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Cardio Diagnostics Holdings, Inc. Expands Provider Network, Adding 15 New Provider Organizations From Across the United States
Businesswire· 2025-10-21 12:35
CHICAGO--(BUSINESS WIRE)--Cardio Diagnostics Holdings, Inc. today announced the Company has partnered with 15 new provider organizations across the United States. ...
Cardio Diagnostics (CDIO) - 2025 Q2 - Quarterly Report
2025-08-14 20:16
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, 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 311 West Superior Street, Suite 444 Chicago, Illinois 60654 (Address of principal executive offices) (Zip Code) C ...
Cardio Diagnostics (CDIO) - 2025 Q1 - Quarterly Report
2025-05-15 20:20
Part I — Financial Information [Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) The company's unaudited Q1 2025 financial statements show a net loss of **$1.64 million**, a significant reduction from **$4.16 million** in Q1 2024, with cash and assets increasing after a reverse stock split Condensed Consolidated Balance Sheets (unaudited) | | March 31, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | **Total current assets** | **$10.54 million** | **$8.79 million** | | **Total assets** | **$12.28 million** | **$10.62 million** | | **Total current liabilities** | **$0.54 million** | **$0.63 million** | | **Total liabilities** | **$0.90 million** | **$1.06 million** | | **Total stockholders' equity** | **$11.38 million** | **$9.56 million** | Condensed Consolidated Statements of Operations (unaudited) | | Three Months Ended March 31, 2025 ($) | Three Months Ended March 31, 2024 ($) | | :--- | :--- | :--- | | **Revenue** | **$940** | **$15.93 thousand** | | **Total operating expenses** | **$1.63 million** | **$4.17 million** | | **Loss from operations** | **($1.63 million)** | **($4.16 million)** | | **Net loss** | **($1.64 million)** | **($4.16 million)** | | **Net loss per common share** | **($0.97)** | **($5.93)** | Condensed Consolidated Statements of Cash Flows (unaudited) | | Three Months Ended March 31, 2025 ($) | Three Months Ended March 31, 2024 ($) | | :--- | :--- | :--- | | **Net cash used in operating activities** | **($1.40 million)** | **($1.23 million)** | | **Net cash used in investing activities** | **($47.42 thousand)** | **($69.94 thousand)** | | **Net cash provided by financing activities** | **$3.31 million** | **$1.58 million** | | **Net increase in cash** | **$1.86 million** | **$279.62 thousand** | | **Cash - End of period** | **$9.69 million** | **$1.56 million** | - On May 12, 2025, the company executed a 1-for-30 reverse stock split to regain compliance with Nasdaq's minimum bid price requirement. All share and per-share amounts in the financial statements have been retroactively adjusted[35](index=35&type=chunk)[37](index=37&type=chunk)[111](index=111&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the significant reduction in Q1 2025 net loss to **$1.64 million**, driven by lower stock-based compensation, and highlights the company's focus on commercializing AI-driven cardiovascular tests and securing **$14.68 million** in ATM financing - The company's primary business is developing and commercializing AI-driven, epigenetics-based clinical tests for cardiovascular diseases like coronary heart disease (CHD), stroke, and heart failure[118](index=118&type=chunk)[119](index=119&type=chunk) - The significant decrease in net loss for Q1 2025 compared to Q1 2024 was primarily driven by a **$2.58 million** reduction in General and Administrative expenses, largely due to lower stock compensation expense (**$30.61 thousand** in Q1 2025 vs. **$2.52 million** in Q1 2024)[131](index=131&type=chunk)[136](index=136&type=chunk) - As of May 15, 2025, the company has raised **$14.68 million** in net proceeds from its At-the-Market (ATM) sales agreement, which serves as a primary source of liquidity[126](index=126&type=chunk)[144](index=144&type=chunk) - Management anticipates that existing funds will be sufficient to fund activities for the next 12 months, but acknowledges the need to raise additional capital through equity or debt to support operations beyond that period[151](index=151&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," the company is not required to provide quantitative and qualitative disclosures about market risk - Pursuant to Item 305(e) of Regulation S-K, the Company is not required to provide market risk disclosures as it qualifies as a "smaller reporting company"[176](index=176&type=chunk) [Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were ineffective as of March 31, 2025, due to a