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    Cadrenal Therapeutics Reports First-Quarter 2025 Financial Results and Provides Corporate Update

    5/8/25 8:00:00 AM ET
    $ABT
    $CVKD
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $ABT alert in real time by email

    Leadership appointment strengthens strategic and development capabilities

    FDA Type D Meeting provides additional guidance for advancing the clinical development of tecarfarin

    Collaboration Agreement with Abbott (NYSE:ABT) validates the need for new anticoagulation options

    Cadrenal Therapeutics, Inc. (NASDAQ:CVKD), a biopharmaceutical company developing therapeutics for patients with cardiovascular disease, today reported its financial results for the first quarter ended March 31, 2025, and provided an update on the strategic focus of the company and clinical development of tecarfarin.

    "In the first quarter of 2025, Cadrenal continued to build on the momentum we achieved during 2024," said Quang X. Pham, Chairman & CEO. "The appointment of James Ferguson, M.D., FACC, FAHA, as our Chief Medical Officer positions us for success in reviewing potential assets to add to our portfolio and designing and executing our clinical program for tecarfarin. The finalized Collaboration Agreement with Abbott validates the critical need in the market for a new anticoagulant for patients with left ventricular assist devices (LVADs). And our meeting with the FDA provided additional guidance in the design of a pivotal trial."

    Highlights from the Quarter Ended March 31, 2025, and Other Recent Events:

    Leadership Advances

    In February 2025, Cadrenal appointed James J. Ferguson, M.D., FACC, FAHA, as Chief Medical Officer to lead the review of business development opportunities to expand the Company's pipeline and drive the late-stage clinical development of tecarfarin for conditions requiring chronic anticoagulation therapy.

    Regulatory Update

    In February 2025, Cadrenal met with the U.S. Food and Drug Administration (FDA) for a Type D meeting. The FDA provided additional guidance on the appropriate design for a Phase 3 tecarfarin trial and welcomed submission of a final study design for review.

    Collaboration Agreement with Abbott

    In March 2025, we announced a Collaboration Agreement with Abbott (NYSE:ABT) to support our pivotal TECarfarin Anticoagulation and Hemocompatibility with Left Ventricular Assist Devices (TECH-LVAD) trial. Under the agreement, Abbott will share insights from recent HeartMate 3™ clinical trials and will support Cadrenal with trial design, site identification, trial awareness, and HeartMate 3™ expertise.

    Operational Milestones

    During the quarter, Cadrenal successfully completed the technical transfer and manufacturing of its tecarfarin drug substance (API) from a CDMO site located in Asia to a CDMO site in the United States. This initiative was done to support the company's clinical and regulatory development strategy for tecarfarin and to improve supply chain security.

    Cadrenal also conducted strategic market opportunity research for multiple indications, including patients with left ventricular assist devices. This research indicates that tecarfarin is uniquely positioned to provide clinical value to patients in the rapidly growing LVAD market, which is projected to nearly double by 2032. This research also showed that tecarfarin has the potential to provide clinical benefit in additional high-need cardiovascular, renal, and mechanical heart valve indications, reinforcing tecarfarin's potential value proposition for patients.

    Participation in Key Investor, Medical, and Business Development Conferences

    Cadrenal was active during the first quarter in several significant conferences to build corporate visibility and underscore its commitment to advancing innovation in anticoagulation therapy. Investor interactions included participation at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, a Company presentation at the BIO CEO and Investor Conference in New York, and, after the close of the quarter, a Company presentation at the Centri Capital Conference at Nasdaq headquarters in New York. Shortly after the quarter's close, Cadrenal participated in the 18th National Conference on Anticoagulation Therapy in Washington, D.C.

    Strategic Development Collaborations

    Cadrenal continues to explore opportunities to add to the Company's clinical pipeline and collaborate with potential development partners to advance the development of tecarfarin for patients with LVADs and for other indications requiring chronic anticoagulation.

    First Quarter 2025 Financial Highlights

    Research and development expenses for the quarter ended March 31, 2025, were $1.7 million compared to $0.6 million for the same period in 2024. General and administrative expenses for the quarter ended March 31, 2025, were $2.3 million compared to $1.1 million for the same period in 2024. Cadrenal reported a net loss of $3.8 million for the quarter ending March 31, 2025, compared to $1.7 million for the same period in 2024.

    On March 31, 2025, Cadrenal had cash and cash equivalents of $7.3 million, compared to $10.0 million as of December 31, 2024. The Company had approximately 1.9 million shares of common stock outstanding as of March 31, 2025.

    About Cadrenal Therapeutics, Inc.

    Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing therapeutics for patients with cardiovascular disease. Cadrenal's lead investigational product is tecarfarin, a novel oral vitamin K antagonist anticoagulant that addresses unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used off-label for a number of indications, extensive clinical and real-world data have shown it can have significant, serious side effects. With tecarfarin, Cadrenal is advancing an innovative solution to address the unmet needs in anticoagulation therapy, aiming to reduce the clinical complexities of warfarin and capture value in a market with high demand for safer, more manageable treatment options.

