CVKD 8-K
Cadrenal Therapeutics, Inc. (CVKD)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 2.02 Results of Operations and Financial Condition.
On August 13, 2026, Cadrenal Therapeutics, Inc., a Delaware corporation (the “Company”), issued a press release that included financial information for the quarter ended June 30, 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 August 13, 2026 | |
| 104 | Cover Page Interactive Data File (the cover page XBRL tags are embedded within in the inline XBRL document) |
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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: August 13, 2026 | CADRENAL THERAPEUTICS, INC. | |
| By: | /s/ Quang X. Pham | |
| Name: | Quang X. Pham | |
| Title: | Chairman and Chief Executive Officer | |
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Exhibit 99.1
Cadrenal Therapeutics Reports Second Quarter 2026 Financial Results; Provides a Corporate Update on the Cardiac Acute Critical Care Franchise and the Strategic Partnering Process
Late-breaking Phase 2 CAD-1005 data presented at ISTH support a late-stage portfolio organized around preoperative safety, orphan regulatory acceleration, and postoperative shielding
PONTE VEDRA, Fla., August 13, 2026 - Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions, today reported financial results for the second quarter ended June 30, 2026, and provided a corporate update on the launch of a structured strategic partnering process following significant clinical, regulatory, and portfolio progress across its Cardiac Acute Critical Care Franchise.
“The second quarter and subsequent weeks marked an important milestone for Cadrenal,” said Quang X. Pham, Chairman and Chief Executive Officer of Cadrenal Therapeutics. “Our objective is to convert clinical and regulatory progress into strategic value while remaining capital disciplined. We are also pursuing multiple nondilutive grants to advance our programs. With CAD-1005, frunexian, and tecarfarin addressing complementary acute, critical care, and orphan cardiovascular opportunities, and CAD-2000 extending the 12-LOX platform to treat chronic conditions, we believe Cadrenal offers a differentiated pipeline that addresses critical unmet needs for high-risk patients.”
“Having achieved regulatory guidance on the Phase 3 path for CAD-1005, we delivered a late-breaking presentation to the global thrombosis community on Phase 2 data for CAD-1005, which demonstrated an absolute reduction of more than 25% in thrombotic events. Our portfolio, now organized into a Cardiac Acute Critical Care Franchise spanning pre-operative safety, orphan regulatory acceleration, and post-operative shielding, is structured to demonstrate to prospective partners how our assets can address multiple high-value needs across the cardiac surgery continuum.”
The strategic alignment of the Cardiac Acute Critical Care (CACC) Franchise organizes Cadrenal’s portfolio into three commercial pillars.
| Strategic pillar | Program / focus | Key point | ||
| Pre-Operative Safety | Frunexian IV for HIT-susceptible patients undergoing coronary artery bypass graft (CABG) surgery | Intended to replace volatile alternative anticoagulation protocols and establish a predictable safety profile before surgery. | ||
| Orphan Regulatory Acceleration | Orphan Drug Designation strategy for HIT patients undergoing cardiac surgery | Intended to support seven years of post-approval market exclusivity, fee waivers, and targeted tax credits. | ||
| Post-Operative Shield | CAD-1005 for Cardiac Surgery-Associated HIT and Cardiac Surgery-Associated Acute Kidney Injury | Described as supported by clinical data presented at the ISTH congress in July 2026 regarding its renal-protective profile. |
Recent Highlights
| ● | Presented late-breaking Phase 2 data on CAD-1005 at the International Society of Thrombosis and Hemostasis (ISTH) 2026 Congress in Paris. The randomized, blinded, placebo-controlled study demonstrated an absolute reduction of more than 25% in thrombotic events when CAD-1005 was added to standard anticoagulant therapy, with a favorable safety profile and renal-protective baseline. |
| ● | Launched a structured partnering process to explore development, licensing, and commercialization transactions for CAD-1005, frunexian, and tecarfarin. Cadrenal is pursuing a capital-efficient model focused on strategic out-licensing, portfolio monetization, and commercial co-development rather than independently funding large late-stage clinical trials. |
