INVO Fertility, Inc.

INVO Fertility, Inc. operates within the fertility treatment and therapeutic development industry, focusing on providing access to in vitro fertilization through its proprietary INVOcell device and related clinic services. The company’s core business model is structured around three distinct operating segments: Fertility Clinic Services, the INVOcell Device, and Therapeutics. The Fertility Clinic Services segment generates revenue from the provision of fertility treatments and related services at company-owned clinics. The INVOcell Device segment derives revenue from the sale of the INVOcell product, a medical device used in the fertility treatment process. The Therapeutics segment is engaged in the development of therapeutic products, including in-process research and development assets acquired through business combinations. For the fiscal year ended December 31, 2025, the company reported total revenue of $6,969,000 ¹, a decrease from $8,036,000 ² in the prior year. The net loss attributable to common stockholders for 2025 was $17,092,000 ³, compared to a net loss of $14,258,000 ⁴ in 2024. The company’s financial position reflects significant ongoing operational losses and a complex capital structure involving multiple series of convertible preferred stock, convertible notes, and warrants.

Significant operational developments during the fiscal year included a series of financing transactions and amendments to existing debt agreements. The company entered into an Amended and Restated Debenture with a holder of its 7% Secured Convertible Debenture, which was subsequently amended and restated again in August 2025. Additionally, the company entered into an Exercise and Reload Agreement with a holder of Series C-2 Preferred Stock, and a Securities Purchase Agreement in December 2025 for the sale of common stock and warrants. The company also amended its related party demand notes with JAG Multi Investments, LLC, extending the maturity date and increasing the principal amount. A subsequent event in February 2026 involved a warrant inducement agreement and a private placement with Family Beginnings, PC, which included the issuance of Series D Preferred Stock. The company’s ability to continue as a going concern is dependent on its ability to raise additional capital, as it has experienced recurring losses and negative cash flows from operations.

The company’s outlook, as disclosed in the filing, is heavily contingent on its ability to secure additional financing to fund operations and meet its obligations. Management has stated that the company will need to raise additional capital to continue as a going concern. The filing does not provide specific quantitative revenue or earnings guidance for future periods. The company’s growth vectors are implied through its segment structure, with the Fertility Clinic Services segment being the primary revenue driver, generating $6,969,000 ¹ in external revenue for 2025, while the INVOcell Device segment generated $0 ⁵ in external revenue and the Therapeutics segment also generated $0 ⁶ in external revenue for the same period. The margin trajectory is not explicitly forecasted, but the company’s cost structure is reflected in its operating expenses, which include significant selling, general and administrative costs of $8,411,000 ⁷ for 2025, and research and development expenses of $1,000 ⁸ for the same year. Capital allocation plans are centered on managing liquidity through debt and equity financings, as evidenced by the numerous amendments to convertible notes and the issuance of preferred stock and warrants during the year. The company’s future performance is tied to its ability to grow clinic revenue and advance its therapeutic pipeline, though no specific milestones or timelines are provided in the filing.

The most material risks disclosed in the filing center on the company’s liquidity and going concern status, as it has experienced recurring losses from operations and negative cash flows. The company explicitly states that it will need to raise additional capital to continue as a going concern, and there is no assurance that such financing will be available on acceptable terms. A significant operational risk is the company’s dependence on a single product, the INVOcell device, and its fertility clinic services for all of its revenue. The company faces intense competition in the fertility services market from larger, better-capitalized providers. Regulatory risks are present as the company’s products and services are subject to extensive FDA and other governmental regulations. The company’s substantial debt obligations, including convertible notes payable of $1,000 ⁹ and related party demand notes of $1,000 ¹⁰ as of December 31, 2025, create financial risk, particularly given the conversion features and potential dilution for existing shareholders. The company also faces risks related to its ability to maintain the listing of its common stock on The Nasdaq Stock Market.

The tone of management’s message, as reflected in the business overview and risk factors, is one of cautious necessity, emphasizing the critical need for additional capital to sustain operations. Management’s primary strategic priorities, as disclosed, are to continue operating its fertility clinics, to develop and commercialize the INVOcell device, and to advance its therapeutic assets. The filing does not include a direct letter to shareholders or specific forward-looking guidance ranges from management. The strategic emphasis is on navigating the company’s liquidity challenges through ongoing financing activities, including the amendment of existing debt instruments and the issuance of equity and equity-linked securities. The company’s ability to execute its business plan is explicitly tied to its success in raising capital, as stated in the going concern disclosure.