material weakness in internal control over financial reporting, with remediation plans in progress - Management identified a material weakness in internal control over financial reporting: inadequate segregation of duties within the financial reporting process due to limited staff resources[179](index=179&type=chunk) - Remediation plans are in progress and include developing a formalized approval matrix for significant financial transactions and exploring the automation of key accounting processes[180](index=180&type=chunk)[183](index=183&type=chunk) Part II — Other Information [Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) As of March 31, 2025, the company is not a party to any litigation deemed material to its ongoing operations - The Company reports that it is not a party to any material litigation as of the period ended March 31, 2025[185](index=185&type=chunk) [Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the risk factors previously disclosed in the company's 2024 Annual Report on Form 10-K have been reported - No material changes to the risk factors from the company's 2024 Annual Report on Form 10-K have been reported[186](index=186&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=39&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 quarter - None reported for the period[187](index=187&type=chunk) [Other Information](index=39&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, modified, or terminated a Rule 10b-5 trading arrangement during the fiscal quarter ended March 31, 2025 - No directors or officers adopted, modified, or terminated a Rule 10b-5 trading arrangement during the quarter[190](index=190&type=chunk) [Exhibits](index=39&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Quarterly Report on Form 10-Q, including required officer certifications - The report includes a list of filed exhibits, such as the Agreement and Plan of Merger, Certificate of Incorporation, and various officer certifications required by the Sarbanes-Oxley Act[191](index=191&type=chunk)[192](index=192&type=chunk)[193](index=193&type=chunk)
Cardio Diagnostics (CDIO) - 2024 Q4 - Annual Report
2025-03-20 20:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-41097 Redeemable warrants, each warrant exercisable for one share of common stock CDIOW The Nasdaq Stock Market LLC CARDIO DIAGNOSTICS HOLD ...
Cardio Diagnostics (CDIO) - 2024 Q3 - Quarterly Report
2024-11-13 21:21
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, 2024 ☐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) | --- | --- | --- | |- ...
Cardio Diagnostics (CDIO) - 2024 Q2 - Quarterly Report
2024-08-12 20:30
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, 2024 ☐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) | --- | --- | --- | |------ ...
Cardio Diagnostics (CDIO) - 2024 Q1 - Quarterly Report
2024-05-15 20:30
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 March 31, 2024 ☐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 ...
Cardio Diagnostics (CDIO) - 2023 Q4 - Annual Report
2024-04-01 21:15
PART I [Business Overview](index=3&type=section&id=Item%201.%20Business) Cardio Diagnostics develops AI-driven genetic-epigenetic tests for proactive cardiovascular disease management - Cardio Diagnostics was founded in 2017 to develop and commercialize AI-driven DNA biomarker testing technology for cardiovascular diseases, aiming to transform care from reactive to proactive[107](index=107&type=chunk)[108](index=108&type=chunk)[332](index=332&type=chunk) - The company's core technology, the AI-driven Integrated Genetic-Epigenetic Engine™, enables rapid development of diagnostic solutions by identifying robust genetic and epigenetic biomarkers[108](index=108&type=chunk)[131](index=131&type=chunk)[132](index=132&type=chunk) - Key products include Epi+Gen CHD™ (three-year symptomatic CHD risk assessment), PrecisionCHD™ (early detection of coronary heart disease), and HeartRisk™ (a cardiovascular risk intelligence platform)[119](index=119&type=chunk)[133](index=133&type=chunk)[146](index=146&type=chunk) - Cardio's strategy involves building compelling evidence, engaging experts and stakeholders, prioritizing strategic acquisitions, pursuing payor coverage, and evaluating FDA pathways[110](index=110&type=chunk) - The company has secured an Innovative Technology Contract from Vizient, Inc., covering over **60% of U.S. hospitals**, and an agreement with Family Medicine Specialists to test at least **1,200 patients**[119](index=119&type=chunk)[183](index=183&type=chunk) - Cardio holds **five patent families**, including issued patents in multiple countries and numerous pending