UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2025

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934‌

For the transition period from to

Commission file number 001-41596

CADRENAL THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware		88-0860746
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

822 A1A North, Suite 306 Ponte Vedra, Florida		32082
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (904) 300-0701

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

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

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☒

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

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of November 10, 2025, there were 2,075,845 outstanding shares of common stock, par value $0.001 per share, of Cadrenal Therapeutics, Inc.

CADRENAL THERAPEUTICS, INC.

QUARTERLY REPORT ON FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2025

TABLE OF CONTENTS

		Page
	PART I. FINANCIAL INFORMATION	1

Item 1.	Financial Statements (Unaudited)	1
	Balance Sheets at September 30, 2025 and December 31, 2024	1
	Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2025 and 2024	2
	Statements of Changes in Stockholders’ Equity for the Three and Nine Months Ended September 30, 2025 and 2024	3
	Statements of Cash Flows for the Nine Months Ended September 30, 2025 and 2024	4
	Notes to Financial Statements	5
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	18
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	24
Item 4.	Controls and Procedures	25

	PART II. OTHER INFORMATION	26

Item 1.	Legal Proceedings	26
Item 1A.	Risk Factors	26
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	27
Item 3.	Defaults Upon Senior Securities	27
Item 4.	Mine Safety Disclosures	28
Item 5.	Other Information	28
Item 6.	Exhibits	28

SIGNATURES		29

PART I. FINANCIAL INFORMATION

CADRENAL THERAPEUTICS, INC.

BALANCE SHEETS

	September 30, 2025			December 31,
	(unaudited)			2024
Assets:
Current assets:
Cash and cash equivalents	$	3,860,082		$	10,017,942
Interest receivable		12,791			38,153
Prepaid expenses and other current assets		116,015			42,257
Deferred offering costs		90,838			14,445
Total current assets		4,079,726			10,112,797
Property, plant and equipment, net		5,729			6,944
Other assets		2,167			3,792
Total assets	$	4,087,622		$	10,123,533
Liabilities and Stockholders' Equity:
Current liabilities:
Accounts payable	$	614,127		$	1,502,468
Accrued liabilities		738,548			1,181,490
Total current liabilities		1,352,675			2,683,958
Total liabilities		1,352,675			2,683,958
Stockholders’ equity:
Preferred stock, $0.001 par value, 7,500,000 shares authorized, no shares issued and outstanding at September 30, 2025 and December 31, 2024		-			-
Common stock, $0.001 par value; 75,000,000 shares authorized, 2,059,754 shares issued and outstanding as of September 30, 2025; 1,782,486 shares issued and outstanding as of December 31, 2024		2,059			1,782
Additional paid-in capital		38,654,043			33,160,576
Accumulated deficit		(35,921,155	)		(25,722,783	)
Total stockholders’ equity		2,734,947			7,439,575
Total liabilities and stockholders’ equity	$	4,087,622		$	10,123,533

The accompanying notes are an integral part of these financial statements.

CADRENAL THERAPEUTICS, INC.

STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(unaudited)

	Three Months Ended September 30,						Nine Months Ended September 30,
	2025			2024			2025			2024
Operating expenses:
General and administrative expenses	$	2,044,937		$	1,674,905		$	6,955,907		$	4,013,336
Research and development expenses		688,465			784,646			3,433,845			2,667,382
Depreciation expense		401			407			6,319			1,473
Total operating expenses		2,733,803			2,459,958			10,396,071			6,682,191
Loss from operations		(2,733,803	)		(2,459,958	)		(10,396,071	)		(6,682,191	)
Other income
Interest and dividend income		48,098			52,129			197,699			218,092
Total other income		48,098			52,129			197,699			218,092
Net loss and comprehensive loss	$	(2,685,705	)	$	(2,407,829	)	$	(10,198,372	)	$	(6,464,099	)

Net loss per common share, basic and diluted (1)	$	(1.31	)	$	(2.18	)	$	(5.23	)	$	(5.24	)
Weighted average number of common shares used in computing net loss per common share, basic and diluted (1)		2,044,033			1,104,005			1,950,703			1,234,672

(1)	All share and per share information has been retroactively adjusted to reflect the 1-for-15 reverse stock split effected on August 20, 2024. See Note 6, Stockholders’ Equity for additional information.

The accompanying notes are an integral part of these financial statements.

CADRENAL THERAPEUTICS, INC.

STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(unaudited)

For the three months ended September 30, 2025
	Common Stock				Additional Paid-In		Accumulated			Total Stockholders’
	Shares		Amount		Capital		Deficit			Equity
Balance, June 30, 2025		2,007,113	$	2,006	$	37,532,357	$	(33,235,450	)	$	4,298,913
Equity-based compensation - options		-		-		473,384		-			473,384
Proceeds from sale of common stock, net issuance costs of $35,628		50,434		51		632,302		-			632,353
Exercise of stock options		2,207		2		16,000		-			16,002
Net loss		-		-		-		(2,685,705	)		(2,685,705	)
Balance, September 30, 2025		2,059,754	$	2,059	$	38,654,043	$	(35,921,155	)	$	2,734,947

For the nine months ended September 30, 2025
	Common Stock				Additional Paid-In		Accumulated			Total Stockholders’
	Shares		Amount		Capital		Deficit			Equity
Balance, December 31, 2024		1,782,486	$	1,782	$	33,160,576	$	(25,722,783	)	$	7,439,575
Equity-based compensation - options		-		-		1,481,418		-			1,481,418
Issuance of common stock for consulting services		35,000		35		133,340		-			133,375
Proceeds from sale of common stock, net issuance costs of $184,647		236,728		237		3,830,714		-			3,830,951
Exercise of stock options		5,540		5		47,995		-			48,000
Net loss		-		-		-		(10,198,372	)		(10,198,372	)
Balance, September 30, 2025		2,059,754	$	2,059	$	38,654,043	$	(35,921,155	)	$	2,734,947

For the three months ended September 30, 2024
	Common Stock (1)					Additional Paid-In		Accumulated			Total Stockholders’
	Shares			Amount		Capital (1)		Deficit			Equity
Balance, June 30, 2024		1,067,231		$	1,067	$	23,118,872	$	(19,127,685	)	$	3,992,254
Rounding of fractional shares from reverse stock split		(36	)		-		-		-			-
Equity-based compensation - options		-			-		195,583		-			195,583
Issuance of common stock for consulting services		13,333			13		104,384		-			104,397
Proceeds from sale of common stock, net issuance costs of $107,831		154,144			154		1,527,792		-			1,527,946
Net loss		-			-		-		(2,407,829	)		(2,407,829	)
Balance, September 30, 2024		1,234,672		$	1,234	$	24,946,631	$	(21,535,514	)	$	3,412,351

For the nine months ended September 30, 2024
	Common Stock (1)					Additional Paid-In		Accumulated			Total Stockholders’
	Shares			Amount		Capital (1)		Deficit			Equity
Balance, December 31, 2023		868,184		$	868	$	22,762,922	$	(15,071,415	)	$	7,692,375
Issuance of common shares from exercise of pre-funded warrants		199,047			199		99		-			298
Rounding of fractional shares from reverse stock split		(36	)		-		-		-			-
Equity-based compensation - options		-			-		551,434		-			551,434
Issuance of common stock for consulting services		13,333			13		104,384		-			104,397
Proceeds from sale of common stock, net issuance costs of $107,831		154,144			154		1,527,792		-			1,527,946
Net loss		-			-		-		(6,464,099	)		(6,464,099	)
Balance, September 30, 2024		1,234,672		$	1,234	$	24,946,631	$	(21,535,514	)	$	3,412,351

(1)	All share and per share information has been retroactively adjusted to reflect the 1-for-15 reverse stock split effected on August 20, 2024. See Note 6, Stockholders’ Equity for additional information.

The accompanying notes are an integral part of these financial statements.

CADRENAL THERAPEUTICS, INC.

STATEMENTS OF CASH FLOWS

(unaudited)

	Nine Months Ended September 30,
	2025			2024
Cash flows from operating activities:
Net loss	$	(10,198,372	)	$	(6,464,099	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense		6,319			1,473
Equity-based compensation		1,614,793			655,831
Non-cash lease expense		-			(317	)
Changes in operating assets and liabilities:
Interest receivable		25,362			24,093
Prepaid expenses		(73,758	)		(126,126	)
Deferred offering costs		(76,393	)		(116,884	)
Other assets		1,624			-
Accounts payable		(888,341	)		329,504
Accrued liabilities		(442,941	)		129,681
Net cash used in operating activities		(10,031,707	)		(5,566,844	)
Cash flows used in investing activities:
Investment in property and equipment		(5,104	)		-
Net cash used in investing activities		(5,104	)		-
Cash flows from financing activities:
Proceeds from sale of common stock		4,015,598			1,635,777
Issuance costs from sale of common stock		(184,647	)		(107,831	)
Proceeds from exercise of warrants		-			298
Proceeds from exercise of stock options		48,000			-
Net cash provided by financing activities		3,878,951			1,528,244
Net change in cash and cash equivalents		(6,157,860	)		(4,038,600	)
Cash and cash equivalents – beginning of the period		10,017,942			8,402,500
Cash and cash equivalents – end of the period	$	3,860,082		$	4,363,900

The accompanying notes are an integral part of these financial statements.

