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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 6, 2024
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 August 6, 2024, Cadrenal Therapeutics, Inc. (the “Company”)
issued a press release regarding the initiation of collaborative efforts with Abbott to advance
the Company’s planned pivotal trial evaluating tecarfarin’s effectiveness in patients with recently implanted left ventricular
assist devices (“LVADs”).
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 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.
The press release furnished as Exhibit 99.1
to this Current Report on Form 8-K includes “safe harbor” language pursuant to the Private Securities Litigation Reform Act
of 1995, as amended, indicating that certain statements contained therein are “forward-looking” rather than historical.
Item 8.01. Other Events.
On August 6, 2024, the Company issued a press release regarding the
initiation of collaborative efforts with Abbott to advance the Company’s planned pivotal trial evaluating tecarfarin’s effectiveness
in patients with recently implanted LVADs.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
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 6, 2024 |
CADRENAL THERAPEUTICS, INC. |
|
|
|
By: |
/s/ Quang Pham |
|
Name: |
Quang Pham |
|
Title: |
Chairman and Chief Executive Officer |
2
Exhibit 99.1
Cadrenal Therapeutics and Abbott Initiate Collaborative
Effort to Advance Novel Anticoagulant Tecarfarin for Patients with LVADs
PONTE VEDRA, Fla., Aug. 6, 2024 /PRNewswire/ -- Cadrenal
Therapeutics, Inc., (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage, new-generation Vitamin K Antagonist
(VKA) oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients
with implanted cardiac devices and those with rare cardiovascular conditions, announced today that it has been in discussions with
Abbott (NYSE: ABT) about Cadrenal’s planned pivotal study of tecarfarin in patients with recently implanted LVADs. All patients with LVADs
require lifelong anticoagulation (AC) to protect against thromboembolic events.
In April 2024, tecarfarin received FDA Orphan Drug Designation (ODD)
to prevent blood clots and strokes in patients with implanted mechanical circulatory support devices such as LVADs.
Currently, the only LVAD available in the United States is the HeartMate
3™, manufactured by Abbott, which has been shown to be superior to all prior LVADs.
A recent secondary analysis of the ARIES-HM3 study conducted by Abbott
on the necessity of aspirin therapy demonstrated that maintaining high-quality AC can result in further improvement of outcomes with the
HeartMate 3 LVAD.
“We are pleased that Abbott has initiated a collaborative effort
with us for this trial, which we believe is very important to LVAD patients,” said Quang Pham, Chairman and Chief Executive of Cadrenal
Therapeutics. “We believe that tecarfarin has the potential to further improve AC treatment for HeartMate 3 patients.”
Prior clinical studies provide evidence that tecarfarin yields improved
AC quality, particularly in patients on multiple medications and those with impaired renal function, both of which are common in LVAD
patients.
ABOUT CADRENAL THERAPEUTICS, INC.
Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation
therapy. Tecarfarin is a new-generation Vitamin K Antagonist (VKA) oral and reversible anticoagulant (blood thinner) to prevent heart
attacks, strokes, and deaths due to blood clots in patients with implanted cardiac devices and those with rare cardiovascular conditions. Tecarfarin
has orphan drug designation from the FDA for the prevention of thrombosis and thromboembolism (blood clots) in patients with an implanted
mechanical circulatory support device, which includes the left ventricular assist device (LVAD). Tecarfarin also has orphan drug and fast-track
designations from the FDA for the prevention of systemic thromboembolism of cardiac origin in patients with end-stage kidney disease (ESKD)
and atrial fibrillation (AFib). Tecarfarin is specifically designed to use a different metabolism pathway than the oldest and most commonly
prescribed VKA warfarin. Tecarfarin has been evaluated in eleven (11) human clinical trials in more than 1,000 individuals. In Phase 1,
Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with
chronic kidney disease. For more information, please visit www.cadrenal.com.
Safe Harbor Statement
Any statements contained 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.” These statements include statements regarding Cadrenal’s planned pivotal study of tecarfarin in patients with recently
implanted LVADs, maintaining high-quality AC resulting in further improvement of outcomes with the HeartMate 3 LVAD, the collaborative
effort with Abbott for the trial being very important to LVAD patients and tecarfarin having the potential to further improve AC treatment
for HeartMate 3 patients. The words “anticipate,” “believe,” “continue,” “could,” “estimate,”
“expect,” “intend,” “may,” “plan,” “potential,” “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. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various important factors, including the ability of tecarfarin to improve
outcomes in patients with a HeartMate 3, the ability of the Company to advance tecarfarin with patients with left ventricular assist devices
(LVADs), and those with AFib and ESKD, the collaboration with Abbott being successful and the other risk factors described in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2023, and the Company’s subsequent filings with the SEC, 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:
Cadrenal Therapeutics:
Matthew Szot, CFO
858-337-0766
press@cadrenal.com
Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com
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Cadrenal Therapeutics (NASDAQ:CVKD)
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