10-Q 1 form10-q.htm
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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 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 ☒

 

As of August 14, 2024, 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. 19
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk. 28
ITEM 4. Controls and Procedures. 29
     
PART II - OTHER INFORMATION  
     
ITEM 1. Legal Proceedings. 30
ITEM 1A. Risk Factors. 30
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds. 30
ITEM 3. Defaults Upon Senior Securities. 30
ITEM 4. Mine Safety Disclosures. 30
ITEM 5. Other Information. 30
ITEM 6. Exhibits. 31
  Signatures 32

 

2
 

 


PART I – FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

 

MARIZYME, INC.

Condensed Consolidated Balance Sheets

 

   June 30, 2024     December 31, 2023 
   (unaudited)      
ASSETS:          
Current          
Cash  $5,222   $148,465 
Accounts receivable   -    60,284 
Other receivables   35,848    35,797 
Prepaid expenses   854,148    699,377 
Inventory   26,869    24,855 
Total current assets   922,087    968,778 
Non-current          
Property, plant and equipment, net   -    12,500 
Operating lease right-of-use assets, net   899,411    1,101,211 
Intangible assets, net   14,146,575    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   20,612,486    21,046,297 
Total assets  $21,534,573   $22,015,075 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT):          
Current          
Accounts payable and accrued expenses  $3,269,250   $2,322,064 
Notes payable   1,541,627    633,692 
Due to related parties   287,900    230,153 
Convertible notes, net - Units Private Placement   17,022,717    14,288,335 
Convertible notes, net - OID   990,636    2,694,256 
Operating lease obligations   439,508    434,082 
Total current liabilities   23,551,638    20,602,582 
Non-current          
Operating lease obligations, net of current portion   459,903    667,129 
Agreement obligation   1,000,000    - 
Contingent liabilities   5,903,000    5,406,000 
Total non-current liabilities   7,362,903    6,073,129 
Total liabilities   30,914,541    26,675,711 
           
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   -    - 
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  
Additional paid-in capital   152,123,457    146,543,921 
Accumulated deficit   (161,635,217)   (151,336,349)
Total stockholders’ equity (deficit)   (9,379,968)   (4,660,636)
Total liabilities and stockholders’ equity (deficit)  $21,534,573   $22,015,075 

 

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

 

3
 

 

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 
Direct cost of revenue   -    49,611    9,647    88,886 
Gross profit   -    135,128    23,208    224,827 
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 
Salary expenses   355,525    335,004    665,684    601,972 
Research and development   312,333    691,393    634,200    1,297,390 
Stock-based compensation   41,588    160,762    95,852    371,728 
Depreciation and amortization   121,277    210,293    230,054    420,631 
Royalty expense   -    162,065    1,957    198,248 
Other general and administrative expenses   419,961    2,867,749    754,141    3,375,073 
Total operating expenses   1,589,360    4,939,110    2,984,660    7,161,692 
Total operating loss   (1,589,360)   (4,803,982)   (2,961,452)   (6,936,865)
                     
Other income (expense)                    
Interest and accretion expenses   (2,938,416)   (13,424,169)   (7,100,246)   (15,121,870)
Other income   200,000    -    200,000    - 
Change in fair value of contingent liabilities   88,000    714,000    (497,000)   1,990,000 
Gain (loss) on debt extinguishment   667,200    (684,682)   559,830    (684,682)
Borrowing costs   (500,000)   -    (500,000)   -  
Loss on issuance of debt   -    (2,377,569)   -    (2,377,569)
Total other expense   (2,483,216)   (15,772,420)   (7,337,416)   (16,194,121)
Net loss  $(4,072,576)  $(20,576,402)  $(10,298,868)  $(23,130,986)
Loss per share – basic and diluted  $(0.03)  $(0.48)  $(0.08)  $(0.55)
Weighted average number of shares of common stock outstanding – basic and diluted   131,793,088    43,187,439    131,793,088    41,979,194 

 

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

 

4
 

 

MARIZYME, INC.

