PONTE VEDRA, Fla., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome the limitations of current anticoagulation therapy, today announced that members of its management team, including Quang X. Pham, CEO, will hold partnering and investor meetings during the 44th Annual J.P. Morgan Healthcare Conference, to be held January 12-15, 2026 in San Francisco, CA. “Attending the events surrounding the J.P. Morg ...

Core Insights - Cadrenal Therapeutics has acquired VLX-1005 and related 12-LOX assets from Veralox Therapeutics, enhancing its pipeline with a late-stage drug candidate aimed at the $40 billion global anticoagulation market [1][4] Company Overview - Cadrenal Therapeutics is focused on developing innovative therapeutics to address gaps in anticoagulation management for high-risk patient populations, with three clinical-stage assets including VLX-1005, tecarfarin, and frunexian [6] Product Details - VLX-1005 is a selective small-molecule inhibitor of 12-LOX, targeting immune platelet-mediated inflammation and addressing heparin-induced thrombocytopenia (HIT), which affects up to 5% of patients exposed to heparin [2][8] - The drug has received Orphan Drug Designation and Fast Track designation from the FDA, indicating its potential significance in treating rare conditions [4][8] Clinical Development - Phase 1 studies of VLX-1005 showed it was well tolerated with no serious adverse events, while a Phase 2 study indicated promising reductions in thromboembolic events among patients with suspected HIT [3][4] - The market for HIT treatment is estimated to reach $1 billion in the US and EU, highlighting the commercial potential of VLX-1005 [5] Acquisition Terms - The acquisition agreement includes upfront and milestone payments to Veralox contingent on future clinical and regulatory achievements, as well as royalties on global sales of VLX-1005 [5]

Core Insights - Cadrenal Therapeutics, Inc. has appointed Dr. Lee Scott Golden as an independent director to its Board of Directors, effective immediately [1][3] - Dr. Golden brings over 25 years of experience in the biopharmaceutical industry, particularly in cardiovascular medicine and anticoagulation therapy [2][3] - The company aims to develop novel anticoagulants to address significant unmet needs in both acute and chronic anticoagulation therapy [4] Company Overview - Cadrenal Therapeutics focuses on developing innovative biopharmaceutical products that improve anticoagulation therapy by providing greater predictability, stability, and fewer bleeding complications [4] - The company currently has two clinical-stage assets: tecarfarin, an oral vitamin K antagonist for chronic use, and frunexian, a parenteral small-molecule Factor XIa antagonist for acute hospital settings [4] - The mission is to reshape standards of care in anticoagulation by targeting underserved patient populations [4]

Core Insights - Cadrenal Therapeutics, Inc. has been recognized for its leadership in the biopharmaceutical sector, particularly in anticoagulation therapy, with CEO Quang X. Pham receiving the "Executive of the Year Award" from BioFlorida [1][3] Company Overview - Cadrenal Therapeutics is focused on developing innovative biopharmaceutical products aimed at addressing significant gaps in both acute and chronic anticoagulation therapy [4] - The company is advancing two clinical-stage assets: tecarfarin, an oral vitamin K antagonist for chronic use, and frunexian, a parenteral small-molecule Factor XIa antagonist for acute hospital settings [4] - Cadrenal aims to reshape standards of care in anticoagulation by targeting underserved patient populations and enhancing the predictability, stability, and control of anticoagulant therapies [4] Industry Context - BioFlorida represents a broad spectrum of organizations within Florida's life-science ecosystem, including biotechnology and medical technology, and is dedicated to fostering innovation and economic growth in the sector [2]

Core Insights - Cadrenal Therapeutics, Inc. is focused on developing innovative anticoagulants, tecarfarin and frunexian, to address existing gaps in anticoagulation therapy [3][6] - The company reported a net loss of $2.7 million for Q3 2025, an increase from a net loss of $2.4 million in Q3 2024 [4] - As of September 30, 2025, Cadrenal had cash and cash equivalents of $3.9 million and approximately 2.1 million shares outstanding [5] Financial Highlights - Research and development expenses for Q3 2025 were $0.7 million, down from $0.8 million in Q3 2024 [4] - General and administrative expenses increased to $2.0 million in Q3 2025 from $1.7 million in Q3 2024 [4] - The total operating expenses for Q3 2025 were $2.7 million, compared to $2.5 million in Q3 2024 [12] Clinical Development Updates - The company has progressed the clinical development of tecarfarin, completing its manufacturing in accordance with current good manufacturing practices (cGMP) [8] - Ongoing activities include a single-site U.S. Phase 2 study of tecarfarin in LVAD patients and discussions for a potential multi-site Phase 2 study in dialysis patients [8] - Cadrenal expanded its portfolio by acquiring assets from eXIthera Pharmaceuticals, including frunexian, a Phase 2-ready IV Factor XIa inhibitor [8]

Group 1 - The core valuation of CVKD is based on a probability adjusted DCF model, estimating a share value of $30.00 [1] - The model incorporates potential future revenues from tecarfarin in specific medical applications, including LVADs, ESKD+AFib, and mechanical heart valves [1] - The valuation is highly contingent on the continued clinical success of tecarfarin, with adjustments expected based on future clinical results [1]

