CVKD 10-K & 10-Q changes, risk factors and insider trading

We were formed in January 2022 and have had limited operations to date. We have not yet performed any clinical trials. We have to manufacture product, complete clinical trials and receive regulatory approval of NDAs before commercial sales of our product candidates can commence. The likelihood of success of our business plan must be considered in light of the problems, substantial expenses, difficulties, complications and delays frequently encountered in connection with building and expanding clinical development pharmaceutical businesses and the regulatory and competitive environment in which we operate. Pharmaceutical product development is a highly speculative undertaking, involves a substantial degree of risk and is a capital-intensive business.

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,candidates and we have not demonstrated an ability to perform the functions necessary for the approval or successful commercialization of any product candidate. We have yet to demonstrate our ability to overcome the risks frequently encountered in our industry and are still subject to many of the risks common to such enterprises, including our ability to implement our business plan, market acceptance of our proposed business and lead product, under-capitalization, cash shortages, limitations with respect to personnel, financing and other resources, competition from better funded and experienced companies, and uncertainty of our ability to generate revenues. 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 companytrials, we have yet to prove that we can successfully run a clinical trial.trial and our lead product candidate. There is no assurance that our activities will be successful or will result in any revenues or profit, and the likelihood of our success must be considered in light of the stage of our development. In addition, no assurance can be given that we will be able to consummate our business strategy and plans, or that financial, technological, market, or other limitations may force us to modify, alter, significantly delay, or significantly impede the implementation of such plans. We have insufficient results for investors to use to identify historical trends. Investors should consider our prospects in light of the risk, expenses and difficulties we will encounter as an early-stage company. Our revenue and income potential are unproven and our business model is continually evolving. In fact, we have recently changed our focus from the development of tecarfarin to the development of CAD-1005. We are subject to the risks inherent to the operation of a new business enterprise, and cannot assure you that we will be able to successfully successfully address these risks.

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 product candidates. We may continue to incur operating losses until such time, if ever, as we are able to achieve sufficient levels of revenue from operations. Our ability to achieve profitability will depend on regulatory approval of our product candidatecandidates andand, if approved, the market acceptance of our product offering and our capacity to develop, introduce and sell our product to our targeted markets. In fact, if the FDA determines that we require larger patients numbers in our planned clinical trial of CAD-1005 in patients with HIT or additional clinical trials our financing needs will increase and our ability to commercialize our product candidate will be delayed beyond our currently planned timeline. There can be no assurance that we will ever generate significant sales or achieve profitability. Accordingly, the extent of future losses and the time required to achieve profitability, if ever, cannot be predicted at this point.

Even if we can secure such arrangements, we may continue to have obligations and expenses that exceed the revenue generated by these marketed products. In addition, we could incur significant development and other expenses if we were to make alterations to the manufacturing process for tecarfarin,any product candidate including CAD-1005, for preparation and submission of a supplemental NDA for such alterations, if required by the FDA, and in connection with the launch of tecarfarin,such product, if approved. Further, as we pursue FDA approval for tecarfarin,CAD-1005, we expect that our research and development expenses will continue to increase significantly as we advance our pivotalproduct Phasecandidates 3and conduct planned clinical trial.trials.

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 pivotalclinical Phase 3 clinical trialtrials and to support our development and commercialization efforts for our product candidate, tecarfarin.candidates.

If we do not succeed in raising additional funds on acceptable terms, we will be unable to commence our planned Phase 3 pivotal clinical trialtrials or obtain approval of our product candidate candidates from the FDA and other regulatory authorities.authorities If the FDA determines that we require larger patients numbers in our clinical trial or additional clinical trials our financing needs will increase and our ability to commercialize our product candidate will be delayed beyond our currently planned timeline. In addition, we could be forced to delay, discontinue or curtail product development, forego sales and marketing efforts, and forego licensing in attractive business opportunities.

We believe that our existing cash and cash equivalents will not be sufficient in the aggregate to meet our anticipated cash requirements for at least the next twelve months. We will, however,will require additional financing prior to commencing any clinical trial and 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 pivotalclinical Phase 3 trial.trials. Our liquidity may be negatively impacted as a result of research and development cost increases in addition to general economic and industry factors. We anticipate that, to the extent that we require additional liquidity, it will be funded through the incurrence of other indebtedness, additional equity financings, or a combination of these potential sources of liquidity. In addition, we may raise additional funds to finance future cash needs through grant funding and/or corporate collaboration and licensing arrangements. If we raise additional funds by issuing equity securities or convertible debt, our stockholders will experience dilution. Debt financing, if available, would result in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish valuable rights to our products, future revenue streams or product candidates or to grant licenses on terms that may not be favorable to us. The covenants under future credit facilities may limit our ability to obtain additional debt financing. We cannot be certain that additional funding will be available on acceptable terms, or at all. Any failure to raise capital in the future could have a negative impact on our financial condition and our ability to pursue our business strategies.

