Cadrenal Therapeutics Inc

For the period ended Dec 31, 2023. Filed Mar 11, 2024.

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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2023 · Filed Mar 11, 2024

CVKD$1.37+39.8%Stored close · as of Nov 9, 2026

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Contents

PART I

Forward-Looking Statements

This Annual Report on Form 10-K (this “Annual Report”) contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that involve substantial risks and uncertainties. The forward-looking statements are contained principally in Part I, Item 1. “Business,” Part I, Item 1A. “Risk Factors,” and Part II, Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” but are also contained elsewhere in this Annual Report in some cases you can identify forward-looking statements by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions. These statements are based on our current beliefs, expectations, and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and generally beyond our control, that could cause actual results to differ materially from those expressed, projected or implied in or by the forward-looking statements.

You should refer to Part I, Item 1A. “Risk Factors” section of this Annual Report for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Annual Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. We do not undertake any obligation to update any forward-looking statements. Unless the context requires otherwise, references to “we,” “us,” “our,” and “Cadrenal,” refer to Cadrenal Therapeutics, Inc. and its subsidiaries.

This Annual Report also contains market data related to our business and industry. These market data include projections that are based on a number of assumptions. If these assumptions turn out to be incorrect, actual results may differ from the projections based on these assumptions. As a result, our markets may not grow at the rates projected by these data, or at all. The failure of these markets to grow at these projected rates may harm on our business, results of operations, financial condition and the market price of our common stock.

Note Regarding Company References

Throughout this Annual Report, “Cadrenal,” “the Company,” “we” and “our” refer to Cadrenal Therapeutics, Inc.

Summary Risk Factors

Our business faces significant risks and uncertainties of which investors should be aware before making a decision to invest in our common stock. If any of the following risks are realized, our business, financial condition and results of operations could be materially and adversely affected. The following is a summary of the more significant risks relating to the Company. A more detailed description of our risk factors is set forth below under the caption “Risk Factors” in Item 1A in Part I of this Annual Report.

Risks Related to Our Financial Position and Need for Capital

●	We have a limited operating history, a history of losses and expect to continue to incur losses;

●	Our cash and the proceeds from our initial public offering and July 2023 private placement offering will only fund our operations for a limited time;

●	We will need to raise additional capital.

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

●	Our business is dependent upon the success of tecarfarin, which requires additional clinical testing;
●	All of our current data for tecarfarin are the results of clinical trials conducted by third parties;
●	Our development efforts may not generate data sufficient to support regulatory approval and the FDA may require additional clinical testing resulting in additional costs and delays;
●	Even if we complete our clinical trials, we may not receive regulatory approval for tecarfarin;
●	Fast Track designation and Orphan Drug Designation by the FDA does not assure FDA approval;
●	Even if we obtain regulatory approval, we may not enjoy marketing exclusivity and we may face development, regulatory or labeling difficulties;

●	Clinical trials are very expensive, time-consuming and difficult to design and implement.
●	We may experience delays in the enrollment of patients in any or all of our clinical trials;

●	If tecarfarin is approved, our success depends on our commercialization efforts and market acceptance;
●	We have never submitted an NDA to the FDA or comparable applications to other regulatory authorities;
●	After approval of tecarfarin, it will remain subject to regulatory obligations and other restrictions;
●	We are subject to federal and state obligations and regulations applicable to our marketing practices;
●	We rely on a third-party manufacturer to produce tecarfarin;
●	If the manufacturer fails to comply with stringent regulations, we may face delays;
●	We face substantial competition;
●	Serious adverse effects may be identified with respect to our products, which may harm our business;
●	Recently enacted and future legislation may affect marketing approval and commercialization of tecarfarin;
●	We may be subject to penalties if we violate healthcare fraud and abuse laws or price reporting laws;
●	Our ability to generate product revenues will be diminished if our products sell for inadequate prices;
●	We will rely on third parties to conduct all of our clinical trials;
●	We currently have limited distribution, marketing, support and sales capabilities;
●	Our employees, contractors, consultants, commercial partners and vendors may engage in misconduct;
●	If we are not successful establishing a sales force, our ability to generate sales and profits will be limited;
●	We plan to rely on collaborations with third parties to develop, commercialize, market and promote our products;
●	Our future growth depends, in part, on our ability to penetrate foreign markets;
●	Global health crises may adversely affect our planned operations; and
●	Compliance with regulations regarding the treatment of animals could increase our costs.

Risks Related to Our Intellectual Property

●	We may be unable to obtain and maintain market exclusivity or patent protection for tecarfarin;
●	We may become involved in intellectual property lawsuits, which could be costly and time consuming;
●	Patent law changes in the United States and other jurisdictions could diminish the value of patents;
●	Patent protection depends on compliance with requirements imposed by governmental patent agencies;
●	We may not be able to enforce our intellectual property rights throughout the world; and
●	Our patents expire in 2024 and 2025 and therefore we will lose protection from such patents in the next couple years.

Risks Related to Ownership of Our Common Stock

●	An active public trading market for our Common Stock may not be maintained;
●	We cannot be assured that we will be able to maintain our listing on the Nasdaq Capital Market;
●	Our stock price has been extremely volatile;
●	If favorable research or reports about us are not published our stock price could decline;
●	Our officers, directors, and principal stockholders exercise significant control over our Company;
●	Future sales of Common Stock could result in dilution and could depress the market price of our Common Stock;
●	Our charter documents have anti-takeover provisions;
●	Claims for indemnification by our directors and officers may reduce our available funds;
●	We do not intend to pay dividends in the foreseeable future;
●	Certain members of our management team have limited experience managing a public company;
●	We have incurred significant increased costs as a result of operating as a public company;
●	We are an emerging growth company and may avail ourselves of reduced disclosure requirements or extended transition periods for complying with new or revised accounting standards;
●	There is no public market for our outstanding warrants; and
●	Holders of our outstanding warrants will have no rights as common stockholders with respect to the shares of our Common Stock underlying the warrants until such holders exercise their warrants and acquire our Common Stock, except as otherwise provided in the warrants.

General Company-Related Risks

●	Our business depends upon our ability to attract and keep senior management and key scientific personnel;
●	We will need to increase the size of our organization, and we may experience difficulties managing this;
●	If product liability lawsuits are brought against us, we may incur substantial liabilities;
●	Computer system failures could be costly and expose us to litigation and government enforcement actions;
●	We are increasingly dependent on information technology, and our systems face certain risks, including cybersecurity and data leakage risks;
●	Acquisitions of other businesses could harm our operating results; and
●	Declining general economic or business conditions may have a negative impact on our business.

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