 Equity Incentive Plan, share repurchases, lock-up extensions, and common stock sales. - 2019 Equity Incentive Plan amended in **2024** to reserve **4 million shares**[489](index=489&type=chunk) - Repurchased and cancelled **519,828 shares** for approximately **$7.54 million

Core Insights - Greenwich LifeSciences, Inc. is advancing its Phase III clinical trial, FLAMINGO-01, which evaluates GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][26] - The trial has shown promising preliminary data regarding safety and immune response, leading to potential expansions in patient enrollment and trial design [2][12] Group 1: Trial Progress and Future Plans - The FLAMINGO-01 trial has confirmed that preliminary data for HLA prevalence, safety, and immune response is trending positively in both HLA-A*02 and non-HLA-A*02 patient arms [2] - The non-HLA-A*02 arm was expanded to 250 patients in 2024, with regulatory approval from both EU and US authorities, and further changes are being considered to enhance the trial's market potential [2] - In Q1 2025, the company achieved a screening rate of over 150 patients per quarter across 117 active sites, with plans to activate an additional 40 sites in the EU [3] Group 2: Clinical Sites and Networks - The trial includes approximately 40 US clinical sites, featuring prominent teaching hospitals such as Yale, Johns Hopkins, and Stanford, which are actively recruiting patients [4] - In Europe, the trial has expanded into five countries with 77 activated clinical sites, primarily in Spain, France, Germany, Italy, and Poland [5][6] - Major academic networks in Europe, such as GEICAM in Spain and GBG in Germany, are collaborating in the trial, enhancing its credibility and outreach [7][9] Group 3: Steering Committee and Expert Involvement - The Steering Committee consists of leading experts in breast cancer oncology from prominent hospitals and networks in the US and Europe, contributing to the trial's design and execution [12] - The company is focused on improving the trial's conduct and design to replicate Phase IIb results and prepare for commercialization of GLSI-100 [12] Group 4: About GLSI-100 and Breast Cancer - GLSI-100 is designed for HER2 positive breast cancer patients who have residual disease post-surgery and have completed neoadjuvant and postoperative adjuvant trastuzumab treatment [24] - 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 once 14 events have occurred [24]

Core Viewpoint - Greenwich LifeSciences, Inc. is advancing its Phase III clinical trial FLAMINGO-01 for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, with promising preliminary immune response data indicating effectiveness in both HLA-A*02 and non-HLA-A*02 patient groups [1][4][6]. Group 1: Clinical Trial Updates - The preliminary immune response data from FLAMINGO-01 shows increasing immune responses over time in both HLA-A*02 treated and placebo arms, as well as in the non-HLA-A*02 arm [2][6]. - The company is considering adding a randomized placebo arm for non-HLA-A*02 patients, which could effectively transform the current open label arm into a pivotal Phase III trial [4]. - 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 once 14 events have occurred [8]. Group 2: Market Potential and Patient Eligibility - The potential market for GP2 treatment could reach up to $10 billion annually, with the possibility of doubling the number of eligible patients to approximately 88,000 new patients per year in the US and Europe [4][6]. - The company has filed patent claims for non-HLA-A*02 patients, which may be solely owned by the company, enhancing its market position [6]. Group 3: Previous Clinical Data - In a Phase IIb clinical trial, GLSI-100 demonstrated an 80% or greater reduction in cancer recurrences over five years in HER2/neu 3+ patients, compared to a 20-50% reduction by other approved products [5][11]. - The immune response peaked at six months after the initial vaccinations, indicating a sustained immune response that correlates with reduced metastatic breast cancer recurrences [12]. Group 4: Company Overview - Greenwich LifeSciences is focused on developing GP2, an immunotherapy targeting breast cancer recurrences, particularly in patients who have undergone surgery [13]. - The company is currently conducting the FLAMINGO-01 trial, which is designed to evaluate the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients [8].