Other than our at-the-market facility with H.C. Wainwright & Co., LLC (“H.C.W.”) 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 use such facility or even if we can use such facility there can be no assurance that we will be able to raise sufficient additional capital on acceptable terms, or at all. Availability of funding from the at-the-market at-the-market facility is limited due to certain restrictions. We anticipate that the additional funding we require will be funded through a combination of private and public equity offerings, debt financings and strategic collaborations. Debt financing, if obtained, may involve agreements agreements that include covenants limiting or restricting our ability to take specific actions, including issuing shares of our Common Stock or other securities and incurring additional debt, and could increase our expenses and require that our assets secure such debt. Equity Equity financing, if obtained, could result in dilution to our then existing stockholders and/or require such stockholders to waive certain rights and preferences. If such financing is not available on satisfactory terms, or is not available at all, we may be required to delay, scale back or eliminate the development of business opportunities and our operations and financial condition may be materially adversely affected. We can provide no assurances that any additional sources of financing will be available to us on favorable terms, if at all. In addition, if we are unable to secure sufficient capital to fund our operations, we might have to enter into strategic collaborations that could require us to share commercial rights to our products or product candidates with third parties in ways that we currently do not intend or on terms that may not be favorable to us. If we choose to pursue additional indications and/or geographies for any of our products or product candidates or otherwise expand more rapidly than we presently anticipate, we may also need to raise additional capital sooner than expected.

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

Our business is dependent upon the success of our lead investigational product candidate, tecarfarin,CAD-1005, which requiresrequire 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.candidates. 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,CAD-1005, for which we are currently planning a pivotal Phase 3 clinical trial. Eventrial thoughfor wethe aretreatment pursuingof HIT with a registrationprimary pathwayendpoint basedof onreduction specificin thrombotic events. Even if the FDA inputagrees with andour guidance,planned registration pathway, there are many uncertainties known and unknown that may affect the outcome of the trial. These include adequate patient enrollment, adequate supply of our product candidate, potential changes in the regulatory landscape, the results of the trial being successful, and FDA acceptance of the data to support approval. We will 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,our product candidates, which may never occur. We currently generate no revenues from our product candidate,candidates, and we may never be able to develop or commercialize a marketable drug.

All of our current data for our product candidatecandidates are the results of clinical trials conducted by third parties and do not necessarily provide sufficient evidence that our products products are viable as potential pharmaceutical products.products or that we can successfully conduct clinical trials.

We possess toxicology, pharmacokinetic, and other preclinical data and clinical data on tecarfarinour product candidates from studies and trials conducted several years ago by third parties.parties, Assome of now,which tecarfarinwere several hasyears been tested in eleven clinical trials and is now in preparation to enter a pivotal Phase 3 trial.ago. There is no guarantee that Phase 1 or Phase 2 resultsresults, as applicable, from the clinical trials for our product candidates that were conducted by third-parties can or will be replicated by theour pivotalplanned Phaseclinical 3trials study.for such product candidates. Further, as the clinical trials were conducted by third parties and were completed prior to our ownership of the technology and data, we cannot be assured that such trials were conducted in compliance with applicable statutes, rules, regulations, and guidelines applicable to such trials.

Previous clinical trials using tecarfarinmay have had different trial designs, doses, parameters and endpoints than the planned clinical trials. With respect to our planned Phase 3 clinical trial that is expected to serve as a basis for approval of tecarfarin.CAD-1005, Wewe intend to design the Phase 3 protocol based on input from our recentEOP2 meeting with the FDA,FDA. however,Our therePhase can3 be no assurance that thetrial protocol will still be acceptedsubject byto any further comments we may receive from the FDA.FDA Weupon plantheir toreview use a fixed dose in future clinical trials that we believe provides good coverage givenof the doseprotocol. ranges tested clinically; however, However, it is possible that the doseresults selectedseen will not bein the optimal doseVeralox andPhase so2 drug effectstrial may be limited or not be demonstrated sufficiently in our clinical testing.

