Form 10-Q - Quarterly report [Sections 13 or 15(d)]

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2024

☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT

For the transition period from ______ to _______

Commission File Number: 000-53223

MARIZYME, INC.

(Exact name of registrant as specified in its charter)

Nevada		82-5464863
(State or Other Jurisdiction of		(I.R.S. Employer
Incorporation or Organization)		Identification No.)

555 Heritage Drive, Suite 205, Jupiter, Florida 33458

(Address of principal executive offices) (Zip Code)

(561) 935-9955

(Registrant’s telephone number)

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 and post such files). Yes ☒ No ☐

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

☐	Large accelerated filer	☐	Accelerated filer
☒	Non-accelerated filer	☒	Smaller reporting company
		☐	Emerging growth company

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

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. Yes ☐ No ☒

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

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Not applicable.

As of March 5, 2025, the registrant had 131,793,088 shares of common stock ($0.001 par value) outstanding.

MARIZYME, INC.

FORM 10-Q

TABLE OF CONTENTS

		Page
PART I - FINANCIAL INFORMATION

ITEM 1.	Financial Statements.	3
ITEM 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations.	24
ITEM 3.	Quantitative and Qualitative Disclosures About Market Risk.	33
ITEM 4.	Controls and Procedures.	34

PART II - OTHER INFORMATION

ITEM 1.	Legal Proceedings.	35
ITEM 1A.	Risk Factors.	35
ITEM 2.	Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities.	35
ITEM 3.	Defaults Upon Senior Securities.	35
ITEM 4.	Mine Safety Disclosures.	35
ITEM 5.	Other Information.	35
ITEM 6.	Exhibits.	36
	Signatures	39

PART I – FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

MARIZYME, INC.

Condensed Consolidated Balance Sheets

	September 30, 2024			December 31, 2023
	(Unaudited)
ASSETS:
Current
Cash	$	63,732		$	148,465
Accounts receivable		2,000			60,284
Other receivables		35,879			35,797
Prepaid expenses		726,114			699,377
Inventory		26,869			24,855
Total current assets		854,594			968,778
Non-current
Property, plant and equipment, net		-			12,500
Operating lease right-of-use assets, net		797,405			1,101,211
Intangible assets, net		14,037,798			14,364,129
Prepaid royalties, non-current		120,500			122,457
Deposits		30,000			30,000
Goodwill		5,416,000			5,416,000
Total non-current assets		20,401,703			21,046,297
Total assets	$	21,256,297		$	22,015,075

LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT):
Current
Accounts payable and accrued expenses	$	3,371,483		$	2,322,064
Notes payable		2,739,981			633,692
Due to related parties		302,900			230,153
Convertible notes, net - Units Private Placement		16,698,700			16,328,476
Convertible notes, net - OID		6,421,918			2,694,256
Operating lease obligations		442,221			434,082
Total current liabilities		29,977,203			22,642,723
Non-current
Operating lease obligations, net of current portion		355,184			667,129
Agreement obligation		1,000,000			-
Contingent liabilities		5,463,000			5,406,000
Total non-current liabilities		6,818,184			6,073,129
Total liabilities		36,795,387			28,715,852

Commitments and contingencies (Note 10)		-			-

Stockholders’ equity (deficit):
Preferred stock, $0.001 par value, 25,000,000 shares authorized, no shares issued and outstanding as of September 30, 2024 and December 31, 2023		-			-
Common stock, par value $0.001, 2,000,000,000 shares authorized, issued and outstanding shares - 131,793,088 at September 30, 2024 and December 31, 2023		131,792			131,792
Additional paid-in capital		154,650,064			148,696,200
Accumulated deficit		(170,320,946	)		(155,528,769	)
Total stockholders’ equity (deficit)		(15,539,090	)		(6,700,777	)
Total liabilities and stockholders’ equity (deficit)	$	21,256,297		$	22,015,075

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

MARIZYME, INC.

Condensed Consolidated Statements of Operations

(Unaudited)

	2024			2023			2024			2023
	Three Months Ended September 30,						Nine Months Ended September 30,
	2024			2023			2024			2023

Revenue	$	-		$	181,535		$	32,855		$	495,248
Direct cost of revenue		-			50,989			9,647			139,875
Gross profit		-			130,546			23,208			355,373
Operating expenses:
Professional fees (includes related party amounts of $89,500, $72,000, $319,500, and $216,000, respectively)		118,270			921,552			721,042			1,818,202
Salary expenses		318,019			329,564			983,703			931,536
Research and development		344,139			492,235			978,339			1,789,625
Stock-based compensation		20,794			86,132			116,646			457,860
Depreciation and amortization		108,777			210,293			338,831			630,924
Royalty expense		-			13,014			1,957			211,262
Other general and administrative expenses		445,031			2,934,966			1,199,172			6,310,039
Total operating expenses		1,355,030			4,987,756			4,339,690			12,149,448
Total operating loss		(1,355,030	)		(4,857,210	)		(4,316,482	)		(11,794,075	)

Other income (expense)
Interest and accretion expenses		(1,104,674	)		(1,502,088	)		(6,230,294	)		(11,038,400	)
Other income		-			-			200,000			-
Change in fair value of contingent liabilities		440,000			(1,678,000	)		(57,000	)		312,000
Change in fair value of derivative liabilities		-			(14,454,397	)		-			(14,454,397	)
Gain (loss) on debt extinguishment		59,843			(80,000	)		(3,888,401	)		(21,857,877	)
Borrowing costs		-			-			(500,000	)		-
Loss on issuance of debt		-			(3,974,993	)		-			(6,352,562	)
Total other income (expense)		(604,831	)		(21,689,478	)		(10,475,695	)		(53,391,236	)

Net loss	$	(1,959,861	)	$	(26,546,688	)	$	(14,792,177	)	$	(65,185,311	)

Loss per share – basic and diluted	$	(0.01	)	$	(0.58	)	$	(0.11	)	$	(1.51	)

Weighted average number of shares of common stock outstanding – basic and diluted		131,793,088			45,812,412			131,793,088			43,270,975

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

MARIZYME, INC.

Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit)

Three and Nine Months Ended September 30, 2024 and 2023

(Unaudited)

	Shares		Amount		Capital		Deficit			Equity (Deficit)
	Common Stock				Additional Paid-in		Accumulated			Total Stockholders’
	Shares		Amount		Capital		Deficit			Equity (Deficit)

Balance, December 31, 2022		40,528,191	$	40,528	$	103,370,890	$	(85,989,433	)	$	17,421,985
Stock-based compensation expense		-		-		210,966		-			210,966
Issuance of shares		240,000		240		153,360		-			153,600
Net loss		-		-		-		(2,554,584	)		(2,554,584	)
Balance, March 31, 2023 (unaudited)		40,768,191		40,768		103,735,216		(88,544,017	)		15,231,967
Stock-based compensation expense		-		-		160,762		-			160,762
Issuance of shares		1,946,410		1,946		339,050		-			340,996
Exercise of warrants		2,652,159		2,652		262,564		-			265,216
Increase in fair value of warrants on debt extinguishment		-		-		12,666,268		-			12,666,268
Issuance of warrants on promissory note		-		-		1,333,128		-			1,333,128
Net loss		-		-		-		(36,084,039	)		(36,084,039	)
Balance, June 30, 2023 (unaudited)		45,366,760		45,366		118,496,988		(124,628,056	)		(6,085,702	)
Stock-based compensation expense		-		-		86,132		-			86,132
Issuance of shares		1,300,000		1,300		208,700		-			210,000
Exercise of warrants		-		-		2,934,681		-			2,934,681
Net loss		-		-		-		(26,546,688	)		(26,546,688	)
Balance, September 30, 2023 (unaudited)		46,666,760	$	46,666	$	121,726,501	$	(151,174,744	)	$	(29,401,577	)

	Common Stock				Additional Paid-in		Accumulated			Total Stockholders’
	Shares		Amount		Capital		Deficit			Deficit

Balance, December 31, 2023		131,793,088	$	131,792	$	148,696,200	$	(155,528,769	)	$	(6,700,777	)
Stock-based compensation expense		-		-		54,264		-			54,264
Increase of fair value of warrants in debt extinguishment				-		1,407,934					1,407,934
Net loss		-		-		-		(5,396,490	)		(5,396,490	)
Balance, March 31, 2024 (unaudited, as restated)		131,793,088		131,792		150,158,398		(160,925,259	)		(10,635,069	)
Stock-based compensation expense		-		-		41,588		-			41,588
Increase of fair value of warrants in debt extinguishment		-		-		4,075,749		-			4,075,749
Net loss		-		-		-		(7,435,826	)		(7,435,826	)
Balance, June 30, 2024 (unaudited, as restated)		131,793,088		131,792		154,275,735		(168,361,085	)		(13,953,558	)
Balance		131,793,088		131,792		154,275,735		(168,361,085	)		(13,953,558	)
Stock-based compensation expense		-		-		20,794		-			20,794
Increase of fair value of warrants in debt extinguishment		-		-		344,098		-			344,098
Cancellation of warrants		-		-		9,437		-			9,437
Net loss		-		-		-		(1,959,861	)		(1,959,861	)
Balance, September 30, 2024 (unaudited)		131,793,088	$	131,792	$	154,650,064	$	(170,320,946	)	$	(15,539,090	)
Balance		131,793,088	$	131,792	$	154,650,064	$	(170,320,946	)	$	(15,539,090	)

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

MARIZYME, INC.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

	2024			2023
	Nine Months Ended September 30,
	2024			2023

Cash flows from operating activities:
Net loss	$	(14,792,177	)	$	(65,185,311	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		338,831			630,924
Amortization of right-of-use assets		303,806			286,816
Stock-based compensation		116,646			457,860
Interest and accretion on convertible notes and notes payable		6,230,294			11,038,400
Issuance of warrants for services		-			2,934,680
Change in fair value of contingent liabilities		57,000			(312,000	)
Change in fair value of derivative liabilities		-			14,454,397
Loss on debt extinguishment		3,888,401			21,857,877
Loss on issuance of debt		-			6,352,562
Shares issued as part of the Confidential Settlement Agreement		-			153,600
Shares issued for services		-			168,000
Warrants issued as part of promissory note agreement		-			1,333,128
Borrowing costs		500,000			-
Change in operating assets and liabilities:
Accounts receivable and other receivables		58,201			24,120
Prepaid expenses		(26,737	)		464,367
Inventory		(2,014	)		116,547
Accounts payable and accrued expenses		1,033,824			1,852,865
Due to related parties		72,747			187,097
Operating lease liabilities		(303,806	)		(286,816	)
Net cash used in operating activities		(2,524,984	)		(3,470,887	)

Cash flows from financing activities:
Proceeds from issuance of Convertible Notes - OID, net of issuance cost		-			2,334,000
Proceeds from shares issued for exercise of warrants		-			265,216
Proceeds from notes payable		2,362,000			1,000,000
Repayments of notes payable and Convertible Notes - OID		(421,749	)		(164,250	)
Proceeds from agreement obligation		500,000			-
Net cash provided by financing activities		2,440,251			3,434,966

Net change in cash		(84,733	)		(35,921	)

Cash at beginning of period		148,465			510,865

Cash at end of period	$	63,732		$	474,944

Supplemental disclosure of cash flow information:
Derivative liabilities and debt discount issued in connection with convertible notes	$	-		$	25,555,092
Warrants and debt discount issued in connection with convertible notes	$	-		$	344,959
Settlement of notes payable with convertible notes	$	-		$	2,264,133
Increase of fair value of warrants in debt extinguishment	$	-		$	12,666,268
Shares issued on conversion of convertible notes	$	-		$	84,140

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

MARIZYME, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2024

NOTE 1 – DESCRIPTION OF BUSINESS

Marizyme, Inc. (the “Company” or “Marizyme”) is a Nevada corporation originally incorporated on March 20, 2007, under the name SWAV Enterprises, Ltd. On September 6, 2010, the Company name was changed to GBS Enterprises Inc. and from 2010 to September 2018 the Company was in the software products and advisory services business for email and instant messaging applications. The Company divested that business between December 2016 and September 2018 and focused on the acquisition of life science technologies. 

On March 21, 2018, the Company’s name was changed to Marizyme, Inc., to reflect the new life sciences focus. Marizyme’s common stock is currently quoted on the OTCQB tier of OTC Markets Group, Inc. under the symbol “MRZM”.

NOTE 2 – GOING CONCERN

The Company’s unaudited condensed consolidated financial statements are prepared using accounting principles generally accepted in the United States of America (“U.S. GAAP”) applicable to a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. However, the Company does not have an established source of revenues sufficient to cover its operating costs, which requires the Company to rely on investing and financing activities in order to continue as a going concern. The Company, since its inception, has incurred recurring operating losses and negative cash flows from operations and has an accumulated deficit of $170,320,946 at September 30, 2024 (December 31, 2023 - $155,528,769). Additionally, the Company has negative working capital of $29,122,609 (December 31, 2023 - $21,673,945) and $63,732 (December 31, 2023 - $148,465) of cash on hand, which is not sufficient to fund operations for the next twelve months. These factors raise substantial doubt about the Company’s ability to continue as a going concern.

Under the going concern assumption, an entity is ordinarily viewed as continuing its business for the foreseeable future with neither the intention or necessity of liquidation, ceasing trading, or seeking protection from creditors pursuant to the laws and regulations. Accordingly, assets and liabilities are recorded on the basis that the entity will be able to realize its assets and discharge its liabilities in the normal course of business.

The ability of the Company to continue as a going concern is dependent upon its ability to continue to successfully develop its intangible assets, meet its debt obligations until such time future profitable revenues are achieved, and raise funds beyond its working capital balance in order to finance future development of its intangible assets.

During the next twelve months from the date the unaudited condensed consolidated financial statements were issued, the Company’s foreseeable cash requirements will relate to continuous operations of its business, maintaining its good standing and making the required filings with the Securities and Exchange Commission (the “SEC”), and the payment of expenses associated with its product development. The Company may experience a cash shortfall and be required to raise additional capital. Management intends to raise additional funds by way of a private or public offering. In July 2024, the Company executed a promissory note in favor of Qualigen Therapeutics, Inc., which had previously engaged in an agreement with the Company to advance the commercialization of DuraGraft™ (see Note 11). Under the terms of the promissory note, Qualigen lent the Company $1,250,000, providing temporary financial support as the Company seeks additional funding. During the last quarter of the fiscal year 2024, the Company has secured additional funding of $1,027,400 in the form of short-term loans. While the Company has successfully raised capital in the past and remains confident in its strategy to develop and expand its products, as well as generate sufficient revenue, there is no guarantee of future success. The Company’s ability to continue as a going concern depends on its success in implementing its business plan, generating sufficient revenue, and securing additional funds through public or private offerings.

The unaudited condensed consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation and Principles of Consolidation

The accompanying unaudited condensed consolidated financial statements include the consolidated accounts of the Company and its wholly owned subsidiaries: My Health Logic Inc (“My Health Logic” or “MHL”), Somahlution, Inc., and Somaceutica, Inc. (“Somaceutica”), (collectively, these three entities are referred to as – “Somahlution”), Marizyme Sciences, Inc. (“Marizyme Sciences”), and DuraGraft, Inc (“DuraGraft”). All intercompany transactions have been eliminated on consolidation.

The accompanying unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q have been prepared in conformity with U.S. GAAP. The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K/A filed with the SEC on February 6, 2025 (the “2023 Form 10-K/A”). The condensed consolidated balance sheet as of December 31, 2023 was derived from audited consolidated financial statements included in the 2023 Form 10-K/A but does not include all disclosures required by U.S. GAAP for complete financial statements. The Company’s significant accounting policies are described in Note 1 to those consolidated financial statements.

Interim results may not be indicative of the results that may be expected for the full year or any future periods. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from these interim financial statements. The unaudited condensed consolidated financial statements reflect all adjustments which in the opinion of management are necessary to fairly present the results of operations, financial condition, cash flows and stockholders’ equity (deficit) for the periods indicated. Except as otherwise disclosed, all such adjustments are of a normal recurring nature.

Use of Estimates

The preparation of the unaudited condensed consolidated financial statements in accordance with U.S. GAAP requires management to make use of certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the unaudited condensed consolidated financial statements and the reported amounts of revenue and expenses during the reported periods. The Company bases its estimates on historical experience and on various other assumptions that management believes are reasonable under the circumstances, the results of which form the basis for making judgments about carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates. Significant estimates are related to the recoverability of long-term assets including intangible assets and goodwill, amortization expense, valuation of warrants, stock-based compensation, and contingent liabilities.

Fair Value Measurements

The Company uses the fair value hierarchy to measure the value of its financial instruments. The fair value hierarchy is based on inputs to valuation techniques that are used to measure fair value that are either observable or unobservable. Observable inputs reflect assumptions market participants would use in pricing an asset or liability based on market data obtained from independent sources, while unobservable inputs reflect a reporting entity’s pricing based upon its own market assumptions. The basis for fair value measurements for each level within the hierarchy is described below.

●	Level 1 – Quoted prices for identical assets or liabilities in active markets.
●	Level 2 – Quoted prices for identical or similar assets and liabilities in markets that are not active; or other model-derived valuations whose inputs are directly or indirectly observable or whose significant value drivers are observable.
●	Level 3 – Valuations derived from valuation techniques in which one or more significant inputs to the valuation model are unobservable and for which assumptions are used based on management estimates.

The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value.

The carrying amounts of certain accounts and other receivables, accounts payable and accrued expenses, notes payable, and amounts due to related parties approximate fair value due to the short-term nature of these instruments.

The fair value of lease obligations is determined using discounted cash flows based on the expected amounts and timing of the cash flows discounted using a market rate of interest adjusted for appropriate credit risk.

Contingent Liabilities

The contingent liabilities assumed on the acquisition of Somahlution in 2020 consist of present values of royalty payments, performance warrants and pediatric voucher warrants, future rare pediatric voucher sales, and liquidation preference. Management measured these contingencies in accordance with Level 3 of the fair value hierarchy.

	i.	The performance warrants and pediatric vouchers warrants liabilities were valued using a Monte Carlo simulation model utilizing the following weighted average assumptions: risk free rate of 1.19%, expected volatility of 69.62%, expected dividend of $Nil, and expected life of 5.96 years. For the three and nine months ended September 30, 2024, changes in these assumptions resulted in a $31,000 decrease and $171,000 decrease in fair value of these liabilities, respectively (September 30, 2023 – $406,000 increase and $800,000 decrease, respectively). At September 30, 2024, the fair market value of performance warrants and pediatric vouchers warrants liabilities was $54,000 (December 31, 2023 – $225,000).

	ii.	The present value of royalty payments was measured using the scenario-based methodology. In assessing the value attributed to the royalty payments, the estimated future cash flows were discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the revenue from net sales of the product. The cash flows derived from the Company’s fifteen-year strategic plan are based on managements’ expectations of market growth, industry reports and trends, and past performances. These projections are inherently uncertain due to the evolving impact of the COVID-19 pandemic. The discounted cash flow model included projections surrounding revenue, discount rates, and growth rates. The discount rates used to calculate the present value of royalty payments reflect specific risks of the Company and market conditions and the mid-range was estimated at 20.6%. For the three and nine months ended September 30, 2024, changes in these assumptions resulted in a $409,000 decrease and $228,000 increase in fair value of this liability, respectively (September 30, 2023 – $1,262,000 and $466,000 increase in fair value of this liability, respectively). At September 30, 2024, the fair market value of royalty payments was $3,586,000 (December 31, 2023 – $3,358,000).

	iii.	Rare pediatric voucher sales liability was valued based on the scenario-based methodology where the estimated future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset – 20.6%. The rare pediatric voucher could only be applied for medical devices prior to receiving U.S. Food and Drug Administration (“FDA”) approval. However, because DuraGraft received FDA approval in late 2023, obtaining the rare pediatric voucher is no longer possible. Therefore, as of December 31, 2023, the fair market value of rare pediatric vouchers was $Nil, and there has been no change in the fair market value during the three and nine months ended September 30, 2024.

	iv.	The present value of liquidation preference liability, included in the contingent consideration, was determined using the Black-Scholes option pricing method and represents the fair value of the maximum payment amount according to the agreement. The following assumptions were used in the Black-Scholes option pricing model: risk free rate of 0.21%, expected volatility of 78.93%, expected dividend of $Nil, and expected life of 5 years. No changes to the fair value of liquidation preference liability were recorded in the three and nine months ended September 30, 2024 and 2023. At September 30, 2024, the fair market value of liquidation preference was $1,823,000 (December 31, 2023 – $1,823,000).

Warrants

The detachable warrants attached to the OID Convertible Notes (as such term is hereinafter defined, see Note 7) are classified as equity. These warrants were valued using the Black-Scholes pricing model. The following weighted average assumptions were used in the Black-Scholes model: a risk-free rate of 4.25%, expected volatility of 349.95%, expected dividend yield of $Nil, and an expected life of 0.17 years. During the nine months ended September 30, 2024, the Company extended the maturity dates of certain OID Warrants (as such term is hereinafter defined, see Note 7), as part of modification of OID Convertible Notes that resulted in a substantive modification and extinguishment of old debt. As a result, the Company recognized an incremental fair value increase of $5,827,782 related to the change in the fair value of warrants. $4,778,950 of this amount exceeded the principal of the Convertible Notes and was recognized as a loss on debt extinguishment in the condensed consolidated statement of operations for the nine months ended September 30, 2024 (see Note 7).

Goodwill, Intangible Assets and Impairment

The Company’s Level 3 measurements include the fair value assessment of assets such as in-process research and development (“IPR&D”) intangibles, goodwill, and particularly when considering potential impairments. The significant unobservable inputs used in the fair value measurements of these assets primarily include management’s assumptions regarding future cash flows and discount rates.

As part of the acquisition of Somahlution in 2020, the Company acquired goodwill attributed to the workforce and profitability of the acquired business. A residual method methodology was used to estimate the fair market value goodwill. A pre-tax discount rate based on weighted average cost of capital of 33.8% was used in the fair value assumptions for the assembled workforce acquired.

Additionally, as part of the acquisition of Somahlution in 2020, the Company acquired IPR&D intangible asset “Cyto Protectant Life Sciences” with indefinite economic life. The fair value of IPR&D was determined based on Multi-Period Excess Earning Method valuation approach, using discount rate of 35.2%.

For impairment testing, the Company uses a discounted cash flow (“DCF”) model to estimate the fair value of IPR&D intangibles and goodwill. The key assumptions used in the DCF model include projected cash flows, discount rate and terminal value growth rate. These inputs are highly subjective and require significant management judgment. Changes in these assumptions could have a significant impact on the fair value and any resulting impairment charge.

The Company has no financial assets measured at fair value on a recurring basis. None of the Company’s non-financial assets or liabilities are recorded at fair value on a non-recurring basis. No transfers between levels have occurred during the periods presented.

Marizyme measures the following financial instruments at fair value on a recurring basis. As of September 30, 2024, and December 31, 2023, the fair values of these financial instruments were as follows:

September 30, 2024	Level 1		Level 2		Level 3
	Fair Value Hierarchy
September 30, 2024	Level 1		Level 2		Level 3
Liabilities
Contingent liabilities	$	-	$	-	$	5,463,000
Total	$	-	$	-	$	5,463,000

December 31, 2023	Level 1		Level 2		Level 3
	Fair Value Hierarchy
December 31, 2023	Level 1		Level 2		Level 3
Liabilities
Contingent liabilities	$	-	$	-	$	5,406,000
Total	$	-	$	-	$	5,406,000

The following table provides a rollforward of all liabilities measured at fair value using Level 3 significant unobservable inputs:

Contingent Liabilities
Balance at December 31, 2023	$	5,406,000
Change in fair value of contingent liabilities		57,000
Balance at September 30, 2024	$	5,463,000

Research and Development Expenses and Accruals

All research and development costs are expensed in the period incurred and consist primarily of salaries, payroll taxes, and employee benefits, for individuals involved in research and development efforts, external research and development costs incurred under agreements with contract research organizations and consultants to conduct and support the Company’s ongoing clinical trials of DuraGraft, and costs related to manufacturing DuraGraft for clinical trials. The Company has entered into various research and development contracts with various organizations. Payments of these activities are based on the terms of the individual agreements which matches to the pattern of costs incurred. Payments made in advance are reflected in the accompanying condensed consolidated balance sheets as prepaid expenses. The Company records accruals for estimated costs incurred for ongoing research and development activities. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the services, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates may be required in determining the prepaid or accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates.

Stock-Based Compensation

Stock-based compensation expense for employees and directors is recognized in the unaudited condensed consolidated statements of operations based on estimated amounts, including the grant date fair value and the expected service period. For stock options, the Company estimates the grant date fair value using a Black-Scholes valuation model, which requires the use of multiple subjective inputs including estimated future volatility, expected forfeitures and the expected term of the awards. The Company estimates the expected future volatility based on the stock’s historical price volatility. The stock’s future volatility may differ from the estimated volatility at the grant date. For restricted stock unit (“RSU”) equity awards, the Company estimates the grant date fair value using its closing stock price on the date of grant. The Company recognizes the effect of forfeitures in compensation expense when the forfeitures occur. The estimated forfeiture rates may differ from actual forfeiture rates which would affect the amount of expense recognized during the period. The Company recognizes the value of the awards over the awards’ requisite service or performance periods. The requisite service period is generally the time over which share-based awards vest.

New Accounting Standards and Updates from the Securities and Exchange Commission

In August 2020, the Financial Accounting Standards Board issued Accounting Standards Update (“ASU”) No. 2020-06, “Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity” (“ASU 2020-06”). ASU 2020-06 will simplify the accounting for convertible instruments by reducing the number of accounting models for convertible debt instruments and convertible preferred stock. Limiting the accounting models results in fewer embedded conversion features being separately recognized from the host contract as compared with current U.S. GAAP. Convertible instruments that continue to be subject to separation models are (i) those with embedded conversion features that are not clearly and closely related to the host contract, that meet the definition of a derivative, and that do not qualify for a scope exception from derivative accounting and (ii) convertible debt instruments issued with substantial premiums for which the premiums are recorded as paid-in capital. ASU 2020-06 also amends the guidance for the derivatives scope exception for contracts in an entity’s own equity to reduce form-over-substance-based accounting conclusions. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company has fully adopted ASU 2020-06 as of January 1, 2023, and this adoption does not have a material impact on the way the Company is accounting for its debt.

