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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):
March 12, 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 7.01. Regulation FD Disclosure.
On March 12, 2026, Cadrenal Therapeutics, Inc.
(the “Company”) issued a press release highlighting pre-clinical research demonstrating the potential of its first-in-class
12-lipoxygenase (12-LOX) inhibitor, CAD-1005, to target inflammatory consequences of obesity and Type 2 diabetes. 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 March 12, 2026, the Company issued a press
release highlighting pre-clinical research demonstrating the potential of its first-in-class 12-LOX inhibitor, CAD-1005, to target inflammatory
consequences of obesity and Type 2 diabetes. The study builds on prior animal research showing that inhibiting 12-LOX with CAD-1005 delays
the onset of autoimmune diabetes in non-obese diabetic mice. The findings highlight 12-LOX as a key factor in obesity-associated inflammation
and suggest that 12-LOX inhibition could be a therapeutic strategy to improve glucose homeostasis and peripheral inflammation in the setting
of obesity and type 2 diabetes.
In preclinical models, oral administration of
CAD-1005 (formerly VLX-1005) demonstrated significant therapeutic benefits, including improved glycemic control, reduced pancreatic β-cell
loss, reduced numbers of inflammatory cells in adipose (fat) and pancreatic tissues, and lower levels of pro-inflammatory cytokines in
adipose tissues. Inhibiting 12-LOX acts as a selective “switch” to deactivate these pathways and interrupts a cycle of chronic
inflammation, providing a dual benefit of restoring healthy metabolic signaling and protecting tissues from inflammatory damage.
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 March 12, 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: March 12, 2026 |
CADRENAL THERAPEUTICS, INC. |
| |
|
| |
By: |
/s/ Quang X. Pham |
| |
Name: |
Quang X. Pham |
| |
Title: |
Chairman and Chief Executive Officer |
Exhibit
99.1
Cadrenal Therapeutics Highlights
Research Supporting 12-LOX Inhibition in Reducing
Inflammation in Obesity and Type 2 Diabetes
PONTE VEDRA, FL, March 12, 2026 – Cadrenal
Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing innovative treatments
for life-threatening immune and thrombotic conditions, today highlighted recent scientific findings demonstrating the potential of its
first-in-class 12-lipoxygenase (12-LOX) inhibitor, CAD-1005,
to target inflammatory consequences of obesity and Type 2 diabetes.
The study builds
on prior animal research showing that inhibiting 12-LOX with CAD-1005 delays the onset of autoimmune diabetes in non-obese diabetic mice.
The findings highlight 12-LOX as a key factor in obesity-associated inflammation and suggest that 12-LOX inhibition could be a
therapeutic strategy to improve glucose homeostasis and peripheral inflammation in the setting of obesity and type 2 diabetes.
In the setting of obesity, 12-LOX overexpression leads to:
| ● | Adipocyte dysfunction following recruitment of pro-inflammatory macrophages into adipose tissue triggering an inflammatory reaction
that impairs tissue insulin sensitivity. |
| ● | Elevated 12-LOX activity in the pancreas causes oxidative stress and 𝛽-cell
dedifferentiation, hallmarks of Type 2 Diabetes progression. |
In preclinical models,
oral administration of CAD-1005 (formerly VLX-1005) demonstrated
significant therapeutic benefits, including improved glycemic control, reduced pancreatic β-cell
loss, reduced numbers of inflammatory cells in adipose (fat) and pancreatic
tissues, and lower levels of pro-inflammatory cytokines in adipose tissues.
Inhibiting 12-LOX acts as a selective “switch” to deactivate these pathways and interrupts a cycle of chronic inflammation,
providing a dual benefit of restoring healthy metabolic signaling and protecting tissues from inflammatory damage.
Link to publication: https://link.edgepilot.com/s/ca8ee2a3/c_cA13QyP0eg7_nCqlb4HQ?u=https://pubmed.ncbi.nlm.nih.gov/40186458/
Selective 12-LOX inhibition specifically targets important inflammatory
signaling pathways that were previously difficult to reach, with potential applications across multiple areas. Unlike other treatments
for obesity and diabetes, Cadrenal’s 12-LOX inhibitor is designed to block inflammatory signals in adipose tissues and the pancreas
– key drivers of the metabolic derangements that accompany adiposity and diabetes. Cadrenal believes that CAD-1005 is the only product
in clinical development that uses this mechanism to inhibit adipo-inflammatory signaling and potentially add to the benefits of existing
GLP-1 obesity medications.