As all of ourthe clinical trials for our product candidates to date were conducted by third parties, we cannot be assured that such clinical trials were in compliance with applicable laws, rules and regulations.

WeSince we did not acquire CAD-1005, tecarfarin and frunexian until December 2025, April of 2022,2022 and September 2025, respectively, we do not have first-hand knowledge of how the Phase 1 and Phase 2 clinical trials for such product candidates, as applicable, were completed.completed to date. As such, we cannot be assured that that such clinical trials were conducted in full compliance with applicable laws, rules and regulations. Additionally, we cannot be assured historical data for such trials are accurate and sufficient for acceptance by the FDA. 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 3planned clinical trials or otherwise create risks unknown to us with regards to our technology.

Despite the global burden of cardiovascular disease, investment in cardiovascular drug development has stagnated over the past two decades, with relative underinvestment compared with other therapeutic areas. The reasons for this trend are multifactorial, but of primary concern is the high cost of conducting cardiovascular outcome trials in the current regulatory environment that demands a direct assessment of risks and benefits, using clinically meaningful cardiovascular endpoints. In addition, clinical trials are difficult to design and implement, can take many years to complete and are uncertain as to outcome. Success in early phases of pre-clinical and clinical trials does not ensure that later clinical trials will be successful, and interim results of a clinical trial do not necessarily predict final results. There is no guarantee that our clinical trials will reach statistical significance on their endpoints, or that any product candidate including CAD-1005 will demonstrate superiority to warfarincurrent standard of care or any other therapy. A failure of one or more of clinical trials can occur at any stage of testing. Our product candidate may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining regulatory approval or prevent or limit commercial use with respect to one or all intended indications. In addition, we may experience other numerous unforeseen events during, or as a result of, the clinical trial process that could delay or prevent our ability to continue development. Development stage risks include the following:

Even if we successfully complete our clinical trials, we may not receive regulatory approval for tecarfarin,our product candidates, and we may not be able to commercialize our product candidate candidates and our ability to generate revenue will be limited.

The research, testing, manufacturing, labeling, packaging, storage, approval, sale, marketing, advertising and promotion, pricing, export, import and distribution of drug products are subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries, which regulations differ from country to country. We are not permitted to market our product candidatecandidates in the United States until we receive approval of an NDA from the FDA and and, in non-U.S. marketsmarkets, until we receive the requisite approval from comparable regulatory agencies in such countries. Of the large number of drugs in development, only a small number are submitted for approval to the FDA through an NDA and even fewer are eventually approved for commercialization. We may not succeed at gaining regulatory approval, which would materially harm our business.

The process of obtaining regulatory approvals is expensive, often takes many years, if approval is obtained at all, and can vary substantially based upon, among other things, the type, complexity and novelty of the product candidates involved, the jurisdiction in which regulatory approval is sought and the substantial discretion of the regulatory authorities. Changes in regulatory review for a submitted product application may cause delays in approval or rejection of an application. Regulatory approval obtained in one jurisdiction does not necessarily mean that a product candidate will receive regulatory approval in all jurisdictions in which we may seek approval, but the failure to obtain approval in one jurisdiction may negatively impact our ability to seek or gain approval in a different jurisdiction. Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products in certain 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 tecarfarinour current product candidates or any future product candidates will be harmed.

If a product candidate is intended for the treatment of a serious or life-threatening condition and the product candidate demonstrates the potential to address unmet medical need for this condition, the sponsor may apply for FDA Fast Track designation. However, a Fast Track designation does not ensure that the product candidate will receive marketing approval or that approval will be granted within any particular timeframe. As a result, while weCAS-1005 havehas received Fast Track designation for the treatment and prevention of HIT and tecarfarin for the prevention of systemic thromboembolism of cardiac origin in patients with ESKD and AFib, AFib an, we may not experience a faster development process, review or approval compared to conventional FDA procedures. In addition, the FDA may withdraw Fast Track designation if it believes that the designation is no longer supported by data from our clinical development program. Fast Track designation alone does not guarantee qualification for the FDA’s priority review procedures.procedures and does not assure ultimate approval by the FDA.

Even if we obtain regulatory approval, we will still face ongoing regulatory requirements and tecarfarinour product candidates may face future development and regulatory difficulties.

Even if we receive regulatory approval of tecarfarinour current product candidates or any future product candidates, we will be subject to ongoing regulatory obligations, such as post market surveillance and cGMP requirements, and continued regulatory review, which may result in significant additional expense. We may also be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with product candidates. In addition, third parties on whom we rely must comply with regulatory requirements, and any non-compliance on their part may negatively impact our business, assuming we obtain regulatory authorization at all.

