Cadrenal Therapeutics Inc.

08/13/2026 | Press release | Distributed by Public on 08/13/2026 14:31

Cadrenal Therapeutics Reports Second Quarter 2026 Financial Results; Provides a Corporate Update on the Cardiac Acute Critical Care Franchise and the Strategic Partnering[...]

Cadrenal Therapeutics Reports Second Quarter 2026 Financial Results; Provides a Corporate Update on the Cardiac Acute Critical Care Franchise and the Strategic Partnering Process

Late-breaking Phase 2 CAD-1005 data presented at ISTH support a late-stage portfolio organized around preoperative safety, orphan regulatory acceleration, and postoperative shielding

PONTE VEDRA, Fla., August 13, 2026 - Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions, today reported financial results for the second quarter ended June 30, 2026, and provided a corporate update on the launch of a structured strategic partnering process following significant clinical, regulatory, and portfolio progress across its Cardiac Acute Critical Care Franchise.

"The second quarter and subsequent weeks marked an important milestone for Cadrenal," said Quang X. Pham, Chairman and Chief Executive Officer of Cadrenal Therapeutics. "Our objective is to convert clinical and regulatory progress into strategic value while remaining capital disciplined. We are also pursuing multiple nondilutive grants to advance our programs. With CAD-1005, frunexian, and tecarfarin addressing complementary acute, critical care, and orphan cardiovascular opportunities, and CAD-2000 extending the 12-LOX platform to treat chronic conditions, we believe Cadrenal offers a differentiated pipeline that addresses critical unmet needs for high-risk patients."

"Having achieved regulatory guidance on the Phase 3 path for CAD-1005, we delivered a late-breaking presentation to the global thrombosis community on Phase 2 data for CAD-1005, which demonstrated an absolute reduction of more than 25% in thrombotic events. Our portfolio, now organized into a Cardiac Acute Critical Care Franchise spanning pre-operative safety, orphan regulatory acceleration, and post-operative shielding, is structured to demonstrate to prospective partners how our assets can address multiple high-value needs across the cardiac surgery continuum."

The strategic alignment of the Cardiac Acute Critical Care (CACC) Franchise organizes Cadrenal's portfolio into three commercial pillars.

Strategic pillar Program / focus Key point
Pre-Operative Safety Frunexian IV for HIT-susceptible patients undergoing coronary artery bypass graft (CABG) surgery Intended to replace volatile alternative anticoagulation protocols and establish a predictable safety profile before surgery.
Orphan Regulatory Acceleration Orphan Drug Designation strategy for HIT patients undergoing cardiac surgery Intended to support seven years of post-approval market exclusivity, fee waivers, and targeted tax credits.
Post-Operative Shield CAD-1005 for Cardiac Surgery-Associated HIT and Cardiac Surgery-Associated Acute Kidney Injury Described as supported by clinical data presented at the ISTH congress in July 2026 regarding its renal-protective profile.

Recent Highlights

Presented late-breaking Phase 2 data on CAD-1005 at the International Society of Thrombosis and Hemostasis (ISTH) 2026 Congress in Paris. The randomized, blinded, placebo-controlled study demonstrated an absolute reduction of more than 25% in thrombotic events when CAD-1005 was added to standard anticoagulant therapy, with a favorable safety profile and renal-protective baseline.
Launched a structured partnering process to explore development, licensing, and commercialization transactions for CAD-1005, frunexian, and tecarfarin. Cadrenal is pursuing a capital-efficient model focused on strategic out-licensing, portfolio monetization, and commercial co-development rather than independently funding large late-stage clinical trials.
Solidified a multi-indication strategy for CAD-1005 in heparin-induced thrombocytopenia (HIT) and Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI). The Company believes that the shared cardiac intensive care infrastructure, intravenous administration, and complementary thrombotic and inflammatory mechanisms may create a differentiated critical care asset package for prospective partners.
Submitted a request to the U.S. Food and Drug Administration on July 8, 2026, for Rare Pediatric Disease Designation for tecarfarin for the prevention of life-threatening blood clots inside coronary artery aneurysms in children with Kawasaki Disease.
Signed an agreement with a global firm that has collectively secured over $500 million in non-dilutive funding for life science companies.
Continued advancing CAD-2000, a highly selective, orally bioavailable preclinical 12-lipoxygenase (12-LOX) inhibitor designed for chronic cardiorenal inflammatory and thrombotic indications, as a potential follow-on companion to the Company's intravenous acute care platform.
Signed a private placement that generated approximately $3.0 million in gross proceeds, with up to approximately $5.8 million in additional gross proceeds if the associated warrants are exercised in full for cash. There can be no assurance that any warrants will be exercised.

Second Quarter 2026 Financial Highlights

Research and development expenses for the quarter ended June 30, 2026, were $0.7 million compared to $1.1 million for the same period in 2025. General and administrative expenses were $2.6 million compared to $2.7 million for the same period in 2025. Total operating expenses were $3.3 million compared to $3.7 million for the same period in 2025. Cadrenal reported a net loss of $3.3 million for the quarter ended June 30, 2026, compared to $3.7 million for the same period in 2025.

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As of early August 2026, Cadrenal had approximately $4.2 million in cash and cash equivalents. Based on its current operating plan, the Company believes these resources are expected to fund operations through the first quarter of 2027. The Company's existing cash resources are not sufficient to advance its product candidates to clinical trial readiness or to commence and complete any clinical trials. Cadrenal does not plan to commence a clinical trial unless funding sufficient to complete that trial is in place, which may include capital raised through strategic partnerships, out-licensing agreements, non-dilutive grants, equity or debt financing, or a combination of these sources.

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions. The Company's pipeline includes CAD-1005, tecarfarin, and frunexian. CAD-1005 is a novel investigational therapeutic in development for the treatment of heparin-induced thrombocytopenia (HIT) and Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI). 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. CAD-1005 has an Orphan Drug Designation ("ODD") from the U.S. Food and Drug Administration ("FDA") for prophylaxis of thrombosis in patients with HIT, FDA Fast Track designation for the treatment and prevention of HIT, and an orphan designation from the European Medicines Agency for the treatment of platelet-activating factor 4 disorders. Second-generation 12-LOX oral therapeutics (CAD-2000) 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 and atrial fibrillation, those with left ventricular assist devices, and potentially those with Kawasaki disease (KD), an acute, self-limited, febrile illness that primarily affects children under 5 years old and is the leading cause of acquired heart disease in developed countries. The Company recently submitted a request for Rare Pediatric Disease Designation (RPDD) to the FDA for tecarfarin for "Prevention of the Formation of Life-Threatening Blood Clots Inside Coronary Artery Aneurysms in Children with Kawasaki Disease". Tecarfarin has also received Orphan Drug and Fast Track designations from the FDA.

For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

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Cadrenal Therapeutics Inc. published this content on August 13, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on August 13, 2026 at 20:32 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]