Cadrenal Therapeutics, Inc.
For the period ended Dec 31, 2025. Filed Mar 31, 2026.
View on SEC.govAbout this filing
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.
FY2025 · Filed Mar 31, 2026
CVKD$0.98-2.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-03-13.
0001213900-25-023759
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-31.
0001213900-26-036946
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 47 previous paragraphs and 39 current paragraphs.
19 unchanged; 8 reworded; 12 added; 20 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 2 previous and 2 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (12)
Current report
The Company
Current report
We are a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. As a result of our acquisition of a 12-LOX platform of assets in December 2025, we transitioned our primary strategic focus to the development of CAD-1005 for the treatment of immune-mediated and thrombotic disorders. Our lead product candidate, CAD-1005, is a first-in-class selective 12-LOX inhibitor being developed to treat HIT, a deadly immune-mediated thrombotic disorder. CAD-1005 has been evaluated in a blinded, placebo-controlled study Phase 2 clinical trial of 24 patients as well as Phase 1 clinical trials in more than 100 patients. On March 26, 2026, we completed our EOP2 meeting with the FDA and clarified a potential registrational path for our planned Phase 3 pivotal trial of CAD-1005 in patients with HIT. Our Phase 3 trial protocol will still be subject to additional information which may be set forth in the final meeting minutes from the FDA and any further comments we may receive from the FDA upon their review of the protocol. CAD-1005 has an ODD from the FDA for prophylaxis of thrombosis in patients with HIT, as well as 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.
Current report
Our broader pipeline includes two additional clinical-stage assets —tecarfarin and frunexian. Tecarfarin is an oral vitamin K antagonist (“VKA”) (a warfarin replacement for patients with complex needs) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Specifically, our focus for tecarfarin is for chronic use in patients with kidney dysfunction or left ventricular assist devices (“LVADs”). Tecarfarin has been specifically designed to overcome metabolic factors that can make warfarin less reliable. Frunexian is a first-in-class, Phase 2-ready intravenous (“IV”) Factor XIa inhibitor designed for acute care settings where contact activation of coagulation by medical devices or artificial surfaces is significant. Frunexian is the only IV FXIa inhibitor in clinical development that targets the acute/critical care hospital setting exclusively.
Current report
Recent Developments
Current report
Registered Direct Offering
Current report
On December 15, 2025, we entered into a securities purchase agreement with certain investors named on the signature pages thereto, pursuant to which we sold to such investors an aggregate of: (i) in a registered direct offering, 207,374 shares of Common Stock and, (ii) in a concurrent private placement, unregistered common warrants to purchase up to 414,748 shares of Common Stock. The offering price per share was $10.85. The registered direct offering and concurrent private placement were consummated on December 16, 2025 and we received gross proceeds therefrom of approximately $2.2 million.
Current report
Veralox Asset Purchase
Current report
On December 10, 2025, we entered into the Veralox Purchase Agreement, pursuant to which Veralox sold to us all, or substantially all, of its right title and interest in assets owned or otherwise used or held for use by Veralox in connection with the compound known as CAD-1005, and all back-up and follow-on compounds, including the CAD-2000 series (the “Compounds”), including, without limitation, all intellectual property related to the Compounds, all inventory related to the Compounds, certain contracts including a license agreement, all Permits and other Governmental Authorizations and Books and Records (as such terms are defined in the Veralox Purchase Agreement), free and clear of any liens (the Veralox Assets). The transactions contemplated by the Veralox Purchase Agreement were consummated on December 10, 2025.
Current report
The purchase price for the Veralox Assets consisted of (i) a cash payment of $200,000, (ii) the assumption by us of certain assumed liabilities; (iii) contingent milestone payments in an amount not to exceed $15 million, and (iv) royalty payments.
Current report
Research and development expenses for the years ended December 31, 2025, and 2024 were $4.1 million and $4.2 million, respectively, representing a decrease of $0.1 million, or 2%. The decrease was primarily attributable to a $0.8 million reduction in consulting expenses, partially offset by a $0.5 million increase in expenses associated with the asset purchase agreements completed in September and December 2025, which were expensed as in-process research and development (IPR&D), a $0.2 million increase in personnel expenses, primarily associated with former Chief Medical Officer’s severance agreement entered into in February 2025, a $0.1 million in clinical trial preparation costs, and a $0.1 million increase in stock-based compensation expense. We anticipate research and development expenses to increase when we commence clinical trials.
