Form 8-K

8-K — Cadrenal Therapeutics, Inc.

Accession: 0001213900-26-053075

Filed: 2026-05-07

Period: 2026-05-07

CIK: 0001937993

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — ea0289377-8k_cadrenal.htm (Primary)

EX-99.1 — PRESS RELEASE, ISSUED BY CADRENAL THERAPEUTICS, INC. ON MAY 6, 2026 (ea028937701ex99-1.htm)

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8-K — CURRENT REPORT

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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):

May 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 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 2.02 Results of Operations and Financial

Condition.

On May 7, 2026, Cadrenal Therapeutics, Inc., a

Delaware corporation (the “Company”), issued a press release that included financial information for the quarter ended March

31, 2026. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Item 2.02 and in the press

release attached 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. The information contained in this Item 2.02 and in the press release attached as Exhibit 99.1

to this Current Report on Form 8-K shall not be incorporated by reference into any filing with the U.S. 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 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 May 7, 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: May 7, 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 MAY 6, 2026

EX-99.1

Filename: ea028937701ex99-1.htm · Sequence: 2

Exhibit 99.1

Cadrenal Therapeutics Reports First Quarter

2026 Financial Results and Provides Phase 3 Development Update on CAD-1005 Following End-of-Phase 2 Meeting with FDA

Official FDA meeting minutes and Phase 2

data provide guidance on the pivotal Phase 3 registration path for CAD-1005 in heparin-induced thrombocytopenia (HIT)

PONTE VEDRA, Fla., May 7, 2026 - Cadrenal Therapeutics, Inc.

(Nasdaq: CVKD), a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions,

today reported its financial results for the first quarter ended March 31, 2026, and provided a corporate update highlighting continued

progress in its CAD-1005 program for HIT. The Company has now received the official minutes from its End-of-Phase 2 (EOP2) meeting with

the U.S. Food and Drug Administration (FDA), which provided guidance on key elements of the planned pivotal Phase 3 registration trial

for CAD-1005, Cadrenal’s investigational first-in-class 12-lipoxygenase (12-LOX) inhibitor being developed to treat suspected heparin-induced

thrombocytopenia (HIT). Based on this feedback and Phase 2 data, Cadrenal plans to advance directly to a randomized, blinded, placebo-controlled

Phase 3 study evaluating CAD-1005 added to standard-of-care anticoagulation in patients with HIT.

Recent Highlights

● Received official FDA EOP2 meeting minutes providing guidance on protocol design, study population, dosing, background therapy, exposure,

safety database, and the primary endpoint of new or worsening thrombotic events.

● After considering FDA feedback on a pivotal registration study, Cadrenal plans to advance directly to a randomized, blinded, placebo-controlled

Phase 3 study evaluating CAD-1005 added to the current standard of care for patients with HIT.

● Planned pivotal Phase 3 study, the first randomized, blinded, placebo-controlled registration trial in HIT, will evaluate CAD-1005

in approximately 120 patients across clinical centers worldwide and is intended to support a projected NDA submission in 2029.

● Primary endpoint, centrally adjudicated, is expected to be the incidence of new or worsening thrombotic events in patients with Serotonin

Release Assay (SRA)-confirmed HIT, with at least one planned interim analysis.

● Phase 2 data showed an absolute reduction of more than 25% in thrombotic events when CAD-1005 was added to standard anticoagulant

therapy, supporting the continued advancement of CAD-1005 as Cadrenal’s near-term development priority.

● Continues to position CAD-1005 as a first-in-class, selective 12-LOX inhibitor and the only treatment in clinical development that

targets the underlying immune drivers of HIT, supported by Orphan Drug and Fast Track designations from the FDA and by orphan drug status

from the European Medicines Agency.

“With the official EOP2 meeting minutes now in hand, we believe

the registration path for CAD-1005 in HIT is clearly defined,” commented Quang X. Pham, Chairman & CEO. “The FDA’s guidance

on trial design and the primary endpoint of new or worsening thrombotic events reinforces our confidence in advancing directly to a pivotal

Phase 3 study. We believe CAD-1005 has the potential to be the first new therapy for HIT in more than two decades.”

First Quarter 2026 Financial Highlights

Research and development expenses for the quarter ended March 31, 2026,

were $0.8 million compared to $1.7 million for the same period in 2025. General and administrative expenses were $1.7 million compared

to $2.3 million for the same period in 2025. Total operating expenses were $2.5 million compared to $3.9 million for the same period in

2025. Cadrenal reported a net loss of $2.5 million for the quarter ended March 31, 2026, compared to $3.8 million for the same period

in 2025.

As of March 31, 2026, Cadrenal had cash and cash equivalents of $2.3

million. Subsequent to quarter end, on April 1, 2026, the Company completed a $2.5 million financing, providing additional capital to

support near-term development activities. The Company continues to evaluate financing and strategic alternatives to support its planned

clinical development activities, including the anticipated pivotal Phase 3 trial of CAD-1005 in HIT.

