Co-Diagnostics (CODX) risk factors, FY2025 10-K

Risks Related to Our Business and Industry

1. 01We have limited commercial history upon which to base our prospects and are not certain that we will achieve profitability in the future
2. 02The markets for diagnostic products are intensely competitive, and many of our competitors are much larger and have substantially more financial and human resources than we do. Many have long histories and strong reputations within the industry, and a relatively small number of companies dominate these markets
3. 03We depend on a limited number of third-party suppliers for key raw materials used in the manufacturing of our products, and the loss of these third-party suppliers or their inability to supply us with adequate raw materials could harm our business
4. 04In order to be successful, we must expand our available product lines by commercializing new product candidates, but we may not be able to do so in a timely fashion and at expected costs, or at all
5. 05We are dependent on our senior management team, scientific team, and external advisors, and the loss of any of them could harm our business, including by adversely affecting our ability to effectuate our business strategy
6. 06If we experience significant disruptions in our information technology systems, our business, results of operations and financial condition could be adversely affected
7. 07Cybersecurity risks and the failure to maintain the integrity of company, employee or customer data could expose us to data loss, litigation and liability, and our reputation could be significantly harmed

Risks Related to Our Capital Resources and Impairments

1. 08We will require additional financing and our failure to obtain additional funding would force us to delay, reduce or eliminate our product development programs or commercialization efforts75% rewritten
2. 09Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements. We may be unable to continue to operate without the threat of liquidation for the foreseeable future
3. 10Raising additional capital by issuing securities or through debt financings or licensing arrangements will likely cause dilution to existing stockholders, restrict our operations or require us to relinquish proprietary rights

Risks Related to Regulatory Approval of Our Products and Other Government Regulations

1. 11Our long-term success depends substantially on our ability to obtain regulatory clearance or approval and thereafter commercialize our product candidates; we cannot be certain that we will be able to do so in a timely manner or at allNew
2. 12We may also be subject to international data protection laws, including those in the European Union and other jurisdictions, which impose stringent requirements on the processing and transfer of personal information and authorize significant fines for violationsNew
3. 13We are subject to evolving global data protection and privacy laws, and compliance with such laws may be costly and may expose us to liabilityNew
4. 14We may also be subject to international data protection laws, including the European Union General Data Protection Regulation (“GDPR”) and the United Kingdom GDPR, which impose strict requirements regarding the processing and transfer of personal data and authorize substantial fines for non-complianceNew

Risks Related to Our Intellectual Property

1. 15If the combination of patents, trade secrets and contractual provisions that we rely on to protect our intellectual property is inadequate, our ability to commercialize our products successfully will be harmed, and we may not be able to operate our business profitably
2. 16We rely substantially on our trademarks and trade names. If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be harmed

Risks Related to Litigation from Operating Our Business

1. 17Current or future litigation, government investigations and other legal proceedings may harm our business
2. 18The price of our common stock may fluctuate substantially
3. 19Anti-takeover provisions in our charter documents and Utah law could discourage, delay, or prevent a change of control of our Company and may affect the trading price of our common stock
4. 20We do not currently intend to pay dividends on our common stock
5. 21We are a “smaller reporting company” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors
6. 22We incur substantial costs as a result of being a public company and our management expects to devote substantial time to public company compliance programs
7. 23We incur substantial costs as a result of being a public company and are subject to the continued listing requirements of the NASDAQ Capital Market, our management expects to devote substantial time to public company compliance programs65% rewritten