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 ~~June~~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)

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.

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 ☒

AsSecurities ofregistered ~~August~~pursuant ~~14,~~to ~~2024,~~Section ~~the~~12(b) ~~registrant had 131,793,088 shares~~ of ~~common~~the ~~stock ($0.001 par value) outstanding.~~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.	~~Condensed Consolidated~~ Financial Statements.	3
ITEM 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations.	1924
ITEM 3.	Quantitative and Qualitative Disclosures About Market Risk.	2833
ITEM 4.	Controls and Procedures.	2934
PART II - OTHER INFORMATION
ITEM 1.	Legal Proceedings.	3035
ITEM 1A.	Risk Factors.	3035
ITEM 2.	Unregistered Sales of Equity Securities, ~~and~~ Use of Proceeds, and Issuer Purchases of Equity Securities.	3035
ITEM 3.	Defaults Upon Senior Securities.	3035
ITEM 4.	Mine Safety Disclosures.	3035
ITEM 5.	Other Information.	3035
ITEM 6.	Exhibits.	3136
	Signatures	3239

PART I – FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

MARIZYME, INC.

Condensed Consolidated Balance Sheets

	June 30, 2024			December 31, 2023
	September 30, 2024			December 31, 2023
	(unaudited)
	(Unaudited)
ASSETS:
Current
Cash	$	563,~~222~~732		$	148,465
Accounts receivable		-2,000			60,284
Other receivables		35,~~848~~879			35,797
Prepaid expenses		~~854~~726,~~148~~114			699,377
Inventory		26,869			24,855
Total current assets		~~922~~854,~~087~~594			968,778
Non-current
Property, plant and equipment, net		-			12,500
Operating lease right-of-use assets, net		~~899~~797,~~411~~405			1,101,211
Intangible assets, net		14,~~146~~037,~~575~~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,~~612~~401,~~486~~703			21,046,297
Total assets	$	21,~~534~~256,~~573~~297		$	22,015,075
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT):
Current
Accounts payable and accrued expenses	$	3,~~269~~371,~~250~~483		$	2,322,064
Notes payable		12,~~541~~739,~~627~~981			633,692
Due to related parties		~~287~~302,900			230,153
Convertible notes, net - Units Private Placement		1716,~~022~~698,~~717~~700			1416,~~288~~328,~~335~~476
Convertible notes, net - OID		~~990~~6,~~636~~421,918			2,694,256
Operating lease obligations		~~439~~442,~~508~~221			434,082
Total current liabilities		2329,~~551~~977,~~638~~203			2022,~~602~~642,~~582~~723
Non-current
Operating lease obligations, net of current portion		~~459~~355,~~903~~184			667,129
Agreement obligation		1,000,000			-
Contingent liabilities		5,~~903~~463,000			5,406,000
Total non-current liabilities		76,~~362~~818,~~903~~184			6,073,129
Total liabilities		3036,~~914~~795,~~541~~387			2628,~~675~~715,~~711~~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 June 30, 2024 and December 31, 2023		-			-
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 June 30, 2024 and December 31, 2023		131,792			131,792
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		~~152~~154,~~123~~650,~~457~~064			~~146~~148,~~543~~696,~~921~~200
Accumulated deficit		(~~161~~170,~~635~~320,~~217~~946	)		(~~151~~155,~~336~~528,~~349~~769	)
Total stockholders’ equity (deficit)		(915,~~379~~539,~~968~~090	)		(46,~~660~~700,~~636~~777	)
Total liabilities and stockholders’ equity (deficit)	$	21,~~534~~256,~~573~~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)

	Three Months Ended June 30,						Six Months Ended June 30,
	2024			2023			2024			2023
Revenue	$	-		$	184,739		$	32,855		$	313,713
	Three Months Ended September 30,						Nine Months Ended September 30,
Direct cost of revenue		-			49,611			9,647			88,886
	2024			2023			2024			2023
Gross profit		-			135,128			23,208			224,827
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 $109,500, $161,000, $230,000, $322,000, respectively)		338,676			511,844			602,772			896,650
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		~~355~~318,~~525~~019			~~335~~329,~~004~~564			~~665~~983,~~684~~703			~~601~~931,~~972~~536
Research and development		~~312~~344,~~333~~139			~~691~~492,~~393~~235			~~634~~978,~~200~~339			1,~~297~~789,~~390~~625
Stock-based compensation		4120,~~588~~794			~~160~~86,~~762~~132			95116,~~852~~646			~~371~~457,~~728~~860
Depreciation and amortization		~~121~~108,~~277~~777			210,293			~~230~~338,~~054~~831			~~420~~630,~~631~~924
Royalty expense		-			~~162~~13,~~065~~014			1,957			~~198~~211,~~248~~262
Other general and administrative expenses		~~419~~445,~~961~~031			2,~~867~~934,~~749~~966			~~754~~1,~~141~~199,172			36,~~375~~310,~~073~~039
Total operating expenses		1,~~589~~355,~~360~~030			4,~~939~~987,~~110~~756			24,~~984~~339,~~660~~690			712,~~161~~149,~~692~~448
Total operating loss		(1,~~589~~355,~~360~~030	)		(4,~~803~~857,~~982~~210	)		(24,~~961~~316,~~452~~482	)		(611,~~936~~794,~~865~~075	)
Other income (expense)
Interest and accretion expenses		(21,~~938~~104,~~416~~674	)		(131,~~424~~502,~~169~~088	)		(76,~~100~~230,~~246~~294	)		(1511,~~121~~038,~~870~~400	)
Other income		~~200,000~~-			-			200,000			-
Change in fair value of contingent liabilities		88440,000			~~714~~(1,678,000	)		(~~497~~57,000	)		1312,~~990,~~000
Gain (loss) on debt extinguishment		667,200			(684,682	)		559,830			(684,682	)
Change in fair value of derivative liabilities		-			(14,454,397	)		-			(14,454,397	)
Borrowing costs		(500,000	)		-			(500,000	)		-
Gain (loss) on debt extinguishment		59,843			(80,000	)		(3,888,401	)		(21,857,877	)
Loss on issuance of debt		-			(2,377,569	)		-			(2,377,569	)
Borrowing costs		-			-			(500,000	)		-
Total other expense		(2,483,216	)		(15,772,420	)		(7,337,416	)		(16,194,121	)
Loss on issuance of debt		-			(3,974,993	)		-			(6,352,562	)
Net loss	$	(4,072,576	)	$	(20,576,402	)	$	(10,298,868	)	$	(23,130,986	)
Total other income (expense)		(604,831	)		(21,689,478	)		(10,475,695	)		(53,391,236	)
Loss per share – basic and diluted	$	(0.03	)	$	(0.48	)	$	(0.08	)	$	(0.55	)
Net loss	$	(1,959,861	)	$	(26,546,688	)	$	(14,792,177	)	$	(65,185,311	)
Weighted average number of shares of common stock outstanding – basic and diluted		131,793,088			43,187,439			131,793,088			41,979,194
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 ~~Six~~Nine Months Ended ~~June~~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		~~221~~339,~~540~~050			-			~~223~~340,~~486~~996
Exercise of warrants		2,652,159		2,652		262,564			-			265,216
Issuance of warrants on debt extinguishment		-		-		19,058,426			-			19,058,426
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
Warrants cancelled in debt extinguishment		-		-		(8,426,927	)		-			(8,426,927	)
Net loss		-		-		-			(36,084,039	)		(36,084,039	)
Net loss		-		-		-			(20,576,402	)		(20,576,402	)
Balance, June 30, 2023 (unaudited)		45,366,760		45,366		118,496,988			(124,628,056	)		(6,085,702	)
Balance, June 30, 2023 (unaudited)		45,366,760	$	45,366	$	116,344,709		$	(109,120,419	)	$	7,269,656
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’ ~~Equity~~
	Shares		Amount		Capital		Deficit			(Deficit)
Balance, December 31, 2023		131,793,088	$	131,792	$	~~146~~148,~~543~~696,~~921~~200	$	(~~151~~155,~~336~~528,~~349~~769	)	$	(46,~~660~~700,~~636~~777	)
Stock-based compensation expense		-		-		54,264		-			54,264
Net loss		-		-		-		(6,226,292	)		(6,226,292	)
Increase of fair value of warrants in debt extinguishment				-		1,407,934					1,407,934
Balance, March 31, 2024 (unaudited)		131,793,088	$	131,792	$	146,598,185	$	(157,562,641	)	$	(10,832,664	)
Net loss		-		-		-		(5,396,490	)		(5,396,490	)
Balance		131,793,088	$	131,792	$	146,598,185	$	(157,562,641	)	$	(10,832,664	)
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
Modification of warrants		-		-		5,483,684		-			5,483,684
Increase of fair value of warrants in debt extinguishment		-		-		4,075,749		-			4,075,749
Net loss		-		-		-		(47,~~072~~435,~~576~~826	)		(47,~~072~~435,~~576~~826	)
Balance, June 30, 2024 (unaudited)		131,793,088	$	131,792	$	152,123,457	$	(161,635,217	)	$	(9,379,968	)
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	$	~~152~~154,~~123~~275,~~457~~735	$	(~~161~~168,~~635~~361,~~217~~085	)	$	(913,~~379~~953,~~968~~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)

