10-K/A

UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

WASHINGTON,

D.C. 20549

FORM

10-K/A

(AmendmentNo. 3)

☒	Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
	For the fiscal year ended December 31, 2023

or

☐	Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
	For the transition period from               to

NAYA

BIOSCIENCES, INC. (FORMER NAME: INVO BIOSCIENCE, INC.)

(Exact name of registrant as specified in Charter)

Nevada	001-39701	20-4036208
(State<br> or other jurisdiction of incorporation or organization)	(Commission<br><br> <br>File<br> No.)	(IRS<br> Employee<br><br> <br>Identification<br> No.)

5582Broadcast Court Sarasota, Florida, 34240

(Address of Principal Executive Offices)

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

Securities

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

Title<br> of each class	Trading<br> symbol(s)	Name<br> of each exchange on which registered
Common Stock, $0.0001 par value per share	NAYA	The Nasdaq Stock Market LLC

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES ☐ NO ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. YES ☐ NO ☒

Indicate

by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES ☒ NO ☐

Indicate

by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). YES ☒ NO ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large<br> accelerated filer ☐	Accelerated<br> filer ☐
Non-accelerated<br> filer ☐	Smaller<br> reporting company ☒
	Emerging<br> 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. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). YES ☐ NO ☒

The

aggregate market value of the voting stock and non-voting common equity held by non-affiliates of the registrant as of the last business day of the registrant’s most recently completed second fiscal quarter ended June 30, 2023 was $3,072,404 based upon the closing price of the registrant’s common stock of $4.00 on the NASDAQ as of that date.

The

number of shares outstanding of the registrant’s common stock, $0.0001 par value, as of November 19, 2024 was 4,935,728.

DOCUMENTS

INCORPORATED BY REFERENCE

None.

Explanatory

Note

This Amendment No. 3 to Form 10-K (this “Amendment” or “Amendment No. 3”) amends the Annual Report on Form 10-K for the fiscal year ended December 31, 2023 originally filed on April 16, 2024 (the “Original Filing”) and amended on April 17, 2024 (the “First Amendment”) and on April 29, 2024 (the “Second Amendment”) by NAYA Biosciences, Inc., a Nevada corporation formerly known as INVO Bioscience, Inc. (“NAYA,” the” Company,” “we,” or “us”). We are filing this Amendment to restate our financial statements as of and for the periods ending December 31, 2023, September 30, 2023, June 30, 2023, March 31, 2023, December 31, 2022, September 30, 2022, June 30, 2022, March 31, 2022, December 31, 2021, September 30, 2021, and June 30, 2021 (collectively, the “Previous Financial Statements”). The Previous Financial Statements are restated to correct the discount rates for the valuation of the Company’s right of use asset and corresponding lease liability in each of the Previous Financial Statements. In each of the Previous Financial Statements, the Company had incorrectly used the applicable federal rate rather than the Company’s incremental borrowing rate.

The impact of this error is limited to the Company’s assets and liabilities, and the error did not impact the Company’s revenue, results of operation, earnings (loss) per share, or net equity. The error has not resulted in any change to the Company’s business plan or operations and does not impact any regulatory requirements or management compensation.

This Amendment does not reflect events occurring after the filing of our Original Filing, or modify or update those disclosures, except as disclosed in our financial statement footnote subsequent event disclosures. The following sections of our Original Filing have been amended:

● Part II - Item 8 - Financial Statements and Supplementary Data; and

● Part II - Item 9A – Controls and Procedures

This Amendment has been signed as of a current date and all certifications of our Chief Executive Officer and Chief Financial Officer are given as of a current date. Accordingly, this Amendment should be read in conjunction with our filings made with the Securities and Exchange Commission subsequent to the filing of the Original Filing, the First Amendment, and the Second Amendment.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

Certain statements, other than purely historical information, including estimates, projections, statements relating to our business plans, objectives, and expected operating results, and the assumptions upon which those statements are based, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements generally are identified by the words “believes,” “project,” “expects,” “anticipates,” “estimates,” “intends,” “strategy,” “plan,” “may,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. We intend such forward-looking statements to be covered by the safe-harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995, and are including this statement for purposes of complying with those safe-harbor provisions. Forward-looking statements are based on current expectations and assumptions that are subject to risks and uncertainties which may cause actual results to differ materially from the forward-looking statements. Our ability to predict results or the actual effect of future plans or strategies is inherently uncertain. Factors which could have a material adverse effect on our operations and future prospects on a consolidated basis include, but are not limited to changes in economic conditions, legislative or regulatory changes, availability of capital, interest rates, competition, and the impact of the COVID-19 pandemic on our ability to advance our clinical programs and raise additional financing and generally accepted accounting principles. These risks and uncertainties should also be considered in evaluating forward-looking statements and undue reliance should not be placed on such statements. We undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Further information concerning our business, including additional factors that could materially affect our financial results, is included herein and in our other filings with the Securities and Exchange Commission (“SEC”).

---

PartII

Item8. Financial Statements and Supplementary Data

	Page
Report of Independent Registered Public Accounting Firm (PCAOB ID No. 2738)	F-1
Restated<br> Consolidated Balance Sheets as of December 31, 2023 and 2022	F-2
Consolidated Statements of Operations for the Years Ended December 31, 2023 and 2022	F-3
Consolidated Statements of Stockholders’ Equity (Deficit) for the Period from January 1, 2022 to December 31, 2023	F-4
Restated<br> Consolidated Statements of Cash Flows for the Years Ended December 31, 2023 and 2022	F-5
Notes<br> to Restated Consolidated Financial Statements	F-6

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REPORT

OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and

Stockholders of NAYA Biosciences, Inc.

Opinionon the Consolidated Financial Statements

We have audited the accompanying consolidated balance sheets of NAYA Biosciences, Inc. (former name: INVO Bioscience, Inc.) (the Company) as of December 31, 2023 and 2022, and the related consolidated statements of operations, stockholders’ equity (deficit), and cash flows for each of the years in the two-year period ended December 31, 2023, and the related notes (collectively referred to as the financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the years in the two-year period ended December 31, 2023, in conformity with accounting principles generally accepted in the United States of America.

GoingConcern

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 4 to the consolidated financial statements, the Company has suffered net losses from operations and has a net capital deficiency, which raises substantial doubt about its ability to continue as a going concern. Management’s plans regarding those matters are discussed in Note 4. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Basisfor Opinion

These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.

Restatement of the 2023 and 2022 Consolidated FinancialStatements

---

As discussed in Note 2 to the consolidated financial statements, the accompanying 2023 and 2022 consolidated financial statements have been restated to correct for errors.

CriticalAudit Matter

The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.

Revenue Transactions and ImproperRevenue Recognition

As discussed in Note 1 to the consolidated financial statements, the Company recognizes revenue on arrangements in accordance with ASC 606, Revenue from Contracts with Customers. The core principle of ASC 606 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services. ASC 606 requires companies to assess their contracts to determine the timing and amount of revenue to recognize under the revenue standard. The model has a five-step approach:

Identify the contract with the customer.

Identify the performance obligations in the contract.

Determine the total transaction price.

Allocate the total transaction price to each performance obligation in the contract.

Recognize as revenue when (or as) each performance obligation is satisfied.

Auditing management’s evaluation of revenue from contracts with customers involves significant judgment, given the fact that the agreements require management’s evaluation, identification of the contract and the performance obligation, the total transaction price and the allocation of the total transaction price, the determination of when the performance obligation is satisfied, and consideration that revenue is an inherent fraud risk.

To evaluate the appropriateness and accuracy of the assessment by management, we evaluated management’s assessment in relationship to the relevant agreements.

/s/

M&K CPAS, PLLC

M&K CPAS, PLLC

PCAOB ID: 2738

We have served as the Company’s auditor since 2019.

The Woodlands, TX

April 16, 2024 (November 19, 2024, as to the effects of the restatement discussed in Note 2)

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NAYA

BIOSCIENCES, INC. (FORMER NAME: INVO BIOSCIENCE, INC.)

CONSOLIDATED

BALANCE SHEETS

			2022
			December<br> 31,
			2022<br> (Restated)
ASSETS
Current<br> assets
Cash	232,424		$	90,135
Accounts<br> receivable	140,550			77,149
Inventory	264,507			263,602
Prepaid<br> expenses and other current assets	622,294			190,201
Total<br> current assets	1,259,775			621,087
Property<br> and equipment, net	826,418			436,729
Lease<br> right of use	3,359,058			1,414,124
Intangible<br> assets, net	4,093,431			-
Goodwill	5,878,986			-
Investment in Legacy NAYA	2,172,000			-
Equity investments	916,248			1,237,865
Total<br> assets	18,505,916		$	3,709,805
LIABILITIES<br> AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current<br> liabilities
Accounts<br> payable and accrued liabilities	2,330,381		$	1,349,038
Accrued<br> compensation	722,251			946,262
Notes<br> payable - current portion, net	629,920			100,000
Notes<br> payable - related party, net	880,000			662,644
Notes<br> payable, net	880,000			662,644
Deferred<br> revenue	408,769			119,876
Lease<br> liability, current portion	181,574			160,185
Additional<br> payments for acquisition, current portion	2,500,000			-
Other<br> current liabilities	350,000			-
Total<br> current liabilities	8,002,895			3,338,005
Lease<br> liability, net of current portion	3,356,199			1,347,463
Notes payable – net of current portion	1,253,997			-
Deferred<br> tax liability	-			1,949
Additional<br> payments for acquisition, net of current portion	5,000,000			-
Total<br> liabilities	17,613,091			4,687,417
Stockholders’<br> equity (deficit)
Series<br> B Preferred Stock, 5.00<br> par value; 1,200,000<br> shares authorized; 1,200,000<br> and 0<br> issued and outstanding as of December 31,<br> 2023 and 2022, respectively.	6,000,000			-
Common<br> Stock, .0001<br> par value; 50,000,000<br> shares authorized; 2,492,531<br> and 608,611<br> issued and outstanding as of December 31,<br> 2023 and 2022, respectively	249			61
Additional<br> paid-in capital	52,710,721			48,805,860
Accumulated<br> deficit	(57,818,145	)		(49,783,533	)
Total<br> stockholders’ equity (deficit)	892,825			(977,612	)
Total<br> liabilities and stockholders’ equity (deficit)	18,505,916		$	3,709,805

All values are in US Dollars.

The

accompanying notes are an integral part of these consolidated financial statements.

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NAYA

BIOSCIENCES, INC. (FORMER NAME: INVO BIOSCIENCE, INC.)

CONSOLIDATED

STATEMENTS OF OPERATIONS

	2023			2022
	For the Years Ended
	December<br> 31,
	2023			2022
Revenue:
Clinic<br> revenue		2,862,574			614,854
Product<br> revenue		158,001			207,342
Total<br> revenue		3,020,575			822,196
Operating<br> expenses:
Cost<br> of revenue		1,934,437			850,770
Selling,<br> general and administrative expenses		7,486,454			9,976,563
Research<br> and development expenses		165,945			544,043
Depreciation<br> and amortization		200,894			77,301
Total<br> operating expenses		9,787,730			11,448,677
Loss<br> from operations		(6,767,155	)		(10,626,481	)
Other<br> income (expense):
Loss<br> from equity method joint ventures		(60,270	)		(200,558	)
Impairment from equity method joint venture		(89,794	)		-
Loss from debt extinguishment		(163,278	)		-
Interest<br> income		-			308
Interest<br> expense		(925,909	)		(59,445	)
Foreign<br> currency exchange loss		(420	)		(3,463	)
Total<br> other expenses		(1,239,671	)		(263,158	)
Net<br> loss before income taxes		(8,006,826	)		(10,889,639	)
Provision<br> for income taxes		27,786			2,872
Net<br> loss	$	(8,034,612	)	$	(10,892,511	)
Net<br> loss per common share:
Basic		(5.13	)		(17.97	)
Diluted		(5.13	)		(17.97	)
Weighted<br> average number of common shares outstanding:
Basic		1,565,951			606,130
Diluted		1,565,951			606,130

The

accompanying notes are an integral part of these consolidated financial statements.

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NAYA

BIOSCIENCES, INC. (FORMER NAME: INVO BIOSCIENCE, INC.)

CONSOLIDATED

STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)

	Shares		Amount		Shares		Amount		Capital			Deficit			Total
	Common<br> Stock				Preferred<br> Stock				Additional<br><br> Paid-in			Accumulated
	Shares		Amount		Shares		Amount		Capital			Deficit			Total
Balances,<br> December 31, 2021		596,457	$	60		0	$	0	$	46,201,642		$	(38,891,022	)	$	7,310,680
Common<br> stock issued to directors and employees		4,360		-		-		-		484,807			-			484,807
Common<br> stock issued for services		3,063		-		-		-		123,211			-			123,211
Proceeds<br> from the sale of common stock, net of fees and expenses		4,731		1		-		-		289,800			-			289,801
Stock<br> options issued to directors and employees as compensation		-		-		-		-		1,616,400			-			1,616,400
Warrants<br> issued with notes payable		-		-		-		-		90,000			-			90,000
Net<br> Loss		-		-		-		-		-			(10,892,511	)		(10,892,511	)
Balances,<br> December 31, 2022		608,611	$	61		-	$	-	$	48,805,860		$	(49,783,533	)		(977,612	)
Balances		608,611	$	61		-	$	-	$	48,805,860		$	(49,783,533	)		(977,612	)
Common<br> stock issued to directors and/or employees		4,269		-		-		-		56,936			-			56,936
Common<br> stock issued for services		50,817		5		-		-		287,445			-			287,450
Preferred<br> stock issued		-		-		1,200,000		6,000,000		(3,828,000	)		-			2,172,000
Proceeds<br> from the sale of common stock, net of fees and expenses		1,617,500		161		-		-		5,701,784			-			5,701,945
Common<br> stock issued for liability settlement		16,250		2		-		-		65,196			-			65,198
Common<br> stock issued with notes payable		4,167		1		-		-		56,313			-			56,314
Options<br> exercised for cash		297		-		-		-		2,375			-			2,375
Warrants<br> exercised (cashless)		43,985		4		-		-		(4	)		-			-
Prefunded warrant exercise		146,500		15		-		-		23,039			-			23,054
Stock<br> options issued to directors and employees as compensation		-		-		-		-		1,049,109			-			1,049,109
Warrants<br> issued with notes payable		-		-		-		-		490,668			-			490,668
Rounding<br> for reverse split		135		-		-		-		-			-			-
Net<br> loss		-		-		-		-		-			(8,034,612	)		(8,034,612	)
Balances,<br> December 31, 2023		2,492,531		249		1,200,000		6,000,000		52,710,721			(57,818,145	)		892,825
Balances		2,492,531		249		1,200,000		6,000,000		52,710,721			(57,818,145	)		892,825

The

accompanying notes are an integral part of these consolidated financial statements.

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NAYA

BIOSCIENCES, INC. (FORMER NAME: INVO BIOSCIENCE, INC.)

CONSOLIDATED

STATEMENTS OF CASH FLOWS

	For the Years Ended
	December<br> 31,
	2023			2022
	(Restated)
Cash<br> flows from operating activities:
Net<br> loss	$	(8,034,612	)	$	(10,892,511	)
Adjustments<br> to reconcile net loss to net cash used in operating activities:
Non-cash<br> stock compensation issued for services		287,450			123,211
Non-cash<br> stock compensation issued to directors and/or employees		56,936			484,807
Fair<br> value of stock options issued to employees		1,049,109			1,616,401
Non-cash<br> compensation for services		180,000			120,000
Amortization<br> of discount on notes payable		720,128			52,644
Loss<br> on impairment of intangible assets		-			132,227
Loss<br> from equity method investment		60,270			200,558
Impairment from equity method joint venture		89,794			-
Loss from debt extinguishment		163,278			-
Depreciation<br> and amortization		200,894			77,301
Changes<br> in assets and liabilities:
Accounts<br> receivable		(63,401	)		(26,679	)
Inventory		(905	)		24,171
Prepaid<br> expenses and other current assets		(432,093	)		92,550
Accounts<br> payable and accrued expenses		924,678			904,060
Accrued<br> compensation		(224,011	)		364,573
Deferred<br> revenue		288,893			113,976
Other<br> current liabilities		(226,568	)		-
Leasehold<br> liability		85,191			7,026
Accrued<br> interest		121,864			1,556
Deferred<br> tax liabilities		(1,949	)		810
Net<br> cash used in operating activities		(4,755,054	)		(6,603,319	)
Cash<br> used in investing activities:
Payments<br> to acquire property, plant, and equipment		(444,722	)		(10,785	)
Payments<br> to acquire intangible assets		-			(1,943	)
Investment<br> in joint ventures		(8,447	)		(68,489	)
Payment<br> for acquisitions		(2,041,710	)		-
Net<br> cash used in investing activities		(2,494,879	)		(81,217	)
Cash<br> from financing activities:
Proceeds<br> from notes payable		3,060,250			100,000
Proceeds<br> from notes payable – related parties		100,000			700,000
Proceeds<br> from the sale of common stock, net of offering costs		5,701,948			289,800
Proceeds from warrant exercise		23,051			-
Proceeds<br> from option exercise		2,375			-
Principal<br> payments on notes payable		(1,495,402	)		-
Net<br> cash provided by financing activities		7,392,222			1,089,800
Increase<br> in cash and cash equivalents		142,289			(5,594,736	)
Cash<br> and cash equivalents at beginning of period		90,135			5,684,871
Cash<br> and cash equivalents at end of period	$	232,424		$	90,135
Supplemental<br> disclosure of cash flow information:
Cash<br> paid during the period for:
Interest	$	9,640		$	-
Taxes	$	-		$	800
Noncash<br> activities:
Fair<br> value of warrants issued with debt	$	490,668		$	90,000
Fair value of common stock issued with<br> debt	$	56,314		$	-
Fair<br> value of shares issued for settlement of liability	$	65,198		$	-
Initial<br> ROU asset and lease liability	$	2,145,269		$	-
Fair value of Series B preferred shares<br> issued in exchange for shares of Legacy NAYA common stock	$	2,172,000		$	-

The

accompanying notes are an integral part of these consolidated financial statements.

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NAYA

BIOSCIENCES, INC. (FORMER NAME: INVO BIOSCIENCE, INC.)

NOTES

TO CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER

31, 2023

Note1 – Summary of Significant Accounting Policies

Descriptionof Business

NAYA Biosciences, Inc. a Nevada corporation formerly known as INVO Bioscience, Inc. (“NAYA” or the “Company”) is 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. The Company’s 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 (with one such clinic acquired in August 2023) and the sale and distribution of our technology solution into existing fertility clinics. The Company’s 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.

Basisof Presentation

The accompanying consolidated financial statements present on a consolidated basis the accounts of the Company and its wholly owned subsidiaries and controlled affiliates. The Company presents noncontrolling interest within the equity section of its consolidated balance sheets and the amount of consolidated net income (loss) that is attributable to the Company and to the noncontrolling interest in its consolidated statement of operations. All significant intercompany accounts and transactions have been eliminated in consolidation.

The Company uses the equity method of accounting when it owns an interest in an entity whereby it can exert significant influence over but cannot control the entity’s operations.

The preparation of the Company’s consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods.

The Company considers events or transactions that have occurred after the consolidated balance sheet date of December 31, 2023, but prior to the filing of the consolidated financial statements with the SEC in this Annual Report on Form 10-K, to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure, as applicable. Subsequent events have been evaluated through the date of the filing of this Annual Report on Form 10-K.

Reclassifications

Certain amounts in the consolidated financial statements for the prior year have been reclassified to conform to the current year presentation. These reclassifications had no impact on net earnings, financial position, or cash flows.

BusinessSegments

The Company operates in one segment and therefore segment information is not presented.

BusinessAcquisitions

The Company accounts for all business acquisitions at fair value and expenses acquisition costs as they are incurred. Any identifiable assets acquired and liabilities assumed are recognized and measured at their respective fair values on the acquisition date. If information about facts and circumstances existing as of the acquisition date is incomplete at the end of the reporting period in which a business acquisition occurs, the Company will report provisional amounts for the items for which the accounting is incomplete. The measurement period ends once the Company receives sufficient information to finalize the fair values; however, the period will not exceed one year from the acquisition date. Any adjustments to provisional amounts that are identified during the measurement period are recognized in the reporting period in which the adjustment amounts are determined.

VariableInterest Entities

The Company’s consolidated financial statements include the accounts of the Company, its wholly owned subsidiaries, and variable interest entities (“VIE”), where the Company is the primary beneficiary under the provisions of ASC 810, Consolidation (“ASC 810”). A VIE must be consolidated by its primary beneficiary when, along with its affiliates and agents, the primary beneficiary has both: (i) the power to direct the activities that most significantly impact the VIE’s economic performance; and (ii) the obligation to absorb losses or the right to receive the benefits of the VIE that could potentially be significant to the VIE. The Company reconsiders whether an entity is still a VIE only upon certain triggering events and continually assesses its consolidated VIEs to determine if it continues to be the primary beneficiary. See “Note 6 – Variable Interest Entities” for additional information on the Company’s VIEs.

| F-6 |

| --- |

EquityMethod Investments

Investments in unconsolidated affiliates, which the Company exerts significant influence but does not control or otherwise consolidate are accounted for using the equity method. Equity method investments are initially recorded at cost. These investments are included in investment in joint ventures in the accompanying consolidated balance sheets. The Company’s share of the profits and losses from these investments is reported in loss from equity method joint venture in the accompanying consolidated statements of operations. The Company monitors its investments for other-than-temporary impairment by considering factors such as current economic and market conditions and the operating performance of the investees and records reductions in carrying values when necessary.