CADRENAL THERAPEUTICS, INC.
Notes to Financial Statements

(unaudited)

Note 1. Description of Business and Summary of Significant Accounting Policies

Cadrenal Therapeutics, Inc. (the “Company” or “Cadrenal”) was incorporated on January 25, 2022, in the State of Delaware and is headquartered in Ponte Vedra, Florida. Cadrenal Therapeutics, Inc. is a biopharmaceutical company that develops therapeutics for patients with certain cardiovascular conditions. Cadrenal is focused on developing novel differentiated products to address key gaps in currently available anticoagulation therapeutics. The Company’s lead product candidate is tecarfarin, a novel late-stage, reversible Vitamin K antagonist (a warfarin replacement) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Tecarfarin is specifically designed to overcome metabolic factors that can make warfarin less reliable. Cadrenal has also recently acquired the assets of eXIthera Pharmaceuticals (“eXIthera”), including its proprietary portfolio of investigational intravenous (“IV”) and oral Factor XIa inhibitors. The lead asset in this additional portfolio is frunexian, a first-in-class, Phase 2-ready IV Factor XIa inhibitor designed for acute care settings where contact activation of coagulation by medical devices or artificial surfaces plays a significant role. Frunexian is the only IV FXIa inhibitor in clinical development targeting the acute/critical care hospital setting exclusively.

Cadrenal is pursuing a pipeline-in-a-product approach with tecarfarin. The Company received ODD and fast-track status for tecarfarin in end-stage kidney disease and atrial fibrillation (“ESKD+AFib”). Tecarfarin also received Orphan Drug designation (“ODD”) for advanced heart failure patients with implanted left ventricular assist devices (“LVADs”).

Basis of Presentation

The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for the fair presentation of the Company’s financial statements for the periods presented. The Company’s fiscal year-end is December 31.

The Company’s accompanying financial statements are unaudited. The unaudited interim financial statements have been prepared on the same basis as the audited annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2025, the results of its operations for the three and nine months ended September 30, 2025 and 2024, the statements of changes in stockholders’ equity for the three and nine months ended September 30, 2025 and 2024, and its cash flows for the nine months ended September 30, 2025 and 2024. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2025, and 2024 are also unaudited. The results for the three and nine months ended September 30, 2025, are not necessarily indicative of results to be expected for the year ending December 31, 2025, any other interim periods, or any future year or period. These interim financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2024, and notes thereto, which are included in the Company’s Annual Report on Form 10-K filed with the SEC on March 13, 2025.

Liquidity

The accompanying financial statements have been prepared on the assumption that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The financial statements do not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary if the Company is unable to continue as a going concern. Since its inception, the Company has incurred operating losses and negative cash flows from operations. For the nine months ended September 30, 2025, the Company had a net loss of $10.2 million, which included $1.6 million of non-cash expenses. Cash used in operations totaled $10.0 million. As of September 30, 2025, the Company had cash and cash equivalents of $3.9 million, net working capital of $2.7 million, and an accumulated deficit of $35.9 million.

The Company is projecting that its operating losses and expected capital needs will exceed its existing cash balances and cash expected to be generated from operations for the foreseeable future. In order to meet the Company’s expected obligations, management intends to raise additional funds through partnering, the sale of equity, and debt financings. However, there can be no assurance that the Company will be able to complete partnering transactions or financings on terms acceptable to the Company or at all. As a result, there is uncertainty in the Company’s ability to meet its current operating and capital expenses. These factors, among others, raise substantial doubt about the Company’s ability to continue as a going concern for at least one year from the date the accompanying financial statements are issued. If the Company is unable to raise additional funding to meet its working capital needs in the future, it will be forced to delay or reduce the scope of its research programs and/or limit or cease its operations. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Emerging Growth Company Status

As an “emerging growth company” (“EGC”) under the Jumpstart Our Business Startups Act (“JOBS Act”), the Company may elect to take advantage of certain forms of relief from various reporting requirements that apply to public companies. The relief under the JOBS Act includes an extended transition period for implementing new or revised accounting standards. The Company has elected to take advantage of this extended transition period and, as a result, the Company’s financial statements may not be comparable to those of companies that implement accounting standards as of the effective dates for public companies. The Company may take advantage of the relief afforded under the JOBS Act up until the last day of the fiscal year following the fifth anniversary of an offering or such earlier time that it is no longer an EGC.

Use of Estimates

Preparing financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions made in the accompanying financial statements include, but are not limited to, the fair value of stock-based awards, deferred tax assets and valuation allowance, income tax uncertainties, and certain accruals. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances change. Actual results could differ from those estimates.

Concentration of Credit and Other Risks and Uncertainties

Financial instruments, which potentially subject the Company to significant concentrations of credit risk, consist primarily of cash and cash equivalents. Cash is maintained at high-credit-quality financial institutions; at times, balances may exceed federally insured limits. All interest-bearing and non-interest-bearing cash balances are insured up to $250,000 at each financial institution. Any loss incurred or a lack of access to such funds could have a significant adverse impact on the Company’s financial condition, results of operations, and cash flows.

The Company is subject to several risks common for early-stage biopharmaceutical companies including, but not limited to, dependency on the clinical and commercial success of its product candidate, ability to obtain regulatory approval of its product candidate, the need for substantial additional financing to achieve its goals, uncertainty of broad adoption of its approved products, if any, by physicians and patients, significant competition and untested manufacturing capabilities.

Segment Reporting

Operating segments are defined as components of an entity where separate financial information is evaluated regularly by the chief operating decision maker (“CODM”) in deciding how to allocate resources and assess performance. The Company’s CODM is the Chief Executive Officer, who reviews financial information on a company-wide basis for purposes of allocating resources and assessing financial performance. The Company manages its business activities as a single entity and operates in one reportable segment.

The CODM assesses the performance of its one reportable segment and decides how to allocate resources based on the loss from operations and net loss. The CODM utilizes loss from operations and net loss, as presented on the Company’s statements of operations and comprehensive loss, to evaluate the Company’s business plan, which includes clinical development roadmaps and long-range financial models as key inputs to decisions on resource allocation and its assessment of the performance of the business.

Significant expenses within loss from operations and net loss include research and development and general and administrative expenses, which are each separately presented on the Company’s statements of operations and comprehensive loss. Other segment items include depreciation expense and interest and dividend income as presented on the Company’s statements of operations and comprehensive loss. The accounting policies used to measure the segment’s profit and loss are the same as those described in the summary of significant accounting policies.

The measure of segment assets is reported on the balance sheets as total assets.

Cash and Cash Equivalents

The Company considers all highly liquid investments purchased with original maturities of three months or less from the purchase date to be cash equivalents. Cash and cash equivalents include cash and money market funds.

Stock-Based Compensation

The Company measures its stock-based awards granted to employees, consultants, and directors based on the estimated grant-date fair values of the awards and recognizes the compensation over the requisite service period using the straight-line method. The Company uses the Black-Scholes option-pricing model to estimate the fair value of its stock option awards. The Company accounts for forfeitures as they occur.

The Black-Scholes model requires the use of highly subjective and complex assumptions, which determine the fair value of stock-based payment awards, including the option’s expected term and the price volatility of the underlying stock. The Company estimates the fair value of options granted by using the Black-Scholes model with the following assumptions:

Expected Volatility—The Company estimated volatility for option grants by evaluating the historical volatility of a peer group of companies for the period immediately preceding the option grant for a term that is approximately equal to the options’ expected term.

Expected Term—The expected term of the Company’s options represents the period that the stock-based payment awards are expected to be outstanding. The expected term was estimated using the simplified method for employee stock options since the Company does not have adequate historical exercise data to estimate the expected term.

Deferred Offering Costs

The Company capitalizes certain legal, professional, and other third-party costs that are directly associated with in-process equity financings until such financings are consummated, at which time such costs are recorded against the gross proceeds of the offering. Should an in-process equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the statements of operations and comprehensive loss.

Acquisitions

The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine whether substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If so, the transaction is accounted for as an asset acquisition. If not, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to create outputs, which would meet the definition of a business. Significant judgment is required in the application of the screen test to determine whether an acquisition is a business combination or an acquisition of assets.

Acquisitions that meet the definition of a business combination are accounted for under the acquisition method, which requires allocating the purchase price to the net assets acquired at their respective fair values. In a business combination, any excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill.

For asset acquisitions, a cost-accumulation model is used to determine the cost of an asset acquisition. Direct transaction costs are recognized as part of the cost of an asset acquisition. The Company also evaluates which elements of a transaction should be accounted for as a part of an asset acquisition and which should be accounted for separately. The cost of an asset acquisition, including transaction costs, is allocated to identifiable assets acquired and liabilities assumed based on a relative fair value basis. Goodwill is not recognized in an asset acquisition. Any difference between the cost of an asset acquisition and the fair value of the net assets acquired is allocated to the non-monetary identifiable assets based on their relative fair values. When a transaction accounted for as an asset acquisition includes an in-process research and development ("IPR&D”) asset, the IPR&D asset is only capitalized if it has an alternative future use other than in a particular research and development project. For an IPR&D asset to have an alternative future use: (a) the Company must reasonably expect that it will use the asset acquired in an alternative manner and anticipate economic benefit from that alternative use, and (b) the Company’s use of the asset acquired is not contingent on the further development of the asset subsequent to the acquisition date (that is, the asset can be used in an alternative manner in the condition in which it existed at the acquisition date). Otherwise, amounts allocated to IPR&D that have no alternative use are expensed to research and development. Asset acquisitions may include contingent consideration arrangements that encompass obligations to make future payments to sellers contingent upon the achievement of future financial targets. Contingent consideration is not recognized until all contingencies are resolved and the consideration is paid or probable of payment, at which point the consideration is allocated to the assets acquired on a relative fair value basis.