	Six Months Ended June 30,
	2024			2023
	Nine Months Ended September 30,
	2024			2023
Cash flows from operating activities:
Net loss	$	(1014,~~298~~792,~~868~~177	)	$	(2365,~~130~~185,~~986~~311	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		~~230~~338,~~054~~831			~~420~~630,~~631~~924
Amortization of ROU asset		201,800			-
Amortization of right-of-use assets		303,806			286,816
Stock-based compensation		95116,~~852~~646			~~371~~457,~~728~~860
Interest and accretion on convertible notes and notes payable		76,~~100~~230,~~246~~294			1511,~~121~~038,~~870~~400
Change in fair value of contingent liabilities		497,000			(1,990,000	)
Issuance of warrants for services		-			2,934,680
Gain (loss) on debt extinguishment		(559,830	)		684,682
Change in fair value of contingent liabilities		57,000			(312,000	)
Loss on issuance of debt		-			2,377,569
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		-			~~138~~168,000
Warrants issued as part of promissory note agreement		-			1,333,128
Borrowing costs		500,000			-
Change in operating assets and liabilities:
Accounts and other receivable		60,233			(4,171	)
Accounts receivable and other receivables		58,201			24,120
Prepaid expenses		(~~154~~26,~~771~~737	)		~~519~~464,~~414~~367
Inventory		(2,014	)		75116,~~843~~547
Accounts payable and accrued expenses		~~932~~1,~~496~~033,824			1,~~657~~852,~~909~~865
Due to related parties		5772,747			~~143~~187,~~351~~097
Operating lease liabilities		(~~201~~303,~~800~~806	)		(~~190~~286,~~581~~816	)
Net cash used in operating activities		(12,~~541~~524,~~855~~984	)		(23,~~318~~470,~~013~~887	)
Cash flows from financing activities:
Proceeds from issuance of OID Convertible Notes, net of issuance cost		-			870,000
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 promissory notes		1,040,000			1,000,000
Proceeds from notes payable		2,362,000			1,000,000
Repayments of promissory notes		(141,388	)		(122,842	)
Repayments of notes payable and Convertible Notes - OID		(421,749	)		(164,250	)
Proceeds from agreement		500,000			-
Proceeds from agreement obligation		500,000			-
Net cash provided by financing activities		12,~~398~~440,~~612~~251			23,~~012~~434,~~374~~966
Net change in cash		(~~143~~84,~~243~~733	)		(~~305~~35,~~639~~921	)
Cash at beginning of period		148,465			510,865
Cash at end of period	$	563,~~222~~732		$	~~205~~474,~~226~~944
Supplemental disclosure of cash flow information:
Debt discount issued in connection with warrants modification	$	5,344,229		$	-
Derivative liabilities and debt discount issued in connection with convertible notes	$	-		$	25,555,092
Derivative liabilities and debt discount issued in connection with convertible notes	$	-		$	5,461,702
Warrants and debt discount issued in connection with convertible notes	$	-		$	344,959
Warrants and debt discount issued in connection with convertible notes	$	-		$	19,058,426
Settlement of notes payable with convertible notes	$	-		$	2,264,133
Settlement of notes payable with convertible notes	$	-		$	2,064,133
Increase of fair value of warrants in debt extinguishment	$	-		$	12,666,268
Warrants cancelled in debt extinguishment	$	-		$	8,426,927
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 ~~JUNE~~SEPTEMBER 30, 2024

NOTE 1 – DESCRIPTION OF BUSINESS

~~Maryzime~~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 $~~161~~170,~~635~~320,~~217~~946 at ~~June~~September 30, 2024 (December 31, 2023 - $~~151~~155,~~336~~528,~~349~~769). Additionally, the Company has negative working capital of $2229,~~629~~122,~~551~~ 609 (December 31, 2023 - $1921,~~633~~673,~~804~~945) and $563,~~222~~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~~ 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~~ 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~~ owned subsidiaries: My Health Logic Inc (“My Health Logic” or “MHL”), Somahlution, Inc. ~~(“Somahlution”)~~, 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 ~~accounting principles generally accepted in the United States of America (“~~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 ~~May~~February 136, ~~2024~~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, ~~note~~notes payable, and amounts due to ~~related~~ 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 $0Nil, and expected life of 5.96 years. For the three and ~~six~~nine months ended ~~June~~September 30, 2024, changes in these assumptions resulted in a $9831,000 decrease and $~~140~~171,000 decrease in fair value of these liabilities, respectively (September 30, 2023 – $406,000 increase and $800,000 decrease, respectively). At ~~June~~September 30, 2024, the fair market value of performance warrants and pediatric vouchers warrants liabilities was $8554,000 (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 ~~six~~nine months ended ~~June~~September 30, 2024, changes in these assumptions resulted in a $10409,000 decrease and $~~637~~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 ~~June~~September 30, 2024, the fair market value of royalty payments was $3,~~995~~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 ~~six~~nine months ended ~~June~~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 $0Nil, and expected life of 5 years. No changes to the fair value of liquidation preference liability were recorded in the three and ~~six~~nine months ended ~~June~~September 30, 2024 and 2023. At ~~June~~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 ~~three~~nine ~~and six~~ months ended ~~June~~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,~~483~~827,~~684~~782 related to the change in the fair value of warrants. ~~Of this amount,~~ $54,~~344~~778,~~229~~950 ~~was recorded as a debt discount and is being amortized to interest~~of ~~and~~this ~~accretion~~amount ~~expense~~exceeded ~~using~~ the ~~effective interest method over the term of the OID Convertible Notes. The remaining $139,455, which exceeded the~~ principal of the Convertible Notes, and was recognized as a loss on debt extinguishment in the condensed consolidated ~~statements~~statement of operations for the ~~six~~nine months ended ~~June~~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.