Useof Estimates

In preparing financial statements in conformity with generally accepted accounting principles, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and revenues and expenses during the reported period. Actual results could differ from those estimates.

Cashand Cash Equivalents

For financial statement presentation purposes, the Company considers time deposits, certificates of deposit and all highly liquid investments with original maturities of three months or less to be cash and cash equivalents. At times, cash and cash equivalents balances exceed amounts insured by the Federal Deposit Insurance Corporation.

Inventory

Inventories consist of raw materials, work in process and finished goods and are stated at the lower of cost or net realizable value, using the first-in, first-out method as a cost flow method.

Propertyand Equipment

The Company records property and equipment at cost. Property and equipment is depreciated using the straight-line method over the estimated economic lives of the assets, which are from 3 to 10 years. The Company capitalizes the expenditures for major renewals and improvements that extend the useful lives of property and equipment. Expenditures for maintenance and repairs are charged to expense as incurred. The Company reviews the carrying value of long-lived assets for impairment at least annually or whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The recoverability of long-lived assets is measured by a comparison of its carrying amount to the undiscounted cash flows that the asset or asset group is expected to generate. If such assets are considered impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the property, if any, exceeds its fair market value.

Long-Lived Assets

Long-lived assets and certain identifiable assets related to those assets are periodically reviewed for impairment whenever circumstances and situations change such that there is an indication that the carrying amounts may not be recoverable. If the non-discounted future cash flows of the asset are less than their carrying amount, their carrying amounts are reduced to the fair value and an impairment loss recognized. There was no

impairment recorded during the year ended December 31, 2023,

and an impairment of $132,227

recorded during the year ended December 31, 2022.

| F-7 |

| --- |

FairValue of Financial Instruments

ASC 825-10-50, “Disclosures about Fair Value of Financial Instruments,” requires disclosure of the fair value of certain financial instruments. The carrying value of cash and cash equivalents, accounts payable and borrowings, as reflected in the balance sheets, approximate fair value because of the short-term maturity of these instruments.

Effective January 1, 2008, the Company adopted ASC 820-10, “Fair Value Measurements”, which provides a framework for measuring fair value under GAAP. ASC 820-10 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820-10 requires that valuation techniques maximize the use of observable inputs and minimize the use of unobservable inputs.

IncomeTaxes

The Company is subject to income taxes in the United States and its domestic tax liabilities are subject to the allocation of expenses in multiple state jurisdictions. The Company uses the asset and liability method to account for income taxes. Under this method, deferred income tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The recoverability of deferred tax assets is evaluated by assessing the adequacy of future expected taxable income from all sources, including taxable income in prior carryback years, reversal of taxable temporary differences, forecasted operating earnings and available tax planning strategies. To the extent the Company does not consider it more-likely-than-not that a deferred tax asset will be recovered, a valuation allowance is established.

Concentrationof Credit Risk

Cash includes amounts deposited in financial institutions in excess of insurable Federal Deposit Insurance Corporation (“FDIC”) limits. As of December 31, 2023, the Company did not have cash balances in excess of FDIC limits.

RevenueRecognition

The Company recognizes revenue on arrangements in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”). The core principle of ASC 606 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services ASC 606 requires companies to assess their contracts to determine the timing and amount of revenue to recognize under the new revenue standard. The model has a five-step approach:

1.	Identify<br> the contract with the customer.
2.	Identify<br> the performance obligations in the contract.
3.	Determine<br> the total transaction price.
4.	Allocate<br> the total transaction price to each performance obligation in the contract.
5.	Recognize<br> as revenue when (or as) each performance obligation is satisfied.

| F-8 |

| --- |

Revenue generated from the sale of INVOcell is typically recognized at the time the product is shipped, at which time the title passes to the customer, and there are no further performance obligations.

Revenue generated from clinical and lab services related at the Company’s affiliated INVO Centers is typically recognized at the time the service is performed.

StockBased Compensation

The Company accounts for stock-based compensation under the provisions of Accounting Standards Codification (“ASC”) subtopic 718-10, Compensation (“ASC 718-10”). This statement requires the Company to measure the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award. That cost is recognized over the period in which the employee is required to provide service or based on performance goals in exchange for the award, which is usually the vesting period.

LossPer Share

Basic loss per share calculations are computed by dividing net loss by the weighted-average number of common shares outstanding. Diluted earnings per share are computed similar to basic earnings per share except that the denominator is increased to include potentially dilutive securities. The Company’s diluted loss per share is the same as the basic loss per share for the years ended December 31, 2023, and 2022, as the inclusion of any potential shares would have had an anti-dilutive effect due to the Company generating a loss.

Schedule of Earnings Per Share Basic and Diluted

	2023			2022
	Year Ended<br> <br>December 31,
	2023			2022
Net<br> loss (numerator)	$	(8,034,612	)	$	(10,892,511	)
Basic<br> and diluted weighted-average number of common shares outstanding (denominator)		1,565,951			606,130
Basic<br> and diluted net loss per common share		(5.13	)		(17.97	)

The Company has excluded the following dilutive securities from the calculation of fully diluted shares outstanding because the result would have been anti-dilutive:

Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share

	2023		2022
	As<br> of December 31,
	2023		2022
Options		106,753		64,850
Convertible<br> notes and interest		42,416		-
Convertible preferred shares		1,200,000		-
Unit<br> purchase options and warrants		3,493,269		30,508
Total		4,842,438		95,358

| F-9 |

| --- |

RecentlyAdopted Accounting Pronouncements

The Company has reviewed all recently issued, but not yet effective, accounting pronouncements, and does not believe the future adoption of any such pronouncements will have a material impact on its financial condition or the results of its operations.

Note2 - Restatement of Previously Issued Consolidated Financial Statements

---

As a result of an internal review, the Company identified errors related to its borrowing rate for lease accounting in its previously issued (i) consolidated financial statements as of and for the years ended December 31, 2021, December 31, 2022, and December 31, 2023 included in its Annual Reports on Form 10-K for the years ended December 31, 2021, December 31, 2022, and December 31, 2023 (the “Annual Periods”) and (ii) unaudited condensed consolidated financial statements for the quarters ended June 30, 2021 through June 30, 2024 included in its Quarterly Reports on Form 10-Q for the periods ended March 31, 2022, June 30, 2022, September 30, 2022, March 31, 2023, June 30, 2023, September 30, 2023, March 31, 2024, and June 30, 2024 (the “Interim Periods”, which, together with the Annual Periods, the “Affected Periods”).

The review was prompted by the Company’s receipt of comments issued by the staff of the SEC upon its review of the Company’s annual and quarterly reports. After review of the staff’s comments, discussions with the staff, and investigation and further analysis, the Company determined that it had made an error in the application of generally accepted accounting principles by incorrectly utilizing the applicable federal rates as the discount rates for the valuation of the ROU asset and corresponding lease liability, rather than the Company’s incremental borrowing rates.

The Company evaluated the materiality of these misstatements both qualitatively and quantitatively in accordance with Staff Accounting Bulletin (“SAB”) No. 99, Materiality, and SAB No. 108, Considering the Effects of Prior Year Misstatements in Current YearFinancial Statements, and determined the effect of correcting these misstatements was material to the Affected Periods. As a result of the material misstatements, the Company has restated its consolidated financial statements for the Affected Periods in accordance with ASC 250, Accounting Changes and Error Corrections (the “Restated Consolidated Financial Statements”).

A reconciliation from the amounts previously reported for the Affected Periods to the restated amounts in the Restated Consolidated Financial Statements is provided for the impacted financial statement line items below for: (i) the consolidated balance sheets as of December 31, 2021, December 31, 2022, and December 31, 2023; and (ii) the consolidated statement of cash flows for the years ended December 31, 2021 and December 31, 2023, there was no impact on the consolidated statement of cash flows for the year ended December 31, 2022. The amounts labeled “Restatement Adjustments” represent the effects of the Restatement Adjustments.

| F-10 |

| --- |

The following table presents the effects of the Restatement Adjustments on the Company’s consolidated balance sheet as of December 31, 2021, December 31, 2022, and December 31, 2023:

Schedule of Consolidated Financial Statements

	As Previously		Restatement			As
	December 31, 2021
	As Previously		Restatement			As
	Stated		Adjustments			Restated
ASSETS
Lease right of use	$	2,037,052	$	(472,387	)	$	1,564,665
Total assets	$	10,466,380	$	(472,387	)	$	9,993,993
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Lease liability, current portion	$	221,993	$	(78,477	)	$	143,516
Total current liabilities	$	1,253,004	$	(78,477	)	$	1,174,527
Lease liability, net of current portion	$	1,901,557	$	(393,910	)	$	1,507,647
Total liabilities	$	3,155,700	$	(472,387	)	$	2,683,313
	As Previously		Restatement			As
---	---	---	---	---	---	---	---
	December 31, 2022
	As Previously		Restatement			As
	Stated		Adjustments			Restated
ASSETS
Lease right of use	$	1,808,034	$	(393,910	)	$	1,414,124
Total assets	$	4,103,715	$	(393,910	)	$	3,709,805
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Lease liability, current portion	$	231,604	$	(71,419	)	$	160,185
Total current liabilities	$	3,409,424	$	(71,419	)	$	3,338,005
Lease liability, net of current portion	$	1,669,954	$	(322,491	)	$	1,347,463
Total liabilities	$	5,081,327	$	(393,910	)	$	4,687,417

---

	As Previously		Restatement			As
	December 31, 2023
	As Previously		Restatement			As
	Stated		Adjustments			Restated
ASSETS
Lease right of use	$	5,740,929	$	(2,381,871	)	$	3,359,058
Total assets	$	20,887,787	$	(2,381,871	)	$	18,505,916
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Lease liability, current portion	$	397,554	$	(215,980	)	$	181,574
Total current liabilities	$	8,218,875	$	(215,980	)	$	8,002,895
Lease liability, net of current portion	$	5,522,090	$	(2,165,891	)	$	3,356,199
Total liabilities	$	19,994,962	$	(2,381,871	)	$	17,613,091

---

| F-11 |

| --- |

---

The following table presents the effects of the Restatement Adjustments on the Company’s consolidated statement of cash flows as of December 31, 2021, and December 31, 2023:

	As Previously		Restatement			As
	December 31, 2021
	As Previously		Restatement			As
	Stated		Adjustments			Restated
Supplemental disclosure of cash flow information:
Noncash activities:
Initial ROU asset and lease liability	$	2,096,055	$	(516,240	)	$	1,579,815
	As Previously		Restatement			As
---	---	---	---	---	---	---	---
	December 31, 2023
	As Previously		Restatement			As
	Stated		Adjustments			Restated
Supplemental disclosure of cash flow information:
Noncash activities:
Initial ROU asset and lease liability	$	4,269,881	$	(2,124,612	)	$	2,145,269

There was no impact on the statement of cash flows for the year ended December 31, 2022.

Note3 - Restatement of Previously Issued Unaudited Interim Consolidated Financial Statements

---

The following tables present the effects of the Restatement Adjustments described in Note 2 - Restatement of Previously Issued Consolidated Financial Statements on the Company’s unaudited interim consolidated financial statements for the periods ending June 30, 2021, September 30, 2021, March 31, 2022, June 30, 2022, September 30, 2022, March 31, 2023, June 30, 2023, and September 30, 2023. The Restatement Adjustments for the periods ending March 31, 2024 and June 30, 2024 can be found in the Company’s amended Form 10-Q for the period ending June 30, 2024, filed on November 19, 2024.

The following tables present the effects of the Restatement Adjustments on the Company’s unaudited interim consolidated balance sheets as of the dates indicated:

Schedule of Unaudited Interim Consolidated Financial Statements

	As Previously		Restatement			As
	June 30, 2021
	As Previously		Restatement			As
	Stated		Adjustments			Restated
	(unaudited)		(unaudited)			(unaudited)
ASSETS
Lease right of use	$	1,419,925	$	(390,878	)	$	1,029,046
Total assets	$	9,931,188	$	(390,878	)	$	9,540,310
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities
Lease liability, current portion	$	96,921	$	(48,876	)	$	48,045
Total current liabilities	$	1,717,053	$	(48,876	)	$	1,668,177
Lease liability, net of current portion	$	1,355,323	$	(342,002	)	$	1,013,321
Total liabilities	$	5,572,845	$	(390,878	)	$	5,181,967

| F-12 |

| --- | | | As Previously | | Restatement | | | As | | | --- | --- | --- | --- | --- | --- | --- | --- | | | September 30, 2021 | | | | | | | | | As Previously | | Restatement | | | As | | | | Stated | | Adjustments | | | Restated | | | | (unaudited) | | (unaudited) | | | (unaudited) | | | ASSETS | | | | | | | | | Lease right of use | $ | 1,391,228 | $ | (378,496 | ) | $ | 1,012,732 | | Total assets | $ | 8,145,547 | $ | (378,496 | ) | $ | 7,767,051 | | LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | | | | | | | | | Current liabilities | | | | | | | | | Lease liability, current portion | $ | 107,513 | $ | (48,375 | ) | $ | 59,138 | | Total current liabilities | $ | 2,139,832 | $ | (48,375 | ) | $ | 2,091,457 | | Lease liability, net of current portion | $ | 1,327,693 | $ | (330,121 | ) | $ | 997,572 | | Total liabilities | $ | 5,789,423 | $ | (378,496 | ) | $ | 5,410,927 | | | As Previously | | Restatement | | | As | | | --- | --- | --- | --- | --- | --- | --- | --- | | | March 31, 2022 | | | | | | | | | As Previously | | Restatement | | | As | | | | Stated | | Adjustments | | | Restated | | | | (unaudited) | | (unaudited) | | | (unaudited) | | | ASSETS | | | | | | | | | Lease right of use | $ | 1,980,153 | $ | (452,164 | ) | $ | 1,527,989 | | Total assets | $ | 8,520,233 | $ | (452,164 | ) | $ | 8,068,069 | | LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | | | | | | | | | Current liabilities | | | | | | | | | Lease liability, current portion | $ | 224,361 | $ | (76,809 | ) | $ | 147,552 | | Total current liabilities | $ | 1,084,242 | $ | (76,809 | ) | $ | 1,007,433 | | Lease liability, net of current portion | $ | 1,844,784 | $ | (375,355 | ) | $ | 1,469,429 | | Total liabilities | $ | 2,930,165 | $ | (452,164 | ) | $ | 2,478,001 | | | As Previously | | Restatement | | | As | | | --- | --- | --- | --- | --- | --- | --- | --- | | | June 30, 2022 | | | | | | | | | As Previously | | Restatement | | | As | | | | Stated | | Adjustments | | | Restated | | | | (unaudited) | | (unaudited) | | | (unaudited) | | | ASSETS | | | | | | | | | Lease right of use | $ | 1,923,020 | $ | (432,331 | ) | $ | 1,490,690 | | Total assets | $ | 6,424,873 | $ | (432,331 | ) | $ | 5,992,542 | | LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | | | | | | | | | Current liabilities | | | | | | | | | Lease liability, current portion | $ | 226,749 | $ | (75,078 | ) | $ | 151,671 | | Total current liabilities | $ | 1,279,885 | $ | (75,078 | ) | $ | 1,204,807 | | Lease liability, net of current portion | $ | 1,787,423 | $ | (357,252 | ) | $ | 1,430,171 | | Total liabilities | $ | 3,068,448 | $ | (432,330 | ) | $ | 2,636,118 |

| F-13 |

| --- | | | As Previously | | Restatement | | | As | | | --- | --- | --- | --- | --- | --- | --- | --- | | | September 30, 2022 | | | | | | | | | As Previously | | Restatement | | | As | | | | Stated | | Adjustments | | | Restated | | | | (unaudited) | | (unaudited) | | | (unaudited) | | | ASSETS | | | | | | | | | Lease right of use | $ | 1,865,648 | $ | (412,906 | ) | $ | 1,452,743 | | Total assets | $ | 4,678,275 | $ | (412,906 | ) | $ | 4,265,369 | | LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | | | | | | | | | Current liabilities | | | | | | | | | Lease liability, current portion | $ | 229,169 | $ | (73,282 | ) | $ | 155,887 | | Total current liabilities | $ | 1,660,994 | $ | (73,282 | ) | $ | 1,587,712 | | Lease liability, net of current portion | $ | 1,728,918 | $ | (339,624 | ) | $ | 1,389,294 | | Total liabilities | $ | 3,391,051 | $ | (412,906 | ) | $ | 2,978,145 | | | As Previously | | Restatement | | | As | | | --- | --- | --- | --- | --- | --- | --- | --- | | | March 31, 2023 | | | | | | | | | As Previously | | Restatement | | | As | | | | Stated | | Adjustments | | | Restated | | | | (unaudited) | | (unaudited) | | | (unaudited) | | | ASSETS | | | | | | | | | Lease right of use | $ | 1,750,175 | $ | (375,355 | ) | $ | 1,374,819 | | Total assets | $ | 6,151,156 | $ | (375,355 | ) | $ | 5,775,801 | | LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | | | | | | | | | Current liabilities | | | | | | | | | Lease liability, current portion | $ | 234,050 | $ | (69,489 | ) | $ | 164,561 | | Total current liabilities | $ | 4,450,007 | $ | (69,489 | ) | $ | 4,380,518 | | Lease liability, net of current portion | $ | 1,610,734 | $ | (305,866 | ) | $ | 1,304,867 | | Total liabilities | $ | 6,062,690 | $ | (375,355 | ) | $ | 5,687,335 | | | As Previously | | Restatement | | | As | | | --- | --- | --- | --- | --- | --- | --- | --- | | | June 30, 2023 | | | | | | | | | As Previously | | Restatement | | | As | | | | Stated | | Adjustments | | | Restated | | | | (unaudited) | | (unaudited) | | | (unaudited) | | | ASSETS | | | | | | | | | Lease right of use | $ | 4,004,962 | $ | (1,747,625 | ) | $ | 2,257,337 | | Total assets | $ | 6,638,894 | $ | (1,747,625 | ) | $ | 4,891,269 | | LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | | | | | | | | | Current liabilities | | | | | | | | | Lease liability, current portion | $ | 227,026 | $ | (121,487 | ) | $ | 105,540 | | Total current liabilities | $ | 4,469,150 | $ | (121,487 | ) | $ | 4,347,663 | | Lease liability, net of current portion | $ | 3,873,289 | $ | (1,626,138 | ) | $ | 2,247,151 | | Total liabilities | $ | 8,344,388 | $ | (1,747,625 | ) | $ | 6,596,763 |

| F-14 |

| --- | | | As Previously | | Restatement | | | As | | | --- | --- | --- | --- | --- | --- | --- | --- | | | September 30, 2023 | | | | | | | | | As Previously | | Restatement | | | As | | | | Stated | | Adjustments | | | Restated | | | | (unaudited) | | (unaudited) | | | (unaudited) | | | ASSETS | | | | | | | | | Lease right of use | $ | 5,858,042 | $ | (2,436,160 | ) | $ | 3,421,882 | | Total assets | $ | 19,476,171 | $ | (2,436,160 | ) | $ | 17,040,011 | | LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | | | | | | | | | Current liabilities | | | | | | | | | Lease liability, current portion | $ | 385,836 | $ | (216,527 | ) | $ | 169,309 | | Total current liabilities | $ | 4,884,144 | $ | (216,527 | ) | $ | 4,667,617 | | Lease liability, net of current portion | $ | 5,622,279 | $ | (2,219,633 | ) | $ | 3,402,646 | | Total liabilities | $ | 19,103,372 | $ | (2,436,160 | ) | $ | 16,667,212 |

The following tables present the effects of the Restatement Adjustments on the Company’s unaudited interim condensed consolidated statements of cash flows for the periods indicated:

	As Previously		Restatement			As
	For the Six Months Ended June 30,<br> 2021
	As Previously		Restatement			As
	Stated		Adjustments			Restated
	(unaudited)		(unaudited)			(unaudited)
Supplemental disclosure of cash flow information:
Noncash activities:
Initial ROU asset and lease liability	$	1,374,956	$	(396,534	)	$	978,422
	As Previously		Restatement			As
---	---	---	---	---	---	---	---
	For the Nine Months Ended September<br> 30, 2021
	As Previously		Restatement			As
	Stated		Adjustments			Restated
	(unaudited)		(unaudited)			(unaudited)
Supplemental disclosure of cash flow information:
Noncash activities:
Initial ROU asset and lease liability	$	1,374,956	$	(396,534	)	$	978,422

---

There was no impact on the statement of cash flows for the following periods (i) three months ended March 31, 2022, (ii) six months ended June 30, 2022, (iii) nine months ended September 30, 2022, and (iv) three months ended March 31, 2023.