Core Viewpoint - Greenwich LifeSciences, Inc. has extended the lock-up period for shares owned by its directors, officers, and pre-IPO investors to March 31, 2026, which is approximately 66 months post-IPO, restricting their ability to sell shares during this time [1] Group 1: Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences in patients who have undergone surgery [4] - 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 [2] Group 2: Clinical Trial Details - FLAMINGO-01 is designed to include 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 3: Market Context - In the U.S., one in eight women will develop invasive breast cancer, with around 300,000 new cases and 4 million survivors annually [3] - HER2 protein is expressed in approximately 75% of breast cancers, highlighting the potential market for therapies targeting this receptor [3]

Core Viewpoint - Greenwich LifeSciences, Inc. is progressing with its Phase III clinical trial FLAMINGO-01, evaluating GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, with preliminary safety data indicating a well-tolerated profile and no serious adverse events reported to date [1][2][9]. Group 1: FLAMINGO-01 Trial Updates - The Data Safety Monitoring Board (DSMB) recommended continuing the FLAMINGO-01 study without modifications after two meetings in 2024, with no serious adverse events related to GLSI-100 reported [2][6]. - 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 [10]. Group 2: Phase IIb Safety Data - In the Phase IIb clinical trial, 46 HER2/neu 3+ patients treated with GLSI-100 showed an 80% or greater reduction in cancer recurrences over five years, compared to a 20-50% reduction with other approved products [3][6]. - The Phase IIb safety data indicated that GLSI-100 was well tolerated, with no serious adverse events reported, and the most common adverse events were mild or moderate injection site reactions, accounting for approximately 70% of reported events [4][7]. Group 3: Immunotherapy Insights - Full immunization in the Primary Immunization Series (PIS) elicited a potent immune response, with booster injections prolonging this response for longer-term protection [4]. - Preliminary safety data from FLAMINGO-01 suggests that GP2 immunotherapy continues to be well-tolerated, with no safety signals identified across all study arms [6][9]. Group 4: Future Directions - The company anticipates analyzing immune response data and comparing preliminary results from FLAMINGO-01 to Phase IIb data, with potential presentations at future scientific conferences [9]. - 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 once 14 events have occurred [10].

Core Viewpoint - Greenwich LifeSciences, Inc. is advancing its Phase III clinical trial, FLAMINGO-01, to evaluate GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, with recent updates on HLA data indicating a 46% prevalence of the HLA-A*02 allele among screened patients [1][12]. Group 1: Trial Design and Patient Population - FLAMINGO-01 is a prospective, randomized, double-blinded, multi-center study designed to assess the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients [5][12]. - Approximately 500 patients with the HLA-A*02 allele will be randomized to receive GLSI-100 or a placebo, while an additional 250 patients without the HLA-A*02 allele will be enrolled in an open label arm [6][13]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [13]. Group 2: HLA Data Insights - Preliminary analysis shows that about 46% of all screened patients possess at least one HLA-A*02 allele, aligning with the expected prevalence of 40-50% [2][4]. - The prevalence of double HLA-A*02 alleles, where patients receive the allele from both parents, is approximately 8% [12]. - The trial will also explore various HLA-A types and their combinations to assess immune response and clinical outcomes, potentially informing commercial development strategies [4][11]. Group 3: Ethnic and Racial Prevalence - Among self-reported White patients, approximately 50% have at least one HLA-A*02 allele, with 10% having double HLA-A*02 alleles [12]. - In Hispanic or Latino patients, the prevalence of at least one HLA-A*02 allele is also around 50%, with 7% having double alleles [12]. - For Black or African-American patients, about 40% have at least one HLA-A*02 allele, while the prevalence in Asian patients is approximately 17% [12].

