UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For
the quarterly period ended
OR
For the transition period from to
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(Exact name of registrant as specified in its charter)
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Registrant’s
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Securities registered pursuant to Section 12(b) of the Act:
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Indicate
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Indicate
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of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
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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 | ☐ |
| ☒ | 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
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As
of May 6, 2026, there were
CADRENAL THERAPEUTICS, INC.
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2026
TABLE OF CONTENTS
i
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements (Unaudited)
CADRENAL THERAPEUTICS, INC.
BALANCE SHEETS
| March 31, 2026 | December 31, | |||||||
| (unaudited) | 2025 | |||||||
| Assets: | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Interest receivable | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Deferred offering costs | ||||||||
| Total current assets | ||||||||
| Property, plant and equipment, net | ||||||||
| Other assets | ||||||||
| Total assets | $ | $ | ||||||
| Liabilities and Stockholders’ Equity: | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued liabilities | ||||||||
| Total current liabilities | ||||||||
| Total liabilities | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $ | ||||||||
| Common stock, $ | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
The accompanying notes are an integral part of these financial statements.
1
CADRENAL THERAPEUTICS, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Operating expenses: | ||||||||
| General and administrative expenses | $ | $ | ||||||
| Research and development expenses | ||||||||
| Depreciation expense | ||||||||
| Total operating expenses | ||||||||
| Loss from operations | ( | ) | ( | ) | ||||
| Other income | ||||||||
| Interest and dividend income | ||||||||
| Total other income | ||||||||
| Net loss and comprehensive loss | $ | ( | ) | $ | ( | ) | ||
| Net loss per common share, basic and diluted | $ | ( | ) | $ | ( | ) | ||
| Weighted average number of common shares used in computing net loss per common share, basic and diluted | ||||||||
The accompanying notes are an integral part of these financial statements.
2
CADRENAL THERAPEUTICS, INC.
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(unaudited)
| For the three months ended March 31, 2026 | ||||||||||||||||||||
| Common Stock | Additional Paid-In | Accumulated | Total Stockholders’ | |||||||||||||||||
| Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||
| Balance, December 31, 2025 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Equity-based compensation - options | - | |||||||||||||||||||
| Proceeds from sale of common stock under the ATM, net of issuance costs of $ | ||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Balance, March 31, 2026 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| For the three months ended March 31, 2025 | ||||||||||||||||||||
| Common Stock | Additional Paid-In | Accumulated | Total Stockholders’ | |||||||||||||||||
| Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||
| Balance, December 31, 2024 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Equity-based compensation - options | - | |||||||||||||||||||
| Issuance of common stock for consulting services | ||||||||||||||||||||
| Proceeds from sale of common stock under the ATM, net issuance costs of $ | ||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Balance, March 31, 2025 | $ | $ | $ | ( | ) | $ | ||||||||||||||
The accompanying notes are an integral part of these financial statements.
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CADRENAL THERAPEUTICS, INC.
STATEMENTS OF CASH FLOWS
(unaudited)
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Cash flows used in operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation expense | ||||||||
| Equity-based compensation | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Interest receivable | ( | ) | ||||||
| Prepaid expenses | ( | ) | ( | ) | ||||
| Deferred offering costs | ( | ) | ||||||
| Accounts payable | ( | ) | ||||||
| Accrued liabilities | ( | ) | ( | ) | ||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows used in investing activities: | ||||||||
| Investment in property and equipment | ( | ) | ||||||
| Net cash used in investing activities | ( | ) | ||||||
| Cash flows from financing activities: | ||||||||
| Proceeds from sale of common stock under ATM | ||||||||
| Issuance costs for sale of common stock under ATM | ( | ) | ( | ) | ||||
| Net cash provided by financing activities | ||||||||
| Net change in cash and cash equivalents | ( | ) | ( | ) | ||||
| Cash and cash equivalents – beginning of the period | ||||||||
| Cash and cash equivalents – end of the period | $ | $ | ||||||
The accompanying notes are an integral part of these financial statements.
