Cadrenal Therapeutics Enhances Anticoagulation Pipeline Through Acquisition of eXIthera’s Portfolio of Factor XIa Inhibitors

Rhea-AI Summary

Cadrenal Therapeutics (Nasdaq: CVKD) has acquired eXIthera Pharmaceuticals' portfolio of Factor XIa inhibitors, significantly expanding its anticoagulation pipeline. The acquisition includes frunexian, a Phase 2-ready intravenous Factor XIa inhibitor, and EP-7327, an IND-ready oral Factor XIa inhibitor.

The deal positions Cadrenal as the only company developing both a novel vitamin K antagonist (tecarfarin) and Factor XIa inhibitors, targeting the $38 billion global anticoagulation market. The acquisition terms include milestone payments up to $15 million and future royalties. Sichuan Haisco Pharmaceuticals maintains rights to frunexian in China, with Cadrenal receiving royalties on future Chinese sales.

Positive

• None.

Negative

• Future milestone payment obligations of up to $15 million
• Chinese rights to frunexian already licensed to Sichuan Haisco Pharmaceuticals
• Additional clinical development costs for multiple pipeline assets

Insights

Cardiovascular Therapeutics Specialist

Cadrenal's acquisition of eXIthera's Factor XIa inhibitors significantly expands their anticoagulation portfolio with differentiated bleeding risk profiles.

Cadrenal's acquisition of eXIthera's Factor XIa inhibitor portfolio represents a strategic expansion in the $38 billion global anticoagulation market. The deal brings two key assets: frunexian, a Phase 2-ready IV formulation for acute settings, and EP-7327, an IND-ready oral candidate for chronic conditions.

What makes this acquisition particularly significant is the mechanistic differentiation these compounds offer. Unlike current anticoagulants that broadly impair coagulation and increase bleeding risk, Factor XIa inhibitors provide a more targeted approach. By specifically inhibiting Factor XIa in the coagulation cascade, these compounds may potentially maintain antithrombotic efficacy while reducing hemorrhagic complications—addressing a critical limitation of existing therapies.

The structured deal terms are noteworthy for their milestone-based approach. Cadrenal will pay up to $15 million contingent on future clinical and regulatory achievements, plus royalties upon commercialization. This arrangement preserves capital for actual development activities while still providing upside potential to eXIthera.

This acquisition positions Cadrenal as the only company simultaneously developing both a novel vitamin K antagonist (tecarfarin) and Factor XIa inhibitors. This diversified approach allows them to address multiple patient populations with different risk profiles, from those with mechanical heart valves and LVADs who need vitamin K antagonists to patients requiring anticoagulation with lower bleeding risk profiles.

The China licensing arrangement with Sichuan Haisco Pharmaceuticals provides potential revenue through royalties from the Chinese market while allowing Cadrenal to focus on development in other global regions—a prudent strategy for a smaller biopharmaceutical company with limited resources.

• Acquisition significantly enhances the Company’s pipeline by adding novel assets in acute and chronic anticoagulation settings
• Company is strategically poised to deliver differentiated therapeutics across the spectrum of cardiovascular thrombotic risk

PONTE VEDRA, Fla., Sept. 15, 2025 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome the gaps in anticoagulation therapy, today announced the acquisition of the assets of eXIthera Pharmaceuticals (“eXIthera”), including its proprietary portfolio of investigational intravenous (IV) and oral Factor XIa inhibitors. The acquisition significantly enhances Cadrenal’s pipeline, adding drug candidates that address large and underserved segments of the current $38 billion global anticoagulation market.

eXIthera’s lead asset, frunexian, is a first-in-class, Phase 2-ready intravenous (IV) Factor XIa inhibitor designed for acute care settings where contact activation of coagulation by medical devices plays a significant role, such as cardiopulmonary bypass, catheter thrombosis, and other blood-contacting implanted cardiac devices. The acquisition also includes EP-7327, an oral Factor XIa inhibitor, for the prevention and treatment of major thrombotic conditions.

“With this acquisition, Cadrenal is the only company in the world developing a novel vitamin K antagonist (tecarfarin) and Factor XIa inhibitors, a promising new class of anticoagulants,” said Quang X. Pham, Chairman and CEO of Cadrenal Therapeutics. “These newly acquired assets will expand Cadrenal’s capabilities in an effort to address even more critical gaps in current antithrombotic treatment, especially for patients for whom current therapies are unreliable or carry excessive bleeding risk.”

Unlike current anticoagulants on the market, which increase the risk of bleeding by broadly impairing coagulation, eXIthera’s compounds are mechanism-based inhibitors of Factor XIa, offering high potency, selectivity, and tunable pharmacokinetics. Factor XIa inhibition is one of the most active and exciting areas of current thrombosis research.

