Oragenics (OGEN) risk factors, FY2024 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 concern
2. 02We will need to raise additional capital in the future to complete the development and commercialization of our product candidates and operate our business
3. 03Given our current cash position and significant uncertainties related to future funding opportunities and our 2024 financials, substantial doubt exists regarding our ability to continue as a going concern through one year from the date that the financial statements included in this Annual Report were issued
4. 04Our auditor has expressed substantial doubt about our ability to continue as a going concern and absent additional financing we may be unable to remain a going concern
5. 05We require additional funding to be able to maintain our current level of operations and to fund the further development of our new ONP-002 product candidate; we may not be able to obtain additional funding
6. 06Our 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
7. 07There 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
8. 08With limited resources we have paused our other product candidate research and development and now rely on the progress and success of ONP-002
9. 09We will need to achieve commercial acceptance of our products, if cleared or approved, to generate revenues and achieve profitability
10. 10The 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
11. 11We 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
12. 12The third party upon whom we rely for the supply of ONP-002 is our sole source of supply, and the loss of this supplier could significantly harm our business
13. 13If Odyssey were to convert all of its Series F Convertible Preferred Stock, they would own more than a majority of our outstanding shares of common stock
14. 14The 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
15. 15Our product candidates, if approved, will face significant competition and our failure to compete effectively may prevent us from achieving significant market penetration
16. 16Many of our competitors have significantly greater resources and experience, which may negatively impact our commercial opportunities
17. 17We 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
18. 18If 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
19. 19We 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 condition
20. 20We need to hire and retain additional qualified scientists and other highly skilled personnel to maintain and grow our business
21. 21We might not be successful at acquiring, investing in or integrating businesses, entering into joint ventures or divesting businesses
22. 22We 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
23. 23We 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
24. 24Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited, each of which could harm our business
25. 25If 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. 26Our 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. 27We may be subject to claims challenging the inventorship of our patents and other intellectual property
3. 28Changes in patent law or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our product candidates
4. 29If we are unable to protect our trademarks or other intellectual property from infringement, our business prospects may be harmed
5. 30We may not be able to protect our intellectual property rights throughout the world
6. 31If 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 business
7. 32We 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. 33Our business and operations would suffer in the event of cybersecurity/information systems risk
9. 34Security breaches and other disruptions to our information technology systems or those of the vendors on whom we rely could compromise our information and expose us to liability, reputational damage, or other costs
10. 35We may incur costs of addressing a cybersecurity incident

Risks Related to Government Regulations

1. 36Our 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. 37Clinical trials conducted outside of the United States, present additional risks
3. 38Delays 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. 39Any product candidates that we commercialize will be subject to ongoing and continued regulatory review
5. 40Our 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. 41We 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. 42Our 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. 43Even 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. 44If 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. 45We cannot assure you that we will continue to be listed on the NYSE American
2. 46The issuance of additional equity securities by us in the future would result in dilution to our existing common shareholders
3. 47Our financial results could vary significantly from quarter to quarter and are difficult to predict
4. 48The conversion of our Series F Preferred Stock, and the exercise of currently outstanding warrants could result in significant dilution to the holders of our common stock
5. 49Certain 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
6. 50The 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
7. 51We may be subject to securities litigation, which is expensive and could divert management attention
8. 52Future 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
9. 53The 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
10. 54If 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
11. 55We 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
12. 56If securities or industry analysts publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline
13. 57We 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
14. 58We 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
15. 59We do not intend to pay cash dividends