Any regulatory approvals that we receive for product candidates will require surveillance to monitor the safety and efficacy of the product candidate. The FDA may also require a Risk Evaluation and Mitigation Strategy (“REMS”) program in order to approve product candidates, which could entail requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. The FDA could also require a boxed warning, sometimes referred to as a Black Box Warning on the product label to identify a particular safety risk, which could affect commercial efforts to promote and sell the product. In addition, if the FDA or a comparable foreign regulatory authority approves product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for product candidates will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMPscGMP and current good clinical practices (“GCPs”)GCP for any clinical trials that we conduct post-approval. We are also subject to certain user fees imposed by the regulatory agencies. Later discovery of previously unknown problems with product candidates, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

The FDA’spolicies of the FDA and other regulatory authorities’ policiesauthorities may change, such as those required by the 21st Century Cures Act, and additional government regulations may be enacted enacted that could prevent, limit or delay regulatory approval of tecarfarinour current product candidates or any future product candidates. In addition, it is unclear what changes, if any, the new presidential administration may bring. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.

As part of the regulatory process, we must conduct clinical trials for each product candidate to demonstrate safety and efficacy to the satisfaction of the FDA and other regulatory authorities. As we advance tecarfarinCAD-1005 or any future product candidates we expect that our expenses will increase. The number and design of the clinical trials that will be required varies depending upon product candidate, the condition being evaluated, current medical strategies and the trial results themselves. Therefore, it is difficult to accurately estimate the cost of the clinical trials. Clinical trials are very expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The clinical trial process is also time consuming. We estimate that clinical trials of each of our product candidates including tecarfarin,candidates, will take at least several years years to complete. Furthermore, failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon or repeat clinical trials. The commencement and completion of clinical trials may be delayed or prevented by several factors, including:

In addition, we or the FDA may suspend or terminate our clinical trials at any time if it appears that we are exposing participants to unacceptable health risks or if the FDA finds deficiencies in our Investigational New Drug, or IND,IND submissions or the conduct of these trials. Therefore, we cannot predict with any certainty when, if ever, future clinical trials will commence or be completed.

Delays or difficulty 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.

We may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or other regulatory authorities. The Phase 2 trial of CAD-1005 in patients with HIT enrolled only 24 patients out of a planned 60 and was terminated early. It is unclear whether the trial would have been fully enrolled if it were not terminated early. A pandemic or epidemic would likely make this even more challenging. Even if we are able to enroll a sufficient number of patients in our clinical trials, if the pace of enrollment is slower than we expect, the development costs for our product candidates may increase, and the completion of our trials may be delayed or our trials could become too expensive to complete.

Even if approved, tecarfarinour product candidates may not have labeling that allows us to successfully commercialize it.

The commercial success of tecarfarin and any of our future product candidates will depend in significant measure upon our ability to obtain approval from the FDA and other regulatory authorities of labeling describing a product candidate’s expected features or benefits. Regulatory authorities may approve tecarfarin a product candidate for fewer or more limited indications than we request or may approve tecarfarina product candidate with labeling that does not include the labeling claims necessary or desirable for the successful commercialization of that indication. Failure to achieve approval from the FDA or other regulatory authorities of product labeling containing certain types of information on features or benefits of our products will prevent or substantially limit limit our advertising and promotion of such features in order to differentiate our product candidates or any future product candidates from from those products already existing in the market. This may make it difficult or impossible to achieve commercial success.

If any of our product candidatecandidates is approved, our 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.

We will invest a significant portion of our efforts and financial resources into the development and commercialization of tecarfarin.our product candidates. Product revenues from our product candidate, tecarfarin,candidates which will not be realized until after regulatory approval, if ever, will depend on the successful development, regulatory approval and eventual commercialization of these product candidates. The success of our product candidate will depend on several factors, including the following:

If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize our product candidate, which would materially harm our business. In addition, even if we obtain regulatory approvals for tecarfarin,any of our product candidates, the timing or scope of any approval may prohibit or reduce our ability to commercialize tecarfarinsuch product candidate successfully. For example, if the approval process takes too long, we may miss market opportunities and give other companies the ability to develop competing products or establish market dominance. Also, any regulatory approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render tecarfarin such product candidate not commercially viable. For example, regulatory authorities may grant approval contingent on the performance of costly post-marketing clinical trials or, outside the U.S., they may not accept or approve the price we intend to charge for tecarfarin.a product candidate. Further, the FDA or comparable foreign regulatory authorities may place conditions on approvals, such as risk management plans and Risk Evaluation and Mitigation Strategies, orStrategies REMS,(“REMS”), to assure the safe use of the drug. If the FDA concludes a REMS is needed, the sponsor of the NDA must submit a proposed REMS; the FDA will not approve the NDA without an approved REMS, if required. A REMS could include medication guides, physician communication plans, and/or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. The FDA may also require a REMS for an approved product when new safety information emerges. Any of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescription or dispensing of tecarfarin.such product candidate. Moreover, product approvals may be withdrawn for non-compliance with regulatory standards or if problems occur following the initial marketing of the product. Any of the foregoing scenarios could materially harm the commercial success of tecarfarin.our product candidates.

Our potential future product candidate, tecarfarin,candidates may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success.

The commercial success of any potentialof futureour product product candidates, including tecarfarin,candidates for which we may obtain marketing approval from the FDA or other regulatory authoritiesauthorities, will depend upon their acceptance by the medical community and third-party payors as clinically useful, cost-effective and safe. The degree of market acceptance of any drug depends on a number of factors, such as:

We have never submitted an NDA to the FDA or comparable applications to other regulatory authorities and expect to rely on consultants and third-party contract research organizations,organizations or CROs,(“CROs”), with expertise in this area to assist us in this process. Securing FDA approval requires the submission of pre-clinical, clinical clinical and/or pharmacokinetic data, information about product manufacturing processes and inspection of facilities and supporting information to the FDA for each therapeutic indication to establish a product candidate’s safety and efficacy for each indication. Regulatory authorities in other jurisdictions impose similar requirements. If we are unable to successfully complete the approval process with the FDA or comparable applications of other regulatory authorities, our business will not be successful.

After approval of tecarfarin,a tecarfarinproduct candidate, it will remain subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional risk risk and expense.

The Company Overview

WarrantRecent InducementDevelopments

From January 1, 20252026 through March 13,30, 2025,2026, we sold 72,224168,690 shares of our Common Stock through our at-the-market (ATM) facility with H.C.W.H.C.W., These sales were made at a weighted average price of $20.29 per share, resulting in totalgenerating gross proceeds of approximately $1,466,000$1.4 million and net proceeds of approximately $1,419,000.$1.3 million.

General and administrative expenses for the years ended December 31, 2024,2025, and 20232024 were $6.8$9.4 million and $3.5$6.8 million, respectively, representing an increase of approximately $3.2$2.6 million, or 90%.39%. The increase can beis primarily attributedattributable to a $0.9 million increase in personnel-related expenses as we hired a Chief Operating Officer in February 2024 as well as annual pay raises for management in January 2024, a $1.4$1.6 million increase in expenses related to being a public company, a $0.7$0.4 million increase in stock-based compensation, and a $0.2$0.4 million increase in otherconsulting generalexpenses, and administrative expenses.a $0.1 million increase in professional fees.

Interest and dividend income for the years ended December December 31, 2024,2025, and 20232024 were $0.3$0.2 million and $0.2$0.3 million, respectively. This represents the interest and dividend income earned from our investments in money market funds. The increase in interest and dividend income in the current years can be attributed to higher balances in money market funds.

Since inception, we have incurred losses and utilized utilized cash in operations. To date, we have funded our operations from the proceeds of the sale of convertible and promissory notes, our IPO completed in January 2023, our Private Placement completed in July 2023, our Warrant Inducement completed in November 2024, our December 2025 Registered Offering, and the sale of Common Stock through our ATM facility. We recognized a net loss of $10.7$13.2 million for the year ended December 31, 20242025 which included $1.4 $1.9 million of non-cash expenses. Cash used in operating activities for the year ended December 31, 20242025 totaled $7.4$12.6 million. As of March 13, 2025, we had cash and cash equivalents of approximately $7.9 million, which is expected to be sufficient to fund our operations for at least the next twelve months from the date of the filing of this Annual Report on Form 10-K, however, we will require additional funding to complete our planned Phase 3 clinical trial and submit our NDA.

DuringNet cash provided by financing activities was $9.0 million for the year ended December 31, 2024,2024. netThis cash provided by financing activities totaled $9.0 million, comprisedconsisted of net proceeds from our ATM facility of $4.8 million from sales of common stock under our at-the-market equity program and net proceeds from our Warrant Inducement Agreement of $4.2 million.million from our warrant inducement agreement.

This discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States,States or GAAP.(“GAAP”). The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported expenses incurred during the reporting periods. Significant estimates and assumptions made in the accompanying financial statements include but are not limited to the fair value of financial instruments, the the fair value of stock-based awards, deferred tax assets and valuation allowance, income tax uncertainties, and certain accruals. Our estimates estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimated under different assumption or conditions.

We had an accumulated deficit of approximately $41.5$44.8 million as of MarchJune 31,30, 2026 and a net loss of approximately $2.5$5.8 million for the three six months ended MarchJune 31,30, 2026. 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 theadditional need for additional funds forto the commencement ofadvance our plannedproduct candidates to clinical trial readiness or to commence any clinical trials. Our unaudited financial statementstatements for the threesix months ended MarchJune 31,30, 2026, 2026 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 commencementadvancement of our plannedproduct candidates to clinical trials.trials readiness. These factors raise substantial doubt about our ability to continue as a going concern for one year after the financial statements are issued. Our unaudited financial statements for the quarter ended MarchJune 31,30, 2026 contain an explanatory paragraph with respect to this uncertainty. In addition, in connection with the filing of our Annual Report, our independent registered public accounting firm issued a report that included an explanatory paragraph with respect to this uncertainty. Our liquidity may be negatively impacted as a result of research and development cost increases in addition to general economic and industry factors. In order to meet our expected obligations,capital weneeds, intendmanagement tois raisefocusing on securing additional funds throughfunds, partneringwhich andmay include strategic partnerships, out-licensing agreements, non-dilutive grant funding, sales under our ATM facility with H.C.W., equity andofferings, debt financingsfinancings, or a combination ofthereof. theseHowever, potential sources of liquidity. Therethere can be no assurance that fundingwe will be availableable to complete partnering transactions or financings on terms acceptable terms,to on a timely basis,us or at all.all or that we will be awarded any grant funding. 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 advance our product candidates to clinical trial readiness or to complete the plannedany 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 Quarterly Report on Form 10Q 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.

Our securities are listed on The Nasdaq Capital Market, a national securities exchange. We cannot be assured that we will continue to comply with the rules, regulations or requirements governing the listing of our Common Stock on Nasdaq Capital Market Stock Market LLC (“Nasdaq”) or that our securities will continue to be listed on Nasdaq Capital Market in the future. If Nasdaq should determine at any time that we fail to meet Nasdaq requirements, we may be subject to a delisting action by Nasdaq.

As reported in thisour Quarterly Report on Form 10-Q, at10-Q for the quarter ended March 31, 2026,2026 our stockholders’ equity of $1.8 million isas of March 31, 2026 was below the minimum stockholders’ equity requirement of at least $2,500,000 for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b)(1) (the “Stockholders’ Equity Requirement”). We believe that we have regained compliance with the Stockholders’ Equity Requirement as a result of our receipt of net proceeds of $2.3 million from the exercise of the Existing Warrants in connection with the Warrant Inducement consummated on April 1, 2026. DespiteAs that we believe we have regained compliance withof the Stockholders’ Equitydate Requirement, Nasdaq may issue a deficiency letter subsequent toof the filing of this Quarterly Report on Form 10-Q.10-Q, Nasdaq has not issued a deficiency letter related to our compliance with the Stockholders’ Equity Requirement. Nasdaq will continue to monitor our ongoing compliance with the Stockholders’ Equity Requirement, and if at the time of our next periodic report we do not evidence compliance, we may be subject to delisting.

TheOn NasdaqJuly has22, 2026, the SEC approved Nasdaq’s recently proposed a new rule change changes to (i) adopt NASDAQ Listing Rule 5550(a)(6) to require issuers listed on the Nasdaq Capital Market to maintain a minimum Market Value of Listed Securities (as defined in Nasdaq Listing Rule 5005(a)(23)) (“MVLS”) of at least $5 million for a period of thirty (30) consecutive business days, and (ii) amend Rule 5810 to suspend trading and immediately delist from Nasdaq securities of issuers that do not satisfy the proposed new requirements, and Rule 5815 to set forth the procedures for requesting a hearing before a Hearings Panel and the scope of the Panel’s discretion. MVLS is generally calculated by multiplying the consolidated closing bid price by the number of shares of listed securities outstanding and, where a company has more than one class or series of equity security listed on Nasdaq, the values are aggregated. Under the new rule, if a company’s MVLS remains below $5 million for 30 consecutive business days, Nasdaq will issue a Staff Delisting Determination and immediately suspend trading of the company’s securities.

