UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

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

 

For the quarterly period ended September 30, 2020March 31, 2021

 

[  ] 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

Incorporation or Organization)

(I.R.S. Employer

Identification No.)

225 Chimney Corner Lane,555 Heritage Drive, Suite 2001,205, Jupiter, Florida 33458

(Address of principal executive offices) (Zip Code)

(561) 935-9955

(Registrant’s telephone number)

 

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] 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 [X] 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

[X]

Non-accelerated filer

[X]

Smaller reporting company

[X]

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[X]

 

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. [X]

 

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.

 

The number of the registrant’s shares of common stock outstanding was 35,888,18835,928,188 as of November 13, 2020.



May 6, 2021.

 

MARIZYME, INC.

 

FORM 10-QMARIZYME, INC.

 

FORM 10-Q

TABLE OF CONTENTS

 

Page
PART I—FINANCIAL INFORMATION

Page

ITEM 1.

Consolidated Financial Statements (unaudited)

4

ITEM 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

20

ITEM 3.

Quantitative and Qualitative Disclosures About Market Risk

25

ITEM 4.

Controls and Procedures

26

25

PART II—OTHER INFORMATION

ITEM 1.

Legal Proceedings

28

27

ITEM 1A.

Risk Factors

28

27

ITEM 2.

Unregistered Sales of Equity Securities and Use of Proceeds

28

27

ITEM 3.

Defaults Upon Senior Securities

28

27

ITEM 4.

Mine Safety Disclosures

28

27

ITEM 5.

Other Information

28

27

ITEM 6.

Exhibits

30

27

Signatures

31

29

 



 

PART I – FINANCIAL INFORMATION

 

TABLE OF CONTENTS

 

Index to Financial Statements

Page

Condensed Consolidated Balance Sheets as of September 30, 2020March 31, 2021 (unaudited) and December 31, 2019

2020

4

Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30,March 31, 2021 and 2020 and 2019 (unaudited)

5

Condensed Consolidated Statements of Changes in Stockholders’ Equity for the Three and Nine Months Ended September 30,March 31, 2021 and 2020 and 2019 (unaudited)

6

Condensed Consolidated Statements of Cash Flows for the NineThree Months Ended September 30,March 31, 2021 and 2020 and 2019 (unaudited)

7

Notes to Condensed Consolidated Financial Statements (unaudited)

8

 

8



 

ITEM 1. FINANCIAL STATEMENTS

 

MARIZYME, INC.

and Subsidiaries

Condensed Consolidated Balance Sheets

 

 

 

September 30,

 

December 31,

 

 

2020

 

2019

 

 

(Unaudited)

 

 

ASSETS

 

 

 

 

Current assets

 

 

 

 

Cash

$

5,196,516

$

90

Accounts receivable

 

93,010

 

-

Prepaid expense

 

219,060

 

-

Inventory

 

161,969

 

-

Total current assets

 

5,670,555

 

90

 

 

 

 

 

Fixed assets, net

 

7,779

 

-

 

 

 

 

 

Other assets

 

 

 

 

Intangible assets, net

 

42,802,349

 

28,613,000

 

 

 

 

 

Total assets

$

48,480,683

$

28,613,090

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

Current liabilities

 

 

 

 

Accounts payable and accrued expenses

$

466,119

$

270,218

Total current liabilities

 

466,119

 

270,218

Total liabilities

 

466,119

 

270,218

 

 

 

 

 

Commitments and contingencies (see Note 5)

 

-

 

-

 

 

 

 

 

Stockholders' equity

 

 

 

 

Preferred stock, $0.001 par value, 25,000,000 shares authorized,

 

 

 

 

0 shares issued and outstanding as of September 30,

 

 

 

 

2020 and December 31, 2019

 

-

 

-

Common stock, par value $0.001, 75,000,000 shares authorized,

 

 

 

 

51,888,188 issued and issuable, 35,888,188 outstanding as of September 30,

 

 

 

 

2020, and 35,858,939 issued, 19,858,939 outstanding as of December 31, 2019

 

35,888

 

19,859

 

 

 

 

 

Treasury Stock

 

(16,000)

 

(16,000)

Additional paid in capital

 

81,946,582

 

59,319,594

Accumulated deficit

 

(33,951,905)

 

(30,980,581)

Total stockholders' equity

 

48,014,565

 

28,342,872

Total liabilities and stockholders' equity

$

48,8480,683

$

28,613,090

 

 

 

 

 

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



  March 31,  December 31, 
  2021  2020 
  (unaudited)     
ASSETS        
Current assets        
Cash $834,957  $2,902,762 
Accounts receivable  35,783   40,585 
Prepaid expense  63,100   106,390 
Inventory  44,640   56,340 
Total current assets  978,480   3,106,077 
         
Fixed assets, net  4,122   7,122 
Operating lease right-of-use assets, net  1,257,929   1,317,830 
Intangible assets, net  41,927,293   42,278,211 
Prepaid royalties, non-current  340,969   344,321 
Deposits  30,000   30,000 
         
Total assets $44,538,793  $47,083,561 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Current liabilities        
Accounts payable and accrued expenses $445,069  $478,103 
Operating lease obligations, current portion  304,114   243,292 
Total current liabilities  749,183   721,395 
Non-current liabilities        
Operating lease obligations, non-current portion  978,148   1,074,538 
   978,148   1,074,538 
Total liabilities  1,727,331   1,795,933 
         
Commitments and contingencies (see Note 5)  -   - 
         
Stockholders’ equity        
Preferred stock, $0.001 par value, 25,000,000 shares authorized, 0 shares issued and outstanding as of March 31, 2021 and December 31, 2020  -   - 

Common stock, par value $0.001, 75,000,000 shares authorized, 35,928,188 shares issued and outstanding as of March 31, 2021 and December 31, 2020

  35,928   35,928 
Additional paid in capital  82,411,719   82,077,334 
Accumulated deficit  (39,636,185)  (36,825,634)
Total stockholders’ equity  42,811,462   45,287,628 
Total liabilities and stockholders’ equity $44,538,793  $47,083,561 

 

MARIZYME, INC.

and Subsidiaries

Condensed Consolidated Statements of Operations

(unaudited)

 

 

For the three

months ended

 

For the nine

months ended

 

 

September 30,

 

September 30,

 

 

2020

 

2019

 

2020

 

2019

 

 

 

 

 

 

 

 

 

Revenue

$

124,985

$

-

$

124,985

$

-

 

 

 

 

 

 

 

 

 

Operating expenses

 

 

 

 

 

 

 

 

Direct costs of revenue

 

25,714

 

-

 

25,714

 

-

Professional fees

 

170,753

 

(48,344)

 

494,295

 

189,458

Salary expenses

 

433,318

 

-

 

433,318

 

-

Stock-based compensation

 

1,107,085

 

554,633

 

1,674,200

 

554,633

Other general and administrative expenses

 

453,159

 

2,273

 

468,783

 

70,449

Total operating expenses

 

2,190,028

 

508,562

 

3,096,309

 

814,540

 

 

 

 

 

 

 

 

 

Loss from operations

 

(2,065,043)

 

(508,562)

 

(2,971,324)

 

(814,540)

 

 

 

 

 

 

 

 

 

Net loss

$

(2,065,043)

$

(508,562)

$

(2,971,324)

$

(814,540)

 

 

 

 

 

 

 

 

 

Loss per share - basic and fully diluted

$

(0.08)

$

(0.03)

$

(0.13)

$

(0.04)

 

 

 

 

 

 

 

 

 

Weighted average number of shares of common stock – 

basic and fully diluted

 

29,288,226

 

19,858,939

 

23,161,329

 

19,746,153

 

 

 

 

 

 

 

 

 

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



MARIZYME, INC.

and Subsidiaries

Condensed Consolidated Statement of Changes in Stockholders' Equity

For the Three and Nine Months Ended September 30, 2020 and 2019

(unaudited)

 

Preferred Stock

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Paid in

 

Treasury

 

Accumulated

 

 

 

Shares

 

Amount

 

Shares

 

Amount

 

Capital

 

Stock

 

Deficit

 

Total

Balance, June 30, 2019

-

$

-

 

19,858,939

$

19,859

$

59,265,640

$

(16,000)

$

(30,669,536)

$

28,599,963

Net loss

-

 

-

 

-

 

-

 

-

 

-

 

(508,562)

 

(508,562)

Balance, September 30, 2019

-

$

-

 

19,858,939

 

19,859

$

59,265,640

$

(16,000)

$

(31,178,098)

$

28,091,401

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2018

-

$

-

 

19,740,302

$

19,740

$

58,496,126

$

(16,000)

$

(29,922,542)

$

28,577,324

Issuance of shares

-

 

-

 

118,637

 

119

 

124,881

 

-

 

-

 

125,000

Forgiveness of debt for

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

services

-

 

-

 

-

 

-

 

90,000

 

-

 

-

 

90,000

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

expense

-

 

-

 

-

 

-

 

554,633

 

-

 

-

 

554,633

Net loss  

-

 

-

 

-

 

-

 

-

 

-

 

(814,540)

 

(814,540)

Balance, September 30, 2019

-

$

-

 

19,858,939

$

19,859

$

59,265,640

$

(16,000)

$

(30,737,082)

$

28,532,417

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, June 30, 2020

-

$

-

 

20,183,939

$

20,184

$

60,076,294

$

(16,000)

$

(31,886,862)

$

28,193,616

Sale of common stock

-

 

-

 

5,600,192

 

5,600

 

6,269,464

 

-

 

-

 

6,275,064

Issuance of common stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

for acquisition

-

 

-

 

10,000,000

 

10,000

 

12,490,000

 

-

 

-

 

12,500,000

Issuance of warrants for

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

acquisition

-

 

-

 

-

 

-

 

1,932,300

 

-

 

-

 

1,932,300

Issuance of warrants for

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

services

-

 

-

 

-

 

-

 

253,749

 

-

 

-

 

253,749

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

expense

-

 

-

 

-

 

-

 

802,926

 

-

 

-

 

802,926

Issuance of common stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

for services

-

 

-

 

50,000

 

50

 

62,450

 

-

 

-

 

62,450

Exercise of options for

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

common stock

-

 

-

 

54,057

 

54

 

59,399

 

-

 

-

 

59,453

Net loss  

-

 

-

 

-

 

-

 

-

 

-

 

(2,065,043)

 

(2,065,043)

Balance, September 30, 2020

-

$

-

 

35,888,188

$

35,888

$

81,946,582

$

(16,000)

$

(34,268,905)

$

48,014,565

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2019

-

$

-

 

19,858,939

$

19,859

$

59,319,594

$

(16,000)

$

(30,980,581)

$

28,342,872

Issuance of common stock in

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

lieu of debt

-

 

-

 

195,000

 

195

 

196,755

 

-

 

-

 

196,950

Issuance of common stock in lieu of debt

-

 

-

 

5,000

 

5

 

5,045

 

-

 

-

 

5,050

Issuance of common stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

for services

-

 

-

 

175,000

 

175

 

187,325

 