Income Taxes

Income taxes are accounted for under the asset-and-liability method. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Management makes an assessment of the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Due to the Company’s historical operating performance and net losses, the net deferred tax assets have been fully offset by a valuation allowance.

The Company recognizes uncertain income tax positions at the largest amount, which is more likely than not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. Changes in recognition or measurement are reflected in the period in which judgment occurs. The Company’s policy is to recognize interest and penalties related to the underpayment of income taxes as a component of the provision for income taxes.

Net Loss Per Common Share

Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of shares of common stock and pre-funded warrants outstanding for the period, without consideration for potential dilutive shares of common stock. Diluted net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock and common stock equivalents of potentially dilutive securities outstanding for the period determined using the treasury stock or if-converted methods. Since the Company was in a loss position for all periods presented, basic net loss per common share is the same as diluted net loss per common share since the effects of potentially dilutive securities are anti-dilutive. Shares of common stock subject to repurchase are excluded from the weighted-average shares.

Comprehensive Loss

Comprehensive loss is defined as the change in equity during a period from transactions and other events or circumstances from non-owner sources. Net loss and comprehensive loss were the same for the periods presented in the accompanying financial statements.

Research and Development Expenses

Research and development costs are expensed as incurred and consist of fees paid to other entities that conduct certain research and development activities on the Company’s behalf. Acquired intangible assets are expensed as research and development costs if, at the time of payment, the technology is under development; is not approved by the United States Food and Drug Administration (“FDA”) or other regulatory agencies for marketing; has not reached technical feasibility; or otherwise has no foreseeable alternative future use. Non-refundable advance payments for goods or services to be received in the future for use in research and development activities are capitalized and then expensed as the related goods are delivered or the services are performed.

Patents

Patent costs are comprised primarily of external legal fees, filing fees incurred to file patent applications, and periodic renewal fees to keep the patent in force. They are expensed as incurred as a component of general and administrative expenses.

Note 2. Recent Accounting Pronouncements

Recently Adopted Accounting Pronouncements

In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures. The ASU requires greater disaggregation of information about a reporting entity’s effective tax rate reconciliation and information on income taxes paid. The ASU applies to all entities subject to income taxes and is intended to help investors better understand an entity’s exposure to potential changes in jurisdictional tax legislation and assess income tax information that affects cash flow forecasts and capital allocation decisions. The ASU is effective for annual periods beginning after December 15, 2024, with early adoption permitted. The adoption of this ASU on January 1, 2025, had no material impact on the Company’s financial statements.

Accounting Pronouncements Not Yet Adopted

In November 2024, the FASB issued ASU 2024-03 Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40). The ASU aims to improve financial reporting by requiring that public business entities disclose additional information about specific expense categories in the notes to financial statements at interim and annual reporting periods. In January 2025, the ASU was subsequently amended by ASU 2025-01 to clarify the effective date by which all public business entities are required to adopt the guidance in annual reporting periods beginning after December 15, 2026, and interim periods within annual reporting periods beginning after December 15, 2027. Early adoption of ASU 2024-03 is permitted. The Company is currently evaluating the impact of this guidance on its financial statements.

Note 3. Fair Value Measurements

Assets and liabilities recorded at fair value on a recurring basis in the balance sheet are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows:

●	Level 1 —	Observable inputs such as unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date.

●	Level 2 —	Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the asset or liability. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.

●	Level 3 —	Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

Financial assets and liabilities subject to fair value measurements on a recurring basis, and the level of inputs used in such measurements by major security type are presented in the following table:

	September 30, 2025
	Level 1		Level 2		Level 3		Fair Value
Financial Assets:
Money market funds	$	3,668,250	$	-	$	-	$	3,668,250
Total financial assets	$	3,668,250	$	-	$	-	$	3,668,250

	December 31, 2024
	Level 1		Level 2		Level 3		Fair Value
Financial Assets:
Money market funds	$	9,946,189	$	-	$	-	$	9,946,189
Total financial assets	$	9,946,189	$	-	$	-	$	9,946,189

The carrying amounts of cash and cash equivalents, prepaid expenses, deferred offering costs, accounts payable, and accrued liabilities approximate their fair values due to their short-term nature. There were no transfers of liabilities among the fair value measurement categories during any of the periods presented.

Note 4. Accrued Liabilities

Accrued liabilities consist of the following:

	September 30, 2025		December 31, 2024
Accrued compensation	$	471,964	$	966,575
Accrued research & development		48,203		-
Accrued consulting fees		-		162,606
Accrued professional fees		182,767		5,565
Other		35,614		46,744
Total accrued liabilities	$	738,548	$	1,181,490

Note 5. Asset Purchase Agreement

On September 12, 2025, the Company entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) with eXIthera Pharmaceuticals (the “Seller”). Pursuant to the terms of the Asset Purchase Agreement, the Company acquired all of the rights, title and interests in assets owned or held for use by it in connection with the compounds known as frunexian (EP-7041) and EP-7327 and certain other compounds including all intellectual property, regulatory filings, clinical and non-clinical data, market analyses, commercialization plans, all inventory related to the compounds and other rights. In addition, the Company acquired the exclusive license agreement (the “Haisco License Agreement”) with Sichuan Haisco Pharmaceutical Co., Ltd. (“Haisco”), which relates to the development and commercialization of frunexian in the People’s Republic of China. In consideration of the purchase of the assets, the Company paid $50,000 at closing. As additional consideration, the Asset Purchase Agreement provides for contingent milestone payments by the Company to the Seller upon achievement of development milestones in an amount not to exceed $15 million.

Development Milestones		Milestone payment
First Patient Dosed in Phase 2 Initiated with Frunexian or EP-7327		$500,000 per compound
First Patient Dosed in Phase 1 Initiated with EP-7327		$500,000 per compound
First Patient Dosed in Phase 3 Initiated with Frunexian or EP-7327		$1,000,000 per compound
FDA Approval of New Drug Application for Frunexian or EP-7327		$6,000,000 per compound

As additional consideration, the Company agreed to pay the Seller royalties equal to 2% of annual net sales of the pharmaceutical products containing any compounds that are subject to the Asset Purchase Agreement. In addition, the Company agreed to pay the Seller 50% of all royalties received by the Company from the Haisco Licensing Agreement following the potential future commercialization of frunexian by Haisco. The contingent milestone payments and royalty payments are payable in cash, common stock, or in any combination thereof at the Company’s discretion.

The Company accounted for the transaction as an asset acquisition as substantially all of the estimated fair value of the gross assets acquired was concentrated in a single identified in-process research and development asset, the frunexian asset, thus satisfying the requirements of the screen test in accordance with the criteria under ASC 805-10-55-5C. The assets acquired in the transaction were measured based on the fair value of the consideration paid of $50,000 plus direct transaction costs of $151,216, as the fair value of the consideration paid was more readily determinable than the fair value of the assets acquired. The following table summarizes the initial purchase price of the assets acquired:

In process research and development	$	50,000
Transaction costs		151,216
Total	$	201,216

All costs the Company incurred in connection with this Asset Purchase Agreement were recognized as research and development expenses in the Company’s statement of operations and comprehensive loss as these assets had no alternative future use at the time of the acquisition transaction. Due to the nature of the development, regulatory, and sales-based milestones, the contingent consideration was not included in the initial cost of assets purchased, as they are contingent upon events that are outside the Company’s control.

However, upon achievement or anticipated achievement of each milestone, the Company will recognize the related appropriate payment as additional research and development expense. Contingent consideration will not be recorded until it is probable that the milestone events will occur.

Note 6. Stockholders’ Equity

Reverse Stock Split

On July 29, 2024, the Company’s stockholders approved an amendment to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of its shares of common stock, and its Board of Directors subsequently approved a final reverse stock split ratio of 1-for-15. The reverse stock split became effective on August 20, 2024 (the “Effective Date”). On the Effective Date, every 15 shares of issued and outstanding common stock were combined and converted into one issued and outstanding share of common stock. The number of authorized shares of common stock was not reduced and the par value per share of common stock remained unchanged. Fractional shares were canceled, and stockholders received cash in lieu thereof. A proportionate adjustment was also made to the maximum number of shares of common stock issuable under the Cadrenal Therapeutics, Inc. 2022 Successor Equity Incentive Plan. As a result, the number of shares of common stock, stock options, warrants, net loss per share, and exercise prices disclosed throughout these notes to the financial statements, as well as the Quarterly Report on Form 10-Q to which these financial statements and notes thereto are attached, have been retrospectively adjusted to reflect the reverse stock split.

Common Stock

The Company is authorized to issue a total of 75,000,000 shares of common stock, par value of $0.001 per share, and 7,500,000 shares of preferred stock, par value $0.001 per share.

Holders of common stock are entitled to one vote for each share of common stock held of record for the election of the Company’s directors and all other matters requiring stockholder action. Holders of common stock will be entitled to receive such dividends, if any, as may be declared from time to time by the Company’s Board in its discretion out of funds legally available therefor.

On January 24, 2023, the Company consummated its initial public offering (“IPO”) and issued 93,333 shares of its common stock at a public offering price of $75.00 per share, generating gross proceeds of $7.0 million and net proceeds of $5.4 million.

