GeoVax Labs (GOVX) risk factors, FY2025 10-K

Risks Related to Our Business and Capital Requirements

1. 01We have a history of operating losses, and we expect losses to continue for the foreseeable future
2. 02We have received a going concern opinion from our auditors
3. 03Our business will require continued funding. If we do not receive adequate funding, we may not be able to continue our operations72% rewritten
4. 04Significant disruptions of information technology systems or breaches of information security systems could adversely affect our business

Risks Related to Development and Commercialization of Product Candidates and Dependence on Third Parties

1. 05Our products are still being developed and are unproven. These products may not be successful
2. 06We depend upon key personnel who may terminate their employment with us at any time. If we were to lose the services of any of these individuals, our business and operations may be adversely affected
3. 07Regulatory and legal uncertainties could result in significant costs or otherwise harm our business
4. 08We face intense competition and rapid technological change that could result in products that are superior to, or earlier to the market than, the products we will be commercializing or developing
5. 09Our product candidates are based on new medical technology and, consequently, are inherently risky. Concerns about the safety and efficacy of our products could limit our future success
6. 10We may experience delays in our clinical trials that could adversely affect our financial results and our commercial prospects
7. 11Failure to obtain timely regulatory approvals required to exploit the commercial potential of our products could increase our future development costs or impair our future sales
8. 12State pharmaceutical marketing compliance and reporting requirements may expose us to regulatory and legal action by state governments or other government authorities
9. 13Changes in healthcare law and implementing regulations, as well as changes in healthcare policy, may impact our business in ways that we cannot currently predict, and may have a significant adverse effect on our business and results of operations
10. 14We may not be successful in establishing collaborations for product candidates we seek to commercialize, which could adversely affect our ability to discover, develop, and commercialize products
11. 15We do not have manufacturing, sales or marketing experience
12. 16Our products under development may not gain market acceptance
13. 17We may be required to defend lawsuits or pay damages for product liability claims
14. 18Reimbursement decisions by third-party payors may have an adverse effect on pricing and market acceptance. If there is not sufficient reimbursement for our products, it is less likely that they will be widely used

Risks Related to Our Intellectual Property

1. 19Our success depends on our ability to obtain, maintain, protect, and enforce our intellectual property and our proprietary technologies
2. 20We could lose our license rights to our important intellectual property if we do not fulfill our contractual obligations to our licensors
3. 21Other parties may claim that we infringe their intellectual property or proprietary rights, which could cause us to incur significant expenses or prevent us from selling products
4. 22Any inability to protect our or our licensors ’ intellectual property rights in the United States and foreign countries could limit our ability to prevent others from manufacturing or selling our products
5. 23The laws of some foreign countries do not protect proprietary information to the same extent as the laws of the United States, and many companies have encountered significant problems and costs in protecting their proprietary information in these foreign countries
6. 24Changes in United States patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates
7. 25The patent protection and patent prosecution for our product candidates is dependent in part on third parties
8. 26Changes to the Biologics Price Competition and Innovation Act ’ s exclusivity provisions could affect our market exclusivityNew

Risks Related to Our Securities

1. 27The market price of our Common Stock is highly volatile
2. 28The sale or issuance of additional shares of our Common Stock or other equity securities could result in additional dilution to our stockholders35% rewritten
3. 29Certain provisions of our certificate of incorporation which authorize the issuance of shares of preferred stock may make it more difficult for a third party to effect a change in control
4. 30We have never paid dividends and have no plans to do so
5. 31Public company compliance may make it more difficult for us to attract and retain officers and directors
6. 32Our Certificate of Incorporation and Bylaws may be amended by the affirmative vote of a majority of our stockholders
7. 33Broker-dealers may be discouraged from effecting transactions in shares of our Common Stock if we are considered to be a penny stock and thus subject to the penny stock rules61% rewritten