Cadrenal Therapeutics Acquires VLX-1005, a First-in-Class Phase 2 12-LOX Inhibitor for Patients with Heparin-Induced Thrombocytopenia (HIT)

Rhea-AI Summary

Cadrenal Therapeutics (NASDAQ: CVKD) announced on Dec 11, 2025 the acquisition of VLX-1005 and related 12-LOX assets from Veralox Therapeutics, adding a late-stage, first-in-class small‑molecule 12‑lipoxygenase inhibitor for heparin‑induced thrombocytopenia (HIT).

VLX-1005 has U.S. Orphan Drug and Fast Track designations, completed two Phase 1 studies showing favorable tolerability, and interim Phase 2 data reporting reductions in thromboembolic events. The release cites a $40 billion global anticoagulation market and an estimated $1 billion HIT market in the US and EU. Veralox may receive upfront, milestone payments and royalties upon commercialization.

Positive

• Adds late-stage, first-in-class 12-LOX asset to CVKD pipeline
• VLX-1005 holds U.S. Orphan Drug and Fast Track designations
• Phase 1 studies showed no deaths or serious adverse events

Negative

• Phase 2 efficacy reported only as interim reductions in events
• Acquisition payments are contingent on unspecified milestones
• Commercial economics include future royalties to Veralox

Key Figures

Global anticoagulation market $40 billion Market size referenced for anticoagulation therapies

HIT incidence in heparin users up to 5% Proportion of patients exposed to heparin who may develop HIT

US patients evaluated for HIT 300,000 per year Annual evaluations for suspected HIT in the United States

Confirmed HIT diagnoses 56,000 per year Estimated annual confirmed HIT cases in the United States

Phase 1 studies Two studies VLX-1005 Phase 1 trials in healthy participants

Phase 2 study ID VLX-1005-003 Phase 2 study in individuals with suspected HIT

HIT market size $1 billion Estimated HIT market size in US and EU mentioned by company

Price move pre-news 11.43% CVKD 24h price change before article publication

Market Reality Check

$11.11 Last Close

Volume Volume 62,816 is 1.99x the 20-day average of 31,622, showing elevated interest ahead of this news. high

Technical Shares at $11.11 are trading below the 200-day MA of $13.81 and sit 51.49% under the 52-week high.

Peers on Argus

CVKD was up 11.43%, while close biotech peers showed mixed moves: ALLR up 2.63%, TENX, DARE modestly down, and NEUP and NRSN down 8.68% and 9.79%. The stronger gain in CVKD versus generally weaker peers points to a company-specific reaction to its pipeline expansion.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 01	Board appointment	Positive	-4.1%	Industry veteran added to board to support late-stage development.
Nov 10	Earnings update	Negative	-3.2%	Q3 loss and higher operating expenses alongside pipeline updates.
Sep 29	Investor conference	Neutral	+3.1%	Participation in virtual investor conference and webcast presentation.
Sep 15	Pipeline acquisition	Positive	+1.6%	Acquisition of Factor XIa portfolio expanding anticoagulation pipeline.
Aug 11	Earnings update	Negative	-1.9%	Q2 results showing higher net loss and ongoing cash use.

Pattern Detected

News-driven moves generally align with the tone of events; the main divergence was a negative reaction to a positive board appointment.

Recent Company History

Over the last six months, Cadrenal has steadily expanded its anticoagulation pipeline and visibility. In August 2025 and November 2025, earnings reports highlighted growing R&D and G&A expenses and liquidity concerns, with shares softening afterward. The September 12, 2025 acquisition of eXIthera’s Factor XIa inhibitors produced a modest positive reaction, as did participation in a September 30, 2025 investor conference. A December 2025 board addition focused on late-stage development drew a small selloff, suggesting some investor sensitivity to execution and financing risks as the pipeline broadens.

Market Pulse Summary

The stock is up +7.5% following this news. A strong positive reaction aligns with Cadrenal’s strategy of building a differentiated anticoagulation pipeline. This Phase 2 12-LOX asset adds to prior acquisitions and taps into a $40 billion market and an estimated $1 billion HIT niche. However, the company’s history of operating losses and reliance on external financing, together with prior insider selling, could constrain how long enthusiasm is sustained if further clinical or financing updates disappoint.

