Cardio Diagnostics Holdings, Inc. 10-K

Item 8 Financial Statements and Supplemental Data INDEX TO FINANCIAL STATEMENTS Page Report of Independent Registered Public Accounting Firm (PCAOB ID 273 ) F-1 Consolidated Balance Sheets as of December 31, 2023 and 2022 F-2 Consolidated Statements of Operations for the Years Ended December 31, 2023 and 2022 F-3 Consolidated Statements of Changes in Stockholders Equity for the Years Ended December 31, 2023 and 2022 F-4 Consolidated Statements of Cash Flows for the Years Ended December 31, 2023 and 2022 F-5 Notes to Consolidated Financial Statements F-6 58 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Board of Directors and Stockholders of Cardio Diagnostics Holdings, Inc. Opinion on the Consolidated Financial Statements We have audited the accompanying consolidated balance sheets of Cardio Diagnostics Holdings, Inc. (the “Company”) as of December 31, 2023 and 2022, and the related consolidated statements of operations, changes in stockholders’ equity, and cash flows for the years ended December 31, 2023 and 2022, and the related notes (collectively referred to as the consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the consolidated financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for the years ended December 31, 2023 and 2022, in conformity with accounting principles generally accepted in the United States of America. Going Concern The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As disclosed in Note 1 to the consolidated financial statements, the Company has generated only nominal revenue in the past two years. The Company had a net loss of $8,376,834 for the year ended December 31, 2023 and an accumulated deficit of $14,368,380 at December 31, 2023. These factors, among others, raise substantial doubt about the ability of the Company to continue as a going concern. Management’s plans regarding these matters are disclosed in Note 1 to the consolidated financial statements. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Basis for Opinion These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion. /s/ Prager Metis CPA’s LLC We have served as the Company’s auditor since 2021 Hackensack, New Jersey April 1, 2024 F- 1 CARDIO DIAGNOSTICS HOLDINGS, INC. CONSOLIDATED BALANCE SHEETS DECEMBER 31, 2023 2022 ASSETS Current assets Cash $ 1,283,523 $ 4,117,521 Accounts receivable 4,960 — Prepaid expenses and other current assets 1,477,197 1,768,366 Total current assets 2,765,680 5,885,887 Long-term assets Property and equipment, net 571,873 — Right of use assets, net 575,227 — Intangible assets, net 21,333 37,333 Deposits 12,850 4,950 Patent and trademark costs, net 515,402 321,308 Total assets $ 4,462,365 $ 6,249,478 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable and accrued expenses $ 243,213 $ 1,098,738 Lease liability – current 223,929 — Finance agreement payable 374,000 849,032 Total current liabilities 841,142 1,947,770 Long-term liabilities Lease liability – long term 663,099 — Total liabilities 1,504,241 1,947,770 Stockholders’ equity Preferred stock, $ .00001 par value; authorized – 100,000,000 shares; 0 shares issued and outstanding as of December 31, 2023 and 2022, respectively — — Common stock, $ .00001 par value; authorized – 300,000,000 shares; 20,540,409 and 9,514,743 shares issued and outstanding as of December 31, 2023 and 2022, respectively 205 95 Additional paid-in capital 17,326,299 10,293,159 Accumulated deficit ( 14,368,380 ) ( 5,991,546 ) Total stockholders’ equity 2,958,124 4,301,708 Total liabilities and stockholders’ equity $ 4,462,365 $ 6,249,478 See accompanying notes to the consolidated financial statements. F- 2 CARDIO DIAGNOSTICS HOLDINGS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS YEARS ENDED DECEMBER 31, 2023 2022 Revenue $ 17,065 $ 950 Operating expenses Sales and marketing 158,514 92,700 Research and development 145,182 40,448 General and administrative expenses 6,936,646 4,400,253 Amortization 19,182 16,000 Total operating expenses 7,259,524 4,549,401 Loss from operations ( 7,242,459 ) ( 4,548,451 ) Other income (expenses) Change in fair value of derivative liability 5,406,220 — Interest income 1,068 — Interest expense ( 6,735,013 ) — Gain on extinguishment of debt 193,350 — Acquisition related expense — ( 112,534 ) Total other income (expenses) ( 1,134,375 ) ( 112,534 ) Loss before provision for income taxes ( 8,376,834 ) ( 4,660,985 ) Provision for income taxes — — Net loss $ ( 8,376,834 ) $ ( 4,660,985 ) Basic and fully diluted income (loss) per common share: Net loss per common share $ ( .66 ) $ ( 1.51 ) Weighted average common shares outstanding – basic and fully diluted 12,685,133 3,087,683 See accompanying notes to the consolidated financial statements. F- 3 CARDIO DIAGNOSTICS HOLDINGS, INC. CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY YEARS ENDED DECEMBER 31, 2023 AND 2022 Additional Common stock Paid-in Accumulated Shares Amount Capital Deficit Totals Balances, December 31, 2021 4,223,494 $ 42 $ 2,398,628 $ ( 1,330,561 ) $ 1,068,109 Common stock and warrants issued for cash 2,484,872 25 11,986,011 — 11,986,036 Placement agent fee — — ( 1,198,604 ) — ( 1,198,604 ) Recapitalization transaction costs — — ( 1,535,035 ) — ( 1,535,035 ) Warrants converted to common stock 66,465 1 ( 1 ) — — Common stock issued in merger with Mana Capital Acquisition Corp. 2,696,578 27 ( 27 ) — — Note receivable converted to common stock in merger 43,334 — ( 433,334 ) — ( 433,334 ) Cash acquired in merger with Mana Capital Acquisition Corp. — — 4,021 — 4,021 Liabilities assumed in merger with Mana Capital Acquisition Corp. — — ( 928,500 ) — ( 928,500 ) Net loss — — — ( 4,660,985 ) ( 4,660,985 ) Balances, December 31, 2022 9,514,743 95 10,293,159 ( 5,991,546 ) 4,301,708 Warrants converted to common stock 100,000 1 389,999 — 390,000 Placement agent fee — — ( 315,000 ) — ( 315,000 ) Restricted stock awards vested 303,547 3 243,997 — 244,000 Notes payable converted to common stock 10,622,119 106 5,604,846 — 5,604,952 Compensation for vested stock options — — 1,035,273 — 1,035,273 Adjustment to liabilities assumed in merger with Mana — — 74,025 — 74,025 Net loss — — — ( 8,376,834 ) ( 8,376,834 ) Balances, December 31, 2023 20,540,409 $ 205 $ 17,326,299 $ ( 14,368,380 ) $ 2,958,124 See accompanying notes to the consolidated financial statements. F- 4 CARDIO DIAGNOSTICS HOLDINGS, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS YEARS ENDED DECEMBER 31, 2023 2022 CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $ ( 8,376,834 ) $ ( 4,660,985 ) Adjustments to reconcile net loss to net cash used in operating activities Depreciation 3,790 — Amortization 107,830 16,000 Acquisition related expense — 112,534 Stock-based compensation expense 1,279,273 — Non-cash interest expense 6,704,522 — Change in fair value of derivative liability ( 5,406,220 ) — Gain on extinguishment of debt ( 193,350 ) — Changes in operating assets and liabilities: Accounts receivable ( 4,960 ) 901 Prepaid expenses and other current assets 758,669 ( 690,821 ) Deposits ( 7,900 ) ( 4,950 ) Accounts payable and accrued expenses ( 781,500 ) 136,353 Lease liability 244,505 — NET CASH USED IN OPERATING ACTIVITIES ( 5,672,175 ) ( 5,090,968 ) CASH FLOWS FROM INVESTING ACTIVITIES: Purchases of property and equipment ( 575,663 ) — Cash acquired from acquisition — 4,021 Repayment of deposit for acquisition — 137,466 Payments for notes receivable — ( 433,334 ) Payments for lease ( 21,352 ) — Patent and trademark costs incurred ( 197,276 ) ( 76,154 ) NET CASH USED IN INVESTING ACTIVITIES ( 794,291 ) ( 368,001 ) CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from sale of common stock — 11,986,036 Proceeds from convertible notes payable 4,500,000 — Proceeds from exercise of warrants 390,000 — Payments of finance agreement ( 942,532 ) ( 188,674 ) Payments of recapitalization transaction costs — ( 1,535,035 ) Payments of placement agent fee ( 315,000 ) ( 1,198,604 ) NET CASH PROVIDED BY FINANCING ACTIVITIES 3,632,468 9,063,723 NET INCREASE (DECREASE) IN CASH ( 2,833,998 ) 3,604,754 CASH – BEGINNING OF YEAR 4,117,521 512,767 CASH – END OF YEAR $ 1,283,523 $ 4,117,521 SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: Cash paid during the year for: Interest $ 30,491 $ 5,829 Income taxes $ — $ — Non-cash investing and financing activities: Common stock issued for acquisition $ — $ 754 Liabilities assumed in acquisition $ — $ 928,500 Debt discount related to derivative liability $ 5,000,000 $ — Notes payable converted to common stock $ 5,000,000 $ — Adjustment to liabilities assumed in acquisition $ 74,025 $ — Financing agreement entered into for prepaid insurance $ 467,500 $ 1,037,706 Right of use asset added for operating lease $ 642,523 $ — See accompanying notes to the consolidated financial statements. F- 5 CARDIO DIAGNOSTICS HOLDINGS, INC. Notes to Consolidated Financial Statements Years Ended December 31, 2023 and 2022 Note 1 – Organization and Basis of Presentation The consolidated financial statements presented are those of Cardio Diagnostics Holdings, Inc., (the “Company”) and its wholly-owned subsidiary, Cardio Diagnostics, Inc. (“Legacy Cardio”). The Company was incorporated as Mana Capital Acquisition Corp. (“Mana”) under the laws of the state of Delaware on May 19, 2021, and Legacy Cardio was formed on January 16, 2017 as an Iowa limited liability company (Cardio Diagnostics, LLC) and was subsequently incorporated as a Delaware C-Corp on September 6, 2019. The Company was formed to develop and commercialize a patent-pending Artificial Intelligence (“AI”)-driven DNA biomarker testing technology (“Core Technology”) for cardiovascular disease invented at the University of Iowa by the Founders, with the goal of becoming one of the leading medical technology companies for enabling precision prevention, early detection and treatment of cardiovascular disease. The Company is transforming the approach to cardiovascular disease from reactive to proactive. The Core Technology is being incorporated into a series of products for major types of cardiovascular disease and associated co-morbidities including coronary heart disease (CHD), stroke, heart failure and diabetes. Business Combination On May 27, 2022, Mana, Mana Merger Sub, Inc. (“Merger Sub”), a wholly-owned direct subsidiary of Mana, Meeshanthini Dogan, the Shareholders’ Representative, and Legacy Cardio entered into the Business Combination Agreement (the “Merger Agreement”). On October 25, 2022, pursuant to the Merger Agreement, Legacy Cardio merged with and into Merger Sub, with Legacy Cardio surviving as the wholly-owned subsidiary of Mana. Subsequent to the merger, Mana changed its name to Cardio Diagnostics Holdings, Inc. Going Concern The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has generated only nominal revenue in the past two years. The Company had a net loss of $ 8,376,834 for the year ended December 31, 2023 and an accumulated deficit of $ 14,368,380 at December 31, 2023. These factors, among others, raise substantial doubt about the ability of the Company to continue as a going concern for a reasonable period of time. The Company’s continuation as a going concern is dependent upon its ability to obtain necessary equity financing and ultimately from generating revenues to continue operations. The Company expects that working capital requirements will continue to be funded through a combination of its existing funds and further issuances of securities. Working capital requirements are expected to increase in line with the growth of the business. Existing working capital, further advances and debt instruments, and anticipated cash flow are expected to be adequate to fund operations over the next twelve months. The Company has no lines of credit or other bank financing arrangements. Additional issuances of equity or convertible debt securities will result in dilution to current stockholders. Further, such securities might have rights, preferences or privileges senior to common stock. Additional financing may not be available upon acceptable terms, or at all. If adequate funds are not available or are not available on acceptable terms, the Company may not be able to take advantage of prospective new business endeavors or opportunities, which could significantly and materially restrict business operations. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. Note 2 – Merger Agreement and Reverse Recapitalization As discussed in Note 1, on October 25, 2022, the Company (formerly known as Mana) and Legacy Cardio entered into the Merger Agreement, which has been accounted for as a reverse recapitalization in accordance with GAAP. Pursuant to the Merger Agreement, the Company acquired cash of $ 4,021 and assumed liabilities of $ 928,500 from Mana. The liabilities assumed of $ 928,500 are payable to two investment bankers and due on October 25, 2023. The assumed liabilities decreased to $ 854,475 , after net of an early payment discount of $ 74,025 issued by one of the two investment bankers on March 22, 2023. On March 27, 2023, the Company accepted the early payment discount and paid Ladenburg the net balance due and payable of $ 419,475 . On October 24, 2023, the Company paid the remaining post-merger liabilities balance of $ 435,000 to Benchmark. Mana’s common stock had a redemption right in connection with the business combination. Mana’s stockholders exercised their right to redeem 6,465,452 shares of common stock, which constituted approximately 99.5 % of the shares with redemption rights, for cash at a redemption price of approximately $ 10.10 per share, for an aggregate redemption amount of $ 65,310,892 . In accounting for the reverse recapitalization, the Company’s legacy issued and outstanding 1,976,749 shares of common stock were reversed and the Mana shares of common stock totaling 9,514,743 were recorded, as described in Note 10. Transactions costs incurred in connection with the recapitalization totaled $ 1,535,035 and were recorded as a reduction to additional paid in capital. As additional consideration for the transaction, Cardio will issue to each holder who was entitled to merger consideration at the Closing, its pro rata proportion of up to 1,000,000 shares of our authorized but unissued common stock (the “Earnout Shares” or “Contingently Issuable Common Stock”), if on or prior to the fourth anniversary of the Closing Date (the “Earnout Period”), the VWAP of the Company’s Common Stock equals or exceeds four different price triggers for 30 of any 40 consecutive trading days, as follows: (i) one-quarter of the Earnout Shares will be issued if the VWAP equals or exceeds $12.50 per share for the stated period; (ii) one-quarter of the Earnout Shares will be issued if the VWAP equals or exceeds $15.00 per share for the stated period; (iii) one-quarter of the Earnout Shares will be issued if the VWAP equals or exceeds $17.50 for the stated period; and (iv) one-quarter of the Earnout Shares will be issued if the VWAP equals or exceeds $20.00 for the stated period. In evaluating the accounting treatment for the earnout, we have concluded that the earnout is not a liability under Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities from Equity, is not subject to the accounting guidance under ASC 718, Compensation—Stock Compensation, and is not subject to derivative accounting under ASC 815, Derivative and Hedging. As such, the earnout is recognized in equity at fair value upon the closing of the Business Combination. As of the date of filing of this Annual Report on Form 10-K, the Company’s common stock did not trade at equal to or greater than $12.50 for a period of at least 30 trading days out of 40 consecutive trading days and the Company has not issued any Earnout Shares. F- 6 Note 3 – Summary of Significant Accounting Policies Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Legacy Cardio. All intercompany accounts and transactions have been eliminated. Use of Estimates in the Preparation of Financial Statements The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the period. Actual results could differ from those estimates. Fair Value Measurements The Company adopted the provisions of ASC Topic 820, Fair Value Measurements and Disclosures, which defines fair value as used in numerous accounting pronouncements, establishes a framework for measuring fair value and expands disclosure of fair value measurements. The estimated fair value of certain financial instruments, including cash and cash equivalents, accounts receivable, accounts payable and accrued expenses are carried at historical cost basis, which approximates their fair values because of the short-term nature of these instruments. The carrying amounts of our short- and long-term credit obligations approximate fair value because the effective yields on these obligations, which include contractual interest rates taken together with other features such as concurrent issuances of warrants and/or embedded conversion options, are comparable to rates of returns for instruments of similar credit risk. ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value: Level 1 – quoted prices in active markets for identical assets or liabilities Level 2 – quoted prices for similar assets and liabilities in active markets or inputs that are observable Level 3 – inputs that are unobservable (for example cash flow modeling inputs based on assumptions) The estimated fair value of the derivative liability was calculated using the Black-Scholes option pricing model. The Company uses Level 3 inputs to value its derivative liabilities. The following table provides a reconciliation of the beginning and ending balances for the major classes of assets and liabilities measured at fair value using significant unobservable inputs (Level 3) and reflects gains and losses for the years ended December 31, 2023 and 2022. Schedule of fair value measurements 2023 2022 Liabilities: Balance of derivative liabilities – beginning of year $ — $ — Issued 9,192,672 — Converted ( 3,786,452 ) — Change in fair value recognized in operations ( 5,406,220 ) — Balance of derivative liabilities – end of year $ — $ — The following table represents the Company’s derivative instruments that are measured at fair value on a recurring basis as of December 31, 2023, for each fair value hierarchy level: Schedule of fair value hierarchy level December 31, 2023 Derivative Liabilities Total Level I $ — $ — Level II $ — $ — Level III $ — $ — F- 7 Convertible Instruments The Company evaluates and accounts for conversion options embedded in convertible instruments in accordance with ASC 815, Derivatives and Hedging Activities. Applicable GAAP requires companies to bifurcate conversion options from their host instruments and account for them as free standing derivative financial instruments according to certain criteria. The criteria include circumstances in which (a) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (b) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under other GAAP with changes in fair value reported in earnings as they occur and (c) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. The Company accounts for convertible instruments (when it has been determined that the embedded conversion options should not be bifurcated from their host instruments) as follows: The Company records, when necessary, discounts to convertible notes for the intrinsic value of conversion options embedded in debt instruments based upon the differences between the fair value of the underlying common stock at the commitment date of the note transaction and the effective conversion price embedded in the note. Debt discounts under these arrangements are amortized over the term of the related debt to their stated date of redemption. The Company accounts for the conversion of convertible debt when a conversion option has been bifurcated using the general extinguishment standards. The debt and equity linked derivatives are removed at their carrying amounts and the shares issued are measured at their then-current fair value, with any difference recorded as a gain or loss on extinguishment of the two separate accounting liabilities. Revenue Recognition The Company offers its products, Epi+Gen CHD and PrecisionCHD, via telemedicine providers, provider organizations such as concierge practices, longevity clinics, and risk-bearing provider organizations, and employer organizations. The Company is continuing to expand its markets and payment optionality, and therefore, other organization types not listed below may be added, and from time-to-time, there may be additional payment options. • Telemedicine For telemedicine, the telemedicine provider collects payments from patients upon completion of eligibility screening and test order. Patients then send their samples to the lab for biomarker assessments. The Company performs all quality control, analytical assessments and report generation and shares test reports with the ordering healthcare provider. Revenue is recognized upon invoicing the telemedicine providers. Telemedicine providers are invoiced at the end of each month for all tests completed since prior invoicing. • Provider organizations For provider organizations, the cost of each test is negotiated prior to testing commencing. Pricing is determined based largely on the provider organization type and testing volume commitment. Upon ordering a test, a patient’s sample is sent to the lab for biomarker assessments. The Company performs all quality control, analytical assessments and report generation and shares test reports with the ordering healthcare provider. Revenue is recognized upon invoicing the provider organization. The provider organization is invoiced the agreed upon pricing at the end of each month for all samples accepted or tests completed since prior invoicing. • Employer organizations For employer organizations, the cost of each test is negotiated prior to testing commencing. Pricing is determined based largely on testing volume commitment. Patient samples are sent to the lab for biomarker assessments. The Company performs all quality control, analytical assessments and report generation and shares test reports with the ordering healthcare provider. Revenue is recognized upon invoicing the employer organization. The employer organization is invoiced the agreed upon pricing once a heart disease fair is completed or all testing is completed. The Company accounts for revenue under Accounting Standards Update (“ASU”) 2014-09, “Revenue from Contracts with Customers (Topic 606)”, using the modified retrospective method. The modified retrospective adoption used by the Company did not result in a material cumulative effect adjustment to the opening balance of accumulated deficit. The Company determines the measurement of revenue and the timing of revenue recognition utilizing the following core principles: 1. Identifying the contract with a customer; 2. Identifying the performance obligations in the contract; 3. Determining the transaction price; 4. Allocating the transaction price to the performance obligations in the contract; and 5. Recognizing revenue when (or as) the Company satisfies its performance obligations. F- 8 Research and Development Research and development costs are expensed as incurred. Research and development costs charged to operations for the years ended December 31, 2023 and 2022 were $ 145,182 and $ 40,448 , respectively. Advertising Costs The Company expenses advertising costs as incurred. Advertising costs of $ 158,514 and $ 92,700 were charged to operations for the years ended December 31, 2023 and 2022, respectively. Cash and Cash Equivalents Cash and cash equivalents are comprised of cash and highly liquid investments with original maturities of 90 days or less at the date of purchase. The Company does no t have any cash equivalents as of December 31, 2023 and 2022. Cash is maintained at a major financial institution. Accounts held at U.S. financial institutions are insured by the FDIC up to $ 250,000 . The Company is exposed to credit risk in the event of default by the financial institutions or the issuers of these investments to the extent the amounts on deposit or invested are in excess of amounts that are insured. Accounts Receivable Accounts receivable is stated at invoiced amount, net of an allowance for doubtful accounts and bear no interest. An allowance for losses is established through a provision for losses charged to expenses. Receivables are charged against the allowance for losses when management believes collectability is unlikely. The allowance (if any) is an amount that management believes will be adequate to absorb estimated losses on existing receivables, based on evaluation of the collectability of the accounts and prior loss experience. Property and Equipment Property and equipment are stated at cost. Maintenance and repairs are charged to expense when incurred. When property and equipment are retired or otherwise disposed of, the related cost and accumulated depreciation are removed from the respective accounts and any gain or loss is credited or charged to income. Depreciation for both financial reporting and income tax purposes is computed using combinations of the straight line and accelerated methods over the estimated lives of the respective assets as follows: Schedule of estimated lives Office and computer equipment 5 years Furniture and fixtures 7 years Intangible Assets Intangible assets are acquired individually or as part of a group of assets, and are initially recorded at cost. The cost of a group of assets acquired in a transaction is allocated to the individual assets based on their relative fair values. Intangible assets are carried at cost less accumulated amortization and any recorded impairment. Intangible