Cardio Diagnostics Holdings, Inc. (CDIO) - 10-K Summary
Business Context and Reporting Period
This Annual Report on Form 10-K covers the fiscal year ended December 31, 2025. Cardio Diagnostics Holdings, Inc. is a medical technology company developing and commercializing epigenetics-based clinical tests for cardiovascular disease (CVD), specifically coronary heart disease (CHD). The company operates as an Emerging Growth Company and a Smaller Reporting Company. Its primary products are Epi+Gen CHD (a three-year risk assessment test) and PrecisionCHD (an early detection test), both categorized as Laboratory-Developed Tests (LDTs). The company maintains a CLIA-certified laboratory in Iowa City, IA, and executive offices in Chicago, IL.
On May 12, 2025, the company effected a 1-for-30 reverse stock split. All share and per-share data in this summary reflect this adjustment retroactively.
Key Financial Metrics (Year Ended Dec 31, 2025)
| Metric | 2025 | 2024 |
|---|---|---|
| Revenue | $14,825 | $34,890 |
| Net Loss | $(6,498,167) | $(8,383,453) |
| Operating Expenses | $6,498,903 | $8,400,767 |
| Cash and Cash Equivalents (End of Period) | $5,110,630 | $7,827,487 |
| Accumulated Deficit | $(29,250,000) | $(22,751,833) |
| Net Cash Used in Operating Activities | $(5,726,833) | $(4,993,104) |
| Net Cash Provided by Financing Activities | $3,429,286 | $11,941,258 |
Capital Structure: As of March 13, 2026, there were 2,959,469 shares of common stock outstanding. The company has an At-the-Market (ATM) sales agreement with Craig-Hallum Capital Group, LLC, under which it sold 292,495 shares in 2025 for gross proceeds of $3.9 million. Subsequent to year-end, an additional 1,133,418 shares were sold for $3.8 million.
Material Changes vs. Prior Period
- Revenue Decline: Revenue decreased by approximately 57% from $34,890 in 2024 to $14,825 in 2025. Management attributes this to the conclusion of a specific testing initiative with Family Medicine Specialists and the onboarding of smaller provider organizations with longer ramp-up times.
- Reduced Net Loss: The net loss narrowed by $1.9 million (22% decrease) primarily due to a significant reduction in General and Administrative (G&A) expenses, driven by lower stock-based compensation and reduced director and officer insurance costs.
- Expense Shifts: While G&A and Sales & Marketing expenses decreased, Research and Development (R&D) expenses increased by $413,246 (181%) due to increased R&D personnel.
- Liquidity Position: Cash reserves decreased by $2.7 million year-over-year, reflecting continued operating losses partially offset by financing proceeds from the ATM offering.
Guidance, Outlook, and Risks
Outlook and Strategy: The company expects to continue incurring losses as it invests in product adoption, marketing, and regulatory efforts. The primary focus for 2026 includes expanding reimbursement efforts with government and commercial payors (currently pursuing Medicare coverage), scaling internal operations, and exploring international expansion (specifically India). Management anticipates that sales and partnership cycles will remain long, potentially spanning 24 months.
Regulatory Environment: In September 2025, the FDA rescinded its May 2024 final rule regulating LDTs as medical devices following a federal court ruling. Oversight has reverted to the Clinical Laboratory Improvement Amendments (CLIA). However, the "VALID Act" was reintroduced in Congress in 2025, indicating ongoing legislative debate regarding LDT regulation.
Key Risks:
- Limited Operating History: The company has generated nominal revenue and has an unproven business model. There is no assurance it will ever achieve profitability.
- Reimbursement Uncertainty: Broad commercial success depends on securing third-party reimbursement (Medicare and commercial payors), a process that may take years. Currently, the company relies on self-pay and specific provider contracts.
- Liquidity and Capital Needs: The company requires additional capital to fund operations beyond the next 12 months. It relies primarily on the ATM offering, which is subject to market volatility and dilution.
- Nasdaq Compliance: The company previously faced delisting risks due to low stock price but regained compliance via the reverse stock split. Continued listing requires maintaining a minimum bid price of $1.00 and a market value of listed securities of at least $5 million.
- Internal Controls: Management identified a material weakness in internal control over financial reporting related to inadequate segregation of duties due to limited staff resources. Remediation efforts are ongoing.
Investor Verification Checklist
- Reimbursement Status: Verify the current status of Medicare coverage determinations for CPT codes 0439U (Epi+Gen CHD) and 0440U (PrecisionCHD) and any progress with commercial payors.
- Cash Runway: Assess the sufficiency of the $5.1 million cash balance against the burn rate of approximately $5.7 million annually to determine the immediate need for further capital raises.
- ATM Offering Capacity: Confirm the remaining capacity under the ATM agreement (approximately $5.3 million as of March 2026) and the impact of recent stock price volatility on the ability to raise funds.
- Regulatory Landscape: Monitor the status of the VALID Act in Congress and any potential new FDA guidance on LDTs that could alter the regulatory pathway.
- Internal Control Remediation: Review future filings for updates on the remediation of the material weakness regarding segregation of duties in financial reporting.