-

 

-

 

187,500

Sale of common stock

-

 

-

 

5,600,192

 

5,600

 

6,269,464

 

-

 

-

 

6,275,0646

Issuance of common stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

for acquisition

-

 

-

 

10,000,000

 

10,000

 

12,490,000

 

-

 

-

 

12,500,000

Issuance of warrants for

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

acquisition

-

 

-

 

-

 

-

 

1,932,300

 

-

 

-

 

1,932,300

Issuance of warrants for

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

services

-

 

-

 

-

 

-

 

253,749

 

-

 

-

 

253,749

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

expense

-

 

-

 

-

 

-

 

1,232,951

 

-

 

-

 

1,232,951

Exercise of options for

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

common stock

-

 

-

 

54,057

 

54

 

59,399

 

-

 

-

 

59,453

Net loss  

-

 

-

 

-

 

-

 

-

 

-

 

(2,971,324)

 

(2,971,324)

Balance, September 30, 2020

-

$

-

 

35,888,188

$

35,888

$

81,946,582

$

(16,000)

$

(33,951,905)

$

48,014,565

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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



MARIZYME, INC.

and Subsidiaries

Condensed Consolidated Statements of Cash Flows

For the nine months ended September 30,

(unaudited)

 

 

2020

 

2019

Cash flows from operating activities:

 

 

 

 

Net loss

$

(2,971,324)

$

(814,540)

Adjustments to reconcile net loss to net cash used in operations:

 

 

 

 

Depreciation expense

 

1,313

 

-

Amortization

 

341,270

 

-

Stock-based compensation

 

1,420,451

 

554,633

Issuance of warrants for services

 

253,749

 

-

Debt forgiven and included in operations

 

-

 

(81,500)

Change in operating assets and liabilities:

 

 

 

 

Accounts receivable

 

(93,010)

 

-

Prepaid expense

 

(62,487)

 

15,000

Inventory

 

21,500

 

-

Accounts payable and accrued expenses

 

140,233

 

201,303

Net cash used in operating activities

 

(948,305)

 

(125,104)

 

 

 

 

 

Cash flows used in investing activities:

 

 

 

 

Purchase of intangible assets

 

(130,333)

 

-

Net cash used in investing activities

 

(130,333)

 

-

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

Shares issued for cash net of offering costs

 

6,275,064

 

125,000

Net cash provided by financing activities

 

6,275,064

 

125,000

 

 

 

 

 

Net increase (decrease) in cash

 

5,196,426

 

(104)

 

 

 

 

 

Cash at beginning of period

 

90

 

104

 

 

 

 

 

Cash at end of period

$

5,196,516

$

-

 

 

 

 

 

Supplemental disclosure of cash flow information:

 

 

 

 

Cash paid for interest

$

-

$

-

Cash paid for taxes

$

-

$

-

 

 

 

 

 

Non-cash investing and financing activities:

 

 

 

 

Debt forgiven from related party and included in capital

$

-

$

90,000

Issuance of common stock in lieu of payables

$

261,453

$

-

Issuance of common stock in connection with business combination

$

12,500,000

$

-

Issuance of warrants in connection with business combination

$

1,932,300

$

-

 

 

 

 

 

 

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



 

MARIZYME, INC.

and Subsidiaries

Condensed Consolidated Statements of Operations

For the Three Months Ended March 31,

(unaudited)

  2021  2020 
       
Revenue $73,952  $- 
         
Operating expenses        
Direct costs of revenue  30,842   - 
Professional fees  659,058   108,019 
Salary expenses  1,036,457   - 
Stock-based compensation  367,718   

221,058

 
Depreciation and amortization  416,595   - 
Other general and administrative expenses  373,833   142,293 
Total operating expenses  2,884,503   471,370 
Total operating loss  (2,810,551)  (471,370)
         
Net loss $(2,810,551) $(471,370)
         
Loss per share – basic and diluted $(0.08) $(0.02)
         
Weighted average number of shares of common stock – basic and diluted  35,928,188   19,887,021 

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

MARIZYME, INC.

and Subsidiaries

Condensed Consolidated Statements of Changes in Stockholders’ Equity

For the Three Months Ended March 31, 2021 and 2020

(unaudited)

      Additional          
  Preferred Stock  Common Stock  Paid in  Treasury  Accumulated    
  Shares  Amount  Shares  Amount  Capital  Stock  Deficit  Total 
Balance, December 31, 2019  -  $-   19,858,939  $19,859  $59,319,594  $(16,000) $(30,980,581) $28,342,872 
Common stock issued  -   -   125,000   125   124,875   -   -   125,000 
Stock-based compensation expense  -   -   -   -   

221,058

   

-

   -   221,058 
Net loss  -   -   -   -   -   -   (471,370)  (471,370)
Balance, March 31, 2020  -  $-   19,983,939  $19,984  $59,665,527  $(16,000) $(31,451,951) $28,217,560 
                                 
Balance, December 31, 2020  -  $-   35,928,188  $35,928  $82,077,334  $-  $(36,825,634) $45,287,628 
Stock-based compensation expense  -   -   -   -   

334,385

   

-

   -   334,385 
Net loss  -   -   -   -   -   -   (2,810,551)  (2,810,551)
Balance, March 31, 2021  -  $-   35,928,188  $35,928  $82,411,719  $-  $(39,636,185) $42,811,462 

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

MARIZYME, INC.

and Subsidiaries

Condensed Consolidated Statements of Cash Flows

For the Three Months Ended March 31,

(unaudited)

  2021  2020 
       
Cash flows from operating activities:        
Net loss $(2,810,551) $(471,370)
Adjustments to reconcile net loss to net cash used in operations:        
Depreciation expense  62,901   - 
Amortization expense  353,694     
Stock-based compensation – stock options  334,385   346,058 
Stock-based compensation – restricted common stock  

33,333

   - 
Change in operating assets and liabilities:        
Accounts receivable  4,802   - 
Prepaid expense  43,290   - 
Inventory  11,700   - 
Accounts payable and accrued expenses  (98,584)  125,282 
Net cash used in operating activities  (2,065,030)  (30)
         
Cash flows used in investing activities:        
Purchase of intangible assets  (2,775)  - 
Net cash used in investing activities  (2,775)  - 
         
Net decrease in cash  (2,067,805)  (30)
         
Cash at beginning of period  2,902,762   90 
         
Cash at end of period $834,957  $60 
         
Supplemental disclosure of cash flow information:        
Cash paid for interest $-  $- 
Cash paid for taxes $-  $- 

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

MARIZYME, INC.

AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2020MARCH 31, 2021

(unaudited)

 

NOTE 1 – ORGANIZATION AND DESCRIPTION OF BUSINESS

 

Overview

 

Marizyme, Inc., a Nevada corporation formerly known as GBS Enterprises Incorporated (the “Company” or “Marizyme”), conducted its primary business through its majority owned subsidiary, GBS Software AG (“GROUP”), a German-based public-company.

 

By December 31, 2016, the Company had sold the controlling interest in GROUP and other subsidiaries, keeping only a minority interest in GROUP. On March 21, 2018, the Company formed a wholly owned subsidiary named Marizyme, Inc., a Nevada corporation, and merged with it, effectively changing the Company’s name to Marizyme, Inc. On June 1, 2018, the Company exchanged the shares of GROUP and all the intercompany assets and liabilities for 100% of the shares of X-Assets Enterprises, Inc, a Nevada Corporation. As part of a type-D business restructuring on September 5, 2018, the Company then distributed the X-Assets shares to its stockholders on a 1 for 1 basis.

 

Beginning after the X-Assets share distribution, Marizyme refocused on the life sciences and began to seek technologies to acquire.

 

On September 12, 2018, the Company consummated an asset acquisition with ACB Holding AB, Reg. No. 559119-5762, a Swedish corporation to acquire all right,rights, title, and interest in their Krillase technology in exchange for 16.98 million shares of Common Stock. Krillase is a naturally occurring enzyme that acts to break protein bonds and has applications in dental care, wound healing, and thrombosis.

 

On December 15, 2019, the Company entered into a contingent asset purchase agreement (the “Agreement”), as amended on March 31, 2020 and May 29, 2020, with Somahlution, LLC, Somahlution, Inc., and Somaceutica, LLC, companies duly organized under the laws of Delaware (collectively, “Somah”) to acquire all of the assets and none of the liabilities of Somah (the “Acquisition”), including DuraGraft®, a one-time intraoperative vascular graft treatment for use in vascular and bypass surgeries that maintains endothelial function and structure, and other related properties. On July 30, 2020, the Company and Somah entered into Amendment No. 3 to the Agreement which finalized this Agreement. Pursuant to the terms of this amendment, it was agreed that, as part of the Acquisition, the Company would acquire the outstanding capital stock of Somahlution, Inc., held by Somahlution, LLC, rather than the assets of Somahlution, Inc. This change to the Agreement was made to accommodate the European Union (“EU”) requirements with respect to the future manufacturing under Somahlution, Inc. of CE marked products for sale in the EU.

 

On September 25, 2020, the Company formed Somaceutica, Inc., a Florida corporation.

 

On September 30, 2020,March 31, 2021, the Company formed Marizyme Sciences, Inc., a Florida corporation.

 

The Company’s common stock, $0.001 par value per share (the “Common Stock”), is currently quoted on the OTC Markets QB Tier under the ticker symbol “MRZM.”

 

Change in Management and the Board of Directors

 

On September 1, 2020, Nicholas DeVito resigned as the Company’s interim chief executive officer and chief financial officer.

 

On September 1, 2020, Bruce Harmon was appointed as the Company’s chief financial officer.

 

On September 1, 2020, James Sapirstein, a director of the Company, became the Company’s interim chief executive officer.

 

On October 30, 2020, Dr. William Hearl was appointed as a Director on the Company’s board of directors.

On November 1, 2020, Dr. Neil J. Campbell was appointed as the Company’s chief executive officer, president, and director.

 

On November 1, 2020, James Sapirstein relinquished his role as interim chief executive officer.


On December 1, 2020, Dr. Steven Brooks was appointed as the Company’s Chief Medical Officer and Executive Vice President of Medical and Regulatory Affairs.

On December 2, 2020, Dr. Donald Very, Jr. was appointed as the Company’s Executive Vice President of Research and Development.


 

MARIZYME, INC.

AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

(unaudited)On January 16, 2021, Roger Schaller was appointed as the Company Executive Vice President of Commercial Operations.

 

On January 29, 2021, Amy Chandler was promoted to Executive Vice President of Regulatory and Quality Affairs.

On February 3, 2021, Julie Kampf was appointed as a Director on the Company’s board of directors.

On February 22, 2021, Dr. Vithal Dhaduk was appointed as a Director on the Company’s board of directors.

On March 18, 2021, Dr. Neil Campbell resigned as Chief Executive Officer, President and Director.

On March 19, 2021, James Sapirstein was appointed as Interim Chief Executive Officer.

On April 2, 2021, Dr. Satish Chandran was terminated as Chief Technology Officer.