Summary of Cadrenal Therapeutics Conference Call Company Overview - **Company**: Cadrenal Therapeutics (Ticker: CVKD) - **Focus**: Development of novel anticoagulant drugs to address gaps in anticoagulation therapy, particularly for high-risk patients and orphan indications [2][15] Industry Context - **Market Size**: The global oral anticoagulation market is approximately $38 billion, with the U.S. market accounting for about $20 billion. Cadrenal targets a specific segment worth around $2 billion, focusing on orphan and high-risk indications [3][4] Key Products and Developments Tecarfarin - **Description**: A next-generation vitamin K antagonist designed for chronic use, with orphan drug and fast track designations for end-stage kidney disease (ESKD), atrial fibrillation (AFib), and left ventricular assist devices [4][7] - **Clinical Trials**: Tecarfarin has been studied in 11 clinical trials involving over 1,000 patients. The largest study, EMBRACE AC, showed that tecarfarin provided better or equivalent coagulation control compared to warfarin, with no thrombotic events and a low incidence of bleeding [8][9] - **Unique Features**: Unlike warfarin, tecarfarin is not metabolized by the hepatic cytochrome P450 system, leading to more predictable drug levels and fewer drug-drug interactions. It is also unaffected by poor kidney function, making it suitable for patients with severe kidney disease [6][9] Fornixum - **Description**: An intravenous factor XIa inhibitor acquired by Cadrenal, designed for acute care settings. It is differentiated by its fast-on, fast-off pharmacokinetics, making it suitable for precise control in hospital environments [6][12] - **Development Status**: Fornixum has completed two phase 1 studies and targets complex cardiac surgery as its primary indication [7][14] Market Opportunities - **Target Indications**: Cadrenal is focusing on high-risk areas where current therapies are inadequate, such as ESKD, AFib, and patients with mechanical heart valves [3][4] - **Regulatory Designations**: Tecarfarin has received orphan drug designation, providing seven years of exclusivity post-approval, and fast track designation for ESKD and AFib [7][15] Future Plans - **Clinical Trials**: A phase 2 study for tecarfarin in dialysis patients is planned to begin enrollment in early 2026, followed by a registration study in 2027. An additional phase 2 study for left ventricular assist devices is also targeted for late 2026 [13][14] - **Strategic Goals**: The primary goal for 2026 is to optimize the formulation of Fornixum for complex cardiac surgery applications [14] Conclusion - **Commitment**: Cadrenal Therapeutics aims to improve anticoagulation management standards through its innovative products, tecarfarin and Fornixum, addressing significant market gaps in both chronic and acute care settings [15]

Core Viewpoint - Cadrenal Therapeutics, Inc. is actively engaging with investors through a webcast presentation and one-on-one meetings at the Lytham Partners Fall 2025 Investor Conference, highlighting its focus on innovative anticoagulation therapies [1][2][3]. Company Overview - Cadrenal Therapeutics, Inc. is a biopharmaceutical company dedicated to developing transformative therapeutics aimed at addressing gaps in anticoagulation therapy [4]. - The company's lead investigational product, tecarfarin, is a novel oral Vitamin K antagonist anticoagulant designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation [4]. - Tecarfarin aims to reduce the clinical complexities associated with managing Vitamin K antagonists, particularly in cases where direct-acting oral anticoagulants (DOACs) are inadequate or unproven [4]. Product Designation - Tecarfarin has received Orphan Drug Designation (ODD) and fast-track designation for the prevention of systemic thromboembolism in patients with end-stage kidney disease and atrial fibrillation (ESKD+AFib) [5]. - The product also holds ODD for the prevention of thromboembolism and thrombosis in patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs) [5].

Core Viewpoint - Cadrenal Therapeutics, Inc. is actively engaging with investors through a webcast presentation and one-on-one meetings at the Lytham Partners Fall 2025 Investor Conference, highlighting its focus on innovative anticoagulation therapies [1][2][3]. Company Overview - Cadrenal Therapeutics, Inc. is a biopharmaceutical company dedicated to developing transformative therapeutics aimed at addressing gaps in anticoagulation therapy [4]. - The company's lead investigational product, tecarfarin, is a novel oral Vitamin K antagonist anticoagulant designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation [4]. - Tecarfarin aims to reduce the clinical complexities associated with managing Vitamin K antagonists, particularly in cases where direct-acting oral anticoagulants (DOACs) are inadequate or unproven [4]. Product Designation - Tecarfarin has received Orphan Drug Designation (ODD) and fast-track designation for the prevention of systemic thromboembolism in patients with end-stage kidney disease and atrial fibrillation [5]. - The product also holds ODD for the prevention of thromboembolism and thrombosis in patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs) [5].

Core Insights - Cadrenal Therapeutics, Inc. has acquired the assets of eXIthera Pharmaceuticals, enhancing its pipeline with investigational intravenous and oral Factor XIa inhibitors, targeting the $38 billion global anticoagulation market [1][2][6] Company Overview - Cadrenal Therapeutics is focused on developing transformative therapeutics to address gaps in anticoagulation therapy, with its lead product being tecarfarin, a novel oral Vitamin K antagonist [7][10] Acquisition Details - The acquisition includes eXIthera's lead asset, frunexian, a Phase 2-ready intravenous Factor XIa inhibitor, and EP-7327, an oral Factor XIa inhibitor for major thrombotic conditions [2][6] - eXIthera will receive milestone payments up to $15 million based on future clinical and regulatory milestones, along with royalties on global sales of the acquired assets [6] Strategic Positioning - The acquisition positions Cadrenal as the only company developing both a novel vitamin K antagonist and Factor XIa inhibitors, aiming to fill critical gaps in current antithrombotic treatments [3][4] - Cadrenal plans to conduct trials for tecarfarin in patients with end-stage kidney disease transitioning to dialysis, and is strategically positioned to deliver differentiated therapeutics for cardiovascular thrombotic risk [4][11] Market Potential - The global anticoagulation market is valued at $38 billion, with the newly acquired assets addressing large and underserved segments [1][8]