Galectin Therapeutics (GALT) risk factors, FY2024 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 operate
2. 02Our NAVIGATE trial was our only active clinical trial, and we currently do not have plans or funding to undertake another clinical trial
3. 03There is substantial doubt about our ability to continue as a going concern
4. 04We are a development stage company and have not yet generated any revenue
5. 05We 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
6. 06Before 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
7. 07Even if we receive regulatory approval, we may be unable to commercialize our product candidates
8. 08There are risks associated with our reliance on third parties to design trial protocols, arrange for and monitor the clinical trials, and collect and analyze data
9. 09There are risks associated with our reliance on third parties for manufacturing belapectin
10. 10We 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
11. 11We face intense competition in the biotechnology and pharmaceutical industries
12. 12The 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
13. 13Our lack of operating experience may cause us difficulty in managing our growth
14. 14We depend on key individuals to develop our products and core technologies and pursue collaborative relationships
15. 15We may fail to comply with our reporting and other requirements under federal securities laws
16. 16Our 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
17. 17We 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. 18We will need regulatory approvals to commercialize our products
2. 19Even 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. 20The 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. 21Data obtained from clinical trials are not necessarily predictive of future results, may be negative or inconclusive, and are susceptible to varying interpretations, which could delay, limit or prevent regulatory clearances
5. 22Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following any marketing approval
6. 23Failure to obtain regulatory approval in international jurisdictions would prevent our product candidates from being marketed abroad

Risks Related to Our Intellectual Property

1. 24Our competitive position is contingent upon the protection of our intellectual property
2. 25the patents of others may have an adverse effect on our business
3. 26We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights, and we may be unable to protect our rights to, or use of, our technology
4. 27Obtaining and maintaining our patent protection depends upon compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
5. 28Our failure to secure trademark registration could adversely affect our ability to market our product candidates and our business
6. 29Confidentiality agreements with employees and others may not adequately prevent disclosure of our trade secrets and other proprietary information and may not adequately protect our intellectual property, which could impede our ability to compete
7. 30We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers

Risks Related to Information Technology and Cybersecurity

1. 31We 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. 32The 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. 33Our 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. 34Nevada 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. 35We may issue additional common stock, which might dilute the net tangible book value per share of our common stock
5. 36A sale of a substantial number of shares of the common stock may cause the price of our common stock to decline
6. 37We 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. 38Our 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. 39Concentration of ownership by our principal stockholders may limit your ability to influence the outcome of director elections and other transactions requiring stockholder approval
9. 40Richard 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. 41Richard E. Uilhlein 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. 42A pandemic similar to the COVID-19 pandemic, or the reemergence of the COVID-19 pandemic could adversely impact our business, including our preclinical studies and clinical trials