Anixa Biosciences (ANIX) risk factors, FY2025 10-K

Risks Related to Our Financial Condition and Operations

1. 01We have a history of losses and may incur additional losses in the future54% rewritten
2. 02We will need additional funding in the future which may not be available on acceptable terms, or at all, and, if available, may result in dilution to our stockholders
3. 03We may have difficulty in raising capital and may consume resources faster than expected
4. 04Failure to effectively manage our potential growth could place strains on our managerial, operational and financial resources and could adversely affect our business and operating results
5. 05We may use our financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater likelihood of success
6. 06Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited

Risks Related to our Research & Development, Clinical and Commercialization Activities

1. 07Our therapeutic and vaccine programs are pre-revenue, and subject to the risks of an early-stage biotechnology company
2. 08If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates
3. 09If we cannot license rights to use technologies on reasonable terms, we may not be able to commercialize new products in the future
4. 10Biotechnology and pharmaceutical product development is a highly speculative undertaking and involves a substantial degree of uncertainty. We have never generated any revenue from biotechnology and pharmaceutical product sales and our biotechnology and pharmaceutical products may never be profitable
5. 11Cancer vaccines are novel and present significant challenges
6. 12CAR-T cell therapies are novel and present significant challenges
7. 13While CAR-T technology has shown positive results in B cell cancers by others, its safety and efficacy has not been seen in solid tumors and we cannot guarantee our CAR-T technology will be safe or effective in ovarian or other cancers
8. 14While pre-clinical testing and the limited human clinical testing of our product candidates has been positive, we may experience unfavorable results once we collect statistically significant data from human clinical trials
9. 15We are dependent on third parties to conduct our pre-clinical studies and clinical trials
10. 16If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected69% rewritten
11. 17In particular, our Phase 1 clinical trial of lira-cel is enrolling patients with late-stage ovarian cancer who have failed conventional treatment, and are willing and able to undergo treatment at MoffittNew
12. 18Delays in patient enrollment may result in increased costs or may affect the timing or outcome of our planned clinical trials, which could prevent completion of the clinical trials and adversely affect our ability to advance the development of lira-cel and our breast cancer vaccine
13. 19Adverse side effects or other safety risks associated with our product candidates could cause us to suspend or discontinue clinical trials or delay or preclude approval67% rewritten
14. 20Vaccine hesitancy, misinformation about vaccine safety, and evolving positions of public health authorities on vaccines could adversely affect the development and commercial success of our cancer vaccine product candidatesNew
15. 21Clinical trials are expensive, time consuming and difficult to design and implement55% rewritten
16. 22In future clinical trials of our breast cancer vaccine we will need to determine efficacy of the breast cancer vaccine as a cancer prevention which will be a considerably more complex clinical trial and will have significantly greater costs than a trial designed to assess therapeutic effectNew
17. 23We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively
18. 24Cell-based therapies rely on the availability of specialty raw materials, which may not be available to us on acceptable terms or at all
19. 25We may form or seek strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements
20. 26The FDA regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our product candidates
21. 27Even if we obtain regulatory approval of our product candidates, the products may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers, third-party payors and others in the medical community

Risks Related to Our Intellectual Property

1. 28If we are unable to obtain and maintain intellectual property protection, our competitive position will be harmed
2. 29Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business
3. 30We rely on licenses from Wistar for our CAR-T technology and Cleveland Clinic for our cancer vaccine technologies, and if we lose any of these licenses we may be subjected to future litigation
4. 31If we do not prevail in such disputes, we may lose any of such license agreements
5. 32If our efforts to protect the proprietary nature of our technologies are not adequate, we may not be able to compete effectively in our market
6. 33Obtaining and maintaining our patents depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent position could be reduced or eliminated for non-compliance with these requirements
7. 34Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court or the USPTO
8. 35We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world

Risks Related to Our Common Stock

1. 36The issuance or sale of shares in the future to raise money or for strategic purposes could reduce the market price of our common stock25% rewritten
2. 37In addition, sales of a substantial amount of our common stock in the public market, or the perception that these sales may occur, could reduce the market price of our common stock. This could also impair our ability to raise additional capital through the sale of our securities
3. 38We may fail to meet market expectations because of fluctuations in quarterly operating results, which could cause the price of our common stock to decline
4. 39Biotechnology company stock prices are especially volatile, and this volatility may depress the price of our common stock
5. 40In addition, we believe that fluctuations in our stock price during applicable periods can also be impacted by changes in governmental regulations in the drug development industry and/or court rulings and/or other developments in our remaining patent licensing and enforcement actions
6. 41Our common stock is currently listed on NASDAQ Capital Market, however if our common stock is delisted for any reason, it will become subject to the SEC’s penny stock rules which may make our shares more difficult to sell
7. 42We are a smaller reporting company and the reduced reporting requirements applicable to smaller reporting companies may make our common stock less attractive to investors
8. 43We do not anticipate declaring any cash dividends on our common stock which may adversely impact the market price of our stock