In connection with the IPO, on January 19, 2023, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Boustead Securities, LLC, as representative of the underwriters (the “Representative”). Pursuant to the Underwriting Agreement, the Company issued to the underwriters a five-year warrant (the “Representative’s Warrant”) to purchase an aggregate of 5,600 shares of the Company’s common stock, which was equal to six percent (6%) of the shares of common stock sold in the IPO. The Representative’s Warrant has an exercise price of $90.00, which was equal to 120% of the public offering price of the common stock in the IPO.

On July 12, 2023, the Company entered into a securities purchase agreement with an institutional investor (the “Investor Selling Stockholder”) pursuant to which the Company sold to the Investor Selling Stockholder in a private placement (the “Private Placement”) (i) an aggregate of 86,667 shares of common stock (the “Shares”), (ii) in lieu of additional Shares, pre-funded warrants to purchase up to an aggregate of 199,047 shares of common stock (the “Pre-Funded Warrants”), and (iii) accompanying common warrants to purchase up to an aggregate of 285,715 shares of common stock (the “Common Warrants”). The combined purchase price of each Share and accompanying Common Warrants was $26.25. The combined purchase price of each Pre-Funded Warrant and accompanying Common Warrants was $26.25.

The Private Placement closed on July 14, 2023. The Company received aggregate gross proceeds from the Private Placement of approximately $7.5 million before deducting the placement agent commissions and offering expenses payable by the Company. H.C.W. acted as the placement agent in the Private Placement, and as part of its compensation, the Company issued to designees of H.C.W. Placement Agent Warrants to purchase up to 18,571 shares of common stock at an exercise price of $32.81.

Each Pre-Funded Warrant had an exercise price equal to $0.0015 per share. The Pre-Funded Warrants were exercisable at any time after their original issuance and would not expire until exercised in full. Each Common Warrant has an exercise price equal to $26.25 per share. The Common Warrants are exercisable at any time after their original issuance and will expire on January 16, 2029. The exercise price and number of shares of common stock issuable upon exercise of the Common Warrant and Pre-Funded Warrant are subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events.

During the year ended December 31, 2024, the Company received notice of the exercise of all of the 199,047 Pre-Funded Warrants. As a result of the respective Pre-Funded Warrant exercises, the Company issued 199,047 shares of common stock. As of September 30, 2025, there are no Pre-Funded Warrants outstanding.

The Common Warrants issued in the Private Placement provide that a holder of Common Warrants, as applicable, will not have the right to exercise any portion of its Common Warrants if such holder, together with its affiliates, and any other party whose holdings would be aggregated with those of the holder for purposes of Section 13(d) or Section 16 of the Exchange Act would beneficially own in excess of 4.99% of the number of shares of common stock outstanding immediately after giving effect to such exercise (the “Beneficial Ownership Limitation”); provided, however, that the holder may increase or decrease the Beneficial Ownership Limitation by giving notice to the Company, with any such increase not taking effect until the sixty-first day after such notice is delivered to the Company but not to any percentage in excess of 9.99%. The Common Warrants may be exercised on a cashless basis if a registration statement registering the shares of common stock underlying the Common Warrants is not effective at the time of exercise.

ATM Facility

During the nine months ended September 30, 2025, the Company sold 236,728 shares of its common stock through its at-the-market (ATM) facility. These sales were made at a weighted average price of $16.96 per share, resulting in total gross proceeds of $4,015,598 and net proceeds of $3,830,951.

Warrant Inducement

On November 1, 2024, the Company entered into a warrant inducement letter agreement (the “Inducement Agreement”) with a holder of the Company’s warrants to purchase shares of the Company’s common stock, issued in a private placement offering that closed on July 14, 2023 (the “Existing Warrants”). Pursuant to the Inducement Agreement, the holder of the Existing Warrants agreed to exercise for cash the Existing Warrants to purchase up to an aggregate of 285,715 registered shares of common stock, at the adjusted exercise price of $16.50 per share (reduced from the initial exercise price of $26.25 per share).

In consideration of the holder’s agreement to exercise the Existing Warrants at the reduced exercise price per share in accordance with the Inducement Agreement, the Company issued to the holder new unregistered Series A-1 common stock warrants (the “Series A-1 Warrants”) to purchase 285,715 shares of common stock and new unregistered Series A-2 common stock warrants (the “Series A-2 Warrants” and, together with the Series A-1 Warrants, the “New Warrants”) to purchase an aggregate of 285,715 shares of common stock, at an exercise price of $16.50 per share. The Series A-1 Warrants were immediately exercisable for a term of five years from the date of issuance, and the Series A-2 Warrants were immediately exercisable for a term of 18 months from the date that the Company’s registration statement on Form S-3 registering the shares issuable upon exercise of the New Warrants had been declared effective (November 22, 2024) by the SEC. The New Warrants contain customary provisions for anti-dilution adjustments to the exercise price, including stock splits, stock dividends, rights offerings, and pro rata distributions.

On November 4, 2024, the transactions contemplated by the Inducement Agreement closed, and the Company received aggregate gross proceeds of approximately $4.7 million for the exercise of the Existing Warrants, before deducting placement agent fees and other expenses totaling $0.5 million.

H.C.W. acted as the placement agent in the Inducement Agreement, and as part of its compensation, the Company issued to designees of H.C.W. Placement Agent Warrants to purchase up to 18,571 shares of common stock at an exercise price of $20.625. The Placement Agent Warrants expire five years after issuance and contain customary provisions for anti-dilution adjustments to the exercise price, including for stock splits, stock dividends, rights offerings, and pro rata distributions.

The Series A-1 Warrants, Series A-2 Warrants, and Placement Agent Warrants were classified as equity, and the offering costs were recorded as debit to additional paid-in capital.

All of the Company’s outstanding warrants provide that the holder thereof has the right to participate in distributions or dividends paid on the Company’s shares of common stock on an as-converted basis.

Warrant Summary

The following table summarizes the total warrants outstanding at September 30, 2025, all of which are classified as equity:

					Outstanding						Outstanding
	Issue Date	Exercise Price Per Share		Expiration Date	as of December 31, 2024		New Issuance		Exercised		as of September 30, 2025
Placement agent warrants	July - Sept 2022	$	45.00	July - Sept 2027		767		-		-		767
Placement agent warrants	Nov 2022	$	15.00	Nov 2027		1,000		-		-		1,000
Representative warrants	Jan 2023	$	90.00	Jan 2028		5,600		-		-		5,600
Placement agent warrants	July 2023	$	32.81	Jan 2029		18,572		-		-		18,572
New Series A-1 warrants	Nov 2024	$	16.50	Nov 2029		285,715		-		-		285,715
New Series A-2 warrants	Nov 2024	$	16.50	May 2026		285,715		-		-		285,715
Placement agent warrants	Nov 2024	$	20.625	Nov 2029		18,571		-		-		18,571
						615,940		-		-		615,940

Issuance of Restricted Common Stock

In October 2024, the Company engaged consultants to perform certain public and investor relations services and issued 50,000 shares of restricted common stock as partial consideration for such services. The Company issued 25,000 shares of fully vested, nonrefundable restricted common stock on October 9, 2024 and the remaining 25,000 shares of restricted common stock were issued on January 8, 2025. On June 29, 2025, the Company issued an additional 10,000 shares of fully vested, nonrefundable restricted common stock, in partial consideration of services performed.

Note 7. Equity-Based Compensation

The Company adopted the Cadrenal Therapeutics, Inc. 2022 Equity Incentive Plan (the “Initial Plan”), on July 11, 2022, which was later amended and restated on October 16, 2022, for purposes of clarifying the application of certain of the rules of the Initial Plan to awards approved before such amendment and restatement of the Initial Plan and to facilitate the transition to the Cadrenal Therapeutics, Inc. 2022 Successor Equity Incentive Plan (the “Successor Plan”) for the issuance and approval of awards after consummation of the IPO. On October 16, 2022, the Board adopted and the Company’s stockholders approved the Cadrenal Therapeutics, Inc. 2022 Successor Equity Incentive Plan (the “2022 Plan”), which is a successor to and continuation of the Initial Plan and became effective on January 19, 2023. Upon the effectiveness of the 2022 Plan, it replaced the Initial Plan, except with respect to awards outstanding under the Initial Plan, and no further awards will be available for grant under the Initial Plan.

Subject to certain adjustments, the maximum number of shares of common stock that could have been issued under the Initial Plan and 2022 Plan was initially 133,333 shares. The maximum number of shares of common stock that may be issued under the 2022 Plan initially automatically increased on January 1 of each calendar year for a period of ten years commencing on January 1, 2024 and ending on (and including) January 1, 2033, to a number of shares of common stock equal to 20% of the total number of shares of common stock outstanding on December 31 of the preceding calendar year; provided, however that the board of directors, or the compensation committee, may act prior to January 1 of a given calendar year to provide that the increase for such year will be a lesser number of shares of common stock. On January 1, 2024, the maximum number of shares of common stock that may be issued under the 2022 Plan increased to 173,636. On July 29, 2024, the Company held its 2024 Annual Meeting of Stockholders (the “2024 Annual Meeting”). At the 2024 Annual Meeting, the Company’s stockholders approved an amendment to the 2022 Plan to increase the number of shares of the Company’s common stock that will be available for awards under the 2022 Plan by 133,333 shares to 306,969 shares and to amend the “evergreen provision” such that the number of reserved shares of common stock available for issuance each year will be 20% of: (i) the shares of common stock outstanding at December 31; plus (ii) the shares of common stock issuable upon exercise of warrants and pre-funded warrants outstanding at December 31. As of September 30, 2025, 40,019 remained available for future issuance. All available shares may be utilized toward the grant of any award under the 2022 Plan.

