Auditor shift and going concern language at INVO Fertility (NAYA)

Rhea-AI Filing Summary

INVO Fertility, Inc. filed an 8-K describing a change in its independent auditor and reiterating prior going concern language. On September 3, 2025, the company notified M&K CPAS, PLLC of its dismissal as independent registered public accounting firm, effective September 5, 2025, a decision approved by the board’s Audit Committee. M&K’s audit reports on the company’s 2023 and 2024 consolidated financial statements did not contain adverse or qualified opinions, but they did express substantial doubt about INVO Fertility’s ability to continue as a going concern. The company states there were no disagreements or reportable events with M&K. On September 5, 2025, the Audit Committee approved the engagement of WithumSmith+Brown, PC as the new independent registered public accounting firm for the year ending December 31, 2025, and INVO Fertility notes it had not previously consulted Withum on accounting or audit matters described in the 8-K.

Positive

• None.

Negative

• Going concern uncertainty: The prior audit reports for 2023 and 2024 from M&K stated there was substantial doubt about INVO Fertility’s ability to continue as a going concern.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported) September 3, 2025

INVO FERTILITY, INC.

(Exact name of registrant as specified in its charter)

Nevada		001-39701		20-4036208
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

5582 Broadcast Court

Sarasota, FL 34240

(Address of principal executive offices, including zip code)

(978) 878-9505

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.0001 par value		IVF		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 4.01 Changes in Registrant’s Certifying Accountant.

(a) Dismissal of Independent Registered Public Accounting Firm

On September 3, 2025, INVO Fertility, Inc. (the “Company”) notified M&K CPAS, PLLC (“M&K”) of its dismissal, effective September 5, 2025, as the Company’s independent registered accounting firm. The decision to change the independent registered public accounting firm was approved by the audit committee (the “Audit Committee”) of the board of directors of the Company.

M&K’s audit reports on the Company’s consolidated financial statements for the fiscal years ended December 31, 2023 and December 31, 2024 did not contain an adverse opinion or disclaimer of opinion and were not qualified as to uncertainty, audit scope, or accounting principles. M&K’s audit reports for the fiscal years ended December 31, 2023 and December 31, 2024 do, however, contain an expression of substantial doubt regarding the Company’s ability to continue as a going concern.

During the Company’s two most recent fiscal years and the subsequent interim period through September 5, 2025, there were no: (i) disagreements, as defined in Item 304(a)(1)(iv) of Regulation S-K under the Exchange Act of 1934, as amended (the “Exchange Act”) and the related instruction thereto, between the Company and M&K on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure, which disagreements, if not resolved to the satisfaction of M&K, would have caused M&K to make reference to the subject matter of the disagreements in connection with its audit report on the Company’s financial statements, or (ii) reportable events (as defined in Item 304(a)(1)(v) of Regulation S-K under the Exchange Act).

The Company has provided M&K with a copy of the disclosures made by the Company in response to this Item 4.01 and has requested that M&K furnish the Company with a letter addressed to the SEC stating whether it agrees with the statements made by the Company in response to this Item 4.01 and, if not, stating the respects in which it does not agree. A letter from M&K is attached hereto as Exhibit 16.1.

(b) Engagement of Independent Registered Public Accounting Firm

On September 5, 2025, the Audit Committee approved the engagement of WithumSmith+Brown, PC (“Withum”) effective immediately as the Company’s independent registered public accounting firm to audit the Company’s consolidated financial statements for the year ending December 31, 2025.

During the Company’s two most recent fiscal years and the subsequent interim period through September 5, 2025, neither the Company, nor anyone on its behalf, consulted Withum regarding (A) the application of accounting principles to a specific transaction, either completed or proposed, or the type of audit opinion that might be rendered on the Company’s financial statements, and neither a written report nor oral advice was provided to the Company by Withum that Withum concluded was an important factor considered by the Company in reaching a decision as to any accounting, auditing, or financial reporting issue, or (B) any matter that was either (i) the subject of a disagreement (as defined in Item 304(a)(1)(iv) of Regulation S-K under the Exchange Act), or (ii) a reportable event (as defined in Item 304(a)(1)(v) of Regulation S-K).

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
16.1		Letter from M&K CPAS, PLLC to the Securities and Exchange Commission dated September 5, 2025
104		Cover Page Interactive Data File (embedded within the Inline XBRL document.)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: September 5, 2025	INVO FERTILITY, INC.
	/s/ Steven Shum
	Steven Shum
	Chief Executive Officer

FAQ

What did INVO Fertility (NAYA) report about its auditor change?

INVO Fertility, Inc. reported that on September 3, 2025 it notified M&K CPAS, PLLC of its dismissal as its independent registered public accounting firm, effective September 5, 2025. The company’s Audit Committee approved this decision and, on September 5, 2025, approved the engagement of WithumSmith+Brown, PC as the new independent registered public accounting firm for the year ending December 31, 2025.

Did INVO Fertility (NAYA) have any disagreements with its former auditor M&K?

The company states that during its two most recent fiscal years and the interim period through September 5, 2025, there were no disagreements with M&K on accounting principles, financial statement disclosure, or auditing scope or procedures, and no reportable events as defined under Item 304(a)(1) of Regulation S-K.

What did the prior INVO Fertility (NAYA) audit reports say about going concern?

M&K’s audit reports on INVO Fertility’s consolidated financial statements for the fiscal years ended December 31, 2023 and December 31, 2024 did not contain adverse or qualified opinions, but they did include an expression of substantial doubt regarding the company’s ability to continue as a going concern.

Who is INVO Fertility’s (NAYA) new independent registered public accounting firm?

The Audit Committee approved the engagement of WithumSmith+Brown, PC as INVO Fertility’s independent registered public accounting firm, effective September 5, 2025, to audit the company’s consolidated financial statements for the year ending December 31, 2025.

Did INVO Fertility (NAYA) previously consult WithumSmith+Brown before appointing them?

INVO Fertility states that during its two most recent fiscal years and the interim period through September 5, 2025, neither the company nor anyone on its behalf consulted WithumSmith+Brown on the application of accounting principles to a specific transaction, the type of audit opinion that might be issued, or any matter involving a disagreement or reportable event.

What document did M&K provide in connection with its dismissal from INVO Fertility (NAYA)?

The company requested that M&K furnish a letter addressed to the SEC stating whether it agrees with INVO Fertility’s disclosures about the change in auditors. This letter is included as Exhibit 16.1 to the 8-K, dated September 5, 2025.