CVKD

The following discussion of risk factors contains forward-looking statements.
These risk factors may be important to understanding any statement in this Annual Report or elsewhere.
The following information should be read in conjunction with Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the consolidated financial statements and related notes beginning on F-1 of this Annual Report.
You should consider carefully the risks and uncertainties described below, in addition to other information contained in this Annual Report, including our consolidated financial statements and related notes.
The risks and uncertainties described below are not the only ones we face.
Our business, financial condition and operating results can be affected by a number of factors, whether currently known or unknown, including but not limited to those described below.
Any one or more of such factors could directly or indirectly cause our actual results of operations and financial condition to vary materially from past or anticipated future results of operations and financial condition.
Any of these factors, in whole or in part, could materially and adversely affect our business, financial condition, results of operations and stock price.
References to past events are provided by way of example only and are not intended to be a complete listing or a representation as to whether or not such factors have occurred in the past or their likelihood of occurring in the future.
Because of the following factors, as well as other factors affecting our financial condition and operating results, past financial performance should not be considered to be a reliable indicator of future performance, and investors should not use historical trends to anticipate results or trends in future periods.
Risks Related to Our Financial Position and Need for Capital Our financial statements have been prepared assuming that we will continue as a going concern.
We had an accumulated deficit of approximately $39.0 million as of December 31, 2025 and a net loss of approximately $13.2 million for the fiscal year ended December 31, 2025.
We expect to incur significant expenses and continued losses from operations for the foreseeable future.
We believe that our existing cash and cash equivalents will not be sufficient to meet our anticipated cash requirements for the next twelve months.
We will require additional financing as we continue to execute our business strategy, including the need for additional funds for the commencement of our planned clinical trials.
Our audited financial statements for the fiscal year ended December 31, 2025, were prepared under the assumption that we will continue as a going concern; however, we have incurred significant losses from operations to date and we expect our expenses to increase in connection with the commencement of our planned clinical trials.
These factors raise substantial doubt about our ability to continue as a going concern for one year after the financial statements are issued.
Our auditor’s report on our audited financial statements for the fiscal year ended December 31, 2025 contains an explanatory paragraph with respect to this uncertainty.
In order to meet our expected obligations, we intend to raise additional funds through partnering and equity and debt financings or a combination of these potential sources of liquidity.
There can be no assurance that funding will be available on acceptable terms, on a timely basis, or at all.
The various ways that we could raise capital carry potential risks.
Any additional financing will likely involve the issuance of our equity securities, which will have a dilutive effect on our stockholders.
Any debt financing, if available, may involve restrictive covenants that may impact our ability to conduct our business.
If we raise funds through partnering, such as collaborations and licensing arrangements, we might be required to relinquish significant rights to our technologies or grant licenses on terms that are not favorable to us.
If we do not succeed in raising additional funds on acceptable terms or at all, we may be unable to complete the planned clinical trials.
As such, we cannot conclude that such plans will be effectively implemented within one year after the date that the financial statements included in this Annual Report are filed with the SEC and there is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt about our ability to continue as a going concern.
Any shutdown of the U.S. federal government may adversely affect our business.
A shutdown of the U.S. federal government may adversely affect our business operations and regulatory compliance.
During such shutdowns, while the SEC’s EDGAR system remains operational, the unavailability of SEC staff to review filings, issue comments, or declare registration statements effective may delay our ability to complete public offerings, respond to comment letters, or obtain timely regulatory approvals.
These delays could impact our access to capital markets, hinder strategic transactions, and create uncertainty around our disclosure obligations.
Additionally, the lack of interpretive guidance or exemptive relief during a shutdown may increase legal and compliance risks.
We continue to monitor developments and adjust our regulatory strategies accordingly, but there can be no assurance that future shutdowns will not materially affect our operations or financial condition.
We are a clinical development biopharmaceutical company with a limited operating history.
We have not yet performed any clinical trials.
In particular, potential investors should consider that we cannot assure you that we will be able to: ● successfully complete the clinical trials necessary to obtain regulatory approval for the marketing of our product candidates, including our Phase 3 trial for CAD-1005 in patients with HIT; ● secure acceptance of our product candidate in the medical community and with third-party payors and consumers; ● if approved for commercial sale, launch commercial sales of our product candidate, whether alone or in collaboration with others; ● successfully build an internal sales force meeting our requirements for the marketing and sale of our product candidates; ● successfully manufacture our clinical product and establish commercial drug supply; ● secure market exclusivity and/or adequate intellectual property protection for our product candidate; ● attract and retain an experienced management, board and scientific advisory team; ● successfully implement or execute our current business plan, and we cannot assure you that our business plan is sound; and ● raise sufficient funds in the capital markets to effectuate our business plan.
