Cadrenal Therapeutics (NASDAQ: CVKD) widens 2025 loss, advances CAD-1005 toward Phase 3

Rhea-AI Filing Summary

Cadrenal Therapeutics, Inc. reported fourth quarter and full-year 2025 results and provided an update on its CAD-1005 program for heparin-induced thrombocytopenia (HIT). The company completed an End-of-Phase 2 FDA meeting on March 26, 2026 to align on a proposed Phase 3 pivotal trial design.

For Q4 2025, research and development expenses were $0.7 million, down from $1.5 million a year earlier, while general and administrative expenses were $2.4 million, down from $2.7 million. Cadrenal posted a quarterly net loss of $3.0 million, improving from a $4.2 million loss in Q4 2024.

For the full year 2025, operating expenses totaled $13.5 million and the net loss was $13.2 million, compared with a $10.7 million net loss in 2024. Cash and cash equivalents were $4.0 million as of December 31, 2025, and the company is evaluating financing and strategic alternatives to support planned clinical development.

Insights

Biopharma financial analyst

Cadrenal narrows Q4 loss, but full-year burn and low cash highlight funding needs.

Cadrenal Therapeutics reduced Q4 2025 operating expenses, with research and development at $0.7M and general and administrative at $2.4M, leading to a quarterly net loss of $3.0M versus $4.2M a year earlier. This suggests tighter cost control late in the year.

However, full-year operating expenses reached $13.5M and net loss was $13.2M, larger than in 2024. Cash and cash equivalents declined to $4.0M at December 31, 2025, from $10.0M a year earlier, underscoring reliance on external funding.

The company highlights CAD-1005 for HIT as its near-term development priority and notes completion of an End-of-Phase 2 FDA meeting on March 26, 2026. Future disclosures in periodic reports may clarify the design and timing of the planned Phase 3 trial and any resulting financing transactions.

8-K Event Classification

2 items: 2.02, 9.01

2 items

Item 2.02 Results of Operations and Financial Condition Financial

Disclosure of earnings results, typically an earnings press release or preliminary financials.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Key Figures

Q4 2025 R&D expense: $0.7 million Q4 2025 G&A expense: $2.4 million Q4 2025 net loss: $3.0 million +5 more

8 metrics

Q4 2025 R&D expense $0.7 million Research and development expenses for quarter ended December 31, 2025

Q4 2025 G&A expense $2.4 million General and administrative expenses for quarter ended December 31, 2025

Q4 2025 net loss $3.0 million Net loss for quarter ended December 31, 2025

Full-year 2025 net loss $13,237,362 Net loss and comprehensive loss for year ended December 31, 2025

Year-end 2025 cash $4,007,789 Cash and cash equivalents as of December 31, 2025

Year-end 2024 cash $10,017,942 Cash and cash equivalents as of December 31, 2024

Shares outstanding 2025 2,338,127 shares Common stock issued and outstanding as of December 31, 2025

Shares outstanding 2024 1,782,486 shares Common stock issued and outstanding as of December 31, 2024

Key Terms

End-of-Phase 2, 12-LOX inhibitor, heparin-induced thrombocytopenia, Orphan Drug, +2 more

6 terms

End-of-Phase 2 regulatory

"including completion of its End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA)"

End-of-phase 2 is the development milestone when a drug or medical treatment completes its mid-stage human testing and the sponsor and regulators review the results to decide whether and how to proceed to larger late-stage trials. It matters to investors because this review signals whether the product showed enough benefit and acceptable safety to justify expensive Phase 3 studies, much like passing a major exam before committing to the final, costly year of a degree, and can materially affect a company’s value and funding needs.

12-LOX inhibitor medical

"CAD-1005, Cadrenal’s first-in-class 12-LOX inhibitor for suspected heparin-induced thrombocytopenia (HIT)"

A 12-lox inhibitor is a drug or compound that blocks the action of the 12‑lipoxygenase enzyme, which helps produce molecules that drive inflammation, blood-clotting behavior, and some processes in cancer cells. For investors, it matters because targeting this specific enzyme is a clear therapeutic strategy: successful inhibitors can become new medicines, affect clinical trial value inflection points, and change forecasts for companies developing treatments in inflammatory, cardiovascular, or oncology markets.

heparin-induced thrombocytopenia medical

"for suspected heparin-induced thrombocytopenia (HIT), a life-threatening, immune-mediated prothrombotic disorder"

An immune reaction to the blood-thinning drug heparin that destroys or disables platelets, the blood cells that stop bleeding, while paradoxically increasing the risk of dangerous clots. Think of it as the body’s security system misidentifying helpful staff and triggering chaos that both lowers protection and creates blockages. Investors care because it can change demand for drugs and devices, drive safety warnings or lawsuits, and affect hospital treatment costs and clinical trial outcomes.

Orphan Drug regulatory

"CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration"

A drug designated for an orphan disease is a medicine developed to treat a rare condition that affects only a small number of people. Regulators often give these drugs special incentives—such as reduced costs, faster review, and temporary exclusive selling rights—to encourage development, which matters to investors because those incentives can make a small market financially viable and reduce competition, much like a temporary patent on a niche product.

