Cardio Diagnostics (CDIO) - 2025 Q3 - Quarterly Report

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]