---

	As Previously		Restatement			As
	For the Six Months Ended June 30,<br> 2023
	As Previously		Restatement			As
	Stated		Adjustments			Restated
	(unaudited)		(unaudited)			(unaudited)
Supplemental disclosure of cash flow information:
Noncash activities:
Initial ROU asset and lease liability	$	2,312,892	$	(1,390,372	)	$	922,520

---

---

	As Previously		Restatement			As
	For the Nine Months Ended September<br> 30, 2023
	As Previously		Restatement			As
	Stated		Adjustments			Restated
	(unaudited)		(unaudited)			(unaudited)
Supplemental disclosure of cash flow information:
Noncash activities:
Initial ROU asset and lease liability	$	4,269,881	$	(2,124,612	)	$	2,145,269

| F-15 |

| --- |

Note4 – Liquidity

Historically,

the Company has funded its cash and liquidity needs through revenue collection, equity financings, notes, and convertible notes. For the years ended December 31, 2023 and 2022, the Company incurred a net loss of approximately $8.0

million and $10.9

million, respectively, and has an accumulated

deficit of approximately $57.8

million as of December 31, 2023. Approximately $2.8

million of the net loss was related to non-cash

expenses for the year ended December 31, 2023, compared to $3.0 million for the year ended December 31, 2022.

The

Company has been dependent on raising capital through debt and equity financings to meet its needs for cash used in operating and investing activities. During 2022, the Company received proceeds of $0.8

million from demand notes and net proceeds of

approximately $0.3

million for the sale of its common stock. During 2023, the

Company received proceeds of $3.2

million from notes and net proceeds of approximately

$5.7 million for the sale of its common stock. Over the next 12 months, the Company’s plan includes growing the Wisconsin Fertility Institute and pursuing additional IVF clinic acquisitions. Until the Company can generate positive cash from operations, it will need to raise additional funding to meet its liquidity needs and to execute its business strategy. As in the past, the Company will seek debt and/or equity financing, which may not be available on reasonable terms, if at all.

Although the Company’s audited consolidated financial statements for the year ended December 31, 2023 were prepared under the assumption that it would continue operations as a going concern, the report of the Company’s independent registered public accounting firm that accompanies the Company’s consolidated financial statements for the year ended December 31, 2023 contains a going concern qualification in which such firm expressed substantial doubt about the Company’s ability to continue as a going concern, based on the consolidated financial statements at that time. Specifically, as noted above, the Company has incurred significant operating losses and the Company expects to continue to incur significant expenses and operating losses as it continues to ramp up the commercialization of INVOcell and develop new INVO Centers. These prior losses and expected future losses have had, and will continue to have, an adverse effect on the Company’s financial condition. If the Company cannot continue as a going concern, its stockholders would likely lose most or all of their investment in the Company.

Note5 – Business Combinations

WisconsinFertility Institute

On August 10, 2023, the Company, through Wood Violet Fertility LLC, a Delaware limited liability company (“Buyer”) and wholly owned subsidiary of INVO Centers LLC (“INVO CTR”), a Delaware company wholly-owned by the Company, consummated its acquisition of the Wisconsin Fertility Institute (“WFI”) for a combined purchase price of $10

million,

of which $2.5

million

was paid on the closing date (net cash paid was $2,150,000

after

a $350,000

holdback)

plus assumption of the inter-company loan owed by WFRSA (as defined below) in the amount of $528,756

.

The remaining three installments of $2.5

million

each will be paid on the subsequent three anniversaries of closing. The sellers have the option to take all or a portion of the final three installments in shares of the Company’s common stock valued at $125.00

,

$181.80

,

and $285.80 , for the second, third, and final installments, respectively.

WFI is comprised of (a) a medical practice, Wisconsin Fertility and Reproductive Surgery Associates, S.C., a Wisconsin professional service corporation d/b/a Wisconsin Fertility Institute (“WFRSA”), and (b) a laboratory services company, Fertility Labs of Wisconsin, LLC, a Wisconsin limited liability company (“FLOW”). WFRSA owns, operates and manages WFI’s fertility practice that provides direct treatment to patients focused on fertility, gynecology and obstetrics care and surgical procedures, and employs physicians and other healthcare providers to deliver such services and procedures. FLOW provides WFRSA with related laboratory services.

The Company purchased the non-medical assets of WFRSA and one hundred percent of FLOW’s membership interests. The Buyer and WFRSA entered into a management services agreement pursuant to which WFRSA outsourced all its non-medical activities to the Buyer.

The Company’s consolidated financial statements for the year ended December 31, 2023 include WFI’s results of operations. For the year ended December 31, 2023, WFI’s results of operations are included from the acquisition date of August 10, 2023 through December 31, 2023. The Company’s consolidated financial statements reflect the preliminary purchase accounting adjustments in accordance with ASC 805 “Business Combinations”, whereby the purchase price was allocated to the assets acquired and liabilities assumed based upon their estimated fair values on the acquisition date.

| F-16 |

| --- |

The following allocation of the purchase price is as follows:

Schedule of Allocation of Purchase Price

Consideration<br> given:
Cash	2,150,000
Holdback	350,000
Additional<br> payments	7,500,000
Business<br> acquisition cost	10,000,000
Assets<br> and liabilities acquired:
FLOW<br> intercompany receivable	528,756
Accounts receivable	214,972
Property<br> and equipment, net	25,292
Other current assets	56,274
Tradename	253,000
Noncompetition<br> agreement	3,961,000
Goodwill	5,878,986
Deferred revenue	(389,524	)
WFRSA<br> intercompany note	(528,756	)
Total<br> assets and liabilities acquired	10,000,000

ProForma Financial Information

The following unaudited pro forma consolidated results of operations for the years ended December 31, 2023 and 2022 assume the acquisition was completed on January 1, 2022:

Schedule of Pro Forma Financial Information

	2023			2022
	Year<br> Ended December 31,
	2023			2022
Pro<br> forma revenue		6,228,171			6,201,871
Pro<br> forma net loss		(7,123,212	)		(9,208,504	)

Pro forma data does not purport to be indicative of the results that would have been obtained had these events actually occurred at the beginning of the periods presented and is not intended to be a projection of future results. The share and per share data have been retroactively reflected for the acquisition.

As of December 31, 2023, the Company has $259,407

in undeposited funds held in reserve that it intends to use towards the Holdback amount once it becomes due.

Note6 – Variable Interest Entities

ConsolidatedVIEs

BloomINVO, LLC

On June 28, 2021, INVO Centers LLC, a Delaware limited liability company (“INVO CTR”) entered into a limited liability company operating agreement (the “Bloom Agreement”) with Bloom Fertility, LLC (“Bloom”) to establish a joint venture entity, formed as “Bloom INVO LLC” (the “Georgia JV”), for the purposes of commercializing INVOcell, and the related IVC procedure, through the establishment of an INVO Center, (the “Atlanta Clinic”) in the Atlanta, Georgia metropolitan area.

In

consideration for the Company’s commitment to contribute up to $800,000

within the 24-month period following the execution

of the Bloom Agreement to support the start-up operations of the Georgia JV, the Georgia JV issued 800

of its units to INVO CTR and in consideration

for Bloom’s commitment to contribute physician services having an anticipated value of up to $1,200,000

over the course of a 24-month vesting period,

the Georgia JV issued 1,200 of its units to Bloom.

The responsibilities of Bloom include providing all medical services required for the operation of the Atlanta Clinic. The responsibilities of INVO CTR include providing certain funding to the Georgia JV, lab services quality management, and providing access to and being the exclusive provider of the INVOcell to the Georgia JV. INVO CTR also performs all required, industry specific compliance and accreditation functions, and product documentation for product registration.

| F-17 |

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The Bloom Agreement provides Bloom with a “profits interest” in the Georgia JV and, in connection with such profits interest, states that profits and losses be allocated to its members based on a hypothetical liquidation of the Georgia JV. In such a scenario, liquidation proceeds would be distributed in the following order: (a) to INVO CTR until the difference between its capital contributions and distributions (the “Hurdle Amount”) equals $0

;

(b) to Bloom until its distributions equal 150 % of the liquidation amounts distributed to INVO CTR (a “catch-up” to rebalance the distributions between members); and (c) thereafter on a pro rata basis. The Georgia JV had no assets or liabilities at the time the units were issued, and, as of December 31, 2023, INVO CTR had made capital contributions greater than the net loss of the Georgia JV. As such, the entire net loss was allocated to INVO CTR, and no loss was allocated to the noncontrolling interest of Bloom.

The Georgia JV opened to patients on September 7, 2021.

The

Company determined the Georgia JV is a VIE, and that the Company is its primary beneficiary because the Company has an obligation to absorb losses that are potentially significant and the Company controls the majority of the activities that impact the Georgia JV’s economic performance, specifically control of the INVOcell and lab services quality management. As a result, the Company consolidated the Georgia JV’s results with its own. As of December 31, 2023, the Company invested $0.9

million in the Georgia JV in the form of capital

contributions as well as $0.5

million in the form of a note. For the years

ended December 31, 2023 and 2022, the Georgia JV recorded net losses of $0.2

million and $0.6

million, respectively. Noncontrolling interest in the Georgia JV was $0.

UnconsolidatedVIEs

HRCFG

INVO, LLC

On March 10, 2021, INVO CTR entered into a limited liability company agreement with HRCFG, LLC (“HRCFG”) to form a joint venture for the purpose of establishing an INVO Center in Birmingham, Alabama. The name of the joint venture entity is HRCFG INVO, LLC (the “Alabama JV”). The Company also provides certain funding to the Alabama JV. Each party owns 50% of the Alabama JV.

The Alabama JV opened to patients on August 9, 2021.

The

Company determined the Alabama JV is a VIE, and that there is no primary beneficiary. As a result, the Company uses the equity method to account for its interest in the Alabama JV. As of December 31, 2023, the Company invested $1.4

million in the Alabama JV in the form of a note.

For the years ended December 31, 2023 and 2022, the Alabama JV recorded net losses of $0.03

million and $0.3

million, respectively, of which the Company recognized

losses from equity method investments of $0.02

million and $0.2

million, respectively.

PositibFertility, S.A. de C.V.

On September 24, 2020, INVO CTR entered into a Pre-Incorporation and Shareholders Agreement with Francisco Arredondo, MD PLLC (“Arredondo”) and Security Health LLC, a Texas limited liability company (“Ramirez”, and together with INVO CTR and Arredondo, the “Shareholders”) under which the Shareholders will commercialize the IVC procedure and offer related medical treatments in Mexico. Each party owns one-third of the Mexican incorporated company, Positib Fertility, S.A. de C.V. (the “Mexico JV”).

The Mexico JV opened to patients on November 1, 2021.

The

Company determined the Mexico JV is a VIE, and that there is no primary beneficiary. As a result, the Company uses the equity method to account for its interest in the Mexico JV. As of December 31, 2023, the Company invested $0.1

million in the Mexico JV. For the years ended

December 31, 2023 and 2022, the Mexico JV recorded net losses of $0.1

million and $0.1

million, respectively, of which the Company recognized

a loss from equity method investments of $0.04

million and $0.05

million, respectively. As of December 31, 2023

the Company determined that this investment is impaired and recognized an impairment of $0.09 million.

| F-18 |

| --- |

The following table summarizes our investments in unconsolidated VIEs:

Schedule of Investments in Unconsolidated Variable Interest Entities

					Carrying<br> Value as of
	Location	Percentage<br> Ownership			December<br> 31, 2023		December<br> 31, 2022
HRCFG<br> INVO, LLC	Alabama,<br> United States		50	%	$	916,248		1,106,905
Positib<br> Fertility, S.A. de C.V.	Mexico		33	%		-		130,960
Total<br> investment in unconsolidated VIEs					$	916,248		1,237,865

Earnings from investments in unconsolidated VIEs were as follows:

Schedule of Earnings from Investments in Unconsolidated Variable Interest Entities

	2023			2022
	Year<br> Ended December 31,
	2023			2022
HRCFG<br> INVO, LLC	$	(16,293	)		(154,954	)
Positib<br> Fertility, S.A. de C.V.		(43,977	)		(45,604	)
Total<br> earnings from unconsolidated VIEs	$	(60,270	)		(200,558	)

The following tables summarize the combined unaudited financial information of our investments in unconsolidated VIEs:

Schedule of Financial Information of Investments in Unconsolidated Variable Interest Entities

	2023			2022
	Year<br> Ended December 31,
	2023			2022
Statements<br> of operations:
Operating<br> revenue	$	1,484,359			1,071,851
Operating<br> expenses		(1,648,890	)		(1,565,558	)
Net<br> loss	$	(164,531	)		(493,707	)
	December<br> 31, 2023			December<br> 31, 2022
---	---	---	---	---	---	---
Balance<br> sheets:
Current<br> assets	$	288,369			267,502
Long-term<br> assets		1,026,873			1,094,490
Current<br> liabilities		(510,091	)		(396,619	)
Long-term<br> liabilities		(123,060	)		(107,374	)
Net<br> assets	$	682,091			857,999

Note7 – Agreements and Transactions with VIE’s

The Company sells the INVOcell to its consolidated and unconsolidated VIEs and anticipates continuing to do so in the ordinary course of business. All intercompany transactions with consolidated entities are eliminated in the Company’s consolidated financial statements. Per ASC 323-10-35-8 the Company eliminates any sales to an unconsolidated VIE for INVOcell inventory that the VIE still has remaining on the books at period end.

The following table summarizes the Company’s transactions with VIEs:

Summary of Transaction with Variable Interest Entities

	2023		2022
	Year<br> Ended December 31,
	2023		2022
Bloom<br> Invo, LLC
INVOcell<br> revenue	$	24,000		13,500
Unconsolidated<br> VIEs
INVOcell<br> revenue	$	6,315		30,000

The Company had balances with VIEs as follows:

Summary of Balances with Variable Interest Entities

	December<br> 31, 2023		December<br> 31, 2022
Bloom<br> Invo, LLC
Accounts<br> receivable	$	31,500		13,500
Notes<br> payable		482,656		468,031
Unconsolidated<br> VIEs
Accounts<br> receivable	$	15,000		46,310

| F-19 |

| --- |

Note8 – Inventory

Components of inventory are:

Schedule of Inventory

	December<br> 31, 2023		December<br> 31, 2022
Raw<br> materials	$	53,479	$	68,723
Finished<br> goods		211,028		194,879
Total<br> inventory	$	264,507	$	263,602

Note9 – Property and Equipment

The estimated useful lives and accumulated depreciation for equipment are as follows as of December 31, 2023, and December 31, 2022:

Schedule of Estimated Useful Lives of Property and Equipment

	Estimated<br> Useful Life
Manufacturing<br> equipment	6<br> to 10<br> years
Medical<br> equipment	10<br> years
Office<br> equipment	3<br> to 7<br> years

Schedule of Property and Equipment

	December<br> 31, 2023			December<br> 31, 2022
Manufacturing<br> equipment	$	132,513		$	132,513
Medical<br> equipment		303,943			283,065
Office<br> equipment		85,404			77,601
Leasehold<br> improvements		538,151			96,817
Property,<br> plant and equipment, gross		538,151			96,817
Less:<br> accumulated depreciation		(233,593	)		(153,267	)
Total<br> equipment, net	$	826,418		$	436,729

During

each of the years ended December 31, 2023, and 2022, the Company recorded depreciation expense of $80,325

and $75,492

, respectively.

Note10 – Intangible Assets & Goodwill

Components of intangible assets are as follows:

Schedule of Finite-Lived Intangible Assets

****	December 31, 2023		****	December 31,<br><br> <br>2022
Tradename	$	253,000		$	-
Noncompetition<br> agreement		3,961,000			-
Goodwill		5,878,986			-
Less: accumulated amortization		(120,569	)		-
Total<br> intangible assets	$	9,972,417		$	-

The Company capitalizes the initial expense related to establishing patents by country and then amortizes the expense over the life of the patent, typically 20 years. It then expenses annual filing fees to maintain the patents. The Company regularly reviews the value of its patents in the marketplace in proportion to the expense it must spend to maintain the patent. The Company fully impaired its patents as of December 31, 2022.

During the years ended December 31, 2023, and 2022, the Company recorded amortization expenses related to patents of $0

and $1,809

, respectively.

The trademarks have an indefinite life and therefore are not amortized. Trademarks are periodically reviewed for impairment whenever circumstances and situations change such that there is an indication that the carrying amounts may not be recoverable. The Company fully impaired its trademarks related to the INVO name as of December 31, 2022.

As part of the acquisition of Wisconsin

Fertility Institute, that closed on August 10, 2023, the Company acquired tradename valued at $253,000, noncompetition agreements valued at $3,961,000 and goodwill of $5,878,986 which includes assembled workforce valued at $34,000. The tradename was deemed to have a useful life of 10 years. The noncompetition agreements were deemed to have a useful life of 5 years. The useful life of the noncompetition agreements was based on the noncompetition clauses in the FLOW Equity Purchase Agreement and WFRSA Asset Purchase Agreement, each of which provides that none of the sellers will engage in any business or services that compete with the respective businesses for 5 years.

Goodwill has an indefinite useful life and is therefore not amortized. The Company reviewed and found no indicators for impairment of the intangible assets related to the acquisition of Wisconsin Fertility Institute as of December 31, 2023.

| F-20 |

| --- |

Note11 – Leases

The Company has various operating lease agreements in place for its office and joint ventures. Per FASB’s ASU 2016-02, Leases Topic 842 (“ASU 2016-02”), effective January 1, 2019, the Company is required to report a right-of-use asset and corresponding liability to report the present value of the total lease payments, with appropriate interest calculation. Historically, the Company utilized the applicable federal rate as of the commencement of the lease; however the Company has determined that utilization of the applicable federal rate was not its comparable incremental borrowing rate. The Company has since calculated the incremental borrowing rate for each lease by developing a synthetic credit rating for the Company as of the commencement date of each lease, adjusting the synthetic credit rating to reflect the collateralized nature of the incremental borrowing rate, the Company’s borrowing rate under other debt facilities, and the market spread between secured and unsecured borrowings, and based on the adjusted synthetic rating and the various terms of the leases, selected the incremental borrowing rate based on the commencement date, duration of the lease, and a corresponding weight-adjusted corporate yield curve. Lease renewal options included in any lease are considered in the lease term if it is reasonably certain the Company will exercise the option to renew. The Company’s operating lease agreements do not contain any material restrictive covenants.

As of December 31, 2023, the Company’s lease components included in the consolidated balance sheet were as follows:

Schedule

of Lease Components

		Stated		Adjustment			Restated
Lease component	Balance sheet classification	December 31, 2023
		As Previously		Restatement			As
		Stated		Adjustment			Restated
Assets
ROU assets - operating lease	Other assets	$	5,740,929	$	(2,381,871	)	$	3,359,058
Total ROU assets		$	5,740,929	$	(2,381,871	)	$	3,359,058
Liabilities
Current operating lease liability	Current liabilities	$	397,554	$	(215,980	)	$	181,574
Long-term operating lease liability	Other liabilities		5,522,090		(2,165,891	)		3,356,199
Total lease liabilities		$	5,919,644	$	(2,381,871	)	$	3,537,772

As of December 31, 2022, the Company’s lease components included in the consolidated balance sheet were as follows:

		Stated		Adjustment			Restated
Lease component	Balance sheet classification	December 31, 2022
		As Previously		Restatement			As
		Stated		Adjustment			Restated
Assets
ROU assets - operating lease	Other assets	$	1,808,034	$	(393,910	)	$	1,414,124
Total ROU assets		$	1,808,034	$	(393,910	)	$	1,414,124
Liabilities
Current operating lease liability	Current liabilities	$	231,604	$	(71,419	)	$	160,185
Long-term operating lease liability	Other liabilities		1,669,954		(322,491	)		1,347,463
Total lease liabilities		$	1,901,557	$	(393,910	)	$	1,507,647

Future minimum lease payments as of December 31, 2023 were as follows:

Schedule of Future Minimum Lease Payments

2024		616,158
2025		622,676
2026		638,469
2027		632,152
2028<br> and beyond		5,311,766
Total<br> future minimum lease payments	$	7,821,221
Less:<br> Interest		(4,283,449	)
Total<br> operating lease liabilities	$	3,537,772

Future minimum lease payments as of December 31, 2022 were as follows:

2023		264,108
2024		251,671
2025		247,960
2026		253,235
2027 and beyond		1,063,010
Total future minimum lease payments	$	2,079,984
Less: Interest		(572,337	)
Total operating lease liabilities	$	1,507,647

For the years ended December 31, 2023 and 2022, the

weighted average remaining lease term for operating leases was 143 months and 107 months, respectively. For the years ended December 31, 2023 and 2022, the weighted average discount rate for operating leases was 13.8% and 7.3%, respectively. The Company paid approximately $0.3 million and $0.1 million in cash for operating lease amounts included in the measurement of lease liabilities for the years ended December 31, 2023 and 2022, respectively. The Company did not have any finance leases as of December 31, 2023 and December 31, 2022.