Cadrenal acquired the 12-LOX portfolio in December
2025. CAD-1005 is also being evaluated for suspected Heparin-Induced Thrombocytopenia (HIT), a severe pro-thrombotic reaction to heparin.
The results of a recent Phase 2 trial demonstrated a reduction in thrombotic events in patients with HIT. Next-generation development
includes CAD-2000, an orally bioavailable 12-LOX inhibitor.
“While our near-term priority
remains the clinical development of CAD-1005 for HIT, these findings highlight the broader potential of 12-LOX inhibition in other inflammatory
conditions,” said Quang X. Pham, CEO of Cadrenal Therapeutics. “We look forward to sharing our findings about 12-LOX
in other disease areas with interested partners.”
About 12-LOX
Lipoxygenases are a family of enzymes involved in lipid metabolism
that facilitate the incorporation of oxygen into polyunsaturated fatty acids. The enzymatic activity of 12-LOX ultimately produces 12-HETE,
a lipid molecule that easily crosses cell membranes. Inside cells, 12-HETE promotes oxidative stress, while outside cells, it modulates
various signaling pathways to regulate inflammation and provoke pro-inflammatory effects. In human blood, 12-LOX is primarily found in
platelets and leukocytes; it is also overexpressed in the pancreas of patients with diabetes and in certain cancer cells. In HIT,
12-LOX plays a key role in platelet activation via the IgG receptor. Early efforts to develop 12-LOX inhibitors struggled because they
lacked specificity for 12-LOX.
About CAD-1005
CAD-1005, an investigational therapy being evaluated for suspected
HIT, is a potent, highly selective small molecule inhibitor of human 12-LOX. It is currently the only selective
12-LOX inhibitor in clinical development. CAD-1005 is designed to target 12-LOX specifically,
a pathway crucial to the primary immune mechanisms that cause HIT. Unlike existing therapies for HIT, which mainly focus on preventing
blood clots, this approach addresses the root cause of HIT. In preclinical models, CAD-1005 has been shown to prevent or treat HIT and
stop the development of thrombocytopenia and blood clots. The drug has not been linked to 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 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 and orphan drug status from the European Medicines
Agency. Second-generation 12-LOX oral therapeutics are also under development for chronic indications.
The Company’s broader pipeline features tecarfarin, a late-stage
oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation,
including for patients with end-stage kidney disease and left ventricular assist devices, and frunexian, a parenteral Factor XIa inhibitor
intended 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 Cadrenal developing
innovative treatments for life-threatening immune and thrombotic conditions; CAD-1005
targeting inflammatory consequences of obesity and Type 2 diabetes; 12-LOX
inhibition improving glucose homeostasis and peripheral inflammation in the setting of obesity and type 2 diabetes; 12-LOX inhibition
having potential applications across multiple areas; Cadrenal’s 12-LOX inhibitor blocking inflammatory signals in adipose tissues
and the pancreas – key drivers of the metabolic derangements that accompany adiposity and diabetes; CAD-1005 inhibiting adipo-inflammatory
signaling and potentially add to the benefits of existing GLP-1 obesity medications; advancing the clinical development of CAD-1005 for
the treatment of HIT; the development of CAD-2000, an orally bioavailable 12-LOX inhibitor; the broader potential
of 12-LOX inhibition in other inflammatory conditions; sharing findings about 12-LOX in other disease areas with interested partners;
CAD-1005 targeting 12-LOX specifically, a pathway crucial to the primary immune mechanisms that cause HIT, and addressing the root
cause of HIT; CAD-1005 successfully preventing or treating HIT and stopping the development of thrombocytopenia and blood clots; Cadrenal
advancing novel therapies for life-threatening immune and thrombotic conditions; Cadrenal developing second-generation 12-LOX oral therapeutics
for chronic indications; tecarfarin preventing heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation,
including for patients with end-stage kidney disease and left ventricular assist devices; and frunexian being used in acute hospital settings.
Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors,
including Cadrenal developing innovative treatments for life-threatening immune
and thrombotic conditions; advancing the clinical development of CAD-1005 for the treatment of HIT;
Cadrenal advancing novel therapies for life-threatening immune and thrombotic conditions; Cadrenal developing second-generation
12-LOX oral therapeutics for chronic indications; tecarfarin preventing heart attacks, strokes, and deaths due to blood clots in patients
requiring chronic anticoagulation, including for patients with end-stage kidney disease and left ventricular assist devices; frunexian
being used in acute hospital settings; 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
