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Brad Hart

General Manager

Brad Hart is responsible for the product strategy of the Helix Core platform – an integrated suite of tools that includes Helix ALM, Helix DAM, Helix IPLM, Helix Plan, Helix Swarm, and all related Helix Core clients and plug-ins. He also leads the Sales and Solutions Engineering team for Digital Creation.

With over two decades of experience in leadership roles at high tech companies, Brad has become an expert in optimizing development pipelines. His specializations include software engineering process, design, and implementation.

In this demo video, solutions engineer Olaf Van Gorp explains how to use API Ops in your Akana API Platform.

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Transcript

Akana 2026 introduces a new feature that allows for effective and reliable promotion of API products to their production environment using command-line functions. This means that promotion can be done in a fully automated manner. Moreover, the process can easily be integrated with existing CI/CD pipeline tools like Jenkins.

All tasks and corresponding responsibilities can easily be allocated to the appropriate teams. For example, the API product team will typically be responsible for the API export and import actions. The DevOps team will take control of review and approval, and push approved updates to the designated repository branch from where they can be imported.

The API Ops tool ensures a consistent import process including any modifications that are necessary from source to target environment. For example, API endpoint hostnames, Oauth domains and even policy configurations may have to be adjusted from one environment to the next.

Also, the API Ops tool can be configured to create any related objects that are not yet present in the target environment, for example policies, contracted apps or API user groups. All in all, this improved way of API product promotion enables repeatable, controlled and auditable deployments.

Once the API product configuration updates have been pushed to the appropriate remote git repository branch, they can be reviewed by the DevOps team. Once approved, the updates can be merged with any other updates into the test branch, from which the API product can be imported into the Akana test environment.

With all API product changes reliably merged into the test branch, the API product team can now import the APIs into the Akana test environment for further API testing.

In summary, the new Akana API Ops feature provides a reliable mechanism for promoting API products and their associated artifacts between environments. Through seamless integration with version control systems like Git, API Ops enables a structured delivery workflow that supports consistent and controlled deployment of API products to production.

Selection highlights the clinical value potential of Cadrenal’s first-in-class 12-lipoxygenase inhibitor for Heparin-Induced Thrombocytopenia (HIT)

First-ever randomized, blinded, placebo-controlled trial in HIT, a life-threatening blood-clotting disorder triggered by an immune reaction to heparin, the most widely used blood thinner in hospitals

Phase-3 ready and addresses a peak $2 billion annual revenue potential in the HIT market

PONTE VEDRA, Fla., June 24, 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 that late-breaking clinical data on its first-in-class 12-lipoxygenase (12-LOX) inhibitor, CAD-1005 (formerly VLX-1005), have been accepted for a prestigious oral presentation at the 34th Congress of the International Society on Thrombosis and Haemostasis (ISTH). The congress will be held live and onsite from July 11-15, 2026, at the Palais des Congrès de Paris in Paris, France.

The abstract, titled “12-lipoxygenase inhibition with VLX-1005 in heparin-induced thrombocytopenia,” was selected by expert peer reviewers for inclusion in the high-profile session on clinical trials and breakthrough innovations.

“The selection of our Phase 2 CAD-1005 study for a late-breakthrough oral presentation at ISTH is another milestone underscoring the scientific integrity and commercial importance of our pipeline,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “Heparin-Induced Thrombocytopenia represents a high-value therapeutic market with significant unmet needs and no approved therapies that target the specific underlying immune mechanisms of HIT. This presentation offers an elite global platform to showcase the clinical potential of CAD-1005.”

“Targeting 12-lipoxygenase is a novel, highly selective therapeutic approach that addresses the root cause of immune-mediated platelet activation in HIT,” added Dr. Steve McKenzie, Professor of Medicine at Thomas Jefferson University, the principal investigator and presenter. “The data we are presenting live in Paris – the first-ever randomized, blinded, placebo-controlled trial in HIT – illustrate how CAD-1005 could fundamentally shift the treatment paradigm for acute thrombotic care and may, if approved, offer a highly differentiated option for these high-risk patients.”