You should read the following management’s discussion and analysis of our financial condition and results of operations in conjunction with our unaudited financial statements and notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q and with our audited financial statements and notes thereto for the year ended December 31, 2025, included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 filed on March 31, 2026 ((the “Annual Report”) with the U.S. Securities and Exchange Commission (the “SEC”). This discussion, particularly information with respect to our future results of operations or financial condition, business strategy, plans and objectives for future operations, includes forward-looking statements that involve risks and uncertainties as described under the heading “Special note regarding forward-looking statements” in this Quarterly Report on Form 10-Q. You should review the disclosure under Part 1, Item 1A of the Annual Report for a discussion of important factors that could cause our actual results to differ materially from those anticipated in these forward-looking statements. References in this Quarterly Report on Form 10-Q to “we,” “us,” “our” and similar first-person expressions refer to Cadrenal Therapeutics, Inc. (“Cadrenal”).

We achieved a major regulatory milestone after completing our End-of-Phase 2 (“EOP2”) meeting with the U.S. Food and Drug Administration (“FDA”) and receiving guidance on key elements of thea Phase 3 pivotal trial for CAD-1005. The EOP2 meeting with the FDA provided critical guidance on protocol design, study population, dosing, background therapy, exposure, the safety database, and the primary endpoint of new or worsening thrombotic events. After considering FDA feedback on a pivotal registration study,study we(a plan120 to advance directly to apatient randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to the current standard of care for patients with HIT.HIT), we have concluded that we do not currently have sufficient funding to commence or complete such a trial and we do not plan to commence any trials until we have the funding in place to complete such trial and therefore our focus has been on preparing for clinical trial readiness.

WeIf expectwe should be successful in obtaining funding that ourwould plannedallow us to commence and complete the pivotal Phase 3 study evaluating CAD-1005 added to the current standard of care for patients with HIT, we expect that the pivotal Phase 3 study will evaluate CAD-1005 in approximately 120 patients across clinical centers worldwide and is intended to support a projected NDANew Drug Application submission in 2029. The primary endpoint of the Phase 3 study is expected to be the incidence of new or worsening thrombotic events in patients with Serotonin Release Assay (SRA)-confirmed HIT, with at least one planned interim analysis. We believe that CAD-1005 is the only treatment in clinical development that targets the underlying immune drivers of HIT. Our Phase 3 trial protocol will remain subject to additional information and any further comments we may receive from the FDA during their review of the final protocol. CAD-1005 has an ODD from the FDA for prophylaxis of thrombosis in patients with HIT, an FDA Fast Track designation for the treatment and prevention of HIT, and an orphan designation from the EMA for the treatment of platelet-activating factor 4 disorders.

The transactions contemplated by the agreement closed on April 1, 2026. We received aggregate gross proceeds of approximately $2.5 million from the exercise of the Existing Warrants, before deducting placement agent fees and other expenses payable by us. H.C. Wainwright & Co., LLC (“H.C.W.”) served as our exclusive placement agent in connection with the transactionsPIPE consummated pursuant to the Inducement Agreement.Transaction. As compensation for H.C.W. serving as our placement agent in connection with the offering,PIPE Transaction, we paid H.C.W. a cash fee equal to 7.0% of the aggregate gross proceeds received upon exercise of the Existing Warrants and we issued to designees of H.C.W. H.C.W unregistered warrants (the “Placement Agent Warrants”) to purchase up to 37,143an aggregate of 62,400 shares of commonCommon stock,Stock, whichequal warrantsto 6.5% of the Pre-Funded Warrant Shares sold in the PIPE Transaction. The Placement Agent Warrants have substantially the same terms as the Series B-1C-1 Warrants, except that they are immediately exercisable for a term of five years from the Effective Date and have an exercise price of $5.625$3.9063 per share, which is equal to 125% of the exercise price of the New Warrants.share.

During the threesix months ended MarchJune 31,30, 2026, we sold 168,690189,035 shares of commonour stockCommon Stock through our at-the-market (ATM) facility with H.C.W. These sales were made at a weighted average price of $8.10$7.71 per share, resulting in total gross proceeds of approximately $1,366,535$1,458,088 and net proceeds of approximately$1,382,670. $1,302,565.During the three months ended June 30, 2026, we sold 20,345 shares of our Common Stock through our ATM facility with H.C.W. These sales were made at a weighted average price of $4.50 per share resulting in total gross proceeds of $91,553 and net proceeds of $80,104.