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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 is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is a first-in-class 12-lipoxygenase (“12-LOX”) inhibitor for the treatment of heparin-induced thrombocytopenia (“HIT”), a deadly immune-mediated thrombotic disorder. CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration, and orphan drug status from the European Medicines Agency. Second-generation 12-LOX oral therapeutics are also under development for chronic conditions.
The Company’s broader pipeline includes tecarfarin, a Phase 3-ready oral vitamin K antagonist for patients with end-stage kidney diseases and left ventricular assist devices, and frunexian, a parenteral Factor XIa inhibitor designed for use in acute hospital settings.
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 March 31, 2026, the results of its operations for the three months ended March 31, 2026 and 2025, the statements of changes in stockholders’ equity for the three months ended March 31, 2026 and 2025, and its cash flows for the three months ended March 31, 2026 and 2025. The financial data and other information disclosed in these notes related to the three months ended March 31, 2026 and 2025 are also unaudited. The results for the three months ended March 31, 2026, are not necessarily indicative of results to be expected for the year ending December 31, 2026, 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, 2025, and notes thereto, which are included in the Company’s Annual Report on Form 10-K filed with the SEC on March 31, 2026.
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 three months ended March 31, 2026, the Company had a net loss of $
5
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 as to 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 $
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 , 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
6
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. |
| ● | Risk-Free Interest Rate — The Company bases the risk-free interest rate on the implied yield currently available on U.S. Treasury securities with maturities consistent with the expected term of the stock option awards. |
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.
7
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
8
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
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.
9
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:
| March 31, 2026 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Fair Value | |||||||||||||
| Financial Assets: | ||||||||||||||||
| Money market funds | $ | $ | $ | $ | ||||||||||||
| Total financial assets | $ | $ | $ | $ | ||||||||||||
| December 31, 2025 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Fair Value | |||||||||||||
| Financial Assets: | ||||||||||||||||
| Money market funds | $ | $ | $ | $ | ||||||||||||
| Total financial assets | $ | $ | $ | $ | ||||||||||||
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.
10
Note 4. Accrued Liabilities
Accrued liabilities consist of the following:
| March 31, 2026 | December 31, 2025 | |||||||
| Accrued compensation | $ | $ | ||||||
| Accrued research and development | ||||||||
| Accrued professional fees | ||||||||
| Other | ||||||||
| Total accrued liabilities | $ | $ | ||||||
Note 5. Asset Purchase Agreement
eXIthera Pharmaceuticals, Inc.
On
September 12, 2025, the Company entered into an Asset Purchase Agreement (the “eXIthera APA”) with eXIthera Pharmaceuticals
(“eXIthera”). Pursuant to the terms of the eXIthera APA, 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 $
| Development Milestones | Milestone
payment | |
| First Patient Dosed in Phase 2 Initiated with Frunexian or EP-7327 | $ | |
| First Patient Dosed in Phase 1 Initiated with EP-7327 | $ | |
| First Patient Dosed in Phase 3 Initiated with Frunexian or EP-7327 | $ | |
| FDA Approval of New Drug Application for Frunexian or EP-7327 | $ |
As
additional consideration, the Company agreed to pay the eXIthera royalties equal to
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 $
| In process research and development | $ | |||
| Transaction costs | ||||
| Total | $ |
11
All costs the Company incurred in connection with the eXIthera APA were recognized as research and development expenses in the Company’s statements 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.
Veralox Therapeutics Inc.
On
December 10, 2025, the Company entered into an Asset Purchase Agreement (the “Veralox APA”) with Veralox Therapeutics, Inc.