NOTE 4 – LEASES

On December 11, 2020, the Company entered into a five-and-a-half-year lease agreement for approximately 10,300 square feet of administrative office and laboratories space, which commenced in December 2020 at a monthly rent of approximately $10,800, increasing by 2.5% annually beginning in the second year of the lease until the end of the term. Additionally, pursuant to the agreement, the Company would pay approximately $12,000 per month in operating expenses.

Effective April 1, 2022, the Company amended its lease agreement for administrative office and laboratories to add an additional 3,053 square feet of space. The monthly cost of total expended lease space is approximately $15,641 increasing to $16,032 in 2024 and will continue to increase by 2.5% annually thereafter until the end of the term. The monthly operating expenses for total expanded premises have increased from approximately $12,000 to $17,500 per month. The term of the lease remains unchanged. As of September 30, 2024, the remaining lease term was 1.83 years. The lease has been classified as an operating lease.

The assets and liabilities from the lease were recognized at the lease commencement date based on the present value of remaining lease payments over the lease term using the discount rate of 3.95%, which is the average commercial interest available at the time.

The total rent expense for the three and nine months ended September 30, 2024 was $129,416 and $290,474, respectively (September 30, 2023 – $81,502 and $274,004, respectively).

The following table summarizes supplemental condensed consolidated balance sheet information related to the operating leases as of September 30, 2024, and December 31, 2023:


	September 30, 2024		December 31, 2023
Operating lease right-of-use assets	$	797,405	$	1,101,211

Operating lease liabilities, current	$	442,221	$	434,082
Operating lease liabilities, non-current		355,184		667,129
Total operating lease liabilities	$	797,405	$	1,101,211

As of September 30, 2024, the maturities of the lease liabilities for the periods ending December 31 are as follows:


2024	$	108,521
2025		444,934
2026		266,034
Total lease payments		819,489
Less: Present value discount		(22,084	)
Total	$	797,405

NOTE 5 – INTANGIBLE ASSETS

Krillase

As part of the asset acquisition of ACB Holding AB, Reg. No. 559119-5762, completed on September 12, 2018, Marizyme acquired all rights, titles, and interest in the Krillase technology, a group of intangible assets valued at $28,600,000. Krillase is a naturally occurring enzyme that acts to break protein bonds and has applications in wound debridement, wound healing, dental care and thrombosis. The useful lives of the intangible assets are based on the life of the patent and related technology. The patents and related technology for Krillase have not been amortized since the acquisition, as they have not yet been put into operations.

At December 31, 2023, management determined that the carrying value of Krillase exceeded its estimated recoverable amount of $Nil as of December 31, 2023. Impairment of $4,250,000 was recognized on Krillase intangible assets and recorded in the impairment of intangible assets in the consolidated statement of operations for the year ended December 31, 2023. There have been no changes in the estimated recoverable amount of Krillase intangible assets in the nine months ended September 30, 2024.

DuraGraft

As part of Somahlution acquisition in 2020, Marizyme purchased $18,170,000 of intangible assets related to the DuraGraft® technology.

At December 31, 2023, management determined that the carrying value of DuraGraft intangible assets exceeded its recoverable amount. Impairment of $2,442,000 was recognized on DuraGraft intangible assets and recorded in the impairment of intangible assets in the consolidated statement of operations for the year ended December 31, 2023. The recoverable amount of DuraGraft intangible assets was estimated at $14,241,384 as of December 31, 2023. There have been no changes in the estimated recoverable amount of DuraGraft intangible assets in the nine months ended September 30, 2024.

My Health Logic

As part of the My Health Logic acquisition in 2021, Marizyme purchased MHL’s lab-on-chip technology platform and its patient-centric, digital point-of-care diagnostic device, MATLOC, fair valued at an aggregate amount of $6,600,000. At December 31, 2023, management determined that carrying value of assets exceeded its recoverable amount. Impairment of $5,777,720 was recognized on MHL’s intangible assets and recorded in the impairment of intangible assets in the consolidated statement of operations for the year ended December 31, 2023. There have been no changes in the estimated recoverable amount of MATLOC intangible assets in the nine months ended September 30, 2024.

Additionally, as part of the My Health Logic acquisition in 2021, the Company recognized goodwill of $1,774,656. At December 31, 2023, management determined that the carrying value of goodwill exceeded its recoverable amount. As a result, the Company recognized an impairment of $1,774,656, which was recorded in the consolidated statement of operations for the year ended December 31, 2023.

	September 30, 2024
	Gross Carrying Amount		Accumulated Amortization			Net Carrying Amount
Patents in process	$	122,745	$	-		$	122,745
DuraGraft patent		5,256,000		(1,684,614	)		3,571,386
DuraGraft - Distributor relationship		308,000		(128,333	)		179,667
DuraGraft IPR&D - Cyto Protectant Life Sciences		10,164,000		-			10,164,000
Total intangible assets, net	$	15,850,745	$	(1,812,947	)	$	14,037,798

	December 31, 2023
	Gross Carrying Amount		Accumulated Amortization			Impairment			Net Carrying Amount
Krillase intangible assets	$	4,250,000	$	-		$	(4,250,000	)	$	-
Patents in process		122,745		-			-			122,745
DuraGraft patent		5,256,000		(1,381,383	)		-			3,874,617
DuraGraft - Distributor relationship		308,000		(105,233	)		-			202,767
DuraGraft IPR&D - Cyto Protectant Life Sciences		12,606,000		-			(2,442,000	)		10,164,000
My Health Logic - Trade name		450,000		(65,090	)		(384,910	)		-
My Health Logic - Biotechnology		4,600,000		(547,941	)		(4,052,059	)		-
My Health Logic - Software		1,550,000		(209,249	)		(1,340,751	)		-
Total intangible assets, net	$	29,142,745	$	(2,308,896	)	$	(12,469,720	)	$	14,364,129

SCHEDULE OF GOODWILL

Goodwill		DuraGraft				My Health Logic				Total
Balance, December 31, 2023 and September 30, 2024		$	5,416,000			$	-			$	5,416,000

The following changes to the Company’s intangible assets had taken place in the periods indicated:

SCHEDULE OF INTANGIBLE ASSETS

Balance, December 31, 2022	$	27,675,020
Impairment		(12,469,720	)
Amortization expense		(841,171	)
Balance, December 31, 2023		14,364,129
Amortization expense		(326,331	)
Balance, September 30, 2024	$	14,037,798

Future amortizations for DuraGraft intangible assets for the next five years will be $435,108 for each year from 2025 through 2029 and $1,575,512 for 2030 and thereafter. Amortization related to in process research and development will be determined upon the Company achieving commercialization.

NOTE 6 – NOTES PAYABLE

a) On October 23, 2023, the Company issued a note payable to Hub International for $165,469 bearing interest at the annual rate of 8% per annum, due August 23, 2024, payable monthly starting November 23, 2023. During the nine months ended September 30, 2024, the Company repaid the note in full and the outstanding balance under the note payable as of September 30, 2024 was $Nil (December 31, 2023 - $130,122).

b) On December 28, 2022, the Company issued a promissory note to Hexin for the principal amount of $750,000 bearing interest at the annual rate of 20% per annum, due June 28, 2023 (the “Hexin Promissory Note”). For the year ended December 31, 2023, the Company accrued $64,133 in interest on the promissory note. Hexin agreed to cancel the Hexin Promissory Note with the outstanding balance of $814,133 (the aggregate amount of principal plus accrued and unpaid interest as of May 30, 2023) in exchange for the issuance of 9,578,040 OID Units (see Note 7), which the Company issued to Hexin on May 30, 2023.

c) On February 2, 2023, the Company issued an unsecured promissory note to Walleye Opportunities Master Fund Ltd. (the “Walleye Promissory Note”) for $1,000,000 with a maturity date of May 7, 2023. The note carried no interest and the principal amount was required to be repaid in full on the maturity date. In the event that the principal amount was not repaid in full on maturity date, the principal amount required to be increased to $1,250,000. At the maturity date of the Walleye Promissory Note, the principal amount remained unpaid, resulting in an increase from $1,000,000 to $1,250,000. Of this increment, $250,000 was recognized as interest expense in the consolidated statement of operations for the year ended December 31, 2023. Walleye agreed to cancel the promissory note, with the outstanding balance of $1,250,000 in exchange for the issuance of 14,705,890 OID Units (see Note 7), which were issued to Walleye on May 30, 2023.

d) As part of the My Health Logic acquisition, completed in November 2021, Marizyme assumed an aggregate of $468,137 in notes payable, the notes were unsecured, bore interest at a rate of 9% per annum with no maturity date. The Company settled an aggregate of $278,678 of these notes payable as part of Unit Purchase Agreement issuances during the year ended December 31, 2022 (see Note 7). For the three and nine months ended September 30, 2024, the Company accrued $5,868 and $17,010 in interest on the notes payable, respectively (September 30, 2023 - $5,344 and $23,710, respectively). As of September 30, 2024, balance of the remaining note payable was $264,535 (December 31, 2023 - $252,223).

e) As of September 30, 2024, the Company has outstanding borrowings under notes payable to Mr. Richmond in the principal amount of $441,000 (December 31, 2023 - $151,000). The notes payable bear no interest and are due on demand.

f) As of September 30, 2024, the Company has outstanding borrowings under a note payable to Santander Bank: Sullivan & Worcester LLP in the principal amount of $515,000 (December 31, 2023 - $65,000). The note payable bears no interest and is due on demand.

g) As of September 30, 2024, the Company has outstanding borrowings under a note payable to Commas International Holding, LLC in the principal amount of $170,000 (December 31, 2023 - $Nil). The note payable bears no interest and is due on demand.

h) As of September 30, 2024, the Company has outstanding borrowings under a note payable to Dr. Vithalbhai Dhaduk in the principal amount of $52,000 (December 31, 2023 - $Nil). The note payable bears no interest and is due on demand.

i) On July 12, 2024, the Company received $1,250,000 in funding from Qualigen Therapeutics, Inc, under a promissory note, bearing interest at an annual rate of 18%. The note is payable on demand. During the three months ended September 30, 2024, the Company accrued $47,446 in interest on the outstanding balance (September 30, 2023 - $Nil). The promissory note is an independent agreement and is not an extension of the Funding Agreement with Qualigen Therapeutics, Inc. (see Note 11).

NOTE 7 - CONVERTIBLE PROMISSORY NOTES AND WARRANTS

From May 2021 to August 2022, the Company conducted a private placement (the “Units Private Placement”) of units (the “Units”) consisting of 10% secured convertible promissory notes (the “Convertible Notes”) and accompanying warrants (the “Class C Warrants”), as were modified or amended from time to time.

In 2021, the Company issued an aggregate of 4,260,594 Units for the proceeds of $6,692,765 net of issuance costs. In 2022, the Company issued additional 4,180,071 Units for the proceeds of $6,500,743 net of issuance cost.

In 2023, the Company amended the conversion price of the Convertible Notes and the exercise price of the Class C Warrants to $0.10 per share.

The Company determined that the terms of the new securities were substantially different from the original securities, and, as such the transaction was accounted for as an extinguishment of debt and the new securities accounted for as a new debt issuance. As a result of this substantial modification, a total of 8,269,237 Units outstanding was replaced with an aggregate of 190,584,260 pro rata Units. The Company determined that the optional conversion feature attached to the Convertible Notes did not meet the definition of derivative liabilities and that the detachable warrants issued did not meet the definition of a liability and therefore was accounted for as an equity instrument. The fair value of $12,666,268 of the warrants issued has been recorded as a component of equity. As the result of this modification, the Company recorded a loss on debt extinguishment of $21,777,877 in consolidated statement of operations for the year ended December 31, 2023.

Additionally, in 2023 due to the non-repayment of the initial principal amount of $1,000,000 under the Walleye Promissory Note by its maturity date of May 7, 2023 (see Note 6), the Company also defaulted under the Convertible Notes on the same date. As the result, the Company accreted a default amount of $6,791,185 to the value of the Convertible Notes in 2023.

Additionally, in 2023, the Company issued an aggregate of 4,207,828 Units for the proceeds of $344,959. In December 2023, several note holders exercised their right to convert Convertible Notes, resulting in an aggregate of $9,340,774 worth of Convertible Notes being converted into common stock of the Company. Additionally, subsequent to the conversion, the Company extended the maturity dates the certain outstanding Convertible Notes.

During the three and nine months ended September 30, 2024, the Company amended certain Convertible Notes, extending their original maturity dates in 2024 by one year from their respective original maturity dates. In connection with the extension of the maturity dates for the outstanding Convertible Notes, the Company executed a substantial modification that led to the extinguishment of the existing Convertible Notes and the issuance of new Convertible Notes. This modification resulted in a gain on extinguishment of $890,549, which has been recognized in the condensed consolidated statements of operations for the nine months ended September 30, 2024 (September 30, 2023 – loss of $21,777,877).

During the three and nine months ended September 30, 2024, the Company recognized interest and accretion expense of $433,868 and $1,260,775, respectively (September 30, 2023 - $529,596 and $3,265,387, respectively) in the condensed consolidated statements of operations.

The Company determined that the optional conversion feature attached to the Convertible Notes did not meet the definition of derivative liability and that the detachable warrants issued did not meet the definition of a liability and therefore was accounted for as an equity instrument.

The following table summarizes supplemental balance sheet information related to the convertible notes, net of debt discount outstanding, as of September 30, 2024 and December 31, 2023:

SCHEDULE OF CONVERTIBLE NOTES

Balance, December 31, 2022	$	2,751,633
Issuance costs		-
Debt accretion		-
Settlement of debt		-
Issuance of convertible notes		-
Debt accretion on Original securities		1,835,741
Debt extinguishment		(4,587,374	)
Convertible notes issued - new securities		19,403,385
Debt discount		(344,959	)
Debt interest and accretion on new securities		1,429,646
Mandatory default amount		6,835,105
Conversion of debt		(9,509,505	)
Extinguishment of debt		(10,276,925	)
Convertible notes issued with extended maturity date		8,791,729
Balance, December 31, 2023		16,328,476
Debt interest and accretion		1,260,775
Extinguishment of debt		(6,160,552	)
Convertible notes issued with extended maturity date		5,270,001
Balance, September 30, 2024	$	16,698,700

	September 30, 2024			December 31, 2023
Convertible notes - total principal	$	17,272,077		$	17,516,865
Unamortized issuance costs and discount		(573,377	)		(1,188,389	)
Convertible Notes, Net of Debt Discount	$	16,698,700		$	16,328,476

	September 30, 2024		December 31, 2023
Current portion	$	16,698,700	$	16,328,476
Non-current portion		-		-
Convertible Notes, Net of Debt Discount	$	16,698,700	$	16,328,476

2023 Convertible Notes and Warrants

In 2023, the Company conducted five separate closings (the “2023 OID Units Closings”) of a private placement of up to $10,000,000 for an aggregate of up to 100,000,000 units (the “OID Units”) under a Unit Purchase Agreement, dated as of May 12, 2023, with accredited investors (the “OID Purchase Agreement”), each consisting of (i) a 15% original issue discount unsecured subordinated convertible promissory note (each, a “OID Convertible Note” and collectively, the “OID Convertible Notes”), convertible into shares of common stock plus additional shares based on accrued interest at $0.10 per share, subject to adjustment, (ii) a warrant for the purchase of 125% of the shares of common stock into which the related OID Convertible Notes may be converted at $0.10 per share, subject to adjustment (the “Class E Warrant”), and (iii) a warrant for the purchase of 125% of the shares of common stock into which the related OID Convertible Note may be converted at $0.20 per share, subject to adjustment (each, a “Class F Warrant,” and each Class F Warrant together with each Class E Warrant collectively, the “OID Warrants”).

Pursuant to the 2023 OID Units Closings, the Company issued 69,876,060 OID Units in aggregate, for the total proceeds of $5,404,452, net of issuance costs.

The Company determined that the optional conversion feature attached to the OID Convertible Notes did not meet the definition of derivative liability and that the detachable warrants originally issued met the definition of a liability and therefore was accounted for as a derivative liability instrument. The warrants were fair valued at $12,292,635 and recorded as derivative liabilities on the condensed consolidated balance sheets. As a result of the warrant liability exceeding the value of the debt principal, the Company recorded a $6,888,475 loss on issuance of debt in the consolidated statement of operations for the year ended December 31, 2023. These warrants were valued using the Black-Scholes pricing method. The changes in the assumptions used to value the warrants as of December 11, 2023, resulted in a $795,934 decrease in fair value of this liability. At December 11, 2023, the fair market value of detachable warrant liability was $11,496,701. Additionally, on December 11, 2023, the Company amended the OID Convertible Notes contracts, resulting in a change in the accounting treatment for the detachable warrants. Following the amendment, the warrants no longer met the definition of liability and were consequently accounted for as equity instruments. This adjustment led to a reclassification of $11,496,701 from derivative liabilities to equity (deficit) in the Company’s condensed consolidated financial statements.

During the nine months ended September 30, 2024, the Company extended the maturity date of certain OID Convertible Notes. While some extensions were deemed minor, the majority of the extended contracts were deemed substantive. This triggered the extinguishment of the existing OID Convertible Notes and the issuance of new OID Convertible Notes. Additionally, the detachable warrants attached to the OID Convertible Notes had their maturity extended by two years. As a result, for the nine months ended September 30, 2024, the Company recognized an incremental fair value increase of $5,827,782 as a change in the fair value of warrants. $4,778,950 of this amount exceeded the principal of the Convertible Notes and was recognized as a loss on debt extinguishment in the condensed consolidated statements of operations for the nine months ended September 30, 2024 (September 30, 2023 - $Nil).

During the three and nine months ended September 30, 2024, the Company recognized interest and accretion expense of $613,186 and $4,885,930, respectively (September 30, 2023 - $843,699 and $993,785, respectively), in the condensed consolidated statements of operations.

The following table summarizes supplemental balance sheet information related to the OID Convertible Notes, net of debt discount outstanding, as of September 30, 2024 and December 31, 2023:

SCHEDULE OF CONVERTIBLE NOTES

OID Convertible Notes, Net of Debt Discount
Balance, December 31, 2022	$	-
Issuance of convertible notes		6,987,606
Issuance cost		(1,583,154	)
Debt discount		(5,404,452	)
Debt accretion		2,694,256
Balance, December 31, 2023		2,694,256
Debt accretion		4,885,930
Extinguishment of debt		(7,264,572	)
Settlement of debt		(109,437	)
Convertible note issued with extended maturity date		6,215,741
Balance, September 30, 2024	$	6,421,918

	September 30, 2024			December 31, 2023
Convertible notes - total principal	$	6,841,769		$	6,987,606
Unamortized issuance costs and discount		(419,851	)		(4,293,350	)
Convertible Notes, Net of Debt Discount	$	6,421,918		$	2,694,256

	September 30, 2024		December 31, 2023
Current portion	$	6,421,918	$	2,694,256
Non-current portion		-		-
Convertible Notes, Net of Debt Discount	$	6,421,918	$	2,694,256

2023 Convertible Notes Terms

The OID Convertible Notes mature nine months from the date of the OID Units Initial Closing and accrue 10% of interest per annum on the outstanding principal amount. The OID Convertible Notes are unsecured and subordinated to any senior indebtedness of the Company. The OID Convertible Notes’ principal and accrued interest may generally be converted at any time at a conversion price of $0.10 per share, subject to adjustment, at the option of the holder, into shares of common stock, subject to certain limitations: (i) conversion would not cause the holder to beneficially own more than 4.99% of the Company’s common stock, or more than 9.99% if the holder beneficially owns more than 4.99% of common stock based on ownership of equity securities of the Company other than the OID Convertible Notes or the respective warrants; and (ii) the Company’s articles of incorporation have been amended to increase the number of authorized shares of common stock to a sufficient amount to permit the full conversion of the OID Convertible Notes (the “Capital Event Amendment”).

2023 Warrants Terms

The Class E Warrants and Class F Warrants are generally exercisable for a period from the date of the Capital Event Amendment until five years from the date of issue. The exercise right is subject to a similar beneficial ownership limitation that applies to conversion of the OID Convertible Notes above, i.e., exercise is permitted only if it would not cause the holder to beneficially own more than 4.99% of the Company’s common stock, or more than 9.99% if the holder beneficially owns more than 4.99% of common stock based on ownership of equity securities of the Company other than the OID Convertible Notes or the Class E Warrants and Class F Warrants.

NOTE 8 – STOCKHOLDERS’ EQUITY (DEFICIT)

a)	*Preferred stock*

The Company is authorized to issue a total number of 25,000,000 shares of “blank check” preferred stock with a par value of $0.001. As of September 30, 2024, and December 31, 2023, there were no shares of preferred stock issued or outstanding.

b)	*Common stock*

The Company is authorized to issue a total number of 2,000,000,000 shares of common stock with a par value of $0.001.

As of September 30, 2024, there were 131,793,088 (December 31, 2023 - 131,793,088) shares of common stock issued and outstanding. During the three and nine months ended September 30, 2024, the Company did not issue any shares of common stock.

c)	*Options*

On May 18, 2021, the Company’s Board of Directors approved the Marizyme, Inc. Amended and Restated 2021 Stock Incentive Plan (“SIP”). The SIP incorporates stock options issued prior to May 18, 2021. The SIP authorized 5,300,000 options for issuance. On December 27, 2022, the Board of Directors requested that stockholders ratify an amendment to the SIP to increase the maximum number of shares of common stock available for issuance pursuant to awards granted under the SIP by 1,900,000 to 7,200,000, which was approved by the stockholders. As of September 30, 2024, there remains 4,304,724 options available for issuance (December 31, 2023 – 2,924,057).

During the three and nine months ended September 30, 2024, the Company granted $Nil (December 31, 2023 – $Nil) share purchase options to directors of the Company.

The summary of option activity for the six months ended September 30, 2024, is as follows:

SCHEDULE OF STOCK OPTION ACTIVITY

	Number of Options			Weighted Average Exercise Price		Weighted Average Contractual Life		Total Intrinsic Value
Outstanding at December 31, 2022		3,925,943		$	1.33		6.06	$	-
Granted/forfeited		-			-		-		-
Outstanding at December 31, 2023		3,925,943			1.33		5.06		-
Forfeited		(211,667	)		1.64		-		-
Expired		(1,168,333	)		1.08		-
Outstanding at September 30, 2024		2,545,943			1.42		6.07		-
Exercisable at September 30, 2024		2,485,943		$	1.41		6.04	$	-

As of September 30, 2024, the Company had the following options outstanding:

Exercise Price		Number of Options Outstanding		Number of Options Exercisable		Weighted Average Remaining Contractual Years		Intrinsic Value
$	1.01		890,943		890,943		4.55	$	-
	1.25		415,000		415,000		6.40		-
	1.37		200,000		200,000		5.88		-
	1.75		800,000		770,000		7.16		-
	2.20		240,000		210,000		7.69		-
$	1.44		2,545,943		2,485,943		6.07	$	-

d)	*Restricted share units*

During the year ended December 31, 2021, the Company granted restricted share awards totaling 350,000 shares of common stock to directors, senior officers, and consultants, contingent upon underlying performance conditions. As of September 30, 2024, the Company determined that only two out of four performance conditions have been met. No compensation cost was recognized for the restricted share awards for the three and nine months ended September 30, 2024 (September 30, 2023 - $Nil and $Nil, respectively).

The following performance conditions attached to the restricted share awards were achieved:

	●	The Company will raise financing for the gross proceeds that equal or exceed $5,000,000, and
	●	The Company will complete valuation reports for acquisition of Somahlution and My Health Logic.

e)	*Warrants*

As of September 30, 2024 and December 31, 2023, there were 633,542,434 and 636,483,634 warrants outstanding, respectively.

SCHEDULE OF WARRANTS OUTSTANDING

	Number			Weighted Average Price
Balance, December 31, 2022		20,048,497		$	2.64
Warrants modified pursuant to debt extinguishment (Note 7)		355,577,447			0.1
Issued pursuant to debt agreements (Note 7)		183,560,497			0.15
Issued		79,949,352			0.11
Exercised		(2,652,159	)		0.1
Balance, December 31, 2023		636,483,634		$	0.12
Cancelled		(2,941,200	)		0.15
Balance, September 30, 2024		633,542,434		$	0.12

The detachable warrants attached to the OID Convertible Notes (see Note 7) are classified as equity. These warrants were valued using the Black-Scholes pricing model. During the three and nine months ended September 30, 2024, the Company extended the maturity dates of certain OID Warrants (see Note 7), resulting in a series of substantive modifications. As a result, the Company recognized an incremental fair value increase of $5,827,782 related to the change in the fair value of warrants. $4,778,950 of this amount exceeded the principal of the Convertible Notes and was recognized as a loss on debt extinguishment in the condensed consolidated statement of operations for the nine months ended September 30, 2024 (see Note 7).

f)	*Stock-based compensation*

During the three and nine months ended September 30, 2024, the Company recorded $20,794 and $116,646 in non-cash share-based compensation, respectively (September 30, 2023 - $86,123 and $457,860, respectively).

NOTE 9 – RELATED PARTY TRANSACTIONS

At September 30, 2024, the Company owed an aggregate of $302,900 (December 31, 2023 - $230,153) to related parties of the Company.

For the three and nine months ended September 30, 2024, the Company incurred $277,000 and $882,000, respectively, for professional services rendered by related parties (September 30, 2023 - $404,750 and $1,214,250, respectively). These services were provided by entities controlled by management, pursuant to various consulting agreements. The total balance outstanding for these services at September 30, 2024 was $302,900 (December 31, 2023 - $7,653).

During the three and nine months ended September 30, 2024, the Company also incurred $208,500 and $632,500 in compensation to Directors and Executive Officers for their services rendered, respectively (September 30, 2023 – $257,750 and $773,250, respectively). The total balance outstanding for these services at September 30, 2024 was $292,500 (December 31, 2023 - $222,500).

Additionally, as part of the Somahlution acquisition in 2020, the Company recorded a prepaid royalty to the shareholders of Somahlution. The former primary beneficial owner is Dr. Vithal Dhaduk, currently a director, and significant shareholder of the Company. During the three and nine months ended September 30, 2024, the Company accrued $Nil and $1,957 in royalties payable incurred on sales of the DuraGraft product outside of the U.S., respectively (September 30, 2023 - $13,014 and $211,262, respectively). This amount was offset against the prepaid royalty receivable.

During the year ended December 31, 2023, the Company and stockholders of Somahlution agreed to reduce the prepaid royalty balance by 50% or by $151,000. At September 30, 2024, the Company had $120,500 in prepaid royalties (December 31, 2023 - $122,457) which had been classified as non-current in the condensed consolidated balance sheets.

