Nanoviricides (NNVC) risk factors, FY2024 10-K

Other

1. 01Because we are subject to these risks, you may have a difficult time evaluating our business and your investment in our company
2. 02Even if we successfully develop and market our drug candidates, we may not generate sufficient or sustainable revenue to achieve or sustain profitability
3. 03We will need to raise substantial additional capital in the future to fund our operations and we may be unable to raise such funds when needed and on acceptable terms
4. 04We cannot provide assurance that the Company’s plans will not change or that changed circumstances will not result in the depletion of its capital resources more rapidly than it currently anticipates
5. 05We have limited experience in drug development, and may not be able to successfully develop any drugs
6. 06Development of pharmaceutical products is a time-consuming process, subject to a number of factors, many of which are outside of our control. Consequently, we can provide no assurance of the successful and timely development of new drugs
7. 07We have limited manufacturing expertise and we may have to rely on external manufacturers
8. 08We must comply with significant and complex government regulations, compliance with which may delay or prevent the commercialization of our drug candidates
9. 09We can provide no assurance that our drug candidates will obtain regulatory approval or that the results of clinical studies will be favorable
10. 10Preclinical and clinical studies of our product candidates may not be successful. If we are unable to generate successful results from preclinical and clinical studies of our product candidates, or experience significant delays in doing so, our business may be materially harmed
11. 11Because the results of preclinical testing are not necessarily predictive of future results, our products may not have favorable results in our planned clinical trials
12. 12We believe we have sufficient funds on hand to complete the remaining tasks of the Phase I clinical trial and obtain a completed clinical study report, and to develop and file a Phase II clinical trial application to evaluate use of NV-387 for the treatment of RSV infection
13. 13The successful development of biopharmaceuticals is highly uncertain. A variety of factors including, pre-clinical study results or regulatory approvals, could cause us to abandon development of our drug candidates
14. 14We have limited experience in conducting or supervising clinical trials and must outsource all clinical trials
15. 15We are subject to risks inherent in conducting clinical trials. The risk of non-compliance with FDA-approved good clinical practices by clinical investigators, clinical sites, or data management services could delay or prevent us from developing or ever commercializing our drug candidates
16. 16Efforts of government and third-party payers to contain or reduce the costs of health care may adversely affect our revenues even if we were to develop an FDA approved drug
17. 17We will rely upon licensed patents to protect our technology. We may be unable to obtain or protect such intellectual property rights, and we may be liable for infringing upon the intellectual property rights of others
18. 18Other companies or organizations may assert patent rights that prevent us from developing and commercializing our drug candidates
19. 19We are dependent upon TheraCour for the rights to develop the products we intend to sell and our license agreements with TheraCour require that TheraCour is the sole developer and supplier of our licensed products
20. 20The expiration or loss of patent protection may adversely affect our future revenues and operating earnings
21. 21We lack suitable facilities for clinical testing; and rely on third parties
22. 22We have limited manufacturing experience
23. 23We may be unable to attract, retain, and motivate skilled personnel which will delay our product development programs and our research and development efforts
24. 24We have no sales and marketing personnel
25. 25Since we cannot predict whether or when we will obtain regulatory approval to commercialize our product candidates, we cannot predict the timing of any future revenue from these product candidates
26. 26Our collaborative relationships with third parties could cause us to expend significant resources and incur substantial business risk with no assurance of financial return
27. 27We employ the use of certain chemical and biological agents and compounds that may be deemed hazardous and we are therefore subject to various environmental laws and regulations. Compliance with these laws and regulations may result in significant costs, which could materially reduce our ability to become profitable
28. 28If we use biological and hazardous materials in a manner that causes injury, we may be liable for damages
29. 29We depend upon our senior management and their loss or unavailability could put us at a competitive disadvantage
30. 30There are conflicts of interest among our officers, directors and stockholders
31. 31We may fail to obtain contracts to supply the U.S. government, and we may be unable to commercialize our drug candidates
32. 32If the U.S. government fails to continue funding bio-defense drug candidate development efforts or fails to purchase sufficient quantities of any future bio-defense drug candidate, we may be unable to generate sufficient revenues to continue operations

Risks Related to the Biotechnology/Biopharmaceutical Industry

1. 33The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition. We may be unable to compete with enterprises equipped with more substantial resources than us
2. 34Our RSV drug does not have any direct competition at present but there are two protective antibodies as well as three vaccines for RSV, although there are no approved treatments other than the highly toxic last-resort drug, ribavirin

Risks Related to the Securities Markets and Investments in Our Common Stock

1. 35General securities market uncertainties resulting from international turmoil
2. 36If we do not meet the continued listing standards of the NYSE American our common stock could be delisted from trading, which could limit investors’ ability to make transactions in our common stock and subject us to additional trading restrictions
3. 37Our Common Stock may be considered a “penny stock” and may be difficult to sell
4. 38Our stock price may be volatile and your investment in our common stock could suffer a decline in value
5. 39There is a risk of market fraud
6. 40A registration of a significant amount of our outstanding restricted stock may have a negative effect on the trading price of our stock
7. 41We do not intend to pay any cash dividends in the foreseeable future and, therefore, any return on your investment in our capital stock must come from increases in the fair market value and trading price of the capital stock
8. 42We may issue additional equity shares to fund the Company’s operational requirements, which would dilute share ownership
9. 43Large amounts of our common stock will be eligible for resale under Rule 144
10. 44The requirements of complying with the Sarbanes-Oxley act may strain our resources and distract management
11. 45Sales of additional equity securities may adversely affect the market price of our common stock and your rights in the Company may be reduced