UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

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

For the quarterly period ended September 30, 2025

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

For the transition period from _____ to _____

Commission File Number: 001-41097

Cardio Diagnostics Holdings, Inc.

(Exact name of registrant as specified in its charter)

Delaware

87-0925574

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

311 West Superior Street, Suite 444

Chicago, Illinois

60654

(Address of principal executive offices)

(Zip Code)

(855) 226-9991

(Registrant’s telephone number, including area code)

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

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

Title of each class

Trading Symbol(s)

Name of each exchange on

which registered

Common Stock, par value $0.00001 per share

CDIO

The NASDAQ Stock Market LLC

Redeemable Warrants, each whole warrant exercisable for one share of Common Stock

CDIOW

The NASDAQ Stock Market LLC

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

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

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

Large accelerated filer	☐	Accelerated filer	☐

Non-accelerated filer	☒	Smaller reporting company	☒

		Emerging growth company	☒

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

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

As of November 12, 2025, there were 1,826,051 shares of the registrant’s Common Stock, $0.00001 par value, issued and outstanding.

CARDIO DIAGNOSTICS HOLDINGS, INC.

FORM 10-Q

For the Quarter Ended September 30, 2025

TABLE OF CONTENTS

Introductory Note		i
Note About Forward-Looking Statements		ii

Part I — Financial Information
Item 1.	Financial Statements (unaudited)	1
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	19
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	27
Item 4.	Controls and Procedures	27

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

INTRODUCTORY NOTE

Unless the context dictates otherwise, references in this Quarterly Report on Form 10-Q to the "Company,” "Cardio,” "we,” "us,” "our,” and similar words are references to Cardio Diagnostics Holdings, Inc., a Delaware corporation, and its consolidated subsidiary. "Legacy Cardio” refers to Cardio Diagnostics, Inc. prior to the October 2022 Business Combination with Mana Capital Acquisition Corp (“Mana”). Legacy Cardio became our wholly-owned subsidiary as a result of that transaction.

Trade names and trademarks of Cardio referred to herein, and their respective logos, are our property. This Quarterly Report on Form 10-Q may contain additional trade names and/or trademarks of other companies, which are the property of their respective owners. We do not intend our use or display of other companies’ trade names and/or trademarks, if any, to imply an endorsement or sponsorship of us by such companies, or any relationship with any of these companies.

SPECIAL NOTE ABOUT FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains “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”). All statements other than statements of historical fact are “forward-looking statements” for purposes of federal and state securities laws, including, but not limited to, changes in laws or regulations, any statements about our business (including the impact of a re-emergence of COVID-19 variants or any other pandemic, epidemic or infectious disease outbreak on our business), financial condition, operating results, plans, objectives, expectations and intentions, any guidance on, or projections of, earnings, revenue or other financial items, or otherwise, and our future liquidity, including cash flows; any statements of any plans, strategies, and objectives of management for future operations, such as the material opportunities that we believe exist for our Company; any statements concerning proposed products and services, developments, mergers or acquisitions; or strategic transactions; any statements regarding management’s view of future expectations and prospects for us; any statements about prospective adoption of new accounting standards or effects of changes in accounting standards; any statements regarding future economic conditions or performance; any statements of belief; any statements of assumptions underlying any of the foregoing; and other statements that are not historical facts. Forward-looking statements may be identified by the use of forward-looking terms such as “anticipate,” “could,” “can,” “may,” “might,” “potential,” “predict,” “should,” “estimate,” “expect,” “project,” “believe,” “think,” “plan,” “envision,” “intend,” “continue,” “target,” “seek,” “contemplate,” “budgeted,” “will,” “would,” and the negative of such terms, other variations on such terms or other similar or comparable words, phrases, or terminology. These forward-looking statements present our estimates and assumptions only as of the date of this Quarterly Report on Form 10-Q and are subject to change.

