8-K

---

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 13, 2023

INVO

BIOSCIENCE, INC.

(Exact name of registrant as specified in its charter)

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

5582Broadcast Court

Sarasota,FL 34240

(Address of principal executive offices, including zip code)

(978) 878-9505

(Registrant’s telephone number, including area code)

NotApplicable

(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<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement<br> 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<br> Stock, $0.0001 par value	INVO	The<br> 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. ☐

Item2.02. Results of Operations and Financial Condition.

On November 13, 2023, INVO Bioscience, Inc. (the “Company”) issued a press release announcing financial results for the period ended September 30, 2023. The text of the press release is furnished as Exhibit 99.1 to this current report.

The information in this Item 2.02 and Exhibit 99.1 hereto shall not be deemed “filed” for the purposes of or otherwise subject to the liabilities under Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Unless expressly incorporated into a filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, the information contained in this Item 2.02 and Exhibit 99.1 hereto shall not be incorporated by reference into any Company filing, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Press Release dated November 13, 2023.
104	Cover<br> Page Interactive Data File (embedded within the Inline XBRL document.)

| -2- |

| --- |

---

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:<br> November 13, 2023	INVO BIOSCIENCE, INC.
	/s/ Steven Shum
	Steven<br> Shum
	Chief<br> Executive Officer

| -3- |

| --- |

---

---

Exhibit99.1

---

INVOReports Record Third Quarter 2023 Financial Results

CompanyExpects to Host Conference Call Shortly After November 20, 2023 Following the Progress of Certain Closing Conditions Pertaining to theAnnounced Merger Agreement with NAYA Biosciences

SARASOTA, Fla., Nov. 13, 2023 /PRNewswire/ — INVO Bioscience, Inc. (Nasdaq: INVO) (“INVO” or the “Company”), a healthcare services fertility company focused on expanding access to advanced treatment worldwide with its INVOcell® medical device and the intravaginal culture (“IVC”) procedure it enables, today announced financial results for the third quarter ended September 30, 2023 and provided a business update.

Q32023 Financial Highlights (all metrics compared to Q3 2022 unless otherwise noted)

●	Revenues<br> of $974,894 increased 314% compared to $235,321.
●	Q3<br> 2023 included only a partial quarter contribution from the recently acquired Wisconsin Fertility Institute (WFI). Pro forma revenue<br> for Q3 2023, assuming a full quarter of WFI, would have been approximately $1.5 million.
●	Adjusted<br> EBITDA was $(0.6) million compared to $(2.0) million. Pro forma adjusted EBITDA, assuming a full quarter contribution from WFI, would<br> have been $(0.3) million and the Company is on a progression towards positive earnings and operating cashflows.
●	Clinic<br> revenue increased 437% to $947,891, compared to $176,395. All reported clinic revenue is derived from the Company’s INVO Centers<br> in Atlanta, Georgia, and WFI (partial quarter) which are consolidated in the Company’s financial statements.
●	Revenue<br> from all clinics, inclusive of both those accounted for as consolidated and under the equity method, was $1,352,881, an increase<br> of 169% compared to $502,993.
●	Total<br> operating costs were approximately $1.9 million, a $0.9 million decrease compared to $2.8 million.
●	Net<br> loss was $(1.2) million compared to $(2.5) million. Pro forma net loss, assuming a full quarter contribution from WFI, would have<br> been $(1.0) million.
●	Exclusive<br> of corporate overhead, the clinics generated positive net income in the period.

RecentOperational and Strategic Highlights

●	On<br> August 10, 2023, INVO acquired WFI, a profitable Madison-based fertility center.
●	Implemented<br> certain corporate expense reductions as part of go-forward plan to focus on its healthcare service strategy and a near-term path<br> to profitability.
●	On<br> October 23, 2023, INVO and NAYA Biosciences Inc., a company dedicated to increasing patient access to breakthrough treatments in<br> oncology and regenerative medicine, jointly announced that they had entered into a definitive merger agreement for INVO to acquire<br> NAYA Biosciences, Inc. (“NAYA”) in an all-stock transaction.