AsAdditionally, as part of the acquisition of Somahlution in 2020, the Company acquired ~~Goodwill~~IPR&D intangible ~~attributed~~asset to“Cyto ~~the~~Protectant ~~workforce~~Life ~~and~~Sciences” ~~profitability~~with ofindefinite ~~the~~economic ~~acquired business~~life. AThe ~~residual~~fair ~~method~~value ~~methodology~~of IPR&D was ~~used~~determined based toon ~~estimate the~~Multi-Period ~~fair~~Excess ~~market~~Earning ~~value~~Method ~~goodwill.~~valuation Aapproach, ~~pre-tax~~using discount rate ~~based on weighted average cost~~ of ~~capital of 33~~35.82% ~~was used in the fair value assumptions for the assembled workforce acquired~~.

~~Additionally,~~For asimpairment ~~part~~testing, of the ~~acquisition~~Company ofuses ~~Somahlution~~a indiscounted ~~2020,~~cash flow (“DCF”) model to estimate the ~~Company~~fair ~~acquired~~value of IPR&D intangibles ~~intangible~~and ~~asset~~goodwill. ~~“Cyto~~The ~~Protectant~~key ~~Life~~assumptions ~~Sciences”~~used ~~with~~in ~~indefinite~~the ~~economic~~DCF ~~life.~~model ~~The~~include ~~fair~~projected ~~value~~cash offlows, ~~IRP&D~~discount ~~was~~rate ~~determined~~and terminal value growth rate. These ~~based~~inputs onare ~~Multi-Period~~highly ~~Excess~~subjective ~~Earning~~and ~~Method~~require ~~valuation~~significant ~~approach,~~management ~~using~~judgment. ~~discount~~Changes ~~rate~~in ofthese 35assumptions could have a significant impact on the fair value and any resulting impairment charge.~~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 June 30, 2024, and December 31, 2023, the fair values of these financial instruments were as follows:~~10

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:

June 30, 2024

Level 1

Level 2

Level 3

September 30, 2024

Level 1

Level 2

Level 3

Fair Value Hierarchy

June 30, 2024

Level 1

Level 2

Level 3

September 30, 2024

Level 1

Level 2

Level 3

Liabilities

Contingent liabilities

5,~~903~~463,000

Total

5,~~903~~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 ~~roll~~rollforward ~~forward~~ 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		~~497~~57,000
Balance at June 30, 2024	$	5,903,000
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 ~~FASB~~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. ~~ASU 2020-06 will be effective for the Company for fiscal years beginning after December 15, 2023.~~ 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~~ 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 ~~pays~~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 ~~June~~September 30, 2024, the remaining lease ~~term~~ term was 21.0883 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 ~~six~~nine months ended ~~June~~September 30, 2024 was $63129,~~885~~416 and $~~161~~290,~~058~~474, respectively (~~June~~September 30, 2023 – $3781,~~674~~ 502 and $~~192~~274,~~502~~004, respectively).

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

	June 30, 2024		December 31, 2023
	September 30, 2024		December 31, 2023
Right-of-use asset	$	899,411	$	1,101,211
Operating lease right-of-use assets	$	797,405	$	1,101,211
Operating lease liabilities, current	$	~~439~~442,~~508~~221	$	434,082
Operating lease liabilities, non-current		~~459~~355,~~903~~184		667,129
Total operating lease liabilities	$	~~899~~797,~~411~~405	$	1,101,211

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

2024	$	~~217~~108,~~041~~521
2025		444,934
2026		266,034
Total lease payments	$	~~928~~819,~~009~~489
Less: Present value discount		(2822,~~598~~084	)
Total	$	~~899~~797,~~411~~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 ~~statements~~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 ~~six~~nine months ended ~~June~~September 30, 2024.

1012

DuraGraft

As part of ~~the~~ Somahlution acquisition in 2020, Marizyme purchased ~~of intangible assets valued at~~ $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 ~~statements~~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 ~~six~~nine months ended ~~June~~September 30, 2024.

My Health Logic

As part of the My Health Logic ~~(“MHL”)~~ 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~~ was recognized on MHL’s intangible assets and recorded in the impairment of intangible assets in the consolidated ~~statements~~ 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 ~~six~~ months ended ~~June~~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 ~~statements~~statement of operations for the year ended December 31, 2023.

	June 30, 2024
	September 30, 2024
	Gross Carrying Amount		Accumulated Amortization			Net Carrying Amount
Patents in process	$	122,745	$	-		$	122,745
DuraGraft patent		5,256,000		(1,~~583~~684,~~537~~614	)		3,~~672~~571,~~463~~386
DuraGraft - Distributor relationship		308,000		(~~120~~128,~~633~~333	)		~~187~~179,~~367~~667
DuraGraft IPR&D - Cyto Protectant Life Sciences		10,164,000		-			10,164,000
	$	15,850,745	$	(1,704,170	)	$	14,146,575
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 intangibles	$	29,142,745	$	(2,308,896	)	$	(12,469,720	)	$	14,364,129
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 June 30, 2024	$	5,416,000	$	-	$	5,416,000
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		(~~217~~326,~~554~~331	)
Balance, June 30, 2024	$	14,146,575
Balance, September 30, 2024	$	14,037,798

1113

Future amortizations for DuraGraft intangible assets for the next five years will be $435,108 for each year from 2025 through 2029 and $1,~~684~~575,~~289~~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. ~~Failure~~During tothe ~~pay~~nine ~~past~~months ~~due~~ended ~~amounts~~September ~~and~~30, ~~monthly~~2024, ~~installments may result in cancellation of~~ the Company~~’s insurance.~~ Asrepaid ofthe ~~June~~note ~~30,~~in ~~2024,~~full and the ~~Company has~~ outstanding balance under the note payable inas ~~the amount~~ of $September 30,~~360~~ 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 ~~statements~~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 ~~Inc.~~ acquisition, completed in November 2021, Marizyme assumed an aggregate of $468,137 in notes payable, ~~the~~ 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 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 ~~six~~nine months ended ~~June~~September 30, 2024, the Company accrued $5,~~602~~868 and $1117,~~142~~010 in interest on the notes payable, respectively (~~June~~ September 30, 2023 - $5,~~298~~344 and $1823,~~366~~710, respectively). As of ~~June~~September 30, 2024, balance of the remaining note payable was $~~255~~264,~~267~~535 (December 31, 2023 - $252,223).

e) As of ~~June~~September 30, 2024, the Company has outstanding borrowings under notes payable to Mr. Richmond in the principal amount of $~~286~~441,000 (December 31, 2023 - $151,000). The notes payable bear no interest and isare due on demand.

f) As of ~~June~~September 30, 2024, the Company has outstanding borrowings under a note payable to Santander Bank: Sullivan & Worcester LLP in the principal amount of $65515,000 (December 31, 2023 - $65,000). The note payable bears no interest and is due on demand.

g) As of ~~June~~September 30, 2024, the Company has outstanding borrowings under a note payable to Commas International Holding, LLC in the principal amount of $~~755~~170,000 (December 31, 2023 - $Nil). The note payable bears no interest and is due on demand.