See Note 2 - Restatement of Previously Issued Consolidated Financial Statements for additional information.

| F-21 |

| --- |

Note12 – Notes Payable

Notes payables consisted of the following:

Schedule

of Notes Payable

			December<br> 31, 2022
Note<br> payable. 35%<br> - 100<br> % cumulative interest. Matures on June<br> 29, 2028	1,451,244		$	-
Related<br> party demand notes with a 10%<br> financing fee. 10%<br> annual interest from issuance. Notes are callable starting March 31, 2023	880,000			770,000
Convertible notes. 10%<br> annual interest. Conversion price of 2.25	410,000			100,000
Cash<br> advance agreement	287,604			-
Less<br> debt discount and financing costs	(264,932	)	$	(107,356	)
Total,<br> net of discount	2,763,916			762,644

All values are in US Dollars.

Related Party Demand Notes

In

the fourth quarter of 2022, the Company received $550,000 through the issuance of five demand notes (the “JAG Notes”) from a related party, JAG Multi Investments LLC (“JAG”). The Company’s Chief Financial Officer is a beneficiary of JAG but does not have any control over JAG’s investment decisions with respect to the Company. The JAG Notes accrue 10% annual interest from their respective dates of issuance. At maturity, the Company agreed to pay outstanding principal, a 10% financing fee and accrued interest

. On

July 10, 2023, the Company received an additional $100,000 from JAG through the issuance of an additional demand note.

In

consideration for subscribing to the JAG Note for $100,000

dated December 29, 2022, and for agreeing to

extend the date on which the other JAG Notes are callable to March 31, 2023, the Company issued JAG a warrant to purchase 17,500 shares of Common Stock. The warrant may be exercised for a period of five (5

)

years from issuance at a price of $10.00 per share. The financing fees for said JAG Note and the fair value of the warrant issued were capped at the total proceeds. The relative fair value of the warrant was recorded as a debt discount and as of December 31, 2023 the Company had fully amortized the discount. On July 10, 2023 JAG agreed to extend the date on which the JAG Notes are callable to September 30, 2023.

In

the fourth quarter of 2022, the Company received $200,000

through the issuance of demand promissory notes

of which (1) $100,000

was received from its Chief Executive Officer

($60,000

on November 29, 2022, $15,000

on December 2, 2022, and $25,000

on December 13, 2022) and (2) $100,000

was received from an entity controlled by its

Chief Financial Officer ($75,000

on November 29, 2022 and $25,000

on December 13, 2022). These notes accrue 10% annual interest accrues from the date of issuance. These notes are callable with 10 days prior written notice. At maturity, the Company agreed to pay outstanding principal, a 10% financing fee and accrued interest.

The financing fees for all demand notes were recorded as a debt discount and as of December 31, 2023 the Company had fully amortized the discount.

For

the year ended December 31, 2023, the Company incurred $75,889 in interest related to these demand notes.

Jan and March 2023 Convertible Notes

In

January and March 2023, the Company issued $410,000

of convertible notes (“Q1 23 Convertible

Notes”), for $310,000

in cash and the conversion of $100,000

of demand notes from the fourth quarter of 2022.

These convertible notes were issued with fixed conversion prices of $10.00

(for the $275,000

issued in January 2023) and $12.00

(for the $135,000

issued in March 2023) and (ii) 5

-year

warrants to purchase 19,375

shares of the Common Stock at an exercise price of $20.00

.

The

cumulative fair value of the warrants at issuance was $132,183

.

This was recognized as a debt discount and will to be amortized on a straight-line basis over the life of the respective notes. For the year ending December 31, 2023 the Company amortized $132,183 of the debt discount and as of December 31, 2023 was fully amortized.

Interest

on these notes accrues at a rate of ten percent (10% ) per annum and is payable at the holder’s option either in cash or in shares of Common Stock at the conversion price set forth in the notes on December 31, 2023

,

unless converted earlier. For the year ended December 31, 2023 the Company incurred $38,411 in interest related to these convertible notes.

All amounts due under these notes are convertible at any time after the issuance date, in whole or in part (subject to rounding for fractional shares), at the option of the holders into the Common Stock at a fixed conversion price for the notes as described above.

As of December 27, 2023, the Company

secured written consent by the note holders of the Q1 23 Convertible Notes for the maturity date to be extended to June 30, 2024. As an incentive for the Q1 23 Convertible Note holders to approve the extension, the Company agreed to lower both the Q1 23 Convertible Notes fixed conversion price and the related warrant exercise price to $2.25. The maturity date extension and the conversion and exercise price reduction applies to all Q1 23 Convertible Notes. As the terms for the note were deemed substantial different, the Company recognized a $163,278 loss from debt extinguishment related to the change in terms.

| F-22 |

| --- |

February 2023 Convertible Debentures

On February 3, and February 17, 2023, the Company entered into securities purchase agreements (the “February Purchase Agreements”) with accredited investors (the “February Investors”) for the purchase of (i) convertible debentures of the Company in the aggregate original principal amount of $500,000

(the “February Debentures”) for a purchase

price of $450,000

,

(ii) warrants (the “February Warrants”) to purchase 12,500 shares (the “February Warrant Shares”) of Common Stock at an exercise price of $15.00

per share, and (iii) 4,167

shares of Common Stock issued as an inducement for issuing the February Debentures. The proceeds, net of placement agent and legal fees, were used for working capital and general corporate purposes.

The

cumulative fair value of the warrants at issuance was $291,207

.

This was recognized as a debt discount and will be amortized on a straight-line basis over the life of the respective notes. For the year ended December 31, 2023 the Company amortized $347,520 of the debt discount and as of December 31, 2023 the Company had fully amortized the discount.

Pursuant to the February Debentures, interest on the February Debentures accrued at a rate of eight percent (8

%)

per annum payable at maturity, one year from the date of the February Debentures. For the year ended December 31, 2023 the Company incurred $9,640 in interest on the February Debentures.

All

amounts due under the February Debentures were convertible at any time after the issuance date, in whole or in part, at the option of the February Investors into Common Stock at an initial price of $10.40 per share. This conversion price was subject to adjustment for stock splits, combinations or similar events and anti-dilution provisions, among other adjustments and is subject to a floor price.

The

Company could prepay the February Debentures at any time in whole or in part by paying a sum of money equal to 105 % of the principal amount to be redeemed, together with accrued and unpaid interest.

While

any portion of each February Debenture remained outstanding, if the Company received cash proceeds of more than $2,000,000 (the “Minimum Threshold”) in the aggregate from any source or series of related or unrelated sources, the February Investors had the right in their sole discretion to require the Company to immediately apply up to 50

%

of all proceeds received by the Company above the Minimum Threshold to repay the outstanding amounts owed under the February Debentures. In April 2023, the Company used $360,151

in proceeds from the RD Offering (as described

in Note 11 below) to repay a portion of the February Debentures. On August 8, 2023, the Company repaid the remaining balance of $139,849 with proceeds from the August Public Offering (as described in Note 16 below).

The

February Warrants included anti-dilution protection whereby a subsequent offering priced below the February Warrants’ strike price then in effect would entitle the February Investors to a reduction of such strike price to the price of such subsequent offering and an increase in the February Warrant Shares determined by dividing the dollar amount for which the February Warrants are exercisable by such lower strike price. As a result of the $2.85

unit purchase price of the August Public Offering

(as described in Note 16 below), following consummation of the August Public Offering, the February Warrants now entitle the February Investors to purchase a total 65,790

at an exercise price of $2.85

per February Warrant Share. On August 8, 2023,

the Company issued 26,391

shares of Common Stock upon exercise of one of

the February Warrants on a net-exercise basis and on August 21, 2023, the Company issued 17,594 shares of Common Stock upon exercise of the other February Warrant on a net-exercise basis. Following these exercises, there were no February Warrants outstanding.

Standard Merchant Cash Advance

On

July 20, 2023, the Company entered into a Standard Merchant Cash Advance Agreement (the “Cash Advance Agreement”) with Cedar Advance LLC (“Cedar”) under which Cedar purchased $543,750

of the Company’s receivables for a gross

purchase price of $375,000

(the “Initial Advance”). The Company

received cash proceeds of $356,250

,

net of a financing fee. Until the purchase price is repaid, the Company agreed to pay Cedar $19,419.64

per week. Since, through the refinancing described

below, the Company repaid Cedar within 30 days, the amount payable under the Initial Advance was reduced from $543,750

to $465,000

.

| F-23 |

| --- |

On

August 31, 2023, the Company refinanced the Initial Advance through the purchase by Cedar of $746,750

of the Company’s receivables for a gross

purchase price of $515,000

(the “Refinanced Advance”). The Company

received net cash proceeds of $134,018

after applying $390,892

towards the repayment of the Initial Advance.

The new Cash Advance Agreement provides that if the Company repays the Refinanced Advance within 30 days then the amount payable to Cedar shall be reduced to $643,750

,

and if the Refinanced Advance is repaid on days 31 to 60 then the amount payable to Cedar shall be reduced to $674,650

.

Until the purchase price is repaid, the Company agreed to pay Cedar $16,594

per week. On September 29, 2023, the Company

repaid $0.3

million of the Cash Advance Agreement with proceeds

from the RLSA Loan (as defined below). As a result of such payment, the weekly payment was reduced to $9,277 .

The

financing fees were recorded as a debt discount. For the year ended December 31, 2023 the Company amortized $122,279

of the debt discount and as of December 31, 2023

had a remaining debt discount balance of $250,721 .

Revenue Loan and Security Agreement

On

September 29, 2023, the Company, Steven Shum, as a Key Person, and the Company’s wholly-owned subsidiaries Bio X Cell, Inc, INVO CTR, Wood Violet Fertility LLC, FLOW and Orange Blossom Fertility LLC as guarantors (the “Guarantors”), entered into a Revenue Loan and Security Agreement (the “Loan Agreement”) with Decathlon Alpha V LP (the “Lender”) under which the Lender advanced a gross amount of $1,500,000 to the Company (the “RSLA Loan”). The RSLA Loan has a maturity date of June 29, 2028, is payable in fixed monthly installments, as set forth in the Loan Agreement, and may be prepaid without penalty at any time. The installments include an interest factor that varies based on when the RSLA Loan is fully repaid and is based on a minimum amount that increases from thirty five percent (35

%)

of the RSLA Loan principal, if fully repaid in the first six months, to one hundred percent (100 %) of the RSLA Loan principal, if fully repaid after 30 months from the RSLA Loan’s effective date.

The

financing fees for the RSLA Loan were recorded as a debt discount. For the year ended December 31, 2023, the Company amortized $790

of the debt discount and as of December 31, 2023

had a remaining debt discount balance of $14,211

.

For the year ended December 31, 2023 the Company incurred $41,244 in interest related to the RSLA Loan.

Note13 – Related Party Transactions

In

the fourth quarter of 2022, the Company received $700,000

through the issuance of demand notes from related

parties, as follows: (a) $500,000

from JAG; (b) $100,000

from our Chief Executive Officer; and (c) $100,000

from our Chief Financial Officer. On July 10,

2023, the Company received an additional $100,000 through the issuance of a demand note from JAG. The Company’s Chief Financial Officer is a beneficiary of JAG but does not have any control over JAG’s investment decisions with respect to the Company. See Note 10 of the Notes to Consolidated Financial Statements for additional information.

As

of December 31, 2023 the Company owed accounts payable to related parties totaling $228,907 , primarily related to unpaid employee expense reimbursements and unpaid board fees.

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Note14 – Stockholders’ Equity

ReverseStock Split

On

June 28, 2023, the Company’s board of directors approved a reverse stock split of the Company’s common stock at a ratio of 1-for-20 and also approved a proportionate decrease in its authorized common stock to 6,250,000

shares from 125,000,000

. On July 26, 2023, the Company filed a certificate of change (with an effective date of July 28, 2023) with the Nevada Secretary of State pursuant to Nevada Revised Statutes 78.209 to effectuate a 1-for-20 reverse stock split of its outstanding common stock. On July 27, 2023, the Company received notice from Nasdaq that the reverse split would take effect at the open of business on July 28, 2023, and the reverse stock split took effect on that date. All share information included in this Form 10-Q has been reflected as if the reverse stock split occurred as of the earliest period presented.

Increasein Authorized Common Stock

On

October 13, 2023, shareholders of the Company approved an increase to the number of authorized shares of the Company’s common stock from 6,250,000

shares

to 50,000,000

shares

as set forth below. On October 13, 2023, the Company filed a Certificate of Amendment to its Articles of Incorporation to increase its authorized shares of common stock from 6,250,000

shares to 50,000,000

shares.

SeriesA Preferred Stock

On

November 20, 2023, the Company filed with the Nevada Secretary of State a Certificate of Designation of Series A Convertible Preferred Stock (the “Series A Certificate of Designation”) which sets forth the rights, preferences, and privileges of the Series A Preferred Stock (the “Series A Preferred”). One million (1,000,000

)

shares of Series A Preferred with a stated value of $5.00 per share were authorized under the Series A Certificate of Designation.

Each

share of Series A Preferred has a stated value of $5.00

,

which is convertible into shares of the Company’s common stock (the “Common Stock”) at a fixed conversion price equal to $2.20 per share, subject to adjustment. The Company may not effect the conversion of any shares of Series A Preferred if, after giving effect to the conversion or issuance, the holder, together with its affiliates, would beneficially own more than 9.99% of the Company’s outstanding Common Stock. Moreover, the Company may not effect the conversion of any shares of Series A Preferred if, after giving effect to the conversion or issuance, the holder, together with its affiliates, would beneficially own more than 19.99% of the Company’s outstanding Common Stock unless and until the Company receives the approval required by the applicable rules and regulations of The Nasdaq Stock Market LLC (or any subsequent trading market).

Each share of Series A Preferred stock shall automatically convert into Common Stock upon the closing of a merger (the “Merger”) of INVO Merger Sub Inc., a wholly owned subsidiary of the Company and a Delaware corporation (“Merger Sub”), with and into NAYA Therapeutics, Inc., a Delaware corporation formerly known as NAYA Biosciences, Inc. (“Legacy NAYA”) pursuant to an Agreement and Plan of Merger, as amended, by and among the Company, Merger Sub, and Legacy NAYA (the “Merger Agreement”).

The holders of Series A Preferred shall be entitled to receive a pro-rata portion, on an as-if converted basis, of any dividends payable on Common Stock.

In

the event of any voluntary or involuntary liquidation, dissolution, or winding up, or sale of the Company (other than the Merger), each holder of Series A Preferred shall be entitled to receive its pro rata portion of an aggregate payment equal to (i) $5.00 , multiplied by (ii) the total number of shares of Series A Preferred Stock issued under the Series A Certificate of Designation.

Other than those rights provided by law, the holders of Series A Preferred shall not have any voting rights.

On December 29, 2023,

the Company entered into

securities purchase agreement (the “Preferred Series A SPA”) with Legacy NAYA for the purchase of 1,000,000

shares

of the Company’s Series A Preferred Stock at a purchase price of $5.00

per

share. The parties agreed that Legacy NAYA’s purchases will be made in tranches in accordance with the following schedule: (1) $500,000

no

later than Dec 29, 2023; (2) $500,000

no

later than January 19, 2024; (3) $500,000

no

later than February 2, 2024; (4) $500,000 no later than February 16, 2024; and (5) an additional amount as may be required prior to closing of the previously announced merger by and among the Company, INVO Merger Sub, Inc. and Legacy NAYA, and to be determined in good faith by the parties to adequately support the Company’s fertility business activities per an agreed forecast, as well as for a period of twelve (12) months post-closing including a catch-up on the Company’s past due accrued payables still outstanding. The Preferred Series A SPA contains customary representations, warranties and covenants of the Company and Legacy NAYA.

On

January 4, 2024, the Company and Legacy NAYA closed on 100,000

shares

of Series A Preferred Stock in the first tranche of this private offering for gross proceeds of $500,000 .

On

April 15, 2024, the Company and Legacy NAYA closed on additional 61,200

shares

of Series A Preferred Stock for additional gross proceeds of $306,000 .

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SeriesB Preferred Stock

On

November 20, 2023, the Company filed with the Nevada Secretary of State a Certificate of Designation of Series B Convertible Preferred Stock (the “Series B Certificate of Designation”) which sets forth the rights, preferences, and privileges of the Series B Preferred Stock (the “Series B Preferred”). One million two hundred (1,200,000

)

shares of Series B Preferred with a stated value of $5.00 per share were authorized under the Series B Certificate of Designation.

Each

share of Series B Preferred has a stated value of $5.00

,

which is convertible into shares of the Company’s common stock (the “Common Stock”) at a fixed conversion price equal to $5.00

per share, subject to adjustment. The Company

may not effect the conversion of any shares of Series B Preferred if, after giving effect to the conversion or issuance, the holder, together with its affiliates, would beneficially own more than 19.99 % of the Company’s outstanding Common Stock unless and until the Company receives the approval required by the applicable rules and regulations of Nasdaq (or any subsequent trading market).

Each share of Series B Preferred stock shall automatically convert into Common Stock upon the closing of the Merger.

The holders of Series B Preferred shall be entitled to receive a pro-rata portion, on an as-if converted basis, of any dividends payable on Common Stock.

In

the event of any voluntary or involuntary liquidation, dissolution, or winding up, or sale of the Company (other than the previously announced merger with Legacy NAYA), each holder of Series B Preferred shall be entitled to receive its pro rata portion of an aggregate payment equal to (i) $5.00 , multiplied by (ii) the total number of shares of Series B Preferred Stock issued under the Series B Certificate of Designation.

Other than those rights provided by law, the holders of Series B Preferred shall not have any voting rights.

On

November 19, 2023, the Company entered into a share exchange agreement (the “Share Exchange Agreement”) with Cytovia Therapeutics Holdings, Inc., a Delaware corporation (“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 Legacy NAYA held by Cytovia (the “Share Exchange”). On November 20, 2023, the Company and Cytovia closed on the exchange of shares. As of December 31, 2023, the Company owns approximately 6.5 % of the outstanding shares of Legacy NAYA’s common stock and had no significant control over Legacy NAYA therefore the asset is accounted for using the fair value method.

February2023 Equity Purchase Agreement

On

February 3, 2023, the Company entered into an equity purchase agreement (the “ELOC”) and registration rights agreement (the “ELOC RRA”) with an accredited investor (the “Feb 3 Investor”) pursuant to which the Company has the right, but not the obligation, to direct the Feb 3 Investor to purchase up to $10.0 million (the “Maximum Commitment Amount”) of shares of Common Stock, in multiple tranches. Further, under the ELOC and subject to the Maximum Commitment Amount, the Company has the right, but not the obligation, to submit notices to the Feb 3 Investor to purchase shares of Common Stock (i) in a minimum amount of not less than $25,000 and (ii) in a maximum amount of up to the lesser of (a) $750,000 or (b) 200% of the Company’s average daily trading value of the Common Stock.

Also

on February 3, 2023, the Company issued to the Feb 3 Investor 7,500 shares of Common Stock for its commitment to enter into the ELOC.

The obligation of the Feb 3 Investor to purchase shares of Common Stock pursuant to the ELOC ends on the earlier of (i) the date on which the purchases under the ELOC equal the Maximum Commitment Amount, (ii) 24 months after the date of the ELOC (February 3, 2025), (iii) written notice of termination by the Company, (iv) the date that the ELOC RRA is no longer effective after its initial effective date, or (v) the date that the Company commences a voluntary case or any person or entity commences a proceeding against the Company pursuant to or within the meaning of federal or state bankruptcy law, a custodian is appointed for the Company or for all or substantially all of its property, or the Company makes a general assignment for the benefit of its creditors (the “Commitment Period”).

During the Commitment Period, and subject to the shares of Common Stock underlying the ELOC be registered, the price that Feb 3 Investor will pay to purchase the shares of Common Stock that it is obligated to purchase under the ELOC shall be 97% of the “market price,” which is defined as the lesser of (i) the lowest closing price of our Common Stock during the 7 trading day-period following the clearance date associated with the applicable put notice from the Company or (ii) the lowest closing bid price of the Common Stock on the principal trading market for the Common Stock (currently, the Nasdaq Capital Market) on the trading day immediately preceding a put date.

To date, the Company has not been in a position to register the shares underlying the ELOC as a result of standstill agreements related to the RD Offering and the August 2023 Offering (both as defined below).

