Tag: Cadrenal Therapeutics

Research News and Market Data on CVKD

Company to present Phase 3-ready pipeline, 12-LOX platform, and pediatric rare-disease expansion to global pharmaceutical partners at the 2026 BIO International Convention in San Diego

Kawasaki disease is the leading cause of acquired heart disease in children in developed nations. Patients are at risk of forming blood clots in coronary arteries and may require lifelong treatment

If the designation is granted and tecarfarin is approved for this indication, Cadrenal would be eligible to receive a Priority Review Voucher-recent open-market valuations for these vouchers have reached into the ~$200 million range

PONTE VEDRA, Fla., June 18, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company advancing late-stage novel therapies for life-threatening immune and thrombotic conditions, today announced plans to submit a Rare Pediatric Disease Designation (RPDD) request to the U.S. Food and Drug Administration (FDA) for tecarfarin as a treatment for pediatric patients with Kawasaki disease (KD) who develop coronary artery aneurysms (CAAs) and require chronic oral anticoagulation.

The announcement comes ahead of the BIO International Convention, June 22-25, 2026, in San Diego, California. Cardenal’s executive leadership team will highlight this rare pediatric initiative and its Phase 3-ready CAD-1005 platform during one-on-one partnering meetings with global and regional pharmaceutical companies.

KD is an acute inflammatory illness and the leading cause of acquired heart disease in children in developed nations. Up to 25% of untreated children with KD develop enlarged coronary arteries or CAAs. Patients with large CAAs are at risk for forming blood clots in those blood vessels – with a continuing lifelong risk for subsequent heart attacks and sudden cardiac death – and require chronic, precise anticoagulation therapy to reduce their higher risk of clot formation.

Tecarfarin is a novel, next-generation Vitamin K antagonist (VKA) that offers a number of potential advantages over warfarin, the current standard VKA in clinical use. Specifically, tecarfarin is designed to overcome limitations of warfarin metabolism and potentially provide more reliable and more consistent anticoagulation than might be possible with warfarin.

“Children with large or giant aneurysms due to KD represent an important underserved orphan population,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “The current standard of care – warfarin – is notoriously unstable in children because of dietary variations, concurrent medications, and genetic differences in liver metabolism. Tecarfarin is metabolized in a completely different way than warfarin, and is being developed to offer a highly stable, predictable alternative. We believe tecarfarin can potentially improve time in therapeutic range for these children, thereby lowering their risk for both catastrophic blood clots and dangerous bleeding events.”

The FDA’s RPDD program targets serious or life-threatening diseases that primarily affect fewer than 200,000 people in the United States from birth through age 18. If the FDA grants the designation and tecarfarin is subsequently approved for this indication, Cadrenal would be eligible to receive a Priority Review Voucher (PRV). These transferable vouchers can be used to accelerate the FDA review of a future drug or sold to another pharmaceutical manufacturer. Following Congress’s extension of the pediatric PRV program through September 30, 2029, recent open-market valuations for these vouchers have reached record highs, with recent sales ranging from $180 million to $205 million.

At the upcoming BIO International Convention, Cadrenal will present a dual-track portfolio strategy designed to maximize value for potential partners:

• The Global Pharma Track: Focusing on CAD-1005, a first-in-class 12-LOX inhibitor. CAD-1005 is Phase 3-ready for Heparin-Induced Thrombocytopenia (HIT) and is advancing into a Phase 2a trial for Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI), addressing a combined, multi-billion-dollar dual-indication acute hospital care market.
• The Regional & Rare Disease Track: Focusing on tecarfarin for Kawasaki disease. This program offers an efficient clinical trial design and strong geographic synergy, particularly for Japanese and East Asian pharmaceutical companies, where the incidence of Kawasaki disease is historically 10 to 15 times higher than in Western nations.

“Our presence at BIO 2026 centers on executing capital-efficient development strategies,” added Mr. Pham. “If we are successful in advancing tecarfarin toward a RPDD, we will create a high-value, de-risked regulatory pathway that aligns with regional partners’ portfolio needs while directing our core internal resources toward our blockbuster CAD-1005 critical care franchise.”

