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]
Cardio Diagnostics (CDIO) - 2025 Q2 - Quarterly Report