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

Three and Six Months Ended June 30, 2024 and 2023

(Unaudited)

 

                     
   Common Stock   Additional Paid-in   Accumulated    Total Stockholders’ 
   Shares   Amount   Capital     Deficit    Equity 
                     
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    221,540    -    223,486 
Exercise of warrants   2,652,159    2,652    262,564    -    265,216 
Issuance of warrants on debt extinguishment   -    -    19,058,426    -    19,058,426 
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   -    -    -    (20,576,402)   (20,576,402)
Balance, June 30, 2023 (unaudited)   45,366,760   $45,366   $116,344,709   $(109,120,419)  $7,269,656 

 

   Common Stock   Additional Paid-in   Accumulated   

Total Stockholders’

Equity

 
   Shares   Amount   Capital     Deficit     (Deficit) 
                     
Balance, December 31, 2023   131,793,088   $131,792   $146,543,921   $(151,336,349)  $(4,660,636)
Stock-based compensation expense   -    -    54,264    -    54,264 
Net loss   -    -    -    (6,226,292)   (6,226,292)
Balance, March 31, 2024 (unaudited)   131,793,088   $131,792   $146,598,185   $(157,562,641)  $(10,832,664)
Stock-based compensation expense   -    -    41,588    -    41,588 
Modification of warrants   -    -    5,483,684    -    5,483,684 
Net loss   -    -    -    (4,072,576)   (4,072,576)
Balance, June 30, 2024 (unaudited)   131,793,088   $131,792   $152,123,457   $(161,635,217)  $(9,379,968)

 

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

 

5
 

 

MARIZYME, INC.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

         
   Six Months Ended June 30, 
   2024   2023 
         
Cash flows from operating activities:          
Net loss  $(10,298,868)  $(23,130,986)
Adjustments to reconcile net loss to net cash used in operating activities:          
Depreciation and amortization   230,054    420,631 
Amortization of ROU asset   201,800    - 
Stock-based compensation   95,852    371,728 
Interest and accretion on convertible notes and notes payable   7,100,246    15,121,870 
Change in fair value of contingent liabilities   497,000    (1,990,000)
Gain (loss) on debt extinguishment   (559,830)   684,682 
Loss on issuance of debt   -    2,377,569 
Shares issued as part of the Confidential Settlement Agreement   -    153,600 
Shares issued for services   -    138,000 
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)
Prepaid expenses   (154,771)   519,414 
Inventory   (2,014)   75,843 
Accounts payable and accrued expenses   932,496    1,657,909 
Due to related parties   57,747    143,351 
Operating lease liabilities   

(201,800

)   

(190,581

)
Net cash used in operating activities   (1,541,855)   (2,318,013)
           
Cash flows from financing activities:          
Proceeds from issuance of OID Convertible Notes, net of issuance cost   -    870,000 
Proceeds from shares issued for exercise of warrants   -    265,216 
Proceeds from promissory notes   1,040,000    1,000,000 
Repayments of promissory notes   (141,388)   (122,842)
Proceeds from agreement   500,000    - 
Net cash provided by financing activities   1,398,612    2,012,374 
           
Net change in cash   (143,243)   (305,639)
           
Cash at beginning of period   148,465    510,865 
           
Cash at end of period  $5,222   $205,226 
           
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  $

-

   $5,461,702 
Warrants and debt discount issued in connection with convertible notes  $-   $19,058,426 
Settlement of notes payable with convertible notes  $-   $2,064,133 
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.

 

6
 

 

MARIZYME, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2024

 

NOTE 1 – DESCRIPTION OF BUSINESS

 

Maryzime, 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 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 $161,635,217 at June 30, 2024 (December 31, 2023 - $151,336,349). Additionally, the Company has negative working capital of $22,629,551 (December 31, 2023 - $19,633,804) and $5,222 (December 31, 2023 - $148,465) of cash on hand, which is not sufficient to fund operations for the next twelve months. These factors raise substantial doubt about the Company’s ability to continue as a going concern.

 

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

 

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

 

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

 

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

 

NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Basis of Presentation and Principles of Consolidation

 

The accompanying unaudited condensed consolidated financial statements include the consolidated accounts of the Company and its wholly owned subsidiaries: My Health Logic Inc (“My Health Logic” or “MHL”), Somahlution, Inc. (“Somahlution”), Somaceutica, Inc. (“Somaceutica”), (collectively – “Somahlution”), Marizyme Sciences, Inc. (“Marizyme Sciences”), and DuraGraft, Inc. 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 filed with the SEC on May 13, 2024 (the “2023 Form 10-K”). The condensed consolidated balance sheet as of December 31, 2023 was derived from audited consolidated financial statements included in the 2023 Form 10-K 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.