ManagementCommentary

“The results of the quarter highlight the transformation of INVO into a growing, innovative healthcare services company leveraging our INVO Centers to drive IVC volume and obtain a greater share of the total fertility cycle revenue,” commented Steve Shum, CEO of INVO. “When you look at the pro forma results for the quarter inclusive of a full quarter contribution from WFI our adjusted EBITDA would have been $(0.3) million, a significant improvement compared to ($2.0) million in the year ago quarter. Equally notable was the fact that our clinics, exclusive of our corporate costs, generated positive net income in the period. With the potential for continued growth from our family of INVO Centers, and more rationalized corporate operating expenses, achieving our stated goal of profitability in 2024 becomes increasingly visible. We look forward to maintaining our focus on driving growth and efficiencies in the business moving forward.”

DefinitiveMerger Agreement

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. Under the terms of the agreement, NAYA Biosciences’ shareholders will receive 7.3333 shares of INVO for each share of NAYA Biosciences at closing, for a total of approximately 18,150,000 shares of INVO. Following the closing of the Merger, the combined company is expected to operate under the name “NAYA Biosciences”.

As described in greater detail in the Company’s SEC filings and press releases, the Merger remains subject to certain closing conditions including shareholder approval, an estimated $5 million or more (at NAYA’s discretion) in interim private financing in INVO at a premium of INVO’s market price at time of financing (“Interim PIPE”), and a private offering by the combined company at a target price of $5.00 per common share of INVO. At this time, there are no further updates on the satisfaction of the closing conditions.

“We are excited by the opportunity to merge INVO and NAYA and having the financial resources to advance both the fertility and newly acquired oncology operations,” commented Shum. “We believe this combination provides the benefit of bringing our existing, revenue-generating operations from our fertility business with an ability to further grow these activities, along with the significant upside potential of innovative cancer therapeutics.”

FinancialResults

Only partial quarter results from WFI, which INVO acquired on August 10, 2023, are included in the results for the three months ended September 30, 2023. Where applicable, pro forma results are provided as if the acquisition closed on July 1, 2023 and therefore would have been included for the entire quarter.

Revenue for the three months ended September 30, 2023, was $974,894 compared to $235,321 for the three months ended September 30, 2023, an increase of 314%. Pro forma revenue for Q3 2023, assuming a full quarter of WFI, would have been $1,492,520, an increase of 534%.

Clinic revenue from the Company’s consolidated INVO Centers was $947,891 during the third quarter of 2023, an increase of 437% compared to $176,395 for the three months ended September 30, 2022. Revenue from all INVO Centers combined was $1,352,881, an increase of 201% compared to the year-ago period.

Selling, general and administrative expenses for the three months ended September 30, 2023, were approximately $1.3 million compared to approximately $2.3 million for the three months ended September 30, 2022. The decrease of approximately $1.0 million, or approximately 46%, was primarily the result of approximately $1.1 million in decreased personnel expenses and approximately $0.2 million in decreased marketing expenses, and was partially offset by a $0.1 million increase in professional fees and a $0.1 million increase in operational expenses related to WFI.

R&D expenses were approximately $0.0 million and $0.2 million for the three months ended September 30, 2023, and September 30, 2022, respectively. The decrease is a result of the Company receiving FDA clearance in June 2023 for its 510(k) application.

Total operating costs were $1.9 million and $2. 8 million for the three months ended September 30, 2023, and September 30, 2022, respectively.

Net loss was $(1.2) million and $(2.5) million for the three months ended September 30, 2023, and September 30, 2022, respectively. Pro forma net loss, assuming a full quarter contribution from WFI, would have been approximately $(1.0) million.

Adjusted EBITDA (see Adjusted EBITDA Table) for the three months ended September 30, 2023, was $(0.6) million, compared to adjusted EBITDA of $(2.0) million for the quarter ended September 30, 2022. Pro forma adjusted EBITDA, assuming a full quarter contribution from WFI, would have been approximately $(0.3) million.

As of September 30, 2023, the Company had approximately $1.1 million in cash.