h) As of ~~June~~September 30, 2024, the Company has outstanding borrowings under a note payable to Dr. Vithalbhai Dhaduk in the principal amount of of $~~150~~52,000 (December 31, 2023 - $Nil). The ~~note~~ 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 ~~were~~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 ~~loss~~liability onand ~~debt~~therefore was accounted for as an equity instrument. The ~~extinguishment~~fair value of $~~684~~12,~~682~~666,268 ~~was~~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 ~~statements~~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 $76,~~378~~791,~~993~~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 ~~six~~nine months ended ~~June~~September 30, 2024, the Company amended certain Convertible ~~Note~~Notes, ~~with~~extending their original maturity dates ofin ~~March 24,~~ 2024 ~~and June~~by ~~17,~~one ~~2024,~~year tofrom ~~extend~~ their ~~term~~respective ~~until~~original ~~March~~maturity ~~24, 2025 and June 17, 2025, respectively~~dates. In connection with the extension of the maturity ~~date~~ dates for the outstanding Convertible Notes, the Company executed a substantial modification that led to the extinguishment of the existing ~~Convertible~~ Convertible Notes and the issuance of new Convertible Notes. This modification resulted in a gain on extinguishment of $~~126~~890,~~521 and $699~~549,~~286,~~ which has been recognized in the condensed consolidated statements of operations for the ~~three~~nine ~~and six~~ months ended ~~June~~September 30, 2024 ~~respectively~~ (~~June~~September 30, 2023 -– ~~$684,682~~loss of ~~and~~ $~~684~~21,~~682~~777, ~~respectively~~877).

During the three and ~~six~~nine months ended ~~June~~September 30, 2024, the Company recognized interest and accretion expense of $1433,~~342,178~~868 and $31,~~433~~260,~~668~~775, ~~respectively~~ respectively (~~June~~September 30, 2023 - $5529,~~730,714~~596 and $73,~~286~~265,~~891~~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 ~~fair~~following ~~value~~table ofsummarizes ~~the~~supplemental ~~warrants~~balance ~~issued~~sheet ~~have~~information ~~been~~related ~~recorded~~to asthe ~~debt~~convertible ~~discount~~notes, ~~and~~net isof ~~being~~debt ~~amortized~~discount ~~to interest and accretion expense using~~outstanding, ~~the~~as ~~effective~~of ~~interest~~September ~~method~~30, ~~over~~2024 ~~the~~and ~~term~~December of31, ~~the Convertible Notes.~~2023:

The following table summarizes supplemental balance sheet information related to the convertible notes, net of debt discount outstanding, as of June 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		(19344,~~403,385~~959	)
Debt accretion on New Securities		17,792,071
Debt interest and accretion on new securities		1,429,646
Mandatory Default Amount		7,378,993
Mandatory default amount		6,835,105
Conversion of debt		(9,~~426~~509,~~260~~505	)
Extinguishment of debt		(10,~~518~~276,~~069~~925	)
Convertible notes issued with extended maturity date		108,~~518~~791,~~069~~729
Debt discount		(1,520,047	)
Balance, December 31, 2023		16,328,476
Debt accretion		63,578
Debt interest and accretion		1,260,775
Balance, December 31, 2023	$	14,288,335
Extinguishment of debt		(6,160,552	)
Debt accretion		3,433,668
Convertible notes issued with extended maturity date		5,270,001
Extinguishment of debt		(4,828,403	)
Balance, September 30, 2024	$	16,698,700
Convertible notes issued with extended maturity date		5,334,069
Debt discount		(1,204,952	)
Balance, June 30, 2024	$	17,022,717

1315

	June 30, 2024			December 31, 2023
	September 30, 2024			December 31, 2023
Convertible notes - total principal	$	1917,~~492~~272,~~617~~077		$	1817,~~955~~516,~~174~~865
Unamortized issuance costs and discount		(2573,~~469,890~~377	)		(41,~~666~~188,~~839~~389	)
Convertible Notes, Net of Debt Discount	$	1716,~~022~~698,~~717~~700		$	1416,~~288~~328,~~335~~476

	June 30, 2024		December 31, 2023
	September 30, 2024		December 31, 2023
Current portion	$	1716,~~022~~698,~~717~~700	$	1416,~~288~~328,~~335~~476
Non-current portion		-		-
Convertible Notes, Net of Debt Discount	$	1716,~~022~~698,~~717~~700	$	1416,~~288~~328,~~335~~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 ~~statements~~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 ~~three~~nine ~~and six~~ months ended ~~June~~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 ~~three~~nine ~~and six~~ months ended ~~June~~September 30, 2024, ~~the~~ the Company recognized an incremental fair value increase of $~~4,075,749 and $~~5,~~483~~827,~~684~~782 as a change in the fair value of warrants~~, respectively~~. ~~Of this amount,~~ $54,~~344~~778,~~229~~950 ~~was recorded as a debt discount and is being amortized to interest and accretion expense using the effective interest method over the term~~ of ~~the OID Convertible Notes. The~~ ~~remaining~~this ~~$139,455,~~amount ~~which~~ 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 ~~three~~nine ~~and six~~ months ended ~~June~~September 30, 2024 ~~respectively~~ (~~June~~September 30, 2023 - $Nil ~~and $Nil, respectively~~).

During the three and ~~six~~nine months ended ~~June~~September 30, 2024, the Company recognized interest and accretion expense of $1613,~~566,561~~186 and $34,~~640~~885,~~609~~930, ~~respectively~~ respectively (~~June~~September 30, 2023 - $~~150~~843,~~086~~699 and $~~150~~993,~~086~~785, respectively), in the condensed consolidated statements of operations.

1416

The following table summarizes supplemental balance sheet information related to the OID Convertible Notes, net of debt discount outstanding, as of ~~June~~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		34,~~640~~885,~~609~~930
Extinguishment of debt		(47,~~961~~264,~~146~~572	)
Unamortized debt discount - issuance costs		(1,415,564	)
Settlement of debt		(109,437	)
Convertible note issued with extended maturity date		6,~~376~~215,~~710~~741
Debt discount		(5,344,229	)
Balance, September 30, 2024	$	6,421,918
Balance, June 30, 2024	$	990,636

	June 30, 2024			December 31, 2023
	September 30, 2024			December 31, 2023
Convertible notes - total principal	$	76,~~200~~841,~~619~~769		$	6,987,606
Unamortized issuance costs and discount		(6419,~~376,710~~851	)		(4,293,350	)
Convertible Notes, Net of Debt Discount	$	~~990~~6,~~636~~421,918		$	2,694,256

	June 30, 2024		December 31, 2023
	September 30, 2024		December 31, 2023
Current portion	$	~~990~~6,~~636~~421,918	$	2,694,256
Non-current portion	$	-	$	-
Convertible Notes, Net of Debt Discount	$	~~990~~6,~~636~~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 ~~June~~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 ~~June~~September 30, 2024, there were 131,793,088 (December 31, 2023 - 131,793,088) shares of common stock issued and outstanding. During ~~the~~ the three and ~~six~~nine months ended ~~June~~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 ~~June~~September 30, 2024, there remains 4,~~230~~304,724 options available for issuance (December 31, 2023 – 2,924,057).