The assumptions used in the Black-Scholes model are set forth below:

	Nine Months Ended September 30, 2025		Nine Months Ended September 30, 2024
Risk-free interest rate	4.18% - 4.40	%	4.09% - 4.83	%
Dividend yield	-		-
Expected term (years)	5.27-5.31		5.27 - 5.31
Volatility	73.0% - 75.4	%	76.4% - 77.7	%

Activity under the Plans for the period from December 31, 2024 to September 30, 2025 is set forth below:

	Number Outstanding			Weighted-Average Exercise Price Per Share		Weighted-Average Remaining Contractual Life (Years)		Aggregate Intrinsic Value
Outstanding at December 31, 2024		156,334		$	13.20		8.35	$	420,720
Granted		280,000			19.78		9.32		-
Exercised		(6,667	)		9.60		-		-
Canceled/forfeited/expired		(3,334	)		9.60		-		-
Outstanding at September 30, 2025		426,333		$	17.61		8.75	$	299,096

Options vested and exercisable at September 30, 2025		169,353		$	15.41		8.11	$	165,989
Options vested and expected to vest as of September 30, 2025		426,333		$	17.61		8.75	$	299,096

The weighted average grant date fair value of options granted during the nine months ended September 30, 2025 was $12.93. At September 30, 2025, the Company had $2.8 million of unrecognized equity-based compensation expense related to stock options, which will be recognized over the weighted average remaining requisite service period of 1.94 years. The Company settles employee stock option exercises with newly issued shares of common stock.

Total equity-based compensation expense and the allocation of equity-based compensation for the periods presented below were as follows:

	Three Months Ended September 30,				Nine Months Ended September 30,
	2025		2024		2025		2024

General and administrative	$	401,718	$	202,066	$	1,183,565	$	365,368
Research and development		71,666		97,914		431,228		290,463
Total equity-based compensation	$	473,384	$	299,980	$	1,614,793	$	655,831

Note 8. Net Loss Per Share

The following table sets forth the computation of the basic and diluted net loss per common share:

	Three Months Ended September 30,						Nine Months Ended September 30,
	2025			2024			2025			2024

Numerator:
Net loss	$	(2,685,705	)	$	(2,407,829	)	$	(10,198,372	)	$	(6,464,099	)
Denominator:
Weighted average common shares outstanding		2,044,033			1,104,005			1,950,703			1,234,672
Net loss per common share, basic and diluted	$	(1.31	)	$	(2.18	)	$	(5.23	)	$	(5.24	)

Since the Company was in a loss position for the periods presented, basic net loss per share is the same as diluted net loss per share as the inclusion of all potential dilutive securities would have been anti-dilutive. For the periods presented, there were no potential dilutive securities other than stock options and warrants.

The following common stock equivalents were excluded from the calculation of diluted net loss per share applicable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:

	As of September 30,
	2025		2024
Anti-dilutive common stock equivalents:
Stock options to purchase common stock		426,233		156,334
Warrants to purchase common stock		615,940		311,652
Total anti-dilutive common stock equivalents		1,042,173		467,986

Note 9. Leases, Commitments, and Contingencies

Leases

In accordance with ASC 842, Leases, the Company determines if an arrangement is or contains a lease at inception. A contract is or contains a lease if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration.

At lease inception, the Company determines whether an arrangement is an operating or capital lease. For operating leases, the Company recognizes rent expense, inclusive of rent escalation, on a straight-line basis over the lease term.

The Company classifies leases at the lease commencement date as operating or finance leases and records a right-of-use asset and a lease liability on the balance sheet for all leases with an initial lease term of greater than 12 months. Leases with an initial term of 12 months or less are not recorded in the balance sheet pursuant to the practical expedient available under ASC 842, but payments are recognized as expenses on a straight-line basis over the lease term.

Finance and operating right-of-use assets and lease liabilities are recognized at the lease commencement date based on the present value of the lease payments over the lease term using the discount rate implicit in the lease. If the rate implicit is not readily determinable, the Company utilizes an estimate of its incremental borrowing rate based upon the available information at the lease commencement date. Operating lease assets are further adjusted for prepaid or accrued lease payments. Operating lease expense is recognized on a straight-line basis over the lease term.

In October 2024, the Company amended its office space lease to extend the term by one additional year. In October 2025, the Company amended its office space lease to extend the term by one additional year. The lease agreement (as amended in October 2025) has a term that extends through October 31, 2026. Operating lease expenses were $6,656 and $6,472 for the three months ended September 30, 2025 and 2024, respectively. Operating lease expenses were $19,969 and $19,866 for the nine months ended September 30, 2025 and 2024, respectively. Cash paid for the office lease was $19,969 and $19,866 for the nine months ended September 30, 2025 and 2024, respectively.

Future annual lease payments under non-cancellable operating leases as of September 30, 2025 were as follows:

2025		$	2,219
Total lease payments		$	2,219

Contingencies

In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications. The Company’s exposure under these agreements is unknown, because it involves claims that may be made against the Company in the future, but have not yet been made. The Company accrues a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated.

Indemnification

In accordance with the Company’s certificate of incorporation and bylaws, the Company indemnifies its officers and directors for certain events or occurrences, subject to certain limits, while they are serving in such capacity. In addition, the Company has entered into indemnification agreements with its officers and directors. There have been no claims to date, and the Company has a directors and officers liability insurance policy that may enable it to recover a portion of any amounts paid for future claims.

Note 10. Subsequent Events

The Company has evaluated events that occurred through November 10, 2025, the date that the financial statements were issued, and determined that there have been no events that have occurred that would require adjustments to its disclosures in the financial statements except for the transactions described below.

From October 1, 2025 through November 10, 2025, the Company sold 16,091 shares of its common stock through its at-the-market (ATM) facility. These sales were made at a weighted average price of $14.16 per share, resulting in total gross proceeds of approximately $227,772 and net proceeds of approximately $219,890.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

You should read the following management’s discussion and analysis of our financial condition and results of operations in conjunction with our unaudited financial statements and notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q and with our audited financial statements and notes thereto for the year ended December 31, 2024, included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed on March 13, 2025 (the “Annual Report”) with the U.S. Securities and Exchange Commission (the “SEC”). This discussion, particularly information with respect to our future results of operations or financial condition, business strategy, plans and objectives for future operations, includes forward-looking statements that involve risks and uncertainties as described under the heading “Special note regarding forward-looking statements” in this Quarterly Report on Form 10-Q. You should review the disclosure under Part 1, Item 1A of the Annual Report for a discussion of important factors that could cause our actual results to differ materially from those anticipated in these forward-looking statements. References in this Quarterly Report on Form 10-Q to “we,” “us,” “our” and similar first-person expressions refer to Cadrenal Therapeutics, Inc. (“Cadrenal”).

Special Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those discussed in the forward-looking statements. The statements contained in this report that are not purely historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “seek,” “should,” “strategy,” “target,” “will,” “would” and similar expressions or variations intended to identify forward-looking statements. These statements are based on the beliefs and assumptions of our management based on information currently available to management. Such forward-looking statements are subject to risks, uncertainties and other important factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified under Part 1, Item 1A of the Annual Report. Furthermore, such forward-looking statements speak only as of the date of this report. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.

Company Overview

The Company

Cadrenal is focused on developing novel differentiated products to address key gaps in currently available anticoagulation therapeutics. Our lead product candidate is tecarfarin, a novel late-stage, reversible Vitamin K antagonist (a warfarin replacement) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Tecarfarin is specifically designed to overcome metabolic factors that can make warfarin less reliable. Cadrenal has also recently acquired the assets of eXIthera Pharmaceuticals (“eXIthera”), including its proprietary portfolio of investigational intravenous (“IV”) and oral Factor XIa inhibitors. The lead asset in this additional portfolio is frunexian, a first-in-class, Phase 2-ready IV Factor XIa inhibitor designed for acute care settings where contact activation of coagulation by medical devices or artificial surfaces plays a significant role. Frunexian is the only IV FXIa inhibitor in clinical development targeting the acute/critical care hospital setting exclusively.

Tecarfarin Historical Considerations

At the time the initial investigational new drug (“IND”) application for tecarfarin was filed by its founding sponsor, warfarin was the only marketed oral anticoagulant, and the strategy was to develop tecarfarin as an alternative vitamin K antagonist (“VKA”) with superior efficacy and safety over warfarin for a broad range of indications including atrial fibrillation (“AFib”), deep vein thrombosis (“DVT”), pulmonary embolism (“PE”), prevention of pulmonary embolism in patients with venous thrombosis, DVT prevention in patients undergoing certain surgical procedures, thrombosis prevention in patients with mechanical heart valves, and prevention of thrombotic complications in patients after a myocardial infarction (heart attack), among others.