Results of Operations for the Three Months Ended MarchJune 31,30 2026 and 2025

The following table summarizes our results of operations for the three months ended MarchJune 31,30, 2026 and 2025.

Research and development expenses were $0.8$0.7 million for the three months ended MarchJune 31,30, 2026, compared to $1.7$1.1 million for the three months ended March 31,June 30, 2025, a decrease of approximately $0.9$0.4 million, or 54%.35%. The decrease was primarily attributable to a $0.5$0.7 million decrease in expenses associated with chemistry, manufacturing, and controls (“CMC”), aand $0.3 million decrease in personnel expenses, a $0.2 million decrease in stock-based compensation, and a $0.1 million decrease in trial readiness expenses. These decreases were partially offset by a $0.2 million increase in consulting expenses and professional fees. We expect research and development expenses to increase when if we commence clinical trials.

Since inception, we have incurred recurring losses and utilized cash in operations. To date, we have funded our operations from the proceeds of the sale of convertible and promissory notes, our IPO completed in January 2023, our private placement offering completed in July 2023, our warrant inducements completed in November 2024 and April 2026, our private placement offering in June 2026, our registered direct offering and concurrent private placement completed in December 2025, and the sale of commonCommon stockStock through our ATM facility with H.C.W.

As of MarchJune 31,30, 2026, we had cash and cash equivalents of $2.3$2.4 million.million, which does not include the net proceeds we received on July 1, 2026 from the PIPE Transaction. For the threesix months ended MarchJune 31,30, 2026, we reported a net loss of $2.5$5.8 million, which included $0.3 $0.9 million of non-cash expenses, and cash used in operating activities of $3.0$5.2 million. On April 1, 2026, we completed a warrant inducement transaction resulting in gross proceeds of approximately $2.5 million, which we expect to partially extend our operational runway. We expect to continue to incur operating losses and negative cash flows for the foreseeable future as we advance our clinical and regulatory activities. Based on our current operating plan, we believe that our existing cash resources will not be sufficient to fund our operating and capital requirements for the next 12 months. With our cash position of $3.5$4.2 million as of early MayAugust 2026, we believe we will be able to fund our operations intothrough Octoberthe 2026first quarter of 2027; however, the current cash will not be sufficient to advance our product candidates to clinical trial readiness or to commence and complete our plannedany clinical trials and no assurances can be provided and our cash runway could differ materially from our expectations based on various factors, many of which are out of our control. ToIn order to meet anticipatedour fundingexpected capital needs, we planmanagement tois seekfocusing on securing additional capitalfunds, throughwhich may include strategic partnerships, out-licensing agreements, non-dilutive grant funding, sales under our ATM facility with H.C.W., equity offerings, debt financings, or a combination thereof. However, there can be no assurance that additional fundingwe will be availableable to complete partnering transactions or financings on terms acceptable terms to us or at all.all or that we will be awarded any grant funding. These factors raise substantial doubt about our ability to continue as a going concern for at least one year following the issuance of the accompanying financial statements. If we are unable to obtain additional financing, we may be required to delay or reduce the scope of our development programs, implement cost-saving measures, or cease operations entirely. The accompanying financial statements do not include any adjustments that might result from this uncertainty.

During the threesix months ended MarchJune 31,30, 2026, cash used in operating activities was $3.0$5.2 million. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used $2.2$4.8 million in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, used $0.8$0.3 million in cash primarily from a $0.7$0.3 million decrease in accrued liabilities and a $0.2 million increase in prepaid expenses, partially offset by a $0.2 million increase in accounts payable.

During the threesix months ended MarchJune 31,30, 2025, cash used in operating activities was $4.6$7.7 million. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used $3.3$6.4 million in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, used $1.3 million in cash primarily from a $0.6 million decrease in accruedaccounts liabilities,payable, a $0.2$0.4 million decrease in accountsaccrued payableliabilities, and a $0.5$0.3 million increase in prepaid expenses.

During the threesix months ended MarchJune 31,30, 2026, net cash provided by financing activities totaled $1.3$3.6 million primarily consisting of $2.3 net proceeds received from the useApril 2026 warrant inducement and $1.4 million received upon the sales of Common Stock in our ATM facility.

During the threesix months ended MarchJune 31,30, 2025, net cash provided by financing activities totaled $2.0$3.2 million from the usesale of Common Stock of our ATM facility.facility and proceeds from the exercise of stock options.