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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) |
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 |
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
