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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):
February 24, 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 8.01. Other Events.
On February 24, 2026, Cadrenal Therapeutics, Inc.
(the “Company”) issued a press release announcing results from a Phase 2 trial evaluating CAD-1005 (formerly VLX-1005) in
patients with heparin-induced thrombocytopenia (“HIT”), a severe pro-thrombotic reaction to heparin, the most commonly used
parenteral anticoagulant.
This randomized, blinded, placebo-controlled trial
evaluated the safety and efficacy of CAD-1005, a selective inhibitor of 12-lipoxygenase (12-LOX), a critical immune signaling pathway
implicated in HIT, in patients receiving standard anticoagulant therapy. To potentially validate a new surrogate endpoint, the previous
investigation new drug sponsor, Veralox Therapeutics, Inc. (“Verolox”) selected platelet count recovery rate as the primary
endpoint. Their trial did not meet its primary endpoint. The secondary endpoint was the incidence of new or worsening thrombotic events,
including radiologic progression, which showed encouraging results. The study concluded in December 2025 following the transfer of program
ownership from Veralox to the Company. Although CAD-1005 did not significantly affect the recovery rate of platelet count, CAD-1005-treated
patients had fewer thrombotic events.
Highlights:
| ● | Primary Endpoint: Thrombotic events continued
to occur even after platelet count recovery in both groups. Platelet recovery rates were similar between the CAD-1005 and placebo arms.
Platelet count recovery did not appear to be a surrogate marker for clinical efficacy. |
| ● | Key Secondary Endpoint: A high rate
of thrombotic events (>75%) was observed in the placebo group, with fewer thrombotic events in the CAD-1005 group (50%), although the
study was not powered to detect statistical significance. Adding an inhibitor of 12-LOX to standard anticoagulants to block the immunological
mechanisms driving HIT may be more effective than anticoagulants alone in preventing thrombotic events. |
A copy of the press release is furnished herewith
as Exhibit 99.1.
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 February 24, 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: February 24, 2026 |
CADRENAL THERAPEUTICS, INC. |
| |
|
| |
By: |
/s/ Quang X. Pham |
| |
Name: |
Quang X. Pham |
| |
Title: |
Chairman and Chief Executive Officer |
Exhibit 99.1
Cadrenal
Therapeutics Announces Phase 2 Results with Encouraging
Reductions in Thrombotic Events for CAD-1005 in HIT, Supporting Clinical Advancement
Greater
than 25% absolute reduction in thrombotic events with CAD-1005 versus placebo on a
background of standard anticoagulant therapy, despite
no difference in platelet count recovery
End-of-Phase 2 Meeting Scheduled for March
2026
PONTE VEDRA, FL, February
24, 2026 – Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing novel therapies for life-threatening
immune and thrombotic conditions, today announced encouraging results from a Phase 2 trial evaluating CAD-1005 (formerly VLX-1005) in
patients with heparin-induced thrombocytopenia (HIT), a severe pro-thrombotic reaction to heparin, the most commonly used parenteral anticoagulant.
This randomized, blinded, placebo-controlled trial evaluated the safety
and efficacy of CAD-1005, a selective inhibitor of 12-lipoxygenase (12-LOX), a critical immune signaling pathway implicated in HIT, in
patients receiving standard anticoagulant therapy. To potentially validate a new surrogate endpoint, the previous investigational new
drug sponsor, Veralox Therapeutics, selected platelet count recovery rate as the primary endpoint. Their trial did not meet this primary
endpoint. The secondary endpoint was the incidence of new or worsening thrombotic events, including radiologic progression, which showed
encouraging results. The study concluded in December 2025 following the transfer of program ownership from Veralox to Cadrenal. Although
CAD-1005 did not significantly affect platelet recovery rate, CAD-1005-treated patients had fewer thrombotic events.
Highlights:
| · | Primary Endpoint: Thrombotic events continued to occur even after platelet count recovery in both groups. Platelet recovery
rates were similar between the CAD-1005 and placebo arms. Platelet count recovery did not appear to be a surrogate marker for clinical
efficacy. |
| · | Key Secondary Endpoint: A high rate of thrombotic events (>75%) was observed in the placebo group, with fewer thrombotic
events in the CAD-1005 group (50%), although the study was not powered to detect statistical significance. Adding an inhibitor of 12-LOX
to standard anticoagulants to block the immunological mechanisms driving HIT may be more effective than anticoagulants alone in preventing
thrombotic events. |
Building on these secondary endpoint results, Cadrenal has been granted
an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) to align on a Phase 3 registration path. The
Company considers this meeting a significant milestone in the development of CAD-1005, the only 12-LOX inhibitor in clinical development
worldwide.
“The encouraging trend toward reduced thrombotic events in the
CAD-1005 treatment arm is strong support for the company’s decision to acquire this asset and rapidly progress its development,”
said Quang X. Pham, CEO of Cadrenal Therapeutics. “Inhibition of 12-LOX is an
exciting therapeutic frontier, potentially targeting numerous inflammatory, thrombotic, and metabolic conditions.”
“We learned two very important things from this study, the only
blinded placebo-controlled trial ever conducted in HIT,” said James Ferguson, MD, Chief Medical Officer of Cadrenal Therapeutics.
