Full Press Release Details
Cadrenal Therapeutics Enhances Anticoagulation Pipeline Through
Acquisition of eXIthera's Portfolio of Factor XIa Inhibitors
PONTE VEDRA, FL, September
15, 2025 - 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."
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.
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:
Lytham Partners, LLC
Robert Blum, Managing Partner