Biovie (BIVI) risk factors, FY2025 10-K

Risks Relating to Our Business and Industry

1. 01Successful development of biopharmaceuticals is highly uncertain and is dependent on numerous factors, many of which are beyond our control
2. 02The concentration of our assets within a certain financial institution could have a material adverse effect on its business, financial condition and results of operations20% rewritten
3. 03We have no products approved for commercial sale, have never generated any revenues and may never achieve revenues or profitability, which could cause us to cease operations
4. 04We are a development stage company with a limited operating history, making it difficult for you to evaluate our business and your investment
5. 05Since inception, we have not established any revenues or operations that would provide financial stability in the long term, and there can be no assurance that we will realize our plans on our projected timetable in order to reach sustainable or profitable operations
6. 06Even if we successfully develop and market BIV201 and/or bezisterim (NE3107), we may not generate sufficient or sustainable revenue to achieve or sustain profitability, which could cause us to cease operations and cause you to lose all of your investment
7. 07If we fail to obtain or maintain Orphan Drug exclusivity for BIV201, we will have to rely on other potential marketing exclusivity, and on our intellectual property rights, which may reduce the length of time that we can prevent competitors from selling generic versions of BIV201
8. 08We 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, which could have a materially adverse effect on our business
9. 09We have limited experience in drug development and may not be able to successfully develop any drugs, which would cause us to cease operations
10. 10We may expend our limited resources to pursue a particular drug candidate or indication and fail to capitalize on drug candidates or indications that may be more profitable or for which there is a greater likelihood of success
11. 11We have no manufacturing experience, and the failure to comply with all applicable manufacturing regulations and requirements could have a materially adverse effect on our business
12. 12We do not currently have the sales and marketing personnel necessary to sell products, and the failure to hire and retain such staff could have a materially adverse effect on our business
13. 13Even if we were to successfully develop approvable drugs, we will not be able to sell these drugs if we or our third-party manufacturers fail to comply with manufacturing regulations, which could have a materially adverse effect on our business
14. 14We must comply with significant and complex government regulations, compliance with which may delay or prevent the commercialization of our product candidates, which could have a materially adverse effect on our business
15. 15If we experience delays or discontinuations of our clinical trials by the FDA or comparable authorities in other countries, or if we fail to obtain registration or other approvals of our products or devices then we could be forced to cease our operations and you will lose all of your investment
16. 16We depend upon our management and their loss or unavailability could put us at a competitive disadvantage which could have a material adverse effect on our business
17. 17We may not be able to attract and retain highly skilled personnel, which could have a materially adverse effect on our business
18. 18The 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, which could cause us to curtail or cease operations
19. 19There may be conflicts of interest among our officers, directors and stockholders
20. 20We indemnify our officers and directors against liability to us and our security holders, and such indemnification could increase our operating costs

Risks Relating to Our Intellectual Property

1. 21We may be unable to obtain or protect intellectual property rights relating to our product candidates, which could have a materially adverse effect on our business
2. 22Patent terms may be inadequate to establish our competitive position on our drug candidates for an adequate amount of time
3. 23We may not be able to protect our intellectual property rights throughout the world
4. 24Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our drug candidates
5. 25We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful, and issued patents directed towards our technology and drug candidates could be found invalid or unenforceable if challenged
6. 26Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation
7. 27We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might subject us to infringement claims or adversely affect our ability to develop and market our drug candidates
8. 28Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could negatively impact the success of our business
9. 29We may be subject to claims by third parties asserting that we or our employees have infringed, misappropriated or otherwise violated their intellectual property rights, or claiming ownership of what we regard as our own intellectual property
10. 30We may be subject to claims challenging the inventorship of our patents and other intellectual property
11. 31Intellectual property rights do not necessarily address all potential threats
12. 32Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of shares of our Common Stock to decline

Risks Relating to Our Common Stock

1. 33Our stock price is and may continue to be volatile and you may not be able to resell our Common Stock at or above the price you paid
2. 34You may experience future dilution as a result of future equity offerings or if we issue shares subject to options, warrants, stock awards or other arrangements59% rewritten
3. 35We may, in the future, issue additional shares of Common Stock, which would reduce investors’ percent of ownership and may dilute our share valueNew
4. 36We effected a reverse stock split on July 7, 2025, and such reverse stock split has caused and could further cause our stock price to decline relative to its value before the reverse stock split and decrease the liquidity of shares of our common stockNew
5. 37The market price and trading volume of our Common Stock may be volatile
6. 38Any failure to maintain effective internal control over financial reporting could harm us
7. 39There is a limited trading market for our Common Stock, which could make it difficult to liquidate an investment in our Common Stock, in a timely manner
8. 40The lack of public company experience of our management team could adversely impact our ability to comply with the reporting requirements of U.S. securities laws, which could have a materially adverse effect on our business
9. 41We are considered a smaller reporting company that is exempt from certain disclosure requirements, which could make our stock less attractive to potential investors
10. 42We are subject to the periodic reporting requirements of the Exchange Act, which require us to incur audit fees and legal fees in connection with the preparation of such reports. These additional costs will negatively affect our ability to earn a profit
11. 43Because we do not intend to pay any cash dividends on our Common Stock, our stockholders will not be able to receive a return on their shares unless they sell them
12. 44We are authorized to issue “blank check” preferred stock without stockholder approval, which could adversely impact the rights of holders of our securities
13. 45Provisions in our Articles of Incorporation, our Bylaws, and Nevada law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our Common Stock