Presentation Details:

- Session Title: Late-Breakthrough Abstracts I: Clinical Trials and Innovation in Thrombosis

- Abstract Title: 12-lipoxygenase inhibition with VLX-1005 in heparin-induced thrombocytopenia

- Date: July 12, 2026

- Session Time: 11:15 AM – 12:00 PM CEST

For additional details regarding the scientific program, please visit the ISTH Congress Official Website.

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 under 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 associated with HIT. CAD-1005 is intended to be used alongside existing standards of care and is being developed to address the underlying biological mechanisms that contribute to disease progression.

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 the leading cause of acquired heart disease in developed countries.

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 late-breakthrough oral presentation at ISTH being a significant milestone that supports the scientific integrity and commercial importance of the Company’s pipeline and the data being presented illustrating how CAD-1005 could fundamentally shift the treatment paradigm for acute thrombotic care, and may, if approved, offer a highly differentiated option for these high-risk patient patients and CAD-1005 being intended to be used in conjunction with existing standards of care and is being developed to address the underlying biological mechanisms contributing to disease progression.

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]

$3 million upfront with up to approximately $5.8 million of potential additional gross proceeds upon the exercise in full of warrants

Net proceeds anticipated to extend cash runway into first quarter of 2027; if warrants are exercised in full for cash, it is anticipated that the cash runway would extend into second half of 2027 to advance partnering opportunities for tecarfarin in Kawasaki Disease (potential rare pediatric disease designation) and CAD-1005 in CSA-AKI and HIT

PONTE VEDRA, Fla., June 30, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) (the “Company”), a biopharmaceutical company advancing late-stage novel therapies for life-threatening immune and thrombotic conditions, today announced that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the issuance and sale of 960,000 shares of its common stock (or pre-funded warrants in lieu thereof), series C-1 warrants to purchase up to an aggregate of 960,000 shares of common stock and series C-2 warrants to purchase up to an aggregate of 960,000 shares of common stock, at a combined purchase price of $3.125 per share (or pre-funded warrant in lieu thereof) and accompanying warrants in a private placement priced at-the-market under Nasdaq rules.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The series C-1 warrants will have an exercise price of $3.00 per share, will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares of common stock issuable upon exercise of the series C-1 warrants (the “Stockholder Approval Date”) and will expire five years after the later of (i) the Stockholder Approval Date and (ii) the effective date of a resale registration statement registering for resale all of the shares of common stock underlying the series C-1 warrants. The series C-2 warrants will have an exercise price of $3.00 per share, will be exercisable immediately upon issuance, and will expire twenty-four months after the effective date of a resale registration statement registering for resale all of the shares of common stock and the shares of common stock underlying the series C-2 warrants.

The aggregate gross proceeds to the Company from the offering are expected to be $3 million, before deducting placement agent fees and other offering expenses. The potential additional gross proceeds to the Company from the series C-1 warrants and the series C-2 warrants, if fully exercised on a cash basis, will be approximately $5.8 million. No assurance can be given that any of the warrants will be exercised, or that the Company will receive cash proceeds from the exercise of the warrants. The offering is expected to close on or about July 1, 2026, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering for working capital purposes.

The securities described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”) and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants sold in the offering, have not been registered under the Act or applicable state securities laws. Accordingly, such securities may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (“SEC”) or an applicable exemption from such registration requirements. Pursuant to a registration rights agreement, the Company has agreed to file one or more registration statements with the SEC covering the resale of the unregistered securities to be issued in the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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, and Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI). 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 the leading cause of acquired heart disease in developed countries.

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 closing of the offering, the satisfaction of customary closing conditions related to the offering, the expected gross proceeds from the offering, the Company seeking stockholder approval, receipt of stockholder approval, the filing of one or more registration statements with the SEC covering the resale of the unregistered securities to be issued in the offering, the intended use of net proceeds from the offering, the potential exercise of the warrants for cash prior to their expiration and the Company’s receipt of potential proceeds therefrom, net proceeds anticipated to extend the Company’s cash runway into first quarter of 2027; and the Company’s cash runway anticipated to be extended into second half of 2027 to advance partnering opportunities for tecarfarin in Kawasaki Disease (potential rare pediatric disease designation) and CAD-1005 in CSA-AKI and HIT.

Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to close the offering, the ability of the Company to obtain stockholder approval, the ability of the Company to advance partnering opportunities for tecarfarin in Kawasaki Disease (potential rare pediatric disease designation) and CAD-1005 in CSA-AKI and HIT; the ability to raise sufficient capital to continue progress of its product candidates; the ability to 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]

- 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, [email protected]

- Capital-efficient strategy focuses on differentiated therapies for cardiac pre- and post-operative critical care and orphan cardiovascular conditions

- Company is exploring development, licensing, and commercialization partnerships for CAD-1005, frunexian, and tecarfarin

- Recently presented Phase 2 CAD-1005 data demonstrated a >25% absolute reduction in thrombotic events in patients with heparin-induced thrombocytopenia

PONTE VEDRA, Fla., July 21, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions, today announced a comprehensive alignment of its clinical portfolio into a Cardiac Acute Critical Care Franchise. Concurrently, the Company has initiated a structured process to secure strategic out-licensing, portfolio monetization, or commercial co-development partnerships for its late-stage assets.

Cadrenal has assembled multiple late-stage critical care cardiovascular assets designed to address serious conditions for which existing treatment options remain inadequate. This capital-efficient operational model addresses a large, unserved therapeutic whitespace, unlocking substantial cumulative platform potential. The strategy positions Cadrenal’s assets as high-value additions which may be capable of delivering immediate value to the pipelines of global companies across rare disease therapies, critical care cardiology, and cardiac intensive care unit (CICU) medical products.

The strategic alignment of the Cardiac Acute Critical Care Franchise organizes Cadrenal’s portfolio into three high-value commercial pillars:

- Pillar 1: Pre-Operative Safety (Frunexian IV): An IV Factor XIa inhibitor for heparin-induced thrombocytopenia (HIT)-susceptible patients undergoing coronary artery bypass graft (CABG) surgery, designed to replace unpredictable alternative protocols. Phase 2-ready.

- Pillar 2: Orphan Regulatory Acceleration (including Tecarfarin for Kawasaki Disease): Leveraging substantial commercial tailwinds, fee waivers, and potential seven-year market exclusivity associated with the potential Orphan Drug Designation (ODD) pathways for cardiac surgery patients. Phase 3-ready.

- Pillar 3: Post-Operative Shield (CAD-1005): A Phase 3-ready IV 12-LOX inhibitor designed to target platelet hyperactivation and thrombotic risk in patients with post-operative Heparin-Induced Thrombocytopenia (HIT). Secondary benefits may include blocking the inflammatory 12-HETE cascade to reduce cardiac surgery-associated acute kidney injury (CSA-AKI).

This franchise framework is strongly supported by the impressive clinical data presented earlier this month at the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress in Paris. The late-breaking Phase 2 data for CAD-1005 demonstrated a compelling medical profile, with a greater than 25% absolute reduction in thrombotic events and a favorable safety and renal-protective baseline.

“Our landmark clinical data presentation at ISTH 2026 has validated the mechanisms and the immense medical value of our Cardiac Acute Critical Care Franchise,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “By organizing our pipeline into three distinct commercial pillars, we are positioning Cadrenal to maximize asset value. Transitioning to a partnership-driven business model enables us to map a direct, efficient path to commercialization alongside global industry leaders.”

In tandem with this strategic focus, the Company is advancing updates to its clinical pipeline for tecarfarin, highlighting its distinct carboxylesterase-1 (CES-1)-mediated metabolism, which helps avoid dangerous drug-drug interactions. This includes expanding clinical protocols to rare pediatric disease indications, such as giant coronary artery aneurysms (CAAs) caused by Kawasaki Disease-potentially qualifying the asset for a high-value, open-market Priority Review Voucher (PRV)-while continuing to support established indications in End-Stage Kidney Disease (ESKD) and Left Ventricular Assist Devices (LVADs).

