Greenwich LifeSciences (GLSI) risk factors, FY2024 10-K

Risks Relating to Our Financial Position and Capital Needs

1. 01We have incurred substantial losses since our inception and anticipate that we will continue to incur substantial and increasing losses for the foreseeable future
2. 02We need significant additional financing to fund our operations and complete the development and, if approved, the commercialization of our product candidate. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts
3. 03We may consider strategic alternatives in order to maximize stockholder value, including financings, strategic alliances, acquisitions or the possible sale of the Company. We may not be able to identify or consummate any suitable strategic alternatives
4. 04Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our product candidate on unfavorable terms to us
5. 05We currently have no source of revenues. We may never generate revenues or achieve profitability
6. 06The Tax Cuts and Jobs Act could adversely affect our business and financial condition
7. 07Our ability to use net operating losses to offset future taxable income may be subject to limitations

Risks Related to the Development and Regulatory Approval of Our Product Candidate

1. 08Clinical-stage biopharmaceutical companies with product candidates in clinical development face a wide range of challenging activities which may entail substantial risk
2. 09We may find it difficult to enroll patients in our clinical trials given the limited number of patients who have the diseases for which our product candidate is being studied which could delay or prevent the start of clinical trials for our product candidate
3. 10Clinical drug development involves a lengthy and expensive process with an uncertain outcome, including the risk of a clinical trial being placed on clinical hold
4. 11Data from our clinical trials that we announce or publish from time to time may change as more patient data become available either through long-term patient follow-up and/or as such data is audited and verified, which could result in material changes to clinical and safety profiles for our products
5. 12In the clinical trials using GP2, improper intradermal injections or poor HLA binding by GP2 may potentially jeopardize the outcome of the trials
6. 13Risks associated with out-licensing GP2 or future product candidates in foreign countries could materially adversely affect the commercialization of our products
7. 14Risks associated with operating in foreign countries could materially adversely affect our product development
8. 15Any of these events could prevent us from achieving or maintaining market acceptance of our product candidate, if approved
9. 16Failure to successfully validate and develop a companion diagnostic for our product candidate could harm our drug development strategy and operational results
10. 17Our future success is dependent on the regulatory approval of our product candidate
11. 18Our current product candidate and future product candidates could fail to receive regulatory approval from the FDA
12. 19Failure to obtain regulatory approval in international jurisdictions would prevent our product candidate from being marketed abroad
13. 20Even if our current candidate receives regulatory approval, it may still face future development and regulatory difficulties
14. 21The occurrence of any event or penalty described above may inhibit our ability to successfully commercialize our product and generate revenues

Risks Related to Our Manufacturing

1. 22We have limited to no manufacturing, sales, marketing or distribution capability and must rely upon third parties for such
2. 23We are subject to a multitude of manufacturing risks, any of which could substantially increase our costs and limit supply of our product candidate
3. 24In the clinical trials using GP2, GM-CSF is also administered and its availability is dependent upon a third-party manufacturer, which may or may not reliably provide GM-CSF, thus jeopardizing the completion of the trials
4. 25If any of our CMOs’ clinical manufacturing facilities are damaged or destroyed or production at such facilities is otherwise interrupted, our business and prospects would be negatively affected

Risks Related to Our Dependence on Third Parties and Our License Agreements

1. 26Our operations or those of the third parties upon whom we depend might be affected by the occurrence of a natural disaster, pandemic, war or other catastrophic event
2. 27We may not realize the benefits of our strategic alliances that we may form in the future
3. 28Our business involves the use of hazardous materials and we and our third-party manufacturers and suppliers must comply with environmental, health and safety laws and regulations, which can be expensive and restrict how we do business
4. 29We may not be able to establish or maintain the third-party relationships that are necessary to develop or potentially commercialize our product candidate

Risks Related to Our Intellectual Property

1. 30We rely on an exclusive license granted to us by HJF with respect to GP2, and if HJF does not adequately defend such license, our business may be harmed
2. 31It is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection. If our patent position does not adequately protect our product candidate, others could compete against us more directly, which would harm our business, possibly materially
3. 32If we fail to comply with our obligations in the agreements under which we may license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose rights that are important to our business
4. 33If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize our product candidate
5. 34We may incur substantial costs as a result of litigation or other proceedings relating to patents and other intellectual property rights
6. 35We may infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop us from commercializing or increase the costs of commercializing our product candidate
7. 36If we are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of our technology and product could be significantly diminished
8. 37We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed alleged trade secrets
9. 38Our intellectual property may not be sufficient to protect our product candidate from competition, which may negatively affect our business as well as limit our partnership or acquisition appeal
10. 39Intellectual property rights and enforcement may be less extensive in jurisdictions outside of the U.S.; thus, we may not be able to protect our intellectual property and third parties may be able to market competitive products that may use some or all of our intellectual property

Risks Related to Commercialization of Our Current Product Candidate and Future Product Candidates

1. 40Our commercial success depends upon attaining significant market acceptance of our current product candidate and future product candidates, if approved, among physicians, patients, healthcare payors and cancer treatment centers
2. 41Even if we are able to commercialize our current product candidate or any future product candidates, the products may not receive coverage and adequate reimbursement from third-party payors in the U.S. and in other countries in which we seek to commercialize our products, which could harm our business
3. 42Healthcare legislative measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations
4. 43Price controls may be imposed in foreign markets, which may adversely affect our future profitability
5. 44Coverage and reimbursement may be limited or unavailable in certain market segments for our product candidate, which could make it difficult for us to sell our product candidates, if licensed, profitably
6. 45We expect the product candidates we develop will be regulated as biological products, or biologics, and therefore they may be subject to competition

Risks Related to Healthcare Compliance Regulations

1. 46Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation
2. 47Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop
3. 48Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain products outside of the U.S. and require us to develop and implement costly compliance programs

Risks Related to our Business Operations

1. 49We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do
2. 50Data collection is governed by restrictive regulations governing the use, processing, and cross-border transfer of personal information
3. 51Significant disruptions of information technology systems, computer system failures or breaches of information security could adversely affect our business
4. 52We will need to grow the size of our organization in the future, and we may experience difficulties in managing this growth
5. 53Our future success depends on our ability to retain our executive officers and to attract, retain and motivate qualified personnel
6. 54We are periodically involved in various litigation and/or regulatory proceedings that, if adversely decided or settled, could materially and adversely affect our business, financial condition, and results of operations
7. 55We may hold cash and cash equivalents at various foreign subsidiaries and in countries outside of the US that may not be readily available to meet cash requirements
8. 56We may be adversely affected by the effects of inflation and a potential recession

Risks Related to Owning our Common Stock

1. 57The price of our common stock may fluctuate substantially
2. 58Market and economic conditions may negatively impact our business, financial condition and share price
3. 59If securities or industry analysts do not publish research or reports, or publish unfavorable research or reports about our business, our stock price and trading volume may decline
4. 60Because certain of our stockholders control a significant number of shares of our common stock, they may have effective control over actions requiring stockholder approval
5. 61Future sales and issuances of our common stock could result in additional dilution of the percentage ownership of our stockholders and could cause our share price to fall
6. 62We are an “emerging growth company” and will be able to avail ourselves of reduced disclosure requirements applicable to emerging growth companies, which could make our common stock less attractive to investors
7. 63We may be at risk of securities class action litigation
8. 64Financial reporting obligations of being a public company in the U.S. are expensive and time-consuming, and our management is required to devote substantial time to compliance matters
9. 65If we fail to maintain an effective system of internal control over financial reporting in the future, we may not be able to accurately report our financial condition, results of operations or cash flows