Form 8-K

8-K — Cadrenal Therapeutics, Inc.

Accession: 0001213900-26-089147

Filed: 2026-08-13

Period: 2026-08-13

CIK: 0001937993

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — ea0302042-8k_cadrenal.htm (Primary)

EX-99.1 — PRESS RELEASE, ISSUED BY CADRENAL THERAPEUTICS, INC. ON AUGUST 13, 2026 (ea030204201ex99-1.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):

August 13, 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 August 13, 2026, Cadrenal Therapeutics, Inc.,

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

30, 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 August 13, 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 13, 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 13, 2026

EX-99.1

Filename: ea030204201ex99-1.htm · Sequence: 2

Exhibit 99.1

Cadrenal Therapeutics Reports Second Quarter

2026 Financial Results; Provides a Corporate Update on the Cardiac Acute Critical Care Franchise and the Strategic Partnering Process

Late-breaking Phase 2 CAD-1005 data presented

at ISTH support a late-stage portfolio organized around preoperative safety, orphan regulatory acceleration, and postoperative shielding

PONTE VEDRA, Fla., August 13, 2026 - 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.

Strategic pillar

Program / focus

Key point

Pre-Operative Safety

Frunexian IV for HIT-susceptible patients undergoing coronary artery bypass graft (CABG) surgery

Intended to replace volatile alternative anticoagulation protocols and establish a predictable safety profile before surgery.

Orphan Regulatory Acceleration

Orphan Drug Designation strategy for HIT patients undergoing cardiac surgery

Intended to support seven years of post-approval market exclusivity, fee waivers, and targeted tax credits.

Post-Operative Shield

CAD-1005 for Cardiac Surgery-Associated HIT and Cardiac Surgery-Associated Acute Kidney Injury

Described as supported by clinical data presented at the ISTH congress in July 2026 regarding its renal-protective profile.

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 $5.8 million; the Company’s belief

that its resources will fund operations through the first quarter of 2027; the Company securing funding sufficient to complete a trial,

which may include capital raised through strategic partnerships, out-licensing agreements, non-dilutive grants, equity or debt financing,

or a combination of these sources; and tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes,

and deaths from blood clots in patients requiring chronic anticoagulation, potentially treating patients 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

CADRENAL THERAPEUTICS, INC.

BALANCE SHEETS

June 30,

2026

December 31,

(unaudited)

2025

Assets:

Current assets:

Cash and cash equivalents

$ 2,388,135

$ 4,007,789

Receivable from issuance of warrants

2,684,904

Interest receivable

5,305

5,096

Prepaid expenses and other current assets

410,105

200,140

Deferred offering costs

95,674

106,342

Total current assets

5,584,123

4,319,367

Property, plant and equipment, net

2,675

5,174

Other assets

2,167

Total assets

$ 5,588,965

$ 4,326,708

Liabilities and Stockholders’ Equity:

Current liabilities:

Accounts payable

$ 871,913

$ 650,663

Accrued liabilities

625,344

937,319

Total current liabilities

1,497,257

1,587,982

Total liabilities

1,497,257

1,587,982

Stockholders’ equity:

Preferred stock, $0.001 par value, 7,500,000 shares authorized, no shares

issued and outstanding as of June 30, 2026 and December 31, 2025

Common stock, $0.001 par value; 75,000,000 shares authorized, 3,098,592

shares issued and outstanding as of June 30, 2026; 2,338,127 shares issued and outstanding as of December 31,

2025

3,098

2,338

Additional paid-in capital

48,867,860

41,696,533

Accumulated deficit

(44,779,250 )

(38,960,145 )

Total stockholders’ equity

4,091,708

2,738,726

Total liabilities and stockholders’ equity

$ 5,588,965

$ 4,326,708

CADRENAL THERAPEUTICS, INC.

STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(unaudited)

Three Months Ended

June 30,

Six Months Ended

June 30,

2026

2025

2026

2025

Operating expenses:

General and administrative expenses

$ 2,634,745

$ 2,656,392

$ 4,377,060

$ 4,910,970

Research and development expenses

705,151

1,077,498

1,476,659

2,745,379

Depreciation expense

504

401

1,059

5,918

Total operating expenses

3,340,400

3,734,291

5,854,778

7,662,267

Loss from operations

(3,340,400 )

(3,734,291 )

(5,854,778 )

(7,662,267 )

Other income

Interest and dividend income

17,835

67,004

35,673

149,600

Total other income

17,835

67,004

35,673

149,600

Net loss and comprehensive loss

$ (3,322,565 )

$ (3,667,287 )

$ (5,819,105 )

$ (7,512,667 )

Net loss per common share, basic and diluted

$ (1.14 )

$ (1.87 )

$ (2.19 )

$ (3.95 )

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

2,913,225

1,961,642

2,661,857

1,903,222

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- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

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dei_TradingSymbol

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

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