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]

SAN FRANCISCO, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome the limitations of current anticoagulation therapy, today highlighted the significant and persistent unmet medical need in heparin-induced thrombocytopenia (HIT) and underscored the promise of its recently acquired investigational drug candidate, VLX-1005, the first and only potent, highly selective 12-LOX inhibitor in clinical testing as ...

PONTE VEDRA, FL / ACCESS Newswire / December 30, 2025 / Some companies enter a market because they see opportunity. Others step in because the situation has become unsustainable, and someone has to fix it. ...

PONTE VEDRA, FL / ACCESS Newswire / December 29, 2025 / Every industry has its forgotten corners. In anticoagulation, those corners turned into entire neighborhoods. ...

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 ...

PONTE VEDRA, FL / ACCESS Newswire / December 12, 2025 / Cadrenal Therapeutics (NASDAQ:CVKD) entered the back half of the year with a calm, almost surgical approach to building out its foundation. While most microcaps lean on noise to stay visible, Cadrenal has let its work do the lifting. Trial preparation moved forward. Manufacturing advanced. Leadership depth expanded inside the clinical ranks. None of it screamed for attention, but each decision made the Company harder to ignore. Quiet progress is sti ...

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].

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]