NutriBand (NTRB) risk factors, FY2025 10-K

Other

1. 01Risks Concerning our Business
2. 02There is economic uncertainty concerning economic policies being pursued by the new administration in the United States that may affect the costs and timing of the process of bringing our products to market through approvals with the FDA
3. 03Our failure to develop our abuse deterrent fentanyl transdermal system will impair our ability to continue in business
4. 04Before we can market in the United States any product which is classified by the FDA as a drug, we must obtain FDA marketing approval
5. 05Risk of delays at FDA due to restructuring and layoffs
6. 06Risk of increased tariffs on foreign goods
7. 07We may encounter delays in completing clinical trials, which would increase our costs and delay market entry
8. 08Our ability to finance our operations and generate revenues depends on the clinical and commercial success of our abuse deterrent fentanyl transdermal system and our other related product candidates, and failure to achieve such success will negatively impact our business
9. 09Since we do not have commercial manufacturing capability, if we are unable to establish manufacturing facilities, we may have to enter into a manufacturing agreement with a manufacturer that has been approved by the FDA
10. 10If we or any third-party manufacturer fails to comply with FDA current good manufacturing practices, we may not be able to sell our products until and unless the manufacturer becomes compliant
11. 11If the FDA implements Risk Evaluation and Mitigation Strategies policies for any of our proposed products, we will need to comply with such policies before we can obtain FDA approval or the product
12. 12Our products will continue to be subject to FDA review after FDA approval is given
13. 13We must continually monitor the safety of our products once approved and marketed for potential adverse events which could jeopardize our ability to continue marketing the products
14. 14If we obtain FDA approval to market our products, we expect to spend considerable time and money complying with federal and state laws and regulations governing their sale, and, if we are unable to fully comply with such laws and regulations, we could face substantial penalties
15. 15Before we can market our products outside of the United States, we will need to obtain regulatory approval in each country in which we propose to sell our products
16. 16If we do not have sufficient product liability insurance, we may be subject to claims that are in excess of our net worth
17. 17Because some of the patches we are developing, such as our abuse deterrent fentanyl patch, have potential severe side effects, we may face liability in the event patients suffer serious, possibly life-threatening, side effects from our products
18. 18We may decide not to continue developing or commercializing any products at any time during development or after approval, which would reduce or eliminate our potential return on investment for those product candidates
19. 19If any of our potential products are approved for marketing but fail to achieve the broad degree of physician or market acceptance necessary for commercial success, our operating results and financial condition will be adversely affected
20. 20The drug delivery industry is subject to rapid technological change, and our failure to keep up with technological developments may impair our ability to market our products
21. 21If we obtain FDA approval, we will face significant competition from better known and better capitalized companies
22. 22Healthcare reforms by governmental authorities, court decisions affecting health care policies and related reductions in pharmaceutical pricing, reimbursement and coverage by third-party payors may adversely affect our business
23. 23It is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection
24. 24If we seek to expand our business through acquisition, we may not be successful in identifying acquisition targets or integrating their businesses with our existing business
25. 25We are dependent on third party distributors for the international marketing of our consumer products and complying with applicable laws
26. 26We are dependent upon our chief executive officer, our president and our chief operating officer
27. 27If we are unable to attract, train and retain technical and financial personnel, our business may be materially and adversely affected
28. 28Our lack of internal controls over financial reporting may affect the market for and price of our common stock
29. 29The market price for our common stock may be volatile and your investment in our common stock could suffer a decline in value
30. 30Raising funds by issuing equity or convertible debt securities could dilute the net tangible book value of the common stock and impose restrictions on our working capital
31. 31Stockholders may experience significant dilution as a result of future equity offerings and other issuances of our common stock or other securities
32. 32Our failure to meet the continued listing requirements of Nasdaq could result in a de-listing of our common stock
33. 33We and our senior executive officers settled an SEC investigation, which may affect the market for and the market price of our common stock and our ability to list on a stock exchange
34. 34Because of our executive officers’ stock ownership and stock ownership of certain other stockholders that have invested in the company, these stockholders have the power to elect all directors and to approve any action requiring stockholder approval
35. 35We may issue preferred stock whose terms could adversely affect the voting power or value of our common stock