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March2023 Registered Direct Offering

On

March 23, 2023, the Company entered into a securities purchase agreement (the “March Purchase Agreement”) with a certain institutional investor, pursuant to which the Company agreed to issue and sell to such investor (i) in a registered direct offering (the “RD Offering”), 69,000

shares of Common Stock, and a pre-funded warrant

(the “Pre-Funded Warrant”) to purchase up to 115,000

shares of Common Stock, at an exercise price

of $0.20

per share, and (ii) in a concurrent private placement

(the “March Warrant Placement”), a common stock purchase warrant (the “March Warrant”), exercisable for an aggregate of up to 276,000

shares of Common Stock, at an exercise price

of $12.60 per share. The securities to be issued in the RD Offering (priced at the marked under Nasdaq rules) were offered pursuant to the Company’s shelf registration statement on Form S-3 (File 333-255096), initially filed by the Company with the SEC under the Securities Act, on April 7, 2021 and declared effective on April 16, 2021. All Pre-Funded Warrants were exercised by the investor in June 2023.

The March Warrant (and the shares of Common Stock issuable upon the exercise of the March Warrant) was not registered under the Securities Act and was offered pursuant to an exemption from the registration requirements of the Securities Act provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder. The March Warrant is immediately exercisable upon issuance, will expire eight years from the date of issuance, and in certain circumstances may be exercised on a cashless basis.

On March 27, 2023, the Company closed the RD Offering and March Warrant Placement, raising gross proceeds of approximately $3

million before deducting placement agent fees

and other offering expenses payable by the Company. In the event the March Warrant were fully exercised for cash, the Company would receive additional gross proceeds of approximately $3.5

million. Under the March Purchase Agreement,

the Company was entitled to use a portion of the net proceeds of the offering to (a) repay the February Debentures, and (b) to make the down payment for the WFI acquisition. The remainder of the net proceeds could be used for working capital, capital expenditures, and other general corporate purposes. The Company used $383,879 in proceeds to repay a portion of the February Debentures and related fees and interest and the remainder of the proceeds were used for working capital and general corporate purposes.

August2023 Public Offering

On

August 4, 2023, the Company, entered into securities purchase agreements (the “Purchase Agreements”) with certain institutional and other investors, pursuant to which the Company agreed to issue and sell to such investors in a public offering (the “August 2023 Offering”), 1,580,000

units (the “Units”) at a price of

$2.85

per Unit, with each Unit consisting of (i) one

share of Common Stock (the “Shares”) of the Company, and (ii) two common stock purchase warrants (the “Warrants”), each exercisable for one share of Common Stock at an exercise price of $2.85

per share. In the aggregate, in the August 2023

Offering the Company issued 1,580,000

Shares and 3,160,000

Warrants. The securities issued in the August 2023 Offering were offered pursuant to the Company’s registration statement on Form S-1 (File 333-273174) (the “Registration Statement”), initially filed by the Company with the SEC under the Securities Act, on July 7, 2023 and declared effective on August 3, 2023.

The

Company closed the Offering on August 8, 2023, raising gross proceeds of approximately $4.5

million before deducting placement agent fees

and other offering expenses payable by the Company. The Company used (i) $2,150,000

to fund the initial installment of the WFI purchase

price (net of a $350,000

holdback) on August 10, 2023, (ii) $1,000,000

to pay Armistice the Armistice Amendment Fee

(as defined below), and (iii) $139,849

to complete repayment of the February Debentures

to the February Investors, plus accrued interest and fees of approximately $10,911 . The Company is using the remaining proceeds from the August 2023 Offering for working capital and general corporate purposes.

In

connection with the August 2023 Offering, on August 4, 2023, the Company entered into a placement agency agreement (the “Placement Agency Agreement”) with Maxim Group LLC (the “Placement Agent”), pursuant to which (i) the Placement Agent agreed to act as placement agent on a “best efforts” basis in connection with the August 2023 Offering and (ii) the Company agreed to pay the Placement Agent an aggregate fee equal to 7.0 % of the gross proceeds (and 5

%

for certain investors) raised in the August 2023 Offering and warrants to purchase up to 110,600

shares of Common Stock at an exercise price of

$3.14 (the “Placement Agent Warrants”). The Placement Agent Warrants (and the shares of Common Stock issuable upon the exercise of the Placement Agent Warrants) were not registered under the Securities Act and were offered pursuant to an exemption from the registration requirements of the Securities Act provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder.

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The

August 2023 Offering was facilitated by the Company entering into an Amendment to Securities Purchase Agreement on July 7, 2023 (the “Armistice Amendment”) with Armistice Capital Markets Ltd. to delete Section 4.12(a) of our March 23, 2023 Securities Purchase Agreement (the “Armistice SPA”) with Armistice pursuant to which we agreed that from March 23, 2023 until 45 days after the effective date of the Resale Registration Statement (as defined below) we would not (i) issue, enter into any agreement to issue or announce the issuance or proposed issuance of any shares of Common Stock or Common Stock Equivalents or (ii) file any registration statement or any amendment or supplement thereto, other than the prospectus supplement filed in connection with that offering and the Resale Registration Statement (the “Subsequent Equity Financing Provision”). In consideration of Armistice’s agreement to enter into the Armistice Amendment and delete the Subsequent Equity Financing Provision from the Armistice SPA, we agreed to pay Armistice a fee a $1,000,000

(the “Armistice Amendment Fee”) within

two days of the closing of the August 2023 Offering. Additionally, we agreed to include a proposal in our proxy statement for our 2023 Annual Meeting of Stockholders for the purpose of obtaining the approval of the holders of a majority of our outstanding voting common stock, to effectuate the reduction of the exercise price (the “Exercise Price Reduction”) set forth in Section 2(b) of the Common Stock Purchase Warrants issued to Armistice on March 27, 2023 (the “Existing Warrants”) to the per unit public offering price of the August 2023 Offering (or $2.85 ), in accordance with Nasdaq Rule 5635(d) (the “Shareholder Approval”) with the recommendation of our board of directors that such proposal be approved. We also agreed to solicit proxies from our shareholders in connection therewith in the same manner as all other management proposals in such proxy statement and that all management-appointed proxyholders shall vote their proxies in favor of such proposal. Further, if we did not obtain Shareholder Approval at the first meeting, we agree to call a meeting every six (6) months thereafter to seek Shareholder Approval until the earlier of the date Shareholder Approval is obtained or the Existing Warrants are no longer outstanding. Until such approval is obtained, the exercise price of the Existing Warrants will remain unchanged. At the annual meeting on December 26, 2023, Company shareholders approved the Exercise Price Reduction.

Year Ended December 31, 2023

During

2023, the Company issued 4,269

shares of Common Stock to employees and directors

and 22,202

shares of Common Stock to consultants with a

fair value of $56,936

and $124,476

, respectively. The shares were issued under the Company’s 2019 Stock Incentive Plan (the “2019 Plan”).

During 2023, the Company issued 21,115

shares of Common Stock to consultants in consideration of services rendered with a fair value of $69,975. These shares were issued pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended. The Company did not receive any cash proceeds from this issuance.

During

2023, the Company issued 297

shares of Common Stock upon the exercise of options.

The Company received proceeds of $2,375 .

In

February 2023, the Company issued 4,167

shares of Common Stock with a fair value of $56,313

as inducement for issuing the February Debentures. The fair value of the shares was recognized as a discount to the February Debentures and will be amortized over the life of the notes.

In

February 2023, the Company 7,500

shares of Common Stock in connection with the

ELOC with a fair value of $93,000 that was expensed in the period.

In

March 2023, the Company issued 69,000

shares of Common Stock in the RD Offering and

March Warrant Placement. The Company received net proceeds of approximately $2.7 million.

In

June 2023, the Company issued 115,000

shares of Common Stock upon exercise prefunded

warrants. The Company received net proceeds of $23,051 .

On

July 11, 2023, the Company issued 16,250 shares of Common Stock in consideration of a settlement with an unrelated third party. These shares were issued pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended. The Company did not receive any cash proceeds from this issuance.

In

August 2023, the Company issued 43,985 shares of Common Stock upon exercise of an existing warrant on a net-exercise basis. These shares were issued pursuant to the exemption from registration provided by Section 4(a)(2) and/or 3(a)(9) of the Securities Act of 1933, as amended.

On

August 8, 2023, the Company issued 1,580,000

shares of Common Stock in the August 2023 Offering.

The Company received net proceeds of approximately $4.1 million.

Note15 – Equity-Based Compensatio****n

Equity Incentive Plans

In

October 2019, the Company adopted the 2019 Plan. Under the 2019 Plan, the Company’s board of directors is authorized to grant stock options to purchase Common Stock, restricted stock units, and restricted shares of Common Stock to its employees, directors, and consultants. The 2019 Plan initially provided for the issuance of 25,000 shares. A provision in the 2019 Plan provides for an automatic annual increase equal to 6% of the total number of shares of Common Stock outstanding on December 31 of the preceding calendar year

.

In January 2023, the number of available shares increased by 36,498

shares bringing the total shares available under

the 2019 Plan to 125,000 .

Options granted under the 2019 Plan generally have a life of 3 to 10 years and exercise prices equal to or greater than the fair market value of the common stock as determined by the Company’s board of directors. Vesting for employees typically occurs over a three-year period.

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The following table sets forth the activity of the options to purchase common stock under the 2019 Plan.

Schedule

of Stock Options Activity

	Number<br> of<br> Shares			Weighted<br> <br> Average<br> Exercise<br> Price		Aggregate<br> <br> Intrinsic <br> Value
Outstanding<br> as of December 31, 2022		64,850		$	68.00	$	-
Granted		59,048			7.74		-
Exercised		(297	)		8.00		-
Canceled		16,848			54.63		-
Balance<br> as of December 31, 2023		106,753			41.90		-
Exercisable<br> as of December 31, 2023		93,227		$	54.61	$	-

The fair value of each option granted is estimated as of the grant date using the Black-Scholes option pricing model with the following assumptions:

Schedule

of Share-Based Payment Award, Stock Options, Valuation Assumptions

	Years ended December 31,
	2023		2022
Risk-free<br> interest rate range	3.60<br> to 3.69	%	1.60<br> to 3.94	%
Expected<br> life of option-years	5.00<br> to 5.63		5.00<br> to 5.77
Expected<br> stock price volatility	106.6<br> to 114.9	%	110.00<br> to 114.6	%
Expected<br> dividend yield	-	%	-	%

The risk-free interest rate is based on U.S. Treasury interest rates, the terms of which are consistent with the expected life of the stock options. Expected volatility is based upon the average historical volatility of the Company’s common stock over the period commensurate with the expected term of the related instrument. The expected life and estimated post-employment termination behavior is based upon historical experience of homogeneous groups, executives and non-executives, within the Company. The Company does not currently pay dividends on its common stock, nor does it expect to do so in the foreseeable future.

Schedule of Share Based Payments Arrangements Options Exercised and Options Vested

	Total<br> Intrinsic <br> Value of Options<br> Exercised		Total<br> Fair <br> Value of Options<br> Vested
Year<br> ended December 31, 2022	$	-	$	1,616,401
Year<br> ended December 31, 2023	$	-	$	1,049,109

For

the year ended December 31, 2023, the weighted average grant date fair value of options granted was $6.38

per share. The Company estimates the fair value

of options at the grant date using the Black-Scholes model. For all stock options granted through December 31, 2023, the weighted average remaining service period is 1.01 years.

RestrictedStock and Restricted Stock Units

In

the year ended December 31, 2023, the Company granted 23,547 in restricted stock units and shares of restricted stock to certain employees, directors, and consultants under the 2019 Plan. Restricted stock issued to employees, directors, and consultants generally vest either at grant or vest over a period of one year from the date of grant.

The following table summarizes the Company’s restricted stock awards activity under the 2019 Plan during the year ended December 31, 2023:

Schedule of Aggregate Restricted Stock Awards and Restricted Stock Unit Activity

	Number of Unvested<br> <br>Shares			Weighted<br> <br>Average<br> <br>Grant Date Fair Value		Aggregate<br> <br>Value<br> <br>of Shares
Balance<br> as of December 31, 2022		3,533		$	8.40	$	29,949
Granted		23,547			4.95		116,618
Vested		(27,055	)		11.60		(310,554	)
Forfeitures		-			-		-
Balance<br> as of December 31, 2023		25			18.42		5,525

The Company recognizes stock compensation

expense on a straight-line basis over the vesting period of the grant. If the restricted stock vests immediately, the corresponding stock compensation expense is recognized immediately. For the year ended December 31, 2023, the Company recognized $315,895 in stock compensation expense related to restricted stock granted under the 2019 plan.

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Note16 – Unit Purchase Options and Warrants

The following table sets forth the activity of unit purchase options:

Schedule

of Unit Purchase Option Activity

	Number<br> of<br> Unit Purchase<br> Options		Weighted<br><br> Average <br> Exercise <br> Price		Aggregate<br> <br> Intrinsic <br> Value
Outstanding<br> as of December 31, 2022		4,649	$	64.00	$	-
Granted		-		-		-
Exercised		-		-		-
Canceled		-		-		-
Balance<br> as of December 31, 2023		4,649		64.00		-

The following table sets forth the activity of warrants:

Schedule of Warrants Activity

	Number<br> of<br> Warrants			Weighted<br> <br> Average <br> Exercise <br> Price		Aggregate<br> <br> Intrinsic <br> Value
Outstanding<br> as of December 31, 2022		25,884		$	30.20	$	-
Granted		3,643,526			3.63		-
Exercised		(180,790	)		1.16		-
Canceled		-			-		-
Balance<br> as of December 31, 2023		3,488,620		$	3.95	$	-

Warrants related to Jan and March 2023 ConvertibleNotes

In January and March 2023, the Company

issued 5-year warrants to purchase 19,375 shares of the Common Stock at an exercise price of $20.00 related to the Q1 23 Convertible Notes. As of December 27, 2023, as an incentive for the Q1 23 Convertible Note holders to approve the extension, the Company agreed to lower the warrant exercise price to $2.25. As the terms for the note were deemed substantial different, the Company recognized a $163,278 loss from debt extinguishment related to the change in terms.

Warrants related to February 2023 ConvertibleDebentures

On February 3, and February 17, 2023,

the Company issued warrants (the “February Warrants”) to purchase 12,500 shares (the “February Warrant Shares”) of Common Stock at an exercise price of $15.00 per share as an inducement for issuing the February Debentures.

The February Warrants included anti-dilution

protection whereby a subsequent offering priced below the February Warrants’ strike price then in effect would entitle the February Investors to a reduction of such strike price to the price of such subsequent offering and an increase in the February Warrant Shares determined by dividing the dollar amount for which the February Warrants are exercisable by such lower strike price. As a result of the $2.85 unit purchase price of the August Public Offering, following consummation of the August Public Offering, the February Warrants now entitle the February Investors to purchase a total 65,790 at an exercise price of $2.85 per February Warrant Share. On August 8, 2023, the Company issued 26,391 shares of Common Stock upon exercise of one of the February Warrants on a net-exercise basis and on August 21, 2023, the Company issued 17,594 shares of Common Stock upon exercise of the other February Warrant on a net-exercise basis. Following these exercises, there were no February Warrants outstanding.

Warrants related to March 2023 Registered Direct Offering

On March 23, 2023, the Company entered into

a securities purchase agreement (the “March Purchase Agreement”) with a certain institutional investor, pursuant to which the Company agreed to issue and sell to such investor (i) in a registered direct offering (the “RD Offering”), 69,000 shares of Common Stock, and a pre-funded warrant (the “Pre-Funded Warrant”) to purchase up to 115,000 shares of Common Stock, at an exercise price of $0.20 per share, and (ii) in a concurrent private placement (the “March Warrant Placement”), a common stock purchase warrant (the “March Warrant”), exercisable for an aggregate of up to 276,000 shares of Common Stock, at an exercise price of $12.60 per share. The securities to be issued in the RD Offering (priced at the marked under Nasdaq rules) were offered pursuant to the Company’s shelf registration statement on Form S-3 (File 333-255096), initially filed by the Company with the SEC under the Securities Act, on April 7, 2021 and declared effective on April 16, 2021. All Pre-Funded Warrants were exercised by the investor in June 2023.

The March Warrant (and the shares of Common Stock issuable upon the exercise of the March Warrant) was not registered under the Securities Act and was offered pursuant to an exemption from the registration requirements of the Securities Act provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder. The March Warrant is immediately exercisable upon issuance, will expire eight years from the date of issuance, and in certain circumstances may be exercised on a cashless basis.

On July 7, 2023, we entered into an Amendment

to Securities Purchase Agreement (the “Armistice Amendment”) with Armistice Capital Markets Ltd. to delete Section 4.12(a) of our March 23, 2023 Securities Purchase Agreement (the “Armistice SPA”) with Armistice pursuant to which we agreed that from March 23, 2023 until 45 days after the effective date of the Resale Registration Statement (as defined below) we would not (i) issue, enter into any agreement to issue or announce the issuance or proposed issuance of any shares of common stock or Common Stock Equivalents or (ii) file any registration statement or any amendment or supplement thereto, other than the prospectus supplement filed in connection with that offering and the Resale Registration Statement (the “Subsequent Equity Financing Provision”). In consideration of Armistice’s agreement to enter into the Armistice Amendment and delete the Subsequent Equity Financing Provision from the Armistice SPA, we agreed to pay Armistice a fee a $1,000,000 (the “Armistice Amendment Fee”) within two days of the closing of the August 2023 Offering. Additionally, we agreed to include a proposal in our proxy statement for our 2023 Annual Meeting of Stockholders for the purpose of obtaining the approval of the holders of a majority of our outstanding voting common stock, to effectuate the reduction of the exercise price (the “Exercise Price Reduction”) set forth in Section 2(b) of the Common Stock Purchase Warrants issued to Armistice on March 27, 2023 (the “Existing Warrants”) to the per unit public offering price of the August 2023 Offering (or $2.85), in accordance with Nasdaq Rule 5635(d) (the “Stockholder Approval”) with the recommendation of our board of directors that such proposal be approved. We also agreed to solicit proxies from our stockholders in connection therewith in the same manner as all other management proposals in such proxy statement and that all management-appointed proxyholders shall vote their proxies in favor of such proposal. Further, if we did not obtain Stockholder Approval at the first meeting, we agreed to call a meeting every six (6) months thereafter to seek Stockholder Approval until the earlier of the date Stockholder Approval is obtained or the Existing Warrants are no longer outstanding. Until such approval was obtained, the exercise price of the Existing Warrants will remain unchanged.

On December 26, 2023, the Company held its 2023 annual meeting of stockholders (the “2023 Annual Meeting”) whereby the Company’s stockholders voted on and approved the Exercise Price Reduction.

Warrants related to August 2023 Public Offering

On August 4, 2023, the Company, entered into securities

purchase agreements (the “Purchase Agreements”) with certain institutional and other investors, pursuant to which the Company agreed to issue and sell to such investors in a public offering (the “August 2023 Offering”), 1,580,000 units (the “Units”) at a price of $2.85 per Unit, with each Unit consisting of (i) one share of Common Stock (the “Shares”) of the Company, and (ii) two common stock purchase warrants (the “Warrants”), each exercisable for one share of Common Stock at an exercise price of $2.85 per share. In the aggregate, in the August 2023 Offering the Company issued 1,580,000 Shares and 3,160,000 Warrants. The securities issued in the August 2023 Offering were offered pursuant to the Company’s registration statement on Form S-1 (File 333-273174) (the “Registration Statement”), initially filed by the Company with the SEC under the Securities Act, on July 7, 2023 and declared effective on August 3, 2023.

In connection with the August 2023 Offering, on August

4, 2023, the Company entered into a placement agency agreement (the “Placement Agency Agreement”) with Maxim Group LLC (the “Placement Agent”), pursuant to which (i) the Placement Agent agreed to act as placement agent on a “best efforts” basis in connection with the August 2023 Offering and (ii) the Company agreed to pay the Placement Agent an aggregate fee equal to 7.0% of the gross proceeds (and 5% for certain investors) raised in the August 2023 Offering and warrants to purchase up to 110,600 shares of Common Stock at an exercise price of $3.14 (the “Placement Agent Warrants”). The Placement Agent Warrants (and the shares of Common Stock issuable upon the exercise of the Placement Agent Warrants) were not registered under the Securities Act and were offered pursuant to an exemption from the registration requirements of the Securities Act provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder.

