Form 8-K
8-K — Cadrenal Therapeutics, Inc.
Accession: 0001213900-26-036937
Filed: 2026-03-31
Period: 2026-03-31
CIK: 0001937993
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Results of Operations and Financial Condition
Item: Financial Statements and Exhibits
Documents
8-K — ea0284258-8k_cadrenal.htm (Primary)
EX-99.1 — PRESS RELEASE, ISSUED BY CADRENAL THERAPEUTICS, INC. ON MARCH 31, 2026 (ea028425801ex99-1.htm)
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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 31, 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 2.02 Results of Operations and Financial
Condition.
On March 31, 2026, Cadrenal Therapeutics, Inc.,
a Delaware corporation (the “Company”), issued a press release that included financial information for the fiscal year ended
December 31, 2025. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 2.02 and in the press
release attached 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. The information contained in this Item 2.02 and in the press release attached as Exhibit 99.1
to this Current Report on Form 8-K 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.
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 31, 2026
104
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1
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 31, 2026
CADRENAL THERAPEUTICS, INC.
By:
/s/ Quang X. Pham
Name:
Quang X. Pham
Title:
Chairman and Chief Executive Officer
2
EX-99.1 — PRESS RELEASE, ISSUED BY CADRENAL THERAPEUTICS, INC. ON MARCH 31, 2026
EX-99.1
Filename: ea028425801ex99-1.htm · Sequence: 2
Exhibit 99.1
Cadrenal Therapeutics Reports Fourth Quarter
2025 Financial Results; Provides Corporate Update on CAD-1005 Program for HIT Following End-of-Phase 2 FDA Meeting
Encouraging Phase 2 HIT data and recent FDA
feedback support continued advancement of CAD-1005 as Cadrenal’s near-term development priority; broader 12-LOX platform remains
a longer-term opportunity
PONTE VEDRA, Fla., March 31, 2026 – Cadrenal Therapeutics,
Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions,
today reported its financial results for the fourth quarter and full year ended December 31, 2025, and provided a corporate update highlighting
recent progress across its CAD-1005 program for HIT and broader 12-LOX inhibitor platform. The update reflects continued progress for
CAD-1005, Cadrenal’s first-in-class 12-LOX inhibitor for suspected heparin-induced thrombocytopenia (HIT), including completion
of its End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) on March 26, 2026, to align on the proposed Phase
3 pivotal trial of CAD-1005 in patients with HIT.
Recent
Highlights
● Reported
encouraging results from a randomized, blinded, placebo-controlled Phase 2 study of CAD-1005
in HIT, with fewer new or worsening thrombotic events observed in patients treated with CAD-1005
on a background of standard anticoagulant therapy.
● Observed
a greater than 25% absolute reduction in thrombotic events in the CAD-1005 treatment arm
versus placebo, while also gaining important insight that platelet count recovery may not
be an appropriate surrogate endpoint for clinical efficacy in HIT.
● On
March 26, 2026, the Company completed its End-of-Phase 2 meeting with the FDA and clarified
a potential registrational path for its planned Phase 3 pivotal trial.
● Incorporation
of FDA feedback into Phase 3 protocol is currently underway.
● Continued
to position CAD-1005 as the only selective 12-LOX inhibitor currently in clinical development,
supported by Orphan Drug and Fast Track designations from the FDA and orphan drug status
from the European Medicines Agency.
● While HIT remains the Company’s near-term development priority, it
continues to see additional scientific support for 12-LOX inhibition beyond HIT, including research in obesity and type 2 diabetes showing
potential improvements in glycemic control, pancreatic beta-cell preservation, and inflammatory signaling.
“CAD-1005 continues to reinforce our conviction that selective
12-LOX inhibition may offer a differentiated approach for patients with HIT, a life-threatening, immune-mediated prothrombotic disorder,
and a serious condition with substantial unmet need,” commented Quang X. Pham, Chairman & CEO. “Despite modern care, mortality
remains high (up to 18-20% in some groups), with many survivors facing limb amputations. The encouraging Phase 2 results, including the
reduction in thrombotic events observed on top of standard anticoagulant therapy, further strengthen our confidence in the program and
in the decision to make CAD-1005 our lead development priority.”
“The recent End-of-Phase 2 meeting with the FDA is an important
milestone in clarifying the regulatory path forward for CAD-1005. As we incorporate FDA feedback and prepare for the next stage of development,
we remain focused on advancing CAD-1005 as our lead priority in HIT. At the same time, we continue to evaluate longer-term opportunities
across our broader 12-LOX platform and other pipeline assets to support future value creation.”