assets with finite useful lives are amortized using a straight-line method over the period of estimated useful life. The estimated useful life of the Company’s intangible assets (Know-how license) is 5 years . The Company evaluates intangible assets for impairment whenever events or changes in circumstances indicate that the assets might be impaired. Patent and Trademark Costs The Company accounts for patents in accordance with ASC 350-30, the Company accounts for patents in accordance with ASC 350-30, General Intangibles Other than Goodwill . The Company capitalizes patent costs representing legal fees associated with filing patent applications and amortize them on a straight-line basis. The Company evaluates its patents’ estimated useful life and begins amortizing the patents when they are brought to the market or otherwise commercialized. Impairment of Long-Lived Assets In accordance with ASC 360-10-35, the Company assesses the valuation of components of its long-lived assets whenever events or circumstances dictate that the carrying value might not be recoverable. The Company bases its evaluation on indicators such as the nature of the assets, the future economic benefit of the assets, any historical or future profitability measurements and other external market conditions or factors that may be present. If such factors indicate that the carrying amount of an asset or asset group may not be recoverable, the Company determines whether an impairment has occurred by analyzing an estimate of undiscounted future cash flows at the lowest level for which identifiable cash flows exist. If the estimate of undiscounted cash flows during the estimated useful life of the asset is less than the carrying value of the asset, the Company recognizes a loss for the difference between the carrying value of the asset and its estimated fair value, generally measured by the present value of the estimated cash flows. Leases The Company accounts for leases under ASC 842, “Leases”. The Company determines if an arrangement is a lease or contains a lease at inception of the arrangement. Operating lease liabilities are recognized based on the present value of the remaining lease payments, discounted using the discount rate for the lease at the commencement date. As the rate implicit in the lease is not readily determinable for the operating lease, the Company generally uses an incremental borrowing rate based on information available at the commencement date to determine the present value of future lease payments. Operating lease right-of-use assets (“ROU assets”) represent the Company’s right to control the use of an identified asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. ROU assets are generally recognized based on the amount of the initial measurement of the lease liability. Lease expense is recognized on a straight-line basis over the lease term. The Company elected to keep leases with an initial term of 12 months or less off the balance sheet. ROU assets are reviewed for impairment when indicators of impairment are present. ROU assets from operating and finance leases are subject to the impairment guidance in ASC 360, Property, Plant, and Equipment, as ROU assets are long-lived nonfinancial assets. ROU assets are tested for impairment individually or as part of an asset group if the cash flows related to the ROU assets are not independent from the cash flows of other assets and liabilities. An asset group is the unit of accounting for long-lived assets to be held and used, which represents the lowest level for which identifiable cash flows are largely independent of the cash flows of other groups of assets and liabilities. Stock-Based Compensation The Company accounts for its stock-based awards granted under its employee compensation plan in accordance with ASC Topic No. 718-20, Awards Classified as Equity, which requires the measurement of compensation expense for all share-based compensation granted to employees and non-employee directors at fair value on the date of grant and recognition of compensation expense over the related service period for awards expected to vest. The Company uses the Black-Scholes option pricing model to estimate the fair value of its stock options and warrants. The Black-Scholes option pricing model requires the input of highly subjective assumptions including the expected stock price volatility of the Company’s common stock, the risk free interest rate at the date of grant, the expected vesting term of the grant, expected dividends, and an assumption related to forfeitures of such grants. Changes in these subjective input assumptions can materially affect the fair value estimate of the Company’s stock options and warrants. F- 9 Income Taxes The Company accounts for income taxes using the asset and liability method in accordance with ASC Topic No. 740, Income Taxes. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities, and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. The Company applies the provisions of ASC Topic No. 740 for the financial statement recognition, measurement and disclosure of uncertain tax positions recognized in the Company’s financial statements. In accordance with this provision, tax positions must meet a more-likely-than-not recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position. Recent Accounting Pronouncements We have reviewed other recent accounting pronouncements and concluded they are either not applicable to the business, or no material effect is expected on the consolidated financial statements as a result of future adoption. Note 4 – Property and Equipment Property and equipment are carried at cost and consist of the following at December 31, 2023 and 2022: Schedule of property and equipment 2023 2022 Office and computer equipment $ 17,394 $ — Furniture and fixtures 76,099 — Leasehold improvements 482,170 — Less: Accumulated depreciation ( 3,790 ) — Total $ 571,873 $ — Leasehold improvements of $ 482,170 represent costs of the buildout of the leased laboratory in Iowa City, Iowa that was completed in January 2024. Depreciation expense of $ 3,790 and $ 0 was charged to operations for the years ended December 31, 2023 and 2022, respectively. Note 5 – Intangible Assets The following table provides detail associated with the Company’s acquired identifiable intangible assets at December 31, 2023 and 2022: Schedule of intangible assets 2023 2022 Know-how license $ 80,000 $ 80,000 Less: Accumulated amortization ( 58,667 ) ( 42,667 ) Total $ 21,333 $ 37,333 Amortization expense charged to operations was $ 16,000 for the years ended December 31, 2023 and 2022, respectively. Note 6 – Patent and Trademark Costs As of December 31, 2023, in the first family of patents and patent applications owned solely by UIRF and is exclusively licensed by Cardio, there are five granted patents (US, EU, China, Australia and Hong Kong) and other pending patent applications. The Company has pending patent applications in patent families two, three, four and five. Legal fees associated with the patents and trademark totaled $ 515,402 and $ 321,308 , net of accumulated amortization of $ 3,182 and $ 0 as of December 31, 2023 and 2022, respectively and are presented in the balance sheet as patent and trademark costs. Amortization expense charged to operations was $ 3,182 for the year ended December 31, 2023. F- 10 Note 7 – Operating Leases The Company determines if a contract is, or contains, a lease at contract inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, current portion of operating lease liabilities and operating lease liabilities, net of current portion in the Company’s consolidated balance sheets. Finance leases are included in property and equipment, current portion of finance lease obligations and finance lease obligations, net of current portion in the Company’s consolidated balance sheets. ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. ROU assets and lease liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. In addition, ROU assets include initial direct costs incurred by the lessee as well as any lease payments made at or before the commencement date and exclude lease incentives. The Company used the implicit rate in the lease in determining the present value of lease payments. Lease terms include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Leases with a term of one year or less are generally not included in ROU assets and corresponding operating lease liabilities. In 2023, the Company entered into a lease agreement for office space in Chicago, Illinois, commencing on August 1, 2023 for a term of three years and four months and expiring on November 30, 2026. The monthly rent for August to November 2023 was abated and the Company started to make monthly rental installments from December 2023 of $12,847. The monthly rental payment increases by approximately 2% every August starting from 2024. On July 20, 2023, the Company entered into another lease agreement for laboratory in Iowa City, Iowa, commencing on August 1, 2023 for a term of five years and four months and expiring on November 30, 2028. The monthly rent for August to November 2023 was abated and the Company agreed to pay a monthly rent of $ 8,505 ( $ 102,060 annually) commencing December 1, 2023. In addition, the landlord agreed to provide the Company with a one-time Tenant Improvement Allowance (“TIA”) in the amount of up to, but not exceeding $50 per rentable square foot of the premises for a maximum allowance of $ 253,000 . Pursuant to ASC Topic 842 Leases, the Company accounted for both leases as operating leases and accounted for the TIA as a lease incentive, which was estimated to be payable on December 1, 2023. The Company received the TIA from landlord in maximum amount of $ 253,000 on January 16, 2024 and recorded a reimbursement receivable from landlord of $ 253,000 as of December 31, 2023, which was included in Prepaid expenses and other current assets on the consolidated balance sheets. During the year ended December 31, 2023, the Company recorded ROU assets of $ 663,875 and operating lease liabilities of $ 642,523 at lease commencement date. The discount rate used to determine the present value is the incremental borrowing rate, estimated to be 4.57 % for Chicago lease and 4.24 % for Iowa City lease, respectively, as the interest rate implicit in our lease is not readily determinable. As of December 31, 2023, operating lease ROU assets and operating lease liabilities are recorded on the consolidated balance sheets as follows: Schedule of operating lease ROU assets and operating lease liabilities December 31, 2023 Operating Lease: Operating lease right-of-use assets, net $ 575,227 Current portion of operating lease liabilities $ 223,929 Operating lease liabilities, net of current portion $ 663,099 As of December 31, 2023, the weighted-average remaining lease terms of the two operating leases were 2.9 years and 4.9 years, respectively. The following table summarizes maturities of operating lease liabilities based on lease terms as of December 31: Schedule of future minimum payments due 2024 $ 257,508 2025 260,611 2026 250,152 2027 102,060 2028 93,555 Total lease payments 963,886 Less: Imputed interest 76,858 Present value of lease liabilities $ 887,028 At December 31, 2023, the Company had the following future minimum payments due under the non-cancelable lease: 2024 $ 257,508 2025 260,611 2026 250,152 2027 102,060 2028 93,555 Total minimum lease payments $ 963,886 Consolidated rental expense for all operating leases was $ 138,266 and $ 53,344 for the years ended December 31, 2023 and 2022, respectively. The following table summarizes the cash paid and related right-of-use operating lease recognized for the year ended December 31, 2023. Schedule of cash paid and related right-of-use operating lease Year Ended December 31, 2023 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 21,352 Right-of-use lease assets obtained in the exchange for lease liabilities: Operating leases $ 4,950 F- 11 Note 8 – Finance Agreement Payable On October 25, 2023, the Company entered into an agreement with a premium financing company to finance its Directors and Officers insurance premiums for 12-month policies effective October 25, 2023. The amount financed of $ 467,500 is payable in 10 monthly installments plus interest at a rate of 8.95 % through August 25, 2024 . Finance agreement payable was $ 374,000 and $ 849,032 at December 31, 2023 and 2022, respectively. $ 449,041 has been recorded in prepaid expenses and is being amortized over the life of the policy. Note 9 – Earnings (Loss) Per Common Share The Company calculates net income (loss) per common share in accordance with ASC 260 “ Earnings Per Share ” (“ASC 260”). Basic and diluted net earnings (loss) per common share was determined by dividing net earnings (loss) applicable to common stockholders by the weighted average number of common shares outstanding during the period. The Company’s potentially dilutive shares, which include outstanding common stock options, common stock warrants, and convertible debt have not been included in the computation of diluted net loss per share for the years ended December 31, 2023 and 2022 as the result would be anti-dilutive. Schedule of anti dilutive earning per share Years Ended December 31, 2023 2022 Stock warrants 7,854,620 7,954,620 Stock options 2,584,599 1,759,599 Total shares excluded from calculation 10,439,219 9,714,219 Note 10 – Stockholders’ Equity Stock Transactions Pursuant to the Business Combination Agreement on October 25, 2022, the Company issued the following securities: Holders of conversion rights issued as a component of units in Mana’s initial public offering (the “Public Rights”) were issued an aggregate of 928,571 shares of the Company’s common stock. Holders of existing shares of common stock of Legacy Cardio and the holder of equity rights of Legacy Cardio (together, the “Legacy Cardio Stockholders”) received an aggregate of 6,883,306 shares of the Company’s Common Stock, calculated based on the exchange ratio of 3.427259 pursuant to the Merger Agreement (the “Exchange Ratio”) for each share of Legacy Cardio Common Stock held or, in the case of the equity rights holder, that number of shares of the Company’s Common Stock equal to 1% of the Aggregate Closing Merger Consideration, as defined in the Merger Agreement. The Legacy Cardio Stockholders received, in addition, an aggregate of 43,334 shares of the Company’s Common Stock (“Conversion Shares”) upon conversion of an aggregate of $ 433,334 in principal amount of promissory notes issued by Mana to Legacy Cardio in connection with its loan of such amount in order to extend Mana’s duration through October 26, 2022 (the “Extension Notes”), which Conversion Shares were distributed to the Legacy Cardio Stockholders in proportion to their respective interest in Legacy Cardio. Mana public stockholders (excluding Mana Capital, LLC, the SPAC sponsor (the “Sponsor”), and Mana’s former officers and directors) own 34,548 shares of the Company’s Common Stock and the Sponsor, Mana’s former officers and directors and certain permitted transferees own 1,625,000 shares of the Company’s Common Stock. Immediately after giving effect to the Business Combination, there were 9,514,743 issued and outstanding shares of the Company’s Common Stock. On October 25, 2022, in connection with the approval of the Business Combination, the Company’s stockholders approved the Cardio Diagnostics Holdings, Inc. 2022 Equity Incentive Plan (the “2022 Plan”). The purpose of the 2022 Plan is to promote the interests of the Company and its stockholders by providing eligible employees, officers, directors and consultants with additional incentives to remain with the Company and its subsidiaries, to increase their efforts to make the Company more successful, to reward such persons by providing an opportunity to acquire shares of Common Stock on favorable terms and to attract and retain the best available personnel to participate in the ongoing business operations of the Company. The 2022 Plan permits the grant of Incentive Stock Options, Nonstatutory Stock Options, Restricted Stock, Restricted Stock Units, Stock Appreciation Rights, Performance Units and Performance Shares. F- 12 The 2022 Plan, as approved, permits the issuance of up to 3,265,516 shares of Common Stock (the “Share Reserve”) upon exercise or conversion of grants and awards made from time to time to officers, directors, employees and consultants, however that the Share Reserve will increase on January 1 st of each calendar year and ending on and including January 1, 2027 (each, an “Evergreen Date”), in an amount equal to the lesser of (i) 7% of the total number of shares of Common Stock outstanding on the December 31 st immediately preceding the applicable Evergreen Date and (ii) such lesser number of shares of Common Stock as determined to be appropriate by the Compensation Committee, which administers the 2022 Plan, in its sole discretion. There was no increase in the Share Reserve on January 1, 2023. Common Stock Issued On March 2, 2023, a shareholder exercised warrants in exchange for 100,000 common shares for proceeds of $ 