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Form 8-K

sec.gov

8-K — Cadrenal Therapeutics, Inc.

Accession: 0001213900-26-107442

Filed: 2026-10-07

Period: 2026-10-07

CIK: 0001937993

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — ea0307947-8k_cadrenal.htm (Primary)

EX-99.1 — PRESS RELEASE, ISSUED BY CADRENAL THERAPEUTICS, INC. ON OCTOBER 7, 2026 (ea0307947ex99-1.htm)

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8-K — CURRENT REPORT

8-K (Primary)

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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): October 7, 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

Symbol(s)

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

October 7, 2026, Cadrenal Therapeutics, Inc. (the “Company”) issued a press release announcing that its Board of Directors

has authorized the Company to initiate a formal strategic process to evaluate opportunities to maximize the value of the Company and

its asset portfolio. Potential opportunities may include licensing or sale of individual assets, development and commercialization partnerships,

portfolio transactions, business combinations, or other strategic transactions. The strategic review is at a preliminary stage, and the

Company has not set a deadline or definitive timetable for the completion of the process. There can be no assurance that the strategic

process will result in any transaction or other strategic outcome.

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 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

October 7, 2026, the Company issued a press release announcing that its Board of Directors has authorized the Company to initiate a formal

strategic process to evaluate opportunities to maximize the value of the Company and its asset portfolio. Potential opportunities may

include licensing or sale of individual assets, development and commercialization partnerships, portfolio transactions, business combinations,

or other strategic transactions. The strategic review is at a preliminary stage, and the Company has not set a deadline or definitive

timetable for the completion of the process. There can be no assurance that the strategic process will result in any transaction or other

strategic outcome.

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 October 7, 2026

104

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

1

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: October 7, 2026

CADRENAL THERAPEUTICS, INC.

By:

/s/ Quang

X. Pham

Name:

Quang X. Pham

Title:

Chairman and Chief Executive Officer

2

EX-99.1 — PRESS RELEASE, ISSUED BY CADRENAL THERAPEUTICS, INC. ON OCTOBER 7, 2026

EX-99.1

Filename: ea0307947ex99-1.htm · Sequence: 2

Exhibit

99.1

CADRENAL

THERAPEUTICS RETAINS TUNGSTEN ADVISORS TO LEAD FORMAL STRATEGIC PROCESS TO MAXIMIZE VALUE OF ITS ORPHAN THROMBO-INFLAMMATORY THERAPEUTICS

● Pipeline

has reached clinical and regulatory maturity following recent alignment with FDA on Phase

3 development pathway for CAD-1005

● Cadrenal

has received strong interest from potential strategic partners

● Cadrenal

will explore all strategic alternatives including corporate partnerships and other strategic

transactions

PONTE

VEDRA, Fla., October 7, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) (“Cadrenal” or the “Company”),

a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions, today announced

that its Board of Directors has initiated a formal strategic process to evaluate opportunities to maximize the value of the Company and

its asset portfolio.

The

initiative builds on Cadrenal’s ongoing strategic partnering discussions and will evaluate a broad range of potential transactions

involving the Company and its clinical- and development-stage programs, including CAD-1005, tecarfarin, frunexian, and CAD-2000, the

Company’s second-generation 12-LOX platform. Potential opportunities may include licensing or sale of individual assets, development

and commercialization partnerships, portfolio transactions, business combinations, or other strategic transactions.

Cadrenal

has engaged Tungsten Advisors as the Company’s exclusive strategic financial advisor in connection with the process.

“Our

pipeline has reached critical clinical and regulatory maturity, anchored by our recent alignment with the FDA on the Phase 3 development

pathway for CAD-1005,” said Quang X. Pham, Chairman and Chief Executive Officer of Cadrenal Therapeutics. “Having received

strong interest from potential strategic partners, we believe a formal strategic process provides the appropriate framework to evaluate

opportunities across our portfolio and determine the paths that can maximize value for our shareholders while advancing these programs

for patients.”