Current report
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. To meet anticipated funding needs, we plan to seek additional capital through strategic partnerships, equity offerings, and/or debt financings. However, there can be no assurance that additional funding will be available on acceptable terms or at all. 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.
Current report
Net cash provided by financing activities was $6.6 million for the year ended December 31, 2025. This consisted primarily of net proceeds of $4.6 million from sales of common stock under our at-the-market equity program and net proceeds of $2.0 million from our December 2025 registered direct offering, with additional proceeds from the exercise of stock options.
Removed paragraphs (20)
Previous report
Company Overview
Previous report
We are developing tecarfarin, our drug candidate, for unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions requiring chronic anticoagulation.
Previous report
There is a lack of approved anticoagulation therapies for certain rare cardiovascular conditions requiring chronic anticoagulation, such as patients with left ventricular assist devices (LVADs), patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib), and patients with catastrophic or thrombotic anti-phospholipid syndrome (APS). For patients with these conditions, treatment guidelines, and not FDA-approved labeling, recommended the use of a vitamin K antagonist (VKA) such as warfarin, despite warfarin’s acknowledged challenges in achieving sufficiently stable and reliable anticoagulation in these patients. Additionally, direct-acting oral anticoagulants (DOACs) like Eliquis and Xarelto have either not shown clinical benefits in these and certain other patient populations, or their efficacy and safety remain uncertain.
Previous report
At the time the initial investigational new drug (IND) application for tecarfarin was filed by its initial sponsor, warfarin was the only marketed oral anticoagulant, and the strategy was to develop tecarfarin as an alternative VKA with superior efficacy and safety over warfarin for a broad range of indications including AFib, deep vein thrombosis (DVT), pulmonary embolism (PE), prevention of pulmonary embolism in patients with venous thrombosis, DVT prevention in patients undergoing certain surgical procedures, thrombosis prevention in patients with mechanical heart valves, and prevention of thrombotic complications in patients after a myocardial infarction (heart attack), among others.
Previous report
While tecarfarin clinical trials were being conducted by the initial IND sponsor, the DOACs were advancing through clinical trials and ultimately approved after demonstrating that they were non-inferior to warfarin in certain indications, including AFib in the general population, prevention of pulmonary embolism in patients with venous thrombus, and prevention of deep vein thrombosis in patients undergoing certain surgical procedures, among others. These DOAC clinical studies resulted in a change in the standard of care for a large percentage of the population that had been previously treated with warfarin, and some of the same population that was initially targeted by prior tecarfarin IND sponsor. Thus, the original broad-label development plan for tecarfarin became much more challenging.
Previous report
Accordingly, we are focusing the development of tecarfarin for rare cardiovascular conditions where patients are unable to achieve sufficiently reliable chronic anticoagulation with warfarin, and where DOACs have either failed or their efficacy and safety remain unproven. These include patients with LVADs, patients with ESKD and AFib, patients with mechanical heart valves and ESKD or resistant to warfarin, and patients with catastrophic or thrombotic APS, among others, where the need for VKA-dependent chronic anticoagulation has been underscored by recent clinical studies. While warfarin-treated patients have fared better than DOAC-treated patients in comparative studies in certain of these cardiovascular conditions, the event rates in these studies remain unacceptably high and the quality of anticoagulation in warfarin-treated patients has repeatedly been shown to be sub-optimal – hence, there continues to be unmet medical needs surrounding the use of warfarin in these patients that are not addressed – or not addressable - by DOACs.
Previous report
Tecarfarin has an orphan drug designation from the FDA for the prevention of thrombosis and thromboembolism (blood clots) in patients with an implanted mechanical circulatory support device, which includes left ventricular assist device (LVAD), a heart pump. Tecarfarin also has orphan drug and fast-track designations from the FDA for the prevention of systemic thromboembolism of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib).
Previous report
Tecarfarin has been evaluated in eleven (11) human clinical trials in over 1,000 individuals; (269 patients were treated for at least six months and 129 patients were treated for one year or more). In Phase 1, Phase 2 and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease (CKD). In the Phase 2/3 trial, EMBRACE-AC, the largest tecarfarin trial with 607 patients having completed it, including those with mechanical heart valves, only 1.6% of the blinded tecarfarin subjects suffered from major bleeding and there were no thrombotic events.