NOTE 2 - GOING CONCERN

 

The accompanying unaudited condensed consolidated financial statements and the factors within it, have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business and the ability of the Company to continue as a going concern for a reasonable period of time. The Company had a net loss of $2,971,324$2,810,551 and cash used in operating activities of $948,305$2,065,030 for the ninethree months ended September 30, 2020.March 31, 2021. As of September 30, 2020,March 31, 2021, the Company had a working capital surplus of $5,204,436,$229,297, and accumulated deficit of $33,951,905.$39,636,185. The Company’s continuation as a going concern is dependent upon its ability to generate revenues and its ability to continue receiving investment capital and loans from third parties to sustain its current level of operations. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The Company is in the process of securing working capital from investors for common stock, convertible notes payable, and/or strategic partnerships. No assurance can be given that the Company will be successful in these efforts. The financial statements do not include any adjustments relating 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

 

The Company follows the accrual basis of accounting in accordance with generally accepted accounting principles in the United States of America (U.S. GAAP).

 

The unaudited condensed consolidated financial statements of the Company for the ninethree month periods ended September 30,March 31, 2021 and 2020 and 2019 have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and pursuant to the requirements for reporting on Form 10-Q and Regulation S-K. Accordingly, they do not include all the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. However, such information reflects all adjustments (consisting solely of normal recurring adjustments), which are, in the opinion of management, necessary for the fair presentation of the financial position and the results of operations. Results shown for interim periods are not necessarily indicative of the results to be obtained for a full fiscal year. The balance sheet information as of December 31, 20192020 was derived from the audited financial statements included in the Company’s financial statements as of and for the year ended December 31, 20192020 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on April 15, 2020.2021. These financial statements should be read in conjunction with that report.

 

Principles of Consolidation

 

The accompanying unaudited condensed consolidated financial statements include all of the accounts of the Company and its wholly owned subsidiaries, Somahlution, Inc. (“Somahlution”), Somaceutica, Inc. (“Somaceutica”) and Marizyme Sciences, Inc. (“Marizyme Sciences”). All significant intercompany balances and transactions have been eliminated.

 

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 allocation of the purchase price in a business combination to the underlying assets and liabilities, allowance for doubtful accounts, recoverability of long-term assets including intangible assets and recoverabilitygoodwill, amortization expense, inventory valuation, valuation of long-term assets including intangible assets and goodwill,warrants, stock-based compensation, and deferred tax valuations.

 



 

MARIZYME, INC.

AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

(unaudited)

NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES(CONTINUED)

Business Combinations

 

The Company accounts for business acquisitions using the acquisition method of accounting based on Accounting Standards Codification (“ASC”) 805 — Business Combinations, which requires recognition and measurement of all identifiable assets acquired and liabilities assumed at their fair value as of the date control is obtained. The Company determines the fair value of assets acquired and liabilities assumed based upon its best estimates of the acquisition-date fair value of assets acquired and liabilities assumed in the acquisition. Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired. Subsequent adjustments to fair value of any contingent consideration are recorded to the Company’s condensed consolidated statements of operations.

 

Stock-Based Compensation

 

Stock-based compensation expense is recorded in accordance with FASB ASC Topic 718, Compensation – Stock Compensation, for stock and stock options awarded in return for services rendered. The expense is measured at the grant-date fair value of the award and recognized as compensation expense on a straight-line basis over the service period, which is the vesting period. The Company estimates forfeitures that it expects will occur and records expense based upon the number of awards expected to vest. The fair value of each option is estimated on the date of grant using the Black-Scholes option pricing model.

 

Cash Equivalents

 

The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. At September 30, 2020March 31, 2021 and December 31, 2019,2020, the Company had no cash equivalents.

 

Reclassifications

Certain amounts in the prior year’s unaudited condensed consolidated financial statements have been reclassified to conform to the current period presentation. These reclassifications had no effect on reported losses, total assets, or stockholders’ equity as previously reported. The reclassifications were for the Statement of Operation which combined its expenses into two categories whereas, for comparison purposes for the three months ended March 31, 2021 to March 31, 2020, professional fees and stock-based compensation was segregated.

Allowance for Doubtful Accounts

 

The Company establishes an allowance for doubtful accounts to ensure trade and notes receivable are not overstated due to non-collectability. The Company’s allowance is based on a variety of factors, including age of the receivable, significant one-time events, historical experience, and other risk considerations. The Company did not have an allowance at September 30, 2020March 31, 2021 or December 31, 2019.2020. The Company haddid not record any bad debt expense in each of $0 and $0 for the ninethree months ended September 30, 2020March 31, 2021 and 2019, respectively. 2020.

Inventory

 

Inventory

Inventory consisted of primarily finished goods and is valued at the lower of cost or net realizable value. Inventory is held in a third-party warehouse in foreign countries. Cost is determined using the FIFO method. The Company decreases the value of inventory for estimated obsolescence equal to the difference between the cost of inventory and the estimated market value, based upon an aging analysis of the inventory on hand, specifically known inventory-related risks, and assumptions about future demand and market conditions. The Company has determined that no inventory of $161,969 and $0reserve was necessary as of September 30, 2020March 31, 2021 and December 31, 2019, respectively.2020.

 

Fair Value of Financial Instruments

 

The Company measures its financial assets and liabilities in accordance with FASB ASC 820 (the “Fair Value Topic”). For certain of our financial instruments, including cash, accounts payable, accrued expenses, and short-term loans the carrying amounts approximate fair value due to their short maturities.

 

We follow accounting guidance for financial and non-financial assets and liabilities. This standard defines fair value, provides guidance for measuring fair value and requires certain disclosures. This standard does not require any new fair value measurements, but rather applies to all other accounting pronouncements that require or permit fair value measurements. This guidance does not apply to measurements related to share-based payments. This guidance discusses valuation techniques, such as the market approach (comparable market prices), the income approach (present value of future income or cash flow), and the cost approach (cost to replace the service capacity of an asset or replacement cost). The guidance utilizes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three broad levels. The following is a brief description of those three levels:

 


Level 1:Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities.


10 

 

MARIZYME, INC.

AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

(unaudited)

NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES(CONTINUED)

Level 1:Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities. 

Level 2:Inputs other than quoted prices that are observable, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active. 

Level 3:Unobservable inputs in which little or no market data exists, therefore developed using estimates and assumptions developed by us, which reflect those that a market participant would use. 

Level 2:Inputs other than quoted prices that are observable, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.
Level 3:Unobservable inputs in which little or no market data exists, therefore developed using estimates and assumptions developed by us, which reflect those that a market participant would use.

  

The Company had no assets or liabilities measured at fair value on a recurring basis at September 30, 2020March 31, 2021 and December 31, 2019.2020.

 

Fixed Assets

 

Fixed assets are recorded at cost. Expenditures for major additions and betterments are capitalized. Maintenance and repairs are charged to operations as incurred. Depreciation is computed by the straight-line method over the assets estimated useful life. Upon the sale or retirement of property and equipment, the related cost and accumulated depreciation are removed from the accounts and any gain or loss is reflected in consolidated statements of operations.

 

Classification

Estimated Useful Lives

Equipment

5 to 7 years

Furniture and fixtures

4 to 7 years

Intangible Assets

Costs incurred to file patent applications and acquired intangibles are capitalized when the Company believes that there is a high likelihood that the patent will be issued and there will be future economic benefit associated with the patent. These costs will be amortized on a straight-line basis over a 20-year life from the date of patent filing. All costs associated with abandoned patent applications are expensed. In addition, the Company will review the carrying value of patents for indicators of impairment on a periodic basis and if it determines that the carrying value is impaired, it values the patent at fair value. As of March 31, 2021, $122,746 has been capitalized for patents which have not been amortized.

Impairment of Long-lived Assets

 

The Company follows ASC paragraph 360-10-05-4 of the FASB Accounting Standards Codification360 for its long-lived assets. The Company’s long-lived assets, such as intellectual property, are required to be reviewed for impairment annually, or whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable.

 

The Company assesses the recoverability of its long-lived assets by comparing the projected undiscounted net cash flows associated with the related long-lived asset or group of long-lived assets over their remaining estimated useful lives against their respective carrying amounts. Impairment, if any, is based on the excess of the carrying amount over the fair value of those assets. Fair value is generally determined using the asset’s expected future discounted cash flows or market value, if readily determinable. If long-lived assets are determined to be recoverable, but the newly determined remaining estimated useful lives are shorter than originally estimated, the net book values of the long-lived assets are depreciated over the newly determined remaining estimated useful lives.

 

The Company determined that there were no impairments of long-lived assets at September 30, 2020March 31, 2021 and December 31, 2019.



2020.

 

MARIZYME, INC.

AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

(unaudited)Revenue Recognition

 

NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES(CONTINUED)

Revenue Recognition

We recognize revenue under Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers, (“ASC 606”). The core principle of the revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services. We only apply the five-step model to contracts when it is probable that we will collect the consideration to which we are entitled in exchange for the goods and services transferred to the customer. The following five steps are applied to achieve that core principle:

 

Step 1:Identify the contract with the customer 

Step 2:Identify the performance obligations in the contract 

Step 3:Determine the transaction price 

Step 4:Allocate the transaction price to the performance obligations in the contract 

Step 5:
Step 1:Identify the contract with the customer
Step 2:Identify the performance obligations in the contract
Step 3:Determine the transaction price
Step 4:Allocate the transaction price to the performance obligations in the contract
Step 5:Recognize revenue when the company satisfies a performance obligation

We have identified one performance obligation

We recognize revenue in two ways. Forwhich is related to our DuraGraft product sales for our Distribution Partner channel, we recognize revenue for product sales at the time of delivery of the product to our Distribution Partner (customer). The customer is invoiced, and Payment Terms are Net 30. For online customers, revenue is recognized, and tender is accepted whenAs our products are shipped to customers. The receipt is based on actual customer purchases. Whenhave an expiration date, if a product expires before use, we receive payment before the customer has been shippedwill replace the product ordered,on the shelf at no charge. Revenue disaggregation for three months ended March 31, 2021 amount received is recorded as deferred revenue until the transaction is complete. Our performance obligations for unfulfilled product orders are typically satisfied within one week. Shippingto $54,319 in Spain, $6,730 in Singapore, $8,656 in Switzerland and handling fees charged to customers relate to fulfillment activities and are included$4,247 in net sales with the corresponding costs recorded in cost of sales.India.

 

In the transaction that acquired the assets of Somahlution, LLC, the Company determined that the CE mark for Europe must be in Somahlution,Marizyme, Inc. in order for Somahlution, Inc. to bill revenue and receive the payments accordingly. The Company has filed in Europe for the CE mark to be in Marizyme, Inc. but, until the time it is approved by the Notified Body, BSI (British Standards Institution), which is projected for fourth quarter 2020,May 2021, Somahlution, LLC provides the billing and receiver of funds. On a periodical basis, the cash received is transferred to Somahlution, Inc.

