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 ...

PONTE VEDRA, FL / ACCESS Newswire / December 12, 2025 / Cadrenal Therapeutics (NASDAQ:CVKD) believes it continues to be misread by the market. Yes, the Company is intentionally narrowly focused. However, the lane it occupies is among the most undertreated areas in medicine. Anticoagulation for difficult-to-treat patients has not seen meaningful reinvention in decades. Warfarin persists due to a lack of innovation. DOACs dominate because alternatives have not evolved. Cadrenal is stepping into that void w ...

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]

Financial Performance - Cadrenal reported a net loss of $2.7 million for Q3 2025, compared to a net loss of $2.4 million for Q3 2024[5]. - The total operating expenses for Q3 2025 were $2.7 million, compared to $2.5 million in Q3 2024[13]. - The accumulated deficit as of September 30, 2025, was $35.9 million, compared to $25.7 million at the end of 2024[11]. - The weighted average number of common shares used in computing net loss per common share for Q3 2025 was approximately 2.04 million[13]. Expenses - Research and development expenses for Q3 2025 were $0.7 million, a decrease from $0.8 million in Q3 2024, while general and administrative expenses increased to $2.0 million from $1.7 million in the same period[5]. Cash Position - As of September 30, 2025, Cadrenal had cash and cash equivalents of $3.9 million, down from $10.0 million at the end of 2024[6]. Product Development - The company completed the manufacturing of tecarfarin drug product in accordance with current good manufacturing practices (cGMP) and is advancing clinical development[4]. - Cadrenal expanded its portfolio by acquiring assets from eXIthera Pharmaceuticals, including the Phase 2-ready IV Factor XIa inhibitor, frunexian[4]. - Cadrenal is in discussions with key partners to advance the development strategy for tecarfarin, targeting significant anticoagulation challenges[3]. Strategic Goals - The company aims to reshape standards of care in anticoagulation by targeting underserved patient populations with its novel therapeutics[7].

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]

Product Development - Cadrenal's lead product candidate, tecarfarin, is designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation [96]. - Tecarfarin has been evaluated in 11 human clinical trials involving over 1,000 individuals, with only 1.6% of subjects experiencing major bleeding in the largest trial, EMBRACE-AC [101]. - The company is evaluating opportunities for additional Phase 2 trials for tecarfarin, potentially advancing clinical trials in 2026 for specific patient groups [102]. - Cadrenal's focus on orphan cardiovascular conditions aims to provide more reliable anticoagulation for patients who cannot achieve optimal results with warfarin or DOACs [99]. Financial Performance - The company reported total operating expenses of $2.73 million for the three months ended September 30, 2025, an increase of 11% compared to $2.46 million in the same period of 2024 [112]. - General and administrative expenses rose to $2.04 million in Q3 2025, up 22% from $1.67 million in Q3 2024, primarily due to increased public company expenses and stock-based compensation [113]. - Research and development expenses for the nine months ended September 30, 2025, were $3.4 million, an increase of $0.7 million or 29% compared to $2.7 million in 2024 [119]. - General and administrative expenses increased to $7.0 million for the nine months ended September 30, 2025, up $3.0 million or 73% from $4.0 million in 2024 [118]. - Total operating expenses for the nine months ended September 30, 2025, were $10.4 million, a 56% increase from $6.7 million in 2024 [117]. - The net loss for the nine months ended September 30, 2025, was $10.2 million, compared to a net loss of $6.5 million in 2024, representing a 46% increase [122]. - Cash used in operating activities for the nine months ended September 30, 2025, was $10.0 million, compared to $5.6 million in 2024 [123]. - Cash and cash equivalents at the end of the period were $3.9 million as of September 30, 2025, down from $4.4 million at the end of 2024 [123]. - Interest and dividend income for the nine months ended September 30, 2025, was $0.1 million, a decrease of 9% from $0.2 million in 2024 [120]. - The company incurred $1.6 million of non-cash expenses as part of the net loss for the nine months ended September 30, 2025 [122]. Strategic Initiatives - Cadrenal acquired assets from eXIthera Pharmaceuticals, including the IV Factor XIa inhibitor frunexian, enhancing its pipeline in the $38 billion global anticoagulation market [106]. - The acquisition includes milestone payments of up to $15 million and royalties of 2% on annual net sales of products covered by valid patents [104][105]. - The company sold 236,728 shares through its at-the-market facility at an average price of $16.96 per share, generating approximately $4.02 million in gross proceeds [108]. - From October 1 to November 10, 2025, Cadrenal sold an additional 16,091 shares at an average price of $14.16, resulting in gross proceeds of approximately $227,772 [109]. - The company plans to seek additional capital through strategic partnerships, equity offerings, and/or debt financings to meet anticipated funding needs [122]. - The company anticipates an increase in research and development expenses when clinical trials commence [119].

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]