applications, protecting methods and compositions for detecting cardiovascular disease and diabetes biomarkers[202](index=202&type=chunk)[209](index=209&type=chunk)[215](index=215&type=chunk) [Company Overview](index=6&type=section&id=Company%20Overview) [Industry Background](index=7&type=section&id=Industry%20Background) [Our Strategy](index=9&type=section&id=Our%20Strategy) [Our Technology](index=10&type=section&id=Our%20Technology) [Our Products and Services](index=11&type=section&id=Our%20Products%20and%20Services) [Our Market Opportunity](index=15&type=section&id=Our%20Market%20Opportunity) [Go-To-Market Strategy for Epi+Gen CHD™ and PrecisionCHD™](index=16&type=section&id=Go-To-Market%20Strategy%20for%20Epi%2BGen%20CHD%E2%84%A2%20and%20PrecisionCHD%E2%84%A2) [Our Competitive Strengths](index=18&type=section&id=Our%20Competitive%20Strengths) [Competition](index=19&type=section&id=Competition) [Intellectual Property](index=21&type=section&id=Intellectual%20Property) [Government Regulation](index=23&type=section&id=Government%20Regulation) [Employees and Human Capital Resources](index=29&type=section&id=Employees%20and%20Human%20Capital%20Resources) [Corporation Information](index=29&type=section&id=Corporation%20Information) [Emerging Growth Status](index=29&type=section&id=Emerging%20Growth%20Status) [Available Information](index=30&type=section&id=Available%20Information) [Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) Cardio Diagnostics faces risks from its limited operating history, unproven business model, intense competition, and regulatory changes - The company has a limited operating history, generated nominal revenue (**$17,065 in 2023**), and incurred significant net losses (**$8,376,834 in 2023**), raising substantial doubt about its ability to continue as a going concern[85](index=85&type=chunk)[299](index=299&type=chunk)[342](index=342&type=chunk) - The market for epigenetic tests is new and unproven, and the company's business model is unproven, making future growth and profitability uncertain[353](index=353&type=chunk)[354](index=354&type=chunk)[355](index=355&type=chunk) - Cardio relies on a limited number of suppliers, contract manufacturers, and a single CLIA laboratory, posing risks of supply chain interruptions and delays[373](index=373&type=chunk)[378](index=378&type=chunk) - The FDA is considering reclassifying Laboratory-Developed Tests (LDTs) as medical devices, which could subject Cardio's tests to stringent premarket clearance/approval and post-market controls, incurring substantial costs and delays[34](index=34&type=chunk)[257](index=257&type=chunk)[236](index=236&type=chunk) - Obtaining adequate coverage and reimbursement from third-party payors for its tests is a challenging, time-consuming, and costly process, which is critical for commercial success and widespread adoption[263](index=263&type=chunk)[283](index=283&type=chunk)[284](index=284&type=chunk) - The company's intellectual property, including core technology licensed from UIRF, could be subject to termination if obligations are breached or if unaffiliated third parties gain access to technical information for competitive products[23](index=23&type=chunk)[25](index=25&type=chunk)[419](index=419&type=chunk)[452](index=452&type=chunk) - Compliance with federal and state privacy and security regulations (e.g., HIPAA, CCPA, CPRA) for personally identifiable and protected health information is critical, with potential for significant liability and reputational harm from breaches or non-compliance[449](index=449&type=chunk)[461](index=461&type=chunk)[474](index=474&type=chunk) [Risk Factor Summary](index=5&type=section&id=Risk%20Factor%20Summary) [Risks Related to Our Limited Operating History and Early Stage of Growth](index=30&type=section&id=Risks%20Related%20to%20Our%20Limited%20Operating%20History%20and%20Early%20Stage%20of%20Growth) [Risks Related to Our Business and Industry](index=34&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) [Risks Related to Our Business Operations](index=38&type=section&id=Risks%20Related%20to%20Our%20Business%20Operations) [Risks Related to Our Intellectual Property](index=40&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) [Risks Related to Government Regulation](index=42&type=section&id=Risks%20Related%20to%20Government%20Regulation) [Risks Related to Customer Privacy, Cybersecurity and Data](index=45&type=section&id=Risks%20Related%20to%20Customer%20Privacy%2C%20Cybersecurity%20and%20Data) [General Risks Affecting Our Company](index=46&type=section&id=General%20Risks%20Affecting%20Our%20Company) [Risks Related to Our Securities](index=47&type=section&id=Risks%20Related%20to%20Our%20Securities) [Unresolved Staff Comments](index=50&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company has no unresolved staff comments to report - The company states that Item 1B is not applicable, indicating no unresolved staff comments[541](index=541&type=chunk) [Cybersecurity](index=50&type=section&id=Item%201C.