\n\u201c2024 for Cadrenal was a year of focus and laying the foundations for advancing tecarfarin into Phase 3 clinical development. With our eyes squarely centered on unmet needs in anticoagulation therapy, we have made strong progress on the partnering, regulatory, and financing fronts,\u201d said Quang X. Pham, Chairman & CEO. \u201cThroughout 2025, our primary focus is on execution, as we move forward to assessing the efficacy and safety of tecarfarin in patients with left ventricular assist devices (LVAD) and consider other important areas of unmet need that a more reliable vitamin K antagonist could address.”\n<\/p>\n
Full Year 2024 Key Accomplishments and Recent Highlights<\/span><\/b><\/p>\n Collaboration Agreement with Abbott<\/b><\/p>\n \nOn March 4, 2025, we announced a Collaboration Agreement with Abbott (NYSE: ABT) to support Cadrenal\u2019s pivotal TECarfarin Anticoagulation and Hemocompatibility with Left Ventricular Assist Devices (TECH-LVAD) trial. Under the agreement, Abbott will share insights from recent HeartMate 3\u2122 clinical trials and will support Cadrenal with trial design, site identification, trial awareness, and HeartMate 3\u2122 expertise.\n<\/p>\n TECH-LVAD Trial Update<\/b><\/p>\n \nOn February 3, 2025, the Company had a Type D meeting with the U.S. Food and Drug Administration (FDA). The FDA provided additional guidance on the design of a future Phase 3 trial of tecarfarin and has requested the Company provide a full study design synopsis and detailed clinical trial design for review.\n<\/p>\n Leadership Advances<\/b><\/p>\n \nCadrenal appointed James J. Ferguson, MD, FACC, FAHA, as Chief Medical Officer to lead the late-stage clinical development of tecarfarin and other indications in rare cardiovascular conditions requiring life-long anticoagulation therapy as well as other business development opportunities to build the Company\u2019s pipeline. Cadrenal also appointed Jeff Cole as Chief Operating Officer to oversee manufacturing, supply chain operations, intellectual property, and pre-commercialization strategies.\n<\/p>\n Operational Milestones<\/b><\/p>\n \nThe Company and its pharmaceutical Contract Development and Manufacturing Organization (CDMO) completed necessary operational readiness activities to supply clinical trial materials for the upcoming tecarfarin pivotal Phase 3 trial in compliance with current Good Manufacturing Practices (cGMP). Cadrenal has also conducted market research in multiple indications, including LVAD, reinforcing Cadrenal\u2019s commitment to continuing pre-commercial work for tecarfarin.\n<\/p>\n Strategic Development Collaborations<\/b><\/p>\n \nCadrenal continues to explore collaboration with potential development partners to advance tecarfarin\u2019s pivotal clinical trial for patients with LVAD and other rare cardiovascular conditions as well as other opportunities to advance the Company\u2019s clinical pipeline.\n<\/p>\n Financial Growth and Fundraising Success<\/b><\/p>\n \nDuring the year ended December 31, 2024, Cadrenal raised approximately $9.8 million in financing transactions, including $5.1 million through an at-the-market (ATM) facility and $4.7 million from warrant exercises.\n<\/p>\n Industry Recognition and Engagement<\/b><\/p>\n \nIn October 2024, Cadrenal joined the Corporate Council of the Anticoagulation Forum (AC Forum). This association will enable the Company to collaborate with anticoagulation therapy thought leaders and 15,000 healthcare professionals to improve anticoagulation outcomes for patients globally. In November 2024, Cadrenal Therapeutics was named Anticoagulation Therapy Company of the Year by Pharma Tech Outlook<\/i>, an industry publication focused on breakthrough pharmaceutical technologies.\n<\/p>\n Orphan Drug Designation for Tecarfarin<\/b><\/p>\n \nIn April 2024, Cadrenal received FDA Orphan Drug Designation (ODD) for tecarfarin to prevent thromboembolism in patients with implanted mechanical circulatory support devices, including LVADs, underscoring the investigational drug\u2019s potential impact on rare cardiovascular conditions. Tecarfarin already has ODD and Fast Track designation from the FDA for the prevention of systemic thromboembolism of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib).\n<\/p>\n Scientific Advocacy and Clinical Evidence<\/b><\/p>\n \nThe clinical need for tecarfarin was highlighted at the November 2024 European Association for Cardio-thoracic Surgery (EACTS) Mechanical Circulatory Support Summit in an address by Mandeep R. Mehra, MD, The William Harvey Distinguished Chair in Advanced Cardiovascular Medicine and Professor, Harvard Medical School. Dr. Mehra presented compelling data on the limitations of warfarin for LVAD patients and the potential of tecarfarin, if approved, to provide a safer alternative to these patients.\n<\/p>\n Financial Results<\/b><\/p>\n \nResearch and development expenses for the year ended December 31, 2024, were $4.2 million compared to $4.1 million for the year ended December 31, 2023. General and administrative expenses for the year ended December 31, 2024, were $6.8 million compared to $3.5 million for the year ended December 31, 2023. Cadrenal reported a net loss of $10.7 million for the year ended December 31, 2024, compared to $8.4 million for the year ended December 31, 2023.\n<\/p>\n \nCadrenal\u2019s cash and cash equivalents totaled $10.0 million as of December 31, 2024, compared to $8.4 million as of December 31, 2023. The Company had approximately 1.8 million shares of common stock outstanding as of December 31, 2024.\n<\/p>\n About Cadrenal Therapeutics, Inc.<\/b><\/p>\n Cadrenal Therapeutics, Inc. <\/a>is a late-stage biopharmaceutical company focused on the development of late-stage asset tecarfarin, a new oral vitamin K antagonist to address 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. Although warfarin is widely used off-label for several rare cardiovascular conditions, extensive clinical and real-world data have shown it to have significant serious side effects. With its innovation, Cadrenal aims to meet the unmet needs of this patient population by relieving them and their healthcare providers of some of warfarin\u2019s greatest clinical challenges.\n<\/p>\n \nCadrenal is pursuing a product-in-a-pipeline approach with tecarfarin. Tecarfarin received Orphan Drug designation (ODD) for advanced heart failure patients with implanted mechanical circulatory support devices, including LVADs. The Company also received ODD and fast-track status for tecarfarin in end-stage kidney disease and atrial fibrillation (ESKD+AFib).\n<\/p>\n \nCadrenal is opportunistically pursuing business development initiatives with a longer-term focus to build a pipeline of specialized cardiovascular therapeutics. For more information, visit www.cadrenal.com<\/a> and connect with us on LinkedIn<\/a>.\n<\/p>\n Safe Harbor<\/b><\/p>\n \nAny statements contained 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 \u201cforward-looking statements.\u201d The words \u201canticipate,\u201d \u201cbelieve,\u201d \u201ccontinue,\u201d \u201ccould,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201cplan,\u201d \u201cpotentially,\u201d \u201cpredict,\u201d \u201cproject,\u201d \u201cshould,\u201d \u201ctarget,\u201d \u201cwill,\u201d \u201cwould\u201d 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 Company\u2019s ability to assess the efficacy and safety of tecarfarin in patients with left ventricular assist devices (LVAD); Abbott supporting Cadrenal with trial design, site identification, trial awareness, and HeartMate 3\u2122 expertise, including sharing insights from its HeartMate 3\u2122 clinical trials; the late-stage clinical development of tecarfarin and other indications in rare cardiovascular conditions requiring life-long anticoagulation therapy as well as other business development opportunities to build the Company\u2019s pipeline; the Company continuing to explore collaborations with potential development partners to advance tecarfarin\u2019s pivotal clinical trial for patients with LVAD and other rare cardiovascular conditions as well as other opportunities; advancing the Company\u2019s clinical pipeline; the Company\u2019s association with the AC Forum enabling the Company to collaborate with anticoagulation therapy thought leaders and 15,000 healthcare professionals to improve anticoagulation outcomes for patients globally; the potential impact of tecarfarin on rare cardiovascular conditions; the potential of tecarfarin, if approved, to provide a safer alternative to LVAD patients; meeting the unmet needs of patients with rare cardiovascular conditions requiring chronic anticoagulation by relieving them and their healthcare providers of some of warfarin\u2019s greatest clinical challenges, and Cadrenal building a pipeline of specialized cardiovascular therapeutics. 