“First, platelet count recovery was not an appropriate surrogate endpoint for clinical efficacy in a trial in which standard therapy
event rates were strikingly high. Secondly, despite the relatively small number of patients, the reduction in thrombotic events with CAD-1005
is extremely encouraging. CAD-1005 could represent a major step forward as the only first-line therapy targeting the immune mechanisms
responsible for HIT.”
“Our field (HIT) is full
of anticoagulant use in the absence of randomized prospective trials,” said Steven E. McKenzie, MD, PhD, Professor of Medicine
at Thomas Jefferson University and a member of the study steering committee. “We are enthusiastic
about CAD-1005 in addressing both the underlying immune mechanism and the unmet medical need for this serious thrombotic disorder.”
Detailed trial results will be presented at a future scientific meeting.
About Heparin-Induced Thrombocytopenia (HIT)
Heparin is the most widely used in-hospital anticoagulant, with over
12 million patients receiving it in the United States each year. Heparin-induced thrombocytopenia (HIT) is a potentially life-threatening
immune-mediated complication of heparin administration that occurs when antibodies to heparin activate platelets, leading to clots throughout
the circulatory system, dramatically lowering platelet counts, and increasing the risk of bleeding. Complications of HIT include deep
vein thrombosis, pulmonary embolism, stroke, myocardial infarction, amputation, and death, with mortality rates for HIT exceeding 20%
in some studies. CAD-1005 is the only treatment in clinical development that targets the underlying immune drivers of HIT.
About CAD-1005
CAD-1005 is an investigational therapy being evaluated for the treatment
of suspected HIT. CAD-1005 is designed to selectively inhibit 12-LOX, a pathway integral to the primary immune mechanisms driving HIT.
Unlike existing therapies for HIT, which are only directed at preventing thrombotic complications, this approach addresses the primary
underlying cause of HIT. In preclinical models of HIT, CAD-1005 has been shown to prevent or treat HIT and halt the development of both
thrombocytopenia and blood clots. The drug has not been associated with increased bleeding in animals or healthy human volunteers. CAD-1005
has received Orphan Drug Designation (ODD) and Fast Track designation from the U.S. Food and Drug Administration, as well as orphan drug
status from the European Medicines Agency.
About the Study
The study was originally planned to enroll 60 patients, but was stopped
in December 2025 after program ownership transferred to Cadrenal. Analysis of all existing trial data was recently completed. The final
dataset includes 24 patients with a presumptive diagnosis of HIT, randomized to receive either CAD-1005 or a matching placebo; all patients
received concomitant standard anticoagulant therapy, either argatroban or bivalirudin. The primary endpoint was the rate of platelet count
recovery; a key secondary endpoint was the development of new or worsening thrombotic events, the composite of death, stroke, systemic
embolism, myocardial infarction, deep venous thrombosis, superficial vein thrombosis, or skin necrosis. Primary analyses focused on 17
patients in whom HIT was confirmed by a central lab functional assay.
About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) 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 for the treatment of 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, as well as orphan drug status from the European
Medicines Agency. Second-generation 12-LOX oral therapeutics are also under development.
The Company’s broader pipeline includes tecarfarin, a Phase 3-ready
oral vitamin K antagonist for the treatment of patients with end-stage kidney disease and those with left ventricular assist devices,
and frunexian, a parenteral, clinical-stage Factor XIa inhibitor designed 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 adding an inhibitor of 12-LOX to standard anticoagulants to block the immunological
mechanisms driving HIT being more effective than anticoagulants alone in preventing thrombotic events; the encouraging trend toward reduced
thrombotic events in the CAD-1005 treatment arm being strong support for the Cadrenal’s decision to acquire this asset and rapidly
progress its clinical development; full trial results being presented at a future scientific meeting; the reduction in thrombotic events
with CAD-1005 being extremely encouraging, despite the relatively small number of patients; CAD-1005 representing a major step forward
as the only first-line therapy targeting the immune mechanisms responsible for HIT; The EOP2 meeting
being a significant milestone in the development of CAD-1005; CAD-1005 addressing both the underlying immune mechanism and the unmet medical
need for this serious thrombotic disorder; the encouraging trend toward reduced thrombotic events in the CAD-1005 treatment arm
being strong support for Cadrenal’s decision to acquire this asset and rapidly progress its development; CAD -1005 addressing the
underlying immune drivers of HIT; and presenting detailed trial results at a future scientific meeting. Actual
results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including
Cadrenal’s ability to advance the clinical development of CAD-1005 for the treatment of HIT, including designing a pivotal Phase
3 registration study acceptable to the FDA; CAD-1005 having the ability to address the underlying immune mechanism and the unmet medical
need for the serious thrombotic disorder; Cadrenal’s ability to continue to advance novel therapeutics to treat or prevent thrombosis
in high-risk patients; Cadrenal’s ability to successfully complete clinical trials on time and achieve desired results and benefits
as expected including support for CAD-1005’s potential to be a treatment option for HIT, Cadrenal’s ability to obtain regulatory
approvals for commercialization of product candidates or to comply with ongoing regulatory requirements
and the other risk factors described in the Company’s Annual Report on
Form 10-K for the year ended December 31, 2024, 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:
Cadrenal Therapeutics:
Matthew Szot, CFO
press@cadrenal.com
Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com