Forward-looking statements involve risks and uncertainties and are based on the current beliefs, expectations, and certain assumptions of management. Some or all of such beliefs, expectations, and assumptions may not materialize or may vary significantly from actual results. Such statements are qualified by important economic, competitive, governmental, and technological factors that could cause our business, strategy, or actual results or events to differ materially from those in our forward-looking statements. Factors that might cause or contribute to such differences include, but are not limited to, the risk factors discussed under the heading “Risk Factors” in Part I, Item IA of our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025 (the “2024 Form 10-K”) and in subsequent reports we file with the SEC. Although we believe that the expectations reflected in our forward-looking statements are reasonable, actual results could differ materially from those projected or assumed in any of our forward-looking statements. Our future financial condition and results of operations, as well as any forward-looking statements, are subject to change, and significant risks and uncertainties that could cause actual conditions, outcomes, and results to differ materially from those indicated by such statements. Consequently, all of the forward-looking statements made in this Form 10-Q are qualified by these cautionary statements and there can be no assurance that the actual results or developments anticipated by the Company will be realized or, even if substantially realized, that they will have the expected consequence to or effects on the Company or its business or operations. The Company assumes no obligations to update any such forward-looking statements.

PART I: FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

CARDIO DIAGNOSTICS HOLDINGS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(UNAUDITED)


	September 30, 2025			December 31, 2024

ASSETS
Current assets
Cash	$	6,355,218		$	7,827,487
Accounts receivable		11,221			18,612
Prepaid expenses and other current assets		561,033			944,683

Total current assets		6,927,472			8,790,782

Long-term assets
Property and equipment, net		744,335			672,861
Right of use assets, net		303,767			432,397
Intangible assets, net		—			5,333
Deposits		12,850			12,850
Patent costs, net		800,478			701,089

Total assets	$	8,788,902		$	10,615,312

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities
Accounts payable and accrued expenses	$	150,734		$	87,661
Lease liability - current		247,714			237,270
Finance agreement payable		—			306,764

Total current liabilities		398,448			631,695

Long-term liabilities
Lease liability – long term		238,883			425,829

Total liabilities		637,331			1,057,524

Stockholders' equity
Preferred stock, $.00001 par value; authorized - 100,000,000 shares; 0 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively		—			—
Common stock, $.00001 par value; authorized - 300,000,000 shares; 1,766,607 and 1,531,468 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively*		18			15
Additional paid-in capital		35,936,185			32,309,606
Accumulated deficit		(27,784,632	)		(22,751,833	)

Total stockholders' equity		8,151,571			9,557,788

Total liabilities and stockholders' equity	$	8,788,902		$	10,615,312

Retroactively restated for thirty-for-one share consolidation on May 12, 2025.

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

CARDIO DIAGNOSTICS HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)


	THREE MONTHS ENDED SEPTEMBER 30,						NINE MONTHS ENDED SEPTEMBER 30,
	2025			2024			2025			2024

Revenue	$	2,855		$	6,580		$	11,270		$	30,378

Operating expenses
Selling, general and administrative expenses		1,714,452			1,415,547			5,032,126			6,879,853

Total operating expenses		1,714,452			1,415,547			5,032,126			6,879,853

Loss from operations		(1,711,597	)		(1,408,967	)		(5,020,856	)		(6,849,475	)

Other income (expenses)
Interest income		189			280			566			843
Interest expense		(3,128	)		(3,879	)		(12,509	)		(15,513	)

Total other income (expenses)		(2,939	)		(3,599	)		(11,943	)		(14,670	)

Loss before provision for income taxes		(1,714,536	)		(1,412,566	)		(5,032,799	)		(6,864,145	)

Provision for income taxes		—			—			—			—

Net loss	$	(1,714,536	)	$	(1,412,566	)	$	(5,032,799	)	$	(6,864,145	)

Basic and fully diluted income (loss) per common share:
Net loss per common share*	$	(0.98	)	$	(1.73	)	$	(2.91	)	$	(9.07	)

Weighted average common shares outstanding - basic and fully diluted*		1,757,900			814,762			1,727,959			757,185

Retroactively restated for thirty-for-one share consolidation on May 12, 2025.