NOTE 10 – COMMITMENTS AND CONTINGENCIES

Contingencies

As part of the DuraGraft Acquisition, completed on July 31, 2020, the Company entered into the Agreement with Somahlution stockholders, whereby Marizyme is legally obligated to pay royalties on all net sales for Somahlution, Inc. The royalties associated with the Agreement are calculated as follows:

Royalties on U.S. sales equal to:

	●	5% on the first $50,000,000 of net sales,
	●	4% on net sales of $50,000,001 up to $200,000,000, and
	●	2% on net sales over $200,000,000.

Royalties on sales outside of the U.S.:

	●	6% on the first $50,000,000 of net sales,
	●	4% on net sales of $50,000,001 up to $200,000,000, and
	●	2% on net sales over $200,000,000.

The royalties are in perpetuity. During the three and nine months ended September 30, 2024, the Company had not earned any revenues from Krillase; however, the Company did incur sales of the DuraGraft products outside of the U.S., of which $Nil and $1,957 in royalties have been accrued and offset against the prepaid royalties receivable, respectively (see Note 9).

Upon receiving FDA clearance for the DuraGraft product and insurance reimbursement approval on the products pursuant to section 2(b) of the Asset Purchase Agreement dated December 15, 2019, the Company will:

	●	Issue performance warrants with a strike price determined based on the average of the closing prices of the Company’s common stock for the 30 calendar days following the date of the public announcement of the FDA approval; and
	●	Upon liquidation of all or substantially all of the assets relating to DuraGraft, the Company will pay 15% of the net sale proceeds up to $20 million.

The Company has entered into arrangements for office and laboratories spaces. As of September 30, 2024, minimum lease payments in relation to lease commitments are payable as described in Note 4.

NOTE 11 – AGREEMENT OBLIGATION

In April 2024, the Company entered into an agreement (the “Agreement”) with Qualigen Therapeutics, Inc. (“Qualigen”) to support the commercialization of DuraGraft™. Under the Agreement, Qualigen paid the Company an exclusivity fee of $200,000 (the “Exclusivity Fee”) on April 11, 2024, securing an exclusivity period until May 31, 2024 (the “Exclusivity Period”) for negotiating a broader strategic relationship. Additionally, the Company received $500,000 in funding from Qualigen (the “Funding Amount”) to assist with the commercial launch of DuraGraft™ in the United States, including funding for post-clearance clinical studies.

In return, Qualigen expects an investment return equal to two times (2x) the Funding Amount (the “Investment Return”). Upon the commercial launch of DuraGraft™ in the United States, the Company is obligated to pay Qualigen up to a cumulative total equal to the Investment Return, calculated at 33% of net sales of the product for the preceding calendar quarter. This payment obligation commences once the Company generates a minimum of $500,000 in net sales in the United States.

As part of the agreement, the Company established a wholly owned subsidiary, DuraGraft, during the nine months ended September 30, 2024, to facilitate the product’s commercialization.

The Exclusivity Fee was recognized as other income in the condensed consolidated statement of operations for the nine months ended September 30, 2024, as it represented payment for exclusive negotiation rights. The Funding Amount was accounted for as a debt liability, due to the significant continuing involvement by the Company and the limitation on Qualigen’s rate of return. The obligation to repay the Investment Return amount in case of agreement cancellation further supports this classification. Given the uncertainty in the timing and amount of future revenue streams, the effective interest rate could not be determined. Therefore, the difference of $500,000 between the Investment Return of $1,000,000, recorded as an Agreement Obligation in the condensed consolidated balance sheet at September 30, 2024, and the Funding Amount was expensed as borrowing costs in the condensed consolidated statement of operations for the nine months ended September 30, 2024.

NOTE 12 – RESTATEMENT OF PREVIOUSLY ISSUED UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

In March 2025, the Board of Directors and management, upon the recommendation of the Audit Committee of the Board of Directors, concluded that certain accounting errors identified in the Company’s financial statements for interim periods ended March 31, 2024 and June 30, 2024, required restatement. As a result, the Company amended those unaudited condensed consolidated financial statements for the interim periods ended March 31, 2024, and June 30, 2024, within this Form 10-Q for the nine months ended September 30, 2024. The Company has not filed, and does not intend to file, amendments to the previously filed Quarterly Reports on Form 10-Q for the quarters ended March 31, 2024 and June 30, 2024, but instead is restating its unaudited interim condensed consolidated financial statements in this Form 10-Q for the nine months ended September 30, 2024.

The Company evaluated the materiality of these errors 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 on Currently Issued Financial Statements”. Based on this evaluation, the Company determined that the effect of these corrections was material to the financial statements for the interim periods ended June 30, 2024 and September 30, 2024. Consequently, the Company restated these financial statements in accordance with Accounting Standards Codification 250, “Accounting Changes and Error Corrections.”

The errors resulted from a material weakness in the proper technical analysis of debt/equity transactions.

The restatements for the Company’s previously issued financial statements as of and for the quarterly periods ended March 31, 2024 and June 30, 2024, included the following:

During the three and nine months ended September 30, 2024, the Company amended certain Convertible Notes – Units Private Placement and Convertible Notes - OID, extending their original maturity dates in 2024 by one year from their respective original maturity dates (see Note7). Additionally, the detachable warrants attached to the Convertible Notes - OID had their maturity extended by two years. The modifications resulted in:

	●	A difference between the reacquisition price of the debt and the net carrying amount of the extinguished debt.
	●	In the original filing, this difference between the reacquisition price of the debt and the net carrying amount of the extinguished debt was incorrectly recorded as part of the convertible debt discount to be amortized over the remaining life of the notes.
	●	In the amendments to the previously filed Quarterly Reports on Form 10-Q for the quarters ended March 31, 2024 and June 30, 2024, the difference had been correctly recognized in the other income/expense of the period of extinguishment as loss and identified as a separate line item.

Additionally, following the recalculation of the carrying value of the notes after extinguishment, the fair market value of the warrants attached to the Convertible Notes – Units Private Placement and Convertible Notes - OID increased. This adjustment impacted the Company’s additional paid-in capital and contributed to the loss on extinguishment recognized in the period.

The restatement had no impact on total net cash flows from operating, investing, or financing activities.

Consolidated Balance Sheet – as March 31, 2024

	Originally Reported			Restatement Adjustment			As Restated
	As of March 31, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT
Current portion of Convertible Notes - Units Private Placement	$	15,807,061		$	409,974		$	16,217,035
Current portion of Convertible Notes - OID	$	5,448,468		$	(607,569	)	$	4,840,899
Total current liabilities	$	25,847,800		$	(197,595	)	$	25,650,205
Total liabilities	$	32,402,707		$	(197,595	)	$	32,205,112

Stockholders’ deficit:
Additional paid-in capital	$	146,598,185		$	3,560,213		$	150,158,398
Accumulated deficit	$	(157,562,641	)	$	(3,362,618	)	$	(160,925,259	)

Consolidated Statement of Operations and Comprehensive Loss - Three Months Ended March 31, 2024

	Originally Reported			Restatement Adjustment			As Restated
	Three months ended March 31, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
Interest and accretion expenses	$	(4,161,830	)	$	1,427,891		$	(2,733,939	)
Loss on debt extinguishment	$	(107,370	)	$	(598,089	)	$	(705,459	)
Total other income (expense)	$	(4,854,200	)	$	829,802		$	(4,024,398	)
Net loss	$	(6,226,292	)	$	829,802		$	(5,396,490	)
Loss per share – basic and diluted	$	(0.05	)	$	0.01		$	(0.04	)

Consolidated Statement of Stockholders’ Deficit – Three Months Ended March 31, 2024

	Originally Reported			Restatement Adjustment			As Restated
	Three month ended March 31, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
Increase of fair value of warrants in debt extinguishment	$	-		$	(1,407,934	)	$	(1,407,934	)
Net loss	$	(6,226,292	)	$	829,802		$	(5,396,490	)
Total stockholders’ deficit	$	(10,832,664	)	$	197,595		$	(10,635,069	)

Consolidated Statement of Cash Flows – Three Months Ended March 31, 2024

	Originally Reported			Restatement Adjustment			As Restated
	Three months ended March 31, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
Net loss	$	(6,226,292	)	$	829,802		$	(5,396,490	)
Interest and accretion on convertible notes and notes payable	$	4,161,830		$	(1,427,891	)	$	2,733,939
Loss on debt extinguishment	$	107,370		$	598,089		$	705,459

Consolidated Balance Sheet – as June 30, 2024

	Originally Reported			Restatement Adjustment			As Restated
	As of June 30, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT
Current portion of Convertible Notes - Units Private Placement	$	17,022,717		$	(482,186	)	$	16,540,531
Current portion of Convertible Notes - OID	$	990,636		$	5,055,776		$	6,046,412
Total current liabilities	$	23,551,638		$	4,573,590		$	28,125,228
Total liabilities	$	30,914,541		$	4,573,590		$	35,488,131

Stockholders’ deficit:
Additional paid-in capital	$	152,123,457		$	2,152,278		$	154,275,735
Accumulated deficit	$	(161,635,217	)	$	(6,725,868	)	$	(168,361,085	)

Consolidated Statement of Operations and Comprehensive Loss - Three Months Ended June 30, 2024

	Originally Reported			Restatement Adjustment			As Restated
	Three months ended June 30, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
Interest and accretion expenses	$	(2,938,416	)	$	546,735		$	(2,391,681	)
Gain (loss) on debt extinguishment	$	667,200		$	(3,909,985	)	$	(3,242,785	)
Total other income (expense)	$	(2,483,216	)	$	(3,363,250	)	$	(5,846,466	)
Net loss	$	(4,072,576	)	$	(3,363,250	)	$	(7,435,826	)
Loss per share – basic and diluted	$	(0.03	)	$	(0.03	)	$	(0.06	)

Consolidated Statement of Stockholders’ Deficit – Three Months Ended June 30, 2024

	Originally Reported			Restatement Adjustment			As Restated
	Three months ended June 30, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
Increase of fair value of warrants in debt extinguishment	$	-		$	4,075,749		$	4,075,749
Modification of warrants	$	5,483,684		$	(5,483,684	)		-
Net loss	$	(4,072,576	)	$	(3,363,250	)	$	(7,435,826	)
Total stockholders’ deficit	$	(9,379,968	)	$	(4,573,590	)	$	(13,953,558	)

Consolidated Statement of Operations and Comprehensive Loss - Six Months Ended June 30, 2024

	Originally Reported			Restatement Adjustment			As Restated
	Six months ended June 30, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
Interest and accretion expenses	$	(7,100,246	)	$	1,974,626		$	(5,125,620	)
Gain on debt extinguishment	$	559,830		$	(4,508,074	)	$	(3,948,244	)
Total other income (expense)	$	(7,337,416	)	$	(2,533,448	)	$	(9,870,864	)
Net loss	$	(10,298,868	)	$	(2,533,448	)	$	(12,832,316	)
Loss per share – basic and diluted	$	(0.08	)	$	(0.02	)	$	(0.10	)

Consolidated Statement of Stockholders’ Deficit – Six Months Ended June 30, 2024

	Originally Reported			Restatement Adjustment			As Restated
	Six months ended June 30, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
Increase of fair value of warrants in debt extinguishment	$	-		$	5,483,683		$	5,483,683
Modification of warrants	$	5,483,684		$	(5,483,684	)		-
Net loss	$	(10,298,868	)	$	(2,533,448	)	$	(12,832,316	)
Total stockholders’ deficit	$	(9,379,968	)	$	(4,573,590	)	$	(13,953,558	)

Consolidated Statement of Cash Flows – Six Months Ended June 30, 2024

	Originally Reported			Restatement Adjustment			As Restated
	Six months ended June 30, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
Net loss	$	(10,298,868	)	$	(2,533,448	)	$	(12,832,316	)
Interest and accretion on convertible notes and notes payable	$	7,100,246		$	(1,974,626	)	$	5,125,620
Gain (loss) on debt extinguishment	$	(559,830	)	$	4,508,074		$	3,948,244

NOTE 13 - SUBSEQUENT EVENTS

The Company has evaluated events that occurred through March 5, 2025, the date that the condensed consolidated financial statements were issued, and determined that except than as set forth below, there have been no events that have occurred that would require adjustments to the Company’s disclosures in the condensed consolidated financial statements.

	1)	During the final quarter of the fiscal year ended December 31, 2024, the Company extended the maturity date of three OID Convertible Notes, originally maturing on December 21, 2024, by one year. Additionally, the maturity of the detachable warrants associated with these OID Convertible Notes was extended by two years.

	2)	During the final quarter of the fiscal year ended December 31, 2024, the Company repaid a short-term loan under a note payable to Dr. Vithalbhai Dhaduk, with a principal amount of $52,000. The note was non-interest bearing.

	3)	In December 2024, the Company secured additional funding totaling $707,404 from Qualigen Therapeutics, Inc. through a promissory note bearing an annual interest rate of 18%. These notes are payable on demand and represent an independent agreement, separate from the existing Funding Agreement with Qualigen Therapeutics, Inc.

	4)	On January 21, 2025, the Company terminated an employment agreement with Catherine Pachuk, the Chief Scientific Officer and Executive Vice President of the Company.

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

This discussion covers the three and nine months ended September 30, 2024 and the subsequent period up to the date of issuance of this Quarterly Report on Form 10-Q. You should read the following discussion and analysis of our financial condition and results of operations in conjunction with the unaudited interim financial statements and notes thereto included in this Quarterly Report on Form 10-Q and with our audited consolidated financial statements and notes thereto for the year ended December 31, 2023 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K/A for the year ended December 31, 2023 (the “Amendment No.1 on 2023 Form 10-K”). You should review the disclosure under the heading “Risk Factors” in this Quarterly Report on Form 10-Q and the Amendment No.1 on 2023 Form 10-K for a discussion of important factors that could cause our actual results to differ materially from those anticipated in these forward-looking statements.

FORWARD-LOOKING STATEMENTS

This quarterly report on Form 10-Q contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 under Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements other than statements of historical facts contained in this quarterly report, including statements regarding our future results of operations and financial position, business strategy, research and development plans and costs, the timing and likelihood of regulatory filings and approvals, commercialization plans, pricing and reimbursement, the potential to develop future product candidates, the timing and likelihood of success of the plans and objectives of management for future operations, and future results of anticipated product development efforts, are forward-looking statements. These statements are often identified by the use of words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “should,” “estimate,” or “continue,” and similar expressions or variations. The forward-looking statements in this quarterly report are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, operating results, business strategy, short-term and long-term business operations and objectives. These forward-looking statements speak only as of the date of this quarterly report and are subject to a number of risks, uncertainties and assumptions, including those described in the Part II, Item 1A under the heading “Risk Factors.” The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

OVERVIEW

Marizyme is a medical technology company changing the landscape of cardiac care by delivering innovative solutions for coronary artery bypass graft (CABG) surgery.

Since October 2023, DuraGraft has been authorized for marketing by the U.S. Food and Drug Administration, or FDA, for use as an intra-operative vascular conduit storage and flushing solution used during CABG surgeries in the United States, subject to applicable risks, mitigation requirements, and control provisions. Since August 2014, DuraGraft has also had the CE marking required to be sold in the EEA, and DuraGraft has therefore been assessed as meeting the EEA safety, health, and environmental protection requirements.

Having received FDA authorization for marketing of DuraGraft, we are proceeding with our plans to commercialize DuraGraft in the United States and continue to generate international revenue growth from sales of DuraGraft. In the U.S. marketplace, we intend to employ a small direct sales force focusing on marketing and sales to hospital integrated networks. We have also begun the process of developing the U.S. CABG market for DuraGraft with select clinical studies, the development of known opinion leaders, or KOLs, the promotion of existing publications, and digital marketing. We will also seek to develop and commercialize additional applications for the technology underlying DuraGraft.

Our DuraGraft commercialization plan using its CE marking and existing distribution partners in select European and Asian countries resumed in the second quarter of 2022, with a targeted approach based on market access, existing KOLs, clinical data and revenue penetration. In Europe and elsewhere, we will continue our DuraGraft marketing efforts relying on our DuraGraft CE marking and our distribution partners. The CE marking signifies that DuraGraft may be sold in the EEA and that DuraGraft has been assessed as meeting safety, health, and environmental protection requirements. We are currently working with local distributors of cardiovascular disease-related products, in accordance with local regulatory requirements, to sell and increase the market share of DuraGraft in Spain, Austria, Switzerland, Germany, Chile, Turkey, Italy, and the UK among others.

We also continue to focus on the development of MAR-FG-001, a technology for use in fat grafting procedures formulated as a tumescent solution base for protecting adipose tissue during adipose tissue harvesting and storage.

We have significantly reduced the development efforts for one of our pipeline technologies, Krillase. Additionally, we terminated our Sponsored Research Agreement for the MATLOC CKD point-of-care device as of July 31, 2024, which resulted in the loss of all rights to the associated license agreement. At this time, no further capital is allocated to the Krillase or MATLOC pipeline technologies.

In the near term, we expect to generate revenue primarily from the sale of DuraGraft through the expansion of our international marketing efforts by our distribution partners in Europe and in other countries that accept CE marking. We anticipate that once we commence marketing and sales operations for DuraGraft in the U.S., we will be able to generate sustainable revenue growth and continue the expansion of DuraGraft and expedite the development of MAR-FG-001 into medical products.

Our Competitive Strengths

We believe that the following competitive strength will enable us to compete effectively:

●

Superior, first-in-class vascular graft storage and flushing solution. DuraGraft is the first and only medical product that has received authorization by the FDA for marketing for use as an intra-operative vascular conduit storage and flushing solution used during CABG surgeries. DuraGraft is also the only product certified for marketing in Europe and other jurisdictions for this indication.

Our Growth Strategies

We strive to grow our business by pursuing the following key growth strategies:

	●	*Commercialize DuraGraft*.
	●	*Develop MAR-FG-001 fat grafting technology and related products.*

Our net loss was approximately $2.0 million and $14.8 million for the three and nine months ended September 30, 2024, respectively (September 30, 2023 - $26.5 million and $65.2 million, respectively). We expect to incur significant expenses and operating losses over the next several years. Accordingly, we will need additional financing to support our continuing operations. We will seek to fund our operations through public or private equity offerings, debt financings, government or other third-party funding, collaborations and licensing arrangements. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would impact our going concern and would have a negative impact on our financial condition and our ability to pursue our business strategy and continue as a going concern. We will need to generate significant revenues to achieve profitability, and we may never do so.

Principal Factors Affecting Our Financial Performance

Our operating results are primarily affected by the following factors:

	●	our ability to generate revenue from sales of our products;

	●	our ability to obtain FDA approval for our products;

	●	our ability to access additional capital and the size and timing of subsequent financings, if any;

	●	the costs of acquiring and utilizing data, technology, and/or intellectual property to successfully reach our goals and to remain competitive;

	●	personnel and facilities costs in any region in which we seek to introduce and market our products;

	●	the costs of sales, marketing, and customer acquisition;

	●	the average price for our products that will be paid by consumers;

	●	the number of our products ordered per quarter;

	●	costs to manufacture our products;

	●	the costs of compliance with any unforeseen regulatory obstacles or governmental mandates in any states or countries in which we seek to operate; and

	●	the costs of any additional clinical studies which are deemed necessary for us to remain viable and competitive in any region of the world.

Smaller Reporting Company

We are a “smaller reporting company” as defined in Rule 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. We will remain a smaller reporting company until the last day of the fiscal year in which (1) the market value of our shares held by non-affiliates equals or exceeds $250 million as of the prior June 30^th, or (2) our annual revenues equaled or exceeded $100 million during such completed fiscal year and the market value of our shares held by non-affiliates equals or exceeds $700 million as of the prior June 30^th.

FINANCIAL OPERATIONS REVIEW

Components of Results of Operations

Revenue

Revenue represents gross product sales less service fees and product returns. For our distribution partner channel, we recognize revenue for product sales at the time of delivery of the product to our distribution partner. As our products have an expiration date, if a product expires, we will replace the product at no charge. Currently, all of our revenue is generated from the sale of DuraGraft in European and Asian markets where the product has the required regulatory approvals.

Direct Cost of Revenue

Direct cost of revenue include primarily product costs, which include all costs directly related to the purchase of raw materials, charges from our contract manufacturing organizations, and manufacturing overhead costs, as well as shipping and distribution charges. Direct cost of revenue also include losses from excess, slow-moving or obsolete inventory and inventory purchase commitments, if any.

Research and Development

All research and development costs are expensed in the period incurred and consist primarily of salaries, payroll taxes, and employee benefits, those individuals involved in research and development efforts, external research and development costs incurred under agreements with contract research organizations and consultants to conduct and support the Company’s ongoing clinical trials of DuraGraft, and costs related to manufacturing DuraGraft for clinical trials. The Company has entered into various research and development contracts with various organizations and other companies.

Professional Fees

Professional fees include legal fees relating to intellectual property development, due diligence and corporate matters, and consulting fees for accounting, finance, and valuation services. Professional fees paid related parties relate to certain consulting services. We anticipate increased expenses related to audit, legal, regulatory, and tax-related services associated with maintaining compliance with SEC requirements, and with listing and maintaining compliance with Nasdaq, if our common stock should be uplisted to trade on the Nasdaq for which there can be no assurance

Salaries and Stock-Based Compensation

Salaries consist of compensation and related personnel costs. Stock-based compensation represents the fair value of equity-settled share awards on stock options granted by the Company to its employees, officers, directors, and consultants. The fair value of awards is calculated using the Black-Scholes option pricing model, which considers the following factors: exercise price, current market price of the underlying shares, expected life, risk-free interest rate, expected volatility, dividend yield, and forfeiture rate.

Other General and Administrative Expenses

Other general and administrative expenses consist principally of marketing and selling expenses, facility costs, administrative and office expenses, director and officer insurance premiums, and investor relations costs associated with operating a public company.

Other Income (Expense)

Other income and expenses consist of mark-to-market adjustments on contingent liabilities assumed on the acquisition of the Somahlution Assets and interest and accretion expenses related to our Convertible Notes.

RESULTS OF OPERATIONS

Comparison of the Three Months Ended September 30, 2024 and 2023

The following table summarizes our results of operations for the three months ended September 30, 2024 and 2023:

	Three Months Ended September 30,
	2024			2023			Change $

Revenue	$	-		$	181,535		$	(181,535	)
Cost of goods sold		-			50,989			(50,989	)
Gross profit		-			130,546			(130,546	)
Operating expenses:
Direct costs of revenue
Professional fees		118,270			921,552			(803,282	)
Salary expenses		318,019			329,564			(11,545	)
Research and development		344,139			492,235			(148,096	)
Stock-based compensation		20,794			86,132			(65,338	)
Depreciation and amortization		108,777			210,293			(101,516	)
Royalty expense		-			13,014			(13,014	)
Other general and administrative expenses		445,031			2,934,966			(2,489,935	)
Total operating expenses		1,355,030			4,987,756			(3,632,726	)
Total operating loss	$	(1,355,030	)	$	(4,857,210	)	$	3,502,180
Other income (expenses):
Interest and accretion expense		(1,104,674	)		(1,502,088	)		397,414
Change in fair value of contingent liabilities		440,000			(1,678,000	)		2,118,000
Change in fair value of derivative liabilities		-			(14,454,397	)		14,454,397
Gain (loss) on debt extinguishment		59,843			(80,000	)		139,843
Loss on issuance of debt		-			(3,974,993	)		3,974,993
Net loss	$	(1,959,861	)	$	(26,546,688	)	$	24,586,827

Revenue

We recognized no revenue for the three months ended September 30, 2024, compared to $0.18 million for the same period in 2023. This decrease is attributed to a halt in inventory production during the three months ended September 30, 2024, due to constraints on the Company’s financial resources.

Direct Costs of Revenue

During the period ended September 30, 2024, we incurred no direct costs of revenue, a decrease of approximately $0.05 million, or 100%, compared to $0.05 million in direct costs of revenue incurred during the three months ended September 30, 2023. The decrease in cost of goods sold was due to the absence of sales and no inventory production during the three months ended September 30, 2024, compared to the corresponding period in 2023.

Professional Fees

Professional fees decreased by approximately $0.8 million or 87.2% to approximately $0.1 million in the three months ended September 30, 2024, compared to approximately $0.9 million in the three months ended September 30, 2023. The decrease is primarily attributed to legal and placement agent fees related to the Company’s Units Private Placement, the OID Units Private Placement, and consulting services expenses for DuraGraft FDA regulatory support during the quarter ended September 30, 2023.

Research and Development

Research and development expenses in the three months ended September 30, 2024 were approximately $0.3 million, approximately a $0.1 million or 30.1% decrease from the comparative period. This reduction in research and development expenses is primarily attributed to the Company’s financing constraints that led to the suspension of European study on DuraGraft as well Company’s decision to suspend expenditures related to FDA approvals for MATLOC and Krillase-related assets during the third quarter of 2023.

Stock-Based Compensation

Stock-based compensation decreased by $0.1 million or 75.9% to approximately $0.02 million for the three months ended September 30, 2024 from approximately $0.1 million in the comparative quarter ended September 30, 2023. This decrease is primarily due to a significant portion of options completing their vesting period in the second quarter of 2023, with no new options granted since the end of fiscal year 2022.

Depreciation and Amortization

Depreciation and amortization decreased to approximately $0.1 million for the three months ended September 30, 2024, down from approximately $0.2 million in the comparative quarter ended September 30, 2023, representing a 48.3% decrease period over period. This decrease is attributed to the impairment of My Health Logic intangible assets at the end of fiscal 2023, which were previously amortized during the comparative quarter.

Royalty Expense

During the comparative quarter ended September 30, 2023, the Company recorded an aggregate of approximately $0.01 million in royalty expense, most of which was accrued on sales of DuraGraft sales outside of the U.S. No royalties were accrued in the current period, as there were no sales of DuraGraft during the three months ended September 30, 2024.

Other General and Administrative Expenses

Other general and administrative expenses decreased by approximately $2.5 million, or 84.8%, to approximately $0.4 million for the three months ended September 30, 2024. This decrease is primarily attributed to the valuation of Class E and Class F Warrants issued in the comparative period.

Other Income (Expenses)

In the three months ended September 30, 2024, the Company incurred approximately $1.1 million in interest and accretion costs related to convertible notes issued at a discount as part of its Units Private Placements. This represents an decrease of $0.4 million, or 26.5%, compared to $1.5 million in the comparative quarter ended September 30, 2023. This decrease was due to the restructuring of multiple Convertible Notes, which resulted in lower interest and accretion expenses in the current period.

