Financial Performance - Cardio's revenue for the year ended December 31, 2025, was $14,825, a decrease of 57.5% from $34,890 in 2024, primarily due to the conclusion of the Family Medicine Specialists' Heart Attack Prevention testing initiative [381]. - The net loss for the year ended December 31, 2025, was $6,498,167, a reduction of $1,885,286 compared to a net loss of $8,383,453 in 2024, mainly due to decreased General and Administrative expenses [380]. - Cash at December 31, 2025 totaled $5,110,630, a decrease of $2,716,857 from $7,827,487 at December 31, 2024 [407]. - Cash used in operating activities for the year ended December 31, 2025 was $5,726,833, compared to $4,993,104 for the year ended December 31, 2024, reflecting an increase in operational cash outflows [408]. - Cash provided by financing activities for the year ended December 31, 2025 was $3,429,286, a significant decrease from $11,941,258 for the year ended December 31, 2024, indicating reduced capital raising efforts [411]. Expenses - Research and Development expenses increased to $641,212 in 2025 from $227,966 in 2024, reflecting an increase of $413,246 due to more personnel in R&D [390]. - General and Administrative expenses decreased to $5,025,570 in 2025 from $6,921,094 in 2024, a reduction of $1,895,524, attributed to lower stock compensation expenses [391]. - Sales and Marketing expenses decreased to $766,888 in 2025 from $1,231,969 in 2024, a decrease of $465,081 due to a restructuring in personnel [389]. - Total amortization expense for the year ended December 31, 2025 was $65,233, compared to $19,738 for the year ended December 31, 2024, indicating a significant increase in amortization costs [395]. - Total other expense for the year ended December 31, 2025 was $(14,089), an improvement from $(17,576) for the year ended December 31, 2024, primarily due to reduced interest expenses [396]. Product Development and Market Expansion - Cardio launched its second product, PrecisionCHD™, in March 2023, an integrated epigenetic-genetic clinical blood test for coronary heart disease detection [372]. - The company has expanded its market presence internationally, with its first international expansion to India, partnering with local organizations to offer testing [372]. - The FDA rescinded its May 2024 final rule regulating Laboratory Developed Tests (LDTs) as medical devices, reverting oversight to CLIA, which may impact future product development and regulatory compliance [379]. Funding and Capital Requirements - The company expects to rely primarily on the ongoing ATM Offering for funding, contingent on favorable market conditions, to meet its cash needs for operations and growth [401]. - The company anticipates that working capital requirements will increase in line with business growth, necessitating additional funds through equity or debt issuance [404]. - The company has incurred losses from operations in each fiscal year since inception, with expectations that this trend will continue for the foreseeable future [402]. Compliance and Legal Matters - The Company received notice from Nasdaq on June 3, 2024, for non-compliance with Listing Rule 5550(a)(2) due to the closing bid price being below $1.00 per share for 30 consecutive business days [423]. - After a reverse stock split in May 2025, the Company regained compliance with the minimum bid price requirement [424]. - The Company is currently in compliance with Nasdaq listing standards, but the market price of its common stock has historically experienced volatility [425]. - If the bid price of the common stock declines below $1.00 per share for a sustained period, the Company could again become non-compliant with Nasdaq's continued listing requirements [426]. - The Company has a contractual obligation to maintain insurance coverage for claims against its directors and officers [421]. - The Company has been contacted by Northland Securities regarding a fee claim of approximately $150,000, but no legal proceedings have been instigated [419]. - The Company believes that the claims asserted in the demand letter regarding the S-4 Registration Statement are without merit and no further disclosures are required [418]. - The Company cannot preclude the possibility that claims or lawsuits related to alleged securities law violations could require significant resources to defend [420].

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential investment opportunities before the market opens [1] Premarket Gainers - Neurogene Inc. (NGNE) is up 34% at $26.42 [3] - Cardio Diagnostics Holdings, Inc. (CDIO) is up 20% at $6.29 [3] - Applied Optoelectronics, Inc. (AAOI) is up 19% at $64.00 [3] - Caris Life Sciences, Inc. (CAI) is up 19% at $22.93 [3] - Block, Inc. (XYZ) is up 18% at $64.59 [3] - MARA Holdings, Inc. (MARA) is up 16% at $9.84 [3] - NCR Atleos Corporation (NATL) is up 14% at $48.13 [3] - Birchtech Corp. (BCHT) is up 12% at $2.70 [3] - The RealReal, Inc. (REAL) is up 11% at $13.80 [3] - Candel Therapeutics, Inc. (CADL) is up 10% at $5.68 [3] Premarket Losers - Duolingo, Inc. (DUOL) is down 24% at $88.30 [4] - Xponential Fitness, Inc. (XPOF) is down 23% at $6.16 [4] - Emergent BioSolutions Inc. (EBS) is down 22% at $8.58 [4] - Flutter Entertainment plc (FLUT) is down 14% at $105.85 [4] - Ginkgo Bioworks Holdings, Inc. (DNA) is down 14% at $8.27 [4] - Willdan Group, Inc. (WLDN) is down 12% at $104.63 [4] - Duos Technologies Group, Inc. (DUOT) is down 12% at $7.67 [4] - CoreWeave, Inc. (CRWV) is down 11% at $85.96 [4] - Zscaler, Inc. (ZS) is down 9% at $152.22 [4] - Progyny, Inc. (PGNY) is down 8% at $20.40 [4]