(“Veralox”). Pursuant to the terms of the Veralox APA, the Company acquired all of the rights, title and interests in assets
owned or held for use by it in connection with the compound known as CAD-1005 (“CAD-1005”), and all back-up and follow-on
compounds, including the CAD-2000 series (the “Compounds”), including, without limitation, all intellectual property related
to the Compounds, all inventory related to the Compounds, certain contracts including a license agreement, all Permits and other Governmental
Authorizations and Books and Records (as such terms are defined in the Veralox APA), free and clear of any liens. In consideration of
the purchase of the assets, the Company paid $
| Development Milestones | Milestone payment | |||
| First Patient Dosed in the First Clinical Trial with CAD-1005 | $ | |||
| First regulatory filing approval to market a pharmaceutical product for human use containing a Compound that is covered by a patent owned or licensed by Veralox (the “Product”) in the United States | $ | |||
| First regulatory filing approval to market a Product outside the United States | $ | |||
| Regulatory filing approval to market a Product for a subsequent indication in the United States | $ | |||
| Regulatory filing approval to market a Product for a subsequent indication outside the United States | $ | |||
As
additional consideration, the Company agreed to pay Veralox royalties equal to
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 CAD-1005 compound 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 $
| In process research and development | $ | |||
| Transaction costs | ||||
| Total | $ |
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All costs the Company incurred in connection with the Veralox APA were recognized as research and development expenses in the Company’s statements of operations and comprehensive loss as these assets had no alternative future use at the time they were acquired. 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.
In
addition, the Company acquired the assignment of an amended and restated exclusive license agreement (the “Old Dominion License
Agreement”) between Veralox and Old Dominion University, as successor in interest to Eastern Virgina Medical School (the “Licensor”),
pursuant to which the Licensor granted Veralox an exclusive worldwide license under the EVMS Patent Rights related to the development
and commercialization of 4-((2-Hydroxy-3-MethoxyBenzyl)Amino) Benzenesulfonamide Derivatives as 12-LOX Inhibitors (collectively the “Assets”).
Pursuant to the Old Dominion License Agreement, the Company will pay Licensor milestone payments in the aggregate amount of $
Note 6. Stockholders’ Equity
Common Stock
The
Company is authorized to issue a total of
Holders
of common stock are entitled to
2025 Direct Registered Offering
On
December 15, 2025, the Company entered into a securities purchase agreement with certain investors. The agreement provided for the sale
and issuance by the Company of an aggregate of: (i) in a registered direct offering,
13
The
offering price was $
The
2025 Common Warrants have an exercise price of $
H.C.
Wainwright & Co., LLC (“H.C.W.”) acted as the placement agent for the Company in connection with the December 2025 Offering,
and as part of its compensation, the Company issued to designees of H.C.W. placement agent warrants (the “Placement Agent Warrants”)
to purchase up to
The 2025 Common Warrants and Placement Agent Warrants were classified as equity, and the offering costs were recorded as a debit to additional paid-in capital.
ATM Facility
During
the three months ended March 31, 2026, the Company sold
Warrant Summary
The following table summarizes the total warrants outstanding at March 31, 2026, all of which are classified as equity:
| Outstanding as of | Outstanding as of | |||||||||||||||||||||||
| Issue Date | Exercise Price Per Share | Expiration Date | December 31, 2025 | New Issuance | Exercised | March 31, 2026 | ||||||||||||||||||
| Placement agent warrants | $ | |||||||||||||||||||||||
| Placement agent warrants | $ | |||||||||||||||||||||||
| Representative warrants | $ | |||||||||||||||||||||||
| Placement agent warrants | $ | |||||||||||||||||||||||
| New Series A-1 warrants | $ | | ||||||||||||||||||||||
| New Series A-2 warrants | $ | | ||||||||||||||||||||||
| Placement agent warrants | $ | | ||||||||||||||||||||||
| Investor Warrants 2025 | $ | |||||||||||||||||||||||
| Placement agent warrants | $ | |||||||||||||||||||||||
| - | ||||||||||||||||||||||||
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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. 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
There
were options granted during the three months ended March 31, 2026.
