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
Rhea-AI Summary
Cadrenal Therapeutics (NASDAQ: CVKD) reported Q1 2026 results and FDA End-of-Phase 2 minutes for CAD-1005 in suspected heparin-induced thrombocytopenia (HIT). The company plans a randomized, blinded, placebo-controlled pivotal Phase 3 (~120 patients) to support a projected NDA submission in 2029. Phase 2 showed >25% absolute reduction in thrombotic events when CAD-1005 was added to standard anticoagulation. Q1 operating loss was $2.5M; cash was $2.3M as of March 31, 2026, and a $2.5M financing closed April 1, 2026.
Positive
- Phase 2 showed an absolute >25% reduction in thrombotic events
- FDA provided EOP2 minutes guiding Phase 3 design and primary endpoint
- Planned randomized, blinded, placebo-controlled Phase 3 in ~120 patients
- Completed $2.5M financing on April 1, 2026 to support near-term activities
- Orphan Drug and Fast Track designations from FDA; orphan status from EMA
Negative
- Cash and cash equivalents totaled only $2.3M as of March 31, 2026
- Company states it continues to evaluate financing and strategic alternatives to support Phase 3
News Market Reaction – CVKD
In the May 7 session, CVKD declined 2.43%, reflecting a moderate negative market reaction. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Earnings,clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Mar 31 | Earnings & trial update | Positive | +20.5% | Q4 2025 earnings plus CAD-1005 Phase 2 and EOP2 path update. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Prior combined earnings/clinical updates for CAD-1005 were followed by a strong positive price reaction.
This announcement continues Cadrenal’s focus on CAD-1005, following multiple 2026 updates. On Feb 24, Phase 2 results showed >25% thrombotic event reduction. Subsequent news in March and April detailed platform expansion and an End-of-Phase 2 FDA meeting, with an identified Phase 3 registration path. The last tagged earnings,clinical trial update on Mar 31, 2026 paired Q4 results with CAD-1005 progress and saw a 20.47% gain, indicating prior enthusiasm for similar combined financial and clinical disclosures.
Key Terms
heparin-induced thrombocytopenia medical
12-lipoxygenase medical
12-LOX medical
serotonin release assay medical
orphan drug regulatory
fast track regulatory
nda regulatory
placebo-controlled medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
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 07, 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 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
As of March 31, 2026, Cadrenal had cash and cash equivalents of
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 | December 31, | |||||||
| (unaudited) | 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, | - | - | ||||||
| Common stock, | 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 | |||||