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

CARDIO DIAGNOSTICS HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

Nine Months Ended September 30, 2025 and 2024

(UNAUDITED)


					Additional
	Common stock				Paid-in		Accumulated
	Shares*		Amount*		Capital		Deficit			Totals

Balances, December 31, 2024		1,531,468	$	15	$	32,309,606	$	(22,751,833	)	$	9,557,788

Common stock issued for cash, net of issuance costs		206,713		2		3,423,782		—			3,423,784

Restricted stock awards vested		502		—		6,000		—			6,000

Compensation for vested stock options		—		—		24,612		—			24,612

Net loss		—		—		—		(1,635,064	)		(1,635,064	)

Balances, March 31, 2025		1,738,683	$	17	$	35,764,000	$	(24,386,897	)	$	11,377,120

Restricted stock awards vested		1,559		—		6,000		—			6,000

Compensation for vested stock options		—		—		24,778		—			24,778

Fractional shares adjustment		27		—		—		—			—

Net loss		—		—		—		(1,683,199	)		(1,683,199	)

Balances, June 30, 2025		1,740,269	$	17	$	35,794,778	$	(26,070,096	)	$	9,724,699

Common stock issued for cash, net of issuance costs		26,338		1		116,645		—			116,646

Compensation for vested stock options		—		—		24,762		—			24,762

Net loss		—		—		—		(1,714,536	)		(1,714,536	)

Balances, September 30, 2025		1,766,607	$	18	$	35,936,185	$	(27,784,632	)	$	8,151,571

Balances, December 31, 2023		684,680	$	7	$	17,326,497	$	(14,368,380	)	$	2,958,124

Common stock and warrants issued for cash, net of issuance costs		34,963		—		1,722,857		—			1,722,857

Restricted stock awards vested		1,323		—		58,000		—			58,000

Compensation for vested stock options		—		—		2,461,404		—			2,461,404

Net loss		—		—		—		(4,163,584	)		(4,163,584	)

Balances, March 31, 2024		720,966	$	7	$	21,568,758	$	(18,531,964	)	$	3,036,801

Common stock issued for cash		55,822		1		1,298,698		—			1,298,699

Restricted stock awards vested		315		—		6,000		—			6,000

Compensation for vested stock options		—		—		20,731		—			20,731

Net loss		—		—		—		(1,287,995	)		(1,287,995	)

Balances, June 30, 2024		777,103	$	8	$	22,894,187	$	(19,819,959	)	$	3,074,236

Common stock issued for cash		233,473		2		2,001,895		—			2,001,897

Restricted stock awards vested		625		—		6,000		—			6,000

Compensation for vested stock options		—		—		16,618		—			16,618

Net loss		—		—		—		(1,412,566	)		(1,412,566	)

Balances, September 30, 2024		1,011,201	$	10	$	24,918,700	$	(21,232,525	)	$	3,686,185

Retroactively restated for thirty-for-one share consolidation on May 12, 2025.

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

CARDIO DIAGNOSTICS HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)


	Nine Months Ended September 30,
	2025			2024

CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(5,032,799	)	$	(6,864,145	)
Adjustments to reconcile net loss to net cash used in operating activities
Depreciation		115,843			76,341
Amortization		188,208			115,632
Stock-based compensation expense		86,152			2,568,753
Changes in operating assets and liabilities:
Accounts receivable		7,391			(9,140	)
Prepaid expenses and other current assets		383,650			846,715
Accounts payable and accrued expenses		63,073			(168,405	)
Lease liability		(176,502	)		(166,560	)

NET CASH USED IN OPERATING ACTIVITIES		(4,364,984	)		(3,600,809	)

CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property and equipment		(187,317	)		(211,127	)
Patent costs incurred		(153,634	)		(138,450	)

NET CASH USED IN INVESTING ACTIVITIES		(340,951	)		(349,577	)

CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from sale of common stock and warrants, net of issuance costs		3,540,430			5,023,453
Payments of finance agreement		(306,764	)		(374,000	)

NET CASH PROVIDED BY FINANCING ACTIVITIES		3,233,666			4,649,453

NET (DECREASE) INCREASE IN CASH		(1,472,269	)		699,067

CASH - BEGINNING OF PERIOD		7,827,487			1,283,523

CASH - END OF PERIOD	$	6,355,218		$	1,982,590

SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
Cash paid during the period for:
Interest	$	12,509		$	15,513
Income taxes	$	—		$	—

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

CARDIO DIAGNOSTICS HOLDINGS, INC.