| Three Months Ended March 31, 2026 | Three Months Ended March 31, 2025 | |||||||
| Risk-free interest rate | ||||||||
| Dividend yield | ||||||||
| Expected term (years) | ||||||||
| Volatility |
Activity under the Plans for the period from December 31, 2025 to March 31, 2026 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, 2025 | $ | $ | ||||||||||||||
| Granted | - | |||||||||||||||
| Exercised | - | |||||||||||||||
| Canceled/forfeited/expired | - | |||||||||||||||
| Outstanding at March 31, 2026 | $ | $ | ||||||||||||||
| Options vested and exercisable at March 31, 2026 | $ | $ | ||||||||||||||
| Options vested and expected to vest as of March 31, 2026 | $ | $ | ||||||||||||||
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The
weighted average grant date fair value of options granted during the year ended December 31, 2025 was $
Total equity-based compensation expense and the allocation of equity-based compensation for the periods presented below were as follows:
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| General and administrative | $ | $ | ||||||
| Research and development | ||||||||
| Total equity-based compensation | $ | $ | ||||||
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 March 31, | ||||||||
| 2026 | 2025 | |||||||
| Numerator: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Denominator: | ||||||||
| Weighted average common shares outstanding | ||||||||
| Net loss per common share, basic and diluted | $ | ( | ) | $ | ( | ) | ||
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 March 31, | ||||||||
| 2026 | 2025 | |||||||
| Anti-dilutive common stock equivalents: | ||||||||
| Stock options to purchase common stock | ||||||||
| Warrants to purchase common stock | ||||||||
| Total anti-dilutive common stock equivalents | ||||||||
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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 2025, the Company amended its office space lease to extend the term by
Future annual lease payments under non-cancellable operating leases as of March 31, 2026 were as follows:
| 2026 | $ | |||
| Total lease payments | $ |
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.
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Note 10. Subsequent Events
The Company has evaluated events that occurred through May 6, 2026, 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.
Warrant Inducement
On April 1, 2026, the Company consummated a private
placement offering (the “Warrant Inducement”), pursuant to which, in exchange for an investor’s exercise for cash of
the Company’s warrants (“Existing Warrants”) to purchase
Upon
consummation of the Warrant Inducement on April 1, 2026, the Company received aggregate gross proceeds of approximately $
Stockholders’ Equity
In this Quarterly Report on Form 10-Q, the Company
reported stockholders’ equity of $
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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, 2025, included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 filed on March 31, 2026 (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
We are a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. As a result of our acquisition of a 12-lipoxygenase (“12-LOX”) platform of assets in December 2025, we shifted our primary strategic focus to developing CAD-1005 for the treatment of immune-mediated and thrombotic disorders. Our lead product candidate, CAD-1005, is a first-in-class selective 12-LOX inhibitor being developed to treat heparin-induced thrombocytopenia (“HIT”), a deadly immune-mediated thrombotic disorder. CAD-1005 has been evaluated in a blinded, placebo-controlled Phase 2 clinical trial of 24 patients and in Phase 1 clinical trials involving more than 100 patients.
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We achieved a major regulatory milestone after completing our End-of-Phase 2 (“EOP2”) meeting with the U.S. Food and Drug Administration (“FDA”) and receiving guidance on key elements of the Phase 3 pivotal trial for CAD-1005. The meeting with the FDA provided critical guidance on protocol design, study population, dosing, background therapy, exposure, the safety database, and the primary endpoint of new or worsening thrombotic events. After considering FDA feedback on a pivotal registration study, we plan to advance directly to a randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to the current standard of care for patients with HIT.
We expect that our planned pivotal Phase 3 study will evaluate CAD-1005 in approximately 120 patients across clinical centers worldwide and is intended to support a projected NDA submission in 2029. The primary endpoint of the Phase 3 study is expected to be the incidence of new or worsening thrombotic events in patients with Serotonin Release Assay (SRA)-confirmed HIT, with at least one planned interim analysis. We believe that CAD-1005 is the only treatment in clinical development that targets the underlying immune drivers of HIT. Our Phase 3 trial protocol will remain subject to additional information and any further comments we may receive from the FDA during their review of the final protocol. CAD-1005 has an ODD from the FDA for prophylaxis of thrombosis in patients with HIT, an FDA Fast Track designation for the treatment and prevention of HIT, and an orphan designation from the EMA for the treatment of platelet-activating factor 4 disorders.