Fourth Quarter 2025 Financial Highlights
Research and development expenses for the quarter ended December 31,
2025, were $0.7 million compared to $1.5 million for the same period in 2024. General and administrative expenses for the quarter ended
December 31, 2025, were $2.4 million compared to $2.7 million for the same period in 2024. Cadrenal reported a net loss of $3.0 million
for the quarter ending December 31, 2025, compared to $4.2 million for the same period in 2024.
On December 31, 2025, Cadrenal had cash and cash equivalents of $4.0
million. The Company is evaluating financing and strategic alternatives to support its planned clinical development activities. The Company
had approximately 2.3 million shares of common stock outstanding as of December 31, 2025.
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, without limitation,
statements regarding the continued progress for CAD-1005 for suspected heparin-induced thrombocytopenia; a potential registrational path
for the Company’s planned Phase 3 pivotal trial; additional scientific support for 12-LOX inhibition beyond HIT; research in obesity
and type 2 diabetes showing potential improvements in glycemic control, pancreatic beta-cell preservation, and inflammatory signaling;
selective 12-LOX inhibition offering a differentiated approach for patients with HIT, a serious condition with substantial unmet need;
continuing to evaluate longer-term opportunities across the Company’s broader 12-LOX platform and other pipeline assets to support
future value creation; the Company’s clinical development plans and timing, regulatory pathway and potential registration strategy
for CAD-1005; the design and initiation of its planned Phase 3 trial, the potential therapeutic and commercial opportunity for CAD-1005
and the Company’s broader pipeline, and the Company’s capital requirements and potential financing or strategic alternatives.
Actual results may differ materially from those indicated by such forward-looking statements as
a result of various important factors, including the ability to continue progress CAD-1005; the ability to successfully plan a registrational
path for the Company’s planned Phase 3 pivotal trial; the ability for 12-LOX inhibition to provide improvements in obesity and type
2 diabetes in glycemic control, pancreatic beta-cell preservation, and inflammatory signaling and support future value creation; the Company’s
ability to raise sufficient funding to commence and complete its planned Phase 3 trial, 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, please contact:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com
2
CADRENAL THERAPEUTICS, INC.
BALANCE SHEETS
December 31,
2025
December 31,
2024
Assets:
Current assets:
Cash and cash equivalents
$ 4,007,789
$ 10,017,942
Interest receivable
5,096
38,153
Prepaid expenses and other current assets
200,140
42,257
Deferred offering costs
106,342
14,445
Total current assets
4,319,367
10,112,797
Property, plant and equipment, net
5,174
6,944
Other assets
2,167
3,792
Total assets
$ 4,326,708
$ 10,123,533
Liabilities and Stockholders’ Equity:
Current liabilities:
Accounts payable
$ 650,663
$ 1,502,468
Accrued liabilities
937,319
1,181,490
Total current liabilities
1,587,982
2,683,958
Total liabilities
1,587,982
2,683,958
Stockholders’ equity:
Preferred stock, $0.001 par value, 7,500,000 shares authorized, no shares issued and outstanding as of December 31, 2025 and 2024
-
-
Common stock, $0.001 par value; 75,000,000 shares authorized, 2,338,127 shares issued and outstanding as of December 31, 2025; 1,782,486 shares issued and outstanding as of December 31, 2024
2,338
1,782
Additional paid-in capital
41,696,533
33,160,576
Accumulated deficit
(38,960,145 )
(25,722,783 )
Total stockholders’ equity
2,738,726
7,439,575
Total liabilities and stockholders’ equity
$ 4,326,708
$ 10,123,533
3
CADRENAL THERAPEUTICS, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
Years Ended
December 31,
2025
2024
Operating expenses:
General and administrative expenses
$ 9,354,135
$ 6,753,726
Research and development expenses
4,100,168
4,205,013
Depreciation expense
6,874
1,880
Total operating expenses
13,461,177
10,960,619
Loss from operations
(13,461,177 )
(10,960,619 )
Other income
Interest and dividend income
223,815
309,251
Total other income
223,815
309,251
Net loss and comprehensive loss
$ (13,237,362 )
$ (10,651,368 )
Net loss per common share, basic and diluted
$ (6.64 )
$ (8.73 )
Weighted average number of common shares used in computing net loss per common share, basic and diluted
1,993,757
1,219,550
4
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