Cadrenal Therapeutics (CVKD) risk factors, FY2024 10-K

Risks Related to Our Financial Position and Need for Capital

1. 01We are a clinical development biopharmaceutical company with a limited operating history
2. 02We have a limited operating history upon which to evaluate our ability to commercialize our product candidate
3. 03We have a history of operating losses and expect to continue to incur substantial losses for the foreseeable future. We may never become profitable or, if achieved, be able to sustain profitability
4. 04We may not be able to generate revenue or achieve profitability in the future. Our failure to achieve or maintain profitability would likely negatively impact the value of our securities and could prevent us from continuing as a going concern
5. 05Our cash and the proceeds from our completed financings will only fund our operations for a limited time, and we will need to raise additional capital to fund our planned pivotal Phase 3 clinical trial and to support our development and commercialization efforts for our product candidate, tecarfarin
6. 06We will also need to raise additional capital to expand our business to meet our long-term business objectives
7. 07Our need for future financing may result in the issuance of additional securities, which will cause investors to experience dilution

Risks Related to Product Development, Regulatory Approval, Manufacturing and Commercialization

1. 08Our business is dependent upon the success of our investigational product candidate, tecarfarin, which requires additional clinical testing before we can seek regulatory approval and potentially launch commercial sales. We do not own any other product candidates or have any other products in clinical development
2. 09All of our current data for our product candidate are the results of clinical trials conducted by third parties and do not necessarily provide sufficient evidence that our products are viable as potential pharmaceutical products
3. 10As all of our clinical trials to date were conducted by third parties, we cannot be assured that such clinical trials were in compliance with applicable laws, rules and regulations
4. 11Our efforts to develop our product candidate may not generate data sufficient to support an application for regulatory approval
5. 12Even if we successfully complete our clinical trials, we may not receive regulatory approval for tecarfarin, and we may not be able to commercialize our product candidate and our ability to generate revenue will be limited
6. 13Fast Track designation by the FDA may not actually lead to a faster development or regulatory review or approval process, and does not assure FDA approval of our product candidate
7. 14Even if we obtain regulatory approval, we will still face ongoing regulatory requirements and tecarfarin may face future development and regulatory difficulties
8. 15Clinical trials are very expensive, time-consuming and difficult to design and implement
9. 16Delays in the enrollment of patients in any or all of our clinical trials could increase our development costs and delay completion of our clinical trials and associated regulatory submissions
10. 17Even if approved, tecarfarin may not have labeling that allows us to successfully commercialize it
11. 18If our product candidate is approved, our success depends on our commercialization efforts, which may not be achieved. If we are unable to commercialize our product candidate, or experience significant delays in doing so, our business could be materially harmed
12. 19Our potential future product candidate, tecarfarin, may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success
13. 20We have never submitted an NDA to the FDA or comparable applications to other regulatory authorities and we may not be successful in achieving approval of our product candidates
14. 21Orphan Drug Designation does not translate to approval and, even if we obtain FDA approval, we may not enjoy marketing exclusivity or other expected benefits
15. 22After approval of tecarfarin, tecarfarin will remain subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional risk and expense
16. 23After approval, our products could be subject to labeling and other restrictions and we may be required to withdraw from the market or be subject to penalties if we fail to comply with regulatory requirements
17. 24We are subject, directly or indirectly, to federal and state obligations and regulations applicable to our marketing practices. If we are unable to comply, or have not complied, with such laws, we could face substantial penalties
18. 25We currently do not have any long-term supply agreements or commercialization partnerships with third-party manufacturers for the production and distribution of tecarfarin and intend to rely upon third parties to produce and distribute our product candidate
19. 26If the manufacturer upon which we rely fails to comply with stringent regulations, we may face delays in the development and commercialization of, or be unable to meet demand for, our product candidates and may lose potential revenues
20. 27We face substantial competition, which may result in others discovering, developing or commercializing competing products more successfully than we do, or, perhaps obtaining approval before our product and, potentially delaying our approval
21. 28If serious adverse effects are identified with respect to any of our product candidates or any of our approved products, we may need to modify or abandon our development of that product candidate, discontinue sale of an approved product, or change our labeling to reflect new safety risks
22. 29Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize tecarfarin and affect the prices we may obtain
23. 30If we market any of our products in a manner that violates healthcare fraud and abuse laws, or if we violate government price reporting laws, we may be subject to civil or criminal penalties
24. 31Our ability to generate product revenues will be diminished if our products sell for inadequate prices or patients are unable to obtain adequate levels of reimbursement
25. 32The impact of recent healthcare reform legislation, other changes in the healthcare industry, and in healthcare spending is currently unknown and may adversely affect our business model
26. 33Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors, which may adversely affect our future profitability
27. 34Any reduction in reimbursement from Medicare, Medicaid or other government programs may result in a similar reduction in payments from private payors, which may adversely affect our future profitability
28. 35We currently have limited distribution, marketing, support and sales capabilities and plan to rely on third-party distribution partners for the distribution, marketing, support and sales of our products which could delay or limit our ability to generate revenue
29. 36Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
30. 37We intend to establish a sales force to market our product candidates. If we are not successful in doing so, our ability to generate sales and profits will be limited
31. 38We plan to rely on collaborations and license arrangements with third parties to commercialize, market and promote our marketed products which may limit our ability to generate revenue and adversely affect our profitability
32. 39Our future growth depends, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties
33. 40Global health crises may adversely affect our planned operations
34. 41Compliance with governmental regulations regarding the treatment of animals used in research could increase our operating costs, which would adversely affect the commercialization of our products

