INVO Fertility, Inc.
For the period ended Dec 31, 2025. Filed Jun 2, 2026.
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FY2025 · Filed Jun 2, 2026
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Item 8. Report of Independent Registered Public Accounting Firm
To the Board of Directors and Shareholders
INVO Fertility, Inc.
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheet of INVO Fertility, Inc. (the “Company”) as of December 31, 2025, and the related consolidated statements of operations, of Stockholders’ Equity and Mezzanine Equity, and of cash flows for year ended December 31, 2025, and the related notes to the consolidated financial statements (collectively referred to as the “consolidated financial statements”). In our opinion, the financial statements present fairly, in all material respects, the consolidated financial position of the Company as of December 31, 2025, and the results of its operations and its cash flows for the year ended December 31, 2025, in conformity with accounting principles generally accepted in the United States of America.
We also have audited the adjustments described in Note 1 that were applied to the recast of the December 31, 2024 consolidated balance sheet, consolidated statement of operations, and cash flows in relation to discontinued operations. In our opinion, such adjustments are appropriate and have been properly applied. We were not engaged to audit, review, or apply any procedures to the 2024 consolidated financial statements of the Company, other than with respect to the adjustment and, accordingly, we do not express an opinion or any other form of assurance on the 2024 consolidated financial statements taken as a whole.
Substantial Doubt Regarding Going Concern
The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. As noted in Note 3 to the consolidated financial statements, the Company has suffered recurring losses and negative cash flows from operations. This raises substantial doubt about the Company’s ability to continue as a going concern. Management’s plans regarding these matters are also included in Note 3. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These consolidated financial statements are the responsibility of the entity’s management. Our responsibility is to express an opinion on these financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the entity’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
Critical Audit Matter Description and How it Was Addressed in the Audit
Accounting for Goodwill Valuation and Impairment – Refer to Note 9
As reflected in the Company’s financial statements at December 31, 2025, the Company’s goodwill was approximately $5.9 million, which requires an annual impairment test. A qualitative assessment includes consideration of the economic, industry and market conditions in addition to the overall financial performance of the Company and these assets. If the qualitative assessment does not conclude that it is more likely than not that the estimated fair value of the reporting unit is greater than the carrying value, the Company performs a quantitative analysis. We identified the evaluation of the Company’s impairment test of goodwill as a critical audit matter due to significant management estimates and judgments inherently required in determining the fair value estimates. Due to these estimates relying heavily on management’s judgement about future performance and market conditions, evaluating the goodwill impairment analysis required significant auditor attention. Additionally, the audit effort involved the use of professionals with specialized skill and knowledge.
Our audit procedures included comparing past forecasts to actual results, assessing whether the valuation model was appropriate, and testing the key assumptions such as revenue growth, margins, discount rates, and long-term growth rates. We also used our valuation specialists to assist in evaluating the reasonableness of the valuation inputs.
Accounting for Complex Equity Transactions – Refer to Note 11, Note 13 and Note 15
The Company entered into several equity transactions during the year that included the issuance of convertible debentures and warrants with various terms and features. We identified the evaluation of the transactions as a critical audit matter due to the significant management estimates and judgements inherently required in determining the accounting treatment and valuation of these transactions. This, in turn, led to a high degree of auditor judgment, subjectivity, and effort in performing procedures to evaluate the reasonableness of management’s significant estimates and assumptions, several of which included the use of complex modeling in determining fair values of the equity instruments. Additionally, the audit effort involved the use of professionals with specialized skills and knowledge.
Our audit procedures included reviewing the underlying agreements, assessing management’s analysis of the applicable accounting literature, and testing the inputs and assumptions used in the fair value calculations. We also involved our valuation specialists to assist in evaluating the model used in the fair value calculations of warrants and derivative liabilities.
Accounting for Variable Interest Entities – Refer to Note 5
the Company has an investment in a joint venture that is a variable interest entity (“VIE”). Management concluded that the Company is not the primary beneficiary of the VIE and therefore did not consolidate the joint venture; instead, the Company accounts for the investment as a non-consolidated equity method investment. We identified the evaluation of the assessment as a critical audit matter due to the significant management judgements inherently required in determining the accounting treatment of the VIE. This, in turn, led to a high degree of auditor judgment, subjectivity, and effort in performing procedures and research to evaluate the reasonableness of management’s significant interpretations, positions and assumptions, several of which included analysis of the VIE’s activities and purposes as written in the partnership agreement compared to its actual operating activities in practice. Additionally, the audit effort involved the use of professionals with specialized skills and knowledge.
Our audit procedures included reviewing the underlying agreements and assessing management’s analysis of the applicable accounting literature. We also involved our technical accounting professionals to assist in evaluating the accounting treatment of the VIE and the reasonableness of management’s judgements.
Emphasis of Matter – Restatement of Unaudited Interim Consolidated Financial Statements
As discussed in Note 1 to the consolidated financial statements, the unaudited consolidated financial statements as of March 31, 2025 and for the three months ended March 31, 2025, as of June 30, 2025 and for the three and six months ended June 30, 2025 and as of September 30, 2025 and for the three and nine months ended September 30, 2025 have been restated to correct misstatements related to equity classifications, warrant classifications and settlement liabilities.
/s/WithumSmith+Brown, PC
We have served as the Company’s auditor since 2025.
Irvine, CA
June 2, 2026
PCAOB ID Number 100
To the Board of Directors and
Stockholders of INVO Fertility, Inc.
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheet of INVO Fertility, Inc. (former name: NAYA Biosciences, Inc. and INVO Bioscience, Inc.) (the Company) as of December 31, 2024, and the related consolidated statements of operations, stockholders’ equity, and cash flows for the year ended December 31, 2024, and the related notes (collectively referred to as the financial statements). In our opinion, the financial statements present fairly, before the effects of the adjustments for the reclassification of discontinued operations as described in Note 1, in all material respects, the financial position of the Company as of December 31, 2024, and the results of its operations and its cash flows for the year ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America.
We were not engaged to audit, review or apply any procedures to the adjustments for the reclassification of discontinued operations as described in Note 1, and accordingly, we do not express an opinion or any other form of assurance about whether such adjustments are appropriate and have been properly applied. Those adjustments were audit by WithumSmith+Brown, PC.
Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 3 to the consolidated financial statements, the Company has suffered net losses from operations and has a net capital deficiency, which raises substantial doubt about its ability to continue as a going concern. Management’s plans regarding those matters are discussed in Note 3. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audit provides a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Goodwill and Intangible Assets
As discussed in Note 4 and 9 to the consolidated financial statements, the Company acquired intangible assets through business combinations in 2024 and 2023. At each reporting period, certain intangible assets are required to be assessed annually for impairment based on the facts and circumstances at that time. Auditing management’s evaluation of intangible assets can be a significant judgment given the fact that the Company uses management estimates on future revenues and expenses which are not easily able to be substantiated.
Given these factors and due to significant judgements made by management, the related audit effort in evaluating management’s judgments in evaluation of intangible assets required a high degree of auditor judgment.
The procedures performed included evaluation of the methods and assumptions used by the Company, tests of the data used and an evaluation of the findings. We evaluated and tested the Company’s significant judgments that determine the impairment evaluation of intangible assets.
/s/ M&K CPAS, PLLC
M&K CPAS, PLLC
PCAOB ID: 2738
We served as the Company’s auditor from September 19, 2019 until September 5, 2025.
The Woodlands, TX
April 29, 2025
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