NOTES TO CONDENSED CONSOLIDATED

FINANCIAL STATEMENTS

(UNAUDITED)

Note 1 - Organization and Basis of Presentation

The condensed 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.

Interim Financial Statements

The following (a) consolidated balance sheet as of December 31, 2024, which has been derived from audited financial statements, and (b) the unaudited condensed consolidated interim financial statements of the Company as of and for the period ended September 30, 2025 have been prepared in accordance with the instructions to Form 10-Q and Rule 8-03 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three and nine months ended September 30, 2025 are not necessarily indicative of results that may be expected for the year ending December 31, 2025 or any future periods. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2024 included in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025.

Reverse Stock Split

The Company held its 2024 annual meeting of stockholders on November 15, 2024, where the Company’s stockholders approved a reverse stock split at a ratio within a range of 1-for-5 and 1-for-40 and granted the Company’s Board of Directors the discretion to determine the timing and ratio of the split within such range.

On April 10, 2025, the Company’s Board of Directors determined to effect the reverse stock split of the common stock at a 1-for-30 ratio (the "Reverse Stock Split”) and approved the filing of a Certificate of Amendment (the "Certificate of Amendment”) to the Third Amended and Restated Certificate of Incorporation of the Company to effect the Reverse Stock Split.

On May 12, 2025, the Company filed the Certificate of Amendment with the Delaware Secretary of State to effect the Reverse Stock Split, effective immediately after the close of trading on Nasdaq on May 12, 2025 (the "Effective Time”). At the Effective Time, every 30 shares of issued and outstanding common stock automatically combined into one issued share of common stock, with no change in par value. No fractional shares were issued as a result of the Reverse Stock Split. Instead of issuing fractional shares, the Company rounded shares up or down to the nearest whole number as determined by DTC at the participant level. The Reverse Stock Split did not modify any voting rights or other terms of the common stock. The Company’s common stock began trading on a Reverse Stock Split-adjusted basis on The Nasdaq Capital Market at the open of the markets on May 13, 2025. The Reverse Stock Split was implemented for the purpose of regaining compliance with the minimum bid price requirement for continued listing of the Company’s common stock on the Nasdaq Capital Market.

As a result of the Reverse Stock Split, the number of shares of common stock outstanding was reduced from 52,160,487 shares to 1,738,683 shares, exclusive of 27 whole shares issued for rounding up fractional shares (which was issued in May 2025), and the number of authorized shares of common stock remains 300 million shares.

Unless otherwise indicated, all issued, and outstanding stock and per share amounts contained in the accompanying condensed consolidated financial statements have been adjusted to reflect the 1-for-30 Reverse Stock Split for all prior periods presented. Proportionate adjustments for the Reverse Stock Split were made to the exercise prices and number of shares issuable under the Company’s equity incentive plans, and the number of shares underlying outstanding equity awards, as applicable.

The impacts of the Reverse Stock Split were applied retroactively for all periods presented in accordance with applicable guidance, less the number of rounded whole shares issued for fractional shares on May 12, 2025. Therefore, prior period amounts are different than those previously reported. Certain amounts within the following tables may not foot due to rounding.

CARDIO DIAGNOSTICS HOLDINGS, INC.

