Cadrenal Therapeutics Reports Fourth Quarter 2025 Financial Results; Provides Corporate Update on CAD-1005 Program for HIT Following End-of-Phase 2 FDA Meeting
Rhea-AI Summary
Cadrenal Therapeutics (Nasdaq: CVKD) reported Q4 and full-year results and provided an update on CAD-1005 for suspected heparin-induced thrombocytopenia (HIT). The company completed an End-of-Phase 2 FDA meeting on March 26, 2026, reported Phase 2 data showing a >25% absolute reduction in thrombotic events, and is incorporating FDA feedback into a planned Phase 3 pivotal protocol.
Cadrenal held $4.0 million cash at December 31, 2025, reported a Q4 net loss of $3.0 million, and is evaluating financing and strategic alternatives to support clinical development.
Positive
- Phase 2 thrombotic events reduction >25% absolute
- Completed End-of-Phase 2 FDA meeting on March 26, 2026
- Orphan Drug and Fast Track designations in place
Negative
- Cash balance of $4.0M at December 31, 2025
- Reported Q4 net loss $3.0M; financing under evaluation
News Market Reaction – CVKD
In the Mar 31 session, CVKD gained 20.47%, reflecting a significant positive market reaction. Argus tracked a peak move of +23.3% during that session. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Mar 12 | Preclinical inflammation data | Positive | -8.0% | New obesity and Type 2 diabetes data for CAD-1005 and 12-LOX platform. |
| Mar 02 | Platform expansion | Positive | +1.2% | Expanded 12-LOX portfolio and encouraging blinded Phase 2 CAD-1005 HIT data. |
| Feb 24 | Phase 2 HIT results | Positive | +16.1% | Phase 2 showed >25% absolute reduction in thrombotic events versus placebo. |
| Jan 12 | Conference HIT update | Positive | +4.4% | JPM presentation highlighting HIT thrombotic burden and VLX-1005 profile. |
| Dec 30 | Pipeline positioning | Positive | -4.2% | Described multi-asset anticoagulation platform spanning chronic and acute settings. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent CAD-1005 and platform news has produced mixed reactions: 3 aligned positive moves and 2 negative divergences despite broadly constructive clinical/platform updates.
Over the past several months, Cadrenal has repeatedly emphasized its 12-LOX and anticoagulation platform. News on Dec 30, 2025 framed the pipeline as hospital-focused across tecarfarin, frunexian, and VLX-1005, but the stock fell. Subsequent updates in Jan–Mar 2026 highlighted HIT thrombotic-risk data, Orphan/Fast Track designations, Phase 2 results showing >25% thrombotic reduction, and preclinical obesity/diabetes data. Market reactions alternated between gains and pullbacks, indicating inconsistent trading responses to clinically positive developments.
Key Terms
heparin-induced thrombocytopenia medical
12-lox inhibitor medical
orphan drug regulatory
fast track regulatory
end-of-phase 2 regulatory
phase 3 pivotal trial medical
thrombotic events medical
platelet count medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
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 (GLOBE NEWSWIRE) -- 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
“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
On December 31, 2025, Cadrenal had cash and cash equivalents of
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
| CADRENAL THERAPEUTICS, INC. BALANCE SHEETS | ||||||||
| December 31, | December 31, | |||||||
| 2025 | 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, | - | - | ||||||
| Common stock, | 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 | ||||||
