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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):
May 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 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 May 7, 2026, Cadrenal Therapeutics, Inc., a
Delaware corporation (the “Company”), issued a press release that included financial information for the quarter ended March
31, 2026. 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 May 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: May 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 Reports First Quarter
2026 Financial Results and Provides Phase 3 Development Update on CAD-1005 Following End-of-Phase 2 Meeting with FDA
Official FDA meeting minutes and Phase 2
data provide guidance on the pivotal Phase 3 registration path for CAD-1005 in heparin-induced thrombocytopenia (HIT)
PONTE VEDRA, Fla., May 7, 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 first quarter ended March 31, 2026, and provided a corporate update highlighting continued
progress in its CAD-1005 program for HIT. The Company has now received the official minutes from its End-of-Phase 2 (EOP2) meeting with
the U.S. Food and Drug Administration (FDA), which provided guidance on key elements of the planned pivotal Phase 3 registration trial
for CAD-1005, Cadrenal’s investigational first-in-class 12-lipoxygenase (12-LOX) inhibitor being developed to treat suspected heparin-induced
thrombocytopenia (HIT). Based on this feedback and Phase 2 data, Cadrenal plans to advance directly to a randomized, blinded, placebo-controlled
Phase 3 study evaluating CAD-1005 added to standard-of-care anticoagulation in patients with HIT.
Recent Highlights
| ● | Received official FDA EOP2 meeting minutes providing guidance on protocol design, study population, dosing, background therapy, exposure,
safety database, and the primary endpoint of new or worsening thrombotic events. |
| ● | After considering FDA feedback on a pivotal registration study, Cadrenal plans to advance directly to a randomized, blinded, placebo-controlled
Phase 3 study evaluating CAD-1005 added to the current standard of care for patients with HIT. |
| ● | Planned pivotal Phase 3 study, the first randomized, blinded, placebo-controlled registration trial in HIT, will evaluate CAD-1005
in approximately 120 patients across clinical centers worldwide and is intended to support a projected NDA submission in 2029. |
| ● | Primary endpoint, centrally adjudicated, is expected to be the incidence of new or worsening thrombotic events in patients with Serotonin
Release Assay (SRA)-confirmed HIT, with at least one planned interim analysis. |
| ● | Phase 2 data showed an absolute reduction of more than 25% in thrombotic events when CAD-1005 was added to standard anticoagulant
therapy, supporting the continued advancement of CAD-1005 as Cadrenal’s near-term development priority. |
| ● | Continues to position CAD-1005 as a first-in-class, selective 12-LOX inhibitor and the only treatment in clinical development that
targets the underlying immune drivers of HIT, supported by Orphan Drug and Fast Track designations from the FDA and by orphan drug status
from the European Medicines Agency. |
“With the official EOP2 meeting minutes now in hand, we believe
the registration path for CAD-1005 in HIT is clearly defined,” commented Quang X. Pham, Chairman & CEO. “The FDA’s guidance
on trial design and the primary endpoint of new or worsening thrombotic events reinforces our confidence in advancing directly to a pivotal
Phase 3 study. We believe CAD-1005 has the potential to be the first new therapy for HIT in more than two decades.”
First Quarter 2026 Financial Highlights
Research and development expenses for the quarter ended March 31, 2026,
were $0.8 million compared to $1.7 million for the same period in 2025. General and administrative expenses were $1.7 million compared
to $2.3 million for the same period in 2025. Total operating expenses were $2.5 million compared to $3.9 million for the same period in
2025. Cadrenal reported a net loss of $2.5 million for the quarter ended March 31, 2026, compared to $3.8 million for the same period
in 2025.
As of March 31, 2026, Cadrenal had cash and cash equivalents of $2.3
million. Subsequent to quarter end, on April 1, 2026, the Company completed a $2.5 million financing, providing additional capital to
support near-term development activities. The Company continues to evaluate financing and strategic alternatives to support its planned
clinical development activities, including the anticipated pivotal Phase 3 trial of CAD-1005 in HIT.
The Company is advancing Phase 3 readiness activities, including protocol
finalization, and expects to provide further updates in the coming quarters.
About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. 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 being developed to treat 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 in development for chronic indications.
