Cadrenal Therapeutics Highlights High Incidence of Thrombotic Complications in Heparin-Induced Thrombocytopenia (HIT) at the J.P. Morgan Healthcare Conference and VLX-1005 as a[...]

SAN FRANCISCO, Jan. 12, 2026 (GLOBE NEWSWIRE) - Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome the limitations of current anticoagulation therapy, today highlighted the significant and persistent unmet medical need in heparin-induced thrombocytopenia (HIT) and underscored the promise of its recently acquired investigational drug candidate, VLX-1005, the first and only potent, highly selective 12-LOX inhibitor in clinical testing as a potential new treatment option.

Cadrenal Therapeutics acquired VLX-1005 in December 2025, recognizing its potential to transform the treatment landscape for HIT and other immune-mediated thrombotic disorders.

Emerging data from a recent Phase 2 clinical trial evaluating VLX-1005 in individuals with suspected HIT suggest that VLX-1005 may reduce thrombotic complications, supporting its further development as a novel, mechanism-based therapy. Early trial results suggest that selective 12-LOX inhibition may offer a differentiated approach by addressing the immune thrombotic drivers of disease rather than solely suppressing coagulation.

HIT is a serious immune-mediated reaction to heparin that paradoxically increases the risk of thrombosis despite a drop in platelet count. It occurs when antibodies activate platelets, triggering widespread clot formation in veins and arteries. Thrombotic complications affect a large proportion of patients and are the primary cause of illness and death in HIT. Recent clinical and translational research continues to reinforce the urgent need for safer, more targeted therapies that address the immune-driven platelet activation underlying this disease.

Recent findings reported in a 2025 American Society of Hematology (ASH) abstract by Shatzel et al. and in a 2025 publication by Ramadan et al. highlight the high incidence and clinical burden of thrombotic complications in HIT, even with current standard-of-care anticoagulation. These data emphasize the limitations of existing therapies, which primarily inhibit coagulation pathways but do not directly modulate the platelet immune responses central to HIT pathophysiology.

Growing scientific evidence has identified 12-lipoxygenase (12-LOX) as a key mediator of platelet activation and immune thrombotic responses. Foundational work by McKenzie et al. (2022) significantly advanced the understanding of 12-LOX signaling in platelet-driven immune thrombosis, including in HIT, supporting the enzyme as a compelling therapeutic target.

Historically, however, drug development efforts targeting 12-LOX have been hindered by a lack of selectivity, raising concerns about off-target effects and safety. This challenge has limited the clinical translation of earlier 12-LOX inhibitors.

VLX-1005 represents a breakthrough in this area. Supported by preclinical and translational studies (Tourdot et al., 2017; Renna et al., 2023), VLX-1005 is the first and only highly selective 12-LOX inhibitor in clinical development. Its selectivity profile is designed to specifically modulate immune-mediated platelet activation while minimizing off-target inhibition of related lipid signaling pathways.

Cadrenal is moving forward rapidly to engage with the U.S. Food and Drug Administration (FDA) to discuss the design of a potential pivotal Phase 3 registration study for VLX-1005 in HIT.

"HIT remains a life-threatening condition with a strikingly high risk of thrombosis despite available therapies," said Quang X. Pham, CEO of Cadrenal Therapeutics. "By selectively targeting 12-LOX, VLX-1005 has the potential to address a core disease mechanism in HIT. We believe this program represents a meaningful opportunity to improve outcomes for patients who currently have limited options."

VLX-1005 has received Orphan Drug Designation (ODD) and Fast Track designation from the U.S. Food and Drug Administration, as well as orphan drug status from the European Medicines Agency. Second-generation oral therapeutics targeting 12-LOX are also under development for type 1 diabetes and other chronic immune-mediated and inflammatory diseases.

Lytham Partners 2026 Investor Healthcare Summit

Cadrenal will participate in a webcast fireside chat at the Lytham Partners 2026 Investor Healthcare Summit, which will be held virtually at 4:30 p.m. ET on Thursday, January 15, 2026.

The webcast can be accessed via the conference home page at https://lythampartners.com/hc2026/ or at https://lythampartners.com/hc2026/cvkd. A replay will also be available through the same links.

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is developing differentiated products designed to 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 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 VLX-1005 as a potential therapeutic solution, the promise of VLX-1005 as a potential new treatment option for HIT, VLX-1005's potential to transform the treatment landscape for HIT and other immune-mediated thrombotic disorders, VLX-1005 reducing thrombotic complications in patients with HIT, selective 12-LOX inhibition offering a differentiated approach by addressing the immune thrombotic drivers of disease rather than solely suppressing coagulation, 12-LOX inhibitor in clinical development advancing into human clinical development, 12-LOX being able to modulate immune-mediated platelet activation while minimizing off-target inhibition of related lipid signaling pathways, Cadrenal moving forward to engage with the FDA to discuss the design of a potential pivotal Phase 3 registration study for VLX-1005 in HIT, the program representing a meaningful opportunity to improve outcomes for patients who currently have limited options. 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, including designing a pivotal Phase 3 registration study acceptable to the FDA; Cadrenal's ability to continue to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; Cadrenal's ability to successfully complete clinical trials on time and achieve desired results and benefits as expected including support for VLX-1005's potential to be a treatment option for HIT and transform the treatment landscape for HIT and other immune-mediated thrombotic disorders, Cadrenal's 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.

For more information, please contact:

Cadrenal Therapeutics:Matthew Szot, [email protected]

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
[email protected]