There

can be no assurance that the strategic process will result in any transaction or other strategic outcome. Cadrenal does not intend to

provide updates on the process unless and until its Board of Directors approves a specific transaction or course of action, or the Company

otherwise determines that disclosure is appropriate or required.

About

Cadrenal Therapeutics, Inc.

Cadrenal

Therapeutics, Inc. is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions.

The Company’s portfolio comprises clinical- and development-stage programs addressing significant unmet needs in critical care

cardiology and orphan cardiovascular conditions.

CAD-1005

is a first-in-class 12-lipoxygenase (12-LOX) inhibitor in development to treat heparin-induced thrombocytopenia (HIT), a serious immune-mediated

thrombotic disorder. CAD-1005 is designed to selectively inhibit 12-LOX, a pathway involved in platelet immune activation and thrombo-inflammatory

signaling in HIT. The program 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. Cadrenal has received FDA feedback on the pathway for a Phase 3 registration study of

CAD-1005 in HIT.

Tecarfarin

is a Phase 3-ready oral vitamin K antagonist under development for patients requiring chronic anticoagulation, including those with end-stage

kidney disease, atrial fibrillation, and implanted left ventricular assist devices. Tecarfarin has received FDA Orphan Drug and Fast

Track designations for certain indications.

Frunexian

is an investigational parenteral small-molecule Factor XIa inhibitor under development for acute and critical care settings, including

major cardiac surgery.

CAD-2000

is a preclinical, next-generation, orally bioavailable 12-lipoxygenase (12-LOX) inhibitor under development as an outpatient Immunology

& Inflammation (I&I) platform. CAD-2000 targets adipo-inflammatory signaling and systemic lipid-driven inflammation to address

chronic metabolic and cardiorenal disorders. Positioned as an oral follow-on companion to CAD-1005, the asset is optimized for broad,

large-market chronic inflammatory indications, including obesity-driven systemic inflammation, metabolic-associated steatohepatitis (MASH),

and chronic cardiorenal diseases. It offers potential therapeutic synergy when combined with existing blockbuster metabolic regimens.

For more information, please visit www.cadrenal.com.

Forward-Looking

Statements

This

press release contains forward-looking statements within the meaning of the federal securities laws. These forward-looking statements

include, among other things, statements regarding the Company’s strategic process; the potential timing, structure, benefits and

outcome of that process; the possibility of any licensing transaction, asset sale, partnership, business combination or other strategic

transaction; the clinical development, regulatory approval and commercialization of CAD-1005, tecarfarin, frunexian, CAD-2000 and the

Company’s other programs; and the potential benefits and market opportunities associated with the Company’s product candidates.

Forward-looking

statements may be identified by words such as “anticipate,” “believe,” “could,” “expect,”

“intend,” “may,” “plan,” “potential,” “should,” “will,” “would”

and similar expressions. Forward-looking statements are based on management’s current expectations and assumptions and are subject

to risks and uncertainties that could cause actual results to differ materially from those expressed or implied.

These

risks and uncertainties include, without limitation, the possibility that the strategic process may not result in a transaction; the

Company’s ability to identify, negotiate and complete any strategic transaction on acceptable terms or at all; potential disruption

to the Company’s business during the strategic process; the Company’s need for additional capital and ability to obtain financing

on acceptable terms; risks associated with clinical development and regulatory approval; the Company’s ability to develop and commercialize

its product candidates; the Company’s ability to maintain the listing of its common stock on The Nasdaq Capital Market; and the

other risks described under the heading “Risk Factors” in Cadrenal’s filings with the Securities and Exchange Commission.

Readers

are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements speak only as of the date of

this press release, and Cadrenal undertakes no obligation to update them except as required by applicable law.

For

more information, please contact:

Cadrenal

Therapeutics, Inc.

Quang X. Pham, CEO

(904) 300-0701

press@cadrenal.com

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