 

7
 

 

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 payable, and amounts due to related parties approximate fair value due to the short-term nature of these instruments.

 

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

 

Contingent Liabilities

 

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

 

  i. The performance warrants and pediatric vouchers warrants liabilities were valued using a Monte Carlo simulation model utilizing the following weighted average assumptions: risk free rate of 1.19%, expected volatility of 69.62%, expected dividend of $0, and expected life of 5.96 years. For the three and six months ended June 30, 2024, changes in these assumptions resulted in a $98,000 and $140,000 decrease in fair value of these liabilities, respectively. At June 30, 2024, the fair market value of performance warrants and pediatric vouchers warrants liabilities was $85,000 (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. 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 months ended June 30, 2024, changes in these assumptions resulted in a $10,000 and $637,000 increase in fair value of this liability, respectively. At June 30, 2024, the fair market value of royalty payments was $3,995,000 (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 months ended June 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 $0, and expected life of 5 years. No changes to the fair value of liquidation preference liability were recorded in the three and six months ended June 30, 2024 and 2023. At June 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 and six months ended June 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 $5,483,684 related to the change in the fair value of warrants. Of this amount, $5,344,229 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 $139,455, which exceeded the principal of the Convertible Notes, was recognized as a loss on debt extinguishment in the condensed consolidated statements of operations for the six months ended June 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 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.

 

8
 

 

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

 

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

 

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

 

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

 

Marizyme measures the following financial instruments at fair value on a recurring basis. As of June 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 
   Fair Value Hierarchy 
June 30, 2024  Level 1   Level 2   Level 3 
Liabilities               
Contingent liabilities  $-   $-   $5,903,000 
Total  $-   $-   $5,903,000 

 

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 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   497,000 
Balance at June 30, 2024  $5,903,000 

 

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.

 

9
 

 

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 issued 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 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 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 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 30, 2024, the remaining lease term was 2.08 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 months ended June 30, 2024 was $63,885 and $161,058, respectively (June 30, 2023 – $37,674 and $192,502, respectively).

 

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

 

   June 30, 2024   December 31, 2023 
Right-of-use asset  $899,411   $1,101,211 
           
Operating lease liabilities, current  $439,508   $434,082 
Operating lease liabilities, non-current   459,903    667,129 
Total operating lease liabilities  $899,411   $1,101,211 

 

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

 

      
2024  $217,041 
2025   444,934 
2026   266,034 
Total lease payments  $928,009 
Less: Present value discount   (28,598)
Total  $899,411 

 

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 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 months ended June 30, 2024.

 

10
 

 

DuraGraft

 

As part of the Somahlution acquisition in 2020, Marizyme purchased of intangible assets valued at $18,170,000 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 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 months ended June 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 recognized on MHL’s intangible assets and recorded in the impairment of intangible assets in the consolidated statements 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 six months ended June 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 of operations for the year ended December 31, 2023.

 

   June 30, 2024
   Gross Carrying Amount   Accumulated Amortization   Net Carrying Amount 
Patents in process  $122,745   $-   $122,745 
DuraGraft patent   5,256,000    (1,583,537)   3,672,463 
DuraGraft - Distributor relationship   308,000    (120,633)   187,367 
DuraGraft IPR&D - Cyto Protectant Life Sciences   10,164,000    -    10,164,000 
   $15,850,745   $(1,704,170)  $14,146,575 

 

   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 

 

 SCHEDULE OF GOODWILL

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

 

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

 

 

Balance, December 31, 2022  $27,675,020 
Impairment   (12,469,720)
Amortization expense   (841,171)
Balance, December 31, 2023  $14,364,129 
Amortization expense   (217,554)
Balance, June 30, 2024  $14,146,575 

 

11
 

 