%20Cybersecurity) Cardio Diagnostics' cybersecurity program, governed by SOC2 and HIPAA, integrates risk management and incident response - Cardio's cybersecurity program is governed by SOC2 and HIPAA frameworks, focusing on identifying, assessing, responding to, and managing cybersecurity risks[532](index=532&type=chunk)[542](index=542&type=chunk) - Key components of the program include skilled information security personnel, external service providers, employee training, periodic policy reviews, and an incident response plan[543](index=543&type=chunk)[544](index=544&type=chunk) - The company has not identified any material risks from known cybersecurity threats that have impacted or are reasonably likely to impact its business[545](index=545&type=chunk) - The Board of Directors oversees cybersecurity risk, with management providing periodic reports on material threats[546](index=546&type=chunk)[547](index=547&type=chunk) [Risk Management and Strategy](index=54&type=section&id=Risk%20Management%20and%20Strategy) [Governance](index=54&type=section&id=Governance) [Properties](index=51&type=section&id=Item%202.%20Properties) Cardio Diagnostics leases its principal executive offices in Chicago and a laboratory in Iowa City under multi-year agreements - The company leases its principal executive offices in Chicago, IL, for approximately **$13,000 per month**, with a **three-year term** commencing December 1, 2023[550](index=550&type=chunk) - A laboratory is leased in Iowa City, IA, for approximately **$8,505 per month**, with a **five-year term** also commencing December 1, 2023[550](index=550&type=chunk) [Legal Proceedings](index=51&type=section&id=Item%203.%20Legal%20Proceedings) Cardio Diagnostics is not currently a party to any material litigation or other legal proceedings - The company is not currently involved in any material litigation or legal proceedings[551](index=551&type=chunk) [Mine Safety Disclosures](index=51&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company has no disclosures related to mine safety - Item 4 is not applicable to the company's operations[557](index=557&type=chunk) PART II [Market for Common Equity and Stockholder Matters](index=51&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Cardio Diagnostics' common stock and warrants are listed on Nasdaq, with no cash dividends anticipated as earnings are reinvested - Common Stock and Warrants are listed on the Nasdaq Capital Market under symbols '**CDIO**' and '**CDIOW**' respectively[574](index=574&type=chunk) - As of April 1, 2024, there were **37 record holders** of common stock and **8,528,766 warrants outstanding**[558](index=558&type=chunk)[560](index=560&type=chunk) - The company has never paid dividends on its common stock and does not anticipate paying any cash dividends in the foreseeable future, intending to retain earnings for business operations and expansion[114](index=114&type=chunk)[502](index=502&type=chunk)[559](index=559&type=chunk) [Market Information](index=55&type=section&id=Market%20Information) [Dividends](index=55&type=section&id=Dividends) [Warrants](index=55&type=section&id=Warrants) [Securities Authorized for Issuance Under Equity Compensation Plans](index=55&type=section&id=Securities%20Authorized%20for%20Issuance%20Under%20Equity%20Compensation%20Plans) [Sales of Unregistered Securities](index=55&type=section&id=Sales%20of%20Unregistered%20Securities) [Issuer Purchases of Equity Securities](index=55&type=section&id=Issuer%20Purchases%20of%20Equity%20Securities) [Reserved](index=52&type=section&id=Item%206.%20Reserved) This item is reserved and contains no information [Management's Discussion and Analysis](index=52&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Cardio Diagnostics, an early-stage medical technology company, reported nominal revenue and increased net losses in 2023, relying on external financing - Cardio's strategy involves leveraging CPT PLA codes, developing additional products (stroke, heart failure, diabetes tests), expanding clinical evidence, increasing adoption across key channels (health systems, self-insured employers), scaling internal operations, and pursuing strategic partnerships/acquisitions[588](index=588&type=chunk) - The company recently launched HeartRisk™, a cardiovascular