Form 8-K - Current report

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): November 22, 2023

INVO BIOSCIENCE, INC.

(Exact name of registrant as specified in its charter)

Nevada

001-39701

20-4036208

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

5582 Broadcast Court

Sarasota, Florida 34240

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (978) 878-9505

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:

Common Stock, $0.0001 par value		INVO		The Nasdaq Stock Market LLC
(Title of Each Class)		(Trading Symbol)		(Name of Each Exchange on Which Registered)

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (CFR §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 8.01 Other Events.

On November 28, 2023, INVO Bioscience, Inc., a Nevada corporation (the “Company”) announced that it had received a notice from The Nasdaq Stock Market, LLC (“Nasdaq”), dated November 22, 2023, informing the Company that it has regained compliance with Nasdaq’s Listing Rule 5550(b)(1) (the “Equity Rule”) for continued listing on The Nasdaq Capital Market, as the Company’s stockholders’ equity met or exceeded $2,500,000. The Company will be subject to a mandatory panel monitor for a period of one year from the date of the notification.

Nasdaq had previously notified the Company on November 23, 2022 that the Company was not in compliance with the Equity Rule because it failed to maintain stockholders’ equity of at least $2,500,000. In order to regain compliance with the rule, the Company was required to demonstrate stockholder’s equity of at least $2,500,000.

As a result of the exchange and based on the reduction in net loss demonstrated in the Company’s Form 10-Q for the quarter ended September 30, 2023, the ongoing and further expected reduction in certain operating costs, including the end of research and development expenses related to securing FDA clearance for the INVOcell label update, and profits from the operations of our previously-acquired clinic, Wisconsin Fertility Institute, the Company’s stockholders’ equity was sufficient to maintain its Nasdaq listing.

A copy of the Company’s press release is attached hereto as Exhibit 99.1 and incorporated into this Item 8.01 by reference.

Item 9.01 Financial Statements and Exhibits.

(d)	Exhibits

Exhibit		Description

99.1		Press Release dated November 28, 2023

104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURE

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: November 28, 2023

	INVO BIOSCIENCE, INC.

	By:	/s/ Steven Shum
		Steven Shum
		Chief Executive Officer

Exhibit 99.1

INVO Bioscience Regains Compliance with Nasdaq Minimum Stockholders’ Equity Requirement

SARASOTA, Fla., November 28, 2023 — INVO Bioscience, Inc. (Nasdaq: INVO) (“INVO” or the “Company”), a healthcare services company focused on expanding access to advanced fertility treatment worldwide with its INVOcell® medical device and the intravaginal culture (“IVC”) procedure it enables, today announced the Company received notice from The Nasdaq Capital Market, LLC (“Nasdaq”), dated November 22, 2023, informing INVO that it has regained compliance with the minimum stockholders’ equity requirement as set forth under NASDAQ Listing Rule 5550(b)(1) for continued listing on Nasdaq. The Company will be subject to a mandatory panel monitor for a period of one year from the date of the notification.

Nasdaq had previously notified INVO on November 23, 2022 that INVO was not in compliance with the minimum stockholders’ equity rule because it failed to maintain stockholders’ equity of at least $2,500,000. In order to regain compliance with the rule, the Company was required to demonstrate stockholder’s equity of at least $2,500,000.

On November 20, 2023, the Company entered into a share exchange agreement with Cytovia Therapeutics Holdings, Inc. (“Cytovia”) for Cytovia’s acquisition of 1,200,000 shares of the Company’s newly designated Series B Preferred Stock in exchange for 163,637 shares of common stock of NAYA Biosciences Inc. (“NAYA”) held by Cytovia valued at $6,000,000. On November 20, 2023, the Company and Cytovia closed on the exchange of shares. Prior to the share exchange, Cytovia owned $50,000,000 in NAYA shares which it received as partial consideration for the acquisition by NAYA of two NK Engager bi-specific antibodies targeting, respectively, GPC3 for the treatment of Hepatocellular Carcinoma and CD38 for the treatment of Multiple Myeloma.

As a result of the exchange and based on the significant reduction in net loss demonstrated in INVO’s Form 10-Q for the quarter ended September 30, 2023, the ongoing and further expected reduction in certain operating costs, including the end of research and development expenses related to securing FDA clearance for the INVOcell label update, and profits from the operations of our previously-acquired clinic, Wisconsin Fertility Institute, the Company’s stockholders’ equity was sufficient to maintain its Nasdaq listing.

As previously noted on October 23, 2023, INVO and NAYA, a company dedicated to increasing patient access to breakthrough treatments in oncology and regenerative medicine, jointly announced that they had entered into a definitive merger agreement (the “Merger”) for INVO to acquire NAYA Biosciences in an all-stock transaction. Both companies are continuing to work on outstanding closing conditions for the contemplated merger including, without limitation, the effectiveness of a registration statement on Form S-4 to be filed by the Company, the approval of the merger by INVO’s stockholders and NAYA’s stockholders, and the completion of equity financings.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, or the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts included in this press release are forward-looking statements. In some cases, forward-looking statements can be identified by words such as “believe,” “intend,” “expect,” “anticipate,” “plan,” “potential,” “continue,” or similar expressions. Such forward-looking statements include risks and uncertainties, and there are important factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These factors, risks, and uncertainties are discussed in INVO Bioscience’s filings with the Securities and Exchange Commission. Investors should not place any undue reliance on forward-looking statements since they involve known and unknown uncertainties and other factors which are, in some cases, beyond INVO Bioscience’s control which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects INVO Bioscience’s current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to operations, results of operations, growth strategy and liquidity. INVO Bioscience assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. The contents of any website referenced in this press release are not incorporated by reference herein.

CONTACT

INVO Bioscience:

Steve Shum

978-878-9505

sshum@invobio.com

INVO Investor Contact:

Robert Blum (Lytham Partners, LLC)

602-889-9700

INVO@lythampartners.com

Cover	Nov. 22, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 22, 2023
Entity File Number	001-39701
Entity Registrant Name	INVO BIOSCIENCE, INC.
Entity Central Index Key	0001417926
Entity Tax Identification Number	20-4036208
Entity Incorporation, State or Country Code	NV
Entity Address, Address Line One	5582 Broadcast Court
Entity Address, City or Town	Sarasota
Entity Address, State or Province	FL
Entity Address, Postal Zip Code	34240
City Area Code	(978)
Local Phone Number	878-9505
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.0001 par value
Trading Symbol	INVO
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false