Cardiff Oncology (CRDF) risk factors, FY2025 10-K

Risks Related to Our Business

1. 01We are a clinical stage company and may never earn a profit69% rewritten
2. 02We will need to raise substantial additional capital to develop and commercialize onvansertib and our failure to obtain funding when needed may force us to delay, reduce or eliminate our product development programs or collaboration efforts65% rewritten
3. 03Management has performed an analysis and concluded that there exists a substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing on terms acceptable to us, if at allNew
4. 04be successfully commercialized by us or by collaborators
5. 05Our product candidate may exhibit undesirable side effects when used alone or in combination with other approved pharmaceutical products or investigational new drugs, which may delay or preclude further development or regulatory approval, or limit their use if approved
6. 06the supply or quality of drug material necessary to conduct our preclinical studies or clinical trials being insufficient, inadequate or unavailable
7. 07We have limited capacity for recruiting and managing clinical trials, which could impair our timing to initiate or complete clinical trials of our product candidate and materially harm our business
8. 08We, and our collaborators, must comply with extensive government regulations in order to advance our product candidate through the development process and ultimately obtain and maintain marketing approval for our products in the U.S. and abroad
9. 09adversely affect the receipt of potential milestone payments and royalties from the sale of our products or product revenues
10. 10fines, civil penalties and criminal prosecutions
11. 11We have limited experience in the development of therapeutic product candidates and therefore may encounter difficulties developing our product candidate or managing our operations in the future
12. 12Dependence on Third-Party ConsultantsNew
13. 13Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results
14. 14Delays in clinical testing could result in increased costs to us and delay our ability to generate revenue
15. 15The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidate, our business will be substantially harmed
16. 16This lengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval to market our product candidate, which would significantly harm our business, results of operations and prospects
17. 17We may be required to suspend or discontinue clinical trials due to unexpected side effects or other safety risks that could preclude approval of our product candidate
18. 18If we fail to comply with healthcare regulations, we could face substantial enforcement actions, including civil and criminal penalties and our business, operations and financial condition could be adversely affected
19. 19We need FDA approval prior to marketing our product candidate in the United States. If we fail to obtain FDA approval to market our product candidate, we will be unable to sell our product candidate in the United States and we will not generate any revenue78% rewritten
20. 20candidate currently under development. Any approvals we may obtain may not cover all of the clinical indications for which we are seeking approval or may contain significant limitations on the conditions of useNew
21. 21If our product candidate is unable to compete effectively with marketed drugs targeting similar indications as our product candidate, our commercial opportunity will be reduced or eliminated
22. 22build an adequate sales and marketing infrastructure for our product candidates
23. 23If the manufacturers upon whom we rely fail to produce our product candidate, in the volumes that we require on a timely basis, or fail to comply with stringent regulations applicable to pharmaceutical drug manufacturers, we may face delays in the development and commercialization of our product candidate
24. 24We may not be able to manufacture our product candidate in commercial quantities, which would prevent us from commercializing our product candidate
25. 25Materials necessary to manufacture our product candidate may not be available on commercially reasonable terms, or at all, which may delay the development and commercialization of our product candidate
26. 26Our product candidate, if approved for sale, may not gain acceptance among physicians, patients, and the medical community, thereby limiting our potential to generate revenues
27. 27the availability of adequate third-party insurance coverage or reimbursement
28. 28Guidelines and recommendations published by various organizations can impact the use of our product61% rewritten
29. 29We do not own or operate any manufacturing facilities. We intend to rely on GMP, FDA validated third-party contractors, at least for the foreseeable future, to formulate and manufacture these preclinical and clinical materialsNew
30. 30our contract manufacturers’ plants being closed as a result of regulatory sanctions or a natural disaster
31. 31In the event that we need to change our third-party contract manufacturers, our preclinical studies, clinical trials or the commercialization of our product candidate could be delayed, adversely affected or terminated, or such a change may result in significantly higher costs
32. 32We do not currently have any internal drug discovery capabilities, and therefore we are dependent on in-licensing or acquiring development programs from third parties in order to obtain additional product candidates
33. 33If a product liability claim is successfully brought against us for uninsured liabilities, or such claim exceeds our insurance coverage, we could be forced to pay substantial damage awards that could materially harm our business
34. 34If we materially breach or default under the Nerviano Licensing Agreement, Nerviano will have the right to terminate the agreement and we could lose critical license rights, which would materially harm our business33% rewritten
35. 35We may delay or terminate the development of our product candidate at any time if we believe the perceived market or commercial opportunity does not justify further investment, which could materially harm our business
36. 36We will need to increase the size of our organization, and we may experience difficulties in managing growth
37. 37Business disruptions could seriously harm future revenue and financial condition and increase our costs and expenses
38. 38Security threats to our information technology infrastructure and/or our physical buildings could expose us to liability and damage our reputation and business
39. 39General economic or business conditions may have a negative impact on our business
40. 40If we use biological and hazardous materials in a manner that causes injury, we could be liable for damages
41. 41Healthcare reform measures could adversely affect our business24% rewritten
42. 42Catastrophic events, including global pandemics such as the COVID-19 pandemic, could materially adversely impact our business, results of operations and financial condition, including our clinical trials
43. 43Geopolitical risks associated with Russia’s invasion of Ukraine could result in increased market volatility and uncertainty, which could negatively impact our business, financial condition, and results of operations
44. 44The increasing use of social media platforms presents new risks and challenges
45. 45Volatile and significantly weakened global economic conditions have in the past and may in the future adversely affect our industry, business, and results of operations