During the three and ~~six~~nine months ended ~~June~~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 ~~June~~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,~~095~~168,~~000~~333	)		1.0108		-
Outstanding at June 30, 2024		2,619,276			1.44		6.37		-
Outstanding at September 30, 2024		2,545,943			1.42		6.07		-
Exercisable at June 30, 2024		2,519,276		$	1.42		6.32	$	-
Exercisable at September 30, 2024		2,485,943		$	1.41		6.04	$	-

As of ~~June~~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		4.8055	$	-
	1.25		415,000		415,000		6.6540		-
	1.37		200,000		200,000		65.1388		-
	1.75		800,000		~~740~~770,000		7.4116		-
	2.20		~~313~~240,~~333~~000		~~273~~210,~~333~~000		7.9469		-
$	1.44		2,~~619~~545,~~276~~943		2,~~519~~485,~~276~~943		6.3707	$	-

1618

d) Restricted ~~Share~~share ~~Units~~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 ~~June~~September 30, 2024, the Company determined that only ~~two~~ two out of four performance conditions have been met. No compensation cost was recognized for the restricted share awards for the three ~~and~~ ~~six~~and nine months ended ~~June~~September 30, 2024 (~~June~~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 ~~June~~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 6)		355,577,447			0.1
Warrants modified pursuant to debt extinguishment (Note 7)		355,577,447			0.1
Issued pursuant to debt agreements (Note 6)		183,560,497			0.15
Issued pursuant to debt agreements (Note 7)		183,560,497			0.15
Issued		79,949,352			0.11
Exercised		(2,652,159	)		0.1
Exercised		-			-
Balance, December 31, 2023		636,483,634		$	0.12
Balance, December 31, 2023 and June 30, 2024		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~~ the Black-Scholes pricing model. During the three and ~~six~~nine months ended ~~June~~September 30, 2024, the Company extended the maturity dates of ~~certain~~ 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,~~483~~827,~~684~~ 782 related to the change in the fair value of warrants. ~~Of this amount,~~ $54,~~344~~778,~~229 was recorded as a debt discount and is being amortized to interest and accretion expense~~950 ~~using the effective interest method over the term~~ of ~~the~~this ~~OID~~amount ~~Convertible Notes. The remaining $139,455, which~~ exceeded the principal of the Convertible Notes, and was recognized as a loss on debt extinguishment in the condensed consolidated ~~statements~~statement of operations for the ~~six~~ nine months ended ~~June~~ September 30, 2024 (see Note 7).

f)	*Stock-based compensation*

During the three and ~~six~~nine months ended ~~June~~September 30, 2024, the Company recorded $4120,~~588~~794 and $95116,~~852~~646 in non-cash share-based compensation, respectively (~~June~~September 30, 2023 - $~~160~~86,~~762~~123 and $~~371~~457,~~728~~860, respectively).

NOTE 9 – RELATED PARTY TRANSACTIONS

At September ~~June~~ 30, 2024, the Company owed an aggregate of $~~287~~302,900 (December 31, 2023 - $230,153) to related parties of the Company.

For the three and ~~six~~nine months ended ~~June~~September 30, 2024, the Company incurred $88277,~~500~~000 and $~~181~~882,000, respectively, for professional services ~~rendered~~ rendered by related parties (~~June~~September 30, 2023 - $72404,~~000~~750 and $~~144~~1,~~000~~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 ~~June~~September 30, 2024 was $16302,~~400~~900 (December 31, 2023 - $7,653).

During the three and ~~six~~nine months ended ~~June~~September 30, 2024, the Company also incurred $208,500 and $~~424~~632,~~000~~500 in compensation to Directors and ~~Executive~~ Executive Officers for their services rendered, respectively (~~June~~September 30, 2023 – $~~332~~257,750 and $~~665~~773,~~500~~250, respectively). The total balance outstanding for these services at ~~June~~September 30, 2024 was $~~271~~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 ~~six~~nine months ended ~~June~~September 30, 2024, the Company accrued $Nil and $1,957 in royalties payable incurred on sales of the DuraGraft product ~~outside~~ outside of the U.S., respectively (~~June~~September 30, 2023 - $1113,~~065~~014 and $47211,~~248~~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 ~~June~~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.

1719

NOTE 10 – COMMITMENTS AND CONTINGENCIES

Contingencies

a) 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 ~~six~~nine months ended ~~June~~September 30, 2024, the Company had not earned any revenues from ~~Krillase,~~ Krillase; however, the Company did incur sales of the DuraGraft products outside of the U.S., onof 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.

c. The Company has entered into arrangements for office and laboratories spaces. AtAs ~~June~~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, ~~Inc.,~~ during the ~~six~~nine months ended ~~June~~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 ~~six~~nine months ended ~~June~~ September 30, 2024, as it represented payment for exclusive negotiation rights. The Funding Amount was accounted for as a debt liability, due to ~~the~~ the significant continuing involvement by the Company and the limitation on Qualigen’s rate of return. The obligation to repay ~~the~~ 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 ~~sheets~~sheet at ~~June~~September 30, 2024, and the Funding Amount was expensed as borrowing costs in the condensed consolidated statement of operations for the ~~six~~nine months ended ~~June~~September 30, 2024.

NOTE 12 -– ~~SUBSEQUENT~~RESTATEMENT ~~EVENTS~~OF PREVIOUSLY ISSUED UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

~~The~~In March ~~Company~~2025, ~~has~~the ~~evaluated~~Board ~~events~~of ~~that~~Directors ~~occurred~~and ~~through~~management, ~~August~~upon ~~14,~~the ~~2024,~~ recommendation of the ~~date~~Audit Committee of the Board of Directors, concluded that certain accounting errors identified in the Company’s financial statements ~~were~~for ~~issued~~interim periods ended March 31, 2024 and ~~determined~~June ~~that~~30, ~~except~~2024, ~~than~~required asrestatement. ~~set~~As ~~forth~~a ~~below~~result, ~~there~~the ~~have~~Company ~~been~~amended nothose ~~events~~unaudited ~~that~~condensed consolidated financial ~~have~~statements ~~occurred~~for ~~that~~the ~~would~~interim ~~require~~periods ~~adjustments~~ended toMarch 31, 2024, and June 30, 2024, within this Form 10-Q for the nine months ended September 30, 2024. The Company’s ~~disclosures~~has innot 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.

	1.	On July 12, 2024, the Company executed a Promissory Note (“Note”) in favor of Qualigen Therapeutics, Inc. (the “Lender”) in the aggregate principal amount of $1,250,000. The Note is due and payable upon demand and the principal bears interest at the rate of 18% per annum. In connection with the issuance of the Note, the Company received proceeds from the Lender in the amount of $1,250,000.
		The Company may prepay all or any part of the outstanding principal or interest due on the Note, at any time, in whole or in part, without premium or penalty. In the event of a default by the Company in the payment of the principal and interest, the Note provides that the Lender will have liquidation preference and a first right of recovery in any future bankruptcy or insolvency proceeding.
	2.	On July 19, 2024, the Company repaid $100,000 to a lender pursuant to the OID Convertible Note agreement. The lender forgave the Company all the interest accrued on the OID Convertible Note.

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.”