While tecarfarin clinical trials were being conducted by the initial IND sponsor, the direct-acting oral anticoagulants (“DOACs”) were advancing through clinical trials and ultimately approved after demonstrating that they were non-inferior to warfarin in specific indications, including AFib in the general population, prevention of pulmonary embolism in patients with venous thrombus, and prevention of deep vein thrombosis in patients undergoing specific surgical procedures, among others. These DOAC clinical studies led to a change in the standard of care for a large percentage of the population that had previously been treated with warfarin, as well as for some of the same population initially targeted by the prior tecarfarin IND sponsor. The DOACs also did not require monthly blood testing and monitoring, thus more convenient for patients. Therefore, the original broad-label development plan for tecarfarin had to be re-evaluated and modified.

Accordingly, we have refocused the development of tecarfarin for orphan cardiovascular conditions where patients are unable to achieve sufficiently reliable chronic anticoagulation with warfarin, and where DOACs have either failed or their efficacy and safety remain unproven, including patients with end-stage kidney disease (“ESKD”) and AFib, and patients with left ventricular assist devices (“LVADs”). While warfarin-treated patients have fared better than DOAC-treated patients in comparative studies in certain of these cardiovascular conditions, the event rates in these studies remain unacceptably high. At the same time, the quality of anticoagulation in warfarin-treated patients in these high-risk circumstances is frequently sub-optimal, and, importantly, sub-optimal anticoagulation is strongly associated with much higher adverse event rates. Thus, there continues to be a need for more reliable anticoagulation than can be achieved with warfarin in patients who are not addressed—or even addressable—by DOACs.

Cadrenal is pursuing a pipeline-in-a-product approach with tecarfarin. Tecarfarin has orphan drug and fast-track designations from the United States Food and Drug Administration (“FDA”) for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with ESKD and AFib. Tecarfarin also has an orphan drug designation from the FDA for the prevention of thrombosis and thromboembolism in patients with an implanted mechanical circulatory support device, which includes LVADs, a mechanical heart pump.

Tecarfarin has been evaluated in eleven (11) human clinical trials in over 1,000 individuals (269 patients were treated for at least six months, and 129 patients were treated for one year or more). In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease (“CKD”). In the Phase 2/3 trial, EMBRACE-AC, the largest tecarfarin trial with 607 patients, including those with mechanical heart valves, only 1.6% of the blinded tecarfarin subjects suffered from major bleeding, and there were no thrombotic events.

Over the course of the year, the development strategy for tecarfarin has continued to evolve. We are focused on the two areas for which we already have orphan designation - LVAD and ESKD with AFib. We have recently completed the manufacturing of tecarfarin drug product in accordance with current good manufacturing practices (cGMP) and are evaluating opportunities for additional Phase 2 trials that will provide important data to de-risk and streamline subsequent registration activities in both areas. This evaluation is ongoing and may include advancing clinical trials in 2026 for stable LVAD patients currently treated with warfarin and/or dialysis patients currently treated with warfarin who would be switched to tecarfarin.

Recent Developments

On September 12, 2025, we entered into an asset purchase agreement (the “Asset Purchase Agreement”) with eXIthera Pharmaceuticals (“eXIthera”), to acquire its assets, including its proprietary portfolio of investigational IV and oral Factor XIa inhibitors, including the compounds known as frunexian (EP-7041) and EP-7327 and certain other compounds, as well as all intellectual property, regulatory filings (including two inactive Investigational New Drug Applications filed with the FDA), clinical and non-clinical data, Chemistry, Manufacturing, and Controls materials (“CMC”), drug substance inventory, books and records, and the exclusive license agreement (the “Haisco License Agreement”) with Sichuan Haisco Pharmaceutical Co., Ltd. (“Haisco”), which relates to development of eXIthera’s lead asset, frunexian, in the Chinese market (collectively, the “Assets”). The transactions contemplated by the Asset Purchase Agreement were consummated on September 12, 2025 (the “Closing”).

The Purchase Price for the Assets consists of (i) $50,000 of transaction closing costs, (ii) the assumption of specific assumed liabilities related to post-closing obligations arising from the Haisco License Agreement, (iii) certain milestone payments, and (iv) royalty payments. We have agreed to pay milestone payments to eXIthera in the aggregate amount of up to $15 million, payable in cash or in our common stock in our sole discretion, upon the achievement of the following clinical and regulatory milestone events:

●

$500,000 upon the occurrence of the first patient dosed in first Phase 2 study initiated after the Closing with respect to frunexian or an Other IV Compound (as such term is defined in the Asset Purchase Agreement);

●

$500,000 upon the occurrence of the first patient dosed in first Phase 1 study initiated after the Closing with respect to EP-7327 or an Other Oral Compound (as such term is defined in the Asset Purchase Agreement);

●

$1,000,000 upon the occurrence of the first patient dosed in first Phase 3 study initiated after the Closing with respect to frunexian or an Other IV Compound;

●

$1,000,000 upon the occurrence of the first patient dosed in first Phase 3 study initiated after the Closing with respect to EP-7327 or an Other Oral Compound);

●

$6,000,000 on the date the FDA grants approval of a New Drug Application (“NDA”) for frunexian or an Other IV Compound;

●

$6,000,000 on the date the FDA grants approval of an NDA for EP-7327 or an Other Oral Compound.

The royalties due to eXIthera by us shall be calculated as follows: 2% of annual net sales of pharmaceutical products containing any of the compounds that are the subject of the Asset Purchase Agreement which are covered by a valid patent, payable from the first commercial sale of a product in each country until the later of: (a) expiration of the last-to-expire valid patent claim that would be infringed by the commercialization in that country, (b) expiration of regulatory exclusivity in that country (including when generic competition occurs), or (c) ten years from the first commercial sale of the product in that country. Additionally, we will pay eXIthera 50% of all royalties actually received by us from Haisco under the existing Haisco License Agreement following the potential future commercialization of frunexian by Haisco.

The Factor XIa inhibitors are the latest and most exciting class of broad-use anticoagulants currently under development around the world. The eXIthera acquisition significantly enhances our pipeline, adding product candidates that address large and underserved segments of the current $38 billion global anticoagulation market. Frunexian is a first-in-class, Phase 2-ready IV Factor XIa inhibitor designed for acute care settings where contact activation of coagulation by medical devices or artificial surfaces plays a significant role, such as cardiopulmonary bypass, catheter thrombosis, and other blood-contacting implanted devices or artificial surfaces. The acquisition also includes EP-7327, an oral Factor XIa inhibitor, for the prevention and treatment of major thrombotic conditions.

These newly acquired small molecules are mechanism-based inhibitors, which bind to Factor XIa and inhibit enzyme activity. As a result, the product candidates are highly potent, which can be an advantage for a target like Factor XIa that requires a high degree of target engagement for efficacy. Unlike other IV small molecules under development, it is the only one specifically targeting the acute/critical care hospital setting. All other agents, whether small molecules or antibodies, are targeting chronic indications. Moreover, the non-small molecule inhibitors are not suited to acute use because of their pharmacodynamics. At present, only frunexian has the potential to replace heparin and other IV-delivered anticoagulants in select acute care hospital settings, with the potential to provide substantial cost savings to the US healthcare system. While the current standard of care for cardiac surgery is heparin, the high doses of heparin used for cardiopulmonary bypass have their own substantial risk of bleeding complications, especially with repeat cardiac surgical procedures.

ATM Facility

During the nine months ended September 30, 2025, we sold 236,728 shares of common stock through our at-the-market (ATM) facility with H.C.W. These sales were made at a weighted average price of $16.96 per share, resulting in total gross proceeds of approximately $4,015,598 and net proceeds of approximately $3,830,951.

From October 1, 2025 through November 10, 2025, we sold 16,091 shares of common stock through our at-the-market (ATM) facility. These sales were made at a weighted average price of $14.16 per share, resulting in total gross proceeds of approximately $227,772 and net proceeds of approximately $219,890.

Results of Operations

Results of Operations for the Three Months Ended September 30, 2025 and 2024

The following table summarizes our results of operations for the three months ended September 30, 2025 and 2024.

	Three Months Ended September 30,
	2025			2024			$ Change			% Change
Operating expenses:
General and administrative expenses	$	2,044,937		$	1,674,905		$	370,032			22	%
Research and development expenses		688,465			784,646			(96,181	)		(12	)%
Depreciation expense		401			407			(6	)		(1	)%
Total operating expenses		2,733,803			2,459,958			273,845			11	%
Loss from operations		(2,733,803	)		(2,459,958	)		(273,845	)		11	%
Other income
Interest and dividend income		48,098			52,129			(4,031	)		(8	)%
Total other income		48,098			52,129			(4,031	)		(8	)%
Net loss and comprehensive loss	$	(2,685,705	)	$	(2,407,829	)	$	(277,876	)		3	%

General and administrative expenses

General and administrative expenses were $2.0 million for the three months ended September 30, 2025, compared to $1.7 million for the three months ended September 30, 2024, an increase of approximately $0.4 million, or 22%. The increase was primarily driven by a $0.3 million increase in expenses related to being a public company, $0.2 million increase in stock-based compensation, and a $0.1 million increase in consulting expenses. These increases were partially offset by a $0.1 million decrease in patent expenses, $0.1 million decrease in personal-related expenses, and a $0.1 million decrease in other expenses.

Research and development expenses

Research and development expenses were $0.7 million for the three months ended September 30, 2025, compared to $0.8 million for the three months ended September 30, 2024, respectively, a decrease of $0.1 million, or 12%. The decrease was primarily attributable to a $0.3 million reduction in consulting expenses, partially offset by a $0.2 million increase in transaction-related expenses associated with the Asset Purchase Agreement completed in September 2025, which was expensed as in-process research and development (IPR&D). We anticipate research and development expenses to increase when we commence clinical trials.

