Galectin Therapeutics (GALT) risk factors, FY2025 10-K

Risks Related to Our Company

1. 01We have incurred net losses to date and must raise additional capital in order to continue to operate37% rewritten
2. 02We are significantly dependent on Mr. Uihlein for financing, and there is no assurance that he will continue to provide fundingNew
3. 03Our NAVIGATE trial was our only active clinical trial83% rewritten
4. 04We have from time to time faced substantial doubt about our ability to continue as a going concern84% rewritten
5. 05We are a development stage company and have not yet generated any revenue
6. 06We are dependent on the success of our lead product candidate, belapectin, and we cannot be certain that our product candidates will receive regulatory approval or be successfully commercialized
7. 07Before obtaining regulatory approval for the sale of any drug candidate, we must conduct extensive pre-clinical studies and clinical trials to demonstrate the safety and efficacy of our product candidates in humans
8. 08Even if we receive regulatory approval, we may be unable to commercialize our product candidates
9. 09We are dependent on third parties for clinical trial design, execution, and manufacturing, and their failure to perform could adversely affect our businessNew
10. 10There are risks associated with our reliance on third parties for manufacturing belapectin
11. 11We are exposed to pre-clinical and clinical liability risks which could place a financial burden upon us, should we be sued, because we do not currently have product liability insurance beyond our general insurance coverage
12. 12We face intense competition in the biotechnology and pharmaceutical industries
13. 13The market for our proposed products is rapidly changing and competitive, and new drugs and new treatments that may be developed by others could impair our ability to maintain and grow our business and remain competitive
14. 14Our lack of operating experience may cause us difficulty in managing our growth
15. 15We depend on key individuals to develop our products and core technologies and pursue collaborative relationships
16. 16We may fail to comply with our reporting and other requirements under federal securities laws
17. 17We have identified a material weakness in our internal control over financial reporting, which, if not remediated, could result in material misstatements in our financial statementsNew
18. 18Our long-term success is dependent not only upon the success of our trials but also upon us being able to capitalize upon potential positive results of our trials, which is not assured
19. 19We have previously been a defendant in a shareholder derivative action, and any possible future such lawsuits may adversely affect our business, financial condition, results of operations and cash flows

Risks Related to the Regulation of our Products

1. 20We will need regulatory approvals to commercialize our products
2. 21Even if we obtain regulatory approvals, our marketed drugs will be subject to ongoing regulatory review. If we fail to comply with ongoing regulatory requirements, we could lose our approvals to market drugs, in which case our business would be materially adversely affected
3. 22The drug development process to obtain FDA approval is very costly and time consuming, and if we cannot complete our clinical trials in a cost-effective manner, our results of operations may be adversely affected
4. 23the costs involved in enforcing or defending patent claims or other intellectual property rightsNew
5. 24Clinical trial data may be negative, inconclusive, or subject to varying interpretations, and our product candidates may cause undesirable side effects, any of which could delay, limit, or prevent regulatory approvalNew
6. 25Failure to obtain regulatory approval in international jurisdictions would prevent our product candidates from being marketed abroad

Risks Related to Our Intellectual Property

1. 26Our competitive position depends upon protection of our intellectual property, and we may be unable to adequately protect our proprietary rightsNew
2. 27We may incur substantial costs from intellectual property litigation, and we may be unable to protect or use our technology84% rewritten
3. 28Trademark registrations, confidentiality agreements, and trade secret protections may be inadequate to protect our intellectual propertyNew

Risks Related to Information Technology and Cybersecurity

1. 29We are dependent on information technology and our systems and infrastructure face certain risks, including from cybersecurity breaches and data leakage

Risks Related to Our Common Stock

1. 30The market price of our common stock may be volatile and adversely affected by several factors. This could subject us to securities class action litigation, and our stockholders could incur substantial losses
2. 31Our board of directors has the power to designate, without stockholder approval, additional series of preferred capital, the shares of which could be senior to our common stock and be entitled to conversion or voting rights that adversely affect the holders of our common stock
3. 32Nevada law and our charter documents could make it more difficult for a third party to acquire us and discourage a takeover, which could depress the trading price of our common stock
4. 33We may issue additional common stock, which might dilute the net tangible book value per share of our common stock
5. 34A sale of a substantial number of shares of the common stock may cause the price of our common stock to decline
6. 35We have not paid cash dividends on our common stock in the past and do not expect to pay cash dividends in the foreseeable future
7. 36Our shares of common stock have been thinly traded, so you may be unable to sell at or near ask prices or even at all if you need to sell your shares to raise money or otherwise desire to liquidate your shares
8. 37Concentration of ownership by our principal stockholders may limit your ability to influence the outcome of director elections and other transactions requiring stockholder approval
9. 38Richard E. Uihlein’s and 10X Fund’s significant ownership positions may deter or prevent efforts by other companies to acquire us, which could prevent our stockholders from realizing a control premium
10. 39Richard E. Uihlein and/or 10X Fund could sell or transfer a substantial number of shares of our common stock, which could depress the price of our securities or result in a change in control of our company
11. 40A pandemic similar to the COVID-19 pandemic could adversely impact our business, including our preclinical studies and clinical trials