Useof Non-GAAP Measure

Adjusted EBITDA is a non-GAAP measure. This measure is not intended to be a substitute for those financial measures reported in accordance with GAAP. Adjusted EBITDA has been included because management believes that, when considered together with the GAAP figures, it provides meaningful information related to our operating performance and liquidity and can enhance an overall understanding of financial results and trends. Adjusted EBITDA may be calculated by us differently than other companies that disclose measures with the same or similar terms. See our attached financials for a reconciliation of this non-GAAP measure to the nearest GAAP measure.

ConferenceCall Details

INVO will announce details for a conference call in a future press release. The conference call is expected to be held after November 20, 2023, and following the progress of certain closing conditions pertaining to the Merger.

AboutINVO Bioscience

We are a healthcare services fertility company dedicated to expanding the assisted reproductive technology (“ART”) marketplace by making fertility care accessible and inclusive to people around the world. Our commercialization strategy is focused on the opening of dedicated “INVO Centers” offering the INVOcell® and IVC procedure (with three centers in North America now operational), the acquisition of US-based, profitable in vitro fertilization (“IVF”) clinics and the sale and distribution of our technology solution into existing fertility clinics. Our proprietary technology, INVOcell®, is a revolutionary medical device that allows fertilization and early embryo development to take place in vivo within the woman’s body. This treatment solution is the world’s first intravaginal culture technique for the incubation of oocytes and sperm during fertilization and early embryo development. This technique, designated as “IVC”, provides patients a more natural, intimate, and more affordable experience in comparison to other ART treatments. We believe the IVC procedure can deliver comparable results at a fraction of the cost of traditional IVF and is a significantly more effective treatment than intrauterine insemination (“IUI”). For more information, please visit www.invobio.com.

SafeHarbor Statement

This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company invokes the protections of the Private Securities Litigation Reform Act of 1995. All statements regarding our expected future financial position, results of operations, cash flows, financing plans, business strategies, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include words such as “anticipate,” “if,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “could,” “should,” “will,” and other similar expressions are forward-looking statements. All forward-looking statements involve risks, uncertainties, and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. Factors that may cause actual results to differ materially from those in the forward-looking statements include those set forth in our filings at www.sec.gov. We are under no obligation to (and expressly disclaim any such obligation to) update or alter our forward-looking statements, whether as a result of new information, future events, or otherwise.

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

INVO BIOSCIENCE, INC.

CONSOLIDATED BALANCE SHEETS

			December 31, 2022
ASSETS
Current assets
Cash	1,055,544		$	90,135
Accounts receivable	116,781			77,149
Inventory	254,220			263,602
Prepaid expenses and other current assets	365,227			190,201
Total current assets	1,791,772			621,087
Property and equipment, net	772,447			436,729
Lease right of use	5,858,042			1,808,034
Intangible assets	1,750,000			-
Goodwill	8,224,708			-
Investment in joint ventures	1,079,202			1,237,865
Total assets	19,476,171		$	4,103,715
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities
Accounts payable and accrued liabilities	1,851,783		$	1,349,038
Accrued compensation	590,598			946,262
Notes payable, current portion	822,574			100,000
Notes payable, related party	880,000			662,644
Deferred revenue	229,921			119,876
Lease liability, current portion	385,836			231,604
Other current liabilities	123,432			-
Total current liabilities	4,884,144			3,409,424
Notes payable, net of current portion	1,095,000			-
Lease liability, net of current portion	5,622,279			1,669,954
Deferred tax liability	1,949			1,949
Additional payments for acquisition	7,500,000			-
Total liabilities	19,103,372			5,081,327
Stockholders’ equity (deficit)
Common Stock, .0001 par value; 50,000,000 shares authorized; 2,474,756 and 608,611 issued and<br> outstanding as of September 30, 2023 and December 31, 2022, respectively	247			61
Additional paid-in capital	56,195,915			48,805,860
Accumulated deficit	(55,823,363	)		(49,783,533	)
Total stockholders’ equity (deficit)	372,799			(977,612	)
	-
Total liabilities and stockholders’ equity (deficit)	19,476,171		$	4,103,715

All values are in US Dollars.

