Cardio Diagnostics (US:CDIO)2026-03-13 21:18Financial 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 - The FDA rescinded its May 2024 final rule regulating Laboratory Developed Tests (LDTs) as medical devices, reverting oversight to CLIA, which may impact future product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].