Core Viewpoint - Premarket trading is showing significant activity with notable price movements indicating potential investment opportunities before the market opens [1] Premarket Gainers - Ventyx Biosciences, Inc. (VTYX) increased by 57% to $15.79 [3] - Cardio Diagnostics Holdings, Inc. (CDIO) rose by 36% to $4.02 [3] - Monte Rosa Therapeutics, Inc. (GLUE) saw a 28% increase to $20.54 [3] - Momentus Inc. (MNTS) gained 27% reaching $12.50 [3] - BioAge Labs, Inc. (BIOA) went up by 13% to $17.50 [3] - Neumora Therapeutics, Inc. (NMRA) increased by 11% to $2.03 [3] - Mobileye Global Inc. (MBLY) rose by 10% to $13.45 [3] - Society Pass Incorporated (SOPA) increased by 10% to $3.47 [3] - SU Group Holdings Limited (SUGP) saw an 8% rise to $6.32 [3] - Critical Metals Corp. (CRML) gained 7% reaching $12.73 [3] Premarket Losers - Evolution Metals & Technologies Corp. (EMAT) decreased by 28% to $15.20 [4] - Ascent Solar Technologies, Inc. (ASTI) fell by 12% to $4.65 [4] - Apogee Enterprises, Inc. (APOG) saw a 10% decline to $33.30 [4] - Next Technology Holding Inc. (NXTT) dropped by 8% to $8.49 [4] - AST SpaceMobile, Inc. (ASTS) decreased by 7% to $90.45 [4] - Nomadar Corp. (NOMA) fell by 7% to $3.66 [4] - EZGO Technologies Ltd. (EZGO) decreased by 7% to $1.99 [4] - Cohen & Company Inc. (COHN) saw a 6% decline to $28.30 [4] - PMGC Holdings Inc. (ELAB) dropped by 4% to $5.34 [4] - Anghami Inc. (ANGH) decreased by 3% to $4.49 [4]

CHICAGO--(BUSINESS WIRE)--Cardio Diagnostics, Aimil Ltd., and Dr. Lal PathLabs announce strategic agreement to launch Cardio Diagnostics' PrecisionCHDâ"¢ test in India. ...

EDINA, Minn. & CHICAGO--(BUSINESS WIRE)--Cardio Diagnostics announced a partnership with the Southdale YMCA, becoming the second YMCA location nationally to partner with Cardio Diagnostics. ...

Financial Performance - Cardio's revenue for the three months ended September 30, 2025, was $2,855, compared to $6,580 for the same period in 2024, representing a decrease of approximately 56.6%[129] - For the nine months ended September 30, 2025, Cardio reported revenue of $11,270, down from $30,378 in 2024, a decline of about 62.9% attributed to the conclusion of a testing initiative[130] - The net loss for the three months ended September 30, 2025, was $1,714,536, an increase of $301,970 from a net loss of $1,412,566 in the same period in 2024[131] - Cardio's net loss for the nine months ended September 30, 2025, was $5,032,799, a decrease of $1,831,346 compared to a net loss of $6,864,145 in 2024, primarily due to reduced general and administrative expenses[132] Expenses - Selling, general and administrative expenses for the three months ended September 30, 2025, were $1,714,452, an increase of 21.1% from $1,415,547 in the same period in 2024[135] - Selling, General and Administrative Expenses for the nine months ended September 30, 2025 totaled $1,312,755, with payroll and related costs being the largest component at $1,312,755[139] - Cash used in operating activities for the nine months ended September 30, 2025 was $4,364,984, an increase from $3,600,809 in the same period of 2024[157] - Cash used in investing activities for the nine months ended September 30, 2025 was $340,951, slightly lower than $349,577 for the same period in 2024[159] Cash Position - As of September 30, 2025, cash totaled $6,355,218, down from $7,827,487 at December 31, 2024, reflecting a decrease of $1,472,269[155] - Cash provided by financing activities for the nine months ended September 30, 2025 was $3,233,666, compared to $4,649,453 for the same period in 2024[160] - The company anticipates ongoing cash needs for day-to-day operations, working capital, and FDA submission activities, indicating a reliance on external financing[148] - The company has sold 1,117,763 shares of Common Stock under a Sales Agreement, resulting in proceeds of $15,061,270, net of offering costs[146] Product Development and Strategy - The company has launched several products, including Epi+Gen CHD™ and PrecisionCHD™, aimed at improving cardiovascular disease detection and management[123] - Cardio's ongoing strategy includes expanding its product offerings and market reach, with plans to develop additional clinical tests for stroke, heart failure, and diabetes[127] - The company is focusing on onboarding additional providers, although there is a ramp-up period of one to three quarters for new organizations to increase test usage[134] - Cardio is exploring potential strategic partnerships and acquisitions to enhance its market position and operational capabilities[127] Internal Controls and Compliance - The Company has identified a material weakness in internal control over financial reporting due to inadequate segregation of duties, which increases the risk of errors or unauthorized transactions[180] - Remediation efforts to address the material weakness related to inadequate segregation of duties are ongoing and have not yet been fully implemented or tested for effectiveness[182] - The Company has conducted an evaluation of its disclosure controls and procedures and concluded that they were not effective during the period covered by the report[177] - The Company is exploring and deploying accounting software with built-in controls to automate certain financial processes, reducing reliance on manual interventions[184] Legal and Regulatory Matters - The Company has not entered into any legal proceedings regarding the claims from Northland Securities, Inc. and does not believe it owes any sum based on the termination of the Yorkville Securities Purchase Agreement[168] - The Company believes that the claims asserted in the Demand Letter regarding the S-4 Registration Statement are without merit and that no further disclosure is required[167] - The Company has not consummated any transaction with any potential party that purportedly was a contact of Boustead Securities in connection with the Placement Agent Agreement and has no plans to do so during the tail period[165] Royalty and Licensing - The Company has paid approximately $1,300 in total royalty fees to the University of Iowa Research Foundation under the exclusive license agreement, based on minimal sales of $65,076 to date[171] - The Company issued 3,639 shares of Common Stock to the University of Iowa Research Foundation in accordance with the Equity Rights under the Exclusive License Agreement[171] Accounting Policies - The Company has not experienced any significant changes to its critical accounting policies and estimates during the three and nine months ended September 30, 2025[175]