| ● | Solidified a multi-indication strategy for CAD-1005 in heparin-induced thrombocytopenia (HIT) and Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI). The Company believes that the shared cardiac intensive care infrastructure, intravenous administration, and complementary thrombotic and inflammatory mechanisms may create a differentiated critical care asset package for prospective partners. |
| ● | Submitted a request to the U.S. Food and Drug Administration on July 8, 2026, for Rare Pediatric Disease Designation for tecarfarin for the prevention of life-threatening blood clots inside coronary artery aneurysms in children with Kawasaki Disease. |
| ● | Signed an agreement with a global firm that has collectively secured over $500 million in non-dilutive funding for life science companies. |
| ● | Continued advancing CAD-2000, a highly selective, orally bioavailable preclinical 12-lipoxygenase (12-LOX) inhibitor designed for chronic cardiorenal inflammatory and thrombotic indications, as a potential follow-on companion to the Company’s intravenous acute care platform. |
| ● | Signed a private placement that generated approximately $3.0 million in gross proceeds, with up to approximately $5.8 million in additional gross proceeds if the associated warrants are exercised in full for cash. There can be no assurance that any warrants will be exercised. |
Second Quarter 2026 Financial Highlights
Research and development expenses for the quarter ended June 30, 2026, were $0.7 million compared to $1.1 million for the same period in 2025. General and administrative expenses were $2.6 million compared to $2.7 million for the same period in 2025. Total operating expenses were $3.3 million compared to $3.7 million for the same period in 2025. Cadrenal reported a net loss of $3.3 million for the quarter ended June 30, 2026, compared to $3.7 million for the same period in 2025.
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As of early August 2026, Cadrenal had approximately $4.2 million in cash and cash equivalents. Based on its current operating plan, the Company believes these resources are expected to fund operations through the first quarter of 2027. The Company’s existing cash resources are not sufficient to advance its product candidates to clinical trial readiness or to commence and complete any clinical trials. Cadrenal does not plan to commence a clinical trial unless funding sufficient to complete that trial is in place, which may include capital raised through strategic partnerships, out-licensing agreements, non-dilutive grants, equity or debt financing, or a combination of these sources.
About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions. The Company’s pipeline includes CAD-1005, tecarfarin, and frunexian. CAD-1005 is a novel investigational therapeutic in development for the treatment of heparin-induced thrombocytopenia (HIT) and Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI). CAD-1005 is designed to selectively inhibit 12-lipoxygenase (12-LOX), an enzyme central to platelet immune activation and thrombo-inflammatory signaling in HIT. CAD-1005 is intended to be used alongside existing standards of care and is being developed to address the underlying biological mechanisms that drive disease progression. CAD-1005 has an Orphan Drug Designation (“ODD”) from the U.S. Food and Drug Administration (“FDA”) for prophylaxis of thrombosis in patients with HIT, FDA Fast Track designation for the treatment and prevention of HIT, and an orphan designation from the European Medicines Agency for the treatment of platelet-activating factor 4 disorders. Second-generation 12-LOX oral therapeutics (CAD-2000) 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 atrial fibrillation, those with left ventricular assist devices, and potentially those with Kawasaki disease (KD), an acute, self-limited, febrile illness that primarily affects children under 5 years old and is the leading cause of acquired heart disease in developed countries. The Company recently submitted a request for Rare Pediatric Disease Designation (RPDD) to the FDA for tecarfarin for “Prevention of the Formation of Life-Threatening Blood Clots Inside Coronary Artery Aneurysms in Children with Kawasaki Disease”. Tecarfarin has also received Orphan Drug and Fast Track designations from the FDA.
For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.