risk intelligence platform, and secured an Innovative Technology Contract from Vizient, Inc[572](index=572&type=chunk)[586](index=586&type=chunk) Key Financial Highlights (Years Ended December 31) | Metric | 2023 | 2022 | | :---------------------------------- | :----------- | :----------- | | Revenue | $17,065 | $950 | | Sales and marketing expenses | $158,514 | $92,700 | | Research and development expenses | $145,182 | $40,448 | | General and administrative expenses | $6,936,646 | $4,400,253 | | Net loss | $(8,376,834) | $(4,660,985) | - Net loss increased by **$3,715,849** in 2023 compared to 2022, primarily due to a **$2,536,393** increase in General and Administrative expenses, including **$1,035,273** in stock compensation[443](index=443&type=chunk)[596](index=596&type=chunk) - The company's continuation as a going concern is dependent on obtaining necessary equity financing and generating revenues, as it has incurred significant losses and accumulated a deficit of **$14,368,380** at December 31, 2023[299](index=299&type=chunk)[342](index=342&type=chunk)[601](index=601&type=chunk) - In 2023, the company received **$4.5 million** from a convertible debenture (fully converted to **10,622,119 common shares**) and **$855,922** (net) from an At-the-Market offering, with **$16.1 million** still available[583](index=583&type=chunk)[590](index=590&type=chunk)[611](index=611&type=chunk) [Overview](index=56&type=section&id=Overview) [Recent Developments](index=57&type=section&id=Recent%20Developments) [Results of Operations](index=58&type=section&id=Results%20of%20Operations) [Liquidity and Capital Resources](index=59&type=section&id=Liquidity%20and%20Capital%20Resources) [Off-Balance Sheet Financing Arrangements](index=60&type=section&id=Off-Balance%20Sheet%20Financing%20Arrangements) [Contractual Obligations](index=60&type=section&id=Contractual%20Obligations) [Critical Accounting Policies and Significant Judgments and Estimates](index=62&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) [Quantitative and Qualitative Disclosures About Market Risk](index=58&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As of December 31, 2023, Cardio Diagnostics was not subject to any material market or interest rate risk - The company reported no exposure to market or interest rate risk as of December 31, 2023[472](index=472&type=chunk) [Financial Statements and Supplemental Data](index=58&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplemental%20Data) This section presents Cardio Diagnostics' audited consolidated financial statements for 2023 and 2022, including balance sheets, statements of operations, cash flows, and notes - The independent auditor, Prager Metis CPA's LLC, issued an opinion stating that the consolidated financial statements for 2023 and 2022 present fairly the company's financial position and cash flows, but noted a 'going concern' uncertainty due to nominal revenue and accumulated deficits[298](index=298&type=chunk)[299](index=299&type=chunk) Consolidated Balance Sheet Highlights (December 31) | Metric | 2023 | 2022 | | :---------------------------------- | :----------- | :----------- | | Cash | $1,283,523 | $4,117,521 | | Total current assets | $2,765,680 | $5,885,887 | | Total assets | $4,462,365 | $6,249,478 | | Total current liabilities | $841,142 | $1,947,770 | | Total liabilities | $1,504,241 | $1,947,770 | | Total stockholders' equity | $2,958,124 | $4,301,708 | | Accumulated deficit | $(14,368,380) | $(5,991,546) | Consolidated Statements of Cash Flows Highlights (Years Ended December 31) | Cash Flow Activity | 2023 | 2022 | | :---------------------------------- | :----------- | :----------- | | Net cash used in operating activities | $(5,672,175) | $(5,090,968) | | Net cash used in investing activities | $(794,291) | $(368,001) | | Net cash provided by financing activities | $3,632,468 | $9,063,723 | | Net increase (decrease) in cash | $(2,833,998) | $3,604,754 | | Cash – End of Year | $1,283,523 | $4,117,521 | - Cash decreased by **$2,833,998** in 2023, primarily due to significant cash used in operating activities (**$5.67 million**) and investing activities (**$0.79 million**), partially offset by cash from financing activities (**$3.63 million**)[614](index=614&type=chunk)[598](index=598&type=chunk)[600](index=600&type=chunk) [Report of Independent Registered Public Accounting Firm](index=65&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) [Consolidated Balance Sheets](index=66&type=section&id=Consolidated%20Balance%20Sheets) [Consolidated Statements of Operations](index=67&type=section&id=Consolidated%20Statements%20of%20Operations) [Consolidated