    Cadrenal is pursuing a pipeline-in-a-product approach with tecarfarin. Tecarfarin received Orphan Drug designation (ODD) for advanced heart failure patients with implanted mechanical circulatory support devices, including Left Ventricular Assisted Devices (LVADs). The Company also received ODD and fast-track status for tecarfarin in end-stage kidney disease and atrial fibrillation (ESKD+AFib).

    Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. For more information, visit https://www.cadrenal.com/ and connect with us on LinkedIn.

    Safe Harbor

    Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potentially," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding the appointment of James Ferguson, M.D., FACC, FAHA, as the Company's Chief Medical Officer positioning the Company for success in reviewing potential assets to add to its portfolio and designing and executing its clinical program for tecarfarin; the finalized Collaboration Agreement with Abbott validating the critical need in the market for a new anticoagulant for patients with left ventricular assist devices (LVADs); Abbott sharing insights from recent HeartMate 3™ clinical trials and supporting Cadrenal with trial design, site identification, trial awareness, and HeartMate 3™ expertise; the LVAD market projected to nearly double by 2032; and tecarfarin having the potential to provide clinical benefit in additional high-need cardiovascular, renal, and mechanical heart valve indications, reinforcing tecarfarin's potential value proposition for patients. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to utilize Abbott's expertise to advance tecarfarin, the ability to successfully collaborate with Abbott, the initiation of the pivotal clinical trial for tecarfarin in LVAD patients by Cadrenal; for tecarfarin to provide clinical benefit in additional high-need cardiovascular, renal, and mechanical heart valve indications, reinforcing tecarfarin's potential value proposition for patients; the ability of Cadrenal to build a pipeline of specialized cardiovascular therapeutics and other assets and the other risk factors described in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, and the Company's subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

    (Tables to Follow)

    Cadrenal Therapeutics, Inc.
    Balance Sheets
     
    March 31, 2025

    December 31, 2024

     

     

    (unaudited)

     
    Assets:
    Current assets:
    Cash and cash equivalents $

    7,336,072

     

    $

    10,017,942

     

    Interest receivable

    24,664

     

    38,153

     

    Prepaid expenses and other current assets

    575,605

     

    42,257

     

    Deferred offering costs

    8,451

     

    14,445

     

    Total current assets

    7,944,792

     

    10,112,797

     

    Property, plant and equipment, net

    4,678

     

    6,944

     

    Other assets

    3,792

     

    3,792

     

    Total assets $

    7,953,262

     

    $

    10,123,533

     

    Liabilities and Stockholders' Equity:
    Current liabilities:
    Accounts payable $

    1,278,402

     

    $

    1,502,468

     

    Accrued liabilities

    561,764

     

    1,181,490

     

    Total current liabilities

    1,840,166

     

    2,683,958

     

    Total liabilities

    1,840,166

     

    2,683,958

     

    Stockholders' equity:
    Preferred stock, $0.001 par value, 7,500,000 shares authorized, no shares issued and outstanding at March 31, 2025 and December 31, 2024

    -

     

    -

     

    Common stock, $0.001 par value; 75,000,000 shares authorized, 1,909,732 shares issued and outstanding as of March 31, 2025; 1,782,486 shares issued and outstanding as of December 31, 2024

    1,909

     

    1,782

     

    Additional paid-in capital

    35,679,350

     

    33,160,576

     

    Accumulated deficit

    (29,568,163

    )

    (25,722,783

    )

    Total stockholders' equity

    6,113,096

     

    7,439,575

     

    Total liabilities and stockholders' equity $

    7,953,262

     

    $

    10,123,533

     

     
    CADRENAL THERAPEUTICS, INC.
    STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (unaudited)

     
     
    Three Months Ended

    March 31,

    2025

     

    2024

     

    Operating expenses:
    General and administrative expenses $

    2,254,577

     

    $

    1,125,993

     

    Research and development expenses

    1,667,882

     

    629,025

     

    Depreciation expense

    5,517

     

    597

     

    Total operating expenses

    3,927,976

     

    1,755,615

     

    Loss from operations

    (3,927,976

    )

    (1,755,615

    )

    Other income
    Interest and dividend income

    82,596

     

    92,327

     

    Total other income

    82,596

     

    92,327

     

    Net loss and comprehensive loss $

    (3,845,380

    )

    $

    (1,663,288

    )

     
    Net loss per common share, basic and diluted (1) $

    (2.09

    )

    $

    (1.56

    )

    Weighted average number of common shares used in computing net loss per common share, basic and diluted (1)

    1,844,072

     

    1,067,231

     

     
    (1) All share and per share information has been retroactively adjusted to reflect the 1-for-15 reverse stock split effected on August 20, 2024.

     

    View source version on businesswire.com: https://www.businesswire.com/news/home/20250507038192/en/

    Corporate and Investor Relations

    Paul Sagan

    LaVoieHealthScience

    (617) 865-0041

    [email protected] 

    Media

    Andrew Korda

    LaVoieHealthScience

    (617) 865-0043

    [email protected] 

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