0001553350-26-000023
SEC filingCardio Diagnostics Holdings, Inc. (CDIO) reported a net loss of $6.5 million for fiscal year 2025, consistent with the prior year's loss of $8.4 million. Revenue was minimal at $15,000, down from $35,000 in 2024, reflecting the company's early-stage commercialization efforts. Total operating expenses were $6.5 million, with general and administrative costs being the largest component at $5.0 million. The company ended the year with $5.1 million in cash, a decrease of $2.7 million from the prior year, primarily due to $5.7 million used in operating activities, partially offset by $3.4 million in net financing proceeds from stock sales. The accumulated deficit increased to $29.2 million. The company's focus remains on driving adoption of its clinical tests (Epi+Gen CHD and PrecisionCHD) and expanding its market reach, with progress noted in setting up a CLIA laboratory and international expansion to India.
Cardio Diagnostics reported a net loss of $6.5 million for fiscal year 2025, an improvement from the $8.4 million loss in 2024. Revenue was minimal at $15,000, down from $34,890 in the prior year. The company's operating expenses totaled $6.5 million, with general and administrative expenses comprising $5.0 million, sales and marketing $767,000, and research and development $641,000. The loss from operations was $6.5 million. The company ended the year with $5.1 million in cash, down from $7.8 million at the end of 2024, reflecting cash used in operations of $5.7 million, partially offset by $3.4 million in net cash provided by financing activities from stock sales.
The company generated only $15,000 in revenue for fiscal year 2025, primarily from sales of its Epi+Gen CHD and PrecisionCHD clinical tests. The minimal revenue reflects the company's early-stage commercialization efforts and long sales cycles, which can extend up to 24 months. The company is focusing on multiple revenue channels including providers, health systems, and employers, and has begun international expansion to India. The company estimates that 146 million adults could potentially benefit from its Epi+Gen CHD test and 60 million adults from its PrecisionCHD test, representing addressable markets of approximately $125 billion and $51 billion respectively based on CMS gapfill pricing of $854 per test.
The company operates at a significant loss with negative operating margins. With revenue of only $15,000 against operating expenses of $6.5 million, the operating loss margin is substantial. The cost structure is dominated by general and administrative expenses ($5.0 million), which includes payroll, legal, insurance, and other overhead costs. Sales and marketing expenses were $767,000, and research and development expenses were $641,000. The company has not yet achieved scale to generate positive margins and continues to invest in commercialization, product development, and evidence generation to support future growth.
The company used $5.7 million in cash from operating activities during 2025, primarily due to the net loss of $6.5 million, adjusted for non-cash items including depreciation ($160,000), amortization ($238,000), and stock-based compensation ($110,000). Investing activities used $419,000 for purchases of property and equipment and patent costs. Financing activities provided $3.4 million from the sale of common stock and warrants, net of issuance costs. The balance sheet shows total assets of $7.8 million, including $5.9 million in current assets (primarily cash of $5.1 million). Total liabilities were $793,000, resulting in stockholders' equity of $7.0 million. The accumulated deficit increased to $29.2 million.
The company expects sales and partnership cycles to continue to be long, especially with current economic uncertainty. Key strategic priorities include leveraging CPT PLA codes and expanding reimbursement efforts with government and commercial payors, developing additional products for stroke, congestive heart failure and diabetes, expanding clinical evidence, offering laboratory services via its CLIA laboratory, and pursuing strategic partnerships or acquisitions. The company notes that obtaining broad payor coverage could take years, which may continue to constrain meaningful revenue generation. Regulatory developments regarding laboratory-developed tests (LDTs) present both risks and opportunities, with the FDA having rescinded its May 2024 final rule regulating LDTs following a federal court ruling.