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. Cadrenal Therapeutics (NASDAQ:CVKD) falls into the second category. Modern medicine is carrying an anticoagulation burden it was never designed to handle. Heparin-induced thrombocytopenia ("HIT") cases trigger chaos. Dialysis patients cycle through unstable drug regimens. Acute care teams juggle bleeding risk and clotting risk every hour of every shift. During all of this, hospitals are being forced to improvise more than they should. Not because they lack skill, but because their tools are stuck in another era.

Cadrenal Therapeutics is working to change that narrative. Though modest in size by traditional measures, the company operates with the urgency and precision of a much larger team confronting a system-level crisis. Its strategy is consistent across every decision, from development focus to pipeline expansion. First, identify where hospitals break, where high-risk patients falter, and where costs spiral. Then develop therapies that directly address those failures.

This is not the typical microcap pattern of hoping for a breakthrough. It is a coordinated response to the parts of anticoagulation where failure is no longer acceptable. Cadrenal is not reacting to market conditions. It is reacting to clinical reality.

Tecarfarin Brings Stability to the Most Unstable Patient Populations

Cadrenal's foundation begins with tecarfarin, a Phase 3-ready therapy designed specifically for patients that modern anticoagulation leaves behind. End-stage kidney disease. Atrial fibrillation in renal-compromised patients. Dialysis transitions that turn routine management into a minefield. These patients are the ones who drive emergency admissions, prolonged hospital stays, and unpredictable outcomes.

Tecarfarin counters that instability with something healthcare has not seen in years. A vitamin K antagonist engineered for control, predictability, and renal safety. It maintains therapeutic levels without the erratic swings of warfarin. It avoids the clearance challenges that make DOACs unsafe for kidney-impaired populations. And it brings reversibility, a feature clinicians value but rarely get from today's drugs.

In many ways, tecarfarin is not just a chronic therapy. It is a stabilizer for a population that creates disproportionate strain across the system. Every dialysis center, every cardiology team, and every hospitalist group understands the consequences of uncontrolled anticoagulation. Tecarfarin is designed to reduce that noise.

Factor XIa Acquisition Turns Cadrenal Into a Hospital-Facing Player

The addition of eXIthera's Factor XIa inhibitor portfolio expanded Cadrenal from a chronic-care company into a force in acute care. Factor XIa is one of the most important targets in modern hematology because it offers the possibility of anticoagulation without the same bleeding liabilities that dominate current therapies. Hospitals have been racing toward solutions that give them better control in high-risk scenarios. Cadrenal now has one.

This acquisition gives the company direct relevance inside operating rooms, ICUs, trauma units, cardiac wards, and interventional suites. These are the settings where anticoagulation risk is measured in minutes, not weeks. One bad swing can alter a treatment plan or put a patient into a downward spiral. Better control is not a luxury here. It is a requirement.

With the XIa portfolio, Cadrenal established a second pillar in its platform. Tecarfarin stabilizes long-term risk. XIa inhibitors manage immediate risk. The strategic symmetry is unmistakable.

VLX-1005 Expands Cadrenal Into the Most Dangerous Anticoagulation Failure: HIT

Then came VLX-1005, a Phase 2 12-LOX inhibitor with Orphan Drug and Fast Track designations for heparin-induced thrombocytopenia. HIT is one of the most feared complications in anticoagulation. It transforms a standard therapy into a crisis that forces teams into emergency protocols and rapid-fire decision-making. The stakes are immediate. The consequences can be fatal.

VLX-1005 positions Cadrenal inside this critical failure point. It is not just another asset. It is a foothold in one of the most urgent unmet needs in all of hospital-based anticoagulation. Few companies touch HIT with serious intent because the development path is steep and the patient population is high acuity. Cadrenal moved toward it instead of away.

This acquisition completes a pipeline that now spans chronic, acute, and immune-mediated complications. Three mechanisms. Three different environments of care. One coherent strategy

A Pipeline Built for a System That Needs Relief, Not Promises

Cadrenal does not resemble a microcap when you step back and study the architecture of its pipeline. It resembles a specialty anticoagulation platform built to intercept the failures that cost hospitals the most. It brings order to chronic instability. It adds precision to acute care. It enters the immune-driven emergencies that force physicians into defensive medicine.

This is why Cadrenal feels less like a traditional development-stage biotech and more like an emergency response framework waiting for its first major deployment. The system needs the relief this portfolio is built to provide. The assets are aligned with real-world pressure rather than theoretical market sizing. And the pathway forward includes milestones that can shift perception quickly.

The market still sees a small company. The healthcare system, if given the option, will see a lifeline. That is the gap Cadrenal is moving into. The only question now is how long it takes investors to realize that this pipeline was never built for incremental gains. It was built for systemic impact.

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is developing differentiated products that bridge critical gaps in current acute and chronic anticoagulation management for rare and high-risk patient populations. It currently has three clinical-stage assets: VLX-1005, a first-in-class Phase 2 12-LOX Inhibitor for patients with HIT, tecarfarin, an oral vitamin K antagonist (VKA) for chronic use in patients with kidney dysfunction or left ventricular assist devices (LVADs), and frunexian, a parenteral small-molecule Factor XIa antagonist for use in acute hospital settings. For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

Safe Harbor

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potentially," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding advancing VLX-1005 for the treatment of HIT; continuing to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the emerging data from VLX-1005 suggesting meaningful potential to improve patient outcomes while maintaining a favorable safety profile; VLX-1005 being a compelling strategic addition to Cadrenal's pipeline; the payment to Veralox of milestone payments contingent upon the achievement of certain future clinical and regulatory milestones as well as royalties on global sales of the acquired assets upon future commercialization; the structure and terms of the agreement enabling Cadrenal to allocate capital to advancing the clinical development of VLX-1005; and developing transformative therapeutics to overcome the limitations of current anticoagulation therapy. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to advance the clinical development of VLX-1005 for the treatment of HIT; the ability to continue to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the ability to successfully complete clinical trials on time and achieve desired results and benefits as expected; the ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements and the other risk factors described in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, and the Company's subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

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SOURCE: Cadrenal Therapeutics