Cardio Diagnostics Holdings, Inc. (CDIO) - Q3 2025 10-Q Summary
Business Context and Reporting Period
This Quarterly Report on Form 10-Q covers the period ended September 30, 2025. Cardio Diagnostics Holdings, Inc. is a medical technology company developing AI-driven DNA biomarker testing for cardiovascular disease. The company operates as a single segment focused on product testing, primarily offering the Epi+Gen CHD and PrecisionCHD tests. The company is classified as a smaller reporting company and an emerging growth company.
Key Financial Metrics
| Metric | Q3 2025 (3 Months) | Q3 2024 (3 Months) | YTD 2025 (9 Months) | YTD 2024 (9 Months) |
|---|---|---|---|---|
| Revenue | $2,855 | $6,580 | $11,270 | $30,378 |
| Net Loss | $(1,714,536) | $(1,412,566) | $(5,032,799) | $(6,864,145) |
| Loss Per Share (Basic/Diluted) | $(0.98) | $(1.73) | $(2.91) | $(9.07) |
| Cash and Cash Equivalents | $6,355,218 (as of Sept 30, 2025) | |||
| Total Assets | $8,788,902 (as of Sept 30, 2025) | |||
| Total Liabilities | $637,331 (as of Sept 30, 2025) | |||
| Stockholders' Equity | $8,151,571 (as of Sept 30, 2025) | |||
| Operating Cash Flow (YTD) | $(4,364,984) | $(3,600,809) |
Note: Per share data and share counts have been retroactively restated for a 1-for-30 reverse stock split effective May 12, 2025.
Material Changes vs. Prior Period
- Revenue Decline: Revenue decreased 56.6% year-over-year for the nine months ended September 30, 2025 ($11,270 vs. $30,378). Management attributes this to the conclusion of the Family Medicine Specialists' Heart Attack Prevention testing initiative. New provider onboarding is ongoing but involves a 1-3 quarter ramp-up period.
- Net Loss Reduction (YTD): The net loss decreased by $1.83 million year-over-year for the nine-month period. This improvement was primarily driven by a significant reduction in stock-based compensation expenses ($86,152 in 2025 vs. $2.57 million in 2024), partially offset by increased payroll and professional fees.
- Net Loss Increase (Quarterly): For the three months ended September 30, 2025, the net loss increased by $301,970 compared to the prior year quarter, driven by higher selling, general, and administrative (SG&A) expenses related to personnel and professional fees.
- Capital Structure: The company completed a 1-for-30 reverse stock split in May 2025 to regain compliance with Nasdaq minimum bid price requirements. Outstanding shares were reduced from approximately 52.16 million to 1.74 million (excluding rounding adjustments).
Guidance, Outlook, and Risks
- Liquidity and Capital Resources: The company holds $6.36 million in cash. Management expects to rely primarily on its At-the-Market (ATM) issuance program to fund operations for the remainder of 2025. As of November 12, 2025, the company had raised approximately $15.06 million net under the ATM agreement. The company anticipates needing additional capital to fund operations beyond the next 12 months.
- Operational Outlook: The company plans to launch its internal laboratory facility in the fourth quarter of 2025. Strategic focus remains on expanding adoption among providers, channel partners, and employers, and developing additional products for stroke, heart failure, and diabetes.
- Regulatory Environment: A federal district court vacated the FDA's final rule regarding Laboratory Developed Tests (LDTs) in March 2025, ruling that LDTs do not meet the definition of a medical device under the FD&C Act. This decision remains in effect as the government did not appeal.
- Internal Controls: Management concluded that disclosure controls and procedures were not effective as of September 30, 2025. A material weakness was identified regarding inadequate segregation of duties due to limited staff resources. Remediation plans, including approval matrices and automation, are in progress but not yet fully implemented.
- Legal Contingencies: The company faces potential claims regarding success fees from terminated placement agent agreements (Boustead Securities, Benchmark Company, Northland Securities). Management believes these claims are without merit and does not expect a material adverse impact, though no legal proceedings have been instigated.
Investor Verification Checklist
- Reverse Stock Split Impact: Verify that all historical per-share data and share counts in external models are adjusted for the 1-for-30 split effective May 12, 2025.
- Revenue Sustainability: Assess the timeline for revenue ramp-up from newly onboarded providers following the conclusion of the Family Medicine Specialists initiative.
- Cash Runway: Monitor the burn rate against the $6.36 million cash balance and the effectiveness of the ATM program in raising additional capital.
- Internal Control Remediation: Track the implementation of the remediation plan for the material weakness in segregation of duties to ensure future financial reporting reliability.
- Legal Claims: Monitor developments regarding the potential fee claims from Boustead Securities, Benchmark, and Northland Securities.