CHICAGO--(BUSINESS WIRE)--Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO), an AI-driven precision cardiovascular medicine company, announced today the nationwide rollout and a significant expansion of its groundbreaking HeartRisk™ platform. HeartRisk combines insights from HIPAA-compliant anonymized and aggregated clinical cardiovascular data obtained through Cardio Diagnostics’ Epi+Gen CHD and PrecisionCHD clinical tests, with industry and geographic data to enable real-time population-level cardiovascula ...

CHICAGO--(BUSINESS WIRE)--Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO), an AI-driven precision cardiovascular medicine company, today announced that the Company’s AI-driven epigenetic-genetic blood tests, Epi+Gen CHD and PrecisionCHD, will be available beginning Q2 2024 in a retail healthcare setting inside the Walmart Supercenter in Round Lake Beach, Illinois. Round Lake Beach, a northern suburb of Chicago in Lake County, has been chosen as the strategic starting point for this retail healthcare initi ...

CHICAGO--(BUSINESS WIRE)--Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO), an AI-driven precision cardiovascular medicine company, announces that Houston-based resTOR Longevity Clinic will integrate Cardio Diagnostics' solutions into its battery of tests for new patients in its longevity-focused concierge clinic. This collaboration marks a significant milestone for Cardio Diagnostics, as resTOR will be the first longevity clinic in America to incorporate Cardio Diagnostics' innovative blood-based epigeneti ...

CHICAGO--(BUSINESS WIRE)--Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO), an AI-driven precision cardiovascular medicine company, today announced the appointment of Dr. Vimal Ramjee, MD FACC CCMS, as a Strategic Advisor. Dr. Ramjee is a cardiologist and a health innovation leader, serving as the National Co-Chair of Cardiology and Innovation at CommonSpirit Health Enterprise and is also a member of the American Heart Association Board of Directors. The appointment of Dr. Ramjee as a Strategic Advisor t ...

Financial Performance - For the nine months ended September 30, 2023, revenue was $11,755, compared to $0 for the same period in 2022[243]. - Cardio's net loss for the nine months ended September 30, 2023, was $6,987,905, an increase of $4,704,977 from the prior year[242]. - Cardio's net loss for the three months ended September 30, 2023, was $1,932,382, compared to $1,150,875 for the same period in 2022, an increase of $781,507[226]. - Total other expenses for the nine months ended September 30, 2023, were $(1,287,444), compared to $(112,534) for the same period in 2022[248]. Expenses - Research and development expenses for the nine months ended September 30, 2023, were $137,690, up from $9,361 in the same period of 2022, reflecting an increase of $128,329[230]. - General and administrative expenses for the nine months ended September 30, 2023, were $5,444,920, compared to $2,083,460 for the same period in 2022, an increase of $3,361,460[246]. - Sales and marketing expenses for the nine months ended September 30, 2023, were $115,226, an increase of $49,653 from $65,573 in the same period of 2022[244]. - The company expects to incur additional annual expenses as a public company, including directors' and officers' liability insurance and increased legal and accounting costs[237]. Shareholder Actions - Cardio issued 231,092 common shares valued at $150,000 to independent directors during the nine months ended September 30, 2023[201]. - Stockholders approved the issuance of up to 20,363,637 shares of common stock upon conversion of $11.2 million in principal amount of convertible debentures[268]. - The first Convertible Debenture of $5.0 million has been fully converted into 10,622,119 shares, leaving 9,741,518 shares available for a second Convertible Debenture of $6.2 million[268]. - If unable to honor conversion requests, the company may need to repay outstanding principal and interest, impacting cash resources for operations and growth[268]. Liabilities - As of September 30, 2023, convertible notes payable amounted to $967,184, net of a debt discount of $732,816[208]. - The company has a liability of $928,500 owed to investment bankers due on October 25, 2023, reflecting a 30% decrease in liability to certain underwriters[222]. - Following the business combination, the company’s financial position reflects liabilities originally incurred by Mana, totaling $928,500[222]. Regulatory Compliance - The company received a Nasdaq deficiency letter indicating its common stock bid price closed below the $1.00 minimum requirement for continued listing[197]. - The company received a letter from Nasdaq indicating non-compliance with the minimum bid price requirement, with a compliance period until March 19, 2024[238]. - The