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\u2019s 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 Cadrenal to provide improved patients outcomes and efficacy and safety for LVAD patients; the ability of Cadrenal to build a pipeline of specialized cardiovascular therapeutics and the other risk factors described in the Company\u2019s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company\u2019s 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.\n<\/p>\n \n(Tables to Follow)\n<\/p>\n December 31, 2024<\/b><\/p>\n<\/td>\n December 31, 2023<\/b><\/p>\n<\/td>\n<\/tr>\n \n10,017,942\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n8,402,500\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n38,153\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n37,248\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n42,257\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n52,425\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n14,445\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n–\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n10,112,797\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n8,492,173\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n6,944\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n2,287\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n–\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n20,998\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n3,792\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n3,792\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n10,123,533\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n8,519,250\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n1,502,468\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n167,319\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n1,181,490\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n638,206\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n–\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n21,350\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n2,683,958\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n826,875\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n2,683,958\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n826,875\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n–\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n–\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n1,782\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n868\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n33,160,576\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n22,762,922\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n(25,722,783\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n(15,071,415\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n<\/tr>\n \n7,439,575\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n7,692,375\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n10,123,533\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n8,519,250\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n Years Ended<\/b><\/p>\n<\/td>\n<\/tr>\n December 31,<\/b><\/p>\n<\/td>\n<\/tr>\n 2024<\/b><\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n 2023<\/b><\/p>\n<\/td>\n<\/tr>\n \n6,753,726\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n3,549,514\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n4,205,013\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n4,081,349\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n1,880\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n1,980\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n10,960,619\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n7,632,843\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n(10,960,619\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n(7,632,843\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n<\/tr>\n \n(309,251\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n(249,092\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n<\/tr>\n \n–\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n3,534\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n–\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n13,567\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n–\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n216,095\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n–\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n740,139\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n(309,251\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n724,243\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n(10,651,368\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n(8,357,086\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n<\/tr>\n \n(8.73\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n \n(9.29\n<\/p>\n<\/td>\n \n)\n<\/p>\n<\/td>\n<\/tr>\n \n1,219,550\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n899,465\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20250313043048\/en\/<\/a><\/span><\/p>\n Corporate and Investor Relations Media KEYWORDS:<\/b> United States North America Florida<\/p>\n INDUSTRY KEYWORDS:<\/b> Health Other Health General Health Clinical Trials Pharmaceutical Cardiology Biotechnology<\/p>\n\n