390,000 . During the year ended December 31, 2023, the Company issued 52,375 common shares to a consultant for services pursuant to vesting of Restricted Stock Units granted, valued at $ 44,000 . During the year ended December 31, 2023, the Company issued 251,172 common shares to the board of directors for services pursuant to vesting of Restricted Stock Units granted, valued at $ 200,000 . In connection with the convertible notes payable (see Note 11 below) the noteholders converted $ 5,000,000 of principal balance to 10,622,119 shares of common stock during the year ended December 31, 2023. The number of shares of common stock issued was determined based on the terms of the convertible notes. The Company sold post-merger 2,484,872 (or 725,032 pre-merger) common shares to various investors for proceeds totaling $ 11,986,036 during the year ended December 31, 2022. The Company paid the placement agent $ 1,198,604 in cash and issued 214,998 warrants. The Company issued post-merger 66,465 (or 19,393 pre-merger) common shares to an investor in settlement of a cashless exercise of a warrant agreement. Warrants On October 1, 2019, the Company issued warrants to a seed funding firm equivalent to 2% of the fully-diluted equity of the Company, or 22,500 common shares at the time of issuance. The warrant is exercisable on the earlier of the closing date of the next Qualified Equity Financing occurring after the issuance of the warrant, and immediately before a Change of Control. The exercise price is the price per share of the shares sold to investors in the next Qualified Equity Financing, or if the warrant becomes exercisable in connection with a Change in Control before the next Qualified Equity Financing, the greater of the quotient obtained by dividing $ 150,000 by the Pre-financing Capitalization, and the price per share paid by investors in the then-most recent Qualified Equity Financing, if any. The warrant will expire upon the earlier of the consummation of any Change of Control, or 15 years after the issuance of the warrant. In April 2022, the Company issued fully vested warrants to investors as part of private placement subscription agreements pursuant to which the Company issued common stock. Each shareholder received warrants to purchase 50% of the common stock issued at an exercise price of $ 3.90 per share with an expiration date of June 30, 2027 . As of May 23, 2022, the Company issued fully vested warrants to investors as part of an additional private placement subscription agreements pursuant to which the Company issued common stock. Each shareholder received warrants to purchase 50% of the common stock issued at an exercise price of $ 6.21 per share with an expiration date of five years from the date of issue. All of the warrants issued by Legacy Cardio were exchanged in the Business Combination for warrants of the Company based on the merger exchange ratio. F- 13 Warrant activity during the years ended December 31, 2023 and 2022 was as follows: Schedule of warrant activity Weighted Average Remaining Warrant Outstanding Average Exercise Price Contractual Life (Years) Warrants outstanding at December 31, 2021 114,924 $ 3.90 5.90 Warrants granted 1,988,973 4.84 Warrants received in merger 5,749,993 11.50 Merger adjustment to prior year 152,730 3.90 Warrants exercised ( 52,000 ) 3.90 Warrants outstanding at December 31, 2022 7,954,620 9.63 4.72 Warrants exercised ( 100,000 ) 3.90 Warrants outstanding at December 31, 2023 7,854,620 $ 9.70 3.72 Options On May 6, 2022, Legacy Cardio granted 513,413 stock options to the board of directors pursuant to the Cardio Diagnostics, Inc. 2022 Equity Incentive Plan. All of the options granted under this legacy plan were exchanged for options under the Company’s 2022 Plan adopted by the Company’s stockholders on October 25, 2022, and based on the exchange ratio for the merger, resulted in a total of 1,759,599 options issued upon closing. Each exchanged option has an exercise price of $ 3.90 per share with an expiration date of May 6, 2032 . The exchanged options fully vested upon closing of the merger. Option activity during the years ended December 31, 2023 and 2022 was as follows: Schedule of option activity Weighted Average Remaining Option Outstanding Average Exercise Price Contractual Life (Years) Options outstanding at December 31, 2021 — $ — Options granted 1,759,599 3.90 Options outstanding at December 31, 2022 1,759,599 3.90 9.35 Options granted 825,000 1.26 Options outstanding at December 31, 2023 2,584,599 $ 3.06 8.71 Note 11 – Convertible Notes Payable On March 8, 2023, the Company entered into a securities purchase agreement (“Securities Purchase Agreement”) with YA II PN, Ltd., an investment fund managed by Yorkville Advisors Global, LP (“Yorkville”) under which the Company agreed to sell and issue to Yorkville convertible debentures (“Convertible Debentures”) in a gross aggregate principal amount of up to $ 11.2 million (“Subscription Amount”). The Convertible Debentures are convertible into shares of common stock of the Company and are subject to various contingencies being satisfied as set forth in the Securities Purchase Agreement. The notes are convertible at any time through the maturity date, which, in each case, is one year from the date of issuance. The conversion price shall be determined on the basis of 92 % of the two lowest VWAP (Volume Weighted Average Prices) of the Common Stock during the prior seven trading day period, initially with a floor conversion price of $ 0.55 , but subsequently lowered by mutual agreement of the parties to $ 0.20 . On March 8, 2023, the Company issued and sold to Yorkville a Convertible Debenture in the principal amount of $ 5.0 million, for which it received $ 4.5 million, with a $ 500,000 original issue discount (“OID”). Interest on the outstanding principal balance accrues at a rate of 0 % and will increase to 15 % upon an Event of Default for so long as it remains uncured. F- 14 The Company recorded a debt discount related to identified embedded derivatives relating to the conversion features (see Note 12) based on fair values as of the inception date of the Note. The calculated debt discount, including the OID, equaled the face of the Note and is being amortized over the term of the note. Yorkville fully converted the initial $ 5,000,000 Convertible Debenture into an aggregate of 10,622,119 common shares during the year ended December 31, 2023. On January 4, 2024, the Company and Yorkville terminated the Securities Purchase Agreement dated as of March 8, 2023, as amended, by the mutual consent of the parties, effective as of January 4, 2024. The First Convertible Debenture has been fully converted, and as of January 4, 2024, the obligation of the Company to issue and sell, and Yorkville’s obligation to purchase, the Second Convertible Debenture has been terminated. At the time of termination, there were no outstanding borrowings, advance notices or shares of Common Stock to be issued under the Securities Purchase Agreement. In addition, there were no fees due by the Company or Yorkville in connection with the termination of the Securities Purchase Agreement. Note 12 – Derivative Liability The Company has determined that the conversion feature embedded in the convertible notes described in Note 11 contain a potential variable conversion amount which constitutes a derivative which has been bifurcated from the note and recorded as a derivative liability at fair value, with a corresponding discount recorded to the associated debt. The excess of the derivative value over the face amount of the note is recorded immediately to interest expense at inception, which aggregated $4,692,672. The Company used the Binomial Black-Scholes Option Pricing model to value the conversion features. The Company used Level 3 inputs for its valuation methodology for the conversion option liability in determining the fair value using a Black-Scholes option-pricing model with the following assumption inputs: Schedule of option liability Year Ended December 31, 2023 Annual dividend yield — Expected life (years) 1.0 Risk-free interest rate 4.89 % - 5.59 % Expected volatility 164 % - 187 % Exercise price $ 0.19 - $ 3.53 Stock price $ 0.22 - $ 5.32 Based upon ASC 840-15-25 (EITF Issue 00-19, paragraph 11) the Company has adopted a sequencing approach regarding the application of ASC 815-40 to its outstanding convertible notes. Pursuant to the sequencing approach, the Company evaluates its contracts based upon earliest issuance date. Note 13 – Income Taxes The reconciliation between income tax expense computed by