Full Press Release Details
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.
"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
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.
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
Cadrenal Therapeutics,
| 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,
of operations and comprehensive loss
| 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 |