Standalone Platform Expansion: Oral 12-LOX (CAD-2000)

Beyond the Cardiac Acute Critical Care Franchise, Cadrenal is advancing its preclinical platform asset, CAD-2000, a highly selective, orally bioavailable 12-lipoxygenase (12-LOX) inhibitor designed to treat chronic cardiorenal inflammatory and thrombotic indications. CAD-2000 serves as a potent oral follow-on companion to the Company’s IV acute care platform, potentially enabling prospective partners to capture extended market share across both acute inpatient settings and chronic outpatient follow-up care.

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. 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. To view how CAD-1005 is intended to work in patients with 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 specialized therapies for critical care cardiology and orphan cardiovascular 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. The Company’s Cardiac Acute Critical Care Franchise also includes frunexian, an investigational intravenous Factor XIa inhibitor designed to provide anticoagulation for patients undergoing major cardiac surgery.

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 under 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 Cadrenal launching a partnering process; advancing its Cardiac Acute Critical Care Assets to transaction readiness following landmark ISTH data presentation; the Company’s capital-efficient strategy focusing on differentiated therapies for cardiac pre- and post-operative critical care and orphan cardiovascular conditions; the Company exploring development, licensing, and commercialization partnerships for CAD-1005, frunexian, and tecarfarin; the Company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions; the Company securing strategic out-licensing, portfolio monetization, or commercial co-development partnerships for its late-stage assets; Cadrenal’s multiple late-stage critical care cardiovascular assets addressing serious conditions for which existing treatment options remain inadequate; the capital-efficient operational model addressing a large, unserved therapeutic whitespace, unlocking substantial cumulative platform potential; Cadrenal’s assets delivering immediate value to the pipelines of global companies across rare disease therapies, critical care cardiology, and cardiac intensive care unit (CICU) medical products; frunexian IV successfully replacing unpredictable alternative protocols; the potential of CAD-1005 to block the inflammatory 12-HETE cascade to reduce cardiac surgery-associated acute kidney injury; positioning Cadrenal to maximize asset value; transitioning to a partnership-driven business model enabling the Company to map a direct, efficient path to commercialization alongside global industry leaders; the Company advancing updates to its clinical pipeline for tecarfarin, highlighting its distinct carboxylesterase-1 (CES-1)-mediated metabolism, which helps avoid dangerous drug-drug interactions; expanding clinical protocols to rare pediatric disease indications, such as giant coronary artery aneurysms (CAAs) caused by Kawasaki Disease-potentially qualifying the asset for a high-value, open-market Priority Review Voucher (PRV)-while continuing to support established indications in End-Stage Kidney Disease (ESKD) and Left Ventricular Assist Devices (LVADs); Cadrenal advancing its preclinical platform asset, CAD-2000, a highly selective, orally bioavailable 12-lipoxygenase (12-LOX) inhibitor designed to treat chronic cardiorenal inflammatory and thrombotic indications.

- Urgent Need for Novel Targets – Recent clinical failure of a competing mechanism highlights urgent need for novel upstream targets, such as 12-LOX, that are being studied to address the root causes of cardio-renal injury

- Dual-Indication Development and Commercialization Strategy Expands the Clinical Advancement of CAD-1005 to target both Heparin-Induced Thrombocytopenia (HIT) and Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI)

- Addresses High-Value Gap in the Acute Care Market -First-in-class positioning in the $1 billion+ U.S. CSA-AKI market following the recent discontinuation of a competitor’s late-stage Phase 3 clinical trial for lack of efficacy

- Global Partnering Potential – Leverages shared in-hospital ICU infrastructure and intravenous (IV) presentation to deliver a critical care asset package

PONTE VEDRA, Fla., Aug. 03, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions, announced a consolidation of its multi-indication strategy for its Cardiac Acute Critical Care (CACC) Franchise, with a focus on CAD-1005 for both HIT and CSA-AKI.