We are a development-stage company and our success is dependent upon our ability to obtain regulatory approval for and commercialize our product candidates and we have not demonstrated an ability to perform the functions necessary for the approval or successful commercialization of any product candidate.
In fact, though individual team members have experience running clinical trials, we have yet to prove that we can successfully run a clinical trial and our lead product candidate.
In fact, we have recently changed our focus from the development of tecarfarin to the development of CAD-1005.
To date, we have not generated any revenue from operations and we expect to continue to incur significant operating losses in connection with the development and sale of our product candidates.
Our ability to achieve profitability will depend on regulatory approval of our product candidates and, if approved, the market acceptance of our product offering and our capacity to develop, introduce and sell our product to our targeted markets.

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Risks Related to Our Financial Position and Need for Capital We are a clinical development biopharmaceutical company with a limited operating history.
In particular, potential investors should consider that we cannot assure you that we will be able to: ● successfully complete the clinical trials necessary to obtain regulatory approval for the marketing of our product candidate, tecarfarin; ● secure acceptance of our product candidate in the medical community and with third-party payors and consumers; ● if approved for commercial sale, launch commercial sales of our product candidate, whether alone or in collaboration with others; ● successfully build an internal sales force meeting our requirements for the marketing and sale of our product candidate, tecarfarin; ● successfully manufacture our clinical product and establish commercial drug supply; ● secure market exclusivity and/or adequate intellectual property protection for our product candidate; ● attract and retain an experienced management, board and scientific advisory team; ● successfully implement or execute our current business plan, and we cannot assure you that our business plan is sound; and ● raise sufficient funds in the capital markets to effectuate our business plan.
We are a development-stage company and our success is dependent upon our ability to obtain regulatory approval for and commercialize our product candidate, tecarfarin, and we have not demonstrated an ability to perform the functions necessary for the approval or successful commercialization of any product candidate.
In fact, though individual team members have experience running clinical trials and our Chief Executive Officer has been involved with the development of tecarfarin for six years, as a company we have yet to prove that we can successfully run a clinical trial.
To date, we have not generated any revenue from operations and we expect to continue to incur significant operating losses in connection with the development and sale of tecarfarin.
Our ability to achieve profitability will depend on regulatory approval of our product candidate and if approved, the market acceptance of our product offering and our capacity to develop, introduce and sell our product to our targeted markets.
We also expect to continue to incur significant operating and capital expenditures and anticipate that our expenses will increase substantially in the foreseeable future as we: ● continue to undertake the pivotal clinical trial for our product candidate; ● seek regulatory approvals for our product candidate; ● implement additional internal systems and infrastructure; and ● hire additional personnel.
In addition, we could incur significant development and other expenses if we were to make alterations to the manufacturing process for tecarfarin, for preparation and submission of a supplemental NDA for such alterations, if required by the FDA, and in connection with the launch of tecarfarin, if approved.
Further, as we pursue FDA approval for tecarfarin, we expect that our research and development expenses will continue to increase significantly as we advance our pivotal Phase 3 clinical trial.
Our 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.
If we do not succeed in raising additional funds on acceptable terms, we will be unable to commence our planned Phase 3 pivotal clinical trial or obtain approval of our product candidate from the FDA and other regulatory authorities.
We believe that our existing cash and cash equivalents will be sufficient in the aggregate to meet our anticipated cash requirements for at least the next twelve months.
We will, however, require additional financing as we continue to execute our business strategy, including that we will require additional funds for the initiation of enrollment of patients and completion of the planned pivotal Phase 3 trial.
Our present and future capital requirements will depend on many factors, including: ● the outcome, timing, and cost of our Phase 3 clinical trial to obtain regulatory approval for tecarfarin in the United States; ● the costs of manufacturing our clinical product and establishing commercial drug supply; ● the degree and rate of market adoption of our products, if approved; ● the emergence of new, competing technologies and products; ● the costs of R&D activities we undertake to develop new products and indications; ● the costs of commercialization activities, including sales, marketing and manufacturing; ● the costs of building an internal sales force meeting our requirements for the marketing and sale of our product candidates, if approved; ● our ability to collaborate with third parties on the development and commercialization of our product candidates and products; ● the level of working capital required to support our growth; and ● our need for additional personnel, information technology or other operating infrastructure to support our growth and operations as a public company.