FDA proposed regulations that could impose significant additional costs on the company if enacted, affecting laboratory developed tests[240]. - A proposed new FDA regulation on laboratory developed tests (LDTs) could classify them as medical devices, requiring adherence to a more stringent regulatory framework[269]. - Compliance with the proposed FDA regulation could be time-consuming and expensive, potentially diverting resources from other business aspects[269]. - The proposed regulation may hinder the company's ability to introduce new tests to the market in a timely manner, affecting competitive position and market share[269]. - Failure to comply with FDA regulations could result in legal actions, including fines and penalties, impacting financial performance[269]. Business Strategy - Cardio aims to develop blood-based products for stroke, heart failure, and diabetes, and expand testing processes to multiple laboratories[221]. - The company plans to pursue acquisitions in the telemedicine, AI, or remote patient monitoring sectors[221]. - Cardio's strategy includes building clinical and health economics evidence to obtain payer reimbursement for its tests[221]. Share Redemption - The company experienced a redemption rate of over 99%, with 6,465,452 shares redeemed for a total of $65,310,892 at approximately $10.10 per share[196].

Part I — Financial Information [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for the period ended June 30, 2023, show a significant increase in net loss, minimal revenue, and improved cash from convertible notes, with details provided across key financial statements and notes [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2023, total assets increased to $6.76 million, total liabilities grew significantly to $3.85 million due to convertible notes and derivative liability, and total stockholders' equity decreased to $2.91 million Condensed Consolidated Balance Sheet Data (unaudited) | Account | June 30, 2023 ($) | December 31, 2022 ($) | | :--- | :--- | :--- | | **Total Assets** | **6,756,904** | **6,249,478** | | Cash | 5,044,328 | 4,117,521 | | **Total Liabilities** | **3,848,380** | **1,947,770** | | Convertible notes payable, net | 915,202 | — | | Derivative liability | 1,998,752 | — | | **Total Stockholders' Equity** | **2,908,524** | **4,301,708** | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported minimal revenue of $1,725, with net loss widening substantially to $4.02 million for the quarter and $5.06 million for the six-month period, primarily due to increased general and administrative expenses and non-cash interest expenses from convertible debt Statement of Operations Highlights (unaudited) | Metric | Three Months Ended June 30, 2023 ($) | Three Months Ended June 30, 2022 ($) | Six Months Ended June 30, 2023 ($) | Six Months Ended June 30, 2022 ($) | | :--- | :--- | :--- | :--- | :--- | | Revenue | 1,725 | — | 1,725 | — | | Total operating expenses | 2,554,866 | 786,964 | 4,257,995 | 1,019,519 | | General and administrative expenses | 2,506,148 | 751,117 | 4,068,276 | 956,144 | | Loss from operations | (2,553,141) | (786,964) | (4,256,270) | (1,019,519) | | Net loss | (4,022,905) | (841,998) | (5,055,523) | (1,132,053) | | Net loss per common share | (0.39) | (0.16) | (0.51) | (0.23) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2023, net cash used in operating activities increased to $2.94 million, while net cash provided by financing activities was $4.01 million, resulting in a $0.93 million increase in the cash balance to $5.04 million Cash Flow Summary (unaudited) | Cash Flow Activity | Six Months Ended June 30, 2023 ($) | Six Months Ended June 30, 2022 ($) | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | (2,941,899) | (580,862) | | Net Cash Used in Investing Activities | (140,273) | (38,606) | | Net Cash Provided by Financing Activities | 4,008,979 | 9,766,727 | | **Net Increase (Decrease) in Cash** | **926,807** | **9,147,259** | | **Cash - End of Period** | **5,044,328** | **9,660,026** | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's October 2022 reverse recapitalization, significant accounting policies including fair value measurements for derivative liabilities, specifics on March 2023 convertible debenture financing, and discussions of commitments and contingencies including disputes with former placement agents - The company completed a business combination with Mana Capital Acquisition Corp. on October 25, 2022, which was accounted for as a reverse recapitalization Legacy Cardio is the accounting predecessor[10](index=10&type=chunk)[49](index=49&type=chunk)[50](index=50&type=chunk) - On March 8, 2023, the company entered into a securities purchase agreement with Yorkville to sell convertible debentures for **up to $11.2 million** The **first tranche of $5.0 