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Note17 – Income Taxes

The provision for income taxes consists of the following for the years ended December 31, 2023, and 2022:

Schedule of Components of Income Tax Expense (Benefit)

	2023			2022
	December<br> 31
	2023			2022
Federal<br> income taxes:
Current	$	-		$	-
Deferred		(860	)		315
Total<br> federal income taxes		(860	)		315
State<br> income taxes:
Current		29,735			2,062
Deferred		(1,089	)		496
Total<br> state income taxes		28,646			2,558
Total<br> income taxes	$	27,786		$	2,872

The effective income tax rate is lower than the U.S. federal and state statutory rates primarily because of the valuation allowance and, to a lesser extent, permanent items. A reconciliation of the 2023 and 2022 federal statutory rate as compared to the effective income tax rate is as follows:

Schedule of Effective Income Tax Rate Reconciliation

	December<br> 31
	2023					2022
Pre-Tax<br> Book Income at Statutory Rate	$	(1,519,297	)	21.00	%	$	(2,202,718	)	21.00	%
State<br> Tax Expense, net		23,719		-0.33	%		1,629		-0.02	%
Permanent<br> Items		226,420		-3.13	%		348,768		-3.33	%
Hanging<br> Credit		-		0.00	%		811		-0.01
True-Ups		(1,949	)	0.03	%		(36,554	)	0.35	%
Change<br> in Federal Valuation Allowance		1,298,892		-17.95	%		1,890,936		-18.03	%
Total<br> Expense	$	27,786		-0.38	%	$	2,872		-0.03	%

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Deferred income taxes reflect the net effect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax. Significant components of the deferred tax assets and liabilities as of December 31, 2023 and 2022, are as follows:

Schedule

of Deferred Tax Assets and Liabilities

	December<br> 31
	2023			2022
Deferred<br> tax assets:
Accrued<br> Compensation	$	195,584		$	243,056
Amortization of Discount Notes Payable		154,349			-
Lease<br> (ASC 842)		720,749			354,840
Charitable<br> Contributions		2,771			2,771
Stock<br> Option Expense		140,699			117,099
Restricted<br> Stock Unit		265,038			62,090
Net<br> Operating Losses		10,255,137			8,395,160
Org<br> Costs		81,255			81,255
-IRC<br> Sec. 174 Expense		204,864			275,519
Investment<br> in HRCFG INVO, LLC		(272,459	)		123,217
Equity<br> in earnings - Positib		(24,054	)		19,950
Gross<br> deferred tax assets		11,723,933			9,674,957
Deferred<br> tax liabilities:
Fixed<br> Assets		(18,733	)		(21,560	)
ROU<br> Lease (ASC 842)		(687,858	)		(340,532	)
Trademark<br> Amortization		(5,858	)		(5,858	)
Legal Fees		115,394			-
Deferred<br> Revenue		(47	)		(47	)
Tax<br> Amortization of Org Cost		(24,912	)		(7,222	)
Gain/Loss<br> on sale of assets		(2,561	)		(2,561	)
Gross<br> deferred tax liability		(624,575	)		(377,780	)
Less:<br> valuation allowance		(11,099,358	)		(9,299,126	)
Net<br> deferred tax liability	$	-		$	(1,949	)

The

Company recorded a full valuation allowance against its net deferred tax asset at December 31, 2023 and 2022 totaling $11.1

million and $9.3

million, respectively. A naked credit resulting from indefinite lived intangibles was valued at December 31, 2023, and 2022 totaling $0 and ($1,949), respectively.

As

of December 31, 2023, the Company has federal net operating loss carryforwards of approximately $32.9

million. Of that amount, $10.2

million will expire, if not utilized, in various

years beginning in 2028 and which are also subject to the limitations of IRC §382. The remaining carryforward amount of $22.7

million, has no expiration period and can be

applied to 80% of taxable income per year in future periods. State net operating loss carryforwards total $21.9

million. Of that amount, $3.5

million will begin to expire in 2033 and are

subject to the limitations of IRC §382. The remaining $18.4 million of state net operating loss carryforwards are similar to the federal net operating loss in that it has no expiration period and can be applied to 100% of state taxable income per year.

Note18 – Commitments and Contingencies

Insurance

The Company’s insurance coverage is carried with third-party insurers and includes: (i) general liability insurance covering third-party exposures; (ii) statutory workers’ compensation insurance; (iv) excess liability insurance above the established primary limits for general liability and automobile liability insurance; (v) property insurance, which covers the replacement value of real and personal property and includes business interruption; and (vi) insurance covering our directors and officers for acts related to our business activities. All coverage is subject to certain limits and deductibles, the terms and conditions of which are common for companies with similar types of operations.

LegalMatters

The Company is not currently subject to any material legal proceedings; however, it could be subject to legal proceedings and claims from time to time in the ordinary course of its business, or legal proceedings it considered immaterial may in the future become material. Regardless of the outcome, litigation can, among other things, be time consuming and expensive to resolve, and can divert management resources.

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LegacyNAYA Merger Agreement

On October 22, 2023, the Company, INVO Merger Sub Inc., a wholly owned subsidiary of the Company and a Delaware corporation (“Merger Sub”), and NAYA Therapeutics, Inc., a Delaware corporation formerly known as NAYA Biosciences, Inc. (“Legacy NAYA”), entered into an Agreement and Plan of Merger, as amended on October 25, 2023 (the “Merger Agreement”).

Upon the terms and subject to the conditions set forth in the Merger Agreement, Merger Sub would merge (the “Merger”) with and into Legacy NAYA, with Legacy NAYA continuing as the surviving corporation and a wholly owned subsidiary of the Company.

At

the effective time and as a result of the Merger, each share of Class A common stock, par value $0.000001

per share, of Legacy NAYA (the “Legacy

NAYA common stock”) outstanding immediately prior to the effective time of the Merger, other than certain excluded shares held by Legacy NAYA as treasury stock or owned by the Company or Merger Sub, would be converted into the right to receive 7.33333

(subject to adjustment as set forth in the Merger

Agreement) shares of a newly designated series of common stock, par value $0.0001

per share, of the Company which shall be entitled

to ten (10) votes per each share (“Company Class B common stock”) for a total of approximately 18,150,000 shares of the Company (together with cash proceeds from the sale of fractional shares, the “Merger Consideration”).

Immediately following the effective time of the Merger, Dr. Daniel Teper, Legacy NAYA’s current chairman and chief executive officer, will be named chairman and chief executive officer of the Company, and the board of directors will be comprised of at least nine (9) directors, of which (i) one shall be Steven Shum, the Company’s current chief executive officer, and (ii) eight shall be identified by Legacy NAYA, of which seven (7) shall be independent directors.

The

completion of the Merger is subject to satisfaction or waiver of certain customary mutual closing conditions, including (1) the adoption of the Merger Agreement by the stockholders of the Company and Legacy NAYA, (2) the absence of any injunction or other order issued by a court of competent jurisdiction or applicable law or legal prohibition prohibiting or making illegal the consummation of the Merger, (3) the completion of due diligence, (4) the completion of a private sale of the Company’s preferred stock at a price per share of $5.00

per share, in a private offering resulting in

an amount equal to at least $2,000,000

of gross proceeds to the Company in the aggregate,

plus an additional amount as may be required prior to closing of the Merger to be determined in good faith by the parties to adequately support the Company’s fertility business activities per an agreed forecast of the Company, as well as for a period of twelve (12) months post-Closing including a catch-up on the Company’s past due accrued payables still outstanding (the “Interim PIPE”), (5) the aggregate of the liabilities of the Company, excluding certain specified liabilities, shall not exceed $5,000,000

,

(6) the receipt of waivers from any and all holders of warrants (and any other similar instruments) to securities of the Company, with respect to any fundamental transaction rights such warrant holders may have under any such warrants, (7) the continued listing of the Company common stock on NASDAQ through the effective time of the Merger and the approval for listing on NASDAQ of the shares of the Company common stock to be issued in connection with the Merger, the interim private offering, and a private offering of shares of Company common stock at a target price of $5.00 per share (subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to the Company common stock) resulting in sufficient cash available for the Company for one year of operations, as estimated by Legacy NAYA, (8) the effectiveness of a registration statement on Form S-4 to be filed by the Company pursuant to which the shares of Company common stock to be issued in connection with the Merger will be registered with the SEC, and the absence of any stop order suspending such effectiveness or proceeding for the purpose of suspending such effectiveness being pending before or threatened by the SEC, and (9) the Company shall have received customary lock-up Agreement from certain Company stockholders. The obligation of each party to consummate the Merger is also conditioned upon (1) the other party having performed in all material respects its obligations under the Merger Agreement and (2) the other party’s representations and warranties in the Merger Agreement being true and correct (subject to certain materiality qualifiers); provided, however, that these conditions, other than with respects to certain representations and warranties, will be deemed waived by the Company upon the closing of the interim private offering.

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The

Merger Agreement contains termination rights for each of the Company and Legacy NAYA, including, among others: (1) if the consummation of the Merger does not occur on or before December 31, 2023 (the “End Date”) (which has since been extended to April 30, 20204), except that any party whose material breach of the Merger Agreement caused or was the primary contributing factor that resulted in the failure of the Merger to be consummated on or before the End Date, (2) if any governmental authority has enacted any law or order making illegal, permanently enjoining, or otherwise permanently prohibiting the consummation of the Merger, and (3) if the required vote of the stockholders of either the Company or Legacy NAYA has not been obtained. The Merger Agreement contains additional termination rights for Legacy NAYA, including, among others: (1) if the Company materially breaches its non-solicitation obligations or fails to take all action necessary to hold a stockholder meeting to approve the transactions contemplated by the Merger Agreement, (2) if the aggregate of the liabilities of the Company, excluding certain specified liabilities, exceed $5,000,000 , (3) if Legacy NAYA determines that the due diligence contingency will not be satisfied by October 26, 2023, (4) if Legacy NAYA determines that the Company has experienced a material adverse effect, or (5) the Company material breaches any representation, warranty, covenant, or agreement such that the conditions to closing would not be satisfied and such breach is incapable of being cured, unless such breach is caused by Legacy NAYA’s failure to perform or comply with any of the covenants, agreements, or conditions hereof to be performed or complied with by it prior to the closing.

If

all of Legacy NAYA’s conditions to closing are satisfied or waived and Legacy NAYA fails to consummate the Merger, Legacy NAYA would be required to pay the Company a termination fee of $1,000,000

.

If all of the Company’s conditions to closing conditions are satisfied or waived and the Company fails to consummate the Merger, the Company would be required to pay Legacy NAYA a termination fee of $1,000,000 .

On

December 27, 2023, the Company entered into second amendment (“Second Amendment”) to the Merger Agreement. Pursuant to the Second Amendment, the parties agreed to extend the End Date to October 14, 2024. The parties further agreed to modify the closing condition for the Interim PIPE from a private offering of shares of Company common stock at a price that is a premium to the market price of the Company common stock in an estimated amount of $5,000,000

or more of gross proceeds to a private offering

of the Company’s preferred stock at a price per share of $5.00

per share in an amount equal to at least $2,000,000

to the Company, plus an additional amount as may be required prior to closing of the Merger to be determined in good faith by the parties to adequately support the Company’s fertility business activities per an agreed forecast, as well as for a period of twelve (12) months post-closing including a catch-up on the Company’s past due accrued payables still outstanding. The parties further agreed to the following schedule (the “Minimum Interim Pipe Schedule”) for the initial $2,000,000: (1) $500,000 no later than December 29, 2023, (2) $500,000 no later than January 19, 2024, (3) $500,000 no later than February 2, 2024, and (4) $500,000 no later than February 16, 2024. The parties also further agreed to modify the covenant of the parties regarding the Interim PIPE to require Legacy NAYA to consummate the Interim PIPE before the closing of the Merger; provided, however, if the Company does not receive the initial gross proceeds pursuant to the Minimum Interim Pipe Schedule, the Company shall be free to secure funding from third parties to make up for short falls on reasonable terms under SEC and Nasdaq regulations.

Since December 31, 2023, the Company entered into a third amendment and fourth amendment to the Merger Agreement, then amended and restated the Merger Agreement, and consummated the Merger pursuant to the amended and restated terms on October 11, 2024. See Note 19 – Subsequent Events.

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Note19 – Subsequent Events

ConsultingShares

In

February 2024, the Company issued 125,500 shares of Common Stock to consultants in consideration of services rendered. These shares were issued pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended. The Company did not receive any cash proceeds from this issuance.

In April 2024, the Company issued 11,655 shares of common stock to consultants in consideration of services rendered. These shares were issued pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended. The Company did not receive any cash proceeds from this issuance.

In May 2024, the Company issued 7,500 shares of common stock to consultants in consideration of services rendered. These shares were issued pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended. The Company did not receive any cash proceeds from this issuance.

In August 2024, the Company issued 42,000 shares of common stock to consultants in consideration of services rendered. These shares were issued pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended. The Company did not receive any cash proceeds from this issuance.

In October 2024, the Company issued 52,000 shares of common stock to consultants in consideration of services rendered. These shares were issued pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended. The Company did not receive any cash proceeds from this issuance.

FutureReceipts Agreement

On

February 26, 2024, the Company finalized an Agreement for the Purchase and Sale of Future Receipts (the “Future Receipts Agreement”) with a buyer (the “Buyer”) under which the Buyer purchased $344,925

of our future sales

for a gross purchase price of $236,250

.

The Company received net proceeds of $225,000

.

Until the purchase price has been repaid, the Company agreed to pay the Buyer $13,797 per week.

TritonPurchase Agreement

On

March 27, 2024, the Company entered into a purchase agreement (the “Triton Purchase Agreement”) with Triton Funds LP (“Triton”), pursuant to which the Company agreed to sell, and Triton agreed to purchase, upon the Company’s request in one or more transactions, up to 1,000,000

shares of the Company’s common stock, par

value $0.0001

per share, providing aggregate gross proceeds

to the Company of up to $850,000

.

Triton will purchase the shares of common stock under the Triton Purchase Agreement at the price of $0.85 per share. The purchase agreement expires upon the earlier of the sale of all 1,000,000 shares of the Company’s common stock or December 31, 2024.

Among other limitations, unless otherwise agreed upon by Triton, each individual sale of shares of common stock will be limited to no more than the number of shares of common stock that would result in the direct or indirect beneficial ownership by Triton of more than 9.99% of the then-outstanding shares of common stock. In addition, the total cumulative number of shares of common stock that may be issued to Triton under the Triton Purchase Agreement may not exceed the requirements of Nasdaq Listing Rule 5635(d), except that such limitation will not apply in the event the Company obtains stockholder approval of the shares of common stock to be issued under the Triton Purchase Agreement, if necessary, in accordance with the requirements of Nasdaq Listing Rule 5635(d).

The Triton Purchase Agreement provides that the Company will file a prospectus supplement (the “Prospectus Supplement”) to its Registration Statement on Form S-3, which was declared effective on April 16, 2021 (File No. 333-255096) (the “Base Registration Statement”), covering the offering and sale of the shares of common stock to Triton pursuant to the Triton Purchase Agreement. Triton’s obligation to purchase shares of common stock under the Triton Purchase Agreement is conditioned upon, among other things, the filing of the Prospectus Supplement and the Base Registration Statement remaining effective.

The Triton Purchase Agreement contains customary representations, warranties, and covenants by each of the Company and Triton. Actual sales of shares of common stock to Triton will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the common stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations. Triton has no right to require any sales of shares of common stock by the Company but is obligated to make purchases of shares of common stock from the Company from time to time, pursuant to directions from the Company, in accordance with the Triton Purchase Agreement. During the term of the Triton Purchase Agreement, Triton has covenanted not to cause or engage in any short selling of shares of common stock.

On

March 27, 2024, the Company sold to Triton private placement warrants to purchase up to 1,000,000

shares of our common

stock at an exercise price of $2.00 per share.

On

March 27, 2024, the Company delivered a purchase notice for 260,000

shares of common stock.

The Company’s common stock traded below the purchase price following the date of the purchase notice, giving Triton the right to return to the Company any of the 260,000

shares. On April 5,

2024, Triton notified the Company that it will return 185,000

shares to the Company

and closed the purchase of 75,000 shares pursuant to the Triton Purchase Agreement for net proceeds of $36,750.

On

April 16, 2024, the Company delivered a purchase notice for 185,000 shares of common stock, which was subsequently closed on April 19, 2024 for net proceeds of $155,000.

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FirstFireSecurities Purchase Agreement

On April 5, 2024, the Company entered into a purchase agreement (the “FirstFire Purchase Agreement”) with FirstFire Global Opportunities Fund, LLC (“FirstFire”), pursuant to which FirstFire agreed to purchase, and the Company agreed to issue and sell, (i) a promissory note with an aggregate principal amount of $275,000.00, which is convertible into shares of the Company’s common stock, according to the terms, conditions, and limitations outlined in the note (the “FirstFire Note”), (ii) a warrant (the “First Warrant”) to purchase 229,167 shares (the “First Warrant Shares”) of the Company’s common stock at an exercise price of $1.20 per share, (iii) a warrant (the “Second Warrant”) to purchase 500,000 shares (the “Second Warrant Shares”) of common stock at an exercise price of $0.01 issued to FirstFire, and (iv) 50,000 shares of common stock (the “Commitment Shares”), for a purchase price of $250,000.

Carter,

Terry, & Company, Inc. acted as placement agent for the transaction, for which it received a cash fee of $25,000 . The proceeds are being used for working capital and general corporate purposes.

Among other limitations, the total cumulative number of shares of common stock that may be issued to FirstFire under the FirstFire Purchase Agreement may not exceed the requirements of Nasdaq Listing Rule 5635(d), except that such limitation will not apply in the event the Company obtains stockholder approval of the shares of common stock to be issued under the Purchase Agreement, if necessary, in accordance with the requirements of Nasdaq Listing Rule 5635(d). The Company has agreed to hold a meeting for the purpose of obtaining this stockholder approval within nine (9) months of the date of the FirstFire Purchase Agreement.

The FirstFire Purchase Agreement contains customary representations, warranties, and covenants by each of the Company and FirstFire. Among other covenants of the parties, the Company granted FirstFire the right to participate in any subsequent placement of securities until the earlier of eighteen (18) months after the date of the FirstFire Purchase Agreement or extinguishment of the FirstFire Note. The Company has also granted customary “piggy-back” registration rights to FirstFire with respect to the shares of common stock underlying the FirstFire Note (the “Conversion Shares”), the First Warrant Shares, the Second Warrant Shares, and the Commitment Shares. FirstFire has covenanted not to cause or engage in any short selling of shares of common stock until the FirstFire Note is fully repaid.

The following sets forth the material terms of the FirstFire Note, the First Warrant, and the Second Warrant.

FirstFire Note

Interestand Maturity. The FirstFire Note carries an interest rate of twelve percent (12

%)

per annum, with the first twelve months of interest, amounting to $33,000.00 , guaranteed, and fully earned as of the issue date. The maturity date of the FirstFire Note is twelve (12) months from the issue date, at which point the Principal Amount, together with any accrued and unpaid interest and other fees, shall be due and payable to the holder of the FirstFire Note.

Conversion.

The holder of the FirstFire Note is entitled to convert any portion of the outstanding and unpaid principal amount and accrued interest into Conversion Shares at a conversion price of $1.00 per share, subject to adjustment. The FirstFire Note may not be converted and Conversion Shares may not be issued under the FirstFire Note if, after giving effect to the conversion or issuance, the holder together with its affiliates would beneficially own in excess of 4.99% of the outstanding common stock. In addition to the beneficial ownership limitations in the FirstFire Note, the number of shares of common stock that may be issued under the FirstFire Note, the First Warrant, the Second Warrant, and under the FirstFire Purchase Agreement (including the Commitment Shares) is limited to 19.99% of the outstanding common stock as of April 5, 2024 (the “Exchange Cap”, which is equal to 523,344 shares of common stock, subject to adjustment as described in the FirstFire Purchase Agreement), unless stockholder approval is obtained by the Company to issue more than the Exchange Cap. The Exchange Cap shall be appropriately adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction.

Prepayment. The Company may prepay the FirstFire Note at any time in whole or in part by paying a sum of money equal to 110% of the sum of the principal amount to be redeemed plus the accrued and unpaid interest.

Future

Proceeds. While any portion of the FirstFire Note is outstanding, if the Company receives cash proceeds of more than $1,500,000

from any source or series of related or unrelated

sources, or more than $1,000,000 from any public offering (the “Minimum Threshold”), the Company shall, within one (1) business day of Company’s receipt of such proceeds, inform FirstFire of such receipt, following which FirstFire shall have the right in its sole discretion to require the Company to immediately apply up to 100% of all proceeds received by the Company above the Minimum Threshold to repay the outstanding amounts owed under the FirstFire Note.

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Covenants. The Company is subject to various covenants that restrict its ability to, among other things, declare dividends, make certain investments, sell assets outside the ordinary course of business, or enter into transactions with affiliates, thereby ensuring the Company operational and financial activities are conducted in a manner that prioritizes the repayment of the FirstFire Note.

Eventsof Default. The FirstFire Note outlines specific events of default and provides FirstFire certain rights and remedies in such events, including but not limited to the acceleration of the FirstFire Note’s due date and a requirement for the Company to pay a default amount. Specific events that constitute a default under the FirstFire Note include, but are not limited to, failure to pay principal or interest when due, breaches of covenants or agreements, bankruptcy or insolvency events, and a failure to comply with the reporting requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Upon an event of default, the FirstFire Note becomes immediately due and payable, and the Borrower is subject to a default sum as stipulated.

The FirstFire Note is subject to, and governed by, the terms and conditions of the FirstFire Purchase Agreement.

In

October 2024, the Company issued 190,000 shares of common stock with a fair value of $190,000 as a result of a partial conversion of the FirstFire Note. No gain or loss was recorded on conversion, as the issuance of common stock was pursuant to the terms of a prior agreement.

First Warrant

The

First Warrant grants the holder thereof the right to purchase up to 229,167

shares of common stock at an exercise price of

$1.20 per share.

