Cadrenal Therapeutics’ Late-Breaking Phase 2 Data Demonstrate Greater Than 25% Reduction in Thrombotic Events in HIT for First-in-Class 12-LOX Inhibitor CAD-1005 at ISTH 2026 Congress
Rhea-AI Summary
Cadrenal Therapeutics (Nasdaq: CVKD) reported late-breaking Phase 2 data for first-in-class 12-LOX inhibitor CAD-1005 in heparin-induced thrombocytopenia (HIT) at the ISTH 2026 Congress in Paris. In the first randomized, blinded, placebo-controlled HIT trial, CAD-1005 showed an absolute reduction of more than 25% in new or worsening thrombotic events versus placebo (50% vs >75%).
The study, which was not powered for statistical significance, also showed no serious adverse events attributable to CAD-1005, no major bleeding in SRA+ patients, and no deaths. CAD-1005 is described as Phase 3‑ready, targets a life-threatening immune-mediated clotting disorder with an estimated $2 billion peak annual revenue opportunity, and holds FDA Orphan Drug and Fast Track designations as well as EMA Orphan Drug status.
AI-generated analysis. How Rhea-AI works. Not financial advice.
Positive
- >25% absolute reduction in thrombotic events vs placebo (50% vs >75%)
- No serious adverse events attributable to CAD-1005 and no deaths reported
- No major bleeding events in SRA+ patients receiving CAD-1005
- First randomized, blinded, placebo-controlled clinical trial conducted in HIT
- CAD-1005 labeled Phase 3-ready with pivotal registration trial planning informed
- CAD-1005 granted FDA Orphan Drug and Fast Track and EMA Orphan Drug designations
- HIT opportunity described as $2 billion estimated peak annual revenue
Negative
- Phase 2 study not sufficiently powered to demonstrate statistical significance
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 24 | ISTH presentation selection | Positive | -2.6% | CAD-1005 Phase 2 HIT data selected for prestigious ISTH late-breaking oral slot. |
| Jun 03 | Partnering event plans | Positive | -3.7% | Plans to showcase Phase 3-ready CAD-1005 and 12-LOX platform at BIO 2026. |
| Apr 30 | End-of-Phase 2 outcome | Positive | +19.3% | FDA End-of-Phase 2 meeting supports advancing CAD-1005 into pivotal Phase 3 in HIT. |
| Feb 24 | Phase 2 topline results | Positive | +16.1% | Phase 2 CAD-1005 data show >25% absolute thrombotic event reduction in HIT. |
| Aug 05 | Tecarfarin trial plans | Positive | +23.7% | Planned tecarfarin trials for ESKD patients transitioning to dialysis with AFib or without. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical trial news has often produced strong moves for CVKD, with three prior tagged events rallying and two recent CAD-1005 updates selling off.
Key Terms
heparin-induced thrombocytopenia medical
12-lipoxygenase medical
placebo-controlled medical
orphan drug regulatory
fast track regulatory
thromboembolic medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Selected as one of three late-breakthrough abstracts: clinical trials and innovation in thrombosis, CAD-1005 took center stage before the global thrombosis community at the largest ISTH meeting in more than a decade.
- Oral presentation by Principal Investigator Dr. Steven E. McKenzie highlighted CAD-1005 as the first randomized, blinded, placebo-controlled trial for Heparin-Induced Thrombocytopenia (HIT).
- Phase 2 data demonstrate an absolute reduction of more than
25% in thrombotic events, supporting the clinical advancement of this Phase 3-ready program. - CAD-1005 targets a life-threatening immune-mediated clotting disorder, with an estimated
$2 billion in peak annual revenue and no currently approved root-cause therapies.
PARIS, July 13, 2026 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing novel therapies for rare immunothrombotic conditions, announced today that late-breaking clinical data from the Phase 2 study of the first-in-class 12-lipoxygenase (12-LOX) inhibitor CAD-1005 were featured in a highly anticipated late-breaking oral presentation at the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress in Paris.
This year's ISTH Congress marked a historic milestone, bringing together clinicians, researchers, scientists, educators and industry leaders from around the world for five days of scientific discovery, collaboration and innovation in thrombosis, hemostasis and vascular biology. Drawing the largest in-person audience in more than a decade, the event attracted over 6,000 registrants and more than 3,100 abstract submissions. As the premier global gathering for cutting-edge scientific research, the ISTH late-breakthrough program is reserved for high-impact clinical trial results and first disclosures that may define future standards of care and clinical practice.
The oral presentation, titled "12-lipoxygenase inhibition with CAD-1005 (formerly known as VLX-1005) in heparin-induced thrombocytopenia," was part of the high-profile session on clinical trials and breakthrough innovations. It marks a historic milestone as the first randomized, blinded, placebo-controlled clinical trial in patients with Heparin-Induced Thrombocytopenia (HIT).