Interest and dividend income

Interest and dividend income for the three months ended September 30, 2025, and 2024 were $0.1 million and $0.1 million, respectively. This income represents the interest and dividends earned from our investments in money market funds.

Results of Operations for the Nine Months Ended September 30, 2025 and 2024

The following table summarizes our results of operations for the nine months ended September 30, 2025, and 2024.

	Nine Months Ended September 30,
	2025			2024			$ Change			% Change
Operating expenses:
General and administrative expenses	$	6,955,907		$	4,013,336		$	2,942,571			73	%
Research and development expenses		3,433,845			2,667,382			766,463			29	%
Depreciation expense		6,319			1,473			4,846			329	%
Total operating expenses		10,396,071			6,682,191			3,713,880			56	%
Loss from operations		(10,396,071	)		(6,682,191	)		(3,713,880	)		56	%
Other income
Interest and dividend income		197,699			218,092			(20,393	)		(9	)%
Total other income		197,699			218,092			(20,393	)		(9	)%
Net loss and comprehensive loss	$	(10,198,372	)	$	(6,464,099	)	$	(3,734,273	)		46	%

General and administrative expenses

General and administrative expenses were $7.0 million for the nine months ended September 30, 2025, compared to $4.0 million for the nine months ended September 30, 2024, an increase of approximately $3.0 million, or 73%. The increase was primarily attributable to a $1.5 million increase in expenses related to being a public company, a $0.8 million increase in stock-based compensation, a $0.3 million increase in consulting expenses, and a $0.1 million increase in personnel-related expenses.

Research and development expenses

Research and development expenses were $3.4 million for the nine months ended September 30, 2025, compared to $2.7 million for the nine months ended September 30, 2024, an increase of $0.7 million, or 29%. The increase was primarily attributable to a $0.5 million increase in chemistry, manufacturing, and controls (“CMC”) expenses , a $0.3 million increase in personnel-related costs, primarily associated with our former Chief Medical Officer’s severance agreement entered into in February 2025, $0.2 million increase in transaction-related expenses associated with the Asset Purchase Agreement completed in September 2025, which was expensed as in-process research and development (IPR&D), a $0.1 million increase in stock-based compensation, and a $0.1 million increase in clinical trial preparation costs. These increases were partially offset by a $0.5 million decrease in consulting expenses. We anticipate research and development expenses to increase when we commence clinical trials.

Interest and dividend income

Interest and dividend income for the nine months ended September 30, 2025, and 2024 were $0.1 million and $0.2 million, respectively. This represents the interest and dividends earned from our investments in money market funds.

Liquidity and Capital Resources

Since inception, we have incurred recurring losses and used cash in operating activities as we continue to advance our development programs. To date, we have funded our operations primarily through the issuance of convertible and promissory notes, our initial public offering completed in January 2023, a private placement completed in July 2023, the warrant inducement transaction completed in November 2024, and the sale of common stock through our at-the-market (“ATM”) facility.

For the nine months ended September 30, 2025, we reported a net loss of $10.2 million, which included $1.6 million of non-cash expenses, and cash used in operating activities of $10.0 million. We expect to continue to incur operating losses and negative cash flows for the foreseeable future as we advance our clinical and regulatory activities. Based on our current operating plan, we believe that our existing cash resources will not be sufficient to fund our operating and capital requirements for the next 12 months. To meet anticipated funding needs, we plan to seek additional capital through strategic partnerships, equity offerings, and/or debt financings. However, there can be no assurance that additional funding will be available on acceptable terms or at all. These factors raise substantial doubt about our ability to continue as a going concern for at least one year following the issuance of the accompanying financial statements. If we are unable to obtain additional financing, we may be required to delay or reduce the scope of our development programs, implement cost-saving measures, or cease operations entirely. The accompanying financial statements do not include any adjustments that might result from this uncertainty.

Cash Flows

The following table summarizes our cash flows for the period presented:

	Nine Months Ended September 30,
	2025			2024
Cash used in operating activities	$	(10,031,707	)	$	(5,566,844	)
Cash used in investing activities		(5,104	)		-
Cash provided by financing activities		3,878,951			1,528,244
Net change in cash		(6,157,860	)		(4,038,600	)
Cash and cash equivalents, beginning of period		10,017,942			8,402,500
Cash and cash equivalents, end of period	$	3,860,082		$	4,363,900

Operating activities

During the nine months ended September 30, 2025, cash used in operating activities was $10.0 million. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used $8.6 million in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, used $1.4 million in cash primarily from a $0.9 million decrease in accounts payable, a $0.4 million decrease in accrued liabilities, and a $0.1 million increase in deferred offering costs.

During the nine months ended September 30, 2024, cash used in operating activities was $5.6 million. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used $5.8 million in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, provided $0.2 million in cash primarily from a $0.3 million increase in accounts payable, a $0.1 million increase in accrued liabilities partially offset by a $0.1 million increase in deferred offering costs, and a $0.1 million increase in prepaid expenses.

Financing activities

During the nine months ended September 30, 2025, net cash provided by financing activities totaled $3.9 million from the use of our ATM facility and proceeds from the exercise of stock options.

During the nine months ended September 30, 2024, net cash provided by financing activities totaled $1.5 million. During the period, we utilized our ATM facility, which generated proceeds of $1.5 million, net of fees.

Critical Accounting Estimates

This discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported expenses incurred during the reporting periods. Significant estimates and assumptions made in the accompanying financial statements include but are not limited to the fair value of financial instruments, the fair value of stock-based awards, deferred tax assets and valuation allowance, income tax uncertainties, and certain accruals. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimated under different assumptions or conditions.

Stock-Based Compensation

We measure our stock-based awards granted to employees, consultants and directors based on the estimated grant-date fair values of the awards and recognize the compensation over the requisite service period. We use the Black-Scholes option-pricing model to estimate the fair value of our stock option awards. Stock-based compensation is recognized using the straight-line method. As the stock compensation expense is based on awards ultimately expected to vest, it is reduced by forfeitures. We account for forfeitures as they occur.

Acquisitions

We evaluate acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or an asset acquisition by first applying a screen test to determine whether substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If so, the transaction is accounted for as an asset acquisition. If not, further determination is required as to whether or not we have acquired inputs and processes that have the ability to create outputs, which would meet the definition of a business. Significant judgment is required in the application of the screen test to determine whether an acquisition is a business combination or an acquisition of assets.

Acquisitions meeting the definition of business combinations are accounted for using the acquisition method of accounting, which requires that the purchase price be allocated to the net assets acquired at their respective fair values. In a business combination, any excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill.

For asset acquisitions, a cost-accumulation model is used to determine the acquisition cost. Direct transaction costs are recognized as part of the cost of an asset acquisition. We also evaluate which elements of a transaction should be accounted for as a part of an asset acquisition and which should be accounted for separately. The cost of an asset acquisition, including transaction costs, is allocated to identifiable assets acquired and liabilities assumed based on a relative fair value basis. Goodwill is not recognized in an asset acquisition. Any difference between the cost of an asset acquisition and the fair value of the net assets acquired is allocated to the non-monetary identifiable assets based on their relative fair values. When a transaction accounted for as an asset acquisition includes an in-process research and development (“IPR&D”) asset, the IPR&D asset is only capitalized if it has an alternative future use other than in a particular research and development project. For an IPR&D asset to have an alternative future use: (a) we must reasonably expect that we will use the asset acquired in the alternative manner and anticipate economic benefit from that alternative use, and (b) our use of the asset acquired is not contingent on further development of the asset subsequent to the acquisition date (that is, the asset can be used in the alternative manner in the condition in which it existed at the acquisition date). Otherwise, amounts allocated to IPR&D that have no alternative use are expensed to research and development. Asset acquisitions may include contingent consideration arrangements that encompass obligations to make future payments to sellers contingent upon the achievement of future financial targets. Contingent consideration is not recognized until all contingencies are resolved and the consideration is paid or probable of payment, at which point the consideration is allocated to the assets acquired on a relative fair value basis.

OFF-BALANCE SHEET ARRANGEMENTS

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined under SEC rules.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

Not applicable because we are a smaller reporting company.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2025. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. We have adopted and maintain disclosure controls and procedures (as defined Rules 13a-15(e) and 15d-15(e) under the Exchange Act) that are designed to provide reasonable assurance that information required to be disclosed in the reports filed under the Exchange Act, such as this Quarterly Report on Form 10-Q, is collected, recorded, processed, summarized, and reported within the time periods specified in the rules of the SEC. Our disclosure controls and procedures are also designed to ensure that such information is accumulated and communicated to management to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of September 30, 2025, our Chief Executive Officer and Chief Financial Officer concluded that, as of such a date, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

During the quarter ended September 30, 2025, there were no changes in our internal control over financial reporting (as defined in Rules 13a 15(f) and 15d 15(f) of the Exchange Act) that occurred that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II: OTHER INFORMATION

Item 1. Legal Proceedings

We are not currently subject to any material legal proceedings.

Item 1A. Risk Factors

Investing in our securities involves a high degree of risk. Please refer to Part I, Item 1A, “Risk Factors,” contained in our Annual Report for a description of certain significant risks and uncertainties to which our business, financial condition and results of operations are subject. Except as set forth below, there have been no material changes from these risk factors as of the date of filing of this Quarterly Report on Form 10-Q.