Our broader pipeline includes two additional clinical-stage assets — tecarfarin and frunexian. Tecarfarin is an oral vitamin K antagonist (“VKA”) (a warfarin replacement for patients with complex needs) designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation. Specifically, our focus for tecarfarin is chronic use in patients with kidney dysfunction and atrial fibrillation, or in those with left ventricular assist devices (“LVADs”). Tecarfarin has been designed to overcome metabolic factors that can make warfarin less reliable. Frunexian is a first-in-class, Phase 2-ready intravenous (“IV”) Factor XIa inhibitor designed for acute care settings where contact activation of coagulation by medical devices or artificial surfaces is significant. Frunexian is the only IV FXIa inhibitor in clinical development that targets the acute/critical care hospital setting exclusively.
Recent Developments
On March 31, 2026, we entered into a warrant inducement letter agreement (the “Inducement Agreement”) with a holder of warrants to purchase shares of our common stock, par value $0.001 per share (the “common stock”), issued in a private placement offering that closed on November 4, 2024 (the “Existing Warrants”). Pursuant to the Inducement Agreement, on April 1, 2026, the holder of the Existing Warrants exercised for cash the Existing Warrants to purchase up to an aggregate of 571,430 shares of common stock, at the adjusted exercise price of $4.50 per share (reduced from the initial exercise price of $16.50 per share) and, in consideration for the investor’s exercise of the Existing Warrants, we issued to such investor new unregistered Series B-1 common stock purchase warrants (the “Series B-1 Warrants”) to purchase an aggregate of 571,430 shares of common stock and new unregistered Series B-2 common stock purchase warrants (the “Series B-2 Warrants” and, together with the Series B-1 Warrants, the “New Warrants”) to purchase an aggregate of 571,430 shares of common stock. The New Warrants are immediately exercisable at an exercise price of $4.50 per share. The Series B-1 Warrants and the Series B-2 Warrants are exercisable for a term of five (5) years and eighteen (18) months, respectively, from the date that a resale registration statement registering the resale of the shares of common stock issuable upon exercise of the New Warrants (the “Resale Registration Statement”) is declared effective by the SEC. The Resale Registration Statement was declared effective on April 29, 2026.
The transactions contemplated by the agreement closed on April 1, 2026. We received aggregate gross proceeds of approximately $2.5 million from the exercise of the Existing Warrants, before deducting placement agent fees and other expenses payable by us. H.C. Wainwright & Co., LLC (“H.C.W.”) served as our exclusive placement agent in connection with the transactions consummated pursuant to the Inducement Agreement. As compensation for H.C.W. serving as our placement agent in connection with the offering, we paid H.C.W. a cash fee equal to 7.0% of the aggregate gross proceeds received upon exercise of the Existing Warrants and we issued to designees of H.C.W. warrants to purchase up to 37,143 shares of common stock, which warrants have substantially the same terms as the Series B-1 Warrants, except that they have an exercise price of $5.625 per share, which is equal to 125% of the exercise price of the New Warrants.
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ATM Facility
During the three months ended March 31, 2026, we sold 168,690 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 $8.10 per share, resulting in total gross proceeds of approximately $1,366,535 and net proceeds of approximately $1,302,565.
Results of Operations
Results of Operations for the Three Months Ended March 31, 2026 and 2025
The following table summarizes our results of operations for the three months ended March 31, 2026 and 2025.
