Oragenics (OGEN) risk factors, FY2025 10-K

Risks Related to Our Business

1. 01We have incurred significant losses since our inception and expect to continue to experience losses for the foreseeable future and may not be able to continue as a going concern92% rewritten
2. 02We will require additional capital to complete the development of ONP-002 and to operate our business, and we may not be able to obtain such capital on acceptable terms, or at allNew
3. 03We have incurred operating losses, have an accumulated deficit, and have historically generated negative cash flows from operations. These conditions initially raised substantial doubt regarding our ability to continue as a going concernNew
4. 04Our independent registered public accounting firm included an explanatory paragraph in its audit report for the year ended December 31, 2025, related to these conditions. Our consolidated financial statements do not include any adjustments that might result if we were unable to continue as a going concernNew
5. 05We will need to raise additional capital in the future to complete the development and commercialization of our product candidates and operate our business83% rewritten
6. 06The market price of our Common Stock may never exceed the Conversion Price of the Series H Preferred StockNew
7. 07The issuance of additional equity securities by us in the future would result in dilution to our existing common shareholders30% rewritten
8. 08Future sales of our Common Stock in the public market could cause our stock price to fallNew
9. 09Our success with regard to the Neurology Assets depends on the viability of our business strategy with regard to those assets, which is unproven and may be unfeasible
10. 10There are substantial inherent risks in attempting to commercialize newly developed products, and, as a result, we may not be able to successfully develop any products
11. 11With limited resources we have paused our other product candidate research and development and now rely on the progress and success of ONP-002
12. 12We will need to achieve commercial acceptance of our products, if cleared or approved, to generate revenues and achieve profitability
13. 13The product candidates included in the Neurology Assets are still in development and we have not obtained authorization from any regulatory agency to commercially distribute such products in any country, and we may never obtain such authorizations
14. 14We are, and will continue to be, dependent in significant part on outside scientists and third-party research institutions for our research and development in order to be able to commercialize our product candidates
15. 15The third-party vendors upon whom we rely for the supply of ONP-002 are our sole source of supply, and the loss of these suppliers could significantly harm our business28% rewritten
16. 16The market opportunities for our concussion drug product candidate may be smaller than we believe them to be, or alternative drugs or technologies may be adopted, before our concussion drug achieve regulatory approval
17. 17Our product candidates, if approved, will face significant competition and our failure to compete effectively may prevent us from achieving significant market penetration
18. 18Many of our competitors have significantly greater resources and experience, which may negatively impact our commercial opportunities
19. 19We may choose not to continue developing or commercializing any of our product candidates at any time during development or after approval, which would reduce or eliminate our potential return on investment for those product candidates
20. 20If any of our product candidates are shown to be ineffective or harmful in humans, we will be unable to generate revenues from these product candidates
21. 21We are heavily dependent upon the ability and expertise of our management team and a very limited number of employees, and the loss of such individuals could have a material adverse effect on our business, operating results or financial condition86% rewritten
22. 22We need to hire and retain additional qualified scientists and other highly skilled personnel to maintain and grow our business32% rewritten
23. 23We might not be successful at acquiring, investing in or integrating businesses, entering into joint ventures or divesting businesses
24. 24We may face product liability exposure, and if successful claims are brought against us, we may incur substantial liability if our insurance coverage for those claims is inadequate
25. 25We may be adversely affected by natural disasters, pandemics and other catastrophic events, and by man-made problems such as terrorism, that could disrupt our business operations, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster
26. 26As of December 31, 2025, we had U.S. federal and state net operating loss carryforwards of approximately $164,834,118 and $138,451,933, respectivelyNew
27. 27If we fail to maintain an effective system of internal controls, we may not be able to accurately report our financial results or prevent fraud