“This acquisition reinforces Cadrenal’s long-term vision of becoming a category leader in anticoagulation,” added Pham. “With tecarfarin planning a trial in patients with end-stage kidney disease transitioning to dialysis, our plans for LVAD patients, and the current addition of frunexian and EP-7327, we believe that Cadrenal is strategically positioned to deliver differentiated therapeutics across the entire spectrum of patients with cardiovascular thrombotic risk.”

Assets Acquired:

• Frunexian: Phase 2-ready IV Factor XIa agent for acute anticoagulation
• EP-7327: IND-ready oral small molecule candidate for chronic indications
• Extensive portfolio of additional novel FXIa small molecules
  
  

Under a pre-existing license agreement, Sichuan Haisco Pharmaceuticals retains rights to frunexian in China, having completed a successful Phase 1 trial there. Under the terms of the license, Cadrenal will be entitled to receive royalties on future sales of frunexian in China.

Deal Terms Overview:

Under the terms of the acquisition agreement, eXIthera will receive milestone payments from Cadrenal totaling up to $15 million, contingent upon the realization of certain future clinical and regulatory milestones. Additionally, eXIthera will be entitled to royalties on global sales of the acquired assets upon future commercialization. The structure and terms of the agreement enable Cadrenal to focus capital deployment on advancing the clinical development of tecarfarin and the acquired assets.

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing transformative therapeutics to overcome the gaps in anticoagulation therapy. Cadrenal’s lead investigational product is tecarfarin, a novel oral Vitamin K antagonist anticoagulant that is designed to address unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used, extensive clinical and real-world data have shown it can have significant, serious side effects. With tecarfarin, Cadrenal aims to reduce the clinical complexities of managing Vitamin K antagonists, particularly where direct-acting oral anticoagulants (DOACs) remain inadequate or unproven.

Tecarfarin received Orphan Drug Designation (ODD) and fast-track designation for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease and atrial fibrillation (ESKD+AFib). The Company also received ODD for the prevention of thromboembolism and thrombosis in patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs).

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 Cadrenal’s ability to deliver differentiated therapeutics across the entire spectrum of cardiovascular thrombotic risk and overcome the gaps in anticoagulation therapy; the acquisition significantly enhancing Cadrenal’s pipeline and addressing large and underserved segments of the global anticoagulation market; the size of the global anticoagulation market; the potential of EP-7327 for the prevention and treatment of major thrombotic conditions; Cadrenal’s ability to address even more critical gaps in current antithrombotic treatment with the acquisition; Cadrenal becoming a leader in anticoagulation; commencement of a trial in patients with end-stage kidney disease transitioning to dialysis; Cadrenal’s receipt of royalties on future sales of frunexian in China; the payment to eXIthera of milestone payments by the Company totaling up to $15 million contingent upon the realization of certain future clinical and regulatory milestones as well as global sales of the acquired assets upon future commercialization; Cadrenal’s ability to focus capital deployment on advancing the clinical development of tecarfarin and the acquired assets; and tecarfarin addressing the unmet needs in anticoagulation therapy; tecarfarin reducing the clinical complexities of managing Vitamin K antagonists. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Cadrenal’s ability to deliver differentiated therapeutics across the entire spectrum of cardiovascular thrombotic risk and overcome the gaps in anticoagulation therapy; the potential of EP-7327 for the prevention and treatment of major thrombotic conditions; Cadrenal’s ability to address even more critical gaps in current antithrombotic treatment; the payment of milestone payments and royalties; Cadrenal successfully advancing tecarfarin and the acquired assets into clinical practice; the commencement of a trial in patients with end-stage kidney disease transitioning to dialysis; tecarfarin addressing the unmet needs in anticoagulation therapy; tecarfarin reducing the clinical complexities of managing Vitamin K antagonists 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.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

FAQ

What did Cadrenal Therapeutics (CVKD) acquire from eXIthera Pharmaceuticals?

Cadrenal acquired eXIthera's portfolio of Factor XIa inhibitors, including frunexian (Phase 2-ready IV drug) and EP-7327 (IND-ready oral drug), along with additional novel FXIa molecules.

How much is Cadrenal paying for the eXIthera acquisition?

Cadrenal will pay up to $15 million in milestone payments contingent on clinical and regulatory achievements, plus future royalties on global sales upon commercialization.

What is the market potential for Cadrenal's expanded anticoagulation pipeline?

The acquisition targets opportunities within the $38 billion global anticoagulation market, with Cadrenal becoming the only company developing both vitamin K antagonists and Factor XIa inhibitors.

What are the key advantages of eXIthera's Factor XIa inhibitors?

The compounds offer high potency, selectivity, and tunable pharmacokinetics, potentially reducing bleeding risk compared to current anticoagulants that broadly impair coagulation.

Who has the rights to frunexian in China?

Sichuan Haisco Pharmaceuticals retains rights to frunexian in China through a pre-existing license agreement, with Cadrenal entitled to receive royalties on future Chinese sales.