 

11 

Direct Cost of SalesRevenue

 

Cost of sales includes the actual cost of merchandise sold and services performed;sold; the cost of transportation of merchandise from vendorsour third-party vendor to our distribution network, stores, or customers; shipping and handling costs from our stores or distribution network to customers; and the operating cost and depreciation of our sourcing and distribution network and online fulfilment centers.distributer.

 

Net Income (Loss) per Share

 

The Company computes basic and diluted income (loss) per share amounts pursuant to section 260-10-45ASC 260 of the FASB Accounting Standards Codification. Basic loss per share is computed by dividing net loss available to common stockholders, by the weighted average number of shares of common stock outstanding during the period, excluding the effects of any potentially dilutive securities. Diluted loss per share is computed by dividing net loss available to common stockholders by the diluted weighted average number of shares of common stock during the period. The diluted weighted average number of common shares outstanding is the basic weighted number of shares adjusted as of the first day of the year for any potentially diluted debt or equity.

 

The dilutive effect of outstanding convertible securities and preferred stock is reflected in diluted earnings per share by application of the if-converted method.

The following is a reconciliation of basic and diluted earnings (loss) per common share for the three and nine months ended September 30, 2020March 31, 2021 and 2019:2020:



  For the Three Months Ended 
  March 31, 
  2021  2020 
Basic and diluted loss per common share        
Numerator:        
Net loss available to common shareholders $(2,846,119) $(471,370)
Denominator:        
Weighted average common shares outstanding  35,928,188   19,887,021 
         
Basic and diluted loss per common share $(0.08) $(0.02)

 

MARIZYME, INC.

AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

(unaudited)

NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES(CONTINUED)

 

 

For the three

months ended

 

For the nine

months ended

 

 

September 30,

 

September 30,

 

 

2020

 

2019

 

2020

 

2019

Basic earnings per common share

 

 

 

 

 

 

 

 

Numerator:

 

 

 

 

 

 

 

 

Net loss available to common stockholders

$

(2,065,043)

$

(508,562)

$

(2,971,324)

$

(814,540)

Denominator:

 

 

 

 

 

 

 

 

Weighted average common shares outstanding

 

29,288,226

 

19,858,939

 

23,161,329

 

19,746,153

 

 

 

 

 

 

 

 

 

Basic loss per common share

$

(0.07)

$

(0.03)

$

(0.13)

$

(0.04)

 

 

 

 

 

 

 

 

 

Diluted loss per common share

 

 

 

 

 

 

 

 

Numerator:

 

 

 

 

 

 

 

 

Net loss available to common stockholders

$

(2,065,043)

$

(508,562)

$

(2,971,324)

$

(814,540)

Denominator:

 

 

 

 

 

 

 

 

Weighted average common shares outstanding

 

29,288,226

 

19,858,939

 

23,161,329

 

19,746,153

 

 

 

 

 

 

 

 

 

Basic loss per common share

$

(0.07)

$

(0.03)

$

(0.13)

$

(0.04)

Income Taxes

 

The Company accounts for income taxes in accordance with FASB ASC 740, “Income Taxes.” Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statements carrying amounts of existing assets and liabilities and loss carryforwards and their respective tax bases.

 

Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income (loss) in the years in which those temporary differences are expected to be recovered or settled.

 

The effect of a change in tax rules on deferred tax assets and liabilities is recognized in operations in the year of change. A valuation allowance is recorded when it is “more likely-than-not” that a deferred tax asset will not be realized.

 

Tax benefits of uncertain tax positions are recognized only if it is more likely than not that the Company will be able to sustain a position taken on an income tax return. The Company has no liability for uncertain tax positions as of September 30, 2020March 31, 2021 and December 31, 2019.2020. Interest and penalties, if any, related to unrecognized tax benefits would be recognized as interest expense. The Company does not have any accrued interest or penalties associated with unrecognized tax benefits, nor was any significant interest expense recognized during the three months ended March 31, 2021 and nine month periods ended September 30, 2020 and 2019.2020.

 

Segment Information

 

In accordance with the provisions of ASC 280-10, “Disclosures about Segments of an Enterprise and Related Information,” the Company is required to report financial and descriptive information about its reportable operating segments. The Company has one operating segmentssegment as of September 30,March 31, 2021 and December 31, 2020.

 

Effect of Recent Accounting Pronouncements

 

Recently Issued Accounting Standards Not Yet Adopted

 

The Company has reviewed all recently issued, but not yet adopted, accounting standards, in order to determine their effects, if any, on its results of operations, financial position or cash flows. Based on that review, the Company believes that no other pronouncements will have a significant effect on its consolidated financial statements.



12 

 

MARIZYME, INC.

AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

(unaudited)Concentration of Credit Risk

 

The Company places its temporary cash investments with financial institutions insured by the FDIC. The Company has amounts over insured limits. Amounts on deposit may at times exceed the FDIC insurance limit. The Company has not experienced any losses in such accounts.

Customer Concentrations

For the three months ended March 31, 2021, four customers/distributors selling to end customers made up 100% of the revenues. As of March 31, 2021, three customers/distributors made up 100% of accounts receivable.

Research and Development

All research and development costs, payments to laboratories and research consultants are expensed when incurred.

NOTE 4 – ACQUISITIONSLEASE

 

Effective January 1, 2020, the Company adopted the provision of Accounting Standards Update (“ASU”) 2016-02, Leases (Topic 842). The provisions of this ASU require the Company to record a right-of-use asset and related lease liability related to their leases.

The Company leases its administrative office and laboratories under an operating lease agreement. The Company entered into an agreement in December 2020 for approximately 8,500 square feet which is for a five-and-one-half year period. The base rent is $10,817 per month. In addition, the Company is obligated to pay monthly operating expenses of approximately $12,000 per month. The lease included incentives of waived base rent for certain periods. The base rent will increase by 2.5% for the second year through the end of the term.

Right-Of-Use Asset and Lease Liability:

The Company’s consolidated balance sheets reflect the value of the right-of-use asset and related lease liability. This value was calculated based on the present value of the remaining base rent lease payments. The discount rate used was 3.95% which is the average commercial interest available at the time. As a result, the value of the right-of-use asset and related lease liability is as follows:

  March 31,  December 31, 
  2021  2020 
Right-of-use asset $1,257,929  $1,317,830 
         
Total lease liability $1,282,262  $1,317,830 
Less: Current portion  304,114   243,292 
Lease liability, net of current portion $978,148  $1,074,538 

The maturities of the lease liabilities are as follows as of March 31, 2021

for the periods ended December 31:

   
    
2021 $156,748 
2022  277,142 
2023  277,142 
2024  277,142 
2025  277,142 
Thereafter  130,950 
Total lease payments  1,396,266 
Less: Present value discount  (114,004)
Total $1,282,262 

For the three months ended March 31, 2021, operating cash flows paid in connection with operating leases amounted to $35,568.

13 

NOTE 5 – ACQUISITIONS

Krillase

 

On September 12, 2018, the Company consummated an asset acquisition with ACB Holding AB, Reg. No. 559119-5762, a Swedish corporation to acquire all right, title and interest in their Krillase technology in exchange for 16.98 million shares of common stock. Krillase is a naturally occurring enzyme that acts to break protein bonds and has applications in wound debridement, would healing, dental care wound healing and thrombosis. The transaction was recorded at the fair value of the shares, $28,600,000. No amortization has been recorded as all of the patents are not yet in a position to produce cash flows. The Company anticipates Krillase being placed into service in 2023. The Company has evaluated this asset for impairment and has determined that due to COVID-19 delaying the next steps for this technology, along with the associated value of the research and development, the status of the clinical trials, and other pertinent proprietary technology, there is no impairment required.

 

During 2020, the Company incurred legal and filing fees of $17,801 associated with a patent application for pharmaceutical compositions and methods for the treatment of thrombosis. The patents are pending.

 

DuraGraft®

 

On December 15, 2019, the Company entered into a contingent asset purchase agreement (the “Agreement”), as amended on March 31, 2020 and May 29, 2020, with Somahlution, LLC, Somahlution, Inc., and Somaceutica, LLC, companies duly organized under the laws of Delaware (collectively, “Somah”) to acquire all of the assets and none of the liabilities of Somah (the “Acquisition”), including DuraGraft®, a one-time intraoperative vascular graft treatment for use in vascular and bypass surgeries that maintains endothelial function and structure, and other related properties. On July 31, 2020, the Company and Somah entered into Amendment No. 3 to the Agreement and the Agreement was finalized. Pursuant to the terms of this amendment, it was agreed that, as part of the Acquisition, the Company would acquire the outstanding capital stock of Somahlution, Inc., held by Somahlution, LLC, rather than the assets of Somahlution, Inc. This change to the Agreement was made to accommodate the European Union (“EU”) requirements with respect to the future manufacturing under Somahlution, Inc. of CE marked products for sale in the EU. In Amendment No. 2, the Company agreed to assume certain payables of Somah related to clinical and medical expenses. These assumed payables were $344,321. It was agreed that the payments on the assumed debts would be recorded as a prepaid royalty against future royalties. As of March 31, 2021 and December 31, 2020, prepaid royalties were $340,969 and $344,321, respectively, and were recorded as a non-current asset. See Note 9.

 

The Company compensated the Somah stockholders as follows: (1) 10,000,000 shares of common stock valued at $1.25 per share (the Company’s stock is thinly traded therefore the value per share was determined by the funding completed on August 3, 2020 which sold 4,610,064 shares of common stock at $1.25 per share, which was the first tranche of a total funding of $7,000,240 (5,600,272 shares, August 3, 2020 and September 25, 2020) which all stock was sold at $1.25 per share); (2) 3,000,000 warrants with a strike price of $5.00 per share and a term of five years; and (3) royalties on all net sales for Somahlution, Inc. of 6% on the first $50 million of net sales, 4% for greater than $50 million up to $200 million, and 2% for greater than $200 million.

 

The Company is in the process of determining the fair value of the royalty component of the total consideration as well as the identifiable intangible assets acquired in business combination. The Company is using a third-party valuation firm and at this time we are unable to estimate the contingent consideration related to the future royalty payment stream amount accurately. The Company is expecting the valuation to be finalized in the Form 10-Q for the period ended June 30, 2021. As such, the following table represents the preliminary consideration in connection with the transaction excluding the fair value of the royalty payment stream:

 

Consideration:

 

 

 

 

 

Common stock shares

$

12,500,000

Fair value of warrants

 

1,932,300

 

$

14,432,300

Consideration given:   
    
Common stock shares given $12,500,000 
Warrants given  1,932,300 
Total consideration given $14,432,300 

 

Fair value of identifiable assets acquired, and liabilities assumed:

 

 

 

Inventory

$

183,469

Fixed assets

 

9,092

Intangible assets

 

14,438,471

Accounts payable and accrued expenses

 

(198,732)

Total

$

14,432,300



MARIZYME, INC.

AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

(unaudited)

NOTE 4 – ACQUISITIONS (CONTINUED)

Fair value of identifiable assets acquired, and liabilities assumed:   
    
Receivable $45,845 
Inventory  229,635 
Fixed assets  9,092 
Intangible assets  14,147,728 
Total identifiable net assets $14,432,300 

 

The Company anticipates a significant fair value to be assigned to identifiable intangible assets such as in process research and development and patents. Included in the preliminary allocation to the fair value of assets acquired and liabilities assumed is an 100% allocation to intangible assets for the consideration in excess of tangible net assets. The Company utilized a preliminary estimated weighted average amortization period of seven years. As such, the Company recorded amortization expense of $341,270 and $341,270 during$353,693 for the three and nine months ended September 30, 2020, respectively.March 31, 2021 and $0 for the three months ended March 31, 2020.

14 

 

Dr. Vithal D. Dhaduk, a co-founder of Somahlution, LLC (“Dhaduk”), is the subject of a complaint filed in the United States District Court, Middle District of Pennsylvania, Civil Action No. 3:17 cv 02243 in December 2017 by Mukeshkkumar B. Patel (“Patel”), a former business partner of Dhaduk, which complaint makes claims of breach of contract, promissory estoppel and unjust enrichment regarding a Memorandum of Understanding, dated July 16, 2015, between Patel and Dhaduk (“MOU”). The MOU provided that Dhaduk would pay Patel $9.45 million as consideration for Patel’s agreement to, among other things, (i) exit certain legal entities that were purportedly jointly owned by certain affiliates of Dhaduk and Patel, including Somahlution LLC, and (ii) relinquish his ownership interests in such entities. On December 2, 2019, the court granted Patel’s motion for summary judgment on his breach of contract claim, which judgment Dhaduk is currently appealing (such legal proceedings, collectively referred to as the “Dhaduk Litigation”). The Company is not a named defendant in the Dhaduk Litigation, and the court’s summary judgment is against Dhaduk in his personal capacity.

 

NOTE 56 – COMMITMENTS AND CONTINGENCIES

 

Legal Matters

 

From time to time, we may be involved in litigation relating to claims arising out of our operations in the normal course of business. As of November 16, 2020,May 6, 2021, there were no pending or threatened lawsuits.

 

Contingencies

On July 13, 2019, the Company signed a consulting agreement with an individual to advise the Board of Directors. The individual receives $30,000 per month through July 13, 2022 and received an option to purchase 250,000 shares of common stock at a strike price of $1.50, which vest monthly through July 13, 2021. The vesting of these options werewas accelerated by the Board on September 2, 2020. See Note 9.10. The agreement also provided for royalties derived directly from the assets related to wound healing, debridement, grafting, dental applications for both human and pet, and thrombosis.thrombosis (see Note 5 – Krillase). The royalties associated with the acquisition of Krillase will be calculated as follows:

Royalties on sales equal to:

10% on net sales

On December 15, 2019, the Company entered into the Agreement, as amended on March 31, 2020 and May 29, 2020, with Somah (see Note 5). The royalties associated with the Agreement will be 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

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

2% on net sales over $200,000,000

 

The royalties are in perpetuity. As of September 30, 2020,March 31, 2021, there has been no revenue therefore norelated to the above royalties.

On July 31, 2020, the Company executed the acquisition of Somah which provides for royalties as stated herein (see Note 4).

 

The Company, after the acquisition of Somah, has been leasing the office space on a month-to-month basis with a monthly rate of $10,701. The Company will maintainmaintained this office space through December 31, 2020.



 

MARIZYME, INC.

AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

(unaudited)

NOTE 5 – COMMITMENTS AND CONTINGENCIES (CONTINUED)

Employment and Consulting Agreements

 

On September 1, 2020, Bruce Harmon executed a consulting agreement and was named as chief financial officer. He is compensated $120,000 annually, received 40,000 shares of common stock vesting over one year. On October 22, 2020, Mr. Harmon received 120,000 options for common stock vesting over three years with an exercise price of $1.25. See Note 9.10. On November 1, 2020, Mr. Harmon became an employee of the Company thereby cancelling the consulting agreement. On March 5, 2021, Mr. Harmon executed a letter of understanding for employment. See Note 1.

 

On November 1, 2020, Dr. Neil J. Campbell executed an employment agreement and was named as chief executive officer, president and director. He is compensated $375,000 annually, received 500,000 options for common stock vesting over three years, with an exercise price of $1.25. On March 18, 2021, Dr. Campbell resigned all positions. See Note 10.Notes 1 and 12. We expect to enter into a settlement and release agreement with Dr. Campbell but as of the date of this report no such agreement has been finalized.

 

On November 30, 2020, Dr. Steven Brooks executed a letter of understanding for employment as chief medical officer.

On December 1, 2020, Dr. Donald Very executed a letter of understanding for employment as executive vice president of research and development.

On January 16, 2021, Roger Schaller executed a letter of understanding for employment as executive vice president of commercial operations.

15 

Risks and Uncertainties

The outbreak of the coronavirus (COVID-19) resulted in increased travel restrictions, and shutdown of businesses, which may cause slower recovery of the economy. We may experience impact from quarantines, market downturns and changes in customer behavior related to pandemic fears and impact on our workforce if the virus continues to spread. In addition, one or more of our customers, partners, service providers or suppliers may experience financial distress, delayed or defaults on payment, file for bankruptcy protection, sharp diminishing of business, or suffer disruptions in their business due to the outbreak. The extent to which the coronavirus impacts our results will depend on future developments and reactions throughout the world, which are highly uncertain and will include emerging information concerning the severity of the coronavirus and the actions taken by governments and private businesses to attempt to contain the coronavirus. It is likely to result in a potential material adverse impact on our business, results of operations and financial condition. Wider-spread COVID-19 globally could prolong the deterioration in economic conditions and could cause decreases in or delays in advertising spending and reduce and/or negatively impact our short-term ability to grow our revenues. Any decreased collectability of accounts receivable, bankruptcy of small and medium businesses, or early termination of agreements due to deterioration in economic conditions could negatively impact our results of operations.

NOTE 67 – FIXED ASSETS

 

Fixed assets, stated at cost, less accumulated depreciation at September 30, 2020March 31, 2021 and December 31, 20192020 consisted of the following:

 

 March 31, December 31, 

 

September 30,

2020

 

December 31,

2019

 2021 2020 

Furniture and equipment

$

701

$

-

 $701  $701 

Computer related

 

7,220

 

-

  7,220   7,220 

Machinery and equipment

 

1,171

 

-

  1,171   1,171 

Less: accumulated depreciation

 

(1,313)

 

-

Total  9,092   9,092 
Less: accumulation depreciation  (4,970)  (1,970)

Property and equipment, net

$

7,779

$

-

 $4,122  $7,122 

 

Depreciation expense for the three and nine months ended September 30,March 31, 2021 and 2020 was $3,000 and 2019 was $1,313.$0, respectively.

 

NOTE 78 –INTANGIBLE ASSETS

 

On September 12, 2018, the Company consummated an asset acquisition with ACB Holding AB, Reg. No. 559119-5762, a Swedish corporation to acquire all right, title and interest in their Krillase technology in exchange for 16.98 million shares of common stock. Krillase is a naturally occurring enzyme that acts to break protein bonds and has applications in dental care, wound healing and thrombosis. The transaction was recorded at the fair value of the shares. No amortization has been recorded as the patents and patent applications are not yet in a position to produce cash flows.

 

During 2020, the Company incurred legal and filing fees of $17,801 associated with a patent application for pharmaceutical compositions and methods for the treatment of thrombosis. The patents are pending. The Company capitalized these costs.

 

On July 31, 2020, the Company executed an agreement with Somah (see Note 4) for the DuraGraft® technology in exchange for 10,000,000 shares of common stock, 3,000,000 warrants and a royalty as stated herein. Somah is engaged in developing products to prevent ischemic injury to organs and tissues and DuraGraft® is a one-time intraoperative vascular graft treatment for use in vascular and bypass surgeries that maintains endothelial function and structure, and other related properties.

 

16 

For

  March 31, 2021  December 31, 2020 
  Gross     Net  Gross     Net 
  Carrying  Accumulated  Carrying  Carrying  Accumulated  Carrying 
  Amount  Amortization  Amount  Amount  Amortization  Amount 
Krillase - Patents, Patent Applications, Research and Development, Clinical Trials, Developed Technology $28,600,000  $-  $28,600,000  $28,600,000  $-  $28,600,000 
DuraGraft - Patents, Patent Applications, Research and Development, Clinical Trials, Developed Technology  14,147,729   (943,182)  13,204,547   14,147,729   (589,489)  13,558,240 
Patents in process  122,746   -   122,746   119,971   -   119,971 
                         
Total Intangibles $42,870,475  $(943,182) $41,927,293  $42,867,700  $(589,489) $42,278,211 

Balance, December 31, 2019 $28,613,000 
Acquired in asset purchase agreement  14,147,729 
Additions  106,971 
Amortization expense  (589,489)
Balance, December 31, 2020  42,278,211 
Additions  2,775 
Amortization expense  (353,693)
Balance, March 31, 2021 $41,927,293 

The Company has recorded amortization expense of $353,693 for the ninethree months ended September 30, 2020, changes toMarch 31, 2021 and $0 for the three months ended March 31, 2020.

The useful lives of the intangible assets wereare based on the life of the patent and related technology. The patents and related technology for Krillase are not currently being amortized as follows:

Balance, December 31, 2019

$

28,613,000

Acquired in asset purchase agreement

 

14,438,471

Acquisitions

 

92,148

Accumulated amortization

 

(341,270)

Balance, September 30, 2020

$

42,802,349



they have not yet been put into operations.

 

MARIZYME, INC.Future amortizations for DuraGraft related intangible assets for the next five years will be $1,414,773 for each year from 2021 through 2026 and $6,484,375 for 2027 and thereafter.

AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

(unaudited)

 

NOTE 89 – RELATED PARTY TRANSACTIONS

 

None.The Company has recorded a prepaid royalty to the shareholders of Somahlution, LLC in regard to the acquisition (see Note 5). The primary beneficial owner is Dr. Vithal Dhaduk, a director of the Company (appointed in 2021) and significant shareholder of the Company. Prepaid royalties were $340,969 at March 31, 2021 and $344,321 at December 31, 2020.

 

NOTE 910 – STOCKHOLDERS’ EQUITY

 

Preferred stock

Our Articles of Incorporation authorize the issuance of 25,000,000 shares of “blank check” preferred stock with a par value of $0.001. As of September 30, 2020,March 31, 2021, and December 31, 2019,2020, there were no shares issued and outstanding, respectively.

 

Common stock

Our Articles of Incorporation authorize the issuance of 75,000,000 shares of common stock with a par value of $0.001.

 

As of September 30,March 31, 2021 and December 31, 2020, there were 51,888,188 shares of common stock issued and issuable, 35,888,188 outstanding and, as of December 31, 2019, 19,858,93935,928,188 shares of common stock issued and outstanding.

 

The following transactions in the Company’s common stock were completed in the nine months ended September 30, 2020:

17 

 

On January 9, 2020, the Company issued 125,000 shares to a consultant who exercised 125,000 options in lieu of $126,250 in accounts payable.