Statements of Changes in Stockholders' Equity](index=68&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) [Consolidated Statements of Cash Flows](index=69&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) [Notes to Consolidated Financial Statements](index=70&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) [Changes in and Disagreements with Accountants](index=59&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reported no changes in or disagreements with accountants on accounting and financial disclosure - The company reported no changes in or disagreements with accountants on accounting and financial disclosure[793](index=793&type=chunk) [Controls and Procedures](index=59&type=section&id=Item%209A.%20Controls%20and%20Procedures) Cardio Diagnostics' disclosure controls were ineffective as of December 31, 2023, though financial statements are fairly presented, with no material changes in internal control - As of December 31, 2023, the company's disclosure controls and procedures were deemed not effective[752](index=752&type=chunk) - Despite the ineffectiveness of disclosure controls, management believes the financial statements fairly present the company's financial position, results of operations, and cash flows[752](index=752&type=chunk) - No material changes in internal control over financial reporting occurred during the period ended December 31, 2023[771](index=771&type=chunk) [Evaluation of Disclosure Controls and Procedures](index=84&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) [Changes in Internal Control over Financial Reporting](index=84&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) [Other Information](index=59&type=section&id=Item%209B.%20Other%20Information) The company reported no other information for this item - The company stated that Item 9B is not applicable[796](index=796&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=59&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) The company reported no disclosures regarding foreign jurisdictions that prevent inspections - The company reported no disclosures regarding foreign jurisdictions that prevent inspections[772](index=772&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=60&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Cardio Diagnostics' corporate governance includes a seven-member Board with independent directors, key executive officers, and policies for ethics and related party transactions - The Board of Directors consists of **seven members**, with Paul Burton, James Intrater, Stanley K. Lau, MD, and Oded Levy identified as independent directors[782](index=782&type=chunk)[783](index=783&type=chunk) - Key executive officers include Meeshanthini V. Dogan (CEO), Robert Philibert (CMO), Elisa Luqman (CFO), Timur Dogan (CTO), and Khullani Abdullahi (VP of Revenue and Strategy)[798](index=798&type=chunk)[799](index=799&type=chunk) - The company has an Audit Committee, Compensation Committee, and Nominating and Corporate Governance Committee, all with independent director representation[808](index=808&type=chunk)[826](index=826&type=chunk)[831](index=831&type=chunk) - A written code of business conduct and ethics applies to all employees and directors, and a policy for reviewing and approving related party transactions is in place[624](index=624&type=chunk)[879](index=879&type=chunk) - The company provides indemnification agreements to its directors and executive officers, which may be broader than statutory provisions, to attract and retain qualified individuals[627](index=627&type=chunk)[815](index=815&type=chunk) [Executive Officers](index=85&type=section&id=Executive%20Officers) [Non-Employee Members of the Board of Directors](index=86&type=section&id=Non-Employee%20Members%20of%20the%20Board%20of%20Directors) [Family Relationships](index=87&type=section&id=Family%20Relationships) [Corporate Governance](index=88&type=section&id=Corporate%20Governance) [Board Committees](index=88&type=section&id=Board%20Committees) [Guidelines for Selecting Director Nominees](index=90&type=section&id=Guidelines%20for%20Selecting%20Director%20Nominees) [Code of Ethics](index=90&type=section&id=Code%20of%20Ethics) [Conflicts of Interest](index=91&type=section&id=Conflicts%20of%20Interest) [Limitation on Liability and Indemnification of Officers and Directors](index=91&type=section&id=Limitation%20on%20Liability%20and%20Indemnification%20of%20Officers%20and%20Directors) [Section 16(a) Beneficial Ownership Reporting Compliance](index=92&type=section&id=Section%2016(a)%20Beneficial%20Ownership%20Reporting%20Compliance) [Executive Compensation](index=67&type=section&id=Item%2011.