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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 |