Additionally, the Company recognized a $0.4 million fair value gain from mark-to-market adjustments on the contingent liabilities assumed from the acquisition of the Somahlution assets, due to changes in the fair value of the contingent consideration. This represents a decrease of $2.1 million compared to the $1.7 million fair value loss recognized in the quarter ended September 30, 2023.

In the three months ended September 30, 2024, the Company recorded a $0.06 million gain on the extinguishment of Convertible Notes - Units Private Placement and Convertible Notes - OID due to the amendment of the maturity dates for certain Notes and warrants attached to those Notes. This represents a $0.2 million increase, or 174.8% compared to $0.08 million loss in the comparative quarter ended September 30, 2023.

Lastly, in the comparative quarter ended September 30, 2023, the Company recorded a gain of $14.5 million gain on issuance of OID Convertible Notes due to the fair value of Class E and Class F warrants exceeding the value of the debt principal. No such loss was recorded in the current quarter ended September 30, 2024.

The Company also recorded a loss of $4.0 million in the comparative quarter ended September 30, 2023 on issuance of 15% OID Convertible Notes due to the fair value of Class E and Class F Warrants exceeding the value of the debt principal. No such loss was recorded in the current quarter ended September 30, 2024.

Comparison of the Nine Months Ended September 30, 2024 and 2023

The following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023:

	Nine Months Ended September 30,
	2024			2023			Change $

Revenue	$	32,855		$	495,248		$	(462,393	)
Direct cost of revenue		9,647			139,875			(130,228	)
Gross profit		23,208			355,373			(332,165	)
Operating expenses:
Direct costs of revenue
Professional fees		721,042			1,818,202			(1,097,160	)
Salary expenses		983,703			931,536			52,167
Research and development		978,339			1,789,625			(811,286	)
Stock-based compensation		116,646			457,860			(341,214	)
Depreciation and amortization		338,831			630,924			(292,093	)
Royalty expense		1,957			211,262			(209,305	)
Other general and administrative expenses		1,199,172			6,310,039			(5,110,867	)
Total operating expenses		4,339,690			12,149,448			(7,809,758	)
Total operating loss	$	(4,316,482	)	$	(11,794,075	)	$	7,477,593
Other income (expenses):
Interest and accretion expense		(6,230,294	)		(11,038,400	)		4,808,106
Other income		200,000			-			200,000
Change in fair value of contingent liabilities		(57,000	)		312,000			(369,000	)
Change in fair value of derivative liabilities		-			(14,454,397	)		14,454,397
Gain (loss) on debt extinguishment		(3,888,401	)		(21,857,877	)		17,969,476
Borrowing costs		(500,000	)		-			(500,000	)
Loss on issuance of debt		-			(6,352,562	)		6,352,562
Net loss	$	(14,792,177	)	$	(65,185,311	)	$	50,393,134

Revenue

We recognized revenue of $0.03 million for the nine months ended September 30, 2024, compared to $0.5 million for the nine months ended September 30, 2023. The decrease is attributed to a halt in inventory production during the first half of 2024 due to constraints on the Company’s financial resources.

Cost of Goods Sold

During the nine months ended September 30, 2024, we incurred $0.01 million in direct costs of revenue, a decrease of $0.1 million, or 93.1%, compared to approximately $0.1 million in direct costs of revenue during the nine months ended September 30, 2023. This decrease in cost of sales is attributed to the minimal sales during the nine months ended September 30, 2024, compared to the corresponding period in 2023.

Professional Fees

Professional fees decreased by approximately $1.1 million or 60.3% to approximately $0.7 million in the nine months ended September 30, 2024 compared to approximately $1.8 million in the nine months ended September 30, 2023. The decrease is primarily attributed to higher professional fees incurred in the prior period, driven by spending on consulting for DuraGraft FDA regulatory and clinical support.

Research and Development

Research and development expenses for the nine months ended September 30, 2024, were approximately $1.0 million, representing a decrease of approximately $0.8 million, or 45.3%, from the comparative period. This reduction is primarily attributed to the Company’s financing constraints that led to the suspension of the European study on DuraGraft and the decision to suspend expenditures related to FDA approvals for MATLOC and Krillase-related assets during the third quarter of 2023.

Stock-Based Compensation

Stock-based compensation decreased by $0.3 million, amounting to approximately $0.1 million for the nine months ended September 30, 2024, compared to approximately $0.5 million for the same period in 2023, representing a 74.5% decrease year over year. This decline is primarily due to a significant portion of options completing their vesting period in the second quarter of 2023 and the absence of new option grants since the end of fiscal year 2022.

Depreciation and Amortization

Depreciation and amortization decreased to approximately $0.3 million for the nine months ended September 30, 2024, down from approximately $0.6 million in the comparative period ended September 30, 2023, representing a 46.3% decrease period over period. This decrease was attributed to the impairment of MATLOC intangible assets at the end of fiscal 2023, which were amortized during the comparative period ended September 30, 2023.

Royalty Expense

During the nine months ended September 30, 2024, the Company recorded a negligent amount in royalty expenses, compared to $0.2 million in the same period in 2023. For the nine months ended September 30, 2023, $0.05 million in royalties payable was incurred on sales of DuraGraft outside the U.S., while the remaining $0.15 million in royalty expenses was recorded as a 50% reduction of the prepaid royalty balance owed to the former beneficial owners of Somahlution. Minimal royalties were accrued in the current period ended September 30, 2024, due to minimal sales of DuraGraft during this time.

Other General and Administrative Expenses

Other general and administrative expenses decreased by $5.1 million, or 81.0%, to approximately $1.2 million for the nine months ended September 30, 2024. This decrease was primarily driven by the following factors: a $0.5 million expense in deferred offering costs related to adjustments to the Convertible Notes recorded in the prior period; a $0.7 million expense in deferred offering costs following the Company’s withdrawal of its registration statement for a public offering in April 2023; a $1.3 million valuation of Class E and Class F Warrants issued in the prior period; and a $2.6 million valuation of Replacement Placement Agent Warrants and OID Units Placement Agent Warrants issued during the nine months ended September 30, 2023.

Other Income (Expenses)

In the nine months ended September 30, 2024, the Company incurred approximately $6.2 million in interest and accretion costs related to convertible notes issued at a discount as part of its Units Private Placements. This represents a decrease of $4.8 million, or 43.6%, compared to $11.0 million in the comparative period ended September 30, 2023. The significant decrease is primarily due to the events in the comparative period: the Company failed to repay the initial principal amount of $1.0 million under the Walleye Promissory Note by its maturity date of May 7, 2023, leading to a default under the Convertible Notes on the same date. This default resulted in a default amount of approximately $6.8 million being accreted to the principal of the Convertible Notes.

In the nine months ended September 30, 2024, pursuant to the agreement with Qualigen, the Company recognized the Exclusivity Fee of $0.2 million under other income. No such income was recognized in the comparative period ended September 30, 2023. Additionally, in accordance with the agreement with Qualigen, the Company also recognized $0.5 million in borrowing costs incurred to secure the funding from Qualigen.

Additionally, the Company recognized a $0.06 million fair value loss from mark-to-market adjustments on the contingent liabilities assumed from the acquisition of the Somahlution assets, due to changes in the fair value of the contingent consideration. This represents a decrease of $0.4 million compared to the $0.3 million fair value gain recognized in the nine months ended September 30, 2023.

In the nine months ended September 30, 2024, the Company recorded a $3.9 million loss on the extinguishment of Convertible Notes - Units Private Placement and Convertible Notes - OID due to the amendment of the maturity dates for certain Notes and warrants attached to those Notes. This represents a $18.0 million increase, or 82.2% compared to $21.9 million loss in the comparative period ended September 30, 2023.

Lastly, in the comparative period ended September 30, 2023, the Company also recorded a loss of $6.4 million on issuance of OID Convertible Notes due to the fair value of Class E and Class F warrants exceeding the value of the debt principal. No such loss was recorded in the nine months ended September 30, 2024.

In the comparative period ended September 30, 2023, the Company recognized a $14.5 million increase in the fair value of detachable warrants issued as part of the OID Convertible Notes transactions. These warrants were subsequently reclassified to equity, and as a result, no revaluation was performed during the nine months ended September 30, 2024.

LIQUIDITY AND CAPITAL RESOURCES

To date, we have incurred significant net losses and negative cash flows from operations. As of September 30, 2024, we had available cash of approximately $0.06 million and accumulated deficit of approximately $170.3 million. We have funded our operations primarily from capital raises.

Debt

As of September 30, 2024, the Company had outstanding convertible notes with varying maturities for an aggregate principal amount of $24.1 million, all payable within approximately 12 months. Future interest payments associated with the convertible notes total $1.0 million.

The Company also issues unsecured short-term promissory notes for operational purposes. As of September 30, 2024, the Company had $2.7 million of promissory notes outstanding, all of which were payable within 12 months or on demand.

Additionally, as part of the Agreement with Qualigen to support the commercialization of DuraGraft™, the Company recorded a long-term Agreement Obligation of $1.0 million.

Leases

The Company has lease arrangements for office and laboratories facilities. As of September 30, 2024, the Company had fixed lease payment obligations of $0.8 million, with $0.4 million payable within 12 months.

Funding Requirements and Other Liquidity Matters

We expect to continue to incur expenses and operating losses for the foreseeable future. We anticipate that our expenses will increase as a result of the following operational and business development efforts:

	●	Increase our expertise and knowledge through hiring and retaining qualified operational, financial and management personnel, who are expected to develop build efficient infrastructure to support development and commercialization of therapies and devices;
	●	Increase in research and development and legal support as we continue to develop our products, conduct clinical trials and pursue FDA clearances;
	●	Expand our product portfolio through the identification and acquisition of additional life science assets; and
	●	Seek to increase awareness about our products to boost sales and distributions internationally.

Until such time, if ever, as we can generate substantial product revenues to support our cost structure, the Company will continue to have to raise funds beyond its current working capital balance in order to finance future development of products, potential acquisitions, and meet its debt obligations until such time as future profitable revenues are achieved.

We expect to finance our cash needs through a combination of private and public equity offerings, debt financings, government or other third-party funding, and collaborations arrangements. To the extent that we raise additional capital through the sale of common stock, convertible securities or other equity securities, the ownership interest of our stockholders may be materially diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the interests of our common stockholders. Debt financing and preferred equity financing, if available, would result in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting our stockholders’ ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct our business. Securing additional financing could require a substantial amount of time and attention from our management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely affect our management’s ability to oversee the development or acquisition of our products.

If we raise additional funds through collaborations, strategic alliances or marketing, distribution, or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves or cease operations, liquidate our assets, reorganize the Company, or a combination of the foregoing. These factors raise substantial doubt about the Company’s ability to continue as a going concern.

Cash Flows

	Nine months ended September 30,
	2024			2023			Change
Net Cash provided by/(used in):
Operating activities	$	(2,524,984	)	$	(3,470,887	)	$	945,903
Financing activities		2,440,251			3,434,966			(994,715	)
Net change in cash	$	(84,733	)	$	(35,921	)	$	(48,812	)

Operating Activities

Net cash used in operating activities was approximately $2.5 million and approximately $3.5 million for the nine months ended September 30, 2024 and 2023, respectively. The decrease in cash flows spent on operating activities is primarily attributable to differences in the timing of payments to our vendors.

Financing Activities

Net cash provided by financing activities for the nine months ended September 30, 2024, was approximately $2.4 million. This amount includes $2.4 million raised from the issuance of promissory notes, with approximately $0.4 million repaid during the period. Additionally, $0.5 million was raised from the agreement with Qualigen. In comparison, for the nine months ended September 30, 2023, net cash provided by financing activities was $3.4 million. This included $2.3 million from the issuance of an OID Convertible Note, $1.0 million from the issuance of the Walleye Promissory Note, and approximately $0.3 million from the exercise of Somahlution Warrants.

Going Concern

The Company, since its inception, has incurred recurring operating losses and negative cash flows from operations and has an accumulated deficit of $170.3 million at September 30, 2024 (December 31, 2023 - $155.5 million). Additionally, the Company has negative working capital of approximately $29.1 million (December 31, 2023 - $21.7 million) and $0.06 million (December 31, 2023 - $0.1 million) of cash on hand, which is not sufficient to fund operations for the next twelve months. These factors raise substantial doubt about the Company’s ability to continue as a going concern.

The accompanying consolidated financial statements have been prepared in conformity with U.S. GAAP, which contemplate continuation of the Company as a going concern and the realization of assets and satisfaction of liabilities in the normal course of business. The ability of the Company to continue its operations is dependent on the execution of management’s plans, which include the raising of capital through the debt and/or equity markets, until such time that funds provided by operations are sufficient to fund working capital requirements. If the Company were not to continue as a going concern, it would likely not be able to realize its assets at values comparable to the carrying value or the fair value estimates reflected in the balances set out in the preparation of the consolidated financial statements.

There can be no assurances that the Company will be successful in generating additional cash from the equity/debt markets or other sources to be used for operations. The consolidated financial statements do not include any adjustments relating to the recoverability of assets and classification of assets and liabilities that might be necessary. Based on the Company’s current resources, the Company will not be able to continue to operate without additional immediate funding. Should the Company not be successful in obtaining the necessary financing to fund its operations, the Company would need to curtail certain or all operational activities and/or contemplate the sale of its assets, if necessary.

Off-Balance Sheet Arrangements

As of September 30, 2024, the Company has no off-balance sheet arrangements that have or are reasonably likely to have a current or future material effect on its financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or GAAP. The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in our financial statements and accompanying notes. We evaluate these estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

While our significant accounting policies are more fully described in “Note 3 – Summary of Significant Accounting Policies”, included in “Item 1. Financial Statements” of this Quarterly Report on Form 10-Q, we believe that the following accounting policies are the most critical for fully understanding and evaluating our financial condition and results of operations.

Impairment

	●	Impairment of long-lived assets: The Company reviews long-lived assets, including property, plant and equipment, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition are less than the carrying amount. The impairment loss, if recognized, would be based on the excess of the carrying value of the impaired asset over its respective fair value.

	●	Goodwill: Goodwill is recorded at the time of purchase for the excess of the amount of the purchase price over the fair values of the identifiable assets acquired and liabilities assumed. The fair value is determined using the estimated discounted future cash flows of the reporting unit. Goodwill is not amortized and instead is tested at least annually for impairment, or more frequently when events or changes in circumstances indicate that goodwill might be impaired. This impairment test is performed annually at December 31. Future adverse changes in market conditions or poor operating results of underlying assets could result in an inability to recover the carrying value of the goodwill, thereby possibly requiring an impairment charge.

	●	In-process research and development assets: IPR&D assets are reviewed for impairment annually, or sooner if events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable, and upon establishment of technological feasibility or regulatory approval. An impairment loss, if any, is calculated by comparing the fair value of the asset to its carrying value. If the asset’s carrying value exceeds its fair value, an impairment loss is recorded for the difference and its carrying value is reduced accordingly. Similar to the impairment test for goodwill, the Company may perform a qualitative approach for testing indefinite-lived intangible assets for impairment.

Fair Value of Derivative and Contingent Liabilities

Our derivative and contingent liabilities are revalued at each reporting period with changes in the fair value of the liabilities recorded as a component of other income (expense) in the statements of operations. There are significant judgments and estimates inherent in the determination of the fair value of these liabilities. If we had made different assumptions including, among others, those related to the timing and probability of various corporate scenarios, discount rates, volatilities and exit valuations, the carrying values of our derivative and contingent liabilities, and our net loss and net loss per common share could have been significantly different.

Stock-Based Compensation Expense

Stock-based compensation expense for employees and directors is recognized in the Statement of Operations based on estimated amounts, including the grant date fair value and the expected service period. For stock options, we estimate the grant date fair value using a Black-Scholes valuation model, which requires the use of multiple subjective inputs including estimated future volatility, expected forfeitures and the expected term of the awards. We estimate the expected future volatility based on the stock’s historical price volatility. The stock’s future volatility may differ from the estimated volatility at the grant date. For restricted stock unit (“RSU”) equity awards, we estimate the grant date fair value using our closing stock price on the date of grant. We recognize the effect of forfeitures in compensation expense when the forfeitures occur. The estimated forfeiture rates may differ from actual forfeiture rates which would affect the amount of expense recognized during the period. We recognize the value of the awards over the awards’ requisite service or performance periods. The requisite service period is generally the time over which our share-based awards vest.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not applicable.

ITEM 4. CONTROLS AND PROCEDURES

Disclosure Controls and Procedures

Disclosure controls and procedures are defined in Rule 13a-15(e) under the Exchange Act to mean controls and other procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.

At the end of the period covered by this Quarterly Report on Form 10-Q an evaluation was carried out under the supervision of and with the participation of our management, including the Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operations of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act). Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were not effective as of September 30, 2024. This conclusion was based on the material weaknesses in our internal control over financial reporting as further described below.

Material Weaknesses

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim consolidated financial statements will not be prevented or detected and corrected on a timely basis. The following material weakness was previously reported in our Annual Report on Form 10-K for the year ended December 31, 2023 and has remained unchanged for the nine months ended September 30, 2024:

●

We did not have sufficient resources with appropriate knowledge, experience and/or training commensurate with our financial reporting requirements to assist us in our timely and efficient preparation and review over our financial reporting.

This material weakness resulted in the restatements of the Company’s financial statements as of and for the quarterly period ended March 31, 2024 and June 30, 2024. Additionally, this material weakness could result in material misstatements of the financial statements that would not be prevented or detected on a timely basis.

See Note 11, “Restatement of Previously Issued Unaudited Interim Condensed Consolidated Financial Statements” for additional information.

To remediate the material weakness described above, since December 31, 2023, management has added, or intends to add, controls to further enhance and revise the design of the existing controls, including the following:

	●	Implementing reassessed design and operation of internal controls over financial reporting and reviewing procedures over the preparation of our financial statements.
	●	Engaging of permanent accounting personnel and consultants to provide support during our quarterly and annual preparation, review, and reporting of our financial statements.
	●	Appointing of qualified personnel to the key management roles to provide oversight and develop stronger controls, policies and procedures.
	●	Maintaining adequate internal qualified personnel to properly supervise and review the information provided by the outside consulting technical experts to ensure certain significant complex transactions and technical matters were properly accounted for.

We cannot assure you that these ongoing or planned measures in response to the material weakness in our internal control over financial reporting will be sufficient to remediate such material weakness or to avoid potential future material weaknesses.

Changes in Internal Control Over Financial Reporting

As discussed above, the management is working on remediating the material weakness in internal control over financial reporting identified above. In the nine months ended September 30, 2024, the Company took the following steps in order to improve its internal controls over financial reporting:

●

Implemented controls around operation of internal control over financial reporting and reviewing procedures over the preparation of our financial statements such that our management believes that the Company had adequate policies and procedures in place to ensure the timely, effective review of assumptions used in measuring the fair value of certain financial instruments.

PART II. OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS.

From time to time, we may become involved in various lawsuits and legal proceedings, which arise, in the ordinary course of business. However, litigation is subject to inherent uncertainties and an adverse result in these or other matters may arise from time to time that may harm our business. We are currently not aware of any such legal proceedings or claims that we believe will have a material adverse effect on our business, financial condition or operating results.

ITEM 1A. RISK FACTORS.

Except as set forth below, there have been no material changes to the risk factors disclosed in the 2023 Form 10-K.

We have incurred losses since inception, and we anticipate that we will incur continued losses for the foreseeable future. Moreover, our independent registered public accounting firm’s report, contained herein, includes an explanatory paragraph that expresses substantial doubt about our ability to continue as a going concern, indicating the possibility that we may not be able to operate in the future.

As of September 30, 2024, we have an accumulated deficit of $170.3 million and incurred a net loss of $14.8 million for the nine months ended September 30, 2024. As of December 31, 2023 and December 31, 2022, the Company had an accumulated deficit of approximately $155.5 million and $86.0 million, respectively. We expect to incur significant and increasing operating losses for the next several years as we expand our acquisition efforts, continue clinical trials, acquire, or license technologies, advance other medical devices into clinical development, complete clinical trials, seek regulatory approval and, if we receive FDA approval, commercialize our products. Primarily because of our losses incurred to date, our expected continued future losses, and limited cash balances, our independent registered public accounting firm has included in its report an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern. Our ability to continue as a going concern is contingent upon, among other factors, the sale of the shares of common stock or obtaining alternate financing. We cannot provide any assurance that we will be able to raise additional capital.

If we are unable to secure additional capital, we may be required to curtail our research and development initiatives and take additional measures to reduce costs in order to conserve our cash in amounts sufficient to sustain operations and meet our obligations. These measures could cause significant delays in our clinical and regulatory efforts, which are critical to the realization of our business plan. The accompanying financial statements do not include any adjustments that may be necessary should we be unable to continue as a going concern. It is not possible for us to predict currently the potential success of our business. The revenue and income potential of our proposed business and operations are currently unknown. If we cannot continue as a viable entity, you may lose some or all your investment in our company.

Management has determined that disclosure controls and procedures and internal control over financial reporting were not effective, identified a material weakness in our internal controls, and a failure to remediate it or any future ineffectiveness of internal controls could have a material adverse effect on the Company’s business and the price of its securities.

Our management determined that our disclosure controls and procedures and internal control over financial reporting, or ICFR, were not effective at September 30, 2024 due to a material weakness in ICFR as of December 31, 2023.

A “material weakness” is a deficiency, or a combination of deficiencies, in ICFR, such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis. As previously reported, we have taken, and plan to continue to take, measures to remediate the Company’s internal weaknesses in ICFR. However, the implementation of these measures may not address any control deficiencies in our ICFR. Our failure to address any control deficiencies could result in inaccuracies in our financial statements and could also impair our ability to comply with applicable financial reporting requirements and related regulatory filings on a timely basis. Moreover, effective ICFR is important to prevent fraud. Failure to report its financial information on an accurate or timely basis may thereby subject the Company to adverse regulatory consequences, including sanctions by the SEC or violations of applicable securities exchange or quotation service listing rules. There could also be a negative reaction in the financial markets due to a loss of investor confidence in the Company and the lack of timeliness or reliability of its financial statements. Confidence in the reliability of the Company’s financial statements may suffer due to the Company’s reporting of a material weakness in its ICFR. This could materially adversely affect the Company’s business, financial condition, results of operations and prospects and lead to a decline in the price of its common stock.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES, USE OF PROCEEDS, AND ISSUER PURCHASES OF EQUITY SECURITIES.

During the three-month period ended September 30, 2024, we did not conduct any unregistered sales of our equity securities that were not previously disclosed in a current report on Form 8-K and we did not repurchase any of our common stock

ITEM 3. DEFAULTS UPON SENIOR SECURITIES.

None.

ITEM 4. MINE SAFETY DISCLOSURES.

Not applicable.

ITEM 5. OTHER INFORMATION.

During the third quarter of 2024, none of our directors or executive officers adopted or terminated any “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement” (as each term is defined in Item 408(a) of Registration S-K).