On April 6, 2020, the Company issued 160,000 shares of common stock to a consultant who exercised 160,000 options in lieu of $161,600 in accounts payable.Options

 

On April 6, 2020,January 13, 2021, the Company issued 5,000 sharesBoard of common stock to a director ofDirectors approved the Company who exercised 5,000 options in exchange for $5,050 in cash.

On April 6, 2020, the Company issued 15,000 shares of common stock to a consultant in exchange for services rendered in the amount of $15,150.

On June 8, 2020, the Company issued 20,000 shares of common stock to a consultant who exercised 20,000 options in lieu of $20,200 in accounts payable.

On July 28, 2020, the Company issued 54,057 shares of common stock in the conversion of $59,453 of debt.

On July 28, 2020, the Company issued 10,000 shares of common stock were issued at a value of $12,500 to two consultants.

On July 31, 2020, the Company completed the Soma Acquisition (see Note 3) whereas 10,000,000 shares of common stock and 3,000,000 warrants were issued.

On August 3, 2020, the Company completed an initial closing of a private placement (the “Private Placement”) with certain accredited investors (the “Investors”) pursuant to which the Company sold and issued to the Investors an aggregate of 4,609,984 shares (the “Shares”) of its CommonMarizyme, Inc. 2021 Stock at a purchase price of $1.25 per share. Each of the Investors is an “accredited investor” as that term is defined in Regulation D, Rule 501(a) under the Securities Act of 1933, as amended (the “Securities Act”Incentive Plan (“SIP”). The SharesSIP incorporates stock options issued and sold in the Private Placement were offered and sold by the Company in reliance on an exemption from registration pursuantprior to Section 4(a)(2)January 13, 2021. The SIP authorized 5,300,000 options for issuance. As of the Securities Act, and Rule 506(b) of Regulation D thereunder.



MARIZYME, INC.

AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

(unaudited)

NOTE 9 – STOCKHOLDERS’ EQUITY(CONTINUED)

In considerationMarch 31, 2021, there remains 512,500 options available for services rendered as the placement agent in the Private Placement, on August 2, 2020, the Company paid Univest Securities LLC cash commissions totaling $460,999, or 8% of the gross proceeds of the Private Placement closing, a 1% non-accountable expense allowance totaling $57,625, and the $31,250 balance (of a total of $37,500) due to the placement agent in advisory fees. Additionally, the Company issued to the placement agent a five-year warrant to purchase an aggregate of 229,499 shares of the Company’s Common Stock at an exercise price of $1.375 per share (the “Agent Warrant”). The Agent Warrant, for which the placement agent paid the Company $100, may be exercised on a cashless basis. The exercise price of the Agent Warrant is subject to adjustment for stock splits, stock dividends, recapitalizations, and the like.

On September 1, 2020, the Company issued 40,000 restricted shares of common stock to Bruce Harmon, the chief financial officer of the Company. The shares vest over a one-year period.

On September 25, 2020, the Company closed on the second tranche of funding in the gross amount of $1,237,760 in exchange for 990,208 shares of common stock. The net amount received by the Company was $1,116,566.

Optionsissuance.

 

The summary of option activity for the ninethree months ended September 30, 2020March 31, 2021 is as follows.follows:

 

Balance outstanding, December 31, 2019
     Weighted  Weighted    
     Average  Average  Total 
  Number of  Exercise  Contractual  Instrinic 
  Options  Price  Life  Value 
Outstanding at December 31, 2020  3,800,943  $1.36         
Granted  732,500  $1.25         
Exercised  -  $-         
Forfeited  -  $-         
Outstanding at March 31, 2021  4,533,443  $1.35   8.82  $123,600 
Exercisable at March 31, 2021  2,960,735  $1.40         

The fair value of each stock option was estimated using the Black Scholes pricing model which takes into account as of the grant date the exercise price (ranging from $1.01 to $1.37 per share in the first quarter of 2021) and expected life of the stock option (10 years in 2021), the current price of the underlying stock and its expected volatility (ranging from 179.31% to 304.44% in the first quarter of 2021), expected dividends (0%) on the stock and the risk-free interest rate (.93%) for the term of the stock option. In addition, the Company recognizes forfeitures as they occur.

The fair value of each stock option was estimated using the Black Scholes pricing model which takes into account as of the grant date the exercise price (ranging from $1.01 to $1.37 per share in 2020) and expected life of the stock option (10 years in 2020), the current price of the underlying stock and its expected volatility (ranging from 179.31% to 304.44% in 2020), expected dividends (0%) on the stock and the risk-free interest rate (.93%) for the term of the stock option. In addition, the Company recognizes forfeitures as they occur.

2,715,000

Issued

450,000

Exercised

(254,057)

Balance outstanding, September 30, 2020

2,910,943

 

The following stock options were granted during the past two years:three months ended March 31, 2021:

 

i)Options to purchase 265,000 shares of common stock were granted to directors effective December 6, 2018. The options allowed the recipient to purchase shares at a price of $1.01 for a period of 10 years. The options vested in one year from the date of the grant.  

ii)On July 13, 2019,January 1, 2021, the Company issued 7,500 options to purchase 2,450,000 shares offor common stock to an officer, directors, and a consultant. The options granted the recipient to purchase shares at a price of $1.50 for a period of 10 years. 200,000 options vested at grant. The remaining options vest at the rate of 90,000 options per month. The Company accelerated the vesting to 100% in September 2020 therefore the remaining amortization was recorded as of September 30, 2020. The Company recorded expenses from issuance through September 30, 2020 of $1,345,438.  Two of the recipients exercised a total of 254,057 options using payables to them in the amount of $261,453 for the exercise price. 

iii)On January 9, 2020, the Company issued options to purchase 250,000 shares of common stock to a consultant. The options granted the recipient to purchase shares at a price of $1.01 for a period of 10 years. The options vest at the rate of 25,000 options per month. The Company accelerated the vesting to 100% in September 2020 therefore the remaining amortization was recorded as of September 30, 2020. The Company recorded expenses from issuance through September 30, 2020 of $222,385. 

iv)On August 18, 2020, the Company issued options to purchase 200,000 shares of common stock to a consultant. The options granted the recipient to purchase shares at a price of $1.37 for a period of 10 years.employee. The options vest over a periodthree years, have an exercise price of eighteen months. As of September 30, 2020,$1.25 and expire in 10 years. For the three months ended March 31, 2021, the Company has recorded $33,012$708 in stock-based compensation. The Black-Scholes value was determined to be $1.13. As of March 31, 2021, there is an unamortized amount of $7,792.


On January 12, 2021, the Company issued 20,000 options for common stock to an employee. The options vest over three years, have an exercise price of $1.25 and expire in 10 years. For the three months ended March 31, 2021, the Company has recorded $1,717 in stock-based compensation. The Black-Scholes value was determined to be $1.19. As of March 31, 2021, there is an unamortized amount of $22,083.

On January 16, 2021, the Company issued 40,000 options for common stock to Roger Schaller, the Company’s executive vice president. The options vest over three years, have an exercise price of $1.25 and expire in 10 years. For the three months ended March 31, 2021, the Company has recorded $3,356 in stock-based compensation. The Black-Scholes value was determined to be $1.22. As of March 31, 2021, there is an unamortized amount of $45,640.

On January 29, 2021, the Company issued 40,000 options for common stock to Amy Chandler, the Company’s executive vice president. The options vest over three years, have an exercise price of $1.25 and expire in 10 years. For the three months ended March 31, 2021, the Company has recorded $2,745 in stock-based compensation. The Black-Scholes value was determined to be $1.22. As of March 31, 2021, there is an unamortized amount of $45,727.

On March 5, 2021, the Company issued 125,000 options for common stock to James Sapirstein, a director of the Company. The options vest over three years, have an exercise price of $1.25 and expire in 10 years. For the three months ended March 31, 2021, the Company has recorded $11,003 in stock-based compensation. The Black-Scholes value was determined to be $1.19. As of March 31, 2021, there is an unamortized amount of $137,747.

On March 5, 2021, the Company issued 125,000 options for common stock to Terry Brostowin, a director of the Company. The options vest over three years, have an exercise price of $1.25 and expire in 10 years. For the three months ended March 31, 2021, the Company has recorded $11,003 in stock-based compensation. The Black-Scholes value was determined to be $1.19. As of March 31, 2021, there is an unamortized amount of $137,747.


18 

 

MARIZYME, INC.

AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

(unaudited)On March 5, 2021, the Company issued 125,000 options for common stock to Dr. William Hearl, a director of the Company. The options vest over three years, have an exercise price of $1.25 and expire in 10 years. For the three months ended March 31, 2021, the Company has recorded $11,003 in stock-based compensation. The Black-Scholes value was determined to be $1.19. As of March 31, 2021, there is an unamortized amount of $137,747.

 

NOTE 9 – STOCKHOLDERS’ EQUITY(CONTINUED)On March 5, 2021, the Company issued 125,000 options for common stock to Julie Kampf, a director of the Company. The options vest over three years, have an exercise price of $1.25 and expire in 10 years. For the three months ended March 31, 2021, the Company has recorded $11,003 in stock-based compensation. The Black-Scholes value was determined to be $1.19. As of March 31, 2021, there is an unamortized amount of $137,747.

 

On March 5, 2021, the Company issued 125,000 options for common stock to Dr. Vithal Dhaduk, a director of the Company. The options vest over three years, have an exercise price of $1.25 and expire in 10 years. For the three months ended March 31, 2021, the Company has recorded $11,003 in stock-based compensation. The Black-Scholes value was determined to be $1.19. As of September 30,March 31, 2021, there is an unamortized amount of $137,747.

The weighted average grant date fair value of options granted during 2020 was $1.25. As of March 31, 2021, the total unamortized stock-based compensation expense amounted to $1,250,144 and will be expensed through December 2023. As of March 31, 2021, the number of options outstanding and exercisable are as follows including weighted average inputs used in calculating stock-based compensation:

 

Exercise

Price

 

Number of

Options

Outstanding

 

Number of

Options

Exercisable

 

Term

 

Remaining

Life in

Years

 

Intrinsic

Value

  Number of Number of     Remaining    
ExerciseExercise Options Options     Life in Intrinsic 
PricePrice Outstanding Exercisable Term Years Value 

$

1.01

 

265,000

 

265,000

 

10 years

 

8.19

 

$

63,600

1.01   515,000   515,000   10 years   7.69 - 7.78   123,600 

$

1.50

 

2,195,943

 

2,195,943

 

10 years

 

8.79

 

$

-

1.25   1,622,500   219,792   10 years   9.56 - 9.92   - 

$

1.01

 

250,000

 

250,000

 

10 years

 

9.28

 

$

60,000

1.37   200,000   30,000   10 years   9.39   - 

$

1.37

 

200,000

 

30,000

 

10 years

 

9.88

 

$

-

1.50   2,195,943   2,195,943   10 years   8.29   - 

 

 

2,910,943

 

2,740,943

 

 

 

 

 

$

123,600

    4,533,443   2,960,735           123,600 

  

Warrants

 

On June 12, 2019, as partAs of a financing, the Company issued warrants to purchase 113,637 shares of Common Stock at a strike price of $3 for a period of three years. All of these warrants were still outstanding as of September 30, 2020.