million** was issued on the same day[98](index=98&type=chunk)[127](index=127&type=chunk)[128](index=128&type=chunk) - The conversion features of the convertible notes are treated as a derivative liability, recorded at fair value The initial fair value of the derivative exceeded the note's face value, resulting in an **immediate charge to interest expense of $4.69 million**[101](index=101&type=chunk)[130](index=130&type=chunk) - The company is in disputes with Boustead Securities over a terminated placement agent agreement and with The Benchmark Company over a right of first refusal for financing activities No legal proceedings have been initiated for these matters[102](index=102&type=chunk)[105](index=105&type=chunk)[132](index=132&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's strategy to commercialize epigenetics-based cardiovascular tests, highlighting the minimal cash proceeds from the October 2022 business combination, the substantial increase in net loss due to higher G&A and interest expenses, and the ongoing reliance on recent convertible debt financing for liquidity and future capital needs - The company's strategy focuses on developing and commercializing epigenetics-based clinical tests for cardiovascular diseases like CHD, stroke, and heart failure[139](index=139&type=chunk)[160](index=160&type=chunk) - The business combination resulted in over 99.5% of Mana's public shares being redeemed, providing **only $4,021 in cash** from the SPAC trust account, significantly impacting the company's capital and growth plans[142](index=142&type=chunk)[196](index=196&type=chunk) - The company's principal source of liquidity has shifted from equity issuances to convertible debt, specifically a March 2023 agreement with Yorkville for **up to $11.2 million**[153](index=153&type=chunk)[174](index=174&type=chunk) Results of Operations Comparison (Six Months Ended June 30) | Metric | 2023 ($) | 2022 ($) | Change ($) | | :--- | :--- | :--- | :--- | | Revenue | 1,725 | — | 1,725 | | General & administrative expenses | 4,068,276 | 956,144 | 3,112,132 | | Total operating expenses | 4,257,995 | 1,019,519 | 3,238,476 | | Net loss | (5,055,523) | (1,132,053) | (3,923,470) | [Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," Cardio Diagnostics Holdings, Inc. is **not required to provide** the information for this item - The company is a "smaller reporting company" and is therefore **not required to provide** quantitative and qualitative disclosures about market risk[236](index=236&type=chunk) [Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were **not effective as of June 30, 2023**, though they believe the financial statements in the Form 10-Q are fairly presented after additional analyses - Management concluded that the company's disclosure controls and procedures were **not effective as of June 30, 2023**[192](index=192&type=chunk) - **No changes were made** to the internal control over financial reporting during the six months ended June 30, 2023, that materially affected, or are reasonably likely to materially affect, internal controls[237](index=237&type=chunk) Part II — Other Information [Legal Proceedings](index=26&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is **not involved in any material legal proceedings** as of June 30, 2023 - As of June 30, 2023, the company is **not involved in any material legal proceedings**[238](index=238&type=chunk) [Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) **No material changes to risk factors** have occurred since the last Annual Report on Form 10-K for the fiscal year ended December 31, 2022 - **No material changes to risk factors** have occurred since the last Annual Report on Form 10-K[239](index=239&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=26&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported **no unregistered sales of equity securities** during the period - There were **no unregistered sales of equity securities** to report for the period[219](index=219&type=chunk) [Other Information](index=26&type=section&id=Item%205.%20Other%20Information) The company entered into two new operating lease agreements effective August 1, 2023, for medical laboratory and office space in Iowa City for **five years and four months**, and for office space in Chicago for a **40-month term** - On July 20, 2023, the company entered into a **five-year, four-month lease** for medical lab and office space in Iowa City, Iowa, with rent commencing December 1, 2023[222](index=222&type=chunk)[240](index=240&type=chunk) - On June 15, 2023, the company entered into a **40-month lease** for office space in Chicago, Illinois, with rent commencing December 1, 2023[225](index=225&type=chunk)[243](index=243&type=chunk) [Exhibits](index=28&type=section&id=Item%206.%20Exhibits) **A list of all exhibits** filed as part of the Quarterly Report on Form 10-Q is provided, including merger agreements, corporate governance documents, financing agreements, new lease agreements, and officer certifications - **A list of all exhibits** filed with or incorporated by reference into the Form 10-Q is provided[229](index=229&type=chunk)[246](index=246&type=chunk)