Wainwright & Co., we do not currently have any arrangements or credit facilities in place as a source of funds, and there can be no assurance that we will be able to raise sufficient additional capital on acceptable terms, or at all.
Risks Related to Product Development, Regulatory Approval, Manufacturing and Commercialization Our 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.
Our business and future success depends upon our ability to obtain regulatory approval of and then successfully commercialize our product candidate, tecarfarin.
Tecarfarin is in late clinical stage development.
Our main focus and the investment of a significant portion of our efforts and financial resources is expected to be in the development of our only product candidate, tecarfarin, for which we are currently planning a Phase 3 clinical trial.
Even though we are pursuing a registration pathway based on specific FDA input and guidance, there are many uncertainties known and unknown that may affect the outcome of the trial.
We also rely on third parties to conduct the appropriate clinical trials, and their failure to perform in accordance with applicable law would have a negative effect on our regulatory submission.
Our future success depends heavily on our ability to successfully manufacture, develop, obtain regulatory approval, and commercialize tecarfarin, which may never occur.
We currently generate no revenues from our product candidate, and we may never be able to develop or commercialize a marketable drug.
All 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.
We possess toxicology, pharmacokinetic, and other preclinical data and clinical data on tecarfarin from studies and trials conducted several years ago by third parties.
As of now, tecarfarin has been tested in eleven clinical trials and is now in preparation to enter a pivotal Phase 3 trial.
There is no guarantee that Phase 1 or Phase 2 results can or will be replicated by the pivotal Phase 3 study.
Previous clinical trials using tecarfarin have had different trial designs, doses, parameters and endpoints than the planned Phase 3 clinical trial that is expected to serve as a basis for approval of tecarfarin.
We intend to design the Phase 3 protocol based on input from our recent meeting with the FDA, however, there can be no assurance that the protocol will be accepted by the FDA.
We plan to use a fixed dose in future clinical trials that we believe provides good coverage given the dose ranges tested clinically; however, it is possible that the dose selected will not be the optimal dose and so drug effects may be limited or not be demonstrated sufficiently in clinical testing.
As 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.
We did not acquire tecarfarin until April of 2022, and do not have first-hand knowledge of how the Phase 1 and Phase 2 clinical trials were completed.
While we are not aware of any issues in relation to such trials and the performance thereof, we cannot be assured that we may learn in the future that there was a failure to abide by such laws, rules and regulations, which could potentially expose us to issues with regards to our Phase 3 clinical trials or otherwise create risks unknown to us with regards to our technology.
There is no guarantee that our clinical trials will reach statistical significance on their endpoints, or demonstrate superiority to warfarin or any other therapy.
Development stage risks include the following: ● although we have FDA minutes documenting our recent meetings with the FDA, the FDA minutes are not binding on the FDA, and the FDA or comparable foreign regulatory authorities or institutional review boards, or IRBs, may disagree with the design or implementation of our clinical trial and refuse to let them proceed; ● we may not be able to provide acceptable evidence of the safety and efficacy of our product candidates or an acceptable benefit/risk profile for our product candidate; ● we may not be able to successfully manufacture drug supplies for our clinical trial; ● the results of our clinical trial may not be satisfactory or may not meet the level of statistical or clinical significance required by the FDA, European Medicines Agency, or EMA, or other comparable foreign regulatory authorities to demonstrate effectiveness; ● we may not be able to determine the optimal dosing of our product candidates; and ● patients in our clinical trial may suffer adverse effects that are deemed related to our product candidates, leading us or regulatory authorities to stop clinical trial temporarily or permanently.
Even 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.
We are not permitted to market our product candidate in the United States until we receive approval of an NDA from the FDA and in non-U.S. markets until we receive the requisite approval from comparable regulatory agencies in such countries.
If we fail to comply with the regulatory requirements in international markets and/or fail to receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of tecarfarin or any future product candidates will be harmed.
As a result, while we have received Fast Track designation for tecarfarin for the prevention of systemic thromboembolism of cardiac origin in patients with ESKD and AFib, we may not experience a faster development process, review or approval compared to conventional FDA procedures.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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