Our financial statements have been prepared assuming that we will continue as a going concern.

We had an accumulated deficit of approximately $35.9 million as of September 30, 2025 and a net loss of approximately $10.2 million for the nine months ended September 30, 2025. We expect to incur significant expenses and continued losses from operations for the foreseeable future. We believe that our existing cash and cash equivalents will not be sufficient to meet our anticipated cash requirements for the next twelve months. We will require additional financing as we continue to execute our business strategy, including the need for additional funds for the commencement of our planned clinical trials. Our unaudited financial statement for the nine months ended September 30, 2025, were prepared under the assumption that we will continue as a going concern; however, we have incurred significant losses from operations to date and we expect our expenses to increase in connection with the commencement of our planned clinical trials. These factors raise substantial doubt about our ability to continue as a going concern for one year after the financial statements are issued. Our unaudited financial statements for the quarter ended September 30, 2025 contain an explanatory paragraph with respect to this uncertainty. Our liquidity may be negatively impacted as a result of research and development cost increases in addition to general economic and industry factors. In order to meet our expected obligations, we intend to raise additional funds through partnering and equity and debt financings or a combination of these potential sources of liquidity. There can be no assurance that funding will be available on acceptable terms, on a timely basis, or at all. The various ways that we could raise capital carry potential risks. Any additional financing will likely involve the issuance of our equity securities, which will have a dilutive effect on our stockholders. Any debt financing, if available, may involve restrictive covenants that may impact our ability to conduct our business. If we raise funds through partnering, such as collaborations and licensing arrangements, we might be required to relinquish significant rights to our technologies or grant licenses on terms that are not favorable to us. If we do not succeed in raising additional funds on acceptable terms or at all, we may be unable to complete the planned clinical trials. As such, we cannot conclude that such plans will be effectively implemented within one year after the date that the financial statements included in this Quarterly Report are filed with the SEC and there is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt about our ability to continue as a going concern.

The shutdown of the U.S. federal government may adversely affect our business.

A prolonged or recurring shutdown of the U.S. federal government may adversely affect our business operations and regulatory compliance. During such shutdowns, while the SEC’s EDGAR system remains operational, the unavailability of SEC staff to review filings, issue comments, or declare registration statements effective may delay our ability to complete public offerings, respond to comment letters, or obtain timely regulatory approvals. These delays could impact our access to capital markets, hinder strategic transactions, and create uncertainty around our disclosure obligations. Additionally, the lack of interpretive guidance or exemptive relief during a shutdown may increase legal and compliance risks. We continue to monitor developments and adjust our regulatory strategies accordingly, but there can be no assurance that future shutdowns will not materially affect our operations or financial condition.

Inadequate funding for the FDA, the SEC and other government agencies, including from government shutdowns, or other disruptions to these agencies’ staffing and operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

Currently, federal agencies in the United States are operating under a federal government shutdown due to the expiration of the continuing resolution that expired on September 30, 2025. The duration of the current government shutdown is unknown. In addition, the current U.S. administration is focused on reducing costs of the federal government generally, including significantly reducing the number of government employees. Without appropriation of additional funding to federal agencies, our business operations related to our product development activities for the U.S. market could be impacted. The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, the ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely is subject to the political process, which is inherently fluid and unpredictable.

Our business depends on timely interactions with the FDA, including the review of regulatory submissions, scheduling of formal meetings, and oversight of clinical trials. Disruptions at the FDA and other federal agencies, including substantial leadership departures, personnel cuts, policy changes and those related to the federal government shutdown, may result in reduced staffing or suspension of non-essential FDA operations, which could delay or cancel meetings with the FDA, hinder regulatory guidance, delay the implementation or enforcement of regulatory requirements in a timely fashion or at all, and postpone the review of IND applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs). These disruptions may also affect the initiation, conduct, and monitoring of clinical trials, particularly those requiring FDA authorization or ongoing regulatory engagement. Interruptions in FDA activities could materially delay our development timelines, increase operational costs, and adversely impact our ability to complete our planned clinical trials and to advance product candidates toward approval and commercialization. Any such delays or uncertainties may have a significant negative effect on our business, financial condition, and results of operations.

If the current U.S. federal government shutdown is prolonged or if the FDA, National Institutes of Health (“NIH”), SEC or the United States Patent and Trademark Office (“USPTO”) experiences significant decreases in funding or personnel, it could significantly impact the ability of the FDA to issue licenses needed for conduct of our clinical trials, the NIH to conduct research or provide grants, and the abilities of the FDA and the USPTO to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

There is substantial uncertainty as to whether and how the new administration will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates and any products for which we obtain approval. Additionally, the new administration could also issue or promulgate executive orders, regulations, policies or guidance that adversely affect us or create a more challenging or costly environment to pursue the development of new therapeutic candidates. Complying with any new legislation and regulatory requirements could be time-intensive and expensive.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

(a) Unregistered Sales of Equity Securities

We did not sell any equity securities during the quarter ended September 30, 2025 and up to the date of the filing of this Quarterly Report on Form 10-Q in transactions that were not registered under the Securities Act other than as previously disclosed in our filings with the SEC.

(b) Use of Proceeds

Not applicable.

(c) Issuer Purchases of Equity Securities

Not applicable.

Item 3. Defaults Upon Senior Securities.

Not applicable.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

During the three months ended September 30, 2025, no officer or director of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “nonRule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K, other than as set forth below.

On September 23, 2025, Quang X. Pham, the Chief Executive Officer of the Company, entered into a written stock selling plan in accordance with Rule 10b5-1 of the Exchange Act and the Company’s Insider Trading Policy, which is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) (the “ Pham 10b5-1 Plan”). The Pham 10b5-1 Plan allows for the sale of a maximum of 154,571 shares of our common stock (less such number of shares of common stock that are sold pursuant to the written stock selling plan in accordance with Rule 10b5-1 that was entered into by Mr. Pham on May 9, 2025, subsequent to September 23, 2025 until the date such prior plan terminates), over an approximate nine month period subject to the terms and conditions of the Pham 10b5-1 Plan, including specified minimum price and volume parameters. The term of the Pham 10b5-1 Plan begins on December 23, 2025 and terminates on September 30, 2026.

On September 18, 2025, Matthew Szot, the Chief Financial Officer of the Company, entered into a written stock selling plan in accordance with Rule 10b5-1 of the Exchange Act and the Company’s Insider Trading Policy, which is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) (the “Szot 10b5-1 Plan”). The maximum number of shares available to be sold under the Szot 10b5-1 Plan will be equal to 100% of all unsold shares (not to exceed 9,933 shares) of common stock from the written stock selling plan entered into by Mr. Szot on May 9, 2025 (the “Prior Szot 10b5-1 Plan”) on the date when such Prior Szot 10b5-1 Plan terminates, over an approximate six and one-half month period subject to the terms and conditions of the Szot 10b5-1 Plan, including specified minimum price and volume parameters, in accordance with Rule 10b5-1. The term of the Szot 10b5-1 Plan begins on December 18, 2025 and terminates on June 30, 2026.

Item 6. Exhibits.

The exhibits filed or furnished as part of this Quarterly Report on Form 10-Q are set forth on the Exhibit Index, which Exhibit Index is incorporated herein by reference.

Exhibit No.		Description
3.1		Amended and Restated Certificate of Incorporation (Incorporated by reference as Exhibit 3.3 to the Registration Statement on Form S-1 (File No. 333-267562) filed on September 22, 2022)
3.2		Amended and Restated Bylaws (Incorporated by reference as Exhibit 3.2 to the Registration Statement on Form S-1 (File No. 333-267562) filed on December 6, 2022)
3.3		Certificate of Amendment of the Amended and Restated Certificate of Incorporation of Cadrenal Therapeutics, Inc. (Incorporated by reference as Exhibit 3.1 to the Current Report on Form 8-K filed on August 20, 2024)
10.1		Purchase Agreement between Cadrenal Therapeutics, Inc. and eXIthera Pharmaceuticals, Inc. (incorporated by reference as Exhibit 10.1 to the Current Report on Form 8-K filed on September 15, 2025)
31.1*		Certification of the Principal Executive Officer Pursuant to Rule 13a-14 and 15d-14 of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2*		Certification of the Principal Financial Officer and Principal Accounting Officer Pursuant to Rule 13a-14 and 15d-14 of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1*		Certification by the Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2*		Certification by the Principal Financial Officer and Principal Accounting Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS		Inline XBRL Instance*
101.SCH		Inline XBRL Taxonomy Extension Schema*
101.CAL		Inline XBRL Taxonomy Extension Calculation*
101.DEF		Inline XBRL Taxonomy Extension Definition*
101.LAB		Inline XBRL Taxonomy Extension Labeled*
101.PRE		Inline XBRL Taxonomy Extension Presentation*
104		Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document)

*	Filed herewith.
#	Management contract or compensatory plan or arrangement required to be identified pursuant to Item 15(a)(3) of this Quarterly Report.

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, thereunto duly authorized.

	Cadrenal Therapeutics, Inc.
	(Registrant)

Dated: November 10, 2025	/s/ Quang X. Pham
	Quang X. Pham
	Chairman of the Board and Chief Executive Officer (Principal Executive Officer)

Dated: November 10, 2025	/s/ Matthew Szot
	Matthew Szot
	Chief Financial Officer
	(Principal Financial and Accounting Officer)

SEC Form 10-Q filed by Cadrenal Therapeutics Inc.