Cadrenal Therapeutics FY Conference Summary Company Overview - **Company**: Cadrenal Therapeutics (Ticker: CVKD) - **Focus**: Bridging critical gaps in anticoagulation for rare and high-risk patients, particularly those with end-stage renal disease (ESKD) and atrial fibrillation (AFib) [3][4] Core Programs 1. **Tecarfarin**: - Phase 3 program targeting kidney-impaired patients with AFib and those with implanted left ventricular assist devices (LVADs) - Orphan drug designation received for ESKD and AFib [4][5] 2. **VLX-1005**: - Acquired from Verilux, recently completed Phase 2 trials for Heparin-Induced Thrombocytopenia (HIT) - Received Orphan and Fast Track designations [5][6][14] 3. **Fruinexian**: - Short-acting Factor XI candidate acquired in Fall 2025, aimed at cardiovascular surgery [5][6] Market Context - **Anticoagulation Landscape**: - Direct Oral Anticoagulants (DOACs) have dominated the market since their introduction, but gaps remain for patients who cannot use them, such as those with mechanical heart valves and LVADs [4][5] - Warfarin, a vitamin K antagonist, is still widely used despite its limitations, particularly in patients with kidney issues [4][5] Regulatory Advantages - **Orphan Drug and Fast Track Designations**: - These designations allow for smaller, more flexible trials, tax credits, fee waivers, and market exclusivity, reducing development costs and risks [21][22] - Fast Track designation enables earlier FDA interactions and rolling submissions [21][22] Unmet Needs and Market Opportunity - **HIT Market**: - Approximately 50,000 new HIT patients are confirmed annually in the U.S., indicating a significant unmet need for effective treatments that do not exacerbate bleeding risks [19][20] - Current treatments are often ineffective, leading to high morbidity and mortality rates [14][19] Future Outlook - **Long-term Strategy**: - Cadrenal aims to provide alternatives to long-standing anticoagulants like warfarin and heparin, particularly for patients with specific needs [25][27] - The company is excited about the potential for oral applications of 12-LOX inhibitors for chronic conditions [32] Key Milestones - **Upcoming Developments**: - Analysis and publication of VLX-1005 Phase 2 data - Ongoing interactions with the FDA for both VLX-1005 and tecarfarin [30][31] Conclusion - **Vision for Impact**: - In five years, Cadrenal aims to be recognized for addressing the needs of patients with HIT, ESKD, and advanced mechanical heart valves, providing effective therapeutic options where larger pharmaceutical companies have not ventured [32]

Core Insights - Cadrenal Therapeutics is addressing the unmet medical need in heparin-induced thrombocytopenia (HIT) with its investigational drug candidate VLX-1005, which is the first and only potent, highly selective 12-LOX inhibitor in clinical testing [1][3][10] Company Developments - Cadrenal acquired VLX-1005 in December 2025, recognizing its potential to transform treatment for HIT and other immune-mediated thrombotic disorders [2] - The company is rapidly engaging with the U.S. Food and Drug Administration (FDA) to discuss the design of a potential pivotal Phase 3 registration study for VLX-1005 in HIT [9] Clinical Insights - Emerging data from a Phase 2 clinical trial suggest that VLX-1005 may reduce thrombotic complications, indicating its potential as a novel therapy that targets immune thrombotic drivers rather than just suppressing coagulation [3][4] - Recent findings highlight the high incidence and clinical burden of thrombotic complications in HIT, emphasizing the limitations of existing therapies that do not directly modulate platelet immune responses [5] Scientific Background - 12-lipoxygenase (12-LOX) has been identified as a key mediator of platelet activation and immune thrombotic responses, making it a compelling therapeutic target [6] - VLX-1005 is designed to selectively modulate immune-mediated platelet activation while minimizing off-target effects, representing a significant advancement in the development of 12-LOX inhibitors [8] Regulatory Status - VLX-1005 has received Orphan Drug Designation (ODD) and Fast Track designation from the FDA, as well as orphan drug status from the European Medicines Agency [10]

Core Insights - Cadrenal Therapeutics, Inc. is focused on developing transformative therapeutics to address limitations in current anticoagulation therapy, particularly for rare and high-risk patient populations [1][2] Company Overview - Cadrenal Therapeutics is engaged in the $40 billion anticoagulation market, aiming to bridge critical gaps in acute and chronic anticoagulation management [2] - The company has three clinical-stage assets: - VLX-1005, a first-in-class Phase 2 12-LOX Inhibitor for patients with heparin-induced thrombocytopenia (HIT) [4][6] - Tecarfarin, an oral vitamin K antagonist (VKA) for chronic use in patients with kidney dysfunction or left ventricular assist devices (LVADs), currently Phase 3-ready [4][6] - Frunexian, a parenteral small-molecule Factor XIa antagonist for acute hospital settings, currently Phase 2-ready [4][6] Upcoming Events - The management team, including CEO Quang X. Pham, will hold partnering and investor meetings during the 44th Annual J.P. Morgan Healthcare Conference from January 12-15, 2026, in San Francisco, CA [1][2] Strategic Focus - The company aims to develop novel, differentiated products that address significant gaps in anticoagulation management for specific patient populations [2][4]

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 [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].