INVO BIOSCIENCE, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

	For the Three Months Ended<br> September 30,						For the Nine Months Ended<br> September 30,
		2023			2022			2023			2022
Revenue:
Clinic revenue	$	947,891		$	176,395		$	1,499,636		$	394,601
Product revenue		27,003			58,926			139,185			149,453
Total revenue		974,894			235,321			1,638,821			544,054
Operating expenses:
Cost of revenue		580,968			248,977			1,047,687			616,184
Selling, general and administrative		1,257,044			2,316,763			5,630,487			7,308,478
Research and development		2,668			175,267			160,038			470,208
Depreciation and amortization		20,504			19,732			59,296			57,361
Total operating expenses		1,861,184			2,760,739			6,897,508			8,452,231
Loss from operations		(886,290	)		(2,525,418	)		(5,258,687	)		(7,908,177	)
Other income (expense):
Gain (loss) from equity method joint ventures		(8,163	)		(21,470	)		(32,110	)		(210,565	)
Interest income		-			34			-			307
Interest expense		(352,085	)		(1,761	)		(743,866	)		(3,319	)
Foreign currency exchange loss		(16	)		(1,008	)		(416	)		(2,922	)
Total other income (expense)		(360,264	)		(24,205	)		(776,392	)		(216,499	)
Loss before income taxes		(1,246,554	)		(2,549,623	)		(6,035,079	)		(8,124,676	)
Income taxes		1,886			-			4,751			800
Net loss	$	(1,248,440	)		(2,549,623	)		(6,039,830	)		(8,125,476	)
Net loss per common share:
Basic	$	(0.70	)	$	(4.19	)	$	(5.76	)	$	(13.42	)
Diluted	$	(0.70	)	$	(4.19	)	$	(5.76	)	$	(13.42	)
Weighted average number of common shares outstanding:
Basic		1,776,898			607,783			1,048,115			605,356
Diluted		1,776,898			607,783			1,048,115			605,356

ADJUSTED EBITDA

	Three Months Ended						Nine Months Ended
	September 30						September 30
	2023			2022			2023			2022
Net loss	$	(1,248,440	)	$	(2,549,623	)	$	(6,039,830	)	$	(8,125,476	)
Interest expense		40,924			1,727			131,607			3,012
Foreign currency exchange loss		16			1,008			416			2,922
Stock-based compensation		13,918			79,479			309,659			524,793
Stock option expense		251,555			426,143			904,305			1,287,427
Non-cash compensation for services		45,000			45,000			135,000			75,000
Amortization of debt discount		311,161			-			612,259			-
Depreciation and amortization		20,504			19,732			59,296			57,361
Adjusted EBITDA	$	(565,362	)	$	(1,976,534	)	$	(3,887,288	)	$	(6,174,961	)
Proforma net loss	$	(998,380	)	$	(2,057,245	)	$	(5,128,430	)	$	(9,571,686	)
Interest expense		40,924			1,727			131,607			3,012
Foreign currency exchange loss		16			1,008			416			2,922
Stock-based compensation		13,918			79,479			309,659			524,793
Stock option expense		251,555			426,143			904,305			1,287,427
Non-cash compensation for services		45,000			45,000			135,000			75,000
Amortization of debt discount		311,161			-			612,259			-
Depreciation and amortization		20,504			19,732			59,296			57,361
Proforma adjusted EBITDA	$	(315,302	)	$	(1,484,156	)	$	(2,975,888	)	$	(7,621,171	)

INVOCenter RESULTS

---

The following tables summarize the combined financial information of our consolidated and equity method joint venture INVO Centers:

	For the Three Months Ended<br> September 30,						For the Nine Months Ended<br> September 30,
	2023			2022			2023			2022
Statements of operations:
Operating revenue	$	1,352,881		$	502,993		$	2,712,021		$	1,170,378
Operating expenses		(1,231,274	)		(721,663	)		(2,745,932	)		(2,123,480	)
Net income	$	121,607		$	(218,670	)	$	(33,911	)	$	(953,102	)
	September 30, 2023			December 31, 2022
---	---	---	---	---	---	---
Balance sheets:
Current assets	$	577,496		$	447,422
Long-term assets		3,780,410			2,000,841
Current liabilities		(1,158,194	)		(735,767	)
Long-term liabilities		(2,777,250	)		(1,042,167	)
Net assets	$	422,462		$	670,329