The Company’s broader pipeline includes tecarfarin, a late-stage
oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation,
including those with end-stage kidney disease and those with 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
continued progress in its CAD-1005 program for HIT ; plans to advance directly to a randomized, blinded, placebo-controlled Phase 3 study
evaluating CAD-1005 added to standard-of-care anticoagulation in patients with HIT; the planned pivotal Phase 3 study being the first
randomized, blinded, placebo-controlled registration trial in HIT; the Phase 3 study evaluating CAD-1005 in approximately 120 patients
across clinical centers worldwide; the trial supporting a projected NDA submission in 2029; the incidence of new or worsening thrombotic
events in patients with Serotonin Release Assay (SRA)-confirmed HIT being the primary endpoint of the trial; the trial having at least
one planned interim analysis; continuing to position CAD-1005 as a first-in-class, selective 12-LOX inhibitor and the only treatment in
clinical development that targets the underlying immune drivers of HIT; the registration path for CAD-1005 in HIT being clearly defined;
and CAD-1005 having the potential to be the first new therapy for HIT in more than two decades. Actual results may differ materially from
those indicated by such forward-looking statements as a result of various important factors, including the ability to raise sufficient
capital to continue progress of CAD-1005; the ability to advance directly to a randomized, blinded, placebo-controlled Phase 3 study evaluating
CAD-1005 added to standard-of-care anticoagulation in patients with HIT; the ability to successfully design and complete the Phase 3 study
and derive the results needed for an NDA submission: 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
Cadrenal Therapeutics,
Inc.
BALANCE
SHEETS
| | |
March 31,
2026
(unaudited) | | |
December 31,
2025 | |
| Assets: | |
| | |
| |
| Current assets: | |
| | |
| |
| Cash and cash equivalents | |
$ | 2,308,137 | | |
$ | 4,007,789 | |
| Interest receivable | |
| 5,466 | | |
| 5,096 | |
| Prepaid expenses and other current assets | |
| 428,071 | | |
| 200,140 | |
| Deferred offering costs | |
| 113,607 | | |
| 106,342 | |
| Total current assets | |
| 2,855,281 | | |
| 4,319,367 | |
| Property, plant and equipment, net | |
| 4,619 | | |
| 5,174 | |
| Other assets | |
| 2,167 | | |
| 2,167 | |
| Total assets | |
$ | 2,862,067 | | |
$ | 4,326,708 | |
| Liabilities and Stockholders’ Equity: | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 824,809 | | |
$ | 650,663 | |
| Accrued liabilities | |
| 240,143 | | |
| 937,319 | |
| Total current liabilities | |
| 1,064,952 | | |
| 1,587,982 | |
| Total liabilities | |
| 1,064,952 | | |
| 1,587,982 | |
| Stockholders’ equity: | |
| | | |
| | |
| Preferred stock, $0.001 par value, 7,500,000 shares authorized, no shares issued and outstanding as of March 31, 2026 and December 31, 2025 | |
| - | | |
| - | |
| Common stock, $0.001 par value; 75,000,000 shares authorized, 2,506,817 shares issued and outstanding as of March 31, 2026; 2,338,127 shares issued and outstanding as of December 31, 2025 | |
| 2,507 | | |
| 2,338 | |
| Additional paid-in capital | |
| 43,251,293 | | |
| 41,696,533 | |
| Accumulated deficit | |
| (41,456,685 | ) | |
| (38,960,145 | ) |
| Total stockholders’ equity | |
| 1,797,115 | | |
| 2,738,726 | |
| Total liabilities and stockholders’ equity | |
$ | 2,862,067 | | |
$ | 4,326,708 | |
Cadrenal Therapeutics,
Inc.
statements
of operations and comprehensive loss
(unaudited)
| | |
Three Months Ended
March 31, | |
| | |
2026 | | |
2025 | |
| Operating expenses: | |
| | |
| |
| General and administrative expenses | |
$ | 1,742,315 | | |
$ | 2,254,577 | |
| Research and development expenses | |
| 771,508 | | |
| 1,667,882 | |
| Depreciation expense | |
| 555 | | |
| 5,517 | |
| Total operating expenses | |
| 2,514,378 | | |
| 3,927,976 | |
| Loss from operations | |
| (2,514,378 | ) | |
| (3,927,976 | ) |
| Other income | |
| | | |
| | |
| Interest and dividend income | |
| 17,838 | | |
| 82,596 | |
| Total other income | |
| 17,838 | | |
| 82,596 | |
| Net loss and comprehensive loss | |
$ | (2,496,540 | ) | |
$ | (3,845,380 | ) |
| | |
| | | |
| | |
| Net loss per common share, basic and diluted | |
$ | (1.04 | ) | |
$ | (2.09 | ) |
| Weighted average number of common shares used in computing net loss per common share, basic and diluted | |
| 2,407,665 | | |
| 1,844,072 | |