Key Terms

orphan drug designation regulatory

"VLX-1005 has received Orphan Drug Designation (ODD) and Fast Track"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

fast track designation regulatory

"received Orphan Drug Designation (ODD) and Fast Track designation"

A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.

AI-generated analysis. Not financial advice.

• Novel first-in-class therapeutic targeting a key immune signaling pathway and the underlying cause of HIT
• It is the first and only potent, highly selective inhibitor of human 12-LOX in clinical testing, distinguishing it from related compounds.
• Orphan Drug and Fast Track designations from the FDA

PONTE VEDRA, Fla., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome the limitations of current anticoagulation therapy, today announced the acquisition of VLX-1005 and related 12-lipoxygenase (12-LOX) assets from Veralox Therapeutics (“Veralox”). The acquisition immediately strengthens Cadrenal’s pipeline with a late-stage, first-in-class drug candidate targeting a critical immune signaling pathway. This acquisition addresses yet another underserved therapeutic opportunity in the $40 billion global anticoagulation market.

VLX-1005 is a novel, potent, selective small-molecule inhibitor of 12-LOX, a key pathway driving immune platelet-mediated inflammation and a contributor to the pathogenesis of HIT. This potentially life-threatening complication can occur in up to 5% of patients exposed to heparin – the most commonly used parenteral anticoagulant - regardless of dose, schedule, or route of administration. HIT antibodies can cause catastrophic and life-threatening arterial and venous thrombosis. Approximately 300,000 patients in the United States are evaluated each year for suspected HIT, and an estimated 56,000 confirmed diagnoses occur each year. Mortality and thromboembolic event (TE) rates remain high despite currently available therapies.

Two Phase 1 studies of VLX-1005 in healthy participants have demonstrated that VLX-1005 was well tolerated, with no deaths, no serious adverse events, and no trend in adverse event reporting with increasing doses. A recent Phase 2 study (VLX-1005-003) evaluated VLX-1005 in individuals with suspected HIT, and interim results demonstrated encouraging reductions in thromboembolic events. These events have become a preferred, clinically meaningful endpoint for regulators, clinicians, and payers, given the rising rates observed in current HIT populations.

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 therapeutics targeting 12-LOX are also under development for type 1 diabetes and other immune-mediated and inflammatory diseases.

“We are pleased the advancement of VLX-1005 for the treatment of HIT will continue under the leadership of Cadrenal,” said Matthew Boxer, Co-Founder of Veralox Therapeutics. “The program has found a home in Cadrenal, where it aligns with a shared vision and excitement regarding the promise 12-LOX technology may offer patients.”

“With the acquisition of VLX-1005, Cadrenal continues to advance novel therapeutics to treat or prevent thrombosis in high-risk patients,” said Quang X. Pham, Chairman and CEO of Cadrenal Therapeutics. “HIT remains a dangerous condition without a therapy that addresses its immune-driven biology. The emerging data from VLX-1005 suggest meaningful potential to improve patient outcomes while maintaining favorable tolerability. We believe this is a compelling strategic addition to our pipeline, with the market size for HIT reaching $1 billion in the US and EU.”

Under the terms of the acquisition agreement, Veralox is eligible to receive upfront and milestone payments contingent on the achievement of specified future clinical and regulatory milestones. Additionally, Veralox 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 allocate capital to advancing the clinical development of VLX-1005.

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.

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 (CVKD) announce on December 11, 2025?

Cadrenal announced the acquisition of VLX-1005 and related 12-LOX assets from Veralox to advance a first-in-class HIT therapy.

What clinical progress does VLX-1005 have for HIT (CVKD)?

VLX-1005 completed two Phase 1 studies with favorable tolerability and an interim Phase 2 study showing reductions in thromboembolic events.

Does VLX-1005 have regulatory designations for HIT (CVKD)?

Yes; VLX-1005 received U.S. Orphan Drug designation and Fast Track designation and orphan status from the European Medicines Agency.

How large is the market opportunity cited for HIT and anticoagulation?

The release cites a $40 billion global anticoagulation market and an estimated $1 billion HIT market in the U.S. and EU.

Will Veralox receive payment under the CVKD acquisition deal?

Yes; Veralox is eligible for upfront and milestone payments contingent on specified clinical and regulatory milestones and royalties on future sales.

Are Phase 2 results for VLX-1005 final for regulatory approval?

No; the announcement refers to interim Phase 2 results, not a completed pivotal readout or regulatory filing.