CHICAGO--(BUSINESS WIRE)--Cardio Diagnostics will be presenting new data at the American Heart Association (AHA) Scientific Sessions. ...

Oct 28, 2025 8:35 AM Eastern Daylight Time Cardio Diagnostics Holdings, Inc. and YMCA of East Tennessee Partner to Bring Heart Health Education and Advanced Testing to East Tennessee Community Share A customized program for YMCA of East Tennessee members will include educational series "Wisdom Wednesdays,†and access to Cardio Diagnostics' AI-powered cardiovascular testing at discounted rates from home or during the Heart Health Fair KNOXVILLE, Tenn. & CHICAGO--(BUSINESS WIRE)--Cardio Diagnostics Holdings, I ...

CHICAGO--(BUSINESS WIRE)--Cardio Diagnostics Holdings, Inc. today announced the Company has partnered with 15 new provider organizations across the United States. ...

Financial Performance - Cardio's revenue for the three months ended June 30, 2025, was $7,475, compared to $7,870 for the same period in 2024, reflecting a decrease of 5%[122] - For the six months ended June 30, 2025, Cardio reported revenue of $8,415, significantly down from $23,798 in 2024, indicating a decrease of approximately 65%[123] - The net loss for the three months ended June 30, 2025, was $1,683,199, an increase of $395,204 from a net loss of $1,287,995 in the same period of 2024[124] - Cardio's net loss for the six months ended June 30, 2025, was $3,318,263, a decrease of $2,133,316 compared to a net loss of $5,451,579 in 2024[124] Expenses - Selling, General and Administrative expenses for the three months ended June 30, 2025, were $1,686,174, up from $1,290,330 in 2024, marking an increase of approximately 31%[126] - Cardio's Selling, General and Administrative expenses for the six months ended June 30, 2025, were $3,317,674, down from $5,464,306 in 2024, a decrease of approximately 39%[129] - Selling, General and Administrative Expenses for the six months ended June 30, 2025 totaled $2,500,000, with payroll and related costs of $961,517 and research and development expenses of $165,296[130] Cash Flow and Financing - Cash used in operating activities for the six months ended June 30, 2025 was $2,971,566, an increase from $2,443,450 for the same period in 2024[148] - Cash provided by financing activities for the six months ended June 30, 2025 was $3,193,711, compared to $2,741,056 for the same period in 2024[151] - As of June 30, 2025, cash totaled $7,966,500, an increase of $139,013 from $7,827,487 at December 31, 2024[146] - The company anticipates ongoing cash needs for day-to-day operations and growth strategy, with reliance on the ongoing ATM Offering if market conditions are favorable[139] - The company has no lines of credit or other bank financing arrangements, and expects to raise additional funds through equity and/or debt issuance[143] - The company has had negative cash flows from operating activities in each fiscal year since inception, and expects this trend to continue in the foreseeable future[141] Product Development - Cardio launched its second product, PrecisionCHD™, in March 2023, aimed at detecting coronary heart disease, following the initial launch of Epi+Gen CHD™ in 2021[116] - The company plans to develop additional products for stroke, congestive heart failure, and diabetes, and expand its clinical and health economics evidence portfolio[120] - The company has received preliminary gapfill pricing from the Centers for Medicare and Medicaid for its Epi+Gen CHD and PrecisionCHD tests, indicating progress in the reimbursement process[116] Shareholder and Equity Matters - As of August 14, 2025, Cardio sold 1,054,841 shares of its Common Stock under a Sales Agreement, generating proceeds of $14,782,871, net of offering costs[118] - The exercise prices of currently outstanding warrants range from $53.40 to $345, with the last reported sales price of Common Stock at $3.82 on August 13, 2025[145] - The Company has had minimal sales of $62,221 to date and has paid approximately $1,300 in total royalty fees to the University of Iowa Research Foundation under the exclusive license agreement[162] - The Company issued 3,639 shares of Common Stock to the University of Iowa Research Foundation in accordance with the Equity Rights under the Exclusive License Agreement[162] Legal and Compliance Matters - The Company believes that the claims asserted in the Demand Letter regarding the S-4 Registration Statement are without merit and that no further disclosure was required[158] - The Company is evaluating a claim from The Benchmark Company, LLC regarding damages owed due to the Yorkville Convertible Debenture Transaction[157] - The Company does not believe it owes Northland Securities, Inc. any sum based on the termination of the Yorkville Securities Purchase Agreement[159] - The SEC completed its review of the S-4 Registration Statement and declared it effective on October 6, 2022[158] Internal Controls - Management identified a material weakness in internal control over financial reporting due to inadequate segregation of duties within the financial reporting process[169] - Remediation efforts to address the material weakness related to inadequate segregation of duties are ongoing and have not yet been fully implemented or tested for effectiveness[170] - The Company has not experienced any significant changes in internal control over financial reporting that materially affect its reporting[172]