Exercisability. The First Warrant is be immediately exercisable and will expire five years from the issuance date. The First Warrant is exercisable, at the option of the holder, in whole or in part, by delivering to the Company a duly executed exercise notice and, at any time a registration statement registering the issuance of the First Warrant Shares under the Securities Act of 1933, as amended (the “Securities Act”) is effective and available for the issuance of such First Warrant Shares, or an exemption from registration under the Securities Act is available for the issuance of such First Warrant Shares, by payment in full in immediately available funds for the number of First Warrant Shares purchased upon such exercise. If a registration statement registering the issuance of the First Warrant Shares underlying the First Warrant under the Securities Act is not effective or available, the holder may, in its sole discretion, elect to exercise the First Warrant through a cashless exercise, in which case the holder would receive upon such exercise the net number of First Warrant Shares determined according to the formula set forth in the First Warrant.

ExerciseLimitation. A holder will not have the right to exercise any portion of the First Warrant if the holder (together with its affiliates) would beneficially own in excess of 4.99% of the number of shares of the common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the First Warrant.

TradingMarket Regulation. Until the Company has obtained stockholder approval of the FirstFire Purchase Agreement and the issuance of the securities issued pursuant thereto, the Company may not issue any First Warrant Shares upon the exercise of the First Warrants if the issuance of such First Warrant Shares, (taken together with the issuance of any shares held by or issuable to the holder under the FirstFire Purchase Agreement or any other agreement with the Company) would exceed the aggregate number of shares which the Company may issue without breaching 523,344 shares (19.9% of the Company’s outstanding common stock) or any of the Company’s obligations under the rules or regulations of Nasdaq.

ExercisePrice Adjustment. Subject to the aforementioned limitations, the exercise price of the First Warrant is subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the common stock, upon any distributions of assets, including cash, stock or other property to our stockholders, and if we issue additional shares of common stock at a price per share that is less than the exercise price then in effect.

FundamentalTransactions. The Company shall not enter into or be a party to a fundamental transaction unless the successor entity assumes all obligations of the Company under the First Warrant and other transaction documents. Upon consummation of a fundamental transaction, then the successor entity will succeed to, and be substituted for the Company, and may exercise every right and power that the Company may exercise and will assume all of the Company’s obligations under the First Warrant with the same effect as if such successor entity had been named in the First Warrant itself.

Rightsas a Stockholder. Except as otherwise provided in the First Warrant or by virtue of such holder’s ownership of shares of common stock, the holder of the First Warrant will not have the rights or privileges of a holder of common stock, including any voting rights, until the holder exercises the First Warrant.

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Second Warrant

The

Second Warrant grants the holder thereof the right to purchase up to 500,000

shares of common stock at an exercise price of

$0.01 per share.

Exercisability. The Second Warrant will only become exercisable on the specific Triggering Event Date, which is the date that an Event of Default occurs under the Note, and will expire five years from such date. The Second Warrant includes a ‘Returnable Warrant’ clause, providing that the Second Warrant shall be cancelled and returned to the Company if the Note is fully extinguished before any Triggering Event Date. The Second Warrant will be exercisable, at the option of each holder, in whole or in part by delivering to the Company a duly executed exercise notice and, at any time a registration statement registering the issuance of the Second Warrant Shares under the Securities Act is effective and available for the issuance of such Second Warrant Shares, or an exemption from registration under the Securities Act is available for the issuance of such shares, by payment in full in immediately available funds for the number of Second Warrant Shares purchased upon such exercise. If a registration statement registering the issuance of Second Warrant Shares under the Securities Act is not effective or available, the holder may, in its sole discretion, elect to exercise the Second Warrant through a cashless exercise, in which case the holder would receive upon such exercise the net number of Second Warrant Shares determined according to the formula set forth in the warrant.

ExerciseLimitation. A holder will not have the right to exercise any portion of the Second Warrant if the holder (together with its affiliates) would beneficially own in excess of 4.99% of the number of shares of the common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Second Warrant.

TradingMarket Regulation. Until the Company has obtained stockholder approval of the FirstFire Purchase Agreement and the issuance of the securities issued pursuant thereto, the Company may not issue any Second Warrant Shares upon the exercise of the Second Warrants if the issuance of such Second Warrant Shares, (taken together with the issuance of any shares held by or issuable to the holder under the FirstFire Purchase Agreement or any other agreement with the Company) would exceed the aggregate number of shares which the Company may issue without breaching 523,344 shares (19.9% of the Company’s outstanding common stock) or any of the Company’s obligations under the rules or regulations of Nasdaq.

ExercisePrice Adjustment. Subject to the aforementioned limitations, the exercise price of the Second Warrant is subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the common stock, upon any distributions of assets, including cash, stock or other property to our stockholders, and if we issue additional shares of common stock at a price per share that is less than the exercise price then in effect.

FundamentalTransactions. The Company shall not enter into or be a party to a fundamental transaction unless the successor entity assumes all obligations of the Company under the Second Warrant and other transaction documents. Upon consummation of a fundamental transaction, then the successor entity will succeed to, and be substituted for the Company, and may exercise every right and power that the Company may exercise and will assume all of the Company’s obligations under the Second Warrant with the same effect as if such successor entity had been named in the Second Warrant itself.

Rightsas a Stockholder. Except as otherwise provided in the Second Warrant or by virtue of such holder’s ownership of shares of common stock, the holder of the Second Warrant will not have the rights or privileges of a holder of common stock, including any voting rights, until the holder exercises the Second Warrant.

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DebtConversion

In

April 2024, the Company issued 109,886 shares of common stock with a fair value of $197,033 as a result of the conversion of the Q1 2023 Convertible Notes and accrued interest thereon. No gain or loss was recorded on conversion, as the issuance of common stock was pursuant to the terms of a prior agreement.

August2023 Offering Warrant Price Reduction

On

April 17, 2024, the Company reduced the exercise price of the August 2023 Warrants from $2.85 per share to $1.20 per share effective April 17, 2024.

In

April 2024, the Company issued 807,000 shares of common stock for proceeds of $968,400 upon the exercise of the August 2023 Warrants.

NasdaqCompliance – Minimum Equity Requirement

On

April 17, 2024, the Company, having reported, on April 16, 2024, stockholders’ equity of $892,825 in the Form 10-K for the period ended December 31, 2023, received notice (the “Notice”) from the staff (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) advising the Company that it no longer complies with Nasdaq Listing Rule 5550(b)(1) that requires companies listed on The Nasdaq Capital Market to maintain stockholders’ equity of at least $2,500,000 (the “Equity Rule”).

In a decision dated November 22, 2023, a Nasdaq Hearings Panel (the “Panel”) previously had confirmed that the Company regained compliance with the Equity Rule. In the decision, the Panel imposed a Mandatory Panel Monitor for a period of one year or until November 22, 2024, which would require Staff to issue a Delist Determination Letter, in the event that the Company failed to maintain compliance with the Equity Rule (the “Panel Monitor”). As a result, the Notice contains the Staff’s determination to delist the Company.

As described in the Notice, under Nasdaq rules, the Company had and exercised its right to request an appeal of this determination to prevent its securities from being delisted and suspended at the opening of business on April 26, 2024. The Company’s hearing to present its appeal of the Staff’s determination in front of the Panel was heard on June 6, 2024.

On June 18, 2024, the Company received a notice from Nasdaq stating that the Panel had granted its request for continued listing on the Exchange until October 14, 2024, subject to the Company demonstrating compliance with Nasdaq’s Listing Rule 5505 (the “Initial Listing Rule”), as it would apply to the proposed Merger with Legacy NAYA. The Initial Listing Rule requires the Company to have a minimum bid price, a minimum of unrestricted publicly held shares, a minimum number of round lot shareholders, a minimum number of market makers, and it requires us to meet its Equity Standard, its Market Value of Listed Securities Standard, or its Net Income Standard.

On November 4, 2024, the Company received a notice from Nasdaq, dated October 30, 2024, informing the Company that it demonstrated compliance with the Equity Rule for continued listing on The Nasdaq Capital Market, as required by the Panel’s decision dated June 18, 2024, as amended. The Company will be subject to a mandatory panel monitor for a period of one year from the date of the notification.

NasdaqCompliance – Minimum Bid Price

On

September 18, 2024, the Company received a letter from the Staff indicating that, based upon the closing bid price of the Company’s common stock for the last 34 consecutive business days, the Company is not currently in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing under Nasdaq Listing Rule 5550(a)(2).

The notice has no immediate effect on the listing of the Company’s common stock, and its common stock will continue to trade on Nasdaq.

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In

accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided an initial period of 180 calendar days, or until May 17, 2025, to regain compliance with the minimum bid price requirement. If at any time before May 17, 2025, the closing bid price of the Company’s common stock closes at or above $1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide written notification that the Company has achieved compliance with the minimum bid price requirement, and the matter would be resolved. If the Company does not regain compliance prior to May 17, 2025, then Nasdaq may grant the Company a second 180 calendar day period to regain compliance, provided the Company (i) meets the continued listing requirement for market value of publicly-held shares and all other initial listing standards for The Nasdaq Capital Market, other than the minimum closing bid price requirement, and (ii) notifies Nasdaq of its intent to cure the deficiency within such second 180 calendar day period, by effecting a reverse stock split, if necessary.

The Company will continue to monitor the closing bid price of its common stock and will consider implementing available options to regain compliance with the minimum bid price requirement under the Nasdaq Listing Rules. If the Company does not regain compliance with the minimum bid price requirement within the allotted compliance periods, the Company will receive a written notification from Nasdaq that its securities are subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that the Company will regain compliance during either compliance period, or maintain compliance with the other Nasdaq listing requirements.

TampaLease Assignment

On

April 19, 2024, INVO Centers LLC (“INVO Centers”), a wholly owned subsidiary of the Company, completed the assignment to Brown Fertility Associates PA (“Brown Fertility”) of its lease with 4602 North Armenia Ave, LLC (the “Landlord”), for the property located at 4602 North Armenia Avenue, Suite 200, Tampa, LLC (the “Premises”). As a result of the doctor for the proposed Tampa INVO Center becoming unavailable and its current focus on prioritizing the acquisition of US-based profitable fertility clinics, the Company opted to assign the lease for the Premises. Brown Fertility paid INVO Centers $475,000 to secure the space and the Company was fully released by the Landlord under the assignment. The Company used $356,546.66 of the assignment proceeds to complete payment to the Landlord for the buildout of the Premises and for rent accrued before the completion of the assignment. The remaining proceeds will be used for general working capital.

ConvertibleNote Extension

As

of June 28, 2024, the Company secured written consent by the Required Holders for the Q1 2023 Convertible Note maturity date to be extended to December 31, 2024. As an incentive for the Required Holders to approve the extension, the Company agreed (a) to lower both the Q1 2023 Convertible Note fixed conversion price and the Q1 2023 Warrants exercise price to $1.20, (b) to provide the Q1 2023 Convertible Note holders the right to demand early repayment at the closing of the Merger with Legacy NAYA or if the Company raises more than $3 million dollars in a single equity raise, and (c) to increase the number of shares of common stock available under the Q1 2023 Warrants to a total of 124,421. The maturity date extension, the conversion reduction and the early repayment right applies to all outstanding Q1 2023 Convertible Notes, and the exercise price reduction and additional warrant coverage applies to all Q1 2023 Warrants.

StandardMerchant Cash Advance Agreement

On

September 25, 2024, the Company entered into a Standard Merchant Cash Advance Agreement (the “Sept 2024 Cash Advance Agreement”) with a buyer (the “Buyer”) under which the Buyer purchased $384,250 of the Company’s future sales for a gross purchase price of $265,000 (the “Transaction”). The Company received net proceeds of $251,750. Until the purchase price has been repaid, the Company agreed to pay the Buyer $9,606 per week. The Company intends to use the proceeds for working capital and general corporate purposes.

The

Company received approval from its senior secured lender, Decathlon to consummate the Transaction pursuant to an Amended and Restated First Amendment (the “RSLA Amendment”) to Revenue Loan and Security Agreement, dated September 29, 2023 between the Company and Decathlon (the “Revenue Loan and Security Agreement”). Pursuant to the Amendment, the minimum interest multiples set forth in the Revenue Loan and Security Agreement will automatically increase by 0.15x as of December 1, 2024 if the Company does not receive equity investments in the net amount of $1,000,000 by November 30, 2024.

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Decathlon, the Buyer, and the Company also signed a subordination agreement in which the Buyer subordinated its rights under the transaction to those of Decathlon.

Amendmentsto Legacy NAYA Agreement and Plan of Merger and Securities Purchase Agreement

Effective

as of May 1, 2024, the Company entered into a third amendment (“Third Amendment”) to the Merger Agreement. Pursuant to the Third Amendment, the parties agreed to extend the End Date to June 30, 2024. The parties further agreed to modify the definition of an “Interim PIPE” to mean (a) a sale of shares of the Company’s Series A Preferred Stock pursuant to the Series A Preferred SPA, as amended (“Phase 1”), plus (b) a sale of shares of the Company’s preferred stock at a price per share of $5.00 per share in a private offering, to be consummated prior to the closing of the Merger, resulting in an amount as may be required, to be determined in good faith by the parties to the Merger Agreement, to adequately support the Company’s fertility business activities per an agreed forecast of the Company as well as for a period of twelve (12) months following the closing, including a catch-up on the Company’s past due accrued payables still outstanding (“Phase 2”). The parties agreed that Phase I must be consummated pursuant to the terms of the Series A Preferred SPA and that Phase II much be consummated prior to the closing of the Merger. The parties also confirmed that the Company remains free to secure any amount of funding from third parties on any terms the Company deems reasonably acceptable under SEC and Nasdaq regulations without the prior written consent of Legacy NAYA. Under the Third Amendment, the Company may terminate the Merger Agreement if Legacy NAYA breaches or fails to perform any of its covenants and agreements set forth in the Securities Purchase Agreement in any respect.

Effective

as of May 1, 2024, the Company entered into an Amendment (the “SPA Amendment”) to the Series A Preferred SPA. Pursuant to the SPA Amendment, the parties agreed to the following closing schedule for Legacy NAYA’s purchases of the remaining 838,800 shares of the Company’s Series A Preferred Stock at a purchase price of $5.00 per share:

Schedule of Closing Price for NAYA's Purchases of Remaining Shares

Closing Date	Shares		Aggregate Purchase Price
May 10, 2024		20,000	$	100,000
May 17, 2024		30,000	$	150,000
May 24, 2024		30,000	$	150,000
May 31, 2024		30,000	$	150,000
June 7, 2024		30,000	$	150,000
June 14, 2024		30,000	$	150,000
June 21, 2024		30,000	$	150,000
June 28, 2024		30,000	$	150,000
July 5, 2024		30,000	$	150,000
On or before the closing of the Merger Agreement, to be determined in good faith by the Subscriber and<br> the Company		598,800	$	2,894,000

Legacy

NAYA purchased a total of 328,780 shares of the Company’s Series A Preferred stock for gross proceeds of $1,643,900.

Effective as of September 12, 2024,

the Company entered into

a fourth amendment (“Fourth Amendment”) to the Merger Agreement. Pursuant to the Fourth Amendment, the parties agreed to extend the End Date to October 14, 2024. The parties further agreed that Legacy NAYA would purchase 27,500 shares of the Company’s Series A Preferred Stock for $137,500 pursuant to Series A Preferred SPA and could purchase up to an additional 72,500 shares of Series A Preferred Stock for an aggregate of $362,500 pursuant to the Securities Purchase Agreement prior to or concurrently with the closing of the Merger. Each party waived prior breaches of the Merger Agreement.

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Each party also agreed to use its best efforts to consummate the transactions contemplated by the Fourth Amendment, including to negotiate in good faith to amend and restate the Merger Agreement (the “A&R Merger Agreement”) to, among other things, (1) provide that the closing of the Merger shall occur simultaneously or shortly after the execution and delivery of the A&R Merger Agreement, and that the parties shall commit to use its respective best efforts to cause the closing to occur on or about October 1, 2024, but, in any case, no later than October 14, 2024, (2) ensure that the revised structure of the Merger shall be in compliance in all material respects with the applicable current listing and governance rules and regulations of the Nasdaq Stock Market, (3) provide that the aggregate merger consideration to be paid by the Company for all of the outstanding shares of Legacy NAYA’s capital stock shall consist of (a) such number of shares of the Company’s common stock as shall represent a number of shares equal to no more than 19.9% of the outstanding shares of the Company’s common stock as of immediately before the effective time of the Merger (the “Common Stock Payment Shares”) and (b) shares of a newly designated Series C Convertible Preferred Stock of the Company (the “Parent Preferred Stock Payment Shares”), (4) include an acknowledgment by the parties that Legacy NAYA shall transfer 85% of the Common Stock Payment Shares to Five Narrow Lane LP (“FNL”), as a secured lender of Legacy NAYA, (5) provide that the Company shall take all action necessary under applicable law to (i) call, give notice of, and hold a meeting of its stockholders as soon as possible after the closing of the Merger, but in any case, no later than 120 days thereafter (the “Stockholder Meeting Deadline”; provided, that, the Company acknowledges that, if the Parent receives comments from the Securities and Exchange Commission (“SEC”) on the proxy statement filed in connection with such stockholder meeting and the Parent uses its best efforts to revise and refile the proxy statement to address such comments, the date of such stockholder meeting may be after the Stockholder Meeting Deadline), for the purpose of, among other things, seeking stockholder approval (the “Stockholder Approval”) of the issuance of all shares of the Company’s common stock issuable upon conversion (the “Series C Conversion Shares”) of the Preferred Stock Payment Shares in accordance with the terms of the Certificate of Designations of Series C Convertible Preferred Stock (the “Series C Certificate of Designations”), and (ii) to file with the SEC a proxy statement for the purpose of obtaining the Stockholder Approval, no later than 35 days after the closing of the Merger, (6) provide that, upon receipt of the Stockholder Approval, the Preferred Stock Payment Shares shall be automatically converted into the Series C Conversion Shares at the conversion price in effect as set forth in the Series C Certificate of Designations; provided that, following such conversion, the Series C Conversion Shares shall represent approximately 60.1% of the outstanding shares of the Company’s common stock; and (7) provide that, as soon as possible after the closing of the Merger, the Company shall file a resale registration statement with the SEC to register the Common Stock Payment Shares and the Series C Conversion Shares in accordance with the terms of a registration rights agreement to be entered into between the parties.

On October 11, 2024 (the “Effective Time”), the Company, Merger Sub, and Legacy NAYA, entered into an Amended and Restated Agreement and Plan of Merger (the “Merger Agreement”) and consummated and the transactions contemplated thereby. Upon the terms and subject to the conditions set forth in the Merger Agreement, Merger Sub merged with and into Legacy NAYA, with Legacy NAYA continuing as the surviving corporation and a wholly owned subsidiary of the Company.

At the Effective Time and as a result of the consummation of the Merger:

●

Each<br> share of Class A common stock, par value $0.000001 per share, and Class B common stock, par<br> value $0.000001 per share, of Legacy NAYA (“Legacy NAYA common stock”) outstanding<br> immediately prior to the effective time of the Merger, other than certain excluded shares<br> held by Legacy NAYA as treasury stock or owned by the Company or Merger Sub, automatically<br> converted into the right to receive 118,148 shares of the Company’s common stock and<br> 30,375 shares of the Company’s newly-designated Series C-1 Convertible Preferred Stock<br> (the “Series C-1 Preferred”). The Series C-1 Preferred is not redeemable, has<br> no voting rights, and may not be converted into shares of the Company’s Common Stock<br> unless and until the Company’s stockholders approve the issuance of common stock upon<br> conversion of the Series C-1 Preferred. If the Company’s stockholders approve the issuance<br> of common stock upon conversion of the Series C-1 Preferred, such Series C-1 Preferred will<br> automatically convert into approximately 29,515,315 shares of the Company’s common<br> stock, subject to adjustment if, as a result of such conversion if, after giving effect to<br> the conversion or issuance, any single holder, together with its affiliates, would beneficially<br> own in excess of 19.99% of the Company’s outstanding common stock.

