# EDGAR Filing Document

**Accession Number:** 0001937993
**File Stem:** 0001213900-26-069902
**Filing Date:** 2026-6
**Character Count:** 16223
**Document Hash:** 84de5ed807e4ea5df857890713d2d029
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-26-069902.hdr.sgml**: 20260618

**ACCESSION NUMBER**: 0001213900-26-069902

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 12

**CONFORMED PERIOD OF REPORT**: 20260618

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260618

**DATE AS OF CHANGE**: 20260618

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Cadrenal Therapeutics, Inc.
- **CENTRAL INDEX KEY:** 0001937993
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 880860746
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-41596
- **FILM NUMBER:** 261100574

**BUSINESS ADDRESS:**
- **STREET 1:** 822 A1A NORTH
- **STREET 2:** SUITE 306
- **CITY:** PONTE VEDRA
- **STATE:** FL
- **ZIP:** 32082
- **BUSINESS PHONE:** 904-300-0701

**MAIL ADDRESS:**
- **STREET 1:** 822 A1A NORTH
- **STREET 2:** SUITE 306
- **CITY:** PONTE VEDRA
- **STATE:** FL
- **ZIP:** 32082

?xml version='1.0' encoding='ASCII'?

**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): **June 18, 2026**

**Cadrenal Therapeutics, Inc.**

*(Exact name of registrant as specified in charter)*

 

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| | | |
|:---|:---|:---|
| **Delaware** | **001-41596** | **88-0860746** |
| **(State or other jurisdiction<br> of incorporation)** | **(Commission File Number)** | **(IRS Employer<br> 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 <br> (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 June 18, 2026, Cadrenal Therapeutics, Inc. (the "Company") issued a press release announcing its plans to submit a Rare Pediatric Disease Designation ("RPDD") request to the U.S. Food and Drug Administration ("FDA") for tecarfarin as a treatment for pediatric patients with Kawasaki disease who develop coronary artery aneurysms ("CAAs") and require chronic oral anticoagulation.

The Company also disclosed its dual-track portfolio strategy that includes: (i) The Global Pharma Track: Focusing on CAD-1005, a first-in-class 12-LOX inhibitor; and (ii) The Regional & Rare Disease Track: Focusing on tecarfarin for Kawasaki disease.

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 June 18, 2026, the Company issued a press release announcing its plans to submit a RPDD request to the FDA for tecarfarin as a treatment for pediatric patients with Kawasaki disease who develop coronary artery aneurysms and require chronic oral anticoagulation.

The Company also disclosed its dual-track portfolio strategy that includes: (i) The Global Pharma Track: Focusing on CAD-1005, a first-in-class 12-LOX inhibitor; and (ii) The Regional & Rare Disease Track: Focusing on tecarfarin for Kawasaki disease.

**Item 9.01 Financial Statements and Exhibits.**

(d) Exhibits

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

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| | |
|:---|:---|
| **Exhibit<br> Number** | **Exhibit Description** |
| 99.1 | [Press Release, issued by Cadrenal Therapeutics, Inc. on June 18, 2026](ea029523401ex99-1.htm) |
| 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: June 18, 2026 | **CADRENAL THERAPEUTICS, INC.** | **CADRENAL THERAPEUTICS, INC.** |
|  | By: | /s/ Quang X. Pham |
|  | Name: | Quang X. Pham |
|  | Title: | Chairman and Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

**Cadrenal Therapeutics to File for FDA Rare Pediatric Disease Designation for Tecarfarin in Kawasaki Disease**

*Company to present Phase 3-ready pipeline, 12-LOX platform, and pediatric rare-disease expansion to global pharmaceutical partners at the 2026 BIO International Convention in San Diego*

 

*Kawasaki disease is the leading cause of acquired heart disease in children in developed nations. Patients are at risk of forming blood clots in coronary arteries and may require lifelong treatment*

 

*If the designation is granted and tecarfarin is approved for this indication, Cadrenal would be eligible to receive a Priority Review Voucher—recent open-market valuations for these vouchers have reached into the ~$200 million range*

PONTE VEDRA, FL — June 18, 2026 — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company advancing late-stage novel therapies for life-threatening immune and thrombotic conditions, today announced plans to submit a Rare Pediatric Disease Designation (RPDD) request to the U.S. Food and Drug Administration (FDA) for tecarfarin as a treatment for pediatric patients with Kawasaki disease (KD) who develop coronary artery aneurysms (CAAs) and require chronic oral anticoagulation.

The announcement comes ahead of the BIO International Convention, June 22–25, 2026, in San Diego, California. Cadrenal's executive leadership team will highlight this rare pediatric initiative and its Phase 3-ready CAD-1005 platform during one-on-one partnering meetings with global and regional pharmaceutical companies.