The Company is advancing Phase 3 readiness activities, including protocol

finalization, and expects to provide further updates in the coming quarters.

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company

advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is a first-in-class 12-LOX

inhibitor being developed to treat heparin-induced thrombocytopenia (HIT), a deadly immune-mediated thrombotic disorder. CAD-1005 has

received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration and orphan drug status from the European Medicines

Agency. Second-generation 12-LOX oral therapeutics are also in development for chronic indications.

The Company’s broader pipeline includes tecarfarin, a late-stage

oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation,

including those with end-stage kidney disease and those with left ventricular assist devices, and frunexian, a parenteral Factor XIa inhibitor

intended for use in acute hospital settings.

For more information, visit https://www.cadrenal.com/

and connect with the Company on LinkedIn.

Safe Harbor

Any statements in this press release about future expectations, plans,

and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.”

The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,”

“intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,”

“target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although

not all forward-looking statements contain these identifying words. These statements include, without limitation, statements regarding

continued progress in its CAD-1005 program for HIT ; plans to advance directly to a randomized, blinded, placebo-controlled Phase 3 study

evaluating CAD-1005 added to standard-of-care anticoagulation in patients with HIT; the planned pivotal Phase 3 study being the first

randomized, blinded, placebo-controlled registration trial in HIT; the Phase 3 study evaluating CAD-1005 in approximately 120 patients

across clinical centers worldwide; the trial supporting a projected NDA submission in 2029; the incidence of new or worsening thrombotic

events in patients with Serotonin Release Assay (SRA)-confirmed HIT being the primary endpoint of the trial; the trial having at least

one planned interim analysis; continuing to position CAD-1005 as a first-in-class, selective 12-LOX inhibitor and the only treatment in

clinical development that targets the underlying immune drivers of HIT; the registration path for CAD-1005 in HIT being clearly defined;

and CAD-1005 having the potential to be the first new therapy for HIT in more than two decades. Actual results may differ materially from

those indicated by such forward-looking statements as a result of various important factors, including the ability to raise sufficient

capital to continue progress of CAD-1005; the ability to advance directly to a randomized, blinded, placebo-controlled Phase 3 study evaluating

CAD-1005 added to standard-of-care anticoagulation in patients with HIT; the ability to successfully design and complete the Phase 3 study

and derive the results needed for an NDA submission: and the other risk factors described in the Company’s Annual Report on Form 10-K

for the year ended December 31, 2025, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent

periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press

release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation

to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Lytham Partners, LLC

Robert Blum, Managing Partner

602-889-9700

CVKD@lythampartners.com

Cadrenal Therapeutics,

Inc.

BALANCE

SHEETS

March 31,

2026

(unaudited)

December 31,

2025

Assets:

Current assets:

Cash and cash equivalents

$ 2,308,137

$ 4,007,789

Interest receivable

5,466

5,096

Prepaid expenses and other current assets

428,071

200,140

Deferred offering costs

113,607

106,342

Total current assets

2,855,281

4,319,367

Property, plant and equipment, net

4,619

5,174

Other assets

2,167

Total assets

$ 2,862,067

$ 4,326,708

Liabilities and Stockholders’ Equity:

Current liabilities:

Accounts payable

$ 824,809

$ 650,663

Accrued liabilities

240,143

937,319

Total current liabilities

1,064,952

1,587,982

Total liabilities

1,064,952

1,587,982

Stockholders’ equity:

Preferred stock, $0.001 par value, 7,500,000 shares authorized, no shares issued and outstanding as of March 31, 2026 and December 31, 2025

Common stock, $0.001 par value; 75,000,000 shares authorized, 2,506,817 shares issued and outstanding as of March 31, 2026; 2,338,127 shares issued and outstanding as of December 31, 2025

2,507

2,338

Additional paid-in capital

43,251,293

41,696,533

Accumulated deficit

(41,456,685 )

(38,960,145 )

Total stockholders’ equity

1,797,115

2,738,726

Total liabilities and stockholders’ equity

$ 2,862,067

$ 4,326,708

Cadrenal Therapeutics,

Inc.

statements

of operations and comprehensive loss

(unaudited)

Three Months Ended

March 31,

2026

2025

Operating expenses:

General and administrative expenses

$ 1,742,315

$ 2,254,577

Research and development expenses

771,508

1,667,882

Depreciation expense

555

5,517

Total operating expenses

2,514,378

3,927,976

Loss from operations

(2,514,378 )

(3,927,976 )

Other income

Interest and dividend income

17,838

82,596

Total other income

17,838

82,596

Net loss and comprehensive loss

$ (2,496,540 )

$ (3,845,380 )

Net loss per common share, basic and diluted

$ (1.04 )

$ (2.09 )

Weighted average number of common shares used in computing net loss per common share, basic and diluted

2,407,665

1,844,072

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