Group 1 - Cardio Diagnostics will host an investor conference call on February 19, 2026, at 3 p.m. Central Time [1]

Core Insights - Cardio Diagnostics Holdings, Inc. will host an investor conference call on February 18, 2026, at 3 p.m. Central Time to discuss its precision molecular approach to cardiovascular disease prevention and early detection [1] - The call will cover updates on commercially available tests, Epi+Gen CHD™ and PrecisionCHD™, recent clinical data, reimbursement progress, and strategic growth initiatives [1] Company Overview - Cardio Diagnostics is a precision cardiovascular medicine company utilizing epigenetics, genetics, and artificial intelligence to enhance the prevention and detection of cardiovascular disease [1] - The company aims to make cardiovascular disease management more accessible, personalized, and precise through its proprietary AI-driven Integrated Genetic-Epigenetic Engine [1] Financial and Operational Updates - The Centers for Medicare and Medicaid Services (CMS) has issued a final gapfill payment rate of $854 for both the Epi+Gen CHD™ and PrecisionCHD™ tests [1] - The company is actively pursuing strategic partnerships, including a recent collaboration with Aimil Ltd. and Dr. Lal PathLabs to launch the PrecisionCHD™ test in India [1]

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]

Core Insights - Cardio Diagnostics, Aimil Ltd., and Dr. Lal PathLabs have formed a strategic agreement to introduce Cardio Diagnostics' PrecisionCHD™ test in India [1] Company Overview - Cardio Diagnostics is focused on launching its PrecisionCHD™ test, which is aimed at improving cardiovascular disease detection [1] - Aimil Ltd. is collaborating in this initiative, indicating a partnership that leverages local expertise for market entry [1] - Dr. Lal PathLabs is involved in the distribution and implementation of the test, enhancing its accessibility in the Indian healthcare market [1]

Core Insights - Cardio Diagnostics has announced a partnership with the Southdale YMCA, marking it as the second YMCA location in the United States to collaborate with the company [1] Company Developments - The partnership with Southdale YMCA signifies Cardio Diagnostics' expansion strategy within community health initiatives [1]

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]

Core Insights - Cardio Diagnostics will present new data at the American Heart Association (AHA) Scientific Sessions [1] Company Summary - Cardio Diagnostics is actively participating in a significant industry event, showcasing its latest research findings [1] Industry Summary - The American Heart Association (AHA) Scientific Sessions serve as a platform for presenting advancements in cardiovascular health and research [1]

Core Insights - Cardio Diagnostics Holdings, Inc. partners with YMCA of East Tennessee to provide heart health education and advanced testing to the community [1][4] - The initiative aims to empower individuals to take proactive steps in cardiovascular wellness through education and early detection tools [2][4] Partnership Details - The program includes "Wisdom Wednesdays," an educational series for YMCA members, and access to discounted AI-powered cardiovascular tests [1][5] - Cardio Diagnostics will offer Epi+Gen CHD and PrecisionCHD tests at special rates, which assess the risk of coronary heart disease and aid in its management [6][8] Community Impact - Heart disease is the leading cause of death in Tennessee, accounting for 22.9% of all deaths, highlighting the need for preventive measures [2] - The YMCA serves over 40,000 members across five locations, emphasizing its role in promoting health and wellness in the Knoxville community [3] Educational Initiatives - Six educational sessions will be held starting in November 2025, focusing on coronary heart disease prevention and management [5] - The first session will feature Cardio Diagnostics' Chief Medical Officer discussing the importance of heart health [5] Testing Accessibility - Community members can access tests through telemedicine, with options for at-home sample collection or at the Heart Health Fair in February 2026 [6][7] - The partnership aims to extend access to cardiovascular testing beyond YMCA members to the entire East Tennessee community [8]