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)

Financial Performance - Cardio's revenue for the year ended December 31, 2024, was $34,890, an increase of 104.8% compared to $17,065 for the year ended December 31, 2023[399]. - Cardio's net loss for the year ended December 31, 2024, was $8,383,453, a slight increase from $8,376,834 in 2023, primarily due to rising general and administrative expenses[398]. - The company incurred a net loss of $8,383,453 for the year ended December 31, 2024, adjusted for non-cash operating items[421]. Expenses - General and administrative expenses increased to $8,169,458 for the year ended December 31, 2024, up by 17.7% from $6,936,646 in 2023, primarily due to increased stock compensation expenses[403]. - Research and development expenses decreased significantly to $29,125 in 2024, down 80% from $145,182 in 2023, attributed to fewer laboratory runs on new product offerings[402]. Cash Flow - Cash at December 31, 2024, totaled $7,827,487, an increase of $6,543,964 compared to $1,283,523 at December 31, 2023[420]. - Cash used in operating activities for the year ended December 31, 2024, was $4,993,104, a decrease from $5,672,175 for the year ended December 31, 2023[421]. - Cash provided by financing activities for the year ended December 31, 2024, was $11,941,258, compared to $3,632,468 for the year ended December 31, 2023[424]. Product Development and Market Strategy - Cardio launched its second product, PrecisionCHD™, in March 2023, following the initial launch of Epi+Gen CHD™ in 2021, expanding its product portfolio for cardiovascular disease[390]. - The company expects to develop additional products for stroke, congestive heart failure, and diabetes, aiming to expand its clinical test offerings[394]. - Cardio's new go-to-market strategy aims to increase the adoption of its products across key channels, including health systems and self-insured employers[394]. Partnerships and Market Reach - The company entered into partnerships with seven new provider organizations across various states, enhancing its market reach and distribution channels[391]. - The company has generated revenue from provider organizations in 2024, indicating progress in its sales and partnership pipeline despite long sales cycles[390]. Financing and Stock Information - The company has entered a Sales Agreement allowing it to sell up to $17 million in common stock, with proceeds of $14,681,556 generated as of March 20, 2025[393]. - As of March 20, 2025, the company sold 30,959,434 shares of Common Stock under the Sales Agreement, resulting in proceeds of $14,681,556, net of offering costs[409]. - The company expects to rely primarily on the ongoing ATM Offering for the remainder of 2025, contingent on favorable market conditions[412]. - The company has no lines of credit or other bank financing arrangements and anticipates needing to raise additional funds through equity and/or debt issuance[416]. - The exercise prices of currently outstanding warrants range from $1.78 to $11.50 per share, with the last reported sales price of Common Stock at $0.4630 on March 17, 2025[418]. Compliance and Regulatory Matters - The Company received a letter from Nasdaq indicating non-compliance with the minimum bid price requirement of $1.00 per share, with an initial compliance period until December 2, 2024, and a potential extension until June 2, 2025[436]. - The Company has not regained compliance with the minimum bid price requirement as of the report date[436]. - If compliance is not achieved within the cure period, Nasdaq could delist the Company's securities[437]. - The Company is required to maintain insurance coverage for claims against its directors and officers as part of its contractual obligations[435]. Accounting Policies - The SEC has requested that registrants list their most critical accounting policies, which are important for portraying financial condition and require complex judgments[439]. - The Company accounts for stock-based compensation using the Black-Scholes option pricing model, which involves subjective assumptions that can materially affect fair value estimates[440]. - As of December 31, 2024, the Company was not subject to any market or interest rate risk[442].