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics is a biopharmaceutical company advancing late-stage novel therapies for life-threatening immune and thrombotic conditions. The company’s pipeline includes CAD-1005, a novel first-in-class 12-LOX inhibitor targeting multiple critical care indications, and tecarfarin, a late-stage oral anticoagulant designed to avoid CYP450 metabolism. CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration, as well as orphan drug status from the European Medicines Agency, for the treatment of Heparin-Induced Thrombocytopenia (HIT). CAD-1005 is also being developed for use in Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI), and second-generation 12-LOX oral therapeutics are in development for chronic indications.

About Tecarfarin

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 those with left ventricular assist devices. Tecarfarin has also received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration.

Safe Harbor Statement

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 regarding plans to file for FDA Rare Pediatric Disease Designation for Tecarfarin in Kawasaki Disease; Cadrenal being eligible to receive a Priority Review Voucher and the value of the voucher; tecarfarin offering a number of potential advantages over warfarin, tecarfarin overcoming limitations of warfarin metabolism and potentially providing more reliable and more consistent anticoagulation than might be possible with warfarin; tecarfarin offering a highly stable, predictable alternative to warfarin; tecarfarin potentially improving time in therapeutic range for these children, thereby lowering their risk for both catastrophic blood clots and dangerous bleeding events and the successful advancement of tecarfarin creating a high-value, de-risked regulatory pathway that aligns with regional partners’ portfolio needs while directing the Company’s core internal resources toward its CAD-1005 critical care franchise Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to raise sufficient capital to continue progress of CAD-1005; the ability for tecarfarin to receive a Rare Pediatric Disease Designation for treatment of Kawasaki Disease; the ability to monetize a priority review voucher if received, the ability to successfully design and complete a dual-track portfolio strategy and maximize value for potential partners; the ability of tecarfarin to overcome limitations of warfarin metabolism and potentially provide more reliable and more consistent anticoagulation than might be possible with warfarin; the ability of tecarfarin offering a highly stable, predictable alternative to warfarin; tecarfarin potentially improving time in therapeutic range for children with Kawasaki Disease, thereby lowering their risk for both catastrophic blood clots and dangerous bleeding events and the successful advancement of tecarfarin creating a high-value, de-risked regulatory pathway that aligns with regional partners’ portfolio needs; ; 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, [email protected]

Research News and Market Data on CVKD

• New high-value indication for Phase 3-ready asset with data intended to support clinical development and strategic partnering discussions
• Additional billion-dollar target- Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI), a serious complication affecting 35,000 U.S. patients annually, with no approved FDA-approved targeted therapies
• Dual-Purpose Synergy – Planned Phase 2a proof-of-concept trial expected to generate safety, renal injury signals, and 12-LOX pathway biology in high-risk cardiac surgery patients, while generating high-value data potentially relevant to the Company’s lead HIT indication
• Capital-Efficient Development: Leverages shared in-hospital ICU infrastructure and an intravenous (IV) formulation to offer a turnkey critical care franchise for a global pharmaceutical partner
• Maximizes 12-LOX Platform Valuation – Strongly positioned for upcoming strategic collaboration and licensing meetings at BIO 2026

PONTE VEDRA, Fla., June 15, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions, today announced that it plans to initiate a Phase 2a proof-of-concept clinical trial of its lead drug candidate, CAD-1005, being studied to prevent Acute Kidney Injury (AKI) in high-risk patients undergoing cardiac surgery. The trial is expected to begin later this year.

“The addition of a CSA-AKI indication further expands CAD-1005’s potential as a multi-billion-dollar critical care platform,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “CAD-1005’s potent, selective 12-LOX inhibition interrupts inflammatory and cell-death cascades frequently associated with cardiac surgery – a mechanism built for success in this population. This dual-indication program offers a turnkey franchise opportunity for pharmaceutical companies seeking to dominate hospital critical care applications and we believe creates a high-value inflection point for Cadrenal to secure a well-capitalized strategic partner and fund our pipeline expansion through non-dilutive collaborations.”

The planned study is intended to expand the clinical evaluation of CAD-1005 into a high-unmet-need acute-care setting while generating data that may be relevant to Cadrenal’s lead Phase 3-ready program in heparin-induced thrombocytopenia (HIT). HIT is a condition caused by an immune response to the widely used hospital blood thinner, heparin, resulting in blood clots that can cause death, amputation, stroke, and significantly increase healthcare costs. The Company expects to discuss the CSA-AKI clinical plan, its implications for CAD-1005’s broader development strategy, and potential non-dilutive collaboration opportunities at the BIO International Convention.