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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 Company converting clinical and regulatory progress into strategic value while remaining capital disciplined; pursuing multiple nondilutive grants to advance the Company’s programs; Cadrenal offering a differentiated pipeline that addresses critical unmet needs for high-risk patients; the CACC Franchise demonstrating to prospective partners how the Company’s assets can address multiple high-value needs across the cardiac surgery continuum; frunexian IV replacing volatile alternative anticoagulation protocols for HIT-susceptible patients undergoing CABG surgery and establishing a predictable safety profile; ODD for HIT supporting seven years of post-approval market exclusivity, fee waivers and targeted tax credits; CAD-1005 serving as a post-operative shield for Cardiac Surgery-Associated HIT and CSA-AKI; the Company’s ability to enter into development, licensing, and commercialization transactions for CAD-1005, frunexian, and tecarfarin; the shared cardiac intensive care infrastructure, intravenous administration, and complementary thrombotic and inflammatory mechanisms creating a differentiated critical care asset package for prospective partners; the FDA’s ultimate decision regarding the Company’s request for RPDD for tecarfarin for the prevention of life-threatening blood clots inside coronary artery aneurysms in children with Kawasaki Disease; CAD-2000 potentially being a follow-on companion to the Company’s intravenous acute care platform; the potential exercise of the warrants issued in the Company’s private placement resulting in gross proceeds of up to $5.8 million; the Company’s belief that its resources will fund operations through the first quarter of 2027; the Company securing funding sufficient to complete a trial, which may include capital raised through strategic partnerships, out-licensing agreements, non-dilutive grants, equity or debt financing, or a combination of these sources; and tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, potentially treating patients with Kawasaki disease. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to advance its programs to clinical trial readiness; the Company’s ability to enter into development, licensing, and commercialization transactions for CAD-1005, frunexian, and tecarfarin; the Company’s ability to secure nondilutive grants to advance its programs; 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
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CADRENAL THERAPEUTICS, INC.
BALANCE SHEETS
| June 30, 2026 | December 31, | |||||||
| (unaudited) | 2025 | |||||||
| Assets: | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 2,388,135 | $ | 4,007,789 | ||||
| Receivable from issuance of warrants | 2,684,904 | - | ||||||
| Interest receivable | 5,305 | 5,096 | ||||||
| Prepaid expenses and other current assets | 410,105 | 200,140 | ||||||
| Deferred offering costs | 95,674 | 106,342 | ||||||
| Total current assets | 5,584,123 | 4,319,367 | ||||||
| Property, plant and equipment, net | 2,675 | 5,174 | ||||||
| Other assets | 2,167 | 2,167 | ||||||
| Total assets | $ | 5,588,965 | $ | 4,326,708 | ||||
| Liabilities and Stockholders’ Equity: | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 871,913 | $ | 650,663 | ||||
| Accrued liabilities | 625,344 | 937,319 | ||||||
| Total current liabilities | 1,497,257 | 1,587,982 | ||||||
| Total liabilities | 1,497,257 | 1,587,982 | ||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $0.001 par value, 7,500,000 shares authorized, no shares issued and outstanding as of June 30, 2026 and December 31, 2025 | - | - | ||||||
| Common stock, $0.001 par value; 75,000,000 shares authorized, 3,098,592 shares issued and outstanding as of June 30, 2026; 2,338,127 shares issued and outstanding as of December 31, 2025 | 3,098 | 2,338 | ||||||
| Additional paid-in capital | 48,867,860 | 41,696,533 | ||||||
| Accumulated deficit | (44,779,250 | ) | (38,960,145 | ) | ||||
| Total stockholders’ equity | 4,091,708 | 2,738,726 | ||||||
| Total liabilities and stockholders’ equity | $ | 5,588,965 | $ | 4,326,708 | ||||
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CADRENAL THERAPEUTICS, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| General and administrative expenses | $ | 2,634,745 | $ | 2,656,392 | $ | 4,377,060 | $ | 4,910,970 | ||||||||
| Research and development expenses | 705,151 | 1,077,498 | 1,476,659 | 2,745,379 | ||||||||||||
| Depreciation expense | 504 | 401 | 1,059 | 5,918 | ||||||||||||
| Total operating expenses | 3,340,400 | 3,734,291 | 5,854,778 | 7,662,267 | ||||||||||||
| Loss from operations | (3,340,400 | ) | (3,734,291 | ) | (5,854,778 | ) | (7,662,267 | ) | ||||||||
| Other income | ||||||||||||||||
| Interest and dividend income | 17,835 | 67,004 | 35,673 | 149,600 | ||||||||||||
| Total other income | 17,835 | 67,004 | 35,673 | 149,600 | ||||||||||||
| Net loss and comprehensive loss | $ | (3,322,565 | ) | $ | (3,667,287 | ) | $ | (5,819,105 | ) | $ | (7,512,667 | ) | ||||
| Net loss per common share, basic and diluted | $ | (1.14 | ) | $ | (1.87 | ) | $ | (2.19 | ) | $ | (3.95 | ) | ||||
| Weighted average number of common shares used in computing net loss per common share, basic and diluted | 2,913,225 | 1,961,642 | 2,661,857 | 1,903,222 | ||||||||||||
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