Full Press Release Details
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.
"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.
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,
For more information, please contact:
Lytham Partners, LLC
Robert Blum, Managing Partner
CADRENAL THERAPEUTICS, INC.
| 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 |
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 |