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]

Regeneron Pharmaceuticals (NasdaqGS:REGN) Update / Briefing November 10, 2025 08:30 AM ET Company ParticipantsGeoff Meacham - Managing DirectorBrian Abrahams - Managing Director and Global Sector HeadRyan Crowe - SVP of Investor RelationsL. Andres Sirulnik - SVP and Clinical Development Unit HeadGeorge Yancopoulos - President and Chief Scientific OfficerDave Reisinger - Responsible for Diversified Biopharma ResearchEvan Seigerman - Managing Director and Head of Healthcare ResearchSimon Baker - Head of Globa ...

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]

Factor XI Program Overview - Regeneron is developing two Factor XI antibodies, REGN7508Cat and REGN9933A2, targeting various indications with different bleeding risk profiles[51] - The company aims to address unmet needs in anticoagulation by potentially reducing bleeding risk while maintaining efficacy[64] - Genetics support targeting Factor XI, as lower FXI levels are associated with reduced VTE and cardioembolic stroke risk[16, 20] Clinical Data and Development - ROXI-VTE-I and ROXI-VTE-II studies showed REGN7508Cat had a numerically lower VTE rate compared to apixaban, while REGN9933A2 had a numerically lower VTE rate compared to enoxaparin in TKR patients[33, 36] - In a pooled analysis, REGN7508Cat showed a 13.6% risk difference reduction in VTE incidence compared to pooled enoxaparin[35] - Interim results from the ROXI-CATH study in catheter-associated thrombosis showed a 66% relative risk reduction in VTE with REGN7508Cat versus placebo[40] - A Phase 1 GI bleed study indicated that REGN7508/REGN9933 resulted in 14% less bleeding risk compared to rivaroxaban + aspirin[46] Commercial Opportunity - The current global anticoagulation market is \$20 billion, with standard-of-care DOAC utilization at approximately 50% due to bleeding risk[12] - The U S Factor XI total addressable market in post-TKR VTE is estimated to be ~800K patients, with a ~40% class share anticipated[56, 75] - The U S Factor XI total addressable market in cancer VTE is estimated to be ~300K patients, with a ~30-35% class share anticipated[56, 85]

Core Insights - Regeneron Pharmaceuticals has reported positive Phase 2 trial results for two investigational factor XI antibodies, REGN7508 and REGN9933, aimed at preventing blood clotting in patients undergoing total knee replacement surgery [2][3][5] - The antibodies are designed to have distinct profiles, with REGN7508 providing stronger anticoagulation and REGN9933 offering a lower risk of bleeding, allowing for tailored anticoagulant therapy based on patient risk profiles [2][3][12] Trial Results - The trials included two open-label, active-controlled Phase 2 studies: ROXI-VTE-I and ROXI-VTE-II, evaluating the efficacy of a single intravenous dose of REGN7508 and REGN9933 for preventing venous thromboembolism (VTE) after knee arthroplasty [4][11] - REGN7508 reduced VTE rates to 7.1%, superior to apixaban's rate of 12.4%, while REGN9933 decreased VTE rates to 17.2%, superior to enoxaparin's rate of 20.6% [5][7] Safety Profile - Both antibodies demonstrated robust anti-clotting effects with no clinically relevant bleeding reported in any treatment arm, indicating a favorable safety profile [5][8][13] - The only treatment-related adverse event was minimal bleeding in the enoxaparin arm, with overall adverse event rates being similar across treatment groups [7][8] Future Development - Regeneron is advancing its factor XI program with ongoing Phase 3 trials for REGN7508, including ROXI-APEX and ROXI-ASPEN, and plans to initiate additional trials for various indications in 2026 [14][12] - The company aims to explore the use of these antibodies in other clinical settings, including atrial fibrillation and cancer-associated thrombosis [14][12]

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 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]