Risks Related to Our Intellectual Property and Data Security and Privacy

1. 28Our limited resources and decision to pause the development of our COVID-19 vaccine candidate to focus on the development of ONP-002 may result in our breach of certain contracts
2. 29We may be subject to claims challenging the inventorship of our patents and other intellectual property
3. 30Changes in patent law or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our product candidates
4. 31If we are unable to protect our trademarks or other intellectual property from infringement, our business prospects may be harmed
5. 32We may not be able to protect our intellectual property rights throughout the world21% rewritten
6. 33If we are sued for infringing intellectual property rights of third parties, it will be costly and time-consuming and an unfavorable outcome in that litigation could have a material adverse effect on our business24% rewritten
7. 34We may become involved in lawsuits to protect or enforce our patents or other intellectual property or the patents of our licensors, which could be expensive and time consuming
8. 35Our business and operations would suffer in the event of cybersecurity/information systems risk
9. 36Security breaches and other disruptions to our information technology systems or those of the vendors on whom we rely on could compromise our information and expose us to liability, reputational damage, or other costs
10. 37We may incur costs of addressing a cybersecurity incident

Risks Related to Government Regulations

1. 38Our product candidates are subject to substantial government regulation, including the regulation of nonclinical testing and clinical trials. If we are unable to obtain regulatory approval for our product candidates, we will be unable to generate revenues
2. 39Clinical trials conducted outside of the United States, present additional risks
3. 40Delays or difficulties in the enrollment of patients in clinical trials may result in additional costs and delays in our ability to generate significant revenues and may delay or prevent our receipt of any regulatory approvals necessary to commercialize our planned and future products
4. 41Any product candidates that we commercialize will be subject to ongoing and continued regulatory review
5. 42Our product candidates may cause serious or undesirable side effects or possess other unexpected properties that could delay or prevent their regulatory approval, limit the commercial profile of approved labeling or result in post-approval regulatory action
6. 43We may also be subject to healthcare laws, regulation and enforcement and our failure to comply with those laws could adversely affect our business, operations and financial condition
7. 44Our employees, independent contractors, principal investigators, consultants, vendors and CROs may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
8. 45Even if our current product candidates or any future product candidates obtain regulatory approval, they may fail to achieve the broad degree of health care payers, physician and patient adoption and use necessary for commercial success
9. 46If we are unable to achieve and maintain coverage and adequate levels of reimbursement for any of our product candidates for which we receive regulatory approval, or any future products we may seek to commercialize, their commercial success may be severely hindered

Risks Related to Our Common Stock

1. 47We cannot assure you that we will continue to be listed on the NYSE American81% rewritten
2. 48Our financial results could vary significantly from quarter to quarter and are difficult to predict
3. 49The conversion of our Series F and Series H Preferred Stock, and the exercise of currently outstanding warrants could result in significant dilution to the holders of our common stock91% rewritten
4. 50Certain provisions of our articles of incorporation, bylaws, executive employment agreements and stock option plan may prevent a change of control of our company that a shareholder may consider favorable
5. 51The market price of our common stock has been, and may continue to be volatile and fluctuate significantly, which could result in substantial losses for shareholders
6. 52We may be subject to securities litigation, which is expensive and could divert management attention
7. 53Future sales or issuances of our common stock in the public markets, or the perception of such sales, could depress the trading price of our common stock
8. 54The requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain qualified members for our Board of Directors
9. 55If we fail to maintain an effective system of internal controls, we may not be able to accurately report our financial results or prevent fraud which could subject us to regulatory sanctions, harm our business and operating results and cause the trading price of our stock to decline
10. 56We will continue to incur significant costs as a result of and devote substantial management time to operating as a public company listed on the NYSE American
11. 57If securities or industry analysts publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline
12. 58We may issue debt or debt securities convertible into equity securities, any of which may be senior to our common stock as to distributions and in liquidation, which could negatively affect the value of our common stock
13. 59We are a “smaller reporting company” and, as a result of the reduced disclosure and governance requirements applicable to smaller reporting companies, our common stock may be less attractive to investors
14. 60We do not intend to pay cash dividends