Following a competitor’s recent Phase 3 failure in CSA-AKI, Cadrenal is highlighting the potential of its 12-LOX inhibitor to address a $1 billion+ market opportunity in this critical care space. CAD-1005 is being studied as a “Post-Operative Shield” that uses 12-lipoxygenase (12-LOX) inhibition intended to target platelet hyperactivation in HIT while simultaneously reducing inflammation-driven injury in patients with CSA-AKI. This dual-mechanism approach is supported by CAD-1005 clinical data presented last month at the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress in Paris. The late-breaking Phase 2 data for CAD-1005 demonstrated a compelling medical profile, with an absolute reduction in thrombotic events greater than 25% and a favorable safety and renal-protective baseline.

“The recent clinical failure of a competing late-stage mechanism highlights the urgent need for novel upstream targets, such as 12-LOX, that address the root causes of cardio-renal injury,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “This trial termination underscores the ongoing clinical challenge of identifying targeted pharmacologic strategies for the treatment of CSA-AKI, as no single drug class has yet demonstrated clear preventive efficacy for the condition. The company is actively pursuing strategic partnerships, including out-licensing or co-development, to leverage its transaction-ready, Phase 3-ready asset.

About CAD-1005

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 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. Second-generation 12-LOX oral therapeutics are also being evaluated for chronic indications. To view how CAD-1005 is intended to work in patients with HIT, visit 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 specialized therapies for critical care cardiology and orphan cardiovascular conditions. Its lead program, CAD-1005, is being investigated as a first-in-class 12-LOX inhibitor for the treatment of heparin-induced thrombocytopenia (HIT), a deadly immune-mediated thrombotic disorder, and Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI). The Company’s Cardiac Acute Critical Care (CACC) portfolio also includes frunexian, an investigational intravenous Factor XIa inhibitor intended to provide anticoagulation for patients undergoing major cardiac surgery.

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.

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 the ability of the Company’s Cardiac Acute Critical Care Franchise to address a crucial unmet need; the Company leveraging shared in-hospital ICU infrastructure and identical intravenous (IV) formulations to deliver a critical care asset package; the Company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions; the potential of CAD-1005 to address a $1B+ market gap; CAD-1005 potentially using 12-LOX inhibition to target platelet hyperactivation in HIT while simultaneously reducing inflammation-driven injury in patients with CSA-AKI; 12-LOX addressing the root causes of cardio-renal injury; identifying targeted pharmacologic strategies for the treatment of CSA-AKI; the company’s pursuit of strategic partnerships, including out-licensing or co-development, to leverage its Phase 3-ready asset; CAD-1005 addressing the underlying biological mechanisms that drive disease progression; the development of second-generation 12-LOX oral therapeutics for the treatment of chronic indications; frunexian potentially providing anticoagulation for patients undergoing major cardiac surgery; tecarfarin potentially treating 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; and the FDA’s determination with respect to the Company’s request for RPDD for 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 advance specialized therapies for critical care cardiology and orphan cardiovascular conditions; the ability to enter into strategic partnerships, including out-licensing or co-development, to leverage its Phase 3-ready asset; the ability of CAD-1005 to address a $1B+ market gap; the ability of 12-LOX inhibition to target platelet hyperactivation in HIT while simultaneously reducing inflammation-driven injury in patients with CSA-AKI; the ability of 12-LOX to address the root causes of cardio-renal injury; the ability to develop second-generation 12-LOX oral therapeutics for the treatment of chronic indications; the ability of frunexian to provide anticoagulation for patients undergoing major cardiac surgery; the ability of tecarfarin to treat patients requiring chronic anticoagulation, including those with end-stage kidney disease and atrial fibrillation, those with left ventricular assist; the ability of the Company to raise sufficient capital to continue the clinical development of its product candidates; 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]

PONTE VEDRA, Fla., Aug. 13, 2026 (GLOBE NEWSWIRE) — 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.