Cardiac surgery remains a cornerstone of cardiovascular care, but it is often complicated by CSA-AKI, which affects roughly 35,000 U.S. patients each year. CSA-AKI represents a potential treatment market estimated at $1 billion annually, a subset of the broader AKI market. CSA-AKI is associated with an approximately 8-fold increase in hospital mortality and significantly increases the risk of progressive, permanent kidney failure. There are currently no FDA-approved targeted pharmacologic therapies to prevent CSA-AKI. Cardiac surgery patients are also at risk for the potentially catastrophic complication of HIT. The planned Phase 2a trial builds on encouraging preclinical data in multiple animal models for CAD-1005 in AKI, as well as existing Phase 1 safety data. Moreover, it leverages the clinical overlap between AKI and HIT in cardiac surgery, enabling Cadrenal to efficiently collect dual-purpose validation data. Thus, in addition to potentially establishing proof of concept in the multi-billion-dollar AKI market, the trial will also generate key safety and mechanistic data that could help to de-risk the pivotal Phase 3 registration path for HIT.

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a first-in-class 12-LOX therapeutic platform focused on thrombosis, inflammation, and the prevention of ischemia-reperfusion-related organ and tissue damage. The Company’s lead asset, CAD-1005, is a selective 12-LOX inhibitor designed to address diseases driven by immune-mediated platelet activation, oxidative stress, and inflammatory tissue injury. CAD-1005 is being developed for heparin-induced thrombocytopenia (HIT), with additional development opportunities in acute kidney injury (AKI) and other critical-care indications characterized by ischemia-reperfusion injury and inflammatory organ damage.

Cadrenal is advancing its 12-LOX platform because this target is suspected to represent a central biological pathway across a broad range of acute and chronic diseases, creating the potential for a differentiated therapeutic pipeline targeting a common disease mechanism. The Company’s plans include developing next-generation oral 12-LOX inhibitors for larger chronic disease opportunities.

Cadrenal’s broader pipeline includes tecarfarin, a late-stage anticoagulant for patients requiring chronic anticoagulation, and frunexian, a Factor XIa inhibitor for acute hospital use.

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

About CAD-1005

CAD-1005 is an investigational therapy under evaluation for the treatment of suspected HIT. CAD-1005 is designed to selectively inhibit 12-LOX, a pathway integral to the primary immune mechanisms that drive HIT. Unlike existing therapies for HIT, which are directed only at preventing thrombotic complications, this approach targets the primary underlying cause of HIT. CAD-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.

About Acute Kidney Injury (AKI)

AKI is one of the most common and serious complications of cardiac surgery, affecting 20-30% of patients after cardiopulmonary bypass (CPB) and requiring renal replacement therapy (RRT) in approximately 1-5% of cases. It significantly increases morbidity, mortality, ICU length of stay, and the long-term risk of chronic kidney disease. There are currently no drugs approved for the prevention of AKI.

About 12-LOX
Lipoxygenases are lipid-metabolizing enzymes that catalyze the conversion of fatty acids into key components of cellular signaling pathways. One of these, 12-Lipoxygenase (12-LOX), plays a key role in the pathogenesis of AKI, immune-mediated platelet activation, and HIT. CAD-1005 is a selective inhibitor of 12-LOX and the only one in clinical-stage development. It has promising preclinical data in AKI and more recent preliminary Phase 2 data in HIT. Genetic depletion or pharmacological inhibition of 12-LOX has been shown to be protective against disease development and/or progression in animal models of diabetes, pulmonary, cardiovascular, and metabolic diseases.

About Heparin-Induced Thrombocytopenia (HIT)

Heparin is the most widely used in-hospital anticoagulant, with more than 12 million patients receiving it in the United States each year. Heparin-induced thrombocytopenia (HIT) is a potentially life-threatening, immune-mediated complication of heparin administration that occurs when antibodies to heparin activate platelets, leading to clots throughout the circulatory system, markedly lowering platelet counts, and increasing the risk of bleeding. Complications of HIT include deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, amputation, and death, with mortality rates for HIT exceeding 20% in some studies. CAD-1005 is the only treatment in clinical development that targets the underlying immune drivers of HIT.