KD is an acute inflammatory illness and the leading cause of acquired heart disease in children in developed nations. Up to 25% of untreated children with KD develop enlarged coronary arteries or CAAs. Patients with large CAAs are at risk for forming blood clots in those blood vessels – with a continuing lifelong risk for subsequent heart attacks and sudden cardiac death - and require chronic, precise anticoagulation therapy to reduce their higher risk of clot formation.

Tecarfarin is a novel, next-generation Vitamin K antagonist (VKA) that offers a number of potential advantages over warfarin, the current standard VKA in clinical use. Specifically, tecarfarin is designed to overcome limitations of warfarin metabolism and potentially provide more reliable and more consistent anticoagulation than might be possible with warfarin.

"Children with large or giant aneurysms due to KD represent an important underserved orphan population," said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. "The current standard of care – warfarin - is notoriously unstable in children because of dietary variations, concurrent medications, and genetic differences in liver metabolism. Tecarfarin is metabolized in a completely different way than warfarin, and is being developed to offer a highly stable, predictable alternative. We believe tecarfarin can potentially improve time in therapeutic range for these children, thereby lowering their risk for both catastrophic blood clots and dangerous bleeding events."

The FDA's RPDD program targets serious or life-threatening diseases that primarily affect fewer than 200,000 people in the United States from birth through age 18. If the FDA grants the designation and tecarfarin is subsequently approved for this indication, Cadrenal would be eligible to receive a Priority Review Voucher (PRV). These transferable vouchers can be used to accelerate the FDA review of a future drug or sold to another pharmaceutical manufacturer. Following Congress's extension of the pediatric PRV program through September 30, 2029, recent open-market valuations for these vouchers have reached record highs, with recent sales ranging from $180 million to $205 million.

At the upcoming BIO International Convention, Cadrenal will present a dual-track portfolio strategy designed to maximize value for potential partners:

● The Global Pharma Track: Focusing on CAD-1005, a first-in-class 12-LOX inhibitor. CAD-1005 is Phase 3-ready for Heparin-Induced Thrombocytopenia (HIT) and is advancing into a Phase 2a trial for Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI), addressing a combined, multi-billion-dollar dual-indication acute hospital care market.

● The Regional & Rare Disease Track: Focusing on tecarfarin for Kawasaki disease. This program offers an efficient clinical trial design and strong geographic synergy, particularly for Japanese and East Asian pharmaceutical companies, where the incidence of Kawasaki disease is historically 10 to 15 times higher than in Western nations.

"Our presence at BIO 2026 centers on executing capital-efficient development strategies," added Mr. Pham. "If we are successful in advancing tecarfarin toward a RPDD, we will create a high-value, de-risked regulatory pathway that aligns with regional partners' portfolio needs while directing our core internal resources toward our blockbuster CAD-1005 critical care franchise."

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics is a biopharmaceutical company advancing late-stage novel therapies for life-threatening immune and thrombotic conditions. The company's pipeline includes CAD-1005, a novel first-in-class 12-LOX inhibitor targeting multiple critical care indications, and tecarfarin, a late-stage oral anticoagulant designed to avoid CYP450 metabolism. CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration, as well as orphan drug status from the European Medicines Agency, for the treatment of Heparin-Induced Thrombocytopenia (HIT). CAD-1005 is also being developed for use in Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI), and second-generation 12-LOX oral therapeutics are in development for chronic indications.

About Tecarfarin

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. Tecarfarin has also received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration.

Safe Harbor Statement

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 plans to file for FDA Rare Pediatric Disease Designation for Tecarfarin in Kawasaki Disease; Cadrenal being eligible to receive a Priority Review Voucher and the value of the voucher*;* tecarfarin offering a number of potential advantages over warfarin, tecarfarin overcoming limitations of warfarin metabolism and potentially providing more reliable and more consistent anticoagulation than might be possible with warfarin; tecarfarin offering a highly stable, predictable alternative to warfarin; tecarfarin potentially improving time in therapeutic range for these children, thereby lowering their risk for both catastrophic blood clots and dangerous bleeding events and the successful advancement of tecarfarin creating a high-value, de-risked regulatory pathway that aligns with regional partners' portfolio needs while directing the Company's core internal resources toward its CAD-1005 critical care franchise 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 for tecarfarin to receive a Rare Pediatric Disease Designation for treatment of Kawasaki Disease; the ability to monetize a priority review voucher if received, the ability to successfully design and complete a dual-track portfolio strategy and maximize value for potential partners; the ability of tecarfarin to overcome limitations of warfarin metabolism and potentially provide more reliable and more consistent anticoagulation than might be possible with warfarin; the ability of tecarfarin offering a highly stable, predictable alternative to warfarin; tecarfarin potentially improving time in therapeutic range for children with Kawasaki Disease, thereby lowering their risk for both catastrophic blood clots and dangerous bleeding events and the successful advancement of tecarfarin creating a high-value, de-risked regulatory pathway that aligns with regional partners' portfolio needs; ; 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, 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