Part I [Part I — Financial Information](index=5&type=section&id=Part%20I%20%E2%80%94%20Financial%20Information) This section presents the unaudited financial statements, management's discussion and analysis, and disclosures on controls and market risks for the reporting period [Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) The company presents its unaudited condensed consolidated financial statements for the quarter ended March 31, 2023, reflecting a **net loss of $1.03 million** and a cash position of **$6.7 million** [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The condensed consolidated balance sheets present the company's financial position, showing **total assets of $8.55 million** and **total liabilities of $5.13 million** as of March 31, 2023 Condensed Consolidated Balance Sheet Summary (unaudited) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $6,707,770 | $4,117,521 | | Total current assets | $8,138,031 | $5,885,887 | | **Total assets** | **$8,551,611** | **$6,249,478** | | **Liabilities & Equity** | | | | Total liabilities | $5,129,496 | $1,947,770 | | Total stockholders' equity | $3,422,115 | $4,301,708 | | **Total liabilities and stockholders' equity** | **$8,551,611** | **$6,249,478** | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The condensed consolidated statements of operations report a **net loss of $1.03 million** for the three months ended March 31, 2023, with no revenue generated Condensed Consolidated Statement of Operations (unaudited) | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Revenue | $0 | $0 | | Total operating expenses | $1,703,129 | $232,555 | | **Net loss** | **$(1,032,618)** | **$(290,055)** | | Net loss per common share | $(0.11) | $(0.07) | | Weighted average common shares outstanding | 9,547,177 | 4,223,494 | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) The condensed consolidated statements of cash flows show a **net increase in cash of $2.59 million** for the three months ended March 31, 2023, primarily from financing activities Condensed Consolidated Statement of Cash Flows Summary (unaudited) | Cash Flow Activity | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,649,067) | $(186,090) | | Net cash used in investing activities | $(52,674) | $(16,436) | | Net cash provided by financing activities | $4,291,990 | $0 | | **Net increase (decrease) in cash** | **$2,590,249** | **$(202,526)** | | Cash - End of period | $6,707,770 | $310,241 | [Notes to Financial Statements](index=9&type=section&id=Notes%20to%20Financial%20Statements) The notes provide detailed information on significant accounting policies, recent business combinations, convertible debenture financing, and various commitments and contingencies - The company completed a business combination with Mana Capital Acquisition Corp. on October 25, 2022, accounted for as a **reverse recapitalization**, with Legacy Cardio as the accounting acquirer[54](index=54&type=chunk)[55](index=55&type=chunk) - On March 8, 2023, the company issued a convertible debenture to Yorkville (YA II PN, Ltd.) for a principal amount of **$5.0 million**, yielding **$4.5 million** in net proceeds after a **$500,000** original issue discount[100](index=100&type=chunk)[102](index=102&type=chunk) - The convertible note's conversion feature was bifurcated and recorded as a derivative liability at a fair value of **$9.19 million** at inception, with the **$4.69 million** excess over face value recognized as interest expense[104](index=104&type=chunk)[63](index=63&type=chunk) - The company faces several commitments and contingencies, including a right of first refusal for future offerings, a dispute with a former placement agent, and a demand letter regarding S-4 Registration Statement disclosures[108](index=108&type=chunk)[110](index=110&type=chunk)[112](index=112&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial performance, highlighting a **net loss of $1.03 million** for Q1 2023, primarily due to increased general and administrative expenses, with liquidity boosted by a **$4.5 million** convertible debenture financing [Overview and Strategy](index=19&type=section&id=Overview%20and%20Strategy) Cardio's primary objective is to develop and commercialize AI-driven, epigenetics-based clinical tests for cardiovascular diseases, supported by a growth strategy focused on new products and market expansion - Cardio's primary objective is to develop and commercialize **AI-driven, epigenetics-based clinical tests** for