On JulyMarch 31, 2021 and December 31, 2020, the Company completed the Somah Acquisition (see Note 4) whereas 10,000,000 shares of common stock and 3,000,000there are 3,393,651 warrants were issued. The warrants have a strike price of $5.00 per share and a term of five years. The fair market value was determined to be $0.6441 per share or $1,932,300.outstanding.

On September 25, 2020, the Company issued two warrants for services. The warrants were for 168,008 and 112,006 with a strike price of $1.375 and a term of five years. The fair market value was determined to be $0.9062 per share or $152,249 and $101,500, respectively, or $253,749, collectively.

 

NOTE 1011 - SUBSEQUENT EVENTS

 

The Company has evaluated subsequent events through the date the financial statements were issued and filed with the Securities and Exchange Commission. The Company has determined that there are no other such events that warrant disclosure or recognition in the financial statements, except as stated herein.

 

19 

On October 1, 2020, the Company entered into a consulting agreement which had various compensation requirements, including the issuance of 20,000 shares of common stock (valued at $1.25 per share) and 36,364 warrants with an exercise price of $1.375.

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

 

On October 22, 2020, the Company issued 50,000 options for common stock to a consultant. The options vest over a three-year period and have an exercise price of $1.25.

On October 22, 2020, the Company issued 120,000 options for common stock to Bruce Harmon, the chief financial officer of the Company. The options vest over a three-year period and have an exercise price of $1.25.

On October 30, 2020, the Company issued 125,000 options for common stock to a consultant. The options vest over a three-year period and have an exercise price of $1.25.

On November 1, 2020, Dr. Neil J. Campbell executed an employment agreement and was named as chief executive officer, president and director. He is compensated $375,000 annually, received 500,000 options for common stock vesting over three years, with an exercise price of $1.25. See Note 5.

On November 9, 2020, the Company issued 15,000 options for common stock vesting over three years, with an exercise price of $1.25, to an employee.



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

SPECIAL NOTE CONCERNING FORWARD-LOOKING STATEMENT

 

We believe that it is important to communicate our future expectations to our security holders and to the public. This report, therefore, contains statements about future events and expectations which are “forward-looking statements” within the meaning of Sections 27A of the Securities Act of 1933 and 21E of the Securities Exchange Act of 1934, including the statements about our plans, objectives, expectations and prospects under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” You can expect to identify these statements by forward-looking words such as “may,” “might,” “could,” “would,” “will,” “anticipate,” “believe,” “plan,” “estimate,” “project,” “expect,” “intend,” “seek” and other similar expressions. Any statement contained in this report that is not a statement of historical fact may be deemed to be a forward-looking statement. Although we believe that the plans, objectives, expectations and prospects reflected in or suggested by our forward-looking statements are reasonable, those statements involve risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements, and we can give no assurance that our plans, objectives, expectations and prospects will be achieved.

 

Company Overview

 

We are a Nevada corporation originally incorporated on March 20, 2007, under the name SWAV Enterprises, Ltd. On September 6, 2010, we changed our name to GBS Enterprises Incorporated and from 2010 to September 2018 we were in the software products and advisory services business for email and instant messaging applications. We divested that business between December 2016 and September 2018 and, since that time, we have begun to focus on the acquisition of life science technologies.

 

We changed our name to Marizyme, Inc. on March 21, 2018, to reflect our new life sciences focus, and our common stock is currently quoted on the OTC Markets’ QB tier under the symbol “MRZM.” We may also examine our options with respect to the listing of our common stock on the Nasdaq Stock market or the NYSE.

 

In the second half of 2018, we acquired the protease-based therapeutic platform called Krillase® from ACB Holding AB.

 

RecentEvents

 

Somahlution Asset Acquisition

 

On July 30, 2020, we acquired all of the assets and certain of the liabilities of Somahlution LLC, or Somahlution, and its related companies, referred to collectively as Somah. Somah was engaged in developing products to prevent ischemic injury to organs and tissues and its products, which we refer to as the “Somah Products,” include DuraGraft®, a one-time intraoperative vascular graft treatment for use in vascular and bypass surgeries that maintains endothelial function and structure, and other related properties. As part of this acquisition, we acquired Somahlution, Inc., a wholly owned subsidiary of Somahlution and holder of the CE marks for manufacture and sale of the DuraGraft® products in the European Union.

 

Pursuant to the terms of the Acquisition, Somah is entitled to appoint two members to our board of directors, one of whom must be independent. Additionally, Dr. Satish Chandran, Somah’s co-founder and Chief Executive Officer, has become our Chief Technical Officer and Dr. Catherine Pachuk, Somah’s Chief Science Officer, has become our Chief Science Officer.

 

Private Placement

 

On August 3, 2020, we conducted an initial closing of a private placement (the “Private Placement”) in which we sold to a number of accredited investors an aggregate of 4,609,984 shares of our common stock, par value $0.001 per share, at a purchase price of $1.25 per share for an aggregate amount of $5,762,480. On September 25, 2020, we conducted a second closing of the Private Placement and sold an additional 990,208 shares of our common stock for an aggregate amount of $1,237,760, for a total Private Placement offering amount of $7,000,240. The offering costs were $725,176, leaving net proceeds of $6,275,064.



 

Our Products

 

OurProducts

Krillase

 

Through our acquisition of the Krillase technology from ACB Holding AB, we have purchased a European Union clinically testedresearched and previously patentedevaluated protease therapeutic platform that has the potential for use in the treatment of chronic wounds/burns.burns, and other clinical applications. Krillase may be classified as a biological drug, however, it has been classified as a Class III medical device in Europe for treating chronic wounds.

 

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Krillase, derived from Antarctic krill, shrimp-like crustaceans, is a combination of endo and exopeptidases that safely and efficiently breaks down thrombogenic material and necrotic tissue. Aorganic material. The mix of proteinases and peptidases in Krillase helps the Antarctic krill digest and break down its food in the extremely cold Antarctic environment. As a result, thethis specialized collection of enzymes provideprovides a unique biochemical “cutting” capability. As a “biochemical knife,” Krillase breakscan potentially break down organic matter, such as necrotic tissue, and thrombogenic material, and can mitigatebiofilms produced by microorganisms. As such, it may be useful in the mitigation or treattreatment of multiple disease states in humans. For example, Krillase may dissolve arterial thrombogenic plaque safely and efficiently. In preclinical studies in Europe, Krillase has demonstrated that it can completely dissolve fresh and organized thrombus faster and more effectively than currently approved fibrinolytic therapy without the potential for bleed outs, and it has demonstrated in both preclinical and clinical studies that it promotesefficiently, promote faster healing and supportssupport the grafting of skin for the treatment of chronic wounds and burns.burns, and reduce bacterial biofilms associated with poor oral health in humans and animals.

 

We have acquired a Krillase basedKrillase-based product pipeline that is focused on developing products that treat a number ofseveral conditions across the critical care market. Itemized below is a breakdown of our currentprojected Krillase pipeline and its development status:pipeline:

 

·MB101 – Therapy for complex wounds and burns: Completed Phase 2B trials in the EU. 

·MB102 – Therapy for acute ischemic stroke: Concept stage. 

·MB104 – Therapy for deep vein thrombosis: Early pre-clinical stage. 

·MB105 – Therapy for dissolving plaque and biofilms on teeth. 

MB101 – Therapy for complex wounds and burns
MB102 – Therapy for acute ischemic stroke
MB104 – Therapy for deep vein thrombosis
MB105 – Therapy for dissolving plaque and biofilms on teeth

 

Krillase received medical device status in the European Union for debridement of deep partial and full-thickness wounds in hospitalized patients, on July 19, 2005. we expect to initiate commercialization

As of the date of this filing, the Company continues to evaluate commercial, clinical, research, and regulatory considerations involved in marketing our Krillase-based product line. Our commercial strategy in developing this product line is two-fold:

First, leverage and maximize near-term revenue generating opportunities with products for commercial or clinical applications that have low regulatory risk,
Second, develop products for applications of the Krillase platform that address unmet medical needs or address medical market needs better than existing products in the marketplace, in clinical applications that have higher regulatory risk, but significant commercial potential.

We anticipate finalizing our development, operation and commercial strategy regarding the Krillase wound healing product for distribution in Europe and South America inplatform by 2022. Krillase will initially be delivered as a sterile, long shelf life lyophilized powder.

 

DuraGraft®

 

On July 31, 2020, weMarizyme closed the acquisition of SomahlutionSomahlution’s product, DuraGraft.

 

The DuraGraft Product

 

Somahlution has been engaged in developing products based on its DuraGraftcytoprotective platform technology, to prevent ischemic injury to organs and tissues in grafting and transplantation surgeries. Its products and product candidates, which are referred to as the Somah Products, include DuraGraft, a one-time intraoperative vascular graft treatment for use in vascular and bypass surgeries that maintains endothelial function and structure, thereby reducing the incidence and complications of graft failure and improving clinical outcomes post bypass surgery.

 

DuraGraft Indications

 

DuraGraft is an “endothelial damage inhibitor” indicated for cardiac bypass, peripheral bypass, and other vascular surgeries. It is CE marked and is approved for marketing in the European Union and several33 countries around the worldworldwide on 4 continents including, but not limited to the European Union, Turkey, Singapore, HingHong Kong, India, the Philippines, and Malaysia. Somahlution has also been focused on developing products to mitigate the effects of ischemia reperfusion injury in other grafting and transplantation surgeries and other indications in which ischemic injury can cause disease. Multiple products derived from the DuraGraftcytoprotective platform technology for several indications are under various stages of development.

 

DuraGraft is a CE-marked endothelial damage inhibitor that protects free vascular grafts and endothelium against ischemic injury.

·

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DuraGraft is approved in Europe for graft protection and preservation during bypass (cardiac and peripheral) and other vascular surgeries.
DuraGraft protects graft tissue from harvesting through anastomosis and is used during coronary artery bypass grafting, or CABG, (and other vascular surgeries) as a treatment to maintain the structural and functional integrity of the endothelium of isolated vascular grafts.
The use of DuraGraft is associated with the reduction of post-CABG complications associated with graft disease and failure; myocardial infarction, repeat revascularization, and major adverse cardiovascular events, or MACE.

Unmet Clinical Needs

CABG remains the standard treatment for multi-vessel coronary artery disease or left main artery disease.
Benefits of CABG are, however, limited by high patient level of vein graft failure (VGF) rates (50%) that have not changed in decades.
“The Early Promise of Coronary Bypass Grafting has not been fulfilled and an insidiously deadly variety of atherosclerosis progressively chokes vein grafts and extinguishes their benefits,” Fitzgibbons, 1996.
“VGF remains one of the leading causes of poor in-hospital and long-term outcomes after CABG,” Harskamp, 2013.
“The Issue of Low Patency Rates Owing to VGF Needs Urgent Attention,” de Vries, 2016.
Vein graft failure is result of damage to graft endothelium that occurs during CABG surgery.
Ischemic reperfusion injury is the primary cause of endothelial damage.
Vein graft failure post-CABG is associated with poor clinical outcomes.
DuraGraft minimizes endothelial damage, reduces graft disease, and improves clinical outcomes.

