INVO Fertility, Inc. (IVF) - 10-K Summary for Fiscal Year Ended December 31, 2025
Business Context and Reporting Period
Company: INVO Fertility, Inc. (formerly NAYA Biosciences, Inc.)
Reporting Period: Fiscal Year Ended December 31, 2025
Business Model: Healthcare services and technology company focused on the fertility marketplace. The company operates four fertility clinics in the U.S. (Wisconsin, Alabama, Georgia, and recently Indiana) offering In Vitro Fertilization (IVF) and Intravaginal Culture (IVC) using its proprietary INVOcell device. The company divested its oncology subsidiary, NAYA Therapeutics, Inc. (NTI), in June 2025 to refocus exclusively on fertility services.
Key Financial Metrics
| Metric | 2025 | 2024 |
|---|---|---|
| Total Revenue | $6.84 million | $6.53 million |
| Net Loss (Continuing Ops) | $(5.34) million | $(7.74) million |
| Net Loss (Including Discontinued Ops) | $(23.32) million | $(9.26) million |
| Cash and Cash Equivalents (End of Period) | $2.08 million | $0.62 million |
| Working Capital | $(7.57) million | $(16.61) million |
| Stockholders' Equity | $7.22 million | $12.58 million |
| Accumulated Deficit | $(91.37) million | $(67.33) million |
Note: The filing text does not provide a specific gross margin percentage, but Cost of Services was $4.28 million against Clinic Revenue of $6.72 million.
Material Changes vs. Prior Period
- Revenue Growth: Total revenue increased 5% to $6.84 million, driven primarily by increased clinical revenue from consolidated clinics (Georgia JV and WFI).
- Discontinued Operations: The company divested NAYA Therapeutics (NTI) in June 2025, resulting in a $16.45 million loss from discontinued operations and a $1.53 million loss on disposition. This significantly impacted the total net loss for 2025 compared to 2024.
- Impairment Charges: Recognized a $1.40 million impairment of intangible assets related to the release of a non-compete agreement in the settlement of the Dr. Pritts litigation. Additionally, a $14.65 million goodwill impairment was recorded for the NTI segment prior to divestiture.
- Financing Activity: Raised approximately $12.4 million from the sale of common stock and $2.9 million from preferred stock sales in 2025. In January 2026 (subsequent event), raised an additional $7.5 million via warrant exercise.
- Debt Restructuring: Extinguished the FNL Senior Secured Convertible Debenture through a series of exchanges for Series C-2 Preferred Stock during 2025.
Guidance, Outlook, Risks, and Contingencies
Outlook and Strategy: Management plans to grow clinic revenue organically and pursue additional profitable fertility clinic acquisitions. The company expects to remain dependent on debt and equity financing to fund operations until it generates sufficient positive cash flow.
Going Concern: The company has incurred an accumulated net loss of $91.4 million since inception. Management has raised substantial doubt about the company's ability to continue as a going concern, as current cash is not expected to fund operations and service debt for the next 12 months without additional financing.
Material Risks:
- Liquidity: Substantial secured indebtedness exists; failure to service debt could lead to asset liquidation.
- Regulatory: Evolving state laws regarding abortion and embryo personhood (e.g., Alabama ruling) could restrict IVF services. The company is subject to FDA regulation for its INVOcell device.
- Internal Controls: The company identified material weaknesses in internal control over financial reporting, including limited segregation of duties and lack of adequate accounting resources for complex transactions.
- Nasdaq Compliance: The company received letters from Nasdaq in April and May 2026 regarding late filing of the 2025 10-K and Q1 2026 10-Q, placing it at risk of delisting if a compliance plan is not accepted.
Contingencies: A $6.0 million settlement liability was established with Dr. Elizabeth Pritts regarding the WFI acquisition. Payments are scheduled through December 2026, with acceleration clauses tied to future fundraising.
Investor Verification Checklist
- Cash Runway: Verify the sufficiency of the $2.08 million cash balance against the $6.0 million Pritts settlement liability and ongoing operating losses.
- Nasdaq Status: Confirm the status of the compliance plan submitted to Nasdaq to avoid delisting.
- Debt Covenants: Review the terms of the Decathlon Revenue Loan and JAG Notes for potential default triggers given the liquidity constraints.
- Internal Controls: Assess the progress of remediation efforts for the identified material weaknesses in financial reporting.
- Regulatory Landscape: Monitor legislative developments in states where clinics operate (Wisconsin, Alabama, Georgia, Indiana) regarding embryo personhood and IVF restrictions.
- Subsequent Events: Review the impact of the February 2026 acquisition of Family Beginnings and the January 2026 warrant inducement on the capital structure.