Previous report
Private Placement
Previous report
On July 12, 2023, we entered into a securities purchase agreement (the “Purchase Agreement”) with an institutional investor (the “Investor”) pursuant to which we sold to the Investor in a private placement priced at-the-market (the “Private Placement”) consistent with the rules of the Nasdaq), (i) an aggregate of 86,667 shares of Common Stock, (ii) in lieu of additional share of Common Stock, pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to an aggregate of 199,047 shares of Common Stock, and (iii) accompanying common warrants (the “Common Warrants”) to purchase up to an aggregate of 285,715 shares of Common Stock. The combined purchase price of each share and accompanying Common Warrants was $26.25. The combined purchase price of each Pre-Funded Warrant and accompanying Common Warrants was $26.25.
Previous report
The Private Placement closed on July 14, 2023. We received aggregate gross proceeds from the Private Placement of approximately $7.5 million before deducting the placement agent commissions and estimated offering expenses payable by us. H.C. Wainwright & Co., LLC (“H.C.W.”) acted as the placement agent in the Private Placement, and as part of its compensation, we issued to designees of H.C.W. Placement Agent Warrants to purchase up to 18,571 shares of Common Stock.
Previous report
Warrant Inducement
Previous report
On November 1, 2024, we entered into a warrant inducement letter agreement (the “Warrant Inducement Agreement”) with a holder (the “Holder”) of outstanding warrants (the “Existing Warrants”) to purchase up to 285,715 shares of Common Stock (the “Existing Warrant Shares”) issued in a private placement offering on July 14, 2023 pursuant to which such holder exercised the Existing Warrants at a reduced exercise price of $16.50 generating approximately $4.7 million in gross proceeds. In consideration of the Holder’s agreement to exercise the Existing Warrants (the “Warrant Exercise”) in accordance with the Warrant Inducement Agreement, we issued to the Holder new unregistered Series A-1 Common Stock purchase warrants to purchase an aggregate of 285,715 shares of Common Stock, equal to 100% of the number of Existing Warrant Shares issued upon exercise of the Existing Warrants and new unregistered Series A-2 Common Stock purchase warrants to purchase an aggregate of 285,715 shares of Common Stock, equal to 100% of the number of Existing Warrant Shares issued upon exercise of the Existing Warrants, at an exercise price of $16.50 per share.
Previous report
Research and development expenses for the years ended December 31, 2024, and 2023 were $4.2 million and $4.1 million, respectively, representing an increase of $0.1 million, or 3%. The prior year included a $3.0 million expense for the issuance of 40,000 shares of Common Stock (valued at $3.0 million) in January 2023 to HESP LLC, pursuant to the terms of an Amendment to the Asset Purchase Agreement. Excluding the $3.0 million stock issuance expense in 2023, research and development expenses increased $3.1 million in 2024 compared to 2023 due to a $1.9 million increase in expenses associated with chemistry, manufacturing, and controls (“CMC”), a $1.0 million increase in consulting fees, and a $0.1 million increase in personnel-related expenses.
Previous report
Change in fair value of derivative liabilities
Previous report
Concurrent with the closing of the IPO in January 2023, note holders converted debt into Common Stock, and accordingly, the derivative financial liabilities were de-recognized and reclassified to stockholders’ equity on January 24, 2023.
Previous report
The derivative liabilities were considered a level 3 fair value financial instrument and were remeasured up to January 24, 2023, which was the date of derecognition. We recorded a non-cash charge of $0.2 million in January 2023. This charge represented the increase in the fair value of the derivative liabilities since the previous measurement date of December 31, 2022. We did not have such activity during the year ended December 31, 2024.
Previous report
Loss on extinguishment of debt
Previous report
We recorded a $0.7 million loss on the extinguishment of debt during the year ended December 31, 2023. This loss represented the unamortized debt discount associated with the convertible notes and the November promissory notes, which were settled concurrent with the IPO. We did not have such activity during the year ended December 31, 2024.
