Form 8-K

8-K — Cadrenal Therapeutics, Inc.

Accession: 0001213900-26-095394

Filed: 2026-08-31

Period: 2026-08-31

CIK: 0001937993

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — ea0303997-8k_cadrenal.htm (Primary)

EX-99.1 — PRESS RELEASE, ISSUED BY CADRENAL THERAPEUTICS, INC. ON AUGUST 31, 2026 (ea030399701ex99-1.htm)

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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):

August 31, 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 ☒

If 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.

On August 31, 2026, Cadrenal Therapeutics, Inc.

(the “Company”) issued a press release announcing positive feedback from a Type D Meeting with the U.S. Food and Drug Administration

(“FDA”) held on July 28, 2026. During the meeting, the Company and the FDA aligned on key aspects of the protocol and Statistical

Analysis Plan for a 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”).

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 through Day 14 or hospital discharge. Additionally,

the FDA agreed to use placebo control in the Phase 3 trial, with existing standard anticoagulation therapeutics for both the CAD-1005

and placebo control arms.

A 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.

On August 31, 2026, the Company issued a press

release announcing positive feedback from a Type D Meeting with the FDA held on July 28, 2026. During the meeting, the Company and the

FDA aligned on key aspects of the protocol and Statistical Analysis Plan for a Phase 3 registrational study of CAD-1005, the Company’s

first-in-class 12-LOX inhibitor in development to treat HIT.

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 through Day 14 or hospital discharge. Additionally,

the FDA agreed to use placebo control in the Phase 3 trial, with existing standard anticoagulation therapeutics for both the CAD-1005

and placebo control arms.

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 August 31, 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: August 31, 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 AUGUST 31, 2026

EX-99.1

Filename: ea030399701ex99-1.htm · Sequence: 2

Exhibit 99.1

Cadrenal Therapeutics Announces Positive Outcome

from FDA Type D Meeting for Phase 3 Registration Study of CAD-1005 in Heparin-Induced Thrombocytopenia

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. – August 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

CVKD@lythampartners.com

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