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| --- | | ● | Certain<br> outstanding debt obligations of Legacy NAYA, including a portion of an amended and restated<br> senior secured convertible debenture issued to FNL, with a combined principal balance of<br> $8,575,833 converted into the right to receive 669,508 shares of the Company’s common<br> stock and 8,576 shares of the Company’s newly-designated Series C-2 Convertible Preferred<br> Stock (the “Series C-2 Preferred”). The Series C-2 Preferred is only redeemable<br> upon a “Bankruptcy Triggering Event” or a “Change of Control” that<br> occurs 210 days after the closing date of the Merger. The Series C-2 Preferred may not be<br> converted into shares of the Company’s Common Stock unless and until the Company’s<br> stockholders approve the issuance of common stock upon conversion of the Series C-2 Preferred.<br> If the Company’s stockholders approve the issuance of common stock upon conversion<br> of the Series C-2 Preferred, such Series C-2 Preferred will be convertible at the option<br> of the holders into approximately 12,441,607 shares of the Company’s common stock ,<br> subject to limitations on beneficial ownership by the holders thereof. | | --- | --- | | ● | The<br> remaining balance of the amended and restated senior secured convertible debenture issued<br> to FNL in the amount of $3,934,146 was exchanged for a 7.0% Senior Secured Convertible Debenture<br> in the principal balance of $3,934,146 due December 11, 2025 (the “Debenture”).<br> A description of the rights, preferences, and privileges of the Debenture are set forth below. | | --- | --- | | ● | Legacy<br> NAYA has been renamed to “NAYA Therapeutics Inc.” | | --- | --- |

In addition, Legacy NAYA stock options shall be converted into Company options to acquire a number of shares of the Company’s common stock equal to the number of shares of Legacy NAYA common stock subject to such Legacy NAYA options multiplied by 8.9108 (the “Exchange Ratio”) (rounded up to the nearest whole share) at an exercise price per share of such Legacy NAYA stock option divided by the Exchange Ratio, and Legacy NAYA restricted stock units shall be converted into Company restricted stock units representing the right to receive a number of shares of the Company’s common stock equal to the number of shares of Legacy NAYA common stock subject to such Legacy NAYA restricted stock unit multiplied by the Exchange Ratio. However, such options may not be exercised for shares of the Company’s common stock and such restricted stock units may not be settled for shares of the Company’s common stock unless and until the Company’s stockholders approve the issuance of common stock upon exercise of such options and settlement of such restricted stock units.

Pursuant to the Merger Agreement, the Company is required to hold a meeting of its stockholders to, among other things, (i) ratify the Merger Agreement and the transactions contemplated thereby, including the Merger, (ii) approve the increase in the amount of authorized shares under the Company’s Second Amended and Restated 2019 Stock Incentive Plan, (iii) approve the issuance of the Company’s common stock issuable upon conversion of the Series C-1 Preferred and Series C-2 Preferred, and (iv) approve an amendment to the Company’s articles of incorporation to (1) increase the number of shares of the Company’s authorized common stock to 100,000,000 shares, and (2) effectuate a reverse stock split of the Company’s common stock at a ratio ranging from any whole number between 1-for-2 and 1-for-20, as determined by the Company’s board of directors in its discretion. The Company also agreed to take all action necessary to hold the aforementioned stockholder meeting as soon as reasonably practicable.

The Company has agreed to file a registration statement with the SEC to register for resale the shares of the Company’s common stock issued pursuant to the Merger and the shares of common stock issuable upon exercise or conversion of the Series C-1 Preferred, the Series C-2 Preferred, and the Debenture, as applicable, as soon as practicable but in no event later than 30 days after the Closing Date.

7.0%Senior Secured Convertible Debenture

In connection with the Merger, on October 11, 2024, the Company issued the Debenture to FNL in an exchange of an outstanding note of Legacy NAYA held by FNL. The Debenture carries an interest rate of seven percent (7%) per annum, payable on the first business day of each calendar month commencing November 1, 2024. The maturity date of the Debenture is December 11, 2025 (the “Maturity Date”), at which point the outstanding principal amount, together with any accrued and unpaid interest and other fees, shall be due and payable to the holder of the Debenture.

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Conversion. At any time after the Company’s stockholders approve the issuance of any Company common stock upon conversion of the Debenture, the holder of the Debenture will be entitled to convert any portion of the outstanding and unpaid principal amount and accrued interest into shares of Company common stock at a conversion price of $0.93055 per share, subject to adjustment as described therein. The Debenture may not be converted and shares of Company common stock may not be issued upon conversion of the Debenture if, after giving effect to the conversion or issuance, the holder together with its affiliates would beneficially own in excess of 4.99% of the outstanding common stock of the Company.

Prepayment. The Company may not prepay the Debenture without the prior written consent of FNL

Monthly Redemption. Commencing March 14, 2025 and on the 14^th^ of each month thereafter until the Maturity Date, the Company shall redeem $437,127.24, plus accrued but unpaid interest and other fees, of the principal amount of the Debenture.

Mandatory Redemption. While any portion of the Debenture is outstanding, if the Company receives gross proceeds of more than $3,000,000

from any equity or debt financings (other than

a public offering as described herein), the Company shall, at the option of the holder, apply one-third (1/3) of such gross proceeds to the redemption of the principal amount of the Debenture, except that if such equity or debt financing is a public offering of the Company’s securities pursuant to a registration statement on Form S-1, the Company shall, at the option of the holder, apply one hundred percent (100%) of such gross proceeds, not to exceed $500,000 , to the redemption of the principal amount of the Debenture.

The Debenture contains events representations, warranties, covenants, and events of default that are customary for similar transactions. Upon an event of default, the Debenture becomes immediately due and payable, and the Borrower is subject to a default rate of interest of 15% per annum and a default sum as stipulated.

JoinderAgreement

In connection with the Merger, the Company entered in a joinder agreement (the “Joinder Agreement”) with FNL dated as of October 11, 2024 to a certain securities purchase agreement dated as of January 3, 2024 by and between Legacy NAYA and FNL (the “FNL SPA”) pursuant to which the Company agreed to become a party to the FNL SPA.

Assignment and AssumptionAgreement

In connection with the Merger, on October 11, 2024, the Company entered in an assignment and assumption agreement (the “Assignment Agreement”), pursuant to which the Company agreed to assume the rights, duties, and liabilities of Legacy NAYA under a certain registration rights agreement dated as of September 12, 2024 by and between Legacy NAYA and FNL, pursuant to which the Company agreed to register FNL’s resale of shares of Company common stock issuable upon conversion of the Debenture and the Series C-2 Preferred as well as certain commitment shares issued to FNL in connection with the transactions.

SecondAmendment to Revenue Loan and Security Agreement

On

October 11, 2024, the Company entered into a second amendment to Revenue Loan and Security Agreement (the “Second Amendment”) with Decathlon, the Company’s CEO, and certain subsidiaries of the Company (the “Guarantors”), pursuant to which Decathlon consented to the Merger and Legacy NAYA becoming a subsidiary of the Company. Pursuant to the Second Amendment, Legacy NAYA joined the Revenue Loan and Security Agreement as a Guarantor. The Company agreed to pay down its loan by at least $500,000 and increase its monthly payments by up to $30,000 if the Company closes a private offering of its securities. The Company also agreed to retain an investment banker to pursue a financing or a sale if it fails to meet certain liquidity covenants. The Company also agreed to enter into an intercreditor agreement with Decathlon and FNL within 5 business days of the Merger.

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NameChange and Application for Symbol Change

On October 15, 2024, the Company changed its corporate name to NAYA Biosciences, Inc., pursuant to an Amendment to Articles of Incorporation filed with the Nevada Secretary of State on October 15, 2024 (the “Name Change”). Pursuant to Nevada law, a stockholder vote was not necessary to effectuate the Name Change.

On October 22, 2024 the Company’s common stock ceased trading under the ticker symbol “INVO” and begin trading under its new ticker symbol, “NAYA”, on the Nasdaq Capital Market.

SeriesC-1 Preferred

The

Company’s Articles of Incorporation, as amended, authorizes the Company to issue 100,000,000 shares of preferred stock, $0.0001 par value per share, issuable from time to time in or more series (“Preferred Stock”). On October 14, 2024, the Company filed with the Nevada Secretary of State a Certificate of Designation of Series C-1 Convertible Preferred Stock (the “Series C-1 Certificate of Designation”) which sets forth the rights, preferences, and privileges of the Series C-1 Preferred. Thirty thousand three hundred seventy five (30,375) shares of Series C-1 Preferred with a stated value of $1,000.00 per share were authorized under the Series C-1 Certificate of Designation.

Each

share of Series C-1 Preferred has a stated value of $1,000.00, which is convertible into shares of the Company’s common stock (the “Common Stock”) at a conversion price equal to $1.02913 per share, subject to adjustment. The Series C-1 Preferred may not be converted into shares of the Company’s Common Stock unless and until the Company’s stockholders approve the issuance of common stock upon conversion of the Series C-1 Preferred. Each share of Series C-1 Preferred shall automatically convert into the Company’s common stock if the Company’s stockholders approve the issuance, except that the Company may not effect such conversion if, after giving effect to the conversion or issuance, the holder, together with its affiliates, would beneficially own in excess of 19.99% of the Company’s outstanding common stock.

Commencing on the ninety-first (91st) day after the first issuance of any Series C-1 Preferred, the holders of Series C-1 Preferred shall be entitled to receive dividends on the stated value at the rate of two percent (2%) per annum, payable in shares of the Company’s common stock at the conversion price. Such dividends shall continue to accrue until paid. Such dividends will not be paid in shares of the Company’s common stock unless and until the Company’s stockholders approve the issuance of common stock upon conversion of the Series C-1 Convertible Preferred Stock. The holders of Series C-1 Preferred shall also be entitled to receive a pro-rata portion, on an as-if convertible basis, of any dividends payable on Common Stock.

The Series C-1 Preferred ranks senior to the Company’s common stock and junior to the Series C-2 Preferred. Subject to the rights of the holders of any senior securities, in the event of any voluntary or involuntary liquidation, dissolution, or winding up, or sale of the Company, each holder of Series C-1 Preferred shall be entitled to receive its pro rata portion of an aggregate payment equal to the amount as would be paid on the Company’s common stock issuable upon conversion of the Series C-1 Preferred, determined on an as-converted basis, without regard to any beneficial ownership limitation.

Other than those rights provided by law, the Series C-1 Preferred has no voting rights. The Series C-1 Preferred is not redeemable.

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SeriesC-2 Preferred Stock

On

October 14, 2024, the Company filed with the Nevada Secretary of State a Certificate of Designation of Series C-2 Convertible Preferred Stock (the “Series C-2 Certificate of Designation”) which sets forth the rights, preferences, and privileges of the Series C-2 Preferred. Eight thousand five hundred seventy six (8,576) shares of Series C-2 Preferred with a stated value of $1,000.00 per share were authorized under the Series C-2 Certificate of Designation.

Each

share of Series C-2 Preferred has a stated value of $1,000.00, which, along with any additional amounts accrued thereon pursuant to the terms of the Series C-2 Certificate of Designation (collectively, the “Conversion Amount”) is convertible into shares of the Company’s common stock (the “Common Stock”) at a conversion price equal to $0.6893 per share, subject to adjustment. The Series C-2 Preferred may not be converted into shares of the Company’s Common Stock unless and until the Company’s stockholders approve the issuance of common stock upon conversion of the Series C-2 Convertible Preferred Stock. Each share of Series C-2 Preferred shall become convertible into the Company’s common stock at the option of the holder of such Series C-2 Preferred shares if the Company’s stockholders approve the issuance of common stock upon conversion of the Series C-2 Preferred, except that the Company may not effect such conversion if, after giving effect to the conversion or issuance, the holder, together with its affiliates, would beneficially own in excess of 9.99% of the Company’s outstanding common stock.

Commencing on the ninety-first (91st) day after the first issuance of any Series C-2 Preferred, the holders of Series C-2 Preferred shall be entitled to receive dividends on the stated value at the rate of ten percent (10%) per annum, payable in shares of the Company’s common stock, with each payment of a dividend payable in shares of the Company’s common stock at a conversion price of eighty-five percent (85%) of the average of the volume weighted average price of the Company’s common stock for the five (5) trading days before the applicable dividend date. Such dividends shall continue to accrue until paid. Such dividends will not be paid in shares of the Company’s common stock unless and until the Company’s stockholders approve the issuance of common stock upon conversion of the Series C-2 Preferred. The holders of Series C-2 Preferred shall also be entitled to receive a pro-rata portion, on an as-if convertible basis, of any dividends payable on Common Stock.

The Series C-2 Preferred ranks senior to the Company’s common stock and to the Series C-1 Preferred. Subject to the rights of the holders of any senior securities, in the event of any voluntary or involuntary liquidation, dissolution, or winding up, or sale of the Company, each holder of Series C-2 Preferred shall be entitled to receive its pro rata portion of an aggregate payment equal to the greater of (a) 125% of the Conversion Amount with respect to such shares, and (b) the amount as would be paid on the Company’s common stock issuable upon conversion of the Series C-2 Preferred, determined on an as-converted basis, without regard to any beneficial ownership limitation.

Other than those rights provided by law, the Series C-2 Preferred has no voting rights. The Series C-2 Preferred is only redeemable upon a “Bankruptcy Triggering Event” or a “Change of Control” that occurs 210 days after the closing date of the Merger.

DebtConversion

On

October 14, 2024, the Company issued 190,000 shares of common stock with a fair value of $190,000 as a result of a partial conversion of the FirstFire Note and accrued interest thereon. No gain or loss was recorded on conversion, as the issuance of common stock was pursuant to the terms of a prior agreement.

Departure of Officer

Effective November 15, 2024, Michael J. Campbell, the Company’s Chief Operating Officer and Vice President of Business Development, retired from the Company, and Mr. Campbell and the Company mutually agreed to terminate his employment agreement.

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Item9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosures

None.

Item9A. Controls and Procedures

Evaluationof Disclosure Controls and Procedures

We maintain disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act, that are designed to be effective in providing reasonable assurance that information required to be disclosed in our reports under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC, and that such information is accumulated and communicated to our management to allow timely decisions regarding required disclosure.

Our management, including the Chief Executive Officer and the Chief Financial Officer, carried out an evaluation of the effectiveness of the Company’s disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, as of the end of the period covered by this report. These disclosure controls and procedures are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is (i) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were not effective as of December 31, 2023 due solely to the events that led to the restatements of our audited financial statements for the periods ending June 30, 2021 through June 30, 2024. As a result, management determined a material weakness in our internal control over financial reporting existed due to the accounting treatment of our right-of-use (“ROU”) asset and corresponding lease liability for our operating leases on our balance sheet. Management’s review was insufficient to identify an error in the incremental borrowing rate that led to our restatement of our financial statements, as described in Notes 2 and 3 to the Notes to Financial Statements included in this Form 10-K. In light of this material weakness, we performed additional analysis as deemed necessary to ensure that our financial statements were prepared in accordance with U.S. generally accepted accounting principles. Accordingly, management believes that the financial statements included in this Annual Report on Form 10-K present fairly in all material respects our financial position, results of operations and cash flows for the period presented.

Management’sReport on Internal Control over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting of the Company. Our management conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal Control—Integrated Framework (1992 Framework) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on the evaluation of our internal control over financial reporting, management has concluded that, as of December 31, 2023, our internal control over financial reporting was not effective due to material weaknesses related to (1) a limited segregation of duties due to our lack of formal control documentation, limited resources, and the small number of employees, and (2) a lack of adequate accounting resources to properly account for complex accounting transactions. Management has determined that these control deficiencies constitute material weaknesses, which could result in material misstatements of significant accounts and disclosures that could result in a material misstatement to our interim or annual financial statements that would not be prevented or detected.

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This annual report does not include an attestation report of the company’s registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by the company’s registered public accounting firm pursuant to rules of the SEC.

Limitationson Effectiveness of Controls and Procedures

Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include, but are not limited to, the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control.

The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

Changesin Internal Control over Financial Reporting

There were no changes to our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the period covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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PartIV

Item15. Exhibits and Financial Statement Schedules

(a) Financial Statements

The following are filed as a part of this report:

1. Financial Statements

	Page
Report of Independent Registered Public Accounting Firm (PCAOB ID No. 2738)	F-1
Restated Consolidated Balance Sheets as of December 31, 2023 and 2022	F-2
Consolidated Statements of Operations for the Years Ended December 31, 2023 and 2022	F-3
Consolidated Statements of Stockholders’ Equity (Deficit) for the Period from January 1, 2022 to December 31, 2023	F-4
Restated Consolidated Statements of Cash Flows for the Years Ended December 31, 2023 and 2022	F-5
Notes<br> to Restated Consolidated Financial Statements	F-6

2. Financial Statement Schedules

Information required by Schedule II is shown in the Notes to Consolidated Financial Statements. All other schedules for which provision is made in the applicable accounting regulation of the Securities and Exchange Commission are not required under the related instructions or are inapplicable, and therefore have been omitted.

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(b) Exhibits

EXHIBIT INDEX

23.1*	Consent of M&K CPAs, PLLC
31.1*	Certification by Principal Executive Officer pursuant to Rule 13a-4(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended.
31.2*	Certification by Principal Financial Officer pursuant to Rule 13a-4(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended.
32.1**	Certification by Chief Executive Officer and Chief Financial Officer pursuant to Rule 13a-14(b) of the Exchange Act and 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS*	Inline<br> XBRL Instance Document
101.SCH*	Inline<br> XBRL Taxonomy Extension Schema Document
101.CAL*	Inline<br> XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*	Inline<br> XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*	Inline<br> XBRL Taxonomy Extension Label Linkbase Document
101.PRE<br> *	Inline<br> XBRL Taxonomy Extension Presentation Linkbase Document
104*	Cover<br> Page Interactive Data File – the cover page of the registrant’s Annual Report on Form 10-K for the year ended December<br> 31, 2022 is formatted in Inline XBRL

* Filed herewith

** Furnished herewith

Item16. Form 10-K Summary

Not applicable.

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SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Annual Report on Form 10-K/A to be signed on its behalf by the undersigned, thereunto duly authorized on November 19, 2024.

	NAYA Biosciences, Inc.
Date:<br> November 19, 2024	By:	/s/ Steven Shum
		Steven Shum
		Chief Executive Officer<br><br> <br>(Principal<br> Executive Officer)

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities indicated on November 19, 2024.

Signature	Title
/s/ Steven Shum	Chief<br> Executive Officer and director
Steven Shum	(Principal<br> Executive Officer)
/s/ Andrea Goren	Chief<br> Financial Officer
Andrea Goren	(Principal<br> Financial and Accounting Officer)
/s/ Matthew Szot
Matthew Szot	Director
/s/ Trent Davis
Trent Davis	Director
/s/ Barbara Ryan
Barbara Ryan	Director
/s/ Rebecca Messina
Rebecca Messina	Director
/s/ Daniel Teper
Daniel Teper	Director
/s/ Lyn Falconio
Lyn Falconio	Director

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Exhibit 23.1

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTINGFIRM

We hereby consent to the incorporation in Registration Statements on Form S-8 Nos. 333-234230, 333-252228, 333-263239, and 333-269258, Form S-3 No. 333-279593, and Form S-1 Nos. 333-272872 and 333-273174 (collectively, the “Registration Statements”) of our report dated April 16, 2024 (except for the effect of the restatement discussed in Note 2, as to which the date is November 19, 2024), of NAYA Biosciences, Inc. (formerly INVO Bioscience, Inc.) relating to the audit of the consolidated financial statements as of December 31, 2023 and 2022, and for the periods then ended, including an explanatory paragraph regarding the Company’s ability to continue as a going concern, and the reference to our firm under the caption “Experts” in the Registration Statements.

/s/ M&K CPA’s, PLLC
The Woodlands, TX
November 19, 2024

EXHIBIT 31.1

CERTIFICATION BY THE PRINCIPAL EXECUTIVE OFFICER

PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACTOF 2002

I, Steven Shum, certify that:

1. I have reviewed this Annual Report on Form 10-K/A of NAYA Biosciences, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 19, 2024	/s/ Steven Shum
	Steven Shum<br><br> <br>Chief Executive Officer

EXHIBIT 31.2

CERTIFICATION BY THE PRINCIPAL FINANCIAL OFFICER

PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACTOF 2002

I, Andrea Goren, certify that:

1. I have reviewed this Annual Report on Form 10-K/A of NAYA Biosciences, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. As the registrant’s certifying officer, I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control for financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under my supervision, to ensure that material information relating to the registrant is made known to me by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under my supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report my conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. As the registrant certifying officer, I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 19, 2024	/s/ Andrea Goren
	Andrea Goren<br><br> <br>Chief Financial Officer

EXHIBIT 32.1

Certification by the Principal Executive OfficerPursuant to

18 U.S.C. Section 1350,

as Adopted Pursuant to Section 906 of the Sarbanes-OxleyAct of 2002

I, Steven Shum, certify pursuant to 18 U. S. C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, the Annual Report on Form 10-K/A of NAYA Biosciences, Inc. (the “Company”) for the year ended December 31, 2023 (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, and that the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: November 19, 2024	/s/ Steven Shum
	Steven Shum,
	Chief Executive Officer and director<br><br> <br>(Principal Executive Officer)

A signed original copy of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

EXHIBIT 32.2

Certification by the Principal Financial OfficerPursuant to

18 U.S.C. Section 1350,

as Adopted Pursuant to Section 906 of the Sarbanes-OxleyAct of 2002

I, Andrea Goren, certify pursuant to 18 U. S. C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, the Annual Report on Form 10-K/A of NAYA Biosciences, Inc. (the “Company”) for the year ended December 31, 2023 (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, and that the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: November 19, 2024	/s/ Andrea Goren
	Andrea Goren
	Chief Financial Officer<br><br> <br>(Principal Financial and Accounting Officer)

A signed original copy of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.