General Company-Related Risks

1. 42If we fail to attract and keep senior management and key scientific personnel, we may be unable to successfully develop tecarfarin or any future product candidates, conduct our clinical trials and commercialize our product candidates or any future products we develop
2. 43We will need to increase the size of our organization, and we may experience difficulties in managing this growth
3. 44If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit the commercialization of any future products we develop
4. 45Our business and operations would suffer in the event of computer system failures
5. 46We are increasingly dependent on information technology, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks
6. 47We may acquire other businesses or form joint ventures or make investments in other companies or technologies that could harm our operating results, dilute our stockholders’ ownership, increase our debt or cause us to incur significant expense
7. 48Changes in general economic or business conditions, including tariff and customs regulations, may have a negative impact on our business
8. 49Global climate change and related regulations could negatively affect our business

Risks Related to Our Intellectual Property

1. 50We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming, and unsuccessful
2. 51If we are sued for infringing the intellectual property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or commercializing our product candidates
3. 52Changes to the patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products
4. 53Obtaining and maintaining our patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements
5. 54We may not be able to enforce our intellectual property rights throughout the world
6. 55Our two issued U.S. patents with respect to tecarfarin expired in 2024 and our foreign patents will expire in April 2025 and, therefore, we will lose protection from all of our patents next month
7. 56We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property

Risks Related to Ownership of Our Common Stock

1. 57An active public trading market for our Common Stock may not be maintained
2. 58We cannot be assured that we will be able to maintain our listing on the Nasdaq Capital Market
3. 59Our stock price has fluctuated in the past, has recently been volatile and may be volatile in the future, and as a result, investors in our Common Stock could incur substantial losses
4. 60If financial or industry analysts do not publish research or reports about our business or if they issue inaccurate or unfavorable commentary or downgrade our Common Stock, our stock price and trading volume could decline
5. 61Our officers and directors exercise significant control over our Company and may be able to control our management and operations, acting in their best interests and not necessarily those of other stockholders
6. 62Future sales and issuances of our Common Stock or rights to purchase Common Stock, including pursuant to our equity incentive plans and outstanding warrants, could result in additional dilution of the percentage ownership of our stockholders and could depress the market price of our Common Stock
7. 63Anti-takeover provisions in our charter documents, and under Delaware law, could make an acquisition of our company, which may be beneficial to our stockholders, more difficult, limit attempts by our stockholders to replace or remove our current management and limit the market price of our Common Stock
8. 64Our amended and restated bylaws, provide that we will indemnify our directors and executive officers, in each case to the fullest extent permitted by Delaware law
9. 65We do not intend to pay dividends in the foreseeable future. As a result, your ability to achieve a return on your investment will depend on appreciation in the price of our Common Stock
10. 66Certain members of our management team have limited experience managing a public company
11. 67We have incurred significant increased costs as a result of operating as a public company, and our management is required to devote substantial time to compliance initiatives
12. 68We have additional securities available for issuance, which, if issued, could adversely affect the rights of the holders of our Common Stock
13. 69Future sales of our Common Stock could cause the market price for our Common Stock to decline
14. 70There is no public market for the outstanding warrants
15. 71Holders of the outstanding warrants will have no rights as common stockholders with respect to the shares our Common Stock underlying the warrants until such holders exercise their warrants and acquire our Common Stock, except as otherwise provided in the warrants