Fast Track regulatory

"Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration"

A fast track designation is a regulatory label that speeds up the review and communication between a drug developer and regulators for treatments addressing serious illnesses or unmet medical needs. For investors, it matters because it can shorten development time and reduce regulatory delays—like getting a VIP lane at the airport—raising the chance of earlier market access and potential revenue, though it does not guarantee approval.

Factor XIa inhibitor medical

"frunexian, a parenteral Factor XIa inhibitor intended for use in acute hospital settings"

A factor XIa inhibitor is a class of medicine that blocks activated factor XI, a protein that helps blood form clots; by slowing one step in the clotting chain reaction it reduces the chance of dangerous clots such as strokes or post-surgery thrombosis. Investors watch these drugs because they promise the market value of traditional blood thinners but with a potentially lower risk of bleeding — like a smarter brake that aims to stop accidents without causing spills — so clinical results and approvals can materially affect sales and company valuations.

Earnings Snapshot

Q4 2025 net loss: $3.0 million

Q4 and full year 2025

Q4 2025 net loss $3.0 million

Full-year 2025 net loss $13,237,362

Year-end 2025 cash $4,007,789

Understanding 8-K Material Events →

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (date of earliest event reported): March 31, 2026

Cadrenal Therapeutics, Inc.

(Exact name of registrant as specified in charter)

Delaware		001-41596		88-0860746
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

822 A1A North, Suite 306

Ponte Vedra, Florida 32082

(Address of principal executive offices and zip code)

(904) 300-0701

(Registrant’s telephone number including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbols		Name of each exchange on which registered
Common Stock, par value $0.001 per share		CVKD		The Nasdaq Stock Market LLC (Nasdaq Capital Market)

Indicate by check mark whether the registrant is an emerging growth company as defined in in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition.

On March 31, 2026, Cadrenal Therapeutics, Inc., a Delaware corporation (the “Company”), issued a press release that included financial information for the fiscal year ended December 31, 2025. 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 March 31, 2026
104		Cover Page Interactive Data File (the cover page XBRL tags are embedded within in the inline XBRL document)

1

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: March 31, 2026	CADRENAL THERAPEUTICS, INC.
	By:	/s/ Quang X. Pham
	Name:	Quang X. Pham
	Title:	Chairman and Chief Executive Officer

2

Exhibit 99.1

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.

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 18-20% 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.

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

2

CADRENAL THERAPEUTICS, INC.

BALANCE SHEETS

		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

3

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

4

FAQ

What did Cadrenal Therapeutics (CVKD) report for its Q4 2025 net loss?

Cadrenal Therapeutics reported a Q4 2025 net loss of $3.0 million, an improvement from $4.2 million in Q4 2024. Lower research and development and general and administrative expenses contributed to the reduced quarterly loss while the company advanced its CAD-1005 HIT program.

How did Cadrenal Therapeutics’ full-year 2025 results compare to 2024?

For 2025, Cadrenal reported a net loss of $13.2 million, wider than the $10.7 million loss in 2024. Total operating expenses rose to $13.5 million, reflecting higher general and administrative and research-related spending to support its development pipeline.

What was Cadrenal Therapeutics’ cash position at December 31, 2025?

Cadrenal Therapeutics had $4.0 million in cash and cash equivalents as of December 31, 2025, down from $10.0 million a year earlier. The company is evaluating financing and strategic alternatives to fund its planned clinical development activities, including the CAD-1005 Phase 3 program.

How much did Cadrenal Therapeutics spend on R&D and G&A in 2025?

In 2025, Cadrenal recorded $4.1 million in research and development expenses and $9.4 million in general and administrative expenses. This compares with $4.2 million and $6.8 million, respectively, in 2024, showing higher overhead alongside relatively stable development spending.

What regulatory milestone did CAD-1005 achieve according to Cadrenal’s 8-K?

CAD-1005 reached an important regulatory milestone with completion of an End-of-Phase 2 FDA meeting on March 26, 2026. The meeting focused on aligning expectations for a proposed Phase 3 pivotal trial in suspected heparin-induced thrombocytopenia, supporting CAD-1005 as the company’s lead development priority.

How many Cadrenal Therapeutics common shares were outstanding at year-end 2025?

Cadrenal Therapeutics had approximately 2,338,127 shares of common stock outstanding as of December 31, 2025. This compares to 1,782,486 shares outstanding a year earlier, reflecting share issuance activity to support operations and the company’s development programs.

Filing Exhibits & Attachments

4 documents

Press Releases

• EX-99.1 PRESS RELEASE, ISSUED BY CADRENAL THERAPEUTICS, INC. ON MARCH 31, 2026 51.6 KB

Other Documents

• EX-101 XBRL SCHEMA FILE 2.9 KB
• EX-101 XBRL LABEL FILE 33.4 KB
• EX-101 XBRL PRESENTATION FILE 21.8 KB