cardiovascular diseases such as coronary heart disease, stroke, and heart failure[119](index=119&type=chunk) - The company's growth strategy focuses on developing new products, building clinical evidence for payer reimbursement, expanding its laboratory network, and pursuing synergistic acquisitions[126](index=126&type=chunk) [Results of Operations](index=21&type=section&id=Results%20of%20Operations) The results of operations show a **net loss of $1.03 million** for Q1 2023, primarily driven by increased general and administrative expenses and partially offset by a non-cash gain from derivative liability Results of Operations Comparison (Q1 2023 vs Q1 2022) | Line Item | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Revenue | $0 | $0 | | Sales and marketing | $49,551 | $22,398 | | Research and development | $86,665 | $1,130 | | General and administrative | $1,562,128 | $205,027 | | **Net Loss** | **$(1,032,618)** | **$(290,055)** | - General and administrative expenses increased by **$1.36 million** year-over-year, mainly due to higher personnel, legal, and accounting costs as a public company and for financing activities[136](index=136&type=chunk) - Total other income was **$670,511**, primarily from a **$5.69 million** non-cash gain on derivative liability fair value change, partially offset by **$5.02 million** in mostly non-cash interest expense[138](index=138&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity was primarily boosted by a **$4.5 million** convertible debenture, but it faces an ongoing need for additional capital due to minimal proceeds from the business combination and expected low warrant exercise cash - The company's principal liquidity source was a **$5.0 million** convertible debenture, yielding **$4.5 million** in cash, with an additional **$6.2 million** debenture planned for Q2 2023 pending approval[141](index=141&type=chunk) - The Business Combination yielded only **$4,021** in cash due to a **~99.5% redemption rate**, delaying growth and acquisition strategies[123](index=123&type=chunk)[145](index=145&type=chunk) - The company has an ongoing need to raise additional capital to fund operations and expansion, having incurred losses since inception[147](index=147&type=chunk)[149](index=149&type=chunk) - Management does not expect significant cash proceeds from warrant exercises, as the current stock price is well below the **$3.90 to $11.50** per share exercise prices[150](index=150&type=chunk) [Critical Accounting Policies](index=26&type=section&id=Critical%20Accounting%20Policies) The company's critical accounting policies involve significant judgments and estimates in areas such as fair value measurements, revenue recognition, patent costs, and stock-based compensation - The company's critical accounting policies involve significant judgments and estimates, particularly in **Fair Value Measurements, Revenue Recognition, Patent Costs, and Stock-Based Compensation**[171](index=171&type=chunk)[174](index=174&type=chunk)[178](index=178&type=chunk)[180](index=180&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is not required to provide quantitative and qualitative disclosures about market risk as it qualifies as a "smaller reporting company" - The company is not required to provide quantitative and qualitative disclosures about market risk as it qualifies as a "smaller reporting company" under SEC rules[182](index=182&type=chunk) [Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were **not effective** as of the end of the quarter, with no material changes to internal control over financial reporting - Based on an evaluation as of the end of the quarter, the company's principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were **not effective**[182](index=182&type=chunk) - There were no changes in the company's internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[185](index=185&type=chunk) Part II [Part II — Other Information](index=29&type=section&id=Part%20II%20%E2%80%94%20Other%20Information) This section covers legal proceedings, risk factors, unregistered sales of equity, defaults, other information, and a list of exhibits [Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) As of March 31, 2023, the company is not involved in any material legal proceedings impacting its ongoing operations - As of March 31, 2023, the company is not involved in any material legal proceedings[188](index=188&type=chunk) [Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) The company highlights significant risks of potential dilution from future issuance of a large number of common shares, including those from warrants, options, and convertible debentures, which could depress stock price - Future sales of a large number of common shares in the public market, or the perception thereof, could cause the stock price to decline, with