%20Executive%20Compensation) Cardio Diagnostics' 2023 executive compensation included base salaries and significant equity awards, with no cash bonuses, and non-employee directors received RSU awards 2023 Summary Compensation Table for Named Executive Officers | Name | Position | 2023 Salary ($) | 2023 Bonus ($) | 2023 Option Awards ($) | 2023 All Other Compensation ($) | 2023 Total ($) | | :---------------------- | :-------------------------------- | :-------------- | :------------- | :--------------------- | :------------------------------ | :------------- | | Meeshanthini V. Dogan | CEO | 300,000 | 0 | 341,640 | 7,253 | 648,893 | | Warren Hosseinion | Non-executive Chairman | 300,000 | 0 | 155,291 | 0 | 455,291 | | Elisa Luqman | CFO | 275,000 | 0 | 72,469 | 0 | 347,469 | - No annual cash bonuses were awarded to NEOs in 2023, though employment agreements provide for eligibility based on performance[866](index=866&type=chunk) - In January 2024, **1,187,826 options** were granted to management under the 2022 Equity Incentive Plan, with most vesting immediately[768](index=768&type=chunk) - Non-employee directors received **$12,500** in RSU awards quarterly in 2023, vesting and settling on the grant date, and similar awards are planned for 2024[664](index=664&type=chunk)[849](index=849&type=chunk) - Employment agreements for the CEO and CFO include annual base salaries (**$300,000** and **$275,000** respectively), eligibility for cash bonuses and long-term incentives, and severance benefits under specific termination conditions[955](index=955&type=chunk)[961](index=961&type=chunk)[962](index=962&type=chunk) [Overview](index=92&type=section&id=Overview) [2023 Summary Compensation Table](index=92&type=section&id=2023%20Summary%20Compensation%20Table) [Narrative to the Summary Compensation Table](index=93&type=section&id=Narrative%20to%20the%20Summary%20Compensation%20Table) [2023 Base Salary](index=93&type=section&id=2023%20Base%20Salary) [Annual Bonuses](index=93&type=section&id=Annual%20Bonuses) [Equity Compensation](index=93&type=section&id=Equity%20Compensation) [Retirement Plan](index=94&type=section&id=Retirement%20Plan) [Employee Benefits and Perquisites](index=94&type=section&id=Employee%20Benefits%20and%20Perquisites) [Outstanding Equity Awards at Fiscal Year-End Table](index=95&type=section&id=Outstanding%20Equity%20Awards%20at%20Fiscal%20Year-End%20Table) [Agreements with Our Executive Officers and Non-Executive Chairman of the Board](index=95&type=section&id=Agreements%20with%20Our%20Executive%20Officers%20and%20Non-Executive%20Chairman%20of%20the%20Board) [Director Compensation](index=96&type=section&id=Director%20Compensation) [Security Ownership of Certain Beneficial Owners and Management](index=71&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) This section details beneficial ownership of Cardio Diagnostics' common stock as of April 1, 2024, with executive officers and directors owning **22.50%** as a group Beneficial Ownership of Common Stock (April 1, 2024) | Name | Amount and Nature of Beneficial Ownership | Approximate Percentage of Outstanding Shares | | :---------------------------------- | :---------------------------------------- | :------------------------------------------- | | Meeshanthini V. Dogan | 3,020,422 | 9.04% | | Robert Philibert | 2,455,257 | 7.35% | | Warren Hosseinion | 618,248 | 1.85% | | Elisa Luqman | 322,772 | 0.97% | | James Intrater | 62,793 | — | | Stanley K. Lau | 91,522 | — | | Oded Levy | 62,793 | — | | Paul Burton | — | — | | Timur Dogan | 563,812 | 1.69% | | Khullani Abdullahi | 318,682 | 0.95% | | All Executive Officers and Directors as a Group (10 individuals) | 7,516,301 | 22.50% | - Percentage ownership is based on **21,591,119 shares** of Common Stock outstanding as of April 1, 2024[4](index=4&type=chunk)[876](index=876&type=chunk) - Beneficial ownership includes shares subject to options or warrants exercisable within **60 days**[665](index=665&type=chunk) [Beneficial Ownership Table](index=96&type=section&id=Beneficial%20Ownership%20Table) [Certain Relationships and Related Transactions, and Director Independence](index=71&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Cardio Diagnostics has a policy for reviewing and approving related party transactions, including an exclusive patent license from UIRF and employment of the CEO's spouse - The company has a policy for reviewing and approving 'related party transactions' exceeding **$120,000** or **1% of average total assets**, involving directors, executive officers, or **5%+ beneficial owners**[879](index=879&type=chunk) - The audit committee is