Form 8-K

8-K — Cadrenal Therapeutics, Inc.

Accession: 0001213900-26-079824

Filed: 2026-07-21

Period: 2026-07-21

CIK: 0001937993

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — ea0298669-8k_cadrenal.htm (Primary)

EX-99.1 — PRESS RELEASE, ISSUED BY CADRENAL THERAPEUTICS, INC. ON JULY 21, 2026 (ea029866901ex99-1.htm)

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8-K — CURRENT REPORT

8-K (Primary)

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0001937993

2026-07-21

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UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

WASHINGTON,

D.C. 20549

FORM

8-K

CURRENT

REPORT

Pursuant

to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date

of Report (date of earliest event reported): July 21, 2026

Cadrenal

Therapeutics, Inc.

(Exact

name of registrant as specified in charter)

Delaware

001-41596

88-0860746

(State

or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS

Employer

Identification No.)

822

A1A North, Suite 306

Ponte

Vedra, Florida 32082

(Address

of principal executive offices and zip code)

(904)

300-0701

(Registrant’s

telephone number including area code)

N/A

(Former

name or former address, if changed since last report)

Check

the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of registrant under any

of the following provisions (see General Instruction A.2. below):

☐

Written communications

pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting

material pursuant to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement

communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement

communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities

registered pursuant to Section 12(b) of the Act:

Title

of each class

Trading

Symbols

Name

of each exchange on which registered

Common Stock, par value

$0.001 per share

CVKD

The Nasdaq Stock Market

LLC

(Nasdaq Capital Market)

Indicate

by check mark whether the registrant is an emerging growth company as defined in in Rule 405 of the Securities Act of 1933 (§230.405

of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging

growth company ☒

an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item

7.01. Regulation FD Disclosure.

July 21, 2026, Cadrenal Therapeutics, Inc. (the “Company”) issued a press release announcing a comprehensive alignment of

its clinical portfolio into a Cardiac Acute Critical Care Franchise and the initiation of a structured process to secure strategic out-licensing,

portfolio monetization, or commercial co-development partnerships for its late-stage assets.

copy of the press release is furnished herewith as Exhibit 99.1. The information in this Item 7.01 and in the press release furnished

as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities

Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities

Act of 1933, as amended, and shall not be incorporated by reference into any filing with the Securities and Exchange Commission (the

“SEC”) made by the Company, whether made before or after the date hereof, regardless of any general incorporation language

in such filing.

Item

8.01. Other Events.

July 21, 2026, the Company issued a press release announcing a comprehensive alignment of its clinical portfolio into a Cardiac Acute

Critical Care Franchise and the initiation of a structured process to secure strategic out-licensing, portfolio monetization, or commercial

co-development partnerships for its late-stage assets.

Item

9.01 Financial Statements and Exhibits.

(d)

Exhibits

The

following exhibits are furnished with this Current Report on Form 8-K:

Exhibit

Number

Exhibit

Description

99.1

Press Release, issued by Cadrenal Therapeutics, Inc. on July 21, 2026

104

Cover Page Interactive

Data File (the cover page XBRL tags are embedded within in the inline XBRL document)

SIGNATURES

Pursuant

to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by

the undersigned hereunto duly authorized.

Dated: July 21, 2026

CADRENAL THERAPEUTICS, INC.

By:

/s/

Quang X. Pham

Name:

Quang X. Pham

Title:

Chairman and Chief Executive Officer

EX-99.1 — PRESS RELEASE, ISSUED BY CADRENAL THERAPEUTICS, INC. ON JULY 21, 2026

EX-99.1

Filename: ea029866901ex99-1.htm · Sequence: 2

Exhibit 99.1

FOR IMMEDIATE RELEASE

Cadrenal Therapeutics Launches Partnering Process

as Its Cardiac Acute Critical Care Assets Advance to Transaction Readiness Following Landmark ISTH Data Presentation:

● 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, FL — July 21, 2026 — 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. 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; tecarfarin potentially treating patients with Kawasaki disease (KD). 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, development, licensing and commercialization for CAD-1005 frunexian, and tecarfarin; the

ability of Cadrenal’s assets to be additions to the pipelines of global companies across rare disease therapies, critical care cardiology,

and cardiac intensive care unit medical products; the ability to benefit from the commercial potential of the Cadrenal’s product

candidates; the ability 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, CVKD@lythampartners.com

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