several effective registration statements covering millions of shares for resale and warrant exercise[190](index=190&type=chunk)[191](index=191&type=chunk)[193](index=193&type=chunk) - A significant number of shares are subject to issuance upon the exercise of outstanding warrants and options, and the conversion of convertible debentures, potentially causing **substantial dilution** to existing security holders[1](index=1&type=chunk)[5](index=5&type=chunk) Outstanding Dilutive Securities | Security Type | Number of Shares/Units | Exercise/Conversion Price Range | | :--- | :--- | :--- | | Public Warrants | 3,249,993 | $11.50 | | Sponsor Warrants | 2,500,000 | $11.50 | | Exchanged Options | 1,759,600 | $3.90 | | Legacy Private Placement Warrants | 2,104,627 | $3.90 - $6.21 | | Convertible Debentures (Principal) | $11.2 million (potential total) | Variable, based on stock price | [Unregistered Sales of Equity Securities and Use of Proceeds](index=31&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds during the reporting period - No unregistered sales of equity securities or use of proceeds were reported[7](index=7&type=chunk) [Defaults upon Senior Securities](index=31&type=section&id=Item%203.%20Defaults%20upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - No defaults upon senior securities were reported[8](index=8&type=chunk) [Other Information](index=31&type=section&id=Item%205.%20Other%20Information) The company reported no other material information for the period - No other information was reported[8](index=8&type=chunk) [Exhibits](index=31&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report, including the Agreement and Plan of Merger, corporate governance documents, warrant agreements, and convertible debenture financing agreements - The report includes a list of exhibits filed or incorporated by reference, such as the Agreement and Plan of Merger, corporate governance documents, warrant agreements, convertible debenture agreements, and Officer Certifications[10](index=10&type=chunk)[6](index=6&type=chunk)

Sales and Marketing for Epi+Gen CHD™ and PrecisionCHD™ with a Focus on Strategic Channel Partnerships Bundling Epi+Gen CHD™, PrecisionCHD™ and future Cardio solutions alongside complementary clinical, analytics, treatment pathways, and services-consulting for primary prevention optimization with key partners expands the ROI of the investment in our solutions. Hiring and Talent to Accelerate Growth Our growth strategy will require investment in internal and external healthcare enterprise sales, marketing and ...

[PART I: FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%3A%20FINANCIAL%20INFORMATION) This section presents the unaudited financial statements of Cardio Diagnostics Holdings, Inc. for the period ended September 30, 2022, reflecting its SPAC status prior to business combination [Financial Statements (Unaudited)](index=5&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS%20(UNAUDITED)) The unaudited financial statements for the period ended September 30, 2022, reflect the company's pre-business combination SPAC status, showing a net loss and assets primarily in a trust account Balance Sheet Summary (as of Sept 30, 2022 vs. Dec 31, 2021) | Metric | September 30, 2022 (Unaudited) | December 31, 2021 (Audited) | | :--- | :--- | :--- | | Cash | $177,681 | $526,625 | | Investments held in Trust Account | $65,573,383 | $65,000,484 | | **Total Assets** | **$65,801,435** | **$65,807,166** | | Total Liabilities | $631,748 | $124,434 | | Common stock subject to possible redemption | $65,523,383 | $65,000,000 | | Total Stockholders' Equity (Deficit) | ($353,696) | $682,732 | Statement of Operations Summary | Metric | Three Months Ended Sept 30, 2022 | Nine Months Ended Sept 30, 2022 | | :--- | :--- | :--- | | Loss from Operations | ($165,291) | ($890,962) | | Investment income on Trust Account | $367,387 | $377,637 | | **Net Income (Loss)** | **$202,269** | **($513,045)** | | Basic and diluted net income (loss) per share | $0.02 | ($0.06) | - The business combination with Legacy Cardio was consummated on **October 25, 2022**, subsequent to this reporting period, with holders of **6,465,452 shares** redeeming their stock for approximately **$65.3 million**[29](index=29&type=chunk)[98](index=98&type=chunk) - To extend the time for business combination, the company received loans totaling **$433,334** from Legacy Cardio, which were deposited into the Trust Account and converted into common stock upon the merger's closing[82](index=82&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management's discussion confirms the company operated as a blank check company with no revenue, with net loss driven by organizational costs and income from trust account interest - The company's activities from inception to **September 30, 2022**, were