"Targeting 12-lipoxygenase is a novel, highly selective therapeutic approach that is intended to address the root cause of immune-mediated platelet activation in HIT," said Dr. Steven E. McKenzie. "The data we presented in Paris illustrated how CAD-1005 could fundamentally shift the treatment paradigm for acute thrombotic care. By showing an encouraging reduction in thrombotic events when added to standard anticoagulation, this therapy may offer a highly differentiated and desperately needed option for these high-risk patients. Clinicians from around the world were enthusiastic about this novel approach to a serious unmet medical need."
Key Phase 2 Highlights Presented:
- Addressing the Root Cause: Unlike standard-of-care anticoagulants that only reduce thrombin generation, CAD-1005 is designed to directly block the underlying 12-LOX immune signaling loop that drives antibody-mediated platelet activation.
- Efficacy Signal: Patients treated with CAD-1005 experienced a reduction of more than
25% in new or worsening thrombotic events compared with the placebo arm (50% vs. >75% ), despite the study not being sufficiently powered for statistical significance. - Safety Signal: No serious adverse events attributable to CAD-1005, no major bleeding in SRA+ patients, and no deaths. Treatment with CAD-1005 was associated with fewer thromboembolic events without an increase in major bleeding.
- Paradigm Shift in Trial Design: The trial established that the traditional platelet count recovery rate is an inadequate surrogate for clinical efficacy, as thrombotic events continued to occur after recovery. This provides critical framework intelligence for Cadrenal’s upcoming pivotal Phase 3 registration trial.
"The selection of the Phase 2 study for a late-breaking presentation at ISTH underscores the scientific integrity and significant commercial potential of CAD-1005," said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. "With our recent financing, we are well-positioned to advance partnering opportunities for CAD-1005 and tecarfarin."
CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA) and Orphan Drug status from the European Medicines Agency (EMA).
About Heparin-Induced Thrombocytopenia (HIT)
HIT is an immune-mediated, prothrombotic adverse drug reaction in which antibodies against platelet factor 4-heparin complexes activate platelets via FcγRIIA receptors, triggering a cascade that can lead to life-threatening thrombosis. Current management relies on non-heparin anticoagulants, which reduce thrombin generation but do not directly address the underlying antibody-mediated platelet activation; new thrombosis remains a major clinical concern even with appropriate anticoagulant therapy.
About CAD-1005
CAD-1005 is a novel investigational therapeutic in development for the treatment of heparin-induced thrombocytopenia (HIT). CAD-1005 is designed to selectively inhibit 12-lipoxygenase (12-LOX), an enzyme central to platelet immune activation and thrombo-inflammatory signaling in HIT. CAD-1005 is intended to be used alongside existing standards of care and is being developed to address the underlying biological mechanisms that drive disease progression. To view how CAD-1005 works in HIT, click https://vimeo.com/1209382706/7dde06dc08?share=copy&fl=sv&fe=ci
About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is being investigated as a first-in-class 12-LOX inhibitor for heparin-induced thrombocytopenia (HIT), a deadly immune-mediated thrombotic disorder. CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration and orphan drug status from the European Medicines Agency. Second-generation 12-LOX oral therapeutics are also in development for chronic indications.
The Company’s broader pipeline includes tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease, those with left ventricular assist devices, and potentially those with Kawasaki disease (KD), an acute, self-limited, febrile illness that primarily affects children <5 years old and is the leading cause of acquired heart disease in developed countries. Tecarfarin has also received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA).
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, without limitation, statements such as targeting 12-lipoxygenase being a novel, highly selective therapeutic approach addressing the root cause of immune-mediated platelet activation in HIT; the data presented in Paris illustrating how CAD-1005 could fundamentally shift the treatment paradigm for acute thrombotic care; the therapy offering a highly differentiated and desperately needed option for these high-risk patients; the selection of the Phase 2 study for a late-breaking presentation at ISTH underscoring the scientific integrity and significant commercial potential of CAD-1005; and the Company being well-positioned to advance partnering opportunities for CAD-1005 and tecarfarin. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to enter into a partnership opportunity for CAD-1005 and tecarfarin; the ability to benefit from the commercial potential of CAD-1005; raise sufficient capital to continue progress of CAD-1005; the ability to advance directly to Phase 3 study evaluating CAD-1005 in patients with HIT; the ability to successfully design and complete the Phase 3 study and derive the results needed for an NDA submission; and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, 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, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.
For more information, please contact:
Lytham Partners, LLC, Robert Blum, Managing Partner, 602-889-9700, CVKD@lythampartners.com