18The 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 ~~six~~nine months ended ~~June~~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 ~~either paused or~~ significantly ~~slowed~~reduced ~~down~~ the development efforts for one of our ~~other~~ pipeline technologies, ~~including~~ Krillase. ~~and~~Additionally, ~~MATLOC.~~we ~~Our~~terminated our Sponsored Research Agreement for the MATLOC CKD point-of-care device isas ~~still~~of ~~being~~July ~~developed through a Sponsored Research Agreement~~31, ~~or SRA. An SRA is an agreement (which may be classified as a grant~~2024, ~~contract or cooperative agreement) under~~ which ~~one~~resulted ~~party~~in (the ~~“Sponsor”)~~loss ~~provides~~of ~~funding~~all ~~to a~~rights ~~second party~~ to ~~support~~ the ~~performance of a specified research project or related activity. The Sponsor may be a foundation, government~~associated ~~agency,~~license ~~for-profit entity, research institute, or another university~~agreement. ~~Apart~~At ~~from~~this ~~the SRA~~time, no ~~additional~~further capital is ~~going~~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.

1924

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 $42.10 million and $1014.38 million for the three and ~~six~~nine months ended ~~June~~September 30, 2024, respectively (~~June~~ September 30, 2023 - $2026.65 million and $2365.12 million, respectively). We expect to incur significant expenses and operating losses over the next ~~several~~ several years. Accordingly, we will need additional financing to support our continuing operations. We will seek to fund our operations ~~through~~ 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.

2126

RESULTS OF OPERATIONS

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

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

	Three Months Ended June 30,
	Three Months Ended September 30,
	2024			2023			Change $
Revenue	$	-		$	~~184~~181,~~739~~535		$	(~~184~~181,~~739~~535	)
Direct cost of revenue		-			49,611			(49,611	)
Cost of goods sold		-			50,989			(50,989	)
Gross profit		-			~~135~~130,~~128~~546			(~~135~~130,~~128~~546	)
Operating expenses:
Direct costs of revenue
Professional fees		~~338~~118,~~676~~270			~~511~~921,~~844~~552			(~~173~~803,~~168~~282	)
Salary expenses		~~355~~318,~~525~~019			~~335~~329,~~004~~564			20(11,~~521~~545	)
Research and development		~~312~~344,~~333~~139			~~691~~492,~~393~~235			(~~379~~148,~~060~~096	)
Stock-based compensation		4120,~~588~~794			~~160~~86,~~762~~132			(~~119~~65,~~174~~338	)
Depreciation and amortization		~~121~~108,~~277~~777			210,293			(89101,~~016~~516	)
Royalty expense		-			~~162~~13,~~065~~014			(~~162~~13,~~065~~014	)
Other general and administrative expenses		~~419~~445,~~961~~031			2,~~867~~934,~~749~~966			(2,~~447~~489,~~788~~935	)
Total operating expenses		1,~~589~~355,~~360~~030			4,~~939~~987,~~110~~756			(3,~~349~~632,~~750~~726	)
Total operating loss	$	(1,~~589~~355,~~360~~030	)	$	(4,~~803~~857,~~982~~210	)	$	3,~~214~~502,~~622~~180
Other income (expenses):
Interest and accretion expense		(21,~~938~~104,~~416~~674	)		(131,~~424~~502,~~169~~088	)		10397,~~485,753~~414
Other income		200,000			-			200,000
Change in fair value of contingent liabilities		440,000			(1,678,000	)		2,118,000
Change in fair value of contingent liabilities		88,000			714,000			(626,000	)
Change in fair value of derivative liabilities		-			(14,454,397	)		14,454,397
Gain (loss) on debt extinguishment		~~667~~59,~~200~~843			(~~684~~80,~~682~~000	)		(1139,~~351,882~~843	)
Borrowing costs		(500,000	)		-			(500,000	)
Loss on issuance of debt		-			(3,974,993	)		3,974,993
Loss on issuance of debt		-			(2,377,569	)		2,377,569
Net loss	$	(1,959,861	)	$	(26,546,688	)	$	24,586,827
Net loss	$	(4,072,576	)	$	(20,576,402	)	$	16,503,826

Revenue

We recognized no revenue for the three months ended ~~June~~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 ~~June~~September 30, 2024, due to constraints on the Company’s financial resources.

Direct Costs of Revenue

During the period ended ~~June~~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 ~~June~~September 30, 2023. The decrease in cost of goods ~~sold~~ sold was due to the absence of sales and no inventory production during the three months ended ~~June~~September 30, 2024, compared to the corresponding period in 2023.

Professional Fees

Professional fees decreased by approximately $0.28 million or 3387.82% to approximately $0.31 million in the three months ended ~~June~~September 30, 2024, compared to approximately $0.59 million in the three months ended ~~June~~September 30, 2023. The decrease is primarily attributed to ~~higher~~legal ~~professional~~and ~~fees~~placement ~~incurred~~agent infees related to the ~~comparative~~Company’s ~~period~~Units Private Placement, ~~driven~~the byOID ~~spending~~Units onPrivate Placement, and consulting services expenses for DuraGraft FDA regulatory ~~and~~support ~~clinical~~during ~~support~~the quarter ended September 30, 2023.

Salary Expenses

Salary expenses in the three months ended June 30, 2024 were approximately $0.4 million, an approximately $0.02 million or 6.1% increase from the comparative quarter. This increase can be attributed to a lower portion of salaries being reclassified to research and development expenses, as the Company reduced its R&D efforts in the latter half of fiscal 2023.

Research and Development

Research and development expenses in the three months ended ~~June~~September 30, 2024 were approximately $0.3 million, approximately a $0.41 million or 5430.81% 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.

2227

Stock-Based Compensation

Stock-based compensation decreased by $0.1 million or 7475.19% to approximately $0.0402 million for the three months ended ~~June~~September 30, 2024 from approximately $0.21 million in the comparative quarter ended ~~June~~September 30, 2023. This decrease is primarily due to a significant portion of options ~~completing~~ 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 ~~June~~September 30, 2024, down from approximately $0.2 ~~million~~ million in the comparative quarter ended ~~June~~September 30, 2023, representing a 4248.3% 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 ~~June~~September 30, 2023, the Company recorded an aggregate of approximately $0.1601 million in royalty ~~expenses. This included $0.01~~expense, ~~million~~most inof ~~royalties~~which ~~payable~~was accrued on sales of DuraGraft sales outside of the U.S. ~~and $0.15 million recorded as a 50% reduction of the prepaid royalty balance owed to the former beneficial owners of Somahlution.~~ No royalties were accrued in the current period, as there were no sales of DuraGraft during the three months ended ~~June~~September 30, 2024.

Other General and Administrative Expenses

Other general and administrative expenses decreased by approximately $2.45 million, or 8584.48%, to approximately $0.4 million for the three months ended ~~June~~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 ~~June~~September 30, 2024, the Company incurred approximately $21.91 million in interest and accretion costs related to ~~convertible~~ convertible notes issued at a discount as part of its Units Private ~~Placement~~Placements. This represents aan decrease of $100.54 million, or 7826.15%, compared to $131.45 million in the comparative quarter ended ~~June~~September 30, 2023. ~~The~~This ~~significant~~ decrease iswas ~~primarily~~ due to the ~~events~~restructuring ~~in the comparative period: the Company failed to repay the initial principal amount~~ of ~~$1.0~~multiple ~~million under the Walleye Promissory Note by its maturity date of May 7, 2023, leading to a default under the~~ Convertible Notes, onwhich ~~the same date. This default~~ resulted in alower ~~default~~interest ~~amount~~and ~~of approximately~~accretion ~~$7.3~~expenses ~~million~~in ~~being accreted to~~ the ~~principal~~current ~~of the Convertible Notes~~period.