applying the federal statutory corporate tax rate and actual income tax expense (benefit) for the year ended December 31, 2023 is as follows: Schedule of effective income tax rate reconciliation Years Ended December 31, 2023 2022 Statutory U.S. federal income tax rate ( 21.0 )% ( 21.0 )% State income taxes, net of federal income tax benefit ( 0.0 )% ( 0.0 )% Tax effect of expenses that are not deductible for income tax purposes: Amortization of debt discount 16.8 % 0.0 % Change in fair value of derivative liability ( 13.5 )% 0.0 % Other ( 0.7 )% 0.0 % Change in Valuation Allowance 18.4 % 21.0 % Effective tax rate 0.0 % 0.0 % F- 15 At December 31, the significant components of the deferred tax assets (liabilities) are summarized below: Schedule of deferred income tax assets 2023 2022 Deferred Tax Assets: Net Operating Losses $ 4,222,999 $ 1,611,487 Other 1,743 1,962 Stock-based compensation 486,448 186,611 Total deferred tax assets 4,711,190 1,800,060 Deferred Tax Liabilities — — Valuation Allowance ( 4,711,190 ) ( 1,800,060 ) Net deferred tax assets $ — $ — As of December 31, 2023, the Company had federal net operating loss carryforwards of approximately $ 11.5 million which may be carried forward indefinitely, and state net operating loss carryforwards of approximately $ 11.5 million (Iowa) and $ 10.9 million (Illinois), respectively which expire at various dates from 2040 through 2043. These net operating loss carryforwards may be used to offset future taxable income and thereby reduce the Company’s U.S. federal income taxes. The net operating losses may be subject to limitation under Internal Revenue Code Section 382 should there be a greater than 50 % change in ownership as determined under the regulations. In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in making this assessment. Based on the assessment, management has established a full valuation allowance against all of the deferred tax assets for every period because it is more likely than not that all of the deferred tax assets will not be realized. In accordance with ASC 740, a valuation allowance must be established if it is more likely than not that the deferred tax assets will not be realized. This assessment is based upon consideration of available positive and negative evidence, which includes, among other things, the Company’s most recent results of operations and expected future profitability. Based on the Company’s cumulative losses in recent years, a full valuation allowance against the Company’s deferred tax assets as of December 31, 2023 has been established as Management believes that the Company will not more likely than not realize the benefit of those deferred tax assets. Therefore, no tax provision has been recorded for the year ended December 31, 2023. The Company complies with the provisions of ASC 740-10 in accounting for its uncertain tax positions. ASC 740-10 addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the financial statements. Under ASC 740-10, the Company may recognize the tax benefit from an uncertain tax position only if it is more likely that not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. Management has determined that the Company has no significant uncertain tax positions requiring recognition under ASC 740-10. The Company is subject to income tax in the U.S., and certain state jurisdictions. The Company has not been audited by the U.S. Internal Revenue Service, or any states in connection with income taxes. The Company’s tax years generally remain open to examination for all federal and state income tax matters until its net operating loss carryforwards are utilized and the applicable statutes of limitation have expired. The federal and state tax authorities can generally reduce a net operating loss (but not create taxable income) for a period outside the statute of limitations in order to determine the correct amount of net operating loss which may be allowed as a deduction against income for a period within the statute of limitations. F- 16 The Company recognizes interest and penalties related to unrecognized tax benefits, if incurred, as a component of income tax expense. No interest or penalties have been recorded for the years ended December 31, 2023 and 2022, respectively. On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was enacted in response to the COVID-19 pandemic. The CARES Act, among other things, permits NOL carryovers and carrybacks to offset 100% of taxable income for taxable years beginning before 2021. In addition, the CARES Act allows NOLs incurred in 2018, 2019, and 2020 to be carried back to each of the five preceding taxable years to generate a refund of previously paid income taxes. The Company is currently evaluating the impact of the CARES Act, but at present does not expect that the NOL carryback provision of the CARES Act would result in a material cash benefit to us. Note 14 – Commitments and Contingencies Prior Relationship of Cardio with Boustead Securities, LLC At the commencement of efforts to pursue what ultimately ended in a terminated business acquisition, Legacy Cardio entered into a Placement Agent and Advisory Services Agreement (the “Placement Agent Agreement”), dated April 12, 2021, with Boustead Securities, LLC (“Boustead Securities”). This agreement was terminated in April 2022, when Legacy Cardio terminated the underlying agreement and plan of merger and the accompanying escrow agreement relating to that proposed business acquisition after efforts to complete the transaction failed, despite several extensions of the closing deadline. Under the terminated Placement Agent Agreement, Legacy Cardio agreed to certain future rights in favor of Boustead Securities, including (i) a two-year tail period during which Boustead Securities would be entitled to compensation if Cardio were to close on a transaction (as defined in the Placement Agent Agreement) with any party that was introduced to Legacy Cardio by Boustead Securities; and (ii) a right of first refusal to act as the Company’s exclusive placement agent for 24-months from the end of the term of the Placement Agent Agreement (the “right of first refusal”). Cardio has taken the position that due to Boustead Securities’ failure to perform as contemplated by the Placement Agent Agreement, these provisions purporting to provide future rights are null and void. Boustead Securities responded to the termination of the Placement Agent Agreement by disputing Legacy Cardio’s contention that it had not performed under the Placement Agent Agreement because, among other things, Boustead Securities had never sought out prospective investors. In its response, Boustead Securities included a list of funds that they had supposedly contacted on Legacy Cardio’s behalf. While Boustead Securities’ contention appears to contradict earlier communications from Boustead Securities in which they indicated that they had not made any such contacts or introductions, Boustead Securities is currently contending that they are due success fees for two years following the termination of the Placement Agent Agreement on any transaction with any person on the list of supposed contacts or introductions. Legacy Cardio strongly disputes this position. Notwithstanding the foregoing, the Company has not consummated any transaction, as defined, with any potential party that purportedly was a contact of Boustead Securities in connection with the Placement Agent Agreement and has no plans to do so at any time during the tail period. No legal proceedings have been instigated by either party, and Cardio believes that the final outcome will not have a material adverse impact on its financial condition. The Benchmark Company, LLC Right of First Refusal As noted in Note 1, the Company completed the business combination on October 25, 2022. In connection with the proposed business combination, by agreement dated May 13, 2022, Mana engaged The Benchmark Company, LLC (“Benchmark”) as its M&A advisor. Upon closing of the business combination, Legacy Cardio assumed the contractual engagement entered into by Mana. On November 14, 2022, the Company and Benchmark entered into Amendment No. 1 Engagement Letter (the “Amendment Engagement”). Pursuant to the Amendment Engagement, the parties agreed that the Company would pay Benchmark $230,000 at the closing of the business combination and an additional $435,000 on October 25, 2023. Both of those payments have been made in full. In addition, the Amendment Engagement provided that Benchmark has been granted a right of first refusal to act as lead or joint-lead investment banker, lead