Risks Related to Our Intellectual Property

1. 46If we are unable to protect our intellectual property effectively, we may be unable to prevent third parties from using our technologies, which would impair our competitive advantage
2. 47The patents issued to us may not be broad enough to provide any meaningful protection, one or more of our competitors may develop more effective technologies, designs or methods without infringing our intellectual property rights and one or more of our competitors may design around our proprietary technologies
3. 48We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights72% rewritten
4. 49infringement is deemed willful, or be required to discontinue or significantly delay development, marketing, selling and licensing of the affected products and intellectual property rightsNew
5. 50Certain rights that we in-license from third-parties are not within our control, and we may be negatively impacted if we lose those rights

Risks Related to Ownership of Our Common Stock

1. 51Our ability to use our net operating loss carryforwards and certain other tax attributes is limited by Sections 382 and 383 of the Internal Revenue Code
2. 52Uncertainties in the interpretation and application of existing, new and proposed tax laws and regulations could materially affect our tax obligations and effective tax rateNew
3. 53The rights of the holders of our common stock may be impaired by the potential issuance of preferred stock
4. 54Our common stock price may be volatile and could fluctuate widely in price, which could result in substantial losses for investors
5. 55period-to-period fluctuations in our financial results
6. 56We have not paid dividends on our common stock in the past and do not expect to pay dividends on our common stock for the foreseeable future. Any return on investment may be limited to the value of our common stock
7. 57If securities or industry analysts do not publish research or reports about our business, or if they adversely change their recommendations regarding our stock, our stock price and trading volume could decline
8. 58Delaware law and our corporate charter and bylaws contain anti-takeover provisions that could delay or discourage takeover attempts that stockholders may consider favorable
9. 59A sale of a substantial number of shares of our common stock may cause the price of our common stock to decline and may impair our ability to raise capital in the future
10. 60We may be subject to stockholder litigation, thereby diverting our resources, which could materially adversely affect our profitability and results of operations
11. 61If we fail to comply with the continued minimum closing bid requirements of the Nasdaq or other requirements for continued listing, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted
12. 62If we discover material weaknesses and other deficiencies in our internal control and accounting procedures, our stock price could decline significantly and raising capital could be more difficult
13. 63We incur significant costs as a result of operating as a public company and our management expects to continue to devote substantial time to public company compliance programs