23Additionally, 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 ~~June~~September 30, 2024, the Company ~~recognized~~recorded ana ~~Exclusivity Fee of~~ $0.206 million ~~under~~gain ~~other~~on ~~income,~~the ~~pursuant~~extinguishment toof ~~the~~Convertible ~~agreement~~Notes ~~with~~- ~~Qualigen.~~Units Private NoPlacement ~~such~~and ~~income~~Convertible ~~was~~Notes ~~recognized~~- inOID ~~the~~due ~~comparative~~to ~~quarter ended~~the ~~June~~amendment ~~30,~~of ~~2023.~~the ~~Additionally,~~maturity indates ~~accordance~~for ~~with~~certain ~~the~~Notes ~~agreement~~and ~~with~~warrants attached ~~Qualigen,~~to ~~the~~those ~~Company~~Notes. ~~also~~This ~~recognized~~represents a $0.52 million inincrease, ~~borrowing costs~~or ~~incurred~~174.8% compared to ~~secure~~$0.08 million loss in the ~~funding~~comparative quarter ~~from~~ended ~~Qualigen~~September 30, 2023.

~~Additionally~~Lastly, in the ~~Company~~comparative ~~recognized~~quarter aended ~~$0.1~~September ~~million~~30, ~~fair~~2023, ~~value~~the ~~gain~~Company ~~from~~recorded ~~mark-to-market~~a ~~adjustments~~gain onof ~~the~~$14.5 million ~~contingent~~gain ~~liabilities~~on ~~assumed~~issuance ~~from the acquisition~~ of ~~the~~OID ~~Somahlution~~Convertible ~~assets,~~Notes due to ~~changes in~~ the fair value of ~~the~~Class ~~contingent~~E ~~consideration.~~and ~~This~~Class ~~represents a decrease of~~F ~~$0.6~~warrants ~~million~~exceeding ~~compared~~the tovalue of the $0debt principal.7 ~~million~~No ~~fair~~such ~~value~~loss ~~gain~~was ~~recognized~~recorded in the current quarter ended ~~June~~September 30, ~~2023~~2024.

InThe ~~the~~Company ~~three~~also ~~months~~recorded ~~ended~~a ~~June~~loss ~~30,~~of ~~2024,~~$4.0 ~~the~~million ~~Company~~in ~~recorded~~the acomparative ~~$0.7~~quarter ~~million~~ended ~~gain~~September 30, 2023 on ~~the~~issuance ~~extinguishment~~ of ~~Convertible~~15% ~~Notes and~~ OID Convertible Notes due to the ~~amendment~~fair value of ~~the~~Class ~~maturity~~E ~~dates for certain Notes~~ and Class ~~warrants~~F ~~attached~~Warrants toexceeding ~~those~~the ~~Notes.~~value ~~This~~of ~~represents~~the adebt $1principal.4 ~~million increase,~~No orsuch ~~197.4% compared to $0.7 million~~ loss was recorded in the ~~comparative~~current quarter ended ~~June~~September 30, ~~2023~~2024.

Lastly, in the comparative quarter ended June 30, 2023, the Company recorded a loss of $2.4 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 current quarter ended June 30, 2024.28

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

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

	Six Months Ended June 30,
	Nine Months Ended September 30,
	2024			2023			Change $
Revenue	$	32,855		$	~~313~~495,~~713~~248		$	(~~280~~462,~~858~~393	)
Direct cost of revenue		9,647			88139,~~886~~875			(79130,~~239~~228	)
Gross profit		23,208			~~224~~355,~~827~~373			(~~201~~332,~~619~~165	)
Operating expenses:
Direct costs of revenue
Professional fees		~~602~~721,~~772~~042			~~896~~1,~~650~~818,202			(~~293~~1,~~878~~097,160	)
Salary expenses		~~665~~983,~~684~~703			~~601~~931,~~972~~536			6352,~~712~~167
Research and development		~~634~~978,~~200~~339			1,~~297~~789,~~390~~625			(~~663~~811,~~190~~286	)
Stock-based compensation		95116,~~852~~646			~~371~~457,~~728~~860			(~~275~~341,~~876~~214	)
Depreciation and amortization		~~230~~338,~~054~~831			~~420~~630,~~631~~924			(~~190~~292,~~577~~093	)
Royalty expense		1,957			~~198~~211,~~248~~262			(~~196~~209,~~291~~305	)
Other general and administrative expenses		~~754~~1,~~141~~199,172			36,~~375~~310,~~073~~039			(25,~~620~~110,~~932~~867	)
Total operating expenses		24,~~984~~339,~~660~~690			712,~~161~~149,~~692~~448			(47,~~177~~809,~~032~~758	)
Total operating loss	$	(24,~~961~~316,~~452~~482	)	$	(611,~~936~~794,~~865~~075	)	$	37,~~975~~477,~~413~~593
Other income (expenses):
Interest and accretion expense		(76,~~100~~230,~~246~~294	)		(1511,~~121~~038,~~870~~400	)		84,~~021~~808,~~624~~106
Other income		200,000			-			200,000
Change in fair value of contingent liabilities		(~~497~~57,000	)		1312,~~990,~~000			(2369,~~487,~~000	)
Gain (loss) on debt extinguishment		559,830			(684,682	)		1,244,512
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		-			(26,~~377~~352,~~569~~562	)		26,~~377~~352,~~569~~562
Net loss	$	(1014,~~298~~792,~~868~~177	)	$	(2365,~~130~~185,~~986~~311	)	$	1250,~~832~~393,~~118~~134

Revenue

We recognized revenue of $0.03 million for the ~~six~~nine months ended ~~June~~September 30, 2024, compared to $0.35 million for the ~~six~~nine months ended September ~~June~~ 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.

~~Direct~~Cost ~~Costs~~ of ~~Revenue~~Goods Sold

During the ~~six~~nine months ended ~~June~~September 30, 2024, we incurred $0.01 million in direct costs of revenue, a decrease of $0.081 million, or 8193.91%, ~~compared~~ compared to approximately $0.091 million in direct costs of revenue during the ~~six~~nine months ended ~~June~~September 30, 2023. This decrease in cost of sales is attributed to the minimal sales during the ~~six~~nine months ended ~~June~~September 30, 2024, compared to the corresponding period in 2023.

Professional Fees

Professional fees decreased by approximately $01.31 million or 3260.83% to approximately $0.67 million in the ~~six~~nine months ended ~~June~~September 30, 2024 compared to to approximately $01.98 million in the ~~six~~nine months ended ~~June~~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.

Salary Expenses

Salary expenses in the six months ended June 30, 2024 were approximately $0.7 million, an approximately $0.06 million or 10.6% increase from the comparative period. This increase can be attributed to a lower portion of salaries being reclassified to research and development expenses, as the Company reduced its R&D efforts in the latter half of fiscal 2023.

Research and Development

“Research and development expenses for the ~~six~~nine months ended ~~June~~September 30, 2024, were approximately $01.60 million, representing a decrease of ~~approximately~~ approximately $0.78 million, or 5145.13%, 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.

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Stock-Based Compensation

Stock-based compensation decreased by $0.3 million, amounting to approximately $0.1 million for the ~~six~~nine months ended ~~June~~September 30, 2024, compared to approximately $0.45 million for the same period in 2023, representing a 74.25% 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 $0.23 million for the ~~six~~nine months ended ~~June~~September 30, 2024, down from approximately $0.46 million in the comparative period ended ~~June~~September 30, 2023, representing a 4546.3% decrease period over period. This decrease was attributed to ~~the~~ the impairment of MATLOC intangible assets at the end of fiscal 2023, which were amortized during the comparative period ended ~~June~~ September 30, 2023.

