Oncolytics Biotech (ONCY) risk factors, FY2025 10-K

Other

1. 01Research and Development Risks
2. 02Any failure or delay in clinical trials for our product candidate, pelareorep, may cause us to incur additional costs or delays or prevent the commercialization of our product candidate and could severely harm our business
3. 03Our business, including our research and development operations, has been and may continue to be adversely affected by a variety of external factors outside our control that may materially impact our ability to raise capital, current licensing agreements, financial conditions, operations and business
4. 04operating expenses and disruptions in the capital and credit markets that may reduce our ability to raise additional capital when needed on acceptable terms, if at all
5. 05We may expend our limited resources to pursue a particular indication and fail to capitalize on indications that may be more profitable or for which there is a greater likelihood of success
6. 06We may not achieve our projected development milestones in the time frames we announce and expect, which could have a material adverse effect on our business, financial condition, and results of operations

Financial Condition Risks

1. 07We have no operating revenues and a history of losses. We have no products approved for commercial sale, and we may never achieve or sustain profitability
2. 08We may not be able to adequately price our product or obtain third-party reimbursement for the cost of our product, which would adversely affect our sales and profitability
3. 09We may be exposed to third-party credit risks through our contractual arrangements. Failure to meet contractual obligations could have a material adverse effect on our business and operations
4. 10We incur some of our expenses in foreign currencies and, therefore, we are exposed to foreign currency exchange rate fluctuations, which may have a material adverse effect on our financial condition and results of operations

Regulatory Risks

1. 11Pharmaceutical products are subject to intense regulatory approval processes. Failure to comply with applicable regulatory requirements can, among other things, result in suspension of regulatory approvals, product recalls, seizure of products, operating restrictions, and criminal prosecution
2. 12The design or execution of our clinical trials may not support regulatory approval
3. 13We are subject to government regulation in many jurisdictions. If we do not comply with healthcare, drug, manufacturing, and environmental regulations, among others, in such jurisdiction, our existing and future operations may be curtailed, and we could be subject to liability
4. 14We have conducted, and may in the future conduct, clinical trials for pelareorep in sites outside the U.S. and the FDA may not accept data from trials conducted in such locations, which would be costly and time-consuming for us and cause delay or permanently halt our development of pelareorep
5. 15A Fast Track designation from the FDA, even if granted, may not lead to a faster development, regulatory review, or approval process, and does not increase the likelihood that our product candidate will receive marketing approval
6. 16conditions and fill an unmet medical need. A clinical program that receives Fast Track designation may benefit from more frequent meetings and communications with the FDA to discuss development plans and ensure the collection of appropriate data needed to support approval
7. 17Changes in tax laws or regulations, or differing interpretations of tax laws, could adversely affect our business, financial condition, and results of operations
8. 18Failure to meet regulatory or ethical expectations on environmental impact, including climate change, could adversely affect our business, financial condition, results of operations, cash flows, and prospects
9. 19Intellectual Property Risks
10. 20Third parties may choose to file patent infringement claims against us, and defending ourselves from such allegations may be costly, time-consuming, distracting to management, and could materially affect our business and operations
11. 21In addition to patented technology, we rely upon unpatented proprietary technology, processes, and know-how. However, these types of trade secrets can be difficult to protect, and we may not be successful in protecting our trade secrets and confidential information
12. 22Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed, which may have an adverse effect on our business
13. 23If we do not obtain protection under the Hatch-Waxman Amendments and similar foreign legislation for extending the term of patents covering our product candidate, our business may be materially harmed
14. 24Intellectual property rights are limited and do not necessarily address all potential threats to our business that could materially affect our financial condition, results of operations, and prospects
15. 25Developments in patent law could have a negative impact on our business
16. 26Our commercial success depends in part on our ability to obtain and maintain patent, trademark, trade secret, and other intellectual property protection for our product candidate and proprietary technologies, as well as our ability to operate without infringing upon the proprietary rights of others

Other Business Risks

1. 27The biotechnology industry is extremely competitive and if our competitors develop and market products that are more effective, safer, or less expensive than our product candidate, our business could be adversely impacted
2. 28Our product candidate may fail or cause harm, subjecting us to product liability claims that we may not adequately be protected against
3. 29We will likely partner with or rely on third parties to market our product. Failure to successfully market our product would have a material adverse effect on our revenue
4. 30is typically extensive information, and you or others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure
5. 31Our product candidate, or the introduction of new products, may require new technologies, including new manufacturing processes, and the emergence of new industry standards may render our product and technologies obsolete, less competitive, or less marketable, which may have a material adverse effect on our business
6. 32Changes in methods of pelareorep manufacturing or formulation may result in additional costs or delay, and may jeopardize our ability, or our strategic partners’ ability, to commence product sales and generate revenue
7. 33We are subject to the restrictions and conditions of the PanCAN Therapeutic Accelerator Award Agreement. Failure to comply with this agreement may adversely affect our financial condition and results of operations
8. 34Negative developments in the field of immuno-oncology, in particular, viral immunotherapy, could damage public perception of pelareorep and negatively affect our business
9. 35We may experience difficulties in expanding our operations successfully and managing future growth, which could negatively affect our business, operations and prospects
10. 36Our failure to comply with data protection laws and regulations could lead to government enforcement actions, which could include civil or criminal penalties, private litigation, and/or adverse publicity and could negatively affect our operating results and business
11. 37Failure to comply with data protection laws and regulations both within and outside of the U.S. could result in government enforcement actions, which could include civil or criminal penalties, private litigation, and/or adverse publicity and could negatively affect our operating results and business
12. 38Use of AI could give rise to legal and regulatory risk and liability, breaches of data security and privacy, and loss of trade secrets or other intellectual property
13. 39The increasing use of social media platforms could give rise to liability, regulatory actions, breaches of data security, harm to our business or reputational damages
14. 40We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties
15. 41Future legal proceedings and the impact of any finding of liability or damages could adversely impact our business, financial condition and results of operations
16. 42We may fail to achieve and maintain adequate internal control over financial reporting pursuant to the requirements of the Sarbanes-Oxley Act and equivalent Canadian legislation
17. 43As a “smaller reporting company,” we are permitted to provide scaled disclosures, which may make our securities less attractive to investors and, if we cease to qualify, could increase our costs and divert management attention
18. 44Barbados law differs from the laws in effect in Canada and the U.S. and may afford less protection to holders of our securities
19. 45Because we are a Canadian company and some of our directors and officers are residents outside the U.S., it may be difficult for investors in the U.S. to enforce civil liabilities against us based solely upon the federal securities laws of the U.S
20. 46Our success is dependent on our key employees and collaborators, as well as our ability to attract, retain and motivate highly qualified scientific personnel
21. 47Public health epidemics and pandemics have adversely affected and could in the future adversely affect our business, results of operations, and financial condition
22. 48Our stock price is subject to volatility, and, as a result, our stockholders’ investment in our stock could decline in value and we could be subject to securities litigation
23. 49Our stockholders may experience dilution as a result of future equity offerings or other equity issuances
24. 50We do not anticipate paying cash dividends for the foreseeable future
25. 51The Domestication will result in additional direct and indirect costs whether or not completed
26. 52The amount of corporate tax payable by us will be affected by the value of our property on the date of the Domestication