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 regarding the plans for a Phase 2a proof-of-concept clinical trial of CAD-1005 being studied to prevent Acute Kidney Injury (AKI) in high-risk patients undergoing cardiac surgery; enrollment to begin later this year; data intended to support clinical development and strategic partnership discussions; CAD-1005’s potential as a multi-billion-dollar critical care platform; the dual-indication program creating a high-value inflection point for Cadrenal to secure a well-capitalized strategic partner and fund its pipeline expansion through non-dilutive collaborations; being strongly positioned for upcoming strategic collaboration and licensing meetings at BIO 2026; potential to establish proof-of-concept in the multi-billion-dollar AKI market and the trial generating key safety and mechanistic data that could help to de-risk the pivotal Phase 3 registration path. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to raise sufficient capital to continue progress of CAD-1005; the ability to advance to Phase 3 study evaluating CAD-1005 in patients with HIT; the ability to successfully design and complete the Phase 2a study and derive the results needed for further clinical development; 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, please contact:

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

Research News and Market Data on CVKD

Lead asset CAD-1005 being researched for prevention of life-threatening blood clots in patients with Heparin-induced Thrombocytopenia (HIT), targets $2 billion peak annual revenue potential

12-LOX could play a central role in inflammatory signaling across high-impact disease areas, including diabetes, obesity, atherosclerosis, and microvascular thrombosis, and is a potential target for therapy and prevention of cancer

Late-stage anticoagulant tecarfarin has U.S. Food and Drug Administration (FDA) Orphan Drug and Fast Track designations for high-risk patients with End-Stage Renal Disease (ESRD) and Atrial Fibrillation (AFib), and those patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs)

PONTE VEDRA, Fla., June 03, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions, today announced its participation in the BIO International Convention 2026 Partnering Event (BIO 2026) taking place June 22-25, 2026, at the San Diego Convention Center.

The Company’s executive management team will host partnering meetings to discuss development and commercialization opportunities for its differentiated pipeline, headlined by CAD-1005, a Phase 3-ready 12-lipoxygenase (12-LOX) inhibitor being investigated for the treatment of patients with Heparin-Induced Thrombocytopenia (HIT), and tecarfarin, a late-stage oral Vitamin K antagonist (VKA) for being investigated for the treatment of patients with conditions for which current anticoagulation profiles are ineffective or suboptimal.

“BIO 2026 comes at a pivotal moment for Cadrenal as we prepare to initiate our Phase 3 registration trial for CAD-1005,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “With Orphan Drug and Fast Track designations from the FDA, we believe we are uniquely positioned to address the significant unmet need in HIT, a condition where no new therapies have been approved in over two decades. We look forward to engaging with potential partners who share our vision of the potential to bring this breakthrough mechanism to patients.”

Highlighting CAD-1005: A Potential First-in-Class Solution for HIT
At the forefront of Cadrenal’s portfolio is CAD-1005, the only selective 12-LOX inhibitor known to us to be currently in clinical development. CAD-1005 is being investigated to target the root cause of HIT-a severe, immune-mediated reaction to heparin that causes life-threatening blood clots and low platelet counts. Unlike current therapies that only reduce the risk of thrombotic complications, CAD-1005 is being investigated to interrupt the immune signaling feedback loop that drives the development and persistence of HIT.

The Company recently completed an End-of-Phase 2 (EOP2) meeting with the FDA, which provided guidance on the registration path for a single pivotal Phase 3 trial. This follows Phase 2 data demonstrating that CAD-1005 could reduce thrombotic events in patients with HIT.

Unlocking the Potential of the 12-LOX Platform
Beyond HIT, Cadrenal is leveraging the BIO 2026 partnering forum to explore broader applications for its proprietary 12-LOX inhibitor platform. Emerging research indicates that 12-LOX may play a central role in inflammatory signaling across high-impact disease areas, including atherosclerosis, microvascular thrombosis, and metabolic conditions such as diabetes and obesity. Additionally, 12-LOX is a potential target for therapy and prevention of cancer.