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.

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.

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 converting clinical and regulatory progress into strategic value while remaining capital disciplined; pursuing multiple nondilutive grants to advance the Company’s programs; Cadrenal offering a differentiated pipeline that addresses critical unmet needs for high-risk patients; the CACC Franchise demonstrating to prospective partners how the Company’s assets can address multiple high-value needs across the cardiac surgery continuum; frunexian IV replacing volatile alternative anticoagulation protocols for HIT-susceptible patients undergoing CABG surgery and establishing a predictable safety profile; ODD for HIT supporting seven years of post-approval market exclusivity, fee waivers and targeted tax credits; CAD-1005 serving as a post-operative shield for Cardiac Surgery-Associated HIT and CSA-AKI; the Company’s ability to enter into development, licensing, and commercialization transactions for CAD-1005, frunexian, and tecarfarin; the shared cardiac intensive care infrastructure, intravenous administration, and complementary thrombotic and inflammatory mechanisms creating a differentiated critical care asset package for prospective partners; the FDA’s ultimate decision regarding the Company’s request for RPDD for tecarfarin for the prevention of life-threatening blood clots inside coronary artery aneurysms in children with Kawasaki Disease; CAD-2000 potentially being a follow-on companion to the Company’s intravenous acute care platform; the potential exercise of the warrants issued in the Company’s private placement resulting in gross proceeds of up to $5.

FDA Alignment on Primary Endpoint and Path Forward for Phase 3 Registration Study

CAD-1005 Targets a Significant Unmet Need, with Approximately 50,000 Confirmed Acute HIT Diagnoses Annually in the U.S. and an Estimated $2 Billion in Peak Annual Revenue Opportunity

PONTE VEDRA, Fla., Aug. 31, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions, today announced positive feedback from a Type D Meeting with the U.S. Food and Drug Administration (FDA) held on July 28, 2026. During the meeting, Cadrenal and the FDA aligned on key aspects of the protocol and Statistical Analysis Plan (SAP) for the Phase 3 registrational study of CAD-1005, the Company’s first-in-class 12-lipoxygenase (12-LOX) inhibitor in development to treat heparin-induced thrombocytopenia (HIT). HIT is a potentially life-threatening immune reaction to heparin, a widely used blood thinner, and can lead to dangerous blood clots.

In the U.S., heparin-induced thrombocytopenia (HIT) is a high-stakes emergency that affects approximately 50,000 patients with acute HIT each year. Current therapeutic options rely on standard anticoagulants to reduce thrombotic risk; however, they do not target the underlying immune mechanisms that drive this destructive cardiovascular cascade. CAD-1005 is a novel 12-LOX inhibitor designed to halt the core immune signaling pathway that drives platelet activation and vascular thrombosis. Developed as an essential add-on to standard anticoagulation, CAD-1005 targets a critical population and is projected to generate $2 billion in peak annual revenue.

During the Type D meeting, the FDA agreed on an optimized definition of worsening HIT for the primary endpoint, based on progression of thrombotic events through Day 14 of treatment or hospital discharge. To ensure high-quality, reliable endpoint evaluation across clinical sites, the worsening component of the primary endpoint will also include extension of an existing thrombus into a new vascular segment or bed, avoiding potential site-to-site variability from manual size measurements. The updated composite primary endpoint will measure the proportion of Serotonin Release Assay-positive (SRA+) participants with adjudicated new or worsening composite thromboembolic events (CTEs) through Day 14 or hospital discharge. Additionally, the FDA agreed to use placebo control in the Phase 3 trial, with standard anticoagulation therapeutics for both the CAD-1005 and placebo control arms.

“We are very pleased with the collaborative, constructive feedback from the FDA during this Type D meeting,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “Securing agreement on the primary endpoint definition and the blinding protocols for our saline control provides greater clarity on the regulatory path forward for CAD-1005. We have incorporated the Agency’s recommendations into our Phase 3 protocol and Statistical Analysis Plan, strengthening the design of a registration study intended to evaluate whether CAD-1005 can reduce dangerous thrombotic events that persist in patients with HIT despite current anticoagulant therapies.”