| Three Months Ended March 31, | ||||||||||||||||
| 2026 | 2025 | $ Change | % Change | |||||||||||||
| Operating expenses: | ||||||||||||||||
| General and administrative expenses | $ | 1,742,315 | $ | 2,254,577 | $ | (512,262 | ) | (23 | )% | |||||||
| Research and development expenses | 771,508 | 1,667,882 | (896,374 | ) | (54 | )% | ||||||||||
| Depreciation expense | 555 | 5,517 | (4,962 | ) | (90 | )% | ||||||||||
| Total operating expenses | 2,514,378 | 3,927,976 | (1,413,598 | ) | (36 | )% | ||||||||||
| Loss from operations | (2,514,378 | ) | (3,927,976 | ) | 1,413,598 | (36 | )% | |||||||||
| Other income | ||||||||||||||||
| Interest and dividend income | 17,838 | 82,596 | (64,758 | ) | (78 | )% | ||||||||||
| Total other income | 17,838 | 82,596 | (64,758 | ) | (78 | )% | ||||||||||
| Net loss and comprehensive loss | $ | (2,496,540 | ) | $ | (3,845,380 | ) | $ | 1,348,840 | (35 | )% | ||||||
General and administrative expenses
General and administrative expenses were $1.7 million for the three months ended March 31, 2026, compared to $2.3 million for the three months ended March 31, 2025, a decrease of approximately $0.5 million, or 23%. The decrease was primarily driven by a $0.2 million decrease in expenses related to being a public company, a $0.1 million decrease in personnel expenses, a $0.1 million decrease in stock-based compensation, and a $0.1 million decrease in consulting expenses.
Research and development expenses
Research and development expenses were $0.8 million for the three months ended March 31, 2026, compared to $1.7 million for the three months ended March 31, 2025, a decrease of approximately $0.9 million, or 54%. The decrease was primarily attributable to a $0.5 million decrease in expenses associated with chemistry, manufacturing, and controls (“CMC”), a $0.3 million decrease in personnel expenses, a $0.2 million decrease in stock-based compensation, and a $0.1 million decrease in trial readiness expenses. These decreases were partially offset by a $0.2 million increase in consulting expenses and professional fees. We expect research and development expenses to increase when we commence clinical trials.
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Liquidity and Capital Resources
Since inception, we have incurred recurring losses and utilized cash in operations. To date, we have funded our operations from the proceeds of the sale of convertible and promissory notes, our IPO completed in January 2023, our private placement offering completed in July 2023, our warrant inducements completed in November 2024 and April 2026, our registered direct offering and concurrent private placement completed in December 2025, and the sale of common stock through our ATM facility with H.C.W.
As of March 31, 2026, we had cash and cash equivalents of $2.3 million. For the three months ended March 31, 2026, we reported a net loss of $2.5 million, which included $0.3 million of non-cash expenses, and cash used in operating activities of $3.0 million. On April 1, 2026, we completed a warrant inducement transaction resulting in gross proceeds of approximately $2.5 million, which we expect to partially extend our operational runway. 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. With our cash position of $3.5 million as of early May 2026, we believe we will be able to fund our operations into October 2026; however, the current cash will not be sufficient to commence and complete our planned clinical trials and no assurances can be provided and our cash runway could differ materially from our expectations based on various factors, many of which are out of our control. To meet anticipated funding needs, we plan to seek additional capital through strategic partnerships, sales under our ATM facility with H.C.W., equity offerings, debt financings, or a combination thereof. 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:
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Cash used in operating activities | $ | (3,002,217 | ) | $ | (4,648,755 | ) | ||
| Cash used in investing activities | - | (3,251 | ) | |||||
| Cash provided by financing activities | 1,302,565 | 1,970,136 | ||||||
| Net change in cash | (1,699,652 | ) | (2,681,870 | ) | ||||
| Cash and cash equivalents, beginning of period | 4,007,789 | 10,017,942 | ||||||
| Cash and cash equivalents, end of period | $ | 2,308,137 | $ | 7,336,072 | ||||
Operating activities
During the three months ended March 31, 2026, cash used in operating activities was $3.0 million. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used $2.2 million in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, used $0.8 million in cash primarily from a $0.7 million decrease in accrued liabilities and a $0.2 million increase in prepaid expenses, partially offset by a $0.2 million increase in accounts payable.
During the three months ended March 31, 2025, cash used in operating activities was $4.6 million. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used $3.3 million in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, used $1.3 million in cash primarily from a $0.6 million decrease in accrued liabilities, a $0.2 million decrease in accounts payable and a $0.5 million increase in prepaid expenses.