The Company’s platform represents a novel approach to modulating inflammation without the broader systemic suppression associated with traditional anti-inflammatory agents. Cadrenal aims to identify strategic collaborations to accelerate the development of its second-generation oral 12-LOX inhibitors (CAD-2000) for these chronic, large-market indications.

Tecarfarin: A Potentially Superior Anticoagulant for Complex Cases
Cadrenal will also present opportunities for tecarfarin, its late-stage oral anticoagulant. Tecarfarin is being designed with the goal of being uniquely metabolized in ways that avoid the drug-drug interactions and renal clearance issues common with warfarin and direct oral anticoagulants (DOACs). Tecarfarin has already received FDA Orphan Drug and Fast Track designations for two specific high-risk populations – patients with End-Stage Renal Disease (ESRD) and Atrial Fibrillation (AFib), and patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs).

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 researched as a first-in-class 12-LOX inhibitor for treating 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, as well as 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 and those with left ventricular assist devices, and frunexian, a parenteral Factor XIa inhibitor intended for use in acute hospital settings.

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 regarding the Company showcasing its Phase 3-ready CAD-1005 and novel 12-LOX platform at BIO 2026; CAD-1005 being researched for the prevention of life-threatening blood clots in patients with HIT; CAD-1005 targeting $2 billion peak annual revenue potential; 12-LOX playing a central role in inflammatory signaling across high-impact disease areas, including diabetes, obesity, atherosclerosis, and microvascular thrombosis; 12-LOX being a potential target for therapy and prevention of cancer; the Company advancing novel therapies for life-threatening immune and thrombotic conditions; the Company’s participation in BIO 2026, taking place June 22-25, 2026, at the San Diego Convention Center; the Company’s executive management team hosting partnering meetings to discuss development and commercialization opportunities for its differentiated pipeline, headlined by CAD-1005, a Phase 3-ready 12-LOX inhibitor being investigated for the treatment of patients with HIT, and tecarfarin, a late-stage oral VKA being investigated for the treatment of patients with conditions for which current anticoagulation profiles are ineffective or suboptimal; Cadrenal preparing to initiate its Phase 3 registration trial for CAD-1005; the Company believing it is uniquely positioned to address the significant unmet need in HIT, a condition where no new therapies have been approved in over two decades; the Company engaging with potential partners who share its vision of the potential to bring this breakthrough mechanism to patients; CAD-1005 being a potential first-in-class solution for HIT; CAD-1005 being investigated to target the root cause of HIT; CAD-1005 being investigated to interrupt the immune signaling feedback loop that drives the development and persistence of HIT; CAD-1005 reducing thrombotic events in patients with HIT; Cadrenal leveraging the BIO 2026 partnering forum to explore broader applications for its proprietary 12-LOX inhibitor platform; 12-LOX playing a central role in inflammatory signaling across high-impact disease areas, including atherosclerosis, microvascular thrombosis, and metabolic conditions such as diabetes and obesity; 12-LOX being a potential target for therapy and prevention of cancer; the Company’s platform representing a novel approach to modulating inflammation without the broader systemic suppression associated with traditional anti-inflammatory agents; Cadrenal aiming to identify strategic collaborations to accelerate the development of its second-generation oral 12-LOX inhibitors (CAD-2000) for these chronic, large-market indications; tecarfarin being a potentially superior anticoagulant for complex cases; Cadrenal presenting opportunities for tecarfarin, its late-stage oral anticoagulant, at BIO 2026; tecarfarin being designed with the goal of being a uniquely metabolized in ways that avoid the drug-drug interactions and renal clearance issues common with warfarin and DOACs; Cadrenal advancing novel therapies for life-threatening immune and thrombotic conditions; CAD-1005 being researched as a first-in-class 12-LOX inhibitor for treating HIT; the development of second-generation 12-LOX oral therapeutics for chronic indications; tecarfarin preventing heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease and those with left ventricular assist devices; and frunexian being used in acute hospital settings. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to 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, [email protected]

Research News and Market Data on CVKD

Official FDA meeting minutes and Phase 2 data provide guidance on the pivotal Phase 3 registration path for CAD-1005 in heparin-induced thrombocytopenia (HIT)

PONTE VEDRA, Fla., May 07, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions, today reported its financial results for the first quarter ended March 31, 2026, and provided a corporate update highlighting continued progress in its CAD-1005 program for HIT. The Company has now received the official minutes from its End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), which provided guidance on key elements of the planned pivotal Phase 3 registration trial for CAD-1005, Cadrenal’s investigational first-in-class 12-lipoxygenase (12-LOX) inhibitor being developed to treat suspected heparin-induced thrombocytopenia (HIT). Based on this feedback and Phase 2 data, Cadrenal plans to advance directly to a randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to standard-of-care anticoagulation in patients with HIT.