Royalty Expense

During the ~~six~~nine months ended ~~June~~September 30, 2024, the Company recorded ~~$0.002~~a ~~million~~negligent amount in royalty expenses, compared to $0.2 million in the same period in 2023. For the ~~six~~nine months ended ~~June~~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 ~~June~~September 30, 2024, due to minimal sales of DuraGraft during this time.

Other General and Administrative Expenses

Other general and administrative expenses decreased by $25.61 million, or 7781.70%, to approximately $01.82 million for the ~~six~~nine months ended ~~June~~September 30, 2024. This decrease iswas primarily ~~attributed~~driven toby the ~~expensing~~following offactors: a $0.5 million expense in deferred offering costs ~~due~~related to adjustments to the Convertible Notes recorded in the ~~comparative~~prior period,; a $0.7 million expense in deferred offering costs ~~related~~following to the Company’s withdrawal of its registration statement for a public offering in April 2023,; ~~and~~a ~~the~~ $1.3 million valuation of Class E and Class F Warrants issued in the ~~comparative~~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 ~~six~~nine months ended ~~June~~September 30, 2024, the Company incurred approximately $76.12 million in interest and accretion costs related to ~~convertible~~ convertible notes issued at a discount as part of its Units Private ~~Placement~~Placements. This represents a decrease of $84.08 million, or 5343.06%, compared to $1511.10 million in the comparative period ended ~~June~~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 $76.38 million being accreted to the principal of the Convertible Notes.

In the ~~six~~nine months ended ~~June~~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 ~~June~~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 $0.406 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 $20.4 million compared to the $2.0.3 million fair value gain recognized in the ~~six~~nine months ended ~~June~~September 30, 2023.

In the ~~six~~nine months ended ~~June~~September 30, 2024, the Company recorded a $03.69 million ~~gain~~loss on the extinguishment of Convertible Notes ~~and~~- ~~OID~~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 $118.20 million increase, or ~~181~~82.82% compared to $021.79 million loss in the comparative period ended ~~June~~September 30, 2023.

Lastly, in the comparative period ended ~~June~~September 30, 2023, the Company also recorded a loss of $26.4 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 ~~six~~nine months ended ~~June~~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 ~~June~~September 30, 2024, we had available cash of of approximately $0.~~005~~06 million and accumulated deficit of approximately $~~161~~170.03 million. We have funded our operations primarily from ~~capital~~ capital raises.

Debt

As of ~~June~~September 30, 2024, the Company had outstanding convertible notes with varying maturities for an aggregate principal amount of $2624.7 1 million, all payable within approximately 12 months. Future interest payments associated with the convertible notes total $81.70 million.

The Company also issues unsecured short-term promissory notes for operational purposes. As of ~~June~~September 30, 2024, the Company had $12.57 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 ~~June~~September 30, 2024, the Company had fixed lease payment ~~obligations~~ obligations of $0.98 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.

2531

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

	Six months ended June 30,
	Nine months ended September 30,
	2024			2023			Change
Net Cash provided by/(used in):
Operating activities	$	(12,~~541~~524,~~855~~984	)	$	(23,~~318~~470,~~013~~887	)	$	~~776~~945,~~158~~903
Financing activities		12,~~398~~440,~~612~~251			23,~~012~~434,~~374~~966			(~~613~~994,~~762~~715	)
Net change in cash	$	(~~143~~84,~~243~~733	)	$	(~~305~~35,~~639~~921	)	$	~~162~~(48,~~396~~812	)

Operating Activities

Net cash used in operating activities was approximately $12.5 million and approximately $2.3.5 million for the ~~six~~nine months ended ~~June~~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 ~~and receipts from our customers~~.

Financing Activities

Net cash provided by financing activities for the ~~six~~nine months ended ~~June~~September 30, 2024, was approximately $12.4 million. This amount includes $12.0 4 million raised from the issuance of promissory notes, with approximately $0.14 million repaid during the period. Additionally, $0.5 ~~million~~ million was raised from the agreement with Qualigen. In comparison, for the ~~six~~nine months ended ~~June~~September 30, 2023, net cash provided by financing activities was $23.04 million. This included $02.93 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 $~~161~~170.63 million at ~~June~~September 30, 2024 (December 31, 2023 - $~~151~~155.35 million). Additionally, the Company has negative working ~~capital~~ capital of approximately $2229.61 million (December 31, 2023 - $1921.67 million) and $0.~~005~~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 ~~condensed~~ 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~~ 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.

2632

Off-Balance Sheet Arrangements

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

2833

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 ~~June~~September 30, 2024. This conclusion was based on the material weaknesses in our internal control over financial reporting as further ~~described~~ 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 ~~six~~nine months ended ~~June~~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 ~~six~~nine months ended ~~June~~September 30, 2024, the Company took the following steps in order to improve its internal controls over ~~financial~~ 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.

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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 ~~June~~September 30, 2024, we have an accumulated deficit of $~~161~~170.63 million and incurred a net loss of $1014.38 million for the ~~six~~nine months ended ~~June~~ September 30, 2024. As of December 31, 2023 and December 31, 2022, the Company had an accumulated deficit of approximately $~~151~~155.3 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~~ 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~~ 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 ~~June~~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, ~~AND~~ USE OF PROCEEDS, AND ISSUER PURCHASES OF EQUITY SECURITIES.

During the three-month period ended ~~June~~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 ~~second~~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).

3035

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		~~Bylaws~~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 3.27 to Form SB8-~~2/A~~K ~~(File No: 333-146748)~~ filed ~~January~~on 14May 18, ~~2008~~2023)
4.1		Unsecured Subordinated Convertible Promissory Note issued by Marizyme, Inc., dated February 6, 2023 (incorporated by reference to Exhibit 4.1 to Form 8-K filed on February 7, 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)
4.2		Class D Common Stock Purchase Warrant issued by Marizyme, Inc. (incorporated by reference to Exhibit 4.2 to Form 8-K filed on February 7, 2023)
3.16		Bylaws (incorporated by reference to Exhibit 3.2 to Form SB-2/A (File No: 333-146748) filed January 14, 2008)
4.3		Promissory Note issued July 12, 2024 to Qualigen Therpaeutics, Inc.(incorporated by reference to Exhibit 10.1 to Form 8-K filed July 18, 2024)
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)
31.1*		Certifications of Principal Executive Officer filed pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
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)
31.2*		Certifications of Principal Financial and Accounting Officer filed pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
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)
32.1**		Certifications of Principal Executive Officer furnished pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
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)
32.2**		Certifications of Principal Financial and Accounting Officer furnished pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
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)
101.INS*		Inline XBRL Instance Document
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)
101.SCH*		Inline XBRL Taxonomy Extension Schema Document
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)
101.CAL*		Inline XBRL Taxonomy Extension Calculation Linkbase Document
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)
101.DEF*		Inline XBRL Taxonomy Extension Definition Linkbase Document
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)
101.LAB*		Inline XBRL Taxonomy Extension Label Linkbase Document
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)
101.PRE*		Inline XBRL Taxonomy Extension Presentation Linkbase Document
104*		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

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

3138

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: August 14, 2024	MARIZYME, INC.
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)

3239

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