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Financing activities
During the three months ended March 31, 2026, net cash provided by financing activities totaled $1.3 million from the use of our ATM facility.
During the three months ended March 31, 2025, net cash provided by financing activities totaled $2.0 million from the use of our ATM facility.
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.
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.
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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 March 31, 2026. 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 March 31, 2026, 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 March 31, 2026, 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.
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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 $41.5 million as of March 31, 2026 and a net loss of approximately $2.5 million for the three months ended March 31, 2026. 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 three months ended March 31, 2026, 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 March 31, 2026 contain an explanatory paragraph with respect to this uncertainty. In addition, in connection with the filing of our Annual Report, our independent registered public accounting firm issued a report that included 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.
We cannot be assured that we will be able to maintain our listing on the Nasdaq Capital Market.
Our securities are listed on The Nasdaq Capital Market, a national securities exchange. We cannot be assured that we will continue to comply with the rules, regulations or requirements governing the listing of our Common Stock on Nasdaq Capital Market or that our securities will continue to be listed on Nasdaq Capital Market in the future. If Nasdaq should determine at any time that we fail to meet Nasdaq requirements, we may be subject to a delisting action by Nasdaq.
As reported in this Quarterly Report on Form 10-Q, at March 31, 2026, our stockholders’ equity of $1.8 million is below the minimum stockholders’ equity requirement of at least $2,500,000 for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b)(1) (the “Stockholders’ Equity Requirement”). We believe that we have regained compliance with the Stockholders’ Equity Requirement as a result of our receipt of net proceeds of $2.3 million from the exercise of the Existing Warrants in connection with the Warrant Inducement consummated on April 1, 2026. Despite that we believe we have regained compliance with the Stockholders’ Equity Requirement, Nasdaq may issue a deficiency letter subsequent to the filing of this Quarterly Report on Form 10-Q. Nasdaq will continue to monitor our ongoing compliance with the Stockholders’ Equity Requirement, and if at the time of our next periodic report we do not evidence compliance, we may be subject to delisting.
The Nasdaq has recently proposed a new rule change to (i) adopt Listing Rule 5550(a)(6) to require issuers listed on the Nasdaq Capital Market to maintain a minimum Market Value of Listed Securities (as defined in Nasdaq Listing Rule 5005(a)(23)) of at least $5 million for a period of thirty (30) consecutive business days, and (ii) amend Rule 5810 to suspend trading and immediately delist from Nasdaq securities of issuers that do not satisfy the proposed new requirements, and Rule 5815 to set forth the procedures for requesting a hearing before a Hearings Panel and the scope of the Panel’s discretion.
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If Nasdaq delists our securities from trading on its exchange at some future date, we would take actions to restore our compliance with The Nasdaq Capital Market’s listing requirements, but we can provide no assurance that any such action taken by us would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below The Nasdaq Capital Market, minimum bid price requirement or prevent future non-compliance with The Nasdaq Capital Market’s listing requirements. In the event of a delisting, we could face significant material adverse consequences, including:
| ● | a limited availability of market quotations for our securities; |
| ● | reduced liquidity with respect to our securities; |
| ● | a determination that our Common Stock is a “penny stock” which will require brokers trading in our ordinary shares to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our ordinary shares; |
| ● | a limited amount of news and analyst coverage for our company; and |
a decreased ability to issue additional securities or obtain additional financing in the future.
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 March 31, 2026 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 March 31, 2026, no officer or director of the Company
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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.
| * | Filed herewith. |
| # | Management contract or compensatory plan or arrangement required to be identified pursuant to Item 15(a)(3) of this Quarterly Report. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Cadrenal Therapeutics, Inc. | |
| (Registrant) | |
| Dated: May 7, 2026 | /s/ Quang X. Pham |
| Quang X. Pham | |
Chairman of the Board and Chief Executive Officer (Principal Executive Officer) |
| Dated: May 7, 2026 | /s/ Matthew Szot |
| Matthew Szot | |
| Chief Financial Officer | |
| (Principal Financial and Accounting Officer) |
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