Recent Highlights

• Received official FDA EOP2 meeting minutes providing guidance on protocol design, study population, dosing, background therapy, exposure, safety database, and the primary endpoint of new or worsening thrombotic events.
• After considering FDA feedback on a pivotal registration study, Cadrenal plans to advance directly to a randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to the current standard of care for patients with HIT.
• Planned pivotal Phase 3 study, the first randomized, blinded, placebo-controlled registration trial in HIT, will evaluate CAD-1005 in approximately 120 patients across clinical centers worldwide and is intended to support a projected NDA submission in 2029.
• Primary endpoint, centrally adjudicated, is expected to be the incidence of new or worsening thrombotic events in patients with Serotonin Release Assay (SRA)-confirmed HIT, with at least one planned interim analysis.
• Phase 2 data showed an absolute reduction of more than 25% in thrombotic events when CAD-1005 was added to standard anticoagulant therapy, supporting the continued advancement of CAD-1005 as Cadrenal’s near-term development priority.
• Continues to position CAD-1005 as a first-in-class, selective 12-LOX inhibitor and the only treatment in clinical development that targets the underlying immune drivers of HIT, supported by Orphan Drug and Fast Track designations from the FDA and by orphan drug status from the European Medicines Agency.

“With the official EOP2 meeting minutes now in hand, we believe the registration path for CAD-1005 in HIT is clearly defined,” commented Quang X. Pham, Chairman & CEO. “The FDA’s guidance on trial design and the primary endpoint of new or worsening thrombotic events reinforces our confidence in advancing directly to a pivotal Phase 3 study. We believe CAD-1005 has the potential to be the first new therapy for HIT in more than two decades.”

First Quarter 2026 Financial Highlights

Research and development expenses for the quarter ended March 31, 2026, were $0.8 million compared to $1.7 million for the same period in 2025. General and administrative expenses were $1.7 million compared to $2.3 million for the same period in 2025. Total operating expenses were $2.5 million compared to $3.9 million for the same period in 2025. Cadrenal reported a net loss of $2.5 million for the quarter ended March 31, 2026, compared to $3.8 million for the same period in 2025.

As of March 31, 2026, Cadrenal had cash and cash equivalents of $2.3 million. Subsequent to quarter end, on April 1, 2026, the Company completed a $2.5 million financing, providing additional capital to support near-term development activities. The Company continues to evaluate financing and strategic alternatives to support its planned clinical development activities, including the anticipated pivotal Phase 3 trial of CAD-1005 in HIT.

The Company is advancing Phase 3 readiness activities, including protocol finalization, and expects to provide further updates in the coming quarters.

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 a first-in-class 12-LOX inhibitor being developed to treat 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 and those with left ventricular assist devices, and frunexian, a parenteral Factor XIa inhibitor intended 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, without limitation, statements regarding continued progress in its CAD-1005 program for HIT ; plans to advance directly to a randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to standard-of-care anticoagulation in patients with HIT; the planned pivotal Phase 3 study being the first randomized, blinded, placebo-controlled registration trial in HIT; the Phase 3 study evaluating CAD-1005 in approximately 120 patients across clinical centers worldwide; the trial supporting a projected NDA submission in 2029; the incidence of new or worsening thrombotic events in patients with Serotonin Release Assay (SRA)-confirmed HIT being the primary endpoint of the trial; the trial having at least one planned interim analysis; continuing to position CAD-1005 as a first-in-class, selective 12-LOX inhibitor and the only treatment in clinical development that targets the underlying immune drivers of HIT; the registration path for CAD-1005 in HIT being clearly defined; and CAD-1005 having the potential to be the first new therapy for HIT in more than two decades. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to raise sufficient capital to continue progress of CAD-1005; the ability to advance directly to a randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to standard-of-care anticoagulation 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, please contact:

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

View full release here.