ITEM 6. EXHIBITS

The following exhibits are filed as part of this report or incorporated by reference:

Exhibit No.		Description
3.1		Articles of Incorporation (incorporated by reference to Exhibit 3.1 to Form SB-2 (File No: 333-146748) filed January 14, 2008)
3.2		Certificate of Amendment to Articles of Incorporation, effective September 6, 2010 (incorporated by reference to Exhibit 3.1.1(2) to Form 10-K filed on July 16, 2012)
3.3		Certificate of Amendment to Articles of Incorporation, effective November 22, 2010 (incorporated by reference to Exhibit 3.1.2 to Form 10-K/A filed on July 15, 2011)
3.4		Certificate of Amendment to the Articles of Incorporation regarding 1-for-29 Reverse Stock Split filed March 20, 2018 (incorporated by reference to Exhibit 3.1.2 to Form 10 (File No. 000-53223) filed on September 12, 2018)
3.5		Series A Non-Convertible Preferred Certificate of Designation filed May 11, 2018 (incorporated by reference to Exhibit 3.1.6 to Form 10-12G filed on September 12, 2018)
3.6		Certificate of Withdrawal of Certificate of Designation, effective January 25, 2022 (incorporated by reference to Exhibit 3.5 to Form S-1 filed on February 14, 2022)
3.7		Articles of Merger between Marizyme, Inc. and GBS Enterprises Incorporated filed May 19, 2018 (incorporated by reference to Exhibit 3.1.5 to Form 10 (File No. 000-53223) filed on September 12, 2018)
3.8		Certificate of Change Pursuant to Nevada Revised Statutes Section 78.209, as filed by Marizyme, Inc. with the Secretary of State of the State of Nevada on August 3, 2022 (incorporated by reference to Exhibit 3.1 to Form 8-K filed on August 3, 2022)
3.9		Certificate of Amendment Pursuant to NRS 78.380 & 78.390 to the Articles of Incorporation filed with the Nevada Secretary of State on December 30, 2022 (incorporated by reference to Exhibit 3.1 to Form 8-K filed on January 5, 2023)
3.10		Certificate of Change Pursuant to NRS 78.209, as filed by Marizyme, Inc. with the Secretary of State of the State of Nevada on January 5, 2023 (incorporated by reference to Exhibit 3.3 to Form 8-K filed on January 17, 2023)
3.11		Certificate of Change Pursuant to NRS 78.209, as filed by Marizyme, Inc. with the Secretary of State of the State of Nevada on January 13, 2023, effective on January 17, 2023 at 4:45 PM Pacific time (incorporated by reference to Exhibit 3.4 to Form 8-K filed on January 17, 2023)
3.12		Certificate of Change Pursuant to NRS 78.209, as filed by Marizyme, Inc. with the Secretary of State of the State of Nevada on January 13, 2023, effective on January 17, 2023 at 5:00 PM Pacific time (incorporated by reference to Exhibit 3.5 to Form 8-K filed on January 17, 2023)
3.13		Certificate of Change Pursuant to NRS 78.209, as filed by Marizyme, Inc. with the Secretary of State of the State of Nevada on January 13, 2023, effective on January 17, 2023 at 5:15 PM Pacific time (incorporated by reference to Exhibit 3.6 to Form 8-K filed on January 17, 2023)
3.14		Certificate of Change Pursuant to NRS 78.209, as filed by Marizyme, Inc. with the Secretary of State of the State of Nevada on May 15, 2023 (incorporated by reference to Exhibit 3.7 to Form 8-K filed on May 18, 2023)
3.15		Certificate of Amendment Pursuant to Nevada Revised Statutes 78.380 & 78.390, as filed by Marizyme, Inc. with the Secretary of State of the State of Nevada on August 16, 2023 (incorporated by reference to Exhibit 3.15 to Form 10-Q filed on August 18, 2023)
3.16		Bylaws (incorporated by reference to Exhibit 3.2 to Form SB-2/A (File No: 333-146748) filed January 14, 2008)
4.1		15% Original Issue Discount Unsecured Subordinated Convertible Promissory Note issued by Marizyme, Inc. to Walleye Opportunities Master Fund Ltd, dated May 12, 2023 (incorporated by reference to Exhibit 4.1 to Form 8-K filed on May 18, 2023)
4.2		Class E Common Stock Purchase Warrant issued by Marizyme, Inc. to Walleye Opportunities Master Fund Ltd, dated May 12, 2022 (incorporated by reference to Exhibit 4.2 to Form 8-K filed on May 18, 2023)
4.3		Class F Common Stock Purchase Warrant issued by Marizyme, Inc. to Walleye Opportunities Master Fund Ltd, dated May 12, 2022 (incorporated by reference to Exhibit 4.3 to Form 8-K filed on May 18, 2023)
4.4		Form of Placement Agent Warrant as to 15% Original Issue Discount Unsecured Subordinated Convertible Promissory Notes (incorporated by reference to Exhibit 4.4 to Form 8-K filed on May 18, 2023)
4.5		Form of Placement Agent Warrant as to Class E Common Stock Purchase Warrants (incorporated by reference to Exhibit 4.5 to Form 8-K filed on May 18, 2023)
4.6		Form of Placement Agent Warrant as to Class F Common Stock Purchase Warrants (incorporated by reference to Exhibit 4.6 to Form 8-K filed on May 18, 2023)
4.7		Class E Common Stock Purchase Warrant issued by Marizyme, Inc. to Hexin Global Ltd., dated May 22, 2023 (incorporated by reference to Exhibit 4.2 to Form 8-K filed on May 24, 2023)
4.8		Class F Common Stock Purchase Warrant issued by Marizyme, Inc. to Hexin Global Ltd., dated May 22, 2023 (incorporated by reference to Exhibit 4.3 to Form 8-K filed on May 24, 2023)
4.9		15% Original Issue Discount Unsecured Subordinated Convertible Promissory Note issued by Marizyme, Inc. to Hexin Global Ltd., dated May 30, 2023 (incorporated by reference to Exhibit 4.1 to Form 8-K filed on June 5, 2023)
4.10		Class E Common Stock Purchase Warrant issued by Marizyme, Inc. to Hexin Global Ltd., dated May 30, 2023 (incorporated by reference to Exhibit 4.2 to Form 8-K filed on June 5, 2023)

4.11		Class F Common Stock Purchase Warrant issued by Marizyme, Inc. to Hexin Global Ltd., dated May 30, 2023 (incorporated by reference to Exhibit 4.3 to Form 8-K filed on June 5, 2023)
4.12		15% Original Issue Discount Unsecured Subordinated Convertible Promissory Note issued by Marizyme, Inc. to Walleye Opportunities Master Fund Ltd, dated May 30, 2023 (incorporated by reference to Exhibit 4.4 to Form 8-K filed on June 5, 2023)
4.13		Class E Common Stock Purchase Warrant issued by Marizyme, Inc. to Walleye Opportunities Master Fund Ltd, dated May 30, 2023 (incorporated by reference to Exhibit 4.5 to Form 8-K filed on June 5, 2023)
4.14		Class F Common Stock Purchase Warrant issued by Marizyme, Inc. to Walleye Opportunities Master Fund Ltd, dated May 30, 2023 (incorporated by reference to Exhibit 4.6 to Form 8-K filed on June 5, 2023)
4.15		15% Original Issue Discount Unsecured Subordinated Convertible Promissory Note issued by Marizyme, Inc. to Frank Maresca, dated May 30, 2023 (incorporated by reference to Exhibit 4.7 to Form 8-K filed on June 5, 2023)
4.16		Class E Common Stock Purchase Warrant issued by Marizyme, Inc. to Frank Maresca, dated May 30, 2023 (incorporated by reference to Exhibit 4.8 to Form 8-K filed on June 5, 2023)
4.17		Class F Common Stock Purchase Warrant issued by Marizyme, Inc. to Frank Maresca, dated May 30, 2023 (incorporated by reference to Exhibit 4.9 to Form 8-K filed on June 5, 2023)
4.18		15% Original Issue Discount Unsecured Subordinated Convertible Promissory Note issued by Marizyme, Inc. to Hexin Global Ltd., dated July 10, 2023 (incorporated by reference to Exhibit 4.1 to Form 8-K filed on July 12, 2023)
4.19		Class E Common Stock Purchase Warrant issued by Marizyme, Inc. to Hexin Global Ltd., dated July 10, 2023 (incorporated by reference to Exhibit 4.2 to Form 8-K filed on July 12, 2023)
4.20		Class F Common Stock Purchase Warrant issued by Marizyme, Inc. to Hexin Global Ltd., dated July 10, 2023 (incorporated by reference to Exhibit 4.3 to Form 8-K filed on July 12, 2023)
4.21		Class C Common Stock Purchase Warrant, dated July 25, 2023, issued to Univest Securities, LLC (incorporated by reference to Exhibit 4.1 to Form 8-K filed on July 31, 2023)
4.22		Class C Common Stock Purchase Warrant, dated July 25, 2023, issued to Bradley Richmond (incorporated by reference to Exhibit 4.2 to Form 8-K filed on July 31, 2023)
4.23		10% Secured Convertible Promissory Note, dated July 25, 2023, issued to Univest Securities, LLC (incorporated by reference to Exhibit 4.3 to Form 8-K filed on July 31, 2023)
4.24		10% Secured Convertible Promissory Note, dated July 25, 2023, issued to Bradley Richmond (incorporated by reference to Exhibit 4.4 to Form 8-K filed on July 31, 2023)
4.25		Placement Agent Warrant, dated July 25, 2023, issued to Univest Securities, LLC (incorporated by reference to Exhibit 4.5 to Form 8-K filed on July 31, 2023)
4.26		Placement Agent Warrant, dated July 25, 2023, issued to Bradley Richmond (incorporated by reference to Exhibit 4.6 to Form 8-K filed on July 31, 2023)
4.27		Form of 15% Original Issue Discount Unsecured Subordinated Convertible Promissory Note issued by Marizyme, Inc., dated August 30, 2023 (incorporated by reference to Exhibit 4.1 to Form 8-K filed on September 5, 2023)
4.28		15% Original Issue Discount Unsecured Subordinated Convertible Promissory Note issued by Marizyme, Inc. to Frank Maresca Jr., dated August 30, 2023 (incorporated by reference to Exhibit 4.2 to Form 8-K filed on September 5, 2023)
4.29		Form of Class E Common Stock Purchase Warrant issued by Marizyme, Inc., dated August 30, 2023 (incorporated by reference to Exhibit 4.3 to Form 8-K filed on September 5, 2023)
4.30		Class E Common Stock Purchase Warrant issued by Marizyme, Inc. to Frank Maresca Jr., dated August 30, 2023 (incorporated by reference to Exhibit 4.4 to Form 8-K filed on September 5, 2023)
4.31		Form of Class F Common Stock Purchase Warrant issued by Marizyme, Inc., dated August 30, 2023 (incorporated by reference to Exhibit 4.5 to Form 8-K filed on September 5, 2023)
4.32		Class F Common Stock Purchase Warrant issued by Marizyme, Inc. to Frank Maresca Jr., dated August 30, 2023 (incorporated by reference to Exhibit 4.6 to Form 8-K filed on September 5, 2023)
4.33		Form of Placement Agent Warrant with respect to 15% Original Issue Discount Unsecured Subordinated Convertible Promissory Notes (incorporated by reference to Exhibit 4.7 to Form 8-K filed on September 5, 2023)
4.34		Form of Placement Agent Warrant with respect to Class E Common Stock Purchase Warrants (incorporated by reference to Exhibit 4.8 to Form 8-K filed on September 5, 2023)
4.35		Form of Placement Agent Warrant with respect to Class F Common Stock Purchase Warrants (incorporated by reference to Exhibit 4.9 to Form 8-K filed on September 5, 2023)
4.36		Placement Agent Warrant, dated October 3, 2023, issued to Univest Securities, LLC (incorporated by reference to Exhibit 4.1 to Form 8-K filed on October 4, 2023)
4.37		Placement Agent Warrant, dated October 3, 2023, issued to Bradley Richmond (incorporated by reference to Exhibit 4.2 to Form 8-K filed on October 4, 2023)
10.1		Waiver and Consent between Marizyme, Inc. and Waichun Logistics Technology Ltd, dated as of April 12, 2023
10.2		Form of Letter Agreement, dated April 13, 2023 (incorporated by reference to Exhibit 10.1 to Form 8-K filed on April 20, 2023)
10.3		Unit Purchase Agreement between Marizyme, Inc. and each investor identified on Appendix A thereto (incorporated by reference to Exhibit 10.1 to Form 8-K filed on May 18, 2023)

10.4		Registration Rights Agreement between Marizyme, Inc. and each of the several purchasers signatory thereto (incorporated by reference to Exhibit 10.2 to Form 8-K filed on May 18, 2023)
10.5		Placement Agency Agreement between Marizyme, Inc. and Univest Securities, LLC, dated April 27, 2023 (incorporated by reference to Exhibit 10.3 to Form 8-K filed on May 18, 2023)
10.6		Unit Purchase Agreement between Marizyme, Inc. and each investor identified on Appendix A thereto, dated as of May 30, 2023 (incorporated by reference to Exhibit 10.1 to Form 8-K filed on June 5, 2023)
10.7		Registration Rights Agreement between Marizyme, Inc. and each of the several purchasers signatory thereto, dated as of May 30, 2023 (incorporated by reference to Exhibit 10.1 to Form 8-K filed on June 5, 2023)
10.8		Cancellation and Exchange Agreement between Marizyme, Inc. and Hexin Global Ltd., dated as of May 30, 2023 (incorporated by reference to Exhibit 10.3 to Form 8-K filed on June 5, 2023)
10.9		Cancellation and Exchange Agreement between Marizyme, Inc. and Walleye Opportunities Master Fund Ltd, dated as of May 30, 2023 (incorporated by reference to Exhibit 10.4 to Form 8-K filed on June 5, 2023)
10.10		Cancellation and Exchange Agreement between Marizyme, Inc. and Frank Maresca, dated as of May 30, 2023 (incorporated by reference to Exhibit 10.5 to Form 8-K filed on June 5, 2023)
10.11		Form of Waiver and Consent with respect to certain registration and exercise rights dated on or around June 9, 2023 (incorporated by reference to Exhibit 10.48 to Registration Statement on Form S-1 filed on July 18, 2023)
10.12		Unit Purchase Agreement between Marizyme, Inc. and the investor identified on Appendix A thereto, dated July 10, 2023 (incorporated by reference to Exhibit 10.1 to Form 8-K filed on July 12, 2023)
10.13		Registration Rights Agreement between Marizyme, Inc. and the purchaser signatory thereto, dated July 10, 2023 (incorporated by reference to Exhibit 10.2 to Form 8-K filed on July 12, 2023)
10.14		Amendment to Registration Rights Agreement, dated July 6, 2023, between Marizyme, Inc. and each of the several investors signatory thereto (incorporated by reference to Exhibit 10.4 to Form 8-K filed on July 12, 2023)
10.15		Waiver and Consent between Marizyme, Inc. and Waichun Logistics Technology Ltd, dated as of April 12, 2023 (incorporated by reference to Exhibit 10.1 to Form 10-Q filed on August 18, 2023)
10.16		Waiver and Consent between Marizyme, Inc. and Bologna Family Restaurant Spa, dated as of June 5, 2023
10.17		Waiver and Consent between Marizyme, Inc. and Allesia Solimeo, dated as of July 20, 2023
10.18		Waiver and Consent between Marizyme, Inc. and Alessandro Solimeo, dated as of July 21, 2023
10.19		Letter Agreement between Marizyme, Inc. and Outside The Box Capital Inc., dated as of August 17, 2023
10.20		Unit Purchase Agreement between Marizyme, Inc. and the investors identified on Appendix A thereto, dated as of August 30, 2023 (incorporated by reference to Exhibit 10.1 to Form 8-K filed on September 5, 2023)
10.21		Registration Rights Agreement between Marizyme, Inc. and the purchasers signatory thereto, dated as of August 30, 2023 (incorporated by reference to Exhibit 10.2 to Form 8-K filed on September 5, 2023)
10.22		Cancellation and Exchange Agreement between Marizyme, Inc. and Frank Maresca Jr., dated as of August 30, 2023 (incorporated by reference to Exhibit 10.3 to Form 8-K filed on September 5, 2023)
10.23		Waiver and Consent between Marizyme, Inc. and Pioneer Capital Anstalt, dated as of September 7, 2023 (incorporated by reference to Exhibit 10.60 to Registration Statement on Form S-1/A filed on October 12, 2023)
10.24		Letter Agreement between Marizyme, Inc. and Univest Securities, LLC, as Unitholder Representative for the Investors, dated October 3, 2023 (incorporated by reference to Exhibit 10.1 to Form 8-K filed on October 4, 2023)
31.1*		Certifications of Principal Executive Officer filed pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2*		Certifications of Principal Financial and Accounting Officer filed pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1**		Certifications of Principal Executive Officer furnished pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2**		Certifications of Principal Financial and Accounting Officer furnished pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS*		Inline XBRL Instance Document
101.SCH*		Inline XBRL Taxonomy Extension Schema Document
101.CAL*		Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*		Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*		Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE*		Inline XBRL Taxonomy Extension Presentation Linkbase Document
104*		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

* Filed herewith

** Furnished herewith

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Date: March 5, 2025	MARIZYME, INC.

		/s/ David Barthel
	Name:	David Barthel
	Title:	Chief Executive Officer
		(Principal Executive Officer)

		/s/ George Kovalyov
	Name:	George Kovalyov
	Title:	Chief Financial Officer
		(Principal Accounting and Financial Officer)

Exhibit 10.1

Exhibit 31.1

CERTIFICATIONS

I, David Barthel, certify that:

	1.	I have reviewed this Quarterly Report on Form 10-Q of Marizyme, 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(s) 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

The registrant’s other certifying officer(s) 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: March 5, 2025

/s/ David Barthel

David Barthel

Chief Executive Officer

(Principal Executive Officer)

Exhibit 31.2

CERTIFICATIONS

I, George Kovalyov, certify that:

	1.	I have reviewed this Quarterly Report on Form 10-Q of Marizyme, 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(s) 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

	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: March 5, 2025

/s/ George Kovalyov

George Kovalyov

Chief Financial Officer

(Principal Financial and Accounting Officer)

Exhibit 32.1

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO SECTION 906
OF THE SARBANES-OXLEY ACT OF 2002

The undersigned Chief Executive Officer of MARIZYME, INC. (the “Company”), DOES HEREBY CERTIFY that:

1. The Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 (the “Report”), fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

2. Information contained in the Report fairly presents, in all material respects, the financial condition and results of operation of the Company.

IN WITNESS WHEREOF, the undersigned has executed this statement on March 5, 2025.

/s/ David Barthel

David Barthel

Chief Executive Officer

(Principal Executive Officer)

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

The forgoing certification is being furnished to the Securities and Exchange Commission pursuant to 18 U.S.C. Section 1350. It is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Exhibit 32.2

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO SECTION 906
OF THE SARBANES-OXLEY ACT OF 2002

The undersigned Chief Financial Officer of MARIZYME, INC. (the “Company”), DOES HEREBY CERTIFY that:

2. Information contained in the Report fairly presents, in all material respects, the financial condition and results of operation of the Company.

IN WITNESS WHEREOF, the undersigned has executed this statement on March 5, 2025.

/s/ George Kovalyov

George Kovalyov

Chief Financial Officer

(Principal Financial and Accounting Officer)

Cover - $ / shares	9 Months Ended
Cover - $ / shares	Sep. 30, 2024	Mar. 05, 2025
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Sep. 30, 2024
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2024
Current Fiscal Year End Date	--12-31
Entity File Number	000-53223
Entity Registrant Name	MARIZYME, INC.
Entity Central Index Key	0001413754
Entity Tax Identification Number	82-5464863
Entity Incorporation, State or Country Code	NV
Entity Address, Address Line One	555 Heritage Drive
Entity Address, Address Line Two	Suite 205
Entity Address, City or Town	Jupiter
Entity Address, State or Province	FL
Entity Address, Postal Zip Code	33458
City Area Code	(561)
Local Phone Number	935-9955
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		131,793,088
Entity Listing, Par Value Per Share	$ 0.001

Condensed Consolidated Balance Sheets - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Current
Cash	$ 63,732	$ 148,465
Accounts receivable	2,000	60,284
Other receivables	35,879	35,797
Prepaid expenses	726,114	699,377
Inventory	26,869	24,855
Total current assets	854,594	968,778
Non-current
Property, plant and equipment, net		12,500
Operating lease right-of-use assets, net	797,405	1,101,211
Intangible assets, net	14,037,798	14,364,129
Prepaid royalties, non-current	120,500	122,457
Deposits	30,000	30,000
Goodwill	5,416,000	5,416,000
Total non-current assets	20,401,703	21,046,297
Total assets	21,256,297	22,015,075
Current
Accounts payable and accrued expenses	3,371,483	2,322,064
Notes payable	2,739,981	633,692
Convertible notes, net - Units Private Placement	16,698,700	16,328,476
Convertible notes, net - OID	6,421,918	2,694,256
Operating lease obligations	442,221	434,082
Total current liabilities	29,977,203	22,642,723
Non-current
Operating lease obligations, net of current portion	355,184	667,129
Agreement obligation	1,000,000
Contingent liabilities	5,463,000	5,406,000
Total non-current liabilities	6,818,184	6,073,129
Total liabilities	36,795,387	28,715,852
Commitments and contingencies (Note 10)
Stockholders’ equity (deficit):
Preferred stock, $0.001 par value, 25,000,000 shares authorized, no shares issued and outstanding as of September 30, 2024 and December 31, 2023
Common stock, par value $0.001, 2,000,000,000 shares authorized, issued and outstanding shares - 131,793,088 at September 30, 2024 and December 31, 2023	131,792	131,792
Additional paid-in capital	154,650,064	148,696,200
Accumulated deficit	(170,320,946)	(155,528,769)
Total stockholders’ equity (deficit)	(15,539,090)	(6,700,777)
Total liabilities and stockholders’ equity (deficit)	21,256,297	22,015,075
Related Party [Member]
Current
Due to related parties	$ 302,900	$ 230,153

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2024	Dec. 31, 2023
Statement of Financial Position [Abstract]
Preferred stock, par value	$ 0.001	$ 0.001
Preferred stock, shares authorized	25,000,000	25,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	2,000,000,000	2,000,000,000
Common stock, shares issued	131,793,088	131,793,088
Common stock, shares outstanding	131,793,088	131,793,088

Condensed Consolidated Statements of Operations (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Income Statement [Abstract]
Revenue		$ 181,535	$ 32,855	$ 495,248
Direct cost of revenue		50,989	9,647	139,875
Gross profit		130,546	23,208	355,373
Operating expenses:
Professional fees (includes related party amounts of $89,500, $72,000, $319,500, and $216,000, respectively)	118,270	921,552	721,042	1,818,202
Salary expenses	318,019	329,564	983,703	931,536
Research and development	344,139	492,235	978,339	1,789,625
Stock-based compensation	20,794	86,132	116,646	457,860
Depreciation and amortization	108,777	210,293	338,831	630,924
Royalty expense		13,014	1,957	211,262
Other general and administrative expenses	445,031	2,934,966	1,199,172	6,310,039
Total operating expenses	1,355,030	4,987,756	4,339,690	12,149,448
Total operating loss	(1,355,030)	(4,857,210)	(4,316,482)	(11,794,075)
Other income (expense)
Interest and accretion expenses	(1,104,674)	(1,502,088)	(6,230,294)	(11,038,400)
Other income			200,000
Change in fair value of contingent liabilities	440,000	(1,678,000)	(57,000)	312,000
Change in fair value of derivative liabilities		(14,454,397)		(14,454,397)
Gain (loss) on debt extinguishment	59,843	(80,000)	(3,888,401)	(21,857,877)
Borrowing costs			(500,000)
Loss on issuance of debt		(3,974,993)		(6,352,562)
Total other income (expense)	(604,831)	(21,689,478)	(10,475,695)	(53,391,236)
Net loss	$ (1,959,861)	$ (26,546,688)	$ (14,792,177)	$ (65,185,311)
Loss per share - basic	$ (0.01)	$ (0.58)	$ (0.11)	$ (1.51)
Loss per share - diluted	$ (0.01)	$ (0.58)	$ (0.11)	$ (1.51)
Weighted average number of shares of common stock outstanding - basic	131,793,088	45,812,412	131,793,088	43,270,975
Weighted average number of shares of common stock outstanding - diluted	131,793,088	45,812,412	131,793,088	43,270,975

Condensed Consolidated Statements of Operations (Unaudited) (Parenthetical) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Related Party [Member]
Related Party Transaction [Line Items]
Professional fees related paty	$ 89,500	$ 72,000	$ 319,500	$ 216,000

Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit) (Unaudited) - USD ($)	Common Stock [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member]	Total
Balance at Dec. 31, 2022	$ 40,528	$ 103,370,890	$ (85,989,433)	$ 17,421,985
Balance, shares at Dec. 31, 2022	40,528,191
Stock-based compensation expense		210,966		210,966
Issuance of shares	$ 240	153,360		153,600
Issuance of shares, shares	240,000
Net loss			(2,554,584)	(2,554,584)
Balance at Mar. 31, 2023	$ 40,768	103,735,216	(88,544,017)	15,231,967
Balance, shares at Mar. 31, 2023	40,768,191
Balance at Dec. 31, 2022	$ 40,528	103,370,890	(85,989,433)	17,421,985
Balance, shares at Dec. 31, 2022	40,528,191
Net loss				(65,185,311)
Balance at Sep. 30, 2023	$ 46,666	121,726,501	(151,174,744)	(29,401,577)
Balance, shares at Sep. 30, 2023	46,666,760
Balance at Mar. 31, 2023	$ 40,768	103,735,216	(88,544,017)	15,231,967
Balance, shares at Mar. 31, 2023	40,768,191
Stock-based compensation expense		160,762		160,762
Issuance of shares	$ 1,946	339,050		340,996
Issuance of shares, shares	1,946,410
Net loss			(36,084,039)	(36,084,039)
Exercise of warrants	$ 2,652	262,564		265,216
Exercise of warrants, shares	2,652,159
Increase of fair value of warrants in debt extinguishment		12,666,268		12,666,268
Issuance of warrants on promissory note		1,333,128		1,333,128
Balance at Jun. 30, 2023	$ 45,366	118,496,988	(124,628,056)	(6,085,702)
Balance, shares at Jun. 30, 2023	45,366,760
Stock-based compensation expense		86,132		86,132
Issuance of shares	$ 1,300	208,700		210,000
Issuance of shares, shares	1,300,000
Net loss			(26,546,688)	(26,546,688)
Exercise of warrants		2,934,681		2,934,681
Balance at Sep. 30, 2023	$ 46,666	121,726,501	(151,174,744)	(29,401,577)
Balance, shares at Sep. 30, 2023	46,666,760
Balance at Dec. 31, 2023	$ 131,792	148,696,200	(155,528,769)	(6,700,777)
Balance, shares at Dec. 31, 2023	131,793,088
Stock-based compensation expense		54,264		54,264
Net loss			(5,396,490)	(5,396,490)
Increase of fair value of warrants in debt extinguishment		1,407,934		1,407,934
Balance at Mar. 31, 2024	$ 131,792	150,158,398	(160,925,259)	(10,635,069)
Balance, shares at Mar. 31, 2024	131,793,088
Balance at Dec. 31, 2023	$ 131,792	148,696,200	(155,528,769)	(6,700,777)
Balance, shares at Dec. 31, 2023	131,793,088
Net loss				(12,832,316)
Increase of fair value of warrants in debt extinguishment				5,483,683
Balance at Jun. 30, 2024	$ 131,792	154,275,735	(168,361,085)	(13,953,558)
Balance, shares at Jun. 30, 2024	131,793,088
Balance at Dec. 31, 2023	$ 131,792	148,696,200	(155,528,769)	(6,700,777)
Balance, shares at Dec. 31, 2023	131,793,088
Net loss				(14,792,177)
Balance at Sep. 30, 2024	$ 131,792	154,650,064	(170,320,946)	(15,539,090)
Balance, shares at Sep. 30, 2024	131,793,088
Balance at Mar. 31, 2024	$ 131,792	150,158,398	(160,925,259)	(10,635,069)
Balance, shares at Mar. 31, 2024	131,793,088
Stock-based compensation expense		41,588		41,588
Net loss			(7,435,826)	(7,435,826)
Increase of fair value of warrants in debt extinguishment		4,075,749		4,075,749
Balance at Jun. 30, 2024	$ 131,792	154,275,735	(168,361,085)	(13,953,558)
Balance, shares at Jun. 30, 2024	131,793,088
Stock-based compensation expense		20,794		20,794
Net loss			(1,959,861)	(1,959,861)
Increase of fair value of warrants in debt extinguishment		344,098		344,098
Cancellation of warrants		9,437		9,437
Balance at Sep. 30, 2024	$ 131,792	$ 154,650,064	$ (170,320,946)	$ (15,539,090)
Balance, shares at Sep. 30, 2024	131,793,088

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)	3 Months Ended				6 Months Ended	9 Months Ended		12 Months Ended
	Sep. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Mar. 31, 2023	Jun. 30, 2024	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Cash flows from operating activities:
Net loss	$ (1,959,861)	$ (5,396,490)	$ (26,546,688)	$ (2,554,584)	$ (12,832,316)	$ (14,792,177)	$ (65,185,311)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	108,777		210,293			338,831	630,924
Amortization of right-of-use assets						303,806	286,816
Stock-based compensation	20,794		86,132			116,646	457,860
Interest and accretion on convertible notes and notes payable		2,733,939			5,125,620	6,230,294	11,038,400
Issuance of warrants for services							2,934,680
Change in fair value of contingent liabilities	(440,000)		1,678,000			57,000	(312,000)
Change in fair value of derivative liabilities			14,454,397				14,454,397
Loss on debt extinguishment	(59,843)	705,459	80,000		3,948,244	3,888,401	21,857,877
Loss on issuance of debt			3,974,993				6,352,562
Shares issued as part of the Confidential Settlement Agreement							153,600
Shares issued for services							168,000
Warrants issued as part of promissory note agreement							1,333,128
Borrowing costs						500,000
Change in operating assets and liabilities:
Accounts receivable and other receivables						58,201	24,120
Prepaid expenses						(26,737)	464,367
Inventory						(2,014)	116,547
Accounts payable and accrued expenses						1,033,824	1,852,865
Due to related parties						72,747	187,097
Operating lease liabilities						(303,806)	(286,816)
Net cash used in operating activities						(2,524,984)	(3,470,887)
Cash flows from financing activities:
Proceeds from issuance of Convertible Notes - OID, net of issuance cost							2,334,000
Proceeds from shares issued for exercise of warrants							265,216
Proceeds from notes payable						2,362,000	1,000,000
Repayments of notes payable and Convertible Notes - OID						(421,749)	(164,250)
Proceeds from agreement obligation						500,000
Net cash provided by financing activities						2,440,251	3,434,966
Net change in cash						(84,733)	(35,921)
Cash at beginning of period		$ 148,465		$ 510,865	$ 148,465	148,465	510,865	$ 510,865
Cash at end of period	$ 63,732		$ 474,944			63,732	474,944	148,465
Supplemental disclosure of cash flow information:
Derivative liabilities and debt discount issued in connection with convertible notes							25,555,092
Warrants and debt discount issued in connection with convertible notes							344,959
Settlement of notes payable with convertible notes							2,264,133
Increase of fair value of warrants in debt extinguishment							12,666,268	$ 12,666,268
Shares issued on conversion of convertible notes							$ 84,140

Pay vs Performance Disclosure - USD ($)	3 Months Ended						6 Months Ended	9 Months Ended
Pay vs Performance Disclosure - USD ($)	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Jun. 30, 2024	Sep. 30, 2024	Sep. 30, 2023
Pay vs Performance Disclosure [Table]
Net Income (Loss)	$ (1,959,861)	$ (7,435,826)	$ (5,396,490)	$ (26,546,688)	$ (36,084,039)	$ (2,554,584)	$ (12,832,316)	$ (14,792,177)	$ (65,185,311)

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Sep. 30, 2024
Insider Trading Arrangements [Line Items]
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

DESCRIPTION OF BUSINESS

9 Months Ended

Sep. 30, 2024

Organization, Consolidation and Presentation of Financial Statements [Abstract]

DESCRIPTION OF BUSINESS

NOTE 1 – DESCRIPTION OF BUSINESS

GOING CONCERN

9 Months Ended

Sep. 30, 2024

Organization, Consolidation and Presentation of Financial Statements [Abstract]

GOING CONCERN

NOTE 2 – GOING CONCERN

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

9 Months Ended

Sep. 30, 2024

Accounting Policies [Abstract]

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation and Principles of Consolidation

Use of Estimates

Fair Value Measurements

●	Level 1 – Quoted prices for identical assets or liabilities in active markets.
●	Level 2 – Quoted prices for identical or similar assets and liabilities in markets that are not active; or other model-derived valuations whose inputs are directly or indirectly observable or whose significant value drivers are observable.
●	Level 3 – Valuations derived from valuation techniques in which one or more significant inputs to the valuation model are unobservable and for which assumptions are used based on management estimates.