Core Insights - Greenwich LifeSciences, Inc. is conducting a Phase III clinical trial, FLAMINGO-01, to evaluate GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][13] - Preliminary analysis of open label HLA data indicates that approximately 46% of screened patients possess at least one HLA-A*02 allele [2][11] - The trial includes a third open label arm for patients without the HLA-A*02 allele, which has been expanded from 100 to 250 patients [7] Trial Design and Patient Population - FLAMINGO-01 is a prospective, randomized, double-blinded, multi-center study with approximately 500 patients with the HLA-A*02 allele randomized to receive GLSI-100 or placebo [5][6] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [13] - The patient population is stratified to balance treated and placebo arms, with a focus on major screening criteria [5] HLA Data Analysis - The open label arm investigates the safety and efficacy of GLSI-100 in patients lacking the HLA-A*02 allele, with potential for immune response conclusions [3][10] - CEO Snehal Patel noted that the 46% prevalence of HLA-A*02 aligns with expectations and supports sample size estimates [4] - The prevalence of double HLA-A*02 alleles is about 8%, with various other HLA types also prevalent among the screened patients [11] Ethnic and Racial Prevalence - Among self-reported White patients, approximately 50% have at least one HLA-A*02 allele, with 10% having double alleles [11] - In Hispanic or Latino populations, 50% have at least one HLA-A*02 allele, with 7% having double alleles [11] - For Black or African-American patients, about 40% have at least one HLA-A*02 allele, while Asian patients show a prevalence of 17% [11] Future Directions - The company is interested in analyzing immune response and efficacy across various HLA types, which may inform commercial development strategies [4][10] - A central laboratory is sequencing DNA to determine HLA types, potentially identifying other alleles that may associate with therapeutic effects [10]

Core Viewpoint - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial, FLAMINGO-01, into Europe to evaluate GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][4]. Group 1: Clinical Trial Expansion - The European Medicines Agency (EMA) has approved the addition of 11 sites in Spain, Germany, and Poland, allowing for approximately 110-115 activated sites in Europe [2]. - The company plans to submit applications to EMA for adding 5-10 additional sites in Ireland, Romania, and potentially other European countries based on interest from principal investigators [3]. Group 2: Trial Details - FLAMINGO-01 is designed to assess 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 [5]. - The trial will include 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 [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]. Group 3: Company Overview - Greenwich LifeSciences is focused on developing GP2, an immunotherapy targeting breast cancer recurrences in patients post-surgery, with a significant portion of breast cancers expressing the HER2 protein [7].

Core Viewpoint - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial, FLAMINGO-01, into Europe to evaluate GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][4]. Clinical Trial Expansion - The European Medicines Agency (EMA) has approved the addition of 11 sites in Spain, Germany, and Poland, allowing for approximately 110-115 activated sites in Europe [2]. - The company plans to submit applications to add 5-10 more sites in Ireland, Romania, and potentially other European countries based on interest from principal investigators [3]. Global Site Activation - In 2024, the company activated sites in all five European countries, which have a population comparable to the U.S. [4]. - Currently, there are about 100 activated sites globally that are screening patients, with a significant increase in patient screening observed in the second half of 2024 [4]. Trial Details - FLAMINGO-01 (NCT05232916) is designed to assess 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 [5]. - The trial will randomize approximately 500 HLA-A*02 patients to receive either GLSI-100 or a 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]. Company Overview - Greenwich LifeSciences focuses on developing GP2, an immunotherapy to prevent breast cancer recurrences in patients post-surgery [7]. - The company is actively engaged in clinical trials and aims to expand its global presence with plans to open up to 150 sites worldwide [5][7].

Core Viewpoint - Greenwich LifeSciences, Inc. is advancing its Phase III clinical trial, FLAMINGO-01, for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, with new clinical sites activated in Poland [1][3]. Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy for breast cancer recurrence prevention in patients post-surgery [10]. - The company is collaborating with Dr. Piotr Wysocki, a prominent figure in breast cancer research in Poland, to facilitate the trial [3][4]. Clinical Trial Details - 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][8]. - The trial will include approximately 500 HLA-A*02 patients randomized to receive either GLSI-100 or a placebo, with an additional 250 patients of other HLA types treated with GLSI-100 [8]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [8]. Market Context - In 2022, Poland reported 24,599 new breast cancer cases, making it the most common cancer among women, accounting for about 25% of all female cancers [2]. - Breast cancer was the second leading cause of cancer-related deaths in women in Poland, with 8,723 deaths recorded in 2022 [2]. Clinical Site Activation - The activation of clinical sites in Poland includes 9 to 11 locations approved by Polish authorities, with the first patient treated in 2024 [3][5]. - Notable participating sites include major oncology centers in cities like Kraków, Opole, and Poznań [6].