# EDGAR Filing Document

**Accession Number:** 0001417926
**File Stem:** 0001641172-25-026757
**Filing Date:** 2025-9
**Character Count:** 8613
**Document Hash:** 4ebbdcb68b2df01cb76c4df04cf6cec8
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001641172-25-026757.hdr.sgml**: 20250905

**ACCESSION NUMBER**: 0001641172-25-026757

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20250903

**ITEM INFORMATION**: Changes in Registrant's Certifying Accountant

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250905

**DATE AS OF CHANGE**: 20250905

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** INVO Fertility, Inc.
- **CENTRAL INDEX KEY:** 0001417926
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 204036208
- **STATE OF INCORPORATION:** NV
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-39701
- **FILM NUMBER:** 251297591

**BUSINESS ADDRESS:**
- **STREET 1:** 5582 BROADCAST COURT
- **CITY:** SARASOTA
- **STATE:** FL
- **ZIP:** 34240
- **BUSINESS PHONE:** (978) 878-9505

**MAIL ADDRESS:**
- **STREET 1:** 5582 BROADCAST COURT
- **CITY:** SARASOTA
- **STATE:** FL
- **ZIP:** 34240

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** NAYA Biosciences, Inc.
- **DATE OF NAME CHANGE:** 20241022

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** INVO Bioscience, Inc.
- **DATE OF NAME CHANGE:** 20090106

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** EMY'S SALSA AJI DISTRIBUTION COMPANY, INC.
- **DATE OF NAME CHANGE:** 20071108

?xml version='1.0' encoding='ASCII'?

**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)

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| | | |
|:---|:---|:---|
| **Nevada** | **001-39701** | **20-4036208** |
| (State or other jurisdiction<br> of incorporation) | (Commission<br> File Number) | (I.R.S. Employer<br> 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:

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| | | |
|:---|:---|:---|
| **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) <u>Dismissal of Independent Registered Public Accounting Firm</u>

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) <u>Engagement of Independent Registered Public Accounting Firm</u>

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).

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| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits.** |

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(d) Exhibits

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 16.1 | [Letter from M&K CPAS, PLLC to the Securities and Exchange Commission dated September 5, 2025](ex16-1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document.) |

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**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.

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

---

## Exhibit 16.1

**Exhibit 16.1**

![](ex16-1_001.jpg)

Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549

Re: INVO Fertility, Inc., Form 8-K Filing Dated September 5, 2025

Ladies and Gentlemen:

We have read the statements included under Item 4.01 of the Form 8-K filed by INVO Fertility, Inc. (the "Company") with the Securities and Exchange Commission, dated September 5, 2025, regarding the change in the Company's independent registered public accounting firm. We agree with the statements concerning our Firm in such Form 8-K; we are not in a position to agree or disagree with the other statements of INVO Fertility, Inc. contained therein.

Sincerely,

*/s/ M&K CPA's, PLLC*

 

M&K CPAS, PLLC

The Woodlands, TX

September 5, 2025