or joint-lead book-runner and/or lead or joint-lead placement agent for all future public and private equity and debt offerings through October 25, 2023. Based on the right of first refusal, Benchmark alleges that it is owed damages because the Company entered into the Yorkville Convertible Debenture Transaction (see Note 11) without first offering Benchmark the right to serve as the lead or joint-lead placement agent for the transaction. The Company is evaluating the claim. No legal proceedings have been instigated. Demand Letter and Potential Mootness Fee Claim On June 25, 2022, a plaintiffs’ securities law firm sent a demand letter to the Company alleging that the Company’s Registration Statement on Form S-4 filed (the “S-4 Registration Statement”) with the Securities and Exchange Commission (“SEC”) on May 31, 2022 omitted material information with respect to the Business Combination and demanding that the Company and its Board of Directors immediately provide corrective disclosures in an amendment or supplement to the Registration Statement. Subsequent thereto, the Company filed amendments to the S-4 Registration Statement on July 27, 2022, August 23, 2022, September 15, 2022, October 4, 2022 and October 5, 2022 in which it responded to various comments of the SEC staff and otherwise updated its disclosure. In October 2022, the SEC completed its review and declared the S-4 registration statement on October 6, 2022. On February 23, 2023 and February 27, 2023, plaintiffs’ securities law firm contacted the Company’s counsel asking who will be negotiating a mootness fee relating to the purported claims set forth in the June 25, 2022 demand letter. The Company vigorously denies that the S-4 Registration Statement, as amended and declared effective, is deficient in any respect and that no additional supplemental disclosures are material or required. The Company believes that the claims asserted in the Demand Letter are without merit and that no further disclosure is required to supplement the S-4 Registration Statement under applicable laws. As of the date of filing of this Annual Report on Form 10-K, no lawsuit has been filed against the Company by that firm. The firm has indicated its willingness to litigate the matter if a mutually satisfactory resolution cannot be agreed upon; however, Cardio believes that the final outcome will not have a material adverse impact on its financial condition. The Company cannot preclude the possibility that claims or lawsuits brought relating to any alleged securities law violations or breaches of fiduciary duty could potentially require significant time and resources to defend and/or settle and distract its management and board of directors from focusing on its business. Northland Securities, Inc. In January 2024, following the Company’s termination of its agreement with Yorkville and in connection with the Company’s recent at the market offering and/or its February 2024 private placement, a managing director of Northland Securities, Inc. (“Northland”) contacted the Company claiming the right to be paid a fee of approximately $ 150,000 pursuant to the agreement of March 1, 2023 between the Company and Northland regarding the Yorkville financing. Subsequently, the Company has been advised by another representative of Northland that Northland would not proceed with any such claim. The Company does not believe that it owes Northland any sum based on the termination of the Yorkville Securities Purchase Agreement and the subsequent financing transactions. The Company cannot preclude the possibility that claims or lawsuits brought relating to any alleged securities law violations or breaches of fiduciary duty could potentially require significant time and resources to defend and/or settle and distract its management and board of directors from focusing on its business. F- 17 Note 15 – Subsequent Events The Company evaluated its December 31, 2023 consolidated financial statements for subsequent events through the date the consolidated financial statements were issued. Common Stock Issued Private Placement On February 2, 2024, the Company completed entering into subscription agreements with 7 accredited investors (the “Subscription Agreements”), whereby the Company issued a total of 561,793 units (“Units”), with each Unit consisting of (i) one share of the Company’s common stock, $ 0.00001 par value (the “Common Stock”), and (ii) one six year Common Stock purchase warrant (the “Warrants”), having an exercise price of $ 1.78 per share (the “Private Placement”). The Private Placement resulted in the issuance to investors of 561,793 shares of Common Stock and 561,793 Warrants. The purchase price of the securities was $ 1.78 per Unit, resulting in gross proceeds to the Company of $ 1,000,000 and paid a fee of $ 100,000 , before deducting placement agent fees (10% or $ 100,000 ) and other offering expenses. The Company intends to use the net proceeds from the Private Placement for working capital and general corporate purposes. The Private Placement closed on February 2, 2024. In connection with the Private Placement, the Company entered into a Placement Agent Agreement with Altitude Capital Group, LLC, as placement agent (“Altitude Capital” or the “Placement Agent”). Pursuant to the Placement Agent Agreement, at closing, Altitude Capital was paid a cash commission equal to 10% of the gross proceeds received by the Company, plus 20% warrant coverage, providing Altitude Capital with the right to purchase 112,353 shares of Common Stock at $ 1.78 per share through February 2, 2030 (the “Placement Agent Warrants”). At-the-Market Issuance On January 26, 2024, the Company entered into an At-the-Market Issuance Sales Agreement (the “Sales Agreement”) with Craig-Hallum Capital Group LLC (“Craig-Hallum”). Pursuant to the Sales Agreement, the Company may sell, at its option, up to an aggregate of $ 17 million in shares of its common stock through Craig-Hallum, as sales agent. Sales of the common stock made pursuant to the Sales Agreement, if any, will be made under the Company’s Registration Statement on Form S-3 filed on January 26, 2024 (File No. 333-276725) (the “Registration Statement”), which was declared effective by the Securities and Exchange Commission on February 1, 2024. The Company made certain customary representations, warranties and covenants concerning the Company and the offering of the Shares. Pursuant to the terms of the Sales Agreement, the Company also provided the Sales Agent with customary indemnification rights, including indemnification against certain liabilities under the Securities Act . The Company will pay the Sales Agent a commission in cash equal to 2.5% of the gross proceeds from the sale of the Shares under the Sales Agreement, if any. In addition, the Company agreed to pay the costs of the Sales Agent’s legal counsel reasonably incurred in connection with entering into the transactions contemplated by the Sales Agreement in an amount not to exceed $55,000. Additionally, pursuant to the terms of the Sales Agreement, the Company agreed to reimburse the Sales Agent’s for its legal fees incurred in connection with its ongoing diligence requirements arising from the transactions contemplated by the Sales Agreement in an amount not to exceed $5,000 in the aggregate per calendar quarter. The offering of Shares will terminate upon the earlier of (i) the sale of the Shares under the Sales Agreement having an aggregate offering price of $17 million or (ii) the termination of the Sales Agreement as permitted therein. The Sales Agreement may be terminated by the Company at any time upon five business days’ prior written notice to the Sales Agent. The Sales Agent may terminate the Sales Agreement at any time by providing written notice to the Company. The Company and the Sales Agent may also terminate the Sales Agreement by mutual agreement. The Company sold 487,083 common shares for gross proceeds totaling $ 877,869 under the Sales Agreement as of the date of this report. The Company has paid Craig-Hallum $ 21,947 in sales commissions. Stock Option Granted On January 23, 2024, the Company authorized an additional 1,071,425 shares to the Equity Incentive Plan Reserve (the “2022 Plan”) and granted 1,187,826 options to management, 1,166,826 of which vested immediately with the remaining 21,000 options subject to 50 % vesting on June 30, 2024 and 100 % vesting on December 31, 2024. Each option has an exercise price of $ 2.11 per share with an expiration date of January 23, 2034 . F- 18 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure None.