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 Viewpoint - Cadrenal Therapeutics is positioned in a niche market that is significantly underserved, focusing on developing innovative anticoagulants for difficult-to-treat patient populations, particularly those with end-stage kidney disease and atrial fibrillation [1][2]. Company Developments - The company has made strides in manufacturing readiness, enhanced its leadership team, and expanded its pipeline, notably through the acquisition of VLX-1005, a Phase 2 program for Heparin-Induced Thrombocytopenia (HIT), which is expected to enhance its strategic position [3][5]. - Cadrenal is transitioning from a single-asset microcap to a multi-faceted clinical platform within the $40 billion anticoagulation market, with the Factor XIa portfolio opening opportunities in acute hospital settings [4][6]. Market Position and Valuation - Despite the expansion of its portfolio, the market continues to undervalue Cadrenal, treating it as a single-asset company rather than recognizing its diverse clinical approaches and potential catalysts [6][7]. - The company is on the verge of significant milestones, with tecarfarin nearing Phase 3 trial readiness and VLX-1005 entering a critical phase for clinical data, which could lead to a reevaluation of its market position [8][9]. Future Outlook - The current period may be the last opportunity for investors to underestimate Cadrenal, as the company is preparing for impactful milestones that could shift market perception from overlooked to obvious [9].

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]