NOTES TO CONDENSED CONSOLIDATED

FINANCIAL STATEMENTS

(UNAUDITED)

The following table illustrates changes in equity, as previously reported prior to, and as adjusted subsequent to, the impact of the Reverse Stock Split retroactively adjusted for the periods presented:

Schedule of subsequent events
	September 30, 2024
	As Previously Reported		Impact of Reverse Stock Split			As Revised
Common stock - shares		30,336,010		(29,324,809	)		1,011,201
Common stock - amount	$	303	$	(293	)	$	10
Additional paid-in capital	$	24,918,407	$	293		$	24,918,700


	June 30, 2024
	As Previously Reported		Impact of Reverse Stock Split			As Revised
Common stock - shares		23,313,070		(22,535,967	)		777,103
Common stock - amount	$	233	$	(225	)	$	8
Additional paid-in capital	$	22,893,962	$	225		$	22,894,187


	March 31, 2024
	As Previously Reported		Impact of Reverse Stock Split			As Revised
Common stock - shares		21,628,974		(20,908,008	)		720,966
Common stock - amount	$	216	$	(209	)	$	7
Additional paid-in capital	$	21,568,549	$	209		$	21,568,758


	December 31, 2024
	As Previously Reported		Impact of Reverse Stock Split			As Revised
Common stock - shares		45,944,039		(44,412,571	)		1,531,468
Common stock - amount	$	459	$	(444	)	$	15
Additional paid-in capital	$	32,309,162	$	444		$	32,309,606


	December 31, 2023
	As Previously Reported		Impact of Reverse Stock Split			As Revised
Common stock - shares		20,540,409		(19,855,729	)		684,680
Common stock - amount	$	205	$	(198	)	$	7
Additional paid-in capital	$	17,326,299	$	198		$	17,326,497

The following table illustrates changes in loss per share and weighted average shares outstanding, as previously reported prior to, and as adjusted subsequent to, the impact of the Reverse Stock Split retroactively adjusted for the periods presented:

Schedule of loss per share and weighted average shares outstanding
	Nine months ended September 30, 2024
	As Previously Reported			Impact of Reverse Stock Split			As Revised
Loss attributable to common shareholders	$	(6,864,145	)	$	—		$	(6,864,145	)
Weighted average shares used to compute basic and diluted EPS		22,715,559			(21,958,374	)		757,185
Loss per share - basic and diluted	$	(0.30	)	$	(8.77	)	$	(9.07	)


	Three months ended September 30, 2024
	As Previously Reported			Impact of Reverse Stock Split			As Revised
Loss attributable to common shareholders	$	(1,412,566	)	$	—		$	(1,412,566	)
Weighted average shares used to compute basic and diluted EPS		24,442,853			(23,628,091	)		814,762
Loss per share - basic and diluted	$	(0.06	)	$	(1.67	)	$	(1.73	)

The following shares of common stock exercisable or issuable from outstanding stock options and warrants were not included in the computation of diluted shares outstanding because the effect would be anti-dilutive:

Schedule of warrants exercisable
	Nine months ended September 30, 2024
	As Previously Reported		Impact of Reverse Stock Split			As Revised
Common stock options		3,868,970		(3,740,004	)		128,966
Common stock warrants		8,528,766		(8,244,474	)		284,292

CARDIO DIAGNOSTICS HOLDINGS, INC.

NOTES TO CONDENSED CONSOLIDATED

FINANCIAL STATEMENTS

(UNAUDITED)

Stock options were adjusted retroactively to give effect to the Reverse Stock Split for the nine months ended September 30, 2024:

Schedule of Warrants adjustment
	As Previously Reported					Impact of Reverse Stock Split					As Revised
	Options Outstanding			Weighted Average Exercise Price		Options Outstanding			Weighted Average Exercise Price		Options Outstanding			Weighted Average Exercise Price
Options outstanding at December 31, 2023		2,584,599		$	3.06		(2,498,446	)	$	88.66		86,153		$	91.72
Options granted		1,292,871		$	1.96		(1,249,775	)	$	56.97		43,096		$	58.93
Options cancelled		(8,500	)	$	2.11		8,217		$	61.19		(283	)	$

SEC Form 10-Q filed by Cardio Diagnostics Holdings Inc.