limited to organizational tasks, the IPO, and identifying and negotiating the business combination with Legacy Cardio[116](index=116&type=chunk) Results of Operations Analysis | Period | Net Income / (Loss) | Key Drivers | | :--- | :--- | :--- | | **Q3 2022** | $202,269 | Interest income of $367,387 from the Trust Account offset operating/franchise tax expenses of $215,291 | | **Nine Months 2022** | ($513,045) | Operating/franchise tax expenses of $1,040,962 exceeded interest income of $377,637 from the Trust Account | - As of **September 30, 2022**, the company had **$177,681** in cash held outside the Trust Account for working capital purposes, and received **$433,334** in loans from Legacy Cardio to fund extensions, which were deposited into the Trust Account[122](index=122&type=chunk)[123](index=123&type=chunk)[124](index=124&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=24&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) The company is exempt from market risk disclosures as it qualifies as a smaller reporting company under SEC regulations - As a **"smaller reporting company,"** the company is exempt from the disclosure requirements of Item 305(e) of Regulation S-K regarding market risk[132](index=132&type=chunk) [Controls and Procedures](index=24&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management concluded that the company's disclosure controls and procedures were not effective as of September 30, 2022, but financial statements are fairly stated - Management concluded that the company's disclosure controls and procedures were **not effective** as of **September 30, 2022**[133](index=133&type=chunk) - No changes were made to the internal control over financial reporting during the nine months ended **September 30, 2022**, that materially affected, or are reasonably likely to materially affect, internal controls[136](index=136&type=chunk) [PART II: OTHER INFORMATION](index=25&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, use of IPO proceeds, and exhibits, confirming no defaults or mine safety issues [Legal Proceedings](index=25&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company reported no legal proceedings - There are no legal proceedings to report[136](index=136&type=chunk) [Risk Factors](index=25&type=section&id=ITEM%201A.%20RISK%20FACTORS) No material changes to risk factors were reported from previous disclosures in the 2021 Form 10-K and Form S-4 registration statement - The company states there have been **no material changes** to the risk factors previously disclosed in its **2021 Form 10-K** and its **Form S-4** registration statement[137](index=137&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=25&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) This section details the use of **$65 million** IPO proceeds placed in a trust account and **$2.5 million** from private placement warrants for working capital - Gross proceeds of **$65 million** were generated from the IPO and over-allotment option exercise, which were placed in a U.S.-based Trust Account[138](index=138&type=chunk)[139](index=139&type=chunk) - Simultaneously with the IPO, **2,500,000 private warrants** were sold to the Sponsor at **$1.00 per warrant**, generating **$2.5 million** under a registration exemption[139](index=139&type=chunk) - Net proceeds of approximately **$900,000** were available for working capital after transaction costs, and were used for expenses related to searching for and negotiating a Business Combination[141](index=141&type=chunk) [Defaults Upon Senior Securities](index=26&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) The company reported no defaults upon senior securities - There are no defaults upon senior securities to report[144](index=144&type=chunk) [Mine Safety Disclosures](index=26&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) The company reported no mine safety disclosures - This item is not applicable to the company[145](index=145&type=chunk) [Other Information](index=26&type=section&id=ITEM%205.%20OTHER%20INFORMATION) The company reported no other information - There is no other information to report[145](index=145&type=chunk) [Exhibits](index=27&type=section&id=ITEM%206.%20EXHIBITS) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including officer certifications and Inline XBRL documents - The exhibits filed with this report include certifications from the Principal Executive Officer and Principal Accounting Officer under **Sections 302 and 906 of the Sarbanes-Oxley Act**, as well as Inline XBRL data files[148](index=148&type=chunk)

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 June 30, 2022 ☐ 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 Mana Capital Acquisition Corp. (Exact name of registrant as specified in its charter) | --- | --- | |------------- ...