responsible for considering the facts and circumstances of each related party transaction, including comparability to arm's-length dealings[879](index=879&type=chunk) - Cardio has an exclusive, worldwide patent license from the University of Iowa Research Foundation (UIRF), and co-founders Meeshanthini Dogan and Robert Philibert are entitled to **25% of income** from earnings from their inventions under UIRF's policy[667](index=667&type=chunk)[878](index=878&type=chunk) - Timur Dogan, spouse of CEO Meeshanthini Dogan, is a full-time employee of the company[878](index=878&type=chunk) [Related Party Policy](index=98&type=section&id=Related%20Party%20Policy) [Exclusive License Agreement with UIRF](index=98&type=section&id=Exclusive%20License%20Agreement%20with%20UIRF) [Invention and Non-Disclosure Agreements](index=98&type=section&id=Invention%20and%20Non-Disclosure%20Agreements) [Principal Accounting Fees and Services](index=72&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) This section details fees paid to Prager Metis CPA's LLC for audit services in 2023 and 2022, with no other services provided, and an audit committee pre-approval policy Fees Paid to Prager Metis CPA's LLC (Years Ended December 31) | Fee Type | 2023 ($) | 2022 ($) | | :------------------ | :------- | :------- | | Audit Fees | 85,500 | 84,000 | | Audit-Related Fees | — | — | | Tax Fees | — | — | | All Other Fees | — | — | | Total Fees | 85,500 | 84,000 | - The audit committee has a policy for pre-approving all auditing services and permitted non-audit services[647](index=647&type=chunk)[882](index=882&type=chunk) - No other professional services were provided by Prager Metis in 2023 that would require considering their compatibility with auditor independence[856](index=856&type=chunk) [Fees Paid to the Independent Registered Public Accounting Firm](index=98&type=section&id=Fees%20Paid%20to%20the%20Independent%20Registered%20Public%20Accounting%20Firm) [Auditor Independence](index=98&type=section&id=Auditor%20Independence) [Pre-Approval Policy](index=98&type=section&id=Pre-Approval%20Policy) PART IV [Exhibits, Financial Statement Schedules](index=73&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists all exhibits and financial statement schedules filed as part of the Annual Report on Form 10-K, including key agreements and certifications - All schedules are omitted if not applicable or if the required information is shown in the Financial Statements or notes[858](index=858&type=chunk) - The consolidated financial statements are listed in the accompanying Index to Financial Statements on page F-1[884](index=884&type=chunk) - The exhibit index includes key documents such as the Agreement and Plan of Merger, the 2022 Equity Incentive Plan, employment agreements, and certifications of principal executive and financial officers[885](index=885&type=chunk) [Financial Statements](index=100&type=section&id=Financial%20Statements) [Exhibit Index](index=100&type=section&id=Exhibit%20Index) [Form 10-K Summary](index=101&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company states that there is no Form 10-K Summary - The company states that there is no Form 10-K Summary[859](index=859&type=chunk)
Cardio Diagnostics Holdings, Inc. to Showcase HeartRisk and Actionable Clinical Intelligence Version 3 at the American College of Cardiology's 73rd Annual Scientific Session
Businesswire· 2024-03-14 12:31
CHICAGO--(BUSINESS WIRE)--Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO), an AI-powered precision cardiovascular medicine company, announces that the Company will showcase its groundbreaking HeartRiskTM and Actionable Clinical IntelligenceTM platforms at the American College of Cardiology’s 73rd Annual Scientific Session (ACC.24), taking place in Atlanta, GA, from April 6-8, 2024. Cardio Diagnostics' mission is in lockstep with this year's ACC.24 conference theme, "Advancing Cardiovascular Care for All." ...
Cardio Diagnostics Holdings, Inc. Announces Issuance of Second U.S. Patent for Compositions and Methods for Detecting Predisposition to Cardiovascular Disease
Businesswire· 2024-03-05 13:31
CHICAGO--(BUSINESS WIRE)--Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO), an AI-driven precision cardiovascular medicine company, announces that the U.S. Patent and Trademark Office has issued a notice of allowance to University of Iowa Research Foundation ("UIRF") for U.S. Application No. 17,857,723 titled Compositions and Methods for Detecting Predisposition to Cardiovascular Disease, which is exclusively licensed to the Company from UIRF, and that was co-invented by Cardio Diagnostics' founders, Meesha ...