Contingent Liabilities

	i.	The performance warrants and pediatric vouchers warrants liabilities were valued using a Monte Carlo simulation model utilizing the following weighted average assumptions: risk free rate of 1.19%, expected volatility of 69.62%, expected dividend of $Nil, and expected life of 5.96 years. For the three and nine months ended September 30, 2024, changes in these assumptions resulted in a $31,000 decrease and $171,000 decrease in fair value of these liabilities, respectively (September 30, 2023 – $406,000 increase and $800,000 decrease, respectively). At September 30, 2024, the fair market value of performance warrants and pediatric vouchers warrants liabilities was $54,000 (December 31, 2023 – $225,000).

	ii.	The present value of royalty payments was measured using the scenario-based methodology. In assessing the value attributed to the royalty payments, the estimated future cash flows were discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the revenue from net sales of the product. The cash flows derived from the Company’s fifteen-year strategic plan are based on managements’ expectations of market growth, industry reports and trends, and past performances. These projections are inherently uncertain due to the evolving impact of the COVID-19 pandemic. The discounted cash flow model included projections surrounding revenue, discount rates, and growth rates. The discount rates used to calculate the present value of royalty payments reflect specific risks of the Company and market conditions and the mid-range was estimated at 20.6%. For the three and nine months ended September 30, 2024, changes in these assumptions resulted in a $409,000 decrease and $228,000 increase in fair value of this liability, respectively (September 30, 2023 – $1,262,000 and $466,000 increase in fair value of this liability, respectively). At September 30, 2024, the fair market value of royalty payments was $3,586,000 (December 31, 2023 – $3,358,000).

	iii.	Rare pediatric voucher sales liability was valued based on the scenario-based methodology where the estimated future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset – 20.6%. The rare pediatric voucher could only be applied for medical devices prior to receiving U.S. Food and Drug Administration (“FDA”) approval. However, because DuraGraft received FDA approval in late 2023, obtaining the rare pediatric voucher is no longer possible. Therefore, as of December 31, 2023, the fair market value of rare pediatric vouchers was $Nil, and there has been no change in the fair market value during the three and nine months ended September 30, 2024.

	iv.	The present value of liquidation preference liability, included in the contingent consideration, was determined using the Black-Scholes option pricing method and represents the fair value of the maximum payment amount according to the agreement. The following assumptions were used in the Black-Scholes option pricing model: risk free rate of 0.21%, expected volatility of 78.93%, expected dividend of $Nil, and expected life of 5 years. No changes to the fair value of liquidation preference liability were recorded in the three and nine months ended September 30, 2024 and 2023. At September 30, 2024, the fair market value of liquidation preference was $1,823,000 (December 31, 2023 – $1,823,000).

Warrants

Goodwill, Intangible Assets and Impairment

September 30, 2024	Level 1		Level 2		Level 3
	Fair Value Hierarchy
September 30, 2024	Level 1		Level 2		Level 3
Liabilities
Contingent liabilities	$	-	$	-	$	5,463,000
Total	$	-	$	-	$	5,463,000

December 31, 2023	Level 1		Level 2		Level 3
	Fair Value Hierarchy
December 31, 2023	Level 1		Level 2		Level 3
Liabilities
Contingent liabilities	$	-	$	-	$	5,406,000
Total	$	-	$	-	$	5,406,000

The following table provides a rollforward of all liabilities measured at fair value using Level 3 significant unobservable inputs:

Contingent Liabilities
Balance at December 31, 2023	$	5,406,000
Change in fair value of contingent liabilities		57,000
Balance at September 30, 2024	$	5,463,000

Research and Development Expenses and Accruals

Stock-Based Compensation

New Accounting Standards and Updates from the Securities and Exchange Commission

LEASES

9 Months Ended

Sep. 30, 2024

Leases

LEASES

NOTE 4 – LEASES

The total rent expense for the three and nine months ended September 30, 2024 was $129,416 and $290,474, respectively (September 30, 2023 – $81,502 and $274,004, respectively).

The following table summarizes supplemental condensed consolidated balance sheet information related to the operating leases as of September 30, 2024, and December 31, 2023:


	September 30, 2024		December 31, 2023
Operating lease right-of-use assets	$	797,405	$	1,101,211

Operating lease liabilities, current	$	442,221	$	434,082
Operating lease liabilities, non-current		355,184		667,129
Total operating lease liabilities	$	797,405	$	1,101,211

As of September 30, 2024, the maturities of the lease liabilities for the periods ending December 31 are as follows:


2024	$	108,521
2025		444,934
2026		266,034
Total lease payments		819,489
Less: Present value discount		(22,084	)
Total	$	797,405

INTANGIBLE ASSETS

9 Months Ended

Sep. 30, 2024

Goodwill and Intangible Assets Disclosure [Abstract]

INTANGIBLE ASSETS

NOTE 5 – INTANGIBLE ASSETS

Krillase

DuraGraft

As part of Somahlution acquisition in 2020, Marizyme purchased $18,170,000 of intangible assets related to the DuraGraft® technology.

My Health Logic

	September 30, 2024
	Gross Carrying Amount		Accumulated Amortization			Net Carrying Amount
Patents in process	$	122,745	$	-		$	122,745
DuraGraft patent		5,256,000		(1,684,614	)		3,571,386
DuraGraft - Distributor relationship		308,000		(128,333	)		179,667
DuraGraft IPR&D - Cyto Protectant Life Sciences		10,164,000		-			10,164,000
Total intangible assets, net	$	15,850,745	$	(1,812,947	)	$	14,037,798

	December 31, 2023
	Gross Carrying Amount		Accumulated Amortization			Impairment			Net Carrying Amount
Krillase intangible assets	$	4,250,000	$	-		$	(4,250,000	)	$	-
Patents in process		122,745		-			-			122,745
DuraGraft patent		5,256,000		(1,381,383	)		-			3,874,617
DuraGraft - Distributor relationship		308,000		(105,233	)		-			202,767
DuraGraft IPR&D - Cyto Protectant Life Sciences		12,606,000		-			(2,442,000	)		10,164,000
My Health Logic - Trade name		450,000		(65,090	)		(384,910	)		-
My Health Logic - Biotechnology		4,600,000		(547,941	)		(4,052,059	)		-
My Health Logic - Software		1,550,000		(209,249	)		(1,340,751	)		-
Total intangible assets, net	$	29,142,745	$	(2,308,896	)	$	(12,469,720	)	$	14,364,129

SCHEDULE OF GOODWILL

Goodwill		DuraGraft				My Health Logic				Total
Balance, December 31, 2023 and September 30, 2024		$	5,416,000			$	-			$	5,416,000

The following changes to the Company’s intangible assets had taken place in the periods indicated:

SCHEDULE OF INTANGIBLE ASSETS

Balance, December 31, 2022	$	27,675,020
Impairment		(12,469,720	)
Amortization expense		(841,171	)
Balance, December 31, 2023		14,364,129
Amortization expense		(326,331	)
Balance, September 30, 2024	$	14,037,798

NOTES PAYABLE

9 Months Ended

Sep. 30, 2024

Notes Payable

NOTES PAYABLE

NOTE 6 – NOTES PAYABLE

CONVERTIBLE PROMISSORY NOTES AND WARRANTS

9 Months Ended

Sep. 30, 2024

Debt Disclosure [Abstract]

CONVERTIBLE PROMISSORY NOTES AND WARRANTS

NOTE 7 - CONVERTIBLE PROMISSORY NOTES AND WARRANTS

In 2023, the Company amended the conversion price of the Convertible Notes and the exercise price of the Class C Warrants to $0.10 per share.

The following table summarizes supplemental balance sheet information related to the convertible notes, net of debt discount outstanding, as of September 30, 2024 and December 31, 2023:

SCHEDULE OF CONVERTIBLE NOTES

Balance, December 31, 2022	$	2,751,633
Issuance costs		-
Debt accretion		-
Settlement of debt		-
Issuance of convertible notes		-
Debt accretion on Original securities		1,835,741
Debt extinguishment		(4,587,374	)
Convertible notes issued - new securities		19,403,385
Debt discount		(344,959	)
Debt interest and accretion on new securities		1,429,646
Mandatory default amount		6,835,105
Conversion of debt		(9,509,505	)
Extinguishment of debt		(10,276,925	)
Convertible notes issued with extended maturity date		8,791,729
Balance, December 31, 2023		16,328,476
Debt interest and accretion		1,260,775
Extinguishment of debt		(6,160,552	)
Convertible notes issued with extended maturity date		5,270,001
Balance, September 30, 2024	$	16,698,700

	September 30, 2024			December 31, 2023
Convertible notes - total principal	$	17,272,077		$	17,516,865
Unamortized issuance costs and discount		(573,377	)		(1,188,389	)
Convertible Notes, Net of Debt Discount	$	16,698,700		$	16,328,476

	September 30, 2024		December 31, 2023
Current portion	$	16,698,700	$	16,328,476
Non-current portion		-		-
Convertible Notes, Net of Debt Discount	$	16,698,700	$	16,328,476

2023 Convertible Notes and Warrants

Pursuant to the 2023 OID Units Closings, the Company issued 69,876,060 OID Units in aggregate, for the total proceeds of $5,404,452, net of issuance costs.

The following table summarizes supplemental balance sheet information related to the OID Convertible Notes, net of debt discount outstanding, as of September 30, 2024 and December 31, 2023:

SCHEDULE OF CONVERTIBLE NOTES

OID Convertible Notes, Net of Debt Discount
Balance, December 31, 2022	$	-
Issuance of convertible notes		6,987,606
Issuance cost		(1,583,154	)
Debt discount		(5,404,452	)
Debt accretion		2,694,256
Balance, December 31, 2023		2,694,256
Debt accretion		4,885,930
Extinguishment of debt		(7,264,572	)
Settlement of debt		(109,437	)
Convertible note issued with extended maturity date		6,215,741
Balance, September 30, 2024	$	6,421,918

	September 30, 2024			December 31, 2023
Convertible notes - total principal	$	6,841,769		$	6,987,606
Unamortized issuance costs and discount		(419,851	)		(4,293,350	)
Convertible Notes, Net of Debt Discount	$	6,421,918		$	2,694,256

	September 30, 2024		December 31, 2023
Current portion	$	6,421,918	$	2,694,256
Non-current portion		-		-
Convertible Notes, Net of Debt Discount	$	6,421,918	$	2,694,256

2023 Convertible Notes Terms

2023 Warrants Terms

STOCKHOLDERS’ EQUITY (DEFICIT)

9 Months Ended

Sep. 30, 2024

Equity [Abstract]

STOCKHOLDERS’ EQUITY (DEFICIT)

NOTE 8 – STOCKHOLDERS’ EQUITY (DEFICIT)

a)	*Preferred stock*

b)	*Common stock*

The Company is authorized to issue a total number of 2,000,000,000 shares of common stock with a par value of $0.001.

c)	*Options*

During the three and nine months ended September 30, 2024, the Company granted $Nil (December 31, 2023 – $Nil) share purchase options to directors of the Company.

The summary of option activity for the six months ended September 30, 2024, is as follows:

SCHEDULE OF STOCK OPTION ACTIVITY

	Number of Options			Weighted Average Exercise Price		Weighted Average Contractual Life		Total Intrinsic Value
Outstanding at December 31, 2022		3,925,943		$	1.33		6.06	$	-
Granted/forfeited		-			-		-		-
Outstanding at December 31, 2023		3,925,943			1.33		5.06		-
Forfeited		(211,667	)		1.64		-		-
Expired		(1,168,333	)		1.08		-
Outstanding at September 30, 2024		2,545,943			1.42		6.07		-
Exercisable at September 30, 2024		2,485,943		$	1.41		6.04	$	-

As of September 30, 2024, the Company had the following options outstanding:

Exercise Price		Number of Options Outstanding		Number of Options Exercisable		Weighted Average Remaining Contractual Years		Intrinsic Value
$	1.01		890,943		890,943		4.55	$	-
	1.25		415,000		415,000		6.40		-
	1.37		200,000		200,000		5.88		-
	1.75		800,000		770,000		7.16		-
	2.20		240,000		210,000		7.69		-
$	1.44		2,545,943		2,485,943		6.07	$	-

d)	*Restricted share units*

The following performance conditions attached to the restricted share awards were achieved:

	●	The Company will raise financing for the gross proceeds that equal or exceed $5,000,000, and
	●	The Company will complete valuation reports for acquisition of Somahlution and My Health Logic.

e)	*Warrants*

As of September 30, 2024 and December 31, 2023, there were 633,542,434 and 636,483,634 warrants outstanding, respectively.

SCHEDULE OF WARRANTS OUTSTANDING

	Number			Weighted Average Price
Balance, December 31, 2022		20,048,497		$	2.64
Warrants modified pursuant to debt extinguishment (Note 7)		355,577,447			0.1
Issued pursuant to debt agreements (Note 7)		183,560,497			0.15
Issued		79,949,352			0.11
Exercised		(2,652,159	)		0.1
Balance, December 31, 2023		636,483,634		$	0.12
Cancelled		(2,941,200	)		0.15
Balance, September 30, 2024		633,542,434		$	0.12

f)	*Stock-based compensation*

RELATED PARTY TRANSACTIONS

9 Months Ended

Sep. 30, 2024

RELATED PARTY TRANSACTIONS

NOTE 9 – RELATED PARTY TRANSACTIONS

At September 30, 2024, the Company owed an aggregate of $302,900 (December 31, 2023 - $230,153) to related parties of the Company.

COMMITMENTS AND CONTINGENCIES

9 Months Ended

Sep. 30, 2024

Commitments and Contingencies Disclosure [Abstract]

COMMITMENTS AND CONTINGENCIES

NOTE 10 – COMMITMENTS AND CONTINGENCIES

Contingencies

Royalties on U.S. sales equal to:

	●	5% on the first $50,000,000 of net sales,
	●	4% on net sales of $50,000,001 up to $200,000,000, and
	●	2% on net sales over $200,000,000.

Royalties on sales outside of the U.S.:

	●	6% on the first $50,000,000 of net sales,
	●	4% on net sales of $50,000,001 up to $200,000,000, and
	●	2% on net sales over $200,000,000.

	●	Issue performance warrants with a strike price determined based on the average of the closing prices of the Company’s common stock for the 30 calendar days following the date of the public announcement of the FDA approval; and
	●	Upon liquidation of all or substantially all of the assets relating to DuraGraft, the Company will pay 15% of the net sale proceeds up to $20 million.

The Company has entered into arrangements for office and laboratories spaces. As of September 30, 2024, minimum lease payments in relation to lease commitments are payable as described in Note 4.

AGREEMENT OBLIGATION

9 Months Ended

Sep. 30, 2024

Agreement Obligation

AGREEMENT OBLIGATION

NOTE 11 – AGREEMENT OBLIGATION

As part of the agreement, the Company established a wholly owned subsidiary, DuraGraft, during the nine months ended September 30, 2024, to facilitate the product’s commercialization.

RESTATEMENT OF PREVIOUSLY ISSUED UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

9 Months Ended

Sep. 30, 2024

Accounting Changes and Error Corrections [Abstract]

RESTATEMENT OF PREVIOUSLY ISSUED UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 12 – RESTATEMENT OF PREVIOUSLY ISSUED UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

The errors resulted from a material weakness in the proper technical analysis of debt/equity transactions.

The restatements for the Company’s previously issued financial statements as of and for the quarterly periods ended March 31, 2024 and June 30, 2024, included the following:

	●	A difference between the reacquisition price of the debt and the net carrying amount of the extinguished debt.
	●	In the original filing, this difference between the reacquisition price of the debt and the net carrying amount of the extinguished debt was incorrectly recorded as part of the convertible debt discount to be amortized over the remaining life of the notes.
	●	In the amendments to the previously filed Quarterly Reports on Form 10-Q for the quarters ended March 31, 2024 and June 30, 2024, the difference had been correctly recognized in the other income/expense of the period of extinguishment as loss and identified as a separate line item.

The restatement had no impact on total net cash flows from operating, investing, or financing activities.

Consolidated Balance Sheet – as March 31, 2024

	Originally Reported			Restatement Adjustment			As Restated
	As of March 31, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT
Current portion of Convertible Notes - Units Private Placement	$	15,807,061		$	409,974		$	16,217,035
Current portion of Convertible Notes - OID	$	5,448,468		$	(607,569	)	$	4,840,899
Total current liabilities	$	25,847,800		$	(197,595	)	$	25,650,205
Total liabilities	$	32,402,707		$	(197,595	)	$	32,205,112

Stockholders’ deficit:
Additional paid-in capital	$	146,598,185		$	3,560,213		$	150,158,398
Accumulated deficit	$	(157,562,641	)	$	(3,362,618	)	$	(160,925,259	)

Consolidated Statement of Operations and Comprehensive Loss - Three Months Ended March 31, 2024

	Originally Reported			Restatement Adjustment			As Restated
	Three months ended March 31, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
Interest and accretion expenses	$	(4,161,830	)	$	1,427,891		$	(2,733,939	)
Loss on debt extinguishment	$	(107,370	)	$	(598,089	)	$	(705,459	)
Total other income (expense)	$	(4,854,200	)	$	829,802		$	(4,024,398	)
Net loss	$	(6,226,292	)	$	829,802		$	(5,396,490	)
Loss per share – basic and diluted	$	(0.05	)	$	0.01		$	(0.04	)

Consolidated Statement of Stockholders’ Deficit – Three Months Ended March 31, 2024

	Originally Reported			Restatement Adjustment			As Restated
	Three month ended March 31, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
Increase of fair value of warrants in debt extinguishment	$	-		$	(1,407,934	)	$	(1,407,934	)
Net loss	$	(6,226,292	)	$	829,802		$	(5,396,490	)
Total stockholders’ deficit	$	(10,832,664	)	$	197,595		$	(10,635,069	)

Consolidated Statement of Cash Flows – Three Months Ended March 31, 2024

	Originally Reported			Restatement Adjustment			As Restated
	Three months ended March 31, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
Net loss	$	(6,226,292	)	$	829,802		$	(5,396,490	)
Interest and accretion on convertible notes and notes payable	$	4,161,830		$	(1,427,891	)	$	2,733,939
Loss on debt extinguishment	$	107,370		$	598,089		$	705,459

Consolidated Balance Sheet – as June 30, 2024

	Originally Reported			Restatement Adjustment			As Restated
	As of June 30, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT
Current portion of Convertible Notes - Units Private Placement	$	17,022,717		$	(482,186	)	$	16,540,531
Current portion of Convertible Notes - OID	$	990,636		$	5,055,776		$	6,046,412
Total current liabilities	$	23,551,638		$	4,573,590		$	28,125,228
Total liabilities	$	30,914,541		$	4,573,590		$	35,488,131

Stockholders’ deficit:
Additional paid-in capital	$	152,123,457		$	2,152,278		$	154,275,735
Accumulated deficit	$	(161,635,217	)	$	(6,725,868	)	$	(168,361,085	)

Consolidated Statement of Operations and Comprehensive Loss - Three Months Ended June 30, 2024

	Originally Reported			Restatement Adjustment			As Restated
	Three months ended June 30, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
Interest and accretion expenses	$	(2,938,416	)	$	546,735		$	(2,391,681	)
Gain (loss) on debt extinguishment	$	667,200		$	(3,909,985	)	$	(3,242,785	)
Total other income (expense)	$	(2,483,216	)	$	(3,363,250	)	$	(5,846,466	)
Net loss	$	(4,072,576	)	$	(3,363,250	)	$	(7,435,826	)
Loss per share – basic and diluted	$	(0.03	)	$	(0.03	)	$	(0.06	)

Consolidated Statement of Stockholders’ Deficit – Three Months Ended June 30, 2024

	Originally Reported			Restatement Adjustment			As Restated
	Three months ended June 30, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
Increase of fair value of warrants in debt extinguishment	$	-		$	4,075,749		$	4,075,749
Modification of warrants	$	5,483,684		$	(5,483,684	)		-
Net loss	$	(4,072,576	)	$	(3,363,250	)	$	(7,435,826	)
Total stockholders’ deficit	$	(9,379,968	)	$	(4,573,590	)	$	(13,953,558	)

Consolidated Statement of Operations and Comprehensive Loss - Six Months Ended June 30, 2024

	Originally Reported			Restatement Adjustment			As Restated
	Six months ended June 30, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
Interest and accretion expenses	$	(7,100,246	)	$	1,974,626		$	(5,125,620	)
Gain on debt extinguishment	$	559,830		$	(4,508,074	)	$	(3,948,244	)
Total other income (expense)	$	(7,337,416	)	$	(2,533,448	)	$	(9,870,864	)
Net loss	$	(10,298,868	)	$	(2,533,448	)	$	(12,832,316	)
Loss per share – basic and diluted	$	(0.08	)	$	(0.02	)	$	(0.10	)

Consolidated Statement of Stockholders’ Deficit – Six Months Ended June 30, 2024

	Originally Reported			Restatement Adjustment			As Restated
	Six months ended June 30, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
Increase of fair value of warrants in debt extinguishment	$	-		$	5,483,683		$	5,483,683
Modification of warrants	$	5,483,684		$	(5,483,684	)		-
Net loss	$	(10,298,868	)	$	(2,533,448	)	$	(12,832,316	)
Total stockholders’ deficit	$	(9,379,968	)	$	(4,573,590	)	$	(13,953,558	)

Consolidated Statement of Cash Flows – Six Months Ended June 30, 2024

	Originally Reported			Restatement Adjustment			As Restated
	Six months ended June 30, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
Net loss	$	(10,298,868	)	$	(2,533,448	)	$	(12,832,316	)
Interest and accretion on convertible notes and notes payable	$	7,100,246		$	(1,974,626	)	$	5,125,620
Gain (loss) on debt extinguishment	$	(559,830	)	$	4,508,074		$	3,948,244

SUBSEQUENT EVENTS

9 Months Ended

Sep. 30, 2024

Subsequent Events [Abstract]

SUBSEQUENT EVENTS

NOTE 13 - SUBSEQUENT EVENTS

	1)	During the final quarter of the fiscal year ended December 31, 2024, the Company extended the maturity date of three OID Convertible Notes, originally maturing on December 21, 2024, by one year. Additionally, the maturity of the detachable warrants associated with these OID Convertible Notes was extended by two years.

	2)	During the final quarter of the fiscal year ended December 31, 2024, the Company repaid a short-term loan under a note payable to Dr. Vithalbhai Dhaduk, with a principal amount of $52,000. The note was non-interest bearing.

	3)	In December 2024, the Company secured additional funding totaling $707,404 from Qualigen Therapeutics, Inc. through a promissory note bearing an annual interest rate of 18%. These notes are payable on demand and represent an independent agreement, separate from the existing Funding Agreement with Qualigen Therapeutics, Inc.

	4)	On January 21, 2025, the Company terminated an employment agreement with Catherine Pachuk, the Chief Scientific Officer and Executive Vice President of the Company.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

9 Months Ended

Sep. 30, 2024

Accounting Policies [Abstract]

Basis of Presentation and Principles of Consolidation

Basis of Presentation and Principles of Consolidation

Use of Estimates

Use of Estimates

Fair Value Measurements

Fair Value Measurements

●	Level 1 – Quoted prices for identical assets or liabilities in active markets.
●	Level 2 – Quoted prices for identical or similar assets and liabilities in markets that are not active; or other model-derived valuations whose inputs are directly or indirectly observable or whose significant value drivers are observable.
●	Level 3 – Valuations derived from valuation techniques in which one or more significant inputs to the valuation model are unobservable and for which assumptions are used based on management estimates.