The Phase 3 trial design will also assess bleeding as a major safety endpoint using standard International Society on Thrombosis and Haemostasis (ISTH) criteria. All safety analyses will be conducted in the safety population of patients who receive at least one dose of the study drug.

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 to the FDA for Rare Pediatric Disease Designation (RPDD) 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.

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 planned Phase 3 registration study of CAD-1005, the development of CAD-1005 to treat HIT; CAD-1005 potentially halting the core immune signaling pathway that drives platelet activation and vascular thrombosis; CAD-1005 being an essential add-on to standard anticoagulation; CAD-1005 unlocking a projected $2 billion in peak annual revenue; the worsening component of the primary endpoint of optimized definition of worsening HIT assessing extension of an existing thrombus into a new vascular segment or bed, avoiding potential site-to-site variability from manual size measurements; the updated composite primary endpoint measuring the proportion of Serotonin Release Assay-positive (SRA+) participants with adjudicated new or worsening composite thromboembolic events (CTEs) through Day 14 or hospital discharge; the regulatory path forward for CAD-1005; the registration study evaluating whether CAD-1005 can reduce dangerous thrombotic events that continue to occur in patients with HIT despite current anticoagulant therapies; the Phase 3 trial design evaluating bleeding as a major safety endpoint using standard International Society on Thrombosis and Haemostasis (ISTH) criteria; all safety analyses in the Phase 3 trial being conducted in the true safety population of patients who receive at least one dose of the study drug; the Company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions; CAD-1005 being successfully developed to treat HIT and CSA-AKI; CAD-1005 selectively inhibiting 12-LOX, an enzyme central to platelet immune activation and thrombo-inflammatory signaling in HIT; CAD-1005 being intended to be used alongside existing standards of care and being developed to address the underlying biological mechanisms that drive disease progression; second-generation 12-LOX oral therapeutics (CAD-2000) being developed for chronic indications; tecarfarin, a late-stage oral vitamin K antagonist, potentially preventing 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; and the FDA’s ultimate decision regarding the Company’s request for RPDD for tecarfarin for the prevention of life-threatening blood clots inside coronary artery aneurysms in children with Kawasaki Disease; Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to advance its programs to clinical trial readiness; the Company’s ability to enter into development, licensing, and commercialization transactions for CAD-1005, frunexian, and tecarfarin; the Company’s ability to secure nondilutive grants to advance its programs; 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

PONTE VEDRA, Fla., Sept. 03, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions, announced that CEO Quang X. Pham will participate in the 28th Annual H.C. Wainwright Global Investment Conference, September 14-16, 2026, at the Lotte New York Palace Hotel in New York City.

A pre-recorded presentation from the Company will be available on demand through the conference portal beginning Friday, September 11, 2026, at 7:00 a.m. ET. A copy of the slide presentation will be available on the investor relations section of the Cadrenal website at https://www.cadrenal.com/investors/.

During the event, Mr. Pham is expected to discuss Cadrenal’s Cardiac Acute Critical Care Franchise, the launch of its structured partnering process for CAD-1005, frunexian, and tecarfarin, and recent Phase 2 clinical data on CAD-1005.

Mr. Pham will be available for one-on-one investor meetings at the conference. Investors interested in scheduling a meeting should contact their H.C. Wainwright representative at [email protected] or Cadrenal’s investor relations at [email protected].

Event Details

Conference: 28th Annual H.C. Wainwright Global Investment Conference

Conference Dates: September 14-16, 2026

Pre-Recorded Virtual Presentation: Available starting Friday, September 11, 2026, at 7:00 a.m. ET

Presentation Access: H.C. Wainwright conference portal

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 to the FDA for Rare Pediatric Disease Designation (RPDD) 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.

For more information, please contact:

Lytham Partners, LLC

Robert Blum, Managing Partner

602-889-9700