\n Cadrenal Therapeutics, Inc.<\/b><\/td>\n<\/tr>\n \n Balance Sheets<\/b><\/td>\n<\/tr>\n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n \n \n Assets:<\/td>\n \n \n \n \n <\/tr>\n \n Current assets:<\/td>\n \n \n \n \n <\/tr>\n \n Cash and cash equivalents<\/td>\n $<\/td>\n \n \n \n $<\/td>\n \n \n \n Interest receivable<\/td>\n \n \n \n \n \n \n \n \n Prepaid expenses and other current assets<\/td>\n \n \n \n \n \n \n \n \n Deferred offering costs<\/td>\n \n \n \n \n \n \n \n \n Total current assets<\/td>\n \n \n \n \n \n \n \n \n Property, plant and equipment, net<\/td>\n \n \n \n \n \n \n \n \n Right of use assets<\/td>\n \n \n \n \n \n \n \n \n Other assets<\/td>\n \n \n \n \n \n \n \n \n Total assets<\/td>\n \n \n \n \n \n \n \n \n Liabilities and Stockholders’ Equity:<\/td>\n \n \n \n \n <\/tr>\n \n Current liabilities:<\/td>\n \n \n \n \n <\/tr>\n \n Accounts payable<\/td>\n $<\/td>\n \n \n \n $<\/td>\n \n \n \n Accrued liabilities<\/td>\n \n \n \n \n \n \n \n \n Operating lease liability<\/td>\n \n \n \n \n \n \n \n \n Total current liabilities<\/td>\n \n \n \n \n \n \n \n \n Total liabilities<\/td>\n \n \n \n \n \n \n \n \n Commitment and contingencies (Note 5)<\/td>\n \n \n \n \n <\/tr>\n \n Stockholders\u2019 equity:<\/td>\n \n \n \n \n <\/tr>\n \n Preferred stock, $0.001 par value, 7,500,000 shares authorized, no shares issued and outstanding at December 31, 2024 and December 31, 2023<\/td>\n \n \n \n \n \n \n \n \n Common stock, $0.001 par value; 75,000,000 shares authorized, 1,782,486 shares issued and outstanding as of December 31, 2024; 868,184 shares issued and outstanding as of December 31, 2023 (1)<\/td>\n \n \n \n \n \n \n \n \n Additional paid-in capital (1)<\/td>\n \n \n \n \n \n \n \n \n Accumulated deficit<\/td>\n \n \n \n \n \n \n \n \n Total stockholders\u2019 equity<\/td>\n \n \n \n \n \n \n \n \n Total liabilities and stockholders\u2019 equity<\/td>\n $<\/td>\n \n \n \n $<\/td>\n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n (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.<\/td>\n<\/tr>\n \n <\/tr>\n \n \u00a0<\/td>\n<\/tr>\n<\/table>\n \n
\n CADRENAL THERAPEUTICS, INC.<\/b><\/td>\n<\/tr>\n \n STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS<\/b><\/td>\n<\/tr>\n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n \n \n \n \n \n \n \n \n Operating expenses:<\/td>\n \n \n \n \n <\/tr>\n \n General and administrative expenses<\/td>\n $<\/td>\n \n \n \n $<\/td>\n \n \n \n Research and development expenses<\/td>\n \n \n \n \n \n \n \n \n Depreciation expense<\/td>\n \n \n \n \n \n \n \n \n Total operating expenses<\/td>\n \n \n \n \n \n \n \n \n Loss from operations<\/td>\n \n \n \n \n \n \n \n \n Other (income) expense:<\/td>\n \n \n \n \n <\/tr>\n \n Interest and dividend income<\/td>\n \n \n \n \n \n \n \n \n Interest expense<\/td>\n \n \n \n \n \n \n \n \n Interest expense, amortization of debt discount<\/td>\n \n \n \n \n \n \n \n \n Change in fair value of derivative liabilities<\/td>\n \n \n \n \n \n \n \n \n Loss on extinguishment of debt<\/td>\n \n \n \n \n \n \n \n \n Total other (income) expense<\/td>\n \n \n \n \n \n \n \n \n Net loss and comprehensive loss<\/td>\n $<\/td>\n \n \n \n $<\/td>\n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Net loss per common share, basic and diluted (1)<\/td>\n $<\/td>\n \n \n \n $<\/td>\n \n \n \n Weighted average number of common shares used in computing net loss per common share, basic and diluted (1)<\/td>\n \n \n \n \n \n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n (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.<\/td>\n<\/tr>\n<\/table>\n <\/p>\n
\n<\/b>
Lisa DeScenza
\n
LaVoieHealthScience
\n
(978) 395-5970
\n
ldescenza@lavoiehealthscience.com
\n<\/a><\/p>\n
\n<\/b>
Andrew Korda
\n
LaVoieHealthScience
\n
(617) 865-0043
\n
akorda@lavoiehealthscience.com<\/a><\/p>\n
![\"Logo\"](\"https:\/\/mms.businesswire.com\/media\/20250313043048\/en\/2409106\/3\/Cadrenal_logo_%283%29.jpg\"){kind=logo}
<\/td>\n<\/tr>\n