Contingent Liabilities

Contingent Liabilities

	i.	The performance warrants and pediatric vouchers warrants liabilities were valued using a Monte Carlo simulation model utilizing the following weighted average assumptions: risk free rate of 1.19%, expected volatility of 69.62%, expected dividend of $Nil, and expected life of 5.96 years. For the three and nine months ended September 30, 2024, changes in these assumptions resulted in a $31,000 decrease and $171,000 decrease in fair value of these liabilities, respectively (September 30, 2023 – $406,000 increase and $800,000 decrease, respectively). At September 30, 2024, the fair market value of performance warrants and pediatric vouchers warrants liabilities was $54,000 (December 31, 2023 – $225,000).

	ii.	The present value of royalty payments was measured using the scenario-based methodology. In assessing the value attributed to the royalty payments, the estimated future cash flows were discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the revenue from net sales of the product. The cash flows derived from the Company’s fifteen-year strategic plan are based on managements’ expectations of market growth, industry reports and trends, and past performances. These projections are inherently uncertain due to the evolving impact of the COVID-19 pandemic. The discounted cash flow model included projections surrounding revenue, discount rates, and growth rates. The discount rates used to calculate the present value of royalty payments reflect specific risks of the Company and market conditions and the mid-range was estimated at 20.6%. For the three and nine months ended September 30, 2024, changes in these assumptions resulted in a $409,000 decrease and $228,000 increase in fair value of this liability, respectively (September 30, 2023 – $1,262,000 and $466,000 increase in fair value of this liability, respectively). At September 30, 2024, the fair market value of royalty payments was $3,586,000 (December 31, 2023 – $3,358,000).

	iii.	Rare pediatric voucher sales liability was valued based on the scenario-based methodology where the estimated future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset – 20.6%. The rare pediatric voucher could only be applied for medical devices prior to receiving U.S. Food and Drug Administration (“FDA”) approval. However, because DuraGraft received FDA approval in late 2023, obtaining the rare pediatric voucher is no longer possible. Therefore, as of December 31, 2023, the fair market value of rare pediatric vouchers was $Nil, and there has been no change in the fair market value during the three and nine months ended September 30, 2024.

	iv.	The present value of liquidation preference liability, included in the contingent consideration, was determined using the Black-Scholes option pricing method and represents the fair value of the maximum payment amount according to the agreement. The following assumptions were used in the Black-Scholes option pricing model: risk free rate of 0.21%, expected volatility of 78.93%, expected dividend of $Nil, and expected life of 5 years. No changes to the fair value of liquidation preference liability were recorded in the three and nine months ended September 30, 2024 and 2023. At September 30, 2024, the fair market value of liquidation preference was $1,823,000 (December 31, 2023 – $1,823,000).

Warrants

Warrants

Goodwill, Intangible Assets and Impairment

Goodwill, Intangible Assets and Impairment

September 30, 2024	Level 1		Level 2		Level 3
	Fair Value Hierarchy
September 30, 2024	Level 1		Level 2		Level 3
Liabilities
Contingent liabilities	$	-	$	-	$	5,463,000
Total	$	-	$	-	$	5,463,000

December 31, 2023	Level 1		Level 2		Level 3
	Fair Value Hierarchy
December 31, 2023	Level 1		Level 2		Level 3
Liabilities
Contingent liabilities	$	-	$	-	$	5,406,000
Total	$	-	$	-	$	5,406,000

The following table provides a rollforward of all liabilities measured at fair value using Level 3 significant unobservable inputs:

Contingent Liabilities
Balance at December 31, 2023	$	5,406,000
Change in fair value of contingent liabilities		57,000
Balance at September 30, 2024	$	5,463,000

Research and Development Expenses and Accruals

Research and Development Expenses and Accruals

Stock-Based Compensation

Stock-Based Compensation

New Accounting Standards and Updates from the Securities and Exchange Commission

New Accounting Standards and Updates from the Securities and Exchange Commission

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)

9 Months Ended

Sep. 30, 2024

Accounting Policies [Abstract]

SCHEDULE OF FAIR VALUES OF FINANCIAL INSTRUMENTS

September 30, 2024	Level 1		Level 2		Level 3
	Fair Value Hierarchy
September 30, 2024	Level 1		Level 2		Level 3
Liabilities
Contingent liabilities	$	-	$	-	$	5,463,000
Total	$	-	$	-	$	5,463,000

December 31, 2023	Level 1		Level 2		Level 3
	Fair Value Hierarchy
December 31, 2023	Level 1		Level 2		Level 3
Liabilities
Contingent liabilities	$	-	$	-	$	5,406,000
Total	$	-	$	-	$	5,406,000

SCHEDULE OF LIABILITIES FAIR VALUE MEASURED

The following table provides a rollforward of all liabilities measured at fair value using Level 3 significant unobservable inputs:

Contingent Liabilities
Balance at December 31, 2023	$	5,406,000
Change in fair value of contingent liabilities		57,000
Balance at September 30, 2024	$	5,463,000

LEASES (Tables)

9 Months Ended

Sep. 30, 2024

Leases

SCHEDULE OF RIGHT-OF-USE ASSET AND RELATED LEASE LIABILITIES

The following table summarizes supplemental condensed consolidated balance sheet information related to the operating leases as of September 30, 2024, and December 31, 2023:


	September 30, 2024		December 31, 2023
Operating lease right-of-use assets	$	797,405	$	1,101,211

Operating lease liabilities, current	$	442,221	$	434,082
Operating lease liabilities, non-current		355,184		667,129
Total operating lease liabilities	$	797,405	$	1,101,211

SCHEDULE OF MATURITIES OF LEASE LIABILITIES

As of September 30, 2024, the maturities of the lease liabilities for the periods ending December 31 are as follows:


2024	$	108,521
2025		444,934
2026		266,034
Total lease payments		819,489
Less: Present value discount		(22,084	)
Total	$	797,405

INTANGIBLE ASSETS (Tables)

9 Months Ended

Sep. 30, 2024

Goodwill and Intangible Assets Disclosure [Abstract]

SCHEDULE OF INTANGIBLE ASSETS AMORTIZATION EXPENSE

	September 30, 2024
	Gross Carrying Amount		Accumulated Amortization			Net Carrying Amount
Patents in process	$	122,745	$	-		$	122,745
DuraGraft patent		5,256,000		(1,684,614	)		3,571,386
DuraGraft - Distributor relationship		308,000		(128,333	)		179,667
DuraGraft IPR&D - Cyto Protectant Life Sciences		10,164,000		-			10,164,000
Total intangible assets, net	$	15,850,745	$	(1,812,947	)	$	14,037,798

	December 31, 2023
	Gross Carrying Amount		Accumulated Amortization			Impairment			Net Carrying Amount
Krillase intangible assets	$	4,250,000	$	-		$	(4,250,000	)	$	-
Patents in process		122,745		-			-			122,745
DuraGraft patent		5,256,000		(1,381,383	)		-			3,874,617
DuraGraft - Distributor relationship		308,000		(105,233	)		-			202,767
DuraGraft IPR&D - Cyto Protectant Life Sciences		12,606,000		-			(2,442,000	)		10,164,000
My Health Logic - Trade name		450,000		(65,090	)		(384,910	)		-
My Health Logic - Biotechnology		4,600,000		(547,941	)		(4,052,059	)		-
My Health Logic - Software		1,550,000		(209,249	)		(1,340,751	)		-
Total intangible assets, net	$	29,142,745	$	(2,308,896	)	$	(12,469,720	)	$	14,364,129

SCHEDULE OF GOODWILL

Goodwill		DuraGraft				My Health Logic				Total
Balance, December 31, 2023 and September 30, 2024		$	5,416,000			$	-			$	5,416,000

SCHEDULE OF INTANGIBLE ASSETS

The following changes to the Company’s intangible assets had taken place in the periods indicated:

SCHEDULE OF INTANGIBLE ASSETS

Balance, December 31, 2022	$	27,675,020
Impairment		(12,469,720	)
Amortization expense		(841,171	)
Balance, December 31, 2023		14,364,129
Amortization expense		(326,331	)
Balance, September 30, 2024	$	14,037,798

CONVERTIBLE PROMISSORY NOTES AND WARRANTS (Tables)

9 Months Ended

Sep. 30, 2024

Short-Term Debt [Line Items]

SCHEDULE OF CONVERTIBLE NOTES

The following table summarizes supplemental balance sheet information related to the convertible notes, net of debt discount outstanding, as of September 30, 2024 and December 31, 2023:

SCHEDULE OF CONVERTIBLE NOTES

Balance, December 31, 2022	$	2,751,633
Issuance costs		-
Debt accretion		-
Settlement of debt		-
Issuance of convertible notes		-
Debt accretion on Original securities		1,835,741
Debt extinguishment		(4,587,374	)
Convertible notes issued - new securities		19,403,385
Debt discount		(344,959	)
Debt interest and accretion on new securities		1,429,646
Mandatory default amount		6,835,105
Conversion of debt		(9,509,505	)
Extinguishment of debt		(10,276,925	)
Convertible notes issued with extended maturity date		8,791,729
Balance, December 31, 2023		16,328,476
Debt interest and accretion		1,260,775
Extinguishment of debt		(6,160,552	)
Convertible notes issued with extended maturity date		5,270,001
Balance, September 30, 2024	$	16,698,700

SCHEDULE OF CONVERTIBLE NOTES NET OF DEBT DISCOUNT

	September 30, 2024			December 31, 2023
Convertible notes - total principal	$	17,272,077		$	17,516,865
Unamortized issuance costs and discount		(573,377	)		(1,188,389	)
Convertible Notes, Net of Debt Discount	$	16,698,700		$	16,328,476

	September 30, 2024		December 31, 2023
Current portion	$	16,698,700	$	16,328,476
Non-current portion		-		-
Convertible Notes, Net of Debt Discount	$	16,698,700	$	16,328,476

OID Convertible Notes [Member]

Short-Term Debt [Line Items]

SCHEDULE OF CONVERTIBLE NOTES

The following table summarizes supplemental balance sheet information related to the OID Convertible Notes, net of debt discount outstanding, as of September 30, 2024 and December 31, 2023:

SCHEDULE OF CONVERTIBLE NOTES

OID Convertible Notes, Net of Debt Discount
Balance, December 31, 2022	$	-
Issuance of convertible notes		6,987,606
Issuance cost		(1,583,154	)
Debt discount		(5,404,452	)
Debt accretion		2,694,256
Balance, December 31, 2023		2,694,256
Debt accretion		4,885,930
Extinguishment of debt		(7,264,572	)
Settlement of debt		(109,437	)
Convertible note issued with extended maturity date		6,215,741
Balance, September 30, 2024	$	6,421,918

SCHEDULE OF CONVERTIBLE NOTES NET OF DEBT DISCOUNT

	September 30, 2024			December 31, 2023
Convertible notes - total principal	$	6,841,769		$	6,987,606
Unamortized issuance costs and discount		(419,851	)		(4,293,350	)
Convertible Notes, Net of Debt Discount	$	6,421,918		$	2,694,256

	September 30, 2024		December 31, 2023
Current portion	$	6,421,918	$	2,694,256
Non-current portion		-		-
Convertible Notes, Net of Debt Discount	$	6,421,918	$	2,694,256

STOCKHOLDERS’ EQUITY (DEFICIT) (Tables)

9 Months Ended

Sep. 30, 2024

Equity [Abstract]

SCHEDULE OF STOCK OPTION ACTIVITY

The summary of option activity for the six months ended September 30, 2024, is as follows:

SCHEDULE OF STOCK OPTION ACTIVITY

	Number of Options			Weighted Average Exercise Price		Weighted Average Contractual Life		Total Intrinsic Value
Outstanding at December 31, 2022		3,925,943		$	1.33		6.06	$	-
Granted/forfeited		-			-		-		-
Outstanding at December 31, 2023		3,925,943			1.33		5.06		-
Forfeited		(211,667	)		1.64		-		-
Expired		(1,168,333	)		1.08		-
Outstanding at September 30, 2024		2,545,943			1.42		6.07		-
Exercisable at September 30, 2024		2,485,943		$	1.41		6.04	$	-

SCHEDULE OF OPTIONS OUTSTANDING AND EXERCISABLE

As of September 30, 2024, the Company had the following options outstanding:

Exercise Price		Number of Options Outstanding		Number of Options Exercisable		Weighted Average Remaining Contractual Years		Intrinsic Value
$	1.01		890,943		890,943		4.55	$	-
	1.25		415,000		415,000		6.40		-
	1.37		200,000		200,000		5.88		-
	1.75		800,000		770,000		7.16		-
	2.20		240,000		210,000		7.69		-
$	1.44		2,545,943		2,485,943		6.07	$	-

SCHEDULE OF WARRANTS OUTSTANDING

	Number			Weighted Average Price
Balance, December 31, 2022		20,048,497		$	2.64
Warrants modified pursuant to debt extinguishment (Note 7)		355,577,447			0.1
Issued pursuant to debt agreements (Note 7)		183,560,497			0.15
Issued		79,949,352			0.11
Exercised		(2,652,159	)		0.1
Balance, December 31, 2023		636,483,634		$	0.12
Cancelled		(2,941,200	)		0.15
Balance, September 30, 2024		633,542,434		$	0.12

RESTATEMENT OF PREVIOUSLY ISSUED UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Tables)

9 Months Ended

Sep. 30, 2024

Accounting Changes and Error Corrections [Abstract]

SCHEDULE OF RESTATEMENT FINANCIAL STATEMENTS

The restatement had no impact on total net cash flows from operating, investing, or financing activities.

Consolidated Balance Sheet – as March 31, 2024

	Originally Reported			Restatement Adjustment			As Restated
	As of March 31, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT
Current portion of Convertible Notes - Units Private Placement	$	15,807,061		$	409,974		$	16,217,035
Current portion of Convertible Notes - OID	$	5,448,468		$	(607,569	)	$	4,840,899
Total current liabilities	$	25,847,800		$	(197,595	)	$	25,650,205
Total liabilities	$	32,402,707		$	(197,595	)	$	32,205,112

Stockholders’ deficit:
Additional paid-in capital	$	146,598,185		$	3,560,213		$	150,158,398
Accumulated deficit	$	(157,562,641	)	$	(3,362,618	)	$	(160,925,259	)

Consolidated Statement of Operations and Comprehensive Loss - Three Months Ended March 31, 2024

	Originally Reported			Restatement Adjustment			As Restated
	Three months ended March 31, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
Interest and accretion expenses	$	(4,161,830	)	$	1,427,891		$	(2,733,939	)
Loss on debt extinguishment	$	(107,370	)	$	(598,089	)	$	(705,459	)
Total other income (expense)	$	(4,854,200	)	$	829,802		$	(4,024,398	)
Net loss	$	(6,226,292	)	$	829,802		$	(5,396,490	)
Loss per share – basic and diluted	$	(0.05	)	$	0.01		$	(0.04	)

Consolidated Statement of Stockholders’ Deficit – Three Months Ended March 31, 2024

	Originally Reported			Restatement Adjustment			As Restated
	Three month ended March 31, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
Increase of fair value of warrants in debt extinguishment	$	-		$	(1,407,934	)	$	(1,407,934	)
Net loss	$	(6,226,292	)	$	829,802		$	(5,396,490	)
Total stockholders’ deficit	$	(10,832,664	)	$	197,595		$	(10,635,069	)

Consolidated Statement of Cash Flows – Three Months Ended March 31, 2024

	Originally Reported			Restatement Adjustment			As Restated
	Three months ended March 31, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
Net loss	$	(6,226,292	)	$	829,802		$	(5,396,490	)
Interest and accretion on convertible notes and notes payable	$	4,161,830		$	(1,427,891	)	$	2,733,939
Loss on debt extinguishment	$	107,370		$	598,089		$	705,459

Consolidated Balance Sheet – as June 30, 2024

	Originally Reported			Restatement Adjustment			As Restated
	As of June 30, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT
Current portion of Convertible Notes - Units Private Placement	$	17,022,717		$	(482,186	)	$	16,540,531
Current portion of Convertible Notes - OID	$	990,636		$	5,055,776		$	6,046,412
Total current liabilities	$	23,551,638		$	4,573,590		$	28,125,228
Total liabilities	$	30,914,541		$	4,573,590		$	35,488,131

Stockholders’ deficit:
Additional paid-in capital	$	152,123,457		$	2,152,278		$	154,275,735
Accumulated deficit	$	(161,635,217	)	$	(6,725,868	)	$	(168,361,085	)

Consolidated Statement of Operations and Comprehensive Loss - Three Months Ended June 30, 2024

	Originally Reported			Restatement Adjustment			As Restated
	Three months ended June 30, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
Interest and accretion expenses	$	(2,938,416	)	$	546,735		$	(2,391,681	)
Gain (loss) on debt extinguishment	$	667,200		$	(3,909,985	)	$	(3,242,785	)
Total other income (expense)	$	(2,483,216	)	$	(3,363,250	)	$	(5,846,466	)
Net loss	$	(4,072,576	)	$	(3,363,250	)	$	(7,435,826	)
Loss per share – basic and diluted	$	(0.03	)	$	(0.03	)	$	(0.06	)

Consolidated Statement of Stockholders’ Deficit – Three Months Ended June 30, 2024

	Originally Reported			Restatement Adjustment			As Restated
	Three months ended June 30, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
Increase of fair value of warrants in debt extinguishment	$	-		$	4,075,749		$	4,075,749
Modification of warrants	$	5,483,684		$	(5,483,684	)		-
Net loss	$	(4,072,576	)	$	(3,363,250	)	$	(7,435,826	)
Total stockholders’ deficit	$	(9,379,968	)	$	(4,573,590	)	$	(13,953,558	)

Consolidated Statement of Operations and Comprehensive Loss - Six Months Ended June 30, 2024

	Originally Reported			Restatement Adjustment			As Restated
	Six months ended June 30, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
Interest and accretion expenses	$	(7,100,246	)	$	1,974,626		$	(5,125,620	)
Gain on debt extinguishment	$	559,830		$	(4,508,074	)	$	(3,948,244	)
Total other income (expense)	$	(7,337,416	)	$	(2,533,448	)	$	(9,870,864	)
Net loss	$	(10,298,868	)	$	(2,533,448	)	$	(12,832,316	)
Loss per share – basic and diluted	$	(0.08	)	$	(0.02	)	$	(0.10	)

Consolidated Statement of Stockholders’ Deficit – Six Months Ended June 30, 2024

	Originally Reported			Restatement Adjustment			As Restated
	Six months ended June 30, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
Increase of fair value of warrants in debt extinguishment	$	-		$	5,483,683		$	5,483,683
Modification of warrants	$	5,483,684		$	(5,483,684	)		-
Net loss	$	(10,298,868	)	$	(2,533,448	)	$	(12,832,316	)
Total stockholders’ deficit	$	(9,379,968	)	$	(4,573,590	)	$	(13,953,558	)

Consolidated Statement of Cash Flows – Six Months Ended June 30, 2024

	Originally Reported			Restatement Adjustment			As Restated
	Six months ended June 30, 2024 (Unaudited)
	Originally Reported			Restatement Adjustment			As Restated
Net loss	$	(10,298,868	)	$	(2,533,448	)	$	(12,832,316	)
Interest and accretion on convertible notes and notes payable	$	7,100,246		$	(1,974,626	)	$	5,125,620
Gain (loss) on debt extinguishment	$	(559,830	)	$	4,508,074		$	3,948,244

GOING CONCERN (Details Narrative) - USD ($)	1 Months Ended
GOING CONCERN (Details Narrative) - USD ($)	Jul. 31, 2024	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Dec. 31, 2023
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Accumulated deficit		$ (170,320,946)	$ (168,361,085)	$ (160,925,259)	$ (155,528,769)
Working capital		(29,122,609)			(21,673,945)
Cash		63,732			$ 148,465
Short-term loans		$ 1,027,400
Co-Development Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Investment capital	$ 1,250,000

SCHEDULE OF FAIR VALUES OF FINANCIAL INSTRUMENTS (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Platform Operator, Crypto Asset [Line Items]
Contingent liabilities	$ 5,463,000	$ 5,406,000
Fair Value, Inputs, Level 1 [Member]
Platform Operator, Crypto Asset [Line Items]
Contingent liabilities
Total
Fair Value, Inputs, Level 2 [Member]
Platform Operator, Crypto Asset [Line Items]
Contingent liabilities
Total
Fair Value, Inputs, Level 3 [Member]
Platform Operator, Crypto Asset [Line Items]
Contingent liabilities	5,463,000	5,406,000
Total	$ 5,463,000	$ 5,406,000

SCHEDULE OF LIABILITIES FAIR VALUE MEASURED (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Platform Operator, Crypto Asset [Line Items]
Change in fair value of contingent liabilities	$ 440,000	$ (1,678,000)	$ (57,000)	$ 312,000
Fair Value, Inputs, Level 3 [Member] \| Derivative and Contingent Liabilities [Member]
Platform Operator, Crypto Asset [Line Items]
Beginning Balance			5,406,000
Change in fair value of contingent liabilities			57,000
Ending Balance	$ 5,463,000		$ 5,463,000

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($)	3 Months Ended			6 Months Ended	9 Months Ended		12 Months Ended
	Sep. 30, 2024	Jun. 30, 2024	Sep. 30, 2023	Jun. 30, 2024	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Midrange average estimated interest rate					20.60%
Liabilities fair value adjustment	$ 409,000		$ 1,262,000		$ 228,000	$ 466,000
Royalty payments					3,586,000		$ 3,358,000
Adjustment of warrants					$ 5,827,782
Goodwill [Member]
Intangible asset percentage	33.80%				33.80%
In Process Research And Development Assets [Member]
Discount rate intangible asset percentage	35.20%				35.20%
Scenario, Adjustment [Member]
Pre tax discount rate percentage					20.60%
Market value
Warrants Liabilities [Member]
Risk free rate					1.19%
Expected volatility					69.62%
Expected dividend
Expected life					5 years 11 months 15 days
Increase (decrease) in operating liabilities	$ 31,000		$ 406,000		$ 171,000	$ 800,000
Warrants liabilities					$ 54,000		225,000
Liquidation Preference [Member]
Risk free rate					0.21%
Expected volatility					78.93%
Expected dividend
Expected life					5 years
Liquidation preference fair market value	1,823,000				$ 1,823,000		$ 1,823,000
OID Convertible Notes [Member]
Risk free rate					4.25%
Expected volatility					349.95%
Expected dividend
Expected life					2 months 1 day
Adjustment of warrants					$ 5,827,782
Convertible notes	$ 4,778,950				$ 4,778,950

SCHEDULE OF RIGHT-OF-USE ASSET AND RELATED LEASE LIABILITIES (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Leases
Operating lease right-of-use assets	$ 797,405	$ 1,101,211
Operating lease liabilities, current	442,221	434,082
Operating lease liabilities, non-current	355,184	667,129
Total operating lease liabilities	$ 797,405	$ 1,101,211

SCHEDULE OF MATURITIES OF LEASE LIABILITIES (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Leases
2024	$ 108,521
2025	444,934
2026	266,034
Total lease payments	819,489
Less: Present value discount	(22,084)
Total	$ 797,405	$ 1,101,211

LEASES (Details Narrative)				1 Months Ended	3 Months Ended		9 Months Ended
LEASES (Details Narrative)	Apr. 01, 2022 USD ($) ft²	Mar. 31, 2022 USD ($)	Dec. 11, 2020 ft²	Dec. 31, 2020 USD ($)	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Lease agreement, description			five-and-a-half-year lease agreement
Administrative office and laboratories space \| ft²			10,300
Payments for rent					$ 129,416	$ 81,502	$ 290,474	$ 274,004
Operating expenses					$ 1,355,030	$ 4,987,756	$ 4,339,690	$ 12,149,448
Operating Lease Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Administrative office and laboratories space \| ft²	3,053
Payments for rent	$ 15,641			$ 10,800
Annually percentage				2.50%			2.50%
Operating expenses				$ 12,000
Increase in operating lease							$ 16,032
Operating lease expense	$ 17,500	$ 12,000
Lease term					1 year 9 months 29 days		1 year 9 months 29 days
Operating lease discount rate					3.95%		3.95%

SCHEDULE OF INTANGIBLE ASSETS AMORTIZATION EXPENSE (Details) - USD ($)	12 Months Ended
	Dec. 31, 2023	Sep. 30, 2024	Dec. 31, 2022
Finite-Lived Intangible Assets [Line Items]
Gross carrying amount	$ 29,142,745	$ 15,850,745
Accumulated amortization	(2,308,896)	(1,812,947)
Net carrying amount	14,364,129	14,037,798	$ 27,675,020
Impairment	(12,469,720)
Patents [Member]
Finite-Lived Intangible Assets [Line Items]
Gross carrying amount	122,745	122,745
Accumulated amortization
Net carrying amount	122,745	122,745
Impairment
DuraGraft Patent [Member]
Finite-Lived Intangible Assets [Line Items]
Gross carrying amount	5,256,000	5,256,000
Accumulated amortization	(1,381,383)	(1,684,614)
Net carrying amount	3,874,617	3,571,386
Impairment
DuraGraft Distributor Relationship [Member]
Finite-Lived Intangible Assets [Line Items]
Gross carrying amount	308,000	308,000
Accumulated amortization	(105,233)	(128,333)
Net carrying amount	202,767	179,667
Impairment
DuraGraft Cyto Protectant [Member]
Finite-Lived Intangible Assets [Line Items]
Gross carrying amount	12,606,000	10,164,000
Accumulated amortization
Net carrying amount	10,164,000	$ 10,164,000
Impairment	(2,442,000)
Krillase Intangible Assets [Member]
Finite-Lived Intangible Assets [Line Items]
Gross carrying amount	4,250,000
Accumulated amortization
Net carrying amount
Impairment	(4,250,000)
My Health Logic - Trade Name [Member]
Finite-Lived Intangible Assets [Line Items]
Gross carrying amount	450,000
Accumulated amortization	(65,090)
Net carrying amount
Impairment	(384,910)
My Health Logic - Biotechnology [Member]
Finite-Lived Intangible Assets [Line Items]
Gross carrying amount	4,600,000
Accumulated amortization	(547,941)
Net carrying amount
Impairment	(4,052,059)
My Health Logic - Software [Member]
Finite-Lived Intangible Assets [Line Items]
Gross carrying amount	1,550,000
Accumulated amortization	(209,249)
Net carrying amount
Impairment	$ (1,340,751)