Previous report
During the year ended December 31, 2023, net cash provided by financing activities totaled $11.9 million as we completed our IPO in January 2023, generating net proceeds of $5.4 million, and we completed a private placement financing in July 2023, generating net proceeds of $6.5 million. We also received $0.3 million from the exercise of warrants that we issued in November 2022, which proceeds were used to repay the notes that were issued in November 2022.
Reworded paragraphs (8)
Previous wording
During the year ended December 31, 2024, we sold 391,243 shares of our Common Stock through our at-the-market (ATM) facility with H.C.W., generating gross proceeds of approximately $5.1 million and net proceeds of approximately $4.8 million.
Current wording
During the year ended December 31, 2025, we sold 307,727 shares of our Common Stock through our at-the-market (ATM) facility with H.C.W., generating gross proceeds of approximately $4.9 million and net proceeds of approximately $4.6 million.
Previous wording
From January 1, 2025 through March 13, 2025, we sold 72,224 shares of our Common Stock through our at-the-market (ATM) facility with H.C.W. These sales were made at a weighted average price of $20.29 per share, resulting in total gross proceeds of approximately $1,466,000 and net proceeds of approximately $1,419,000.
Current wording
From January 1, 2026 through March 30, 2026, we sold 168,690 shares of our Common Stock through our at-the-market (ATM) facility with H.C.W., generating gross proceeds of approximately $1.4 million and net proceeds of approximately $1.3 million.
Previous wording
General and administrative expenses for the years ended December 31, 2024, and 2023 were $6.8 million and $3.5 million, respectively, representing an increase of approximately $3.2 million, or 90%. The increase can be primarily attributed 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 million increase in expenses related to being a public company, a $0.7 million increase in stock-based compensation, and a $0.2 million increase in other general and administrative expenses.
Current wording
General and administrative expenses for the years ended December 31, 2025, and 2024 were $9.4 million and $6.8 million, respectively, representing an increase of approximately $2.6 million, or 39%. The increase is primarily attributable to a $1.6 million increase in expenses related to being a public company, a $0.4 million increase in stock-based compensation, a $0.4 million increase in consulting expenses, and a $0.1 million increase in professional fees.
Previous wording
Interest and dividend income for the years ended December 31, 2024, and 2023 were $0.3 million and $0.2 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.
Current wording
Interest and dividend income for the years ended December 31, 2025, and 2024 were $0.2 million and $0.3 million, respectively. This represents the interest and dividend income earned from our investments in money market funds.
Previous wording
Since inception, we have incurred 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 completed in July 2023, our Warrant Inducement completed in November 2024, and the sale of Common Stock through our ATM facility. We recognized a net loss of $10.7 million for the year ended December 31, 2024 which included $1.4 million of non-cash expenses. Cash used in operating activities for the year ended December 31, 2024 totaled $7.4 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.
Current wording
Since inception, we have incurred 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 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 $13.2 million for the year ended December 31, 2025 which included $1.9 million of non-cash expenses. Cash used in operating activities for the year ended December 31, 2025 totaled $12.6 million.
Previous wording
During the year ended December 31, 2023, cash used in operating activities was $3.5 million. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used $3.7 million in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, provided $0.1 million in cash primarily from a $0.7 million decrease in deferred equity offering costs, partially offset by a decrease in accrued liabilities of $0.2 million and a decrease in accounts payable of $0.2 million.
Current wording
During the year ended December 31, 2025, cash used in operating activities was $12.6 million. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used $11.3 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 $0.9 million decrease in accounts payable, a $0.2 million decrease in accrued liabilities, and a $0.2 million increase in prepaid expenses.
Previous wording
During the year ended December 31, 2024, net cash provided by financing activities totaled $9.0 million, comprised of net proceeds from our ATM facility of $4.8 million and net proceeds from our Warrant Inducement Agreement of $4.2 million.
Current wording
Net cash provided by financing activities was $9.0 million for the year ended December 31, 2024. This consisted of net proceeds of $4.8 million from sales of common stock under our at-the-market equity program and net proceeds of $4.2 million from our warrant inducement agreement.
Previous wording
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, or 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 fair value of stock-based awards, deferred tax assets and valuation allowance, income tax uncertainties, and certain accruals. Our 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.
Current wording
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 (“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 fair value of stock-based awards, deferred tax assets and valuation allowance, income tax uncertainties, and certain accruals. Our 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.