Future amortizations for DuraGraft intangible assets for the next five years will be $435,108 for each year from 2025 through 2029 and $1,684,289 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 to pay past due amounts and monthly installments may result in cancellation of the Company’s insurance. As of June 30, 2024, the Company has outstanding balance under the note payable in the amount of $30,360 (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 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 notes were unsecured, bore interest at a rate of 9% per annum with no maturity date. The Company settled an aggregate of $278,678 of these notes payable as part of Unit Purchase Agreement issuances during the year ended December 31, 2022 (see Note 7). For the three and six months ended June 30, 2024, the Company accrued $5,602 and $11,142 in interest on the notes payable respectively (June 30, 2023 - $5,298 and $18,366, respectively). As of June 30, 2024, balance of the remaining note payable was $255,267 (December 31, 2023 - $252,223).

 

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

 

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

 

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

 

h) As of June 30, 2024, the Company has outstanding borrowings under a note payable to Dr. Vithalbhai Dhaduk in the principal amount of $150,000 (December 31, 2023 - $Nil). The note payable bears no interest and is due on demand.

 

12
 

 

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 replaced with an aggregate of 190,584,260 pro rata Units, and a loss on debt extinguishment of $684,682 was recorded in consolidated statements 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 $7,378,993 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 months ended June 30, 2024, the Company amended certain Convertible Note with original maturity dates of March 24, 2024 and June 17, 2024, to extend their term until March 24, 2025 and June 17, 2025, respectively. In connection with the extension of the maturity date for the outstanding Convertible Notes, the Company executed a substantial modification that led to the extinguishment of the existing Convertible Notes and the issuance of new Convertible Notes. This modification resulted in a gain on extinguishment of $126,521 and $699,286, which has been recognized in the condensed consolidated statements of operations for the three and six months ended June 30, 2024 respectively (June 30, 2023 - $684,682 and $684,682, respectively).

 

During the three and six months ended June 30, 2024, the Company recognized interest and accretion expense of $1,342,178 and $3,433,668, respectively (June 30, 2023 - $5,730,714 and $7,286,891, 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 value of the warrants issued have been recorded as debt discount and is being amortized to interest and accretion expense using the effective interest method over the term of the Convertible Notes.

 

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:

 

Balance, December 31, 2022  $2,751,633 
Issuance costs   - 
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   (19,403,385)
Debt accretion on New Securities   17,792,071 
Mandatory Default Amount   7,378,993 
Conversion of debt   (9,426,260)
Extinguishment of debt   (10,518,069)
Convertible notes issued with extended maturity date   10,518,069 
Debt discount   (1,520,047)
Debt accretion   63,578 
Balance, December 31, 2023  $14,288,335 
Debt accretion   3,433,668 
Extinguishment of debt   (4,828,403)
Convertible notes issued with extended maturity date   5,334,069 
Debt discount   (1,204,952)
Balance, June 30, 2024  $17,022,717 

 

13
 

 SCHEDULE OF CONVERTIBLE NOTES NET OF DEBT DISCOUNT

  

June 30, 2024

   December 31, 2023 
Convertible notes - total principal  $19,492,617   $18,955,174 
Unamortized issuance costs and discount   (2,469,890)   (4,666,839)
Convertible Notes, Net of Debt Discount  $17,022,717   $14,288,335 

 

   June 30, 2024   December 31, 2023 
Current portion  $17,022,717   $14,288,335 
Non-current portion   -    - 
Convertible Notes, Net of Debt Discount  $17,022,717   $14,288,335 

 

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 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 and six months ended June 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 and six months ended June 30, 2024, the Company recognized an incremental fair value increase of $4,075,749 and $5,483,684 as a change in the fair value of warrants, respectively. Of this amount, $5,344,229 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 $139,455, which exceeded the principal of the Convertible Notes, was recognized as a loss on debt extinguishment in the condensed consolidated statements of operations for the three and six months ended June 30, 2024 respectively (June 30, 2023 - $Nil and $Nil, respectively).

 

During the three and six months ended June 30, 2024, the Company recognized interest and accretion expense of $1,566,561 and $3,640,609, respectively (June 30, 2023 - $150,086 and $150,086, respectively), in the condensed consolidated statements of operations.

 

14
 

 

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

  

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   3,640,609 
Extinguishment of debt   (4,961,146