SCHEDULE OF GOODWILL (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Impairment Effects on Earnings Per Share [Line Items]
Balance	$ 5,416,000	$ 5,416,000
DuraGraft [Member]
Impairment Effects on Earnings Per Share [Line Items]
Balance	5,416,000	5,416,000
My Health Logic [Member]
Impairment Effects on Earnings Per Share [Line Items]
Balance

SCHEDULE OF INTANGIBLE ASSETS (Details) - USD ($)	9 Months Ended	12 Months Ended
SCHEDULE OF INTANGIBLE ASSETS (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Goodwill and Intangible Assets Disclosure [Abstract]
Beginning Balance	$ 14,364,129	$ 27,675,020
Impairment		(12,469,720)
Amortization expense	(326,331)	(841,171)
Ending Balance	$ 14,037,798	$ 14,364,129

INTANGIBLE ASSETS (Details Narrative) - USD ($)	9 Months Ended	12 Months Ended
INTANGIBLE ASSETS (Details Narrative) - USD ($)	Sep. 30, 2024	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020	Sep. 12, 2018
Finite-Lived Intangible Assets [Line Items]
Net carrying amount	$ 14,037,798	$ 14,364,129	$ 27,675,020
Impairment of intangible assets		12,469,720
Impairment of intangible assets		(12,469,720)
Goodwill	5,416,000	5,416,000
DuraGraft and My Health Logic [Member]
Finite-Lived Intangible Assets [Line Items]
2025	435,108
2026	435,108
2027	435,108
2028	435,108
2029	435,108
2030 and thereafter	1,575,512
Krillase Technology [Member]
Finite-Lived Intangible Assets [Line Items]
Business acquition intangibles assets						$ 28,600,000
Net carrying amount
Impairment of intangible assets	0	4,250,000
DuraGraft [Member]
Finite-Lived Intangible Assets [Line Items]
Business acquition intangibles assets					$ 18,170,000
Impairment of intangible assets		2,442,000
Intangible assets impairment	$ 0	14,241,384
My Health Logic, Inc. [Member]
Finite-Lived Intangible Assets [Line Items]
Business acquition intangibles assets				$ 6,600,000
Impairment of intangible assets		5,777,720
Goodwill				$ 1,774,656
Impairment charges, goodwill		$ 1,774,656

NOTES PAYABLE (Details Narrative) - USD ($)					3 Months Ended		9 Months Ended		12 Months Ended
NOTES PAYABLE (Details Narrative) - USD ($)	Oct. 23, 2023	May 30, 2023	Feb. 02, 2023	Dec. 28, 2022	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2022	Jul. 12, 2024	Dec. 31, 2023	Feb. 01, 2023	Nov. 30, 2021
Mr Richamond [Member]
Notes payable					$ 441,000		$ 441,000				$ 151,000
Dr. Vithalbhai Dhaduk [Member]
Notes payable					52,000		52,000
Hexin Promissory Note [Member]
Notes payable				$ 750,000
Interest rate				20.00%
Interest expenses											64,133
Debt outstanding				$ 814,133	47,446		47,446
Conversion units				9,578,040
Hub International Limited [Member]
Notes payable	$ 165,469										130,122
Interest rate	8.00%
Debt instrument, maturity date	Aug. 23, 2024
Walleye Opportunities Master Fund Ltd. [Member]
Notes payable			$ 1,000,000
Debt instrument, maturity date			May 07, 2023
Interest expenses											250,000
Debt outstanding			$ 1,250,000
Conversion units		14,705,890
Notes payable increased			1,250,000
Principal amount			$ 1,250,000									$ 1,000,000
MyHealth Logic Acquisition [Member]
Notes payable													$ 468,137
Interest rate													9.00%
Debt outstanding					264,535		264,535				252,223
Aggregate amount settled									$ 278,678
Debt accrued interest					5,868	$ 5,344	17,010	$ 23,710
Santander Bank Sullivan and Worcester LLP [Member]
Notes payable					515,000		515,000				65,000
Commas International Holding, LLC [Member]
Notes payable					$ 170,000		$ 170,000
Qualigen Therapeutics Inc [Member]
Interest rate										18.00%
Principal amount										$ 1,250,000

SCHEDULE OF CONVERTIBLE NOTES (Details) - USD ($)	9 Months Ended	12 Months Ended
SCHEDULE OF CONVERTIBLE NOTES (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Convertible Notes Payable [Member]
Short-Term Debt [Line Items]
Beginning balance	$ 16,328,476	$ 2,751,633
Issuance costs
Debt accretion
Settlement of debt
Issuance of convertible notes
Debt accretion on Original securities		1,835,741
Debt extinguishment		(4,587,374)
Convertible notes issued - new securities		19,403,385
Debt discount		(344,959)
Debt accretion new sercurities		1,429,646
Mandatory Default Amount		6,835,105
Conversion of debt		(9,509,505)
Extinguishment of debt	(6,160,552)	(10,276,925)
Convertible note issued with extended maturity date		8,791,729
Debt interest and accretion	1,260,775
Convertible notes issued with extended maturity date	5,270,001
Ending balance	16,698,700	16,328,476
OID Convertible Notes [Member]
Short-Term Debt [Line Items]
Beginning balance	2,694,256
Issuance costs		(1,583,154)
Debt accretion	4,885,930	2,694,256
Settlement of debt	109,437
Issuance of convertible notes		6,987,606
Debt discount		5,404,452
Extinguishment of debt	(7,264,572)
Convertible note issued with extended maturity date	6,215,741
Ending balance	$ 6,421,918	$ 2,694,256

SCHEDULE OF CONVERTIBLE NOTES NET OF DEBT DISCOUNT (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023	Dec. 31, 2022
Convertible Notes Payable [Member]
Short-Term Debt [Line Items]
Convertible notes - total principal	$ 17,272,077	$ 17,516,865
Unamortized issuance costs and discount	(573,377)	(1,188,389)
Convertible Notes, Net of Debt Discount	16,698,700	16,328,476	$ 2,751,633
Current portion	16,698,700	16,328,476
Non-current portion
OID Convertible Notes [Member]
Short-Term Debt [Line Items]
Convertible notes - total principal	6,841,769	6,987,606
Unamortized issuance costs and discount	(419,851)	(4,293,350)
Convertible Notes, Net of Debt Discount	6,421,918	2,694,256
Current portion	6,421,918	2,694,256
Non-current portion

CONVERTIBLE PROMISSORY NOTES AND WARRANTS (Details Narrative) - USD ($)		3 Months Ended				6 Months Ended	9 Months Ended		12 Months Ended
	Dec. 11, 2023	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2024	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Short-Term Debt [Line Items]
Shares issued in aggregate									4,207,828	4,180,071	4,260,594
Proceeds from Issuance of Common Stock									$ 344,959	$ 6,500,743	$ 6,692,765
Fair value of warrants								$ 12,666,268	12,666,268
Loss on extinguishment of debt									21,777,877
Convertible debt									$ 9,340,774
Gain loss on debt extinguishment		$ 59,843	$ (3,242,785)	$ (705,459)	$ (80,000)	$ (3,948,244)	(3,888,401)	(21,857,877)
Interest and accretion expenses		433,868			529,596		1,260,775	3,265,387
Loss on issuance of debt					3,974,993			6,352,562
Fair value of warrants							5,827,782
Loss on debt extinguishment
Interest and acceration expenses		613,186			$ 843,699		4,885,930	993,785
Class E Warrant [Member]
Short-Term Debt [Line Items]
Conertible warrants									$ 0.10
Class F Warrant [Member]
Short-Term Debt [Line Items]
Conertible warrants									0.20
OID Convertible Notes [Member]
Short-Term Debt [Line Items]
Debt discount							4,778,950
Fair value of warrants							5,827,782
Convertible notes		4,778,950					4,778,950
Private Placement [Member]
Short-Term Debt [Line Items]
Conertible warrants									$ 0.10
Warrants outstanding									$ 10,000,000
Warrants units									100,000,000
Percentage of original issue discount									15.00%
Warrant purchase percentage									125.00%
Convertible Notes [Member]
Short-Term Debt [Line Items]
Principal amount									$ 1,000,000
Maturity date									May 07, 2023
Mandatory default description									the Company also defaulted under the Convertible Notes on the same date. As the result, the Company accreted a default amount of $6,791,185 to the value of the Convertible Notes in 2023.
Gain loss on debt extinguishment							890,549	$ (21,777,877)
Loss on issuance of debt									$ 6,888,475
OID Convertible Notes [Member]
Short-Term Debt [Line Items]
Principal amount		6,841,769					6,841,769		$ 6,987,606
Conversion into shares									69,876,060
Debt discount									$ 5,404,452
Convertible notes		$ 6,421,918					$ 6,421,918		$ 2,694,256
Convertible Debt [Member]
Short-Term Debt [Line Items]
Shares outstanding									8,269,237
Shares replacement units									190,584,260
2023 Convertible Notes Payable [Member]
Short-Term Debt [Line Items]
Debt instrument conversion description							The OID Convertible Notes mature nine months from the date of the OID Units Initial Closing and accrue 10% of interest per annum on the outstanding principal amount. The OID Convertible Notes are unsecured and subordinated to any senior indebtedness of the Company. The OID Convertible Notes’ principal and accrued interest may generally be converted at any time at a conversion price of $0.10 per share, subject to adjustment, at the option of the holder, into shares of common stock, subject to certain limitations: (i) conversion would not cause the holder to beneficially own more than 4.99% of the Company’s common stock, or more than 9.99% if the holder beneficially owns more than 4.99% of common stock based on ownership of equity securities of the Company other than the OID Convertible Notes or the respective warrants; and (ii) the Company’s articles of incorporation have been amended to increase the number of authorized shares of common stock to a sufficient amount to permit the full conversion of the OID Convertible Notes (the “Capital Event Amendment”).
2023 Warrants Terms [Member]
Short-Term Debt [Line Items]
Class of warrant description							The Class E Warrants and Class F Warrants are generally exercisable for a period from the date of the Capital Event Amendment until five years from the date of issue. The exercise right is subject to a similar beneficial ownership limitation that applies to conversion of the OID Convertible Notes above, i.e., exercise is permitted only if it would not cause the holder to beneficially own more than 4.99% of the Company’s common stock, or more than 9.99% if the holder beneficially owns more than 4.99% of common stock based on ownership of equity securities of the Company other than the OID Convertible Notes or the Class E Warrants and Class F Warrants.
Class C Warrant [Member]
Short-Term Debt [Line Items]
Conertible warrants									$ 0.10
Warrant [Member]
Short-Term Debt [Line Items]
Warrants units		633,542,434					633,542,434		636,483,634
Decrease in fair value of this liability	$ 795,934
Fair value of warrants	$ 11,496,701
Warrant [Member] \| Convertible Notes [Member]
Short-Term Debt [Line Items]
Decrease in fair value of this liability									$ 12,292,635

SCHEDULE OF STOCK OPTION ACTIVITY (Details) - USD ($)	9 Months Ended	12 Months Ended
SCHEDULE OF STOCK OPTION ACTIVITY (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023	Dec. 31, 2022
Equity [Abstract]
Number of Options, Outstanding Beginning Balance	3,925,943	3,925,943
Weighted Average Exercise Price, Outstanding Beginning Balance	$ 1.33	$ 1.33
Weighted average contractual life term, outstanding	6 years 25 days	5 years 21 days	6 years 21 days
Total Intrinsic Value, Beginning balance
Number of Options, Forfeited	(211,667)
Weighted Average Exercise Price, Forfeited	$ 1.64
Number of Options, Expired	(1,168,333)
Weighted Average Exercise Price, Expired	$ 1.08
Number of Options, Outstanding Ending Balance	2,545,943	3,925,943	3,925,943
Weighted Average Exercise Price, Outstanding Ending Balance	$ 1.42	$ 1.33	$ 1.33
Total Intrinsic Value, Ending balance
Number of options, Exercisable	2,485,943
Weighted Average Exercise Price, Exercisable	$ 1.41
Weighted average contractual life term, exercisable	6 years 14 days
Total Intrinsic Value, exercisable

SCHEDULE OF OPTIONS OUTSTANDING AND EXERCISABLE (Details) - USD ($)	9 Months Ended
	Sep. 30, 2024	Dec. 31, 2023	Dec. 31, 2022
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Intrinsic Value
Exercise Price Range 1.01 [Member]
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise Price	$ 1.01
Number of Options Outstanding	890,943
Number of Options Exercisable	890,943
Weighted Average Remaining Contractual Years	4 years 6 months 18 days
Intrinsic Value
Exercise Price Range 1.25 [Member]
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise Price	$ 1.25
Number of Options Outstanding	415,000
Number of Options Exercisable	415,000
Weighted Average Remaining Contractual Years	6 years 4 months 24 days
Intrinsic Value
Exercise Price Range 1.37 [Member]
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise Price	$ 1.37
Number of Options Outstanding	200,000
Number of Options Exercisable	200,000
Weighted Average Remaining Contractual Years	5 years 10 months 17 days
Intrinsic Value
Exercise Price Range 1.75 [Member]
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise Price	$ 1.75
Number of Options Outstanding	800,000
Number of Options Exercisable	770,000
Weighted Average Remaining Contractual Years	7 years 1 month 28 days
Intrinsic Value
Exercise Price Range 2.20 [Member]
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise Price	$ 2.20
Number of Options Outstanding	240,000
Number of Options Exercisable	210,000
Weighted Average Remaining Contractual Years	7 years 8 months 8 days
Intrinsic Value
Exercise Price Range 1.44 [Member]
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise Price	$ 1.44
Number of Options Outstanding	2,545,943
Number of Options Exercisable	2,485,943
Weighted Average Remaining Contractual Years	6 years 25 days
Intrinsic Value

SCHEDULE OF WARRANTS OUTSTANDING (Details) - Warrant [Member] - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2024	Dec. 31, 2023
Accumulated Other Comprehensive Income (Loss) [Line Items]
Warrants, Beginning balance	636,483,634	20,048,497
Weighted Average Price, Warrants outstanding, beginning balance	$ 0.12	$ 2.64
Warrants, Warrants modified pursuant to debt extinguishment		$ 355,577,447
Weighted average exercise price, Warrants modified pursuant to debt extinguishment		$ 0.1
Warrants, issued		79,949,352
Weighted average exercise price, Issued		$ 0.11
Warrants, Exercised		(2,652,159)
Weighted average exercise price, Exercised		$ 0.1
Warrants, Cancelled	(2,941,200)
Weighted average exercise price, Cancelled	$ 0.15
Warrants, Ending balance	633,542,434	636,483,634
Weighted Average Price, Warrants outstanding, Ending balance	$ 0.12	$ 0.12
Debt Agreement [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Warrants, issued		183,560,497
Weighted average exercise price, Issued pursuant to debt agreements		$ 0.15

STOCKHOLDERS’ EQUITY (DEFICIT) (Details Narrative) - USD ($)		3 Months Ended			6 Months Ended	9 Months Ended		12 Months Ended
	Dec. 11, 2023	Sep. 30, 2024	Jun. 30, 2024	Sep. 30, 2023	Jun. 30, 2024	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023	Dec. 31, 2021	Dec. 27, 2022	Dec. 26, 2022	May 18, 2021
Accumulated Other Comprehensive Income (Loss) [Line Items]
Preferred stock, shares authorized		25,000,000				25,000,000		25,000,000
Preferred stock, par value		$ 0.001				$ 0.001		$ 0.001
Preferred stock, shares issued		0				0		0
Preferred stock, shares outstanding		0				0		0
Common stock, shares authorized		2,000,000,000				2,000,000,000		2,000,000,000
Common stock, par value		$ 0.001				$ 0.001		$ 0.001
Common stock, shares issued		131,793,088				131,793,088		131,793,088
Common stock, shares outstanding		131,793,088				131,793,088		131,793,088
Share-based payment award, options, grants in period, gross
Compensation cost		$ 0				$ 0
Gross proceeds from sale of equity						5,000,000
Fair value of warrants						5,827,782
Non-cash share-based compensation		$ 20,794		$ 86,123		116,646	$ 457,860
OID Convertible Notes [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Fair value of warrants						5,827,782
Convertible notes						$ 4,778,950
Warrant [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Purchase of warrants		633,542,434				633,542,434		636,483,634
Fair value of warrants	$ 11,496,701
Directors, Senior Officers and Consultants [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Number of restricted share awards granted									350,000
Stock Incentive Plan [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Share authorized												5,300,000
Number of shares available for issuance		4,304,724				4,304,724		2,924,057		7,200,000	1,900,000

RELATED PARTY TRANSACTIONS (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Related Party Transaction [Line Items]
Professional fees related paty	$ 118,270	$ 921,552	$ 721,042	$ 1,818,202
Related Party [Member]
Related Party Transaction [Line Items]
Related party transactions owned	302,900		302,900		$ 230,153
Professional fees related paty	277,000	404,750	882,000	1,214,250
Outstanding balance for services	302,900		302,900		7,653
Director and Executive Officers [Member]
Related Party Transaction [Line Items]
Professional fees related paty	208,500	257,750	632,500	773,250
Outstanding balance for services	292,500		292,500		222,500
DuraGraft [Member]
Related Party Transaction [Line Items]
Royalties payable		$ 13,014	1,957	$ 211,262
Somahlution [Member]
Related Party Transaction [Line Items]
Decrease in prepaid royalties					151,000
Prepaid royalties	$ 120,500		$ 120,500		$ 122,457

COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)	3 Months Ended	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2024
DuraGraft [Member]
Loss Contingencies [Line Items]
Prepaid royalties		$ 1,957
Sale of asset percentage		15.00%
DuraGraft [Member] \| Maximum [Member]
Loss Contingencies [Line Items]
Net proceeds from sale of asset		$ 20,000,000
UNITED STATES \| First 50,000,000 [Member]
Loss Contingencies [Line Items]
Royalties percentage		5.00%
UNITED STATES \| 50,000,001 up to 200,000,000 [Member]
Loss Contingencies [Line Items]
Royalties percentage		4.00%
UNITED STATES \| Over 200,000,000 [Member]
Loss Contingencies [Line Items]
Royalties percentage		2.00%
Non-US [Member] \| First 50,000,000 [Member]
Loss Contingencies [Line Items]
Royalties percentage		6.00%
Non-US [Member] \| 50,000,001 up to 200,000,000 [Member]
Loss Contingencies [Line Items]
Royalties percentage		4.00%
Non-US [Member] \| Over 200,000,000 [Member]
Loss Contingencies [Line Items]
Royalties percentage		2.00%

AGREEMENT OBLIGATION (Details Narrative) - USD ($)	1 Months Ended	9 Months Ended
AGREEMENT OBLIGATION (Details Narrative) - USD ($)	Apr. 30, 2024	Sep. 30, 2024
Agreement Obligation [Member]
Investment return difference in the amount		$ 500,000
Investment return		$ 1,000,000
Agreement [Member] \| Qualigen Therapeutics Inc [Member]
Payments for fees	$ 200,000
Fund received	$ 500,000
Agreement [Member] \| Qualigen Therapeutics Inc [Member] \| Minimum [Member]
Sales percentage	33.00%
Contractual obligation	$ 500,000

SCHEDULE OF RESTATEMENT CONSOLIDATED BALANCE SHEET (Details) - USD ($)	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Dec. 31, 2023
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Current portion of Convertible Notes - Units Private Placement	$ 16,698,700	$ 16,540,531	$ 16,217,035	$ 16,328,476
Current portion of Convertible Notes - OID	6,421,918	6,046,412	4,840,899	2,694,256
Total current liabilities	29,977,203	28,125,228	25,650,205	22,642,723
Total liabilities	36,795,387	35,488,131	32,205,112	28,715,852
Additional paid-in capital	154,650,064	154,275,735	150,158,398	148,696,200
Accumulated deficit	$ (170,320,946)	(168,361,085)	(160,925,259)	$ (155,528,769)
Previously Reported [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Current portion of Convertible Notes - Units Private Placement		17,022,717	15,807,061
Current portion of Convertible Notes - OID		990,636	5,448,468
Total current liabilities		23,551,638	25,847,800
Total liabilities		30,914,541	32,402,707
Additional paid-in capital		152,123,457	146,598,185
Accumulated deficit		(161,635,217)	(157,562,641)
Revision of Prior Period, Reclassification, Adjustment [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Current portion of Convertible Notes - Units Private Placement		(482,186)	409,974
Current portion of Convertible Notes - OID		5,055,776	(607,569)
Total current liabilities		4,573,590	(197,595)
Total liabilities		4,573,590	(197,595)
Additional paid-in capital		2,152,278	3,560,213
Accumulated deficit		$ (6,725,868)	$ (3,362,618)

SCHEDULE OF RESTATEMENT CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS (Details) - USD ($)	3 Months Ended						6 Months Ended	9 Months Ended
	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Jun. 30, 2024	Sep. 30, 2024	Sep. 30, 2023
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Interest and accretion expenses	$ (1,104,674)	$ (2,391,681)	$ (2,733,939)	$ (1,502,088)			$ (5,125,620)	$ (6,230,294)	$ (11,038,400)
Gain on debt extinguishment	59,843	(3,242,785)	(705,459)	(80,000)			(3,948,244)	(3,888,401)	(21,857,877)
Total other income (expense)	(604,831)	(5,846,466)	(4,024,398)	(21,689,478)			(9,870,864)	(10,475,695)	(53,391,236)
Net loss	$ (1,959,861)	$ (7,435,826)	$ (5,396,490)	$ (26,546,688)	$ (36,084,039)	$ (2,554,584)	$ (12,832,316)	$ (14,792,177)	$ (65,185,311)
Loss per share - basic	$ (0.01)	$ (0.06)	$ (0.04)	$ (0.58)			$ (0.10)	$ (0.11)	$ (1.51)
Loss per share - diluted	$ (0.01)	$ (0.06)	$ (0.04)	$ (0.58)			$ (0.10)	$ (0.11)	$ (1.51)
Previously Reported [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Interest and accretion expenses		$ (2,938,416)	$ (4,161,830)				$ (7,100,246)
Gain on debt extinguishment		667,200	(107,370)				559,830
Total other income (expense)		(2,483,216)	(4,854,200)				(7,337,416)
Net loss		$ (4,072,576)	$ (6,226,292)				$ (10,298,868)
Loss per share - basic		$ (0.03)	$ (0.05)				$ (0.08)
Loss per share - diluted		$ (0.03)	$ (0.05)				$ (0.08)
Revision of Prior Period, Reclassification, Adjustment [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Interest and accretion expenses		$ 546,735	$ 1,427,891				$ 1,974,626
Gain on debt extinguishment		(3,909,985)	(598,089)				(4,508,074)
Total other income (expense)		(3,363,250)	829,802				(2,533,448)
Net loss		$ (3,363,250)	$ 829,802				$ (2,533,448)
Loss per share - basic		$ 0.03	$ 0.01				$ 0.02
Loss per share - diluted		$ 0.03	$ 0.01				$ 0.02

SCHEDULE OF RESTATEMENT CONSOLIDATED STATEMENT OF STOCKHOLDERS' DEFICIT (Details) - USD ($)	3 Months Ended						6 Months Ended	9 Months Ended
	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Jun. 30, 2024	Sep. 30, 2024	Sep. 30, 2023
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Increase of fair value of warrants in debt extinguishment	$ 344,098	$ 4,075,749	$ 1,407,934		$ 12,666,268		$ 5,483,683
Net loss	(1,959,861)	(7,435,826)	(5,396,490)	$ (26,546,688)	(36,084,039)	$ (2,554,584)	(12,832,316)	$ (14,792,177)	$ (65,185,311)
Balance	$ (15,539,090)	(13,953,558)	(10,635,069)	$ (29,401,577)	$ (6,085,702)	$ 15,231,967	(13,953,558)	(15,539,090)	$ (29,401,577)
Modification of warrants								$ 5,827,782
Previously Reported [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Increase of fair value of warrants in debt extinguishment
Net loss		(4,072,576)	(6,226,292)				(10,298,868)
Balance		(9,379,968)	(10,832,664)				(9,379,968)
Modification of warrants		5,483,684					5,483,684
Revision of Prior Period, Reclassification, Adjustment [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Increase of fair value of warrants in debt extinguishment		4,075,749	1,407,934				5,483,683
Net loss		(3,363,250)	829,802				(2,533,448)
Balance		(4,573,590)	$ 197,595				(4,573,590)
Modification of warrants		$ (5,483,684)					$ (5,483,684)

SCHEDULE OF RESTATEMENT CONSOLIDATED STATEMENT OF CASH FLOWS (Details) - USD ($)	3 Months Ended						6 Months Ended	9 Months Ended
	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Jun. 30, 2024	Sep. 30, 2024	Sep. 30, 2023
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Net loss	$ (1,959,861)	$ (7,435,826)	$ (5,396,490)	$ (26,546,688)	$ (36,084,039)	$ (2,554,584)	$ (12,832,316)	$ (14,792,177)	$ (65,185,311)
Interest and accretion on convertible notes and notes payable			2,733,939				5,125,620	6,230,294	11,038,400
Gain (loss) on debt extinguishment	$ (59,843)	3,242,785	705,459	$ 80,000			3,948,244	$ 3,888,401	$ 21,857,877
Previously Reported [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Net loss		(4,072,576)	(6,226,292)				(10,298,868)
Interest and accretion on convertible notes and notes payable			4,161,830				7,100,246
Gain (loss) on debt extinguishment		(667,200)	107,370				(559,830)
Revision of Prior Period, Reclassification, Adjustment [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Net loss		(3,363,250)	829,802				(2,533,448)
Interest and accretion on convertible notes and notes payable			(1,427,891)				(1,974,626)
Gain (loss) on debt extinguishment		$ 3,909,985	$ 598,089				$ 4,508,074

SUBSEQUENT EVENTS (Details Narrative) - USD ($)	Dec. 31, 2024	Sep. 30, 2024	Jul. 12, 2024	Dec. 28, 2022
Hexin Promissory Note [Member]
Subsequent Event [Line Items]
Notes payable				$ 750,000
Additional funding		$ 47,446		$ 814,133
Annual interest rate				20.00%
Qualigen Therapeutics Inc [Member]
Subsequent Event [Line Items]
Annual interest rate			18.00%
Subsequent Event [Member] \| Qualigen Therapeutics Inc [Member] \| Hexin Promissory Note [Member]
Subsequent Event [Line Items]
Additional funding	$ 707,404
Annual interest rate	18.00%
Dr. Vithalbhai Dhaduk [Member]
Subsequent Event [Line Items]
Notes payable		$ 52,000
Dr. Vithalbhai Dhaduk [Member] \| Subsequent Event [Member]
Subsequent Event [Line Items]
Notes payable	$ 52,000

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