Commercial Considerations

According to market analysis reports, the size value of the coronary artery bypass graft market globally was approximately $16 billion. This market is forecasted to increase at a CAGR of 5.8% from 2017 to 2025 (Grand View Research, March 2017). Globally, it is estimated that approximately 800,000 CABG procedures are performed each year (Grand View Research, March 2017), with procedures performed in the U.S. being a substantial percentage of the total global procedures performed. In the U.S., it is estimated that approximately 340,000 CABG surgeries are performed each year. The number of CABG procedures performed is predicted to decline at a rate of approximately 0.8% per year to less than 330,000 annually by 2026, primarily due to medical and technological advances in the use of percutaneous coronary intervention, also known as “angioplasty” (idata Research, September 2018).

In 2017, the number of peripheral vascular surgeries, which include angioplasty and bypass of peripheral arteries, vein removal, thrombectomy, and endarterectomy operations, were approximately 3.7 million worldwide. The number of peripheral vascular procedures is forecasted to increase at a CAGR of 3.9% in years 2017 to 2022 and is expected to exceed 4.5 million procedures by 2022 (Research and Markets, October 2018).

The DuraGraft product addresses unmet medical needs in both of these clinical markets. DuraGraft is the firsta CE-marked endothelial damage inhibitor that protects free vascular grafts and endothelium against ischemic injury.

·DuraGraftThe product is the only product approved (in Europe)for use in Europe for graft protection and preservation during bypass (cardiac and peripheral) and other vascular surgeries.

·The company is 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 protects graft tissue from harvesting through anastomosisin Europe, South America, Australia, Africa, the Middle East, and is used during coronary artery bypass grafting, or CABG, (and other vascular surgeries) asthe Far East. As of the date of this filing, the Company anticipates the submission of a treatmentde novo 510k application to maintain the structural and functional integrity of isolated vascular grafts.  



·TheU.S. FDA for the use of DuraGraft is associated within CABG procedures in the reduction4th quarter of post-CABG complications associated with graft disease2021. In anticipation of the filing of the de novo 510k application for DuraGraft, the Company has submitted a pre-submission document in April 2021 to the FDA that describes the strategy for demonstrating the clinical safety and failure; myocardial infarction, repeat revascularization, and major adverse cardiovascular events, or MACE.  

Unmet Clinical Needsefficacy of the product.

 

·CABG remains the standard treatment for multi-vessel coronary artery disease or left main artery disease.  

·Benefits of CABG are, however, limited by high patient level vein graft failure (VGF) rates (~50%) that have not changed in decades.  

·“The Early Promise of Coronary Bypass Grafting has not been fulfilled and an insidiously deadly variety of atherosclerosis progressively chokes vein grafts and extinguishes their benefits,” Fitzgibbons, 1996.  

·“VGF remains one of the leading causes of poor in-hospital and long-term outcomes after CABG,” Harskamp, 2013.  

·“The Issue of Low Patency Rates Owing to VGF Needs Urgent Attention,” de Vries, 2016.  

·Vein graft failure is result of damage to graft endothelium that occurs during CABG surgery.  

·Ischemic reperfusion injury is the primary cause of endothelial damage.  

·Vein graft failure post-CABG is associated with poor clinical outcomes.  

·DuraGraft prevents endothelial damage, prevents graft disease and improves clinical outcomes.  

Our Competitive Strength

 

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

 

Our Krillase platform provides a significant and substantial competitive advantage as:

 

·Clinical studies in Europe have shown Krillase to achieve superior wound healing effects in treatment of necrotic leg ulcers.  

Clinical studies in Europe have shown Krillase to achieve superior wound healing effects in treatment of necrotic leg ulcers.
Our patent protected unique mixture of highly efficient endo and exopeptidases extracted from the digestive tract ofthe Antarctic Krill for use in the removal of dental plaque and other dental applications has not been recreated artificially.

 

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·Our patent protected unique mixture of highly efficient endo and exopeptidases extracted from the digestive tract of the Antarctic Krill for use in the removal of dental plaque and other dental applications has not been recreated artificially.  

 

The DuraGraft platform provides a significant and substantial competitive advantage as:

 

·DuraGraft, CE marked in Europe, is “first-in-class” as the only approved product for sale in Europe for vein graft preservation.  

DuraGraft, CE marked in Europe, is “first-in-class” as the only approved product for sale in Europe for vein graft preservation.

 

Our Growth Strategy

 

Our growth strategy is premised on integrating the acquisition of the Somah assets and the engagement of the Somah personnel in connection with this acquisition and future capital raising offerings, either public or private.

 

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

 

·Complete the integration of the acquisition of the Somah assets and begin (i) the marketing and distribution of the Somah Products, particularly DuraGraft, in Europe and (ii) the development, regulatory approval and commercialization of DuraGraft and related Somah Products in the United States;  

Complete the integration of the acquisition of the Somah assets and begin (i) the marketing and distribution of the Somah Products, particularly DuraGraft, in Europe and (ii) the development, regulatory approval and commercialization of DuraGraft and related Somah Products in the United States;
Begin to commercialize our Krillase platform through the development of (i) manufacturing and distribution in Europe and South America of a Krillase would healing product and (ii) additional Krillase based applications; and
Expand our product portfolio through the identification and acquisition of additional life science assets.

 

·Begin to commercialize our Krillase platform through the development of (i) manufacturing and distribution in Europe and South America of a Krillase would healing product and (ii) additional Krillase based applications; and  

·Expand our product portfolio through the identification and acquisition of additional life science assets.  

The strategic plans described above will require capital. There can be no assurances that we will be able to raise the capital that we will need to execute our plans or that capital, in addition to the amount we raised in the Private Placement, whether through securities offerings, either private or public, will be available to us on acceptable terms, if at all. An inability to raise sufficient funds could cause us to scale back our development and growth plans or discontinue them altogether.



 

Impact of the Coronavirus

 

On January 30, 2020, the World Health Organization, or WHO, announced a global health emergency because of a new strain of coronavirus, COVID-19, originating in Wuhan, China and the risks to the international community as the virus spreads globally beyond its point of origin. On March 11, 2020, the WHO classified the COVID-19 outbreak as a pandemic, based on the rapid increase in exposure globally. The COVID-19 pandemic is affecting the United States and global economies and may affect our prospective future revenues, and our operations and those of third parties with whom we might interact, including by causing disruptions in the development of our product candidates, product marketing efforts and the conduct of current and expected future clinical trials.

 

In addition, the COVID-19 pandemic may affect the operations of the FDA and other health authorities, including such authorities in Europe, which could result in delays of reviews and approvals, including with respect to our product candidates and our plans to submit a Q-sub clinical proposal to the FDA for supporting an additional clinical study if required for the DuraGraft product. While there has been no specific notices of delay from federal or foreign government authorities, potential interruptions, delays or changes to the operations of the FDA, or of any foreign authority with which we might interact, might impact the approval of any applications we plan and will need to file in the future.

 

We have not developed a COVID-19 contingency plan to address the potential challenges and risks presented by this pandemic. If we were to prepare such a plan, there could be no assurance that it would be effective in mitigating the effects of the COVID-19 virus.

 

Emerging Growth Company

 

We qualify as an “emerging growth company” under the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. As a result, we are permitted to, and intend to, rely on exemptions from certain disclosure requirements. For so long as we are an emerging growth company, we will not be required to:

 

·have an auditor report on our internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act;  

have an auditor report on our internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act;
comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (i.e., an auditor discussion and analysis);
submit certain executive compensation matters to stockholder advisory votes, such as “say-on-pay” and “say-on-frequency;” and
disclose certain executive compensation related items such as the correlation between executive compensation and performance and comparisons of the CEO’s compensation to median employee compensation.

 

·comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (i.e., an auditor discussion and analysis);  

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·submit certain executive compensation matters to stockholder advisory votes, such as “say-on-pay” and “say-on-frequency;” and  

·disclose certain executive compensation related items such as the correlation between executive compensation and performance and comparisons of the CEO’s compensation to median employee compensation.  

 

In addition, Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended, or the Securities Act, for complying with new or revised accounting standards.

 

In other words, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to take advantage of the benefits of this extended transition period. Our financial statements may therefore not be comparable to those of companies that comply with such new or revised accounting standards.

 

We will remain an “emerging growth company” for up to five years, or until the earliest of (i) the last day of the first fiscal year in which our total annual gross revenues exceed $1 billion, (ii) the date that we become a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act of 1934, as amended, or the Exchange Act, which would occur if the market value of our shares of common stock that are held by non-affiliates exceeds $700 million as of the last business day of our most recently completed second fiscal quarter or (iii) the date on which we have issued more than $1 billion in non-convertible debt during the preceding three year period.



 

GOING CONCERN

 

The accompanying unaudited consolidated financial statements and the factors within it, have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business and the ability of the Company to continue as a going concern for a reasonable period of time. The Company had a net loss of $2,971,324$2,810,551 and cash used in operating activities of $948,305$2,065,030 for the ninethree months ended September 30, 2020.March 31, 2021. As of September 30, 2020,March 31, 2021, the Company had a working capital surplus of $5,204,436,$229,297, and accumulated deficit of $33,951,905.$39,636,185. The Company’s continuation as a going concern is dependent upon its ability to generate revenues and its ability to continue receiving investment capital and loans from third parties to sustain its current level of operations. The Company is in the process of securing working capital from investors for common stock, convertible notes payable, and/or strategic partnerships. No assurance can be given that the Company will be successful in these efforts. The financial statements do not include any adjustments relating 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.

 

FINANCIAL OPERATIONS OVERVIEW

 

As of September 30, 2020,March 31, 2021, our accumulated deficit is $33,951,230 million.$39,636,185. We expect to incur additional losses to perform further research and development activities and do not currently have any commercial biopharmaceutical products. We do not expect to have such for several years, if at all.

 

Our product development efforts are thus in their early stages and we cannot make estimates of the costs or the time they will take to complete. The risk of completion of any program is high because of the many uncertainties involved in bringing new drugs to market including the long duration of clinical testing, the specific performance of proposed products under stringent clinical trial protocols, the extended regulatory approval and review cycles, our ability to raise additional capital, the nature and timing of research and development expenses and competing technologies being developed by organizations with significantly greater resources.

 

RESULTS OF OPERATIONS

 

Comparison of Three Months Ended September 30,March 31, 2021 and 2020 and 2019

 

Revenues

 

Our total revenue was $124,985$73,952 and $0 for the three months ended September 30,March 31, 2021 and 2020, and 2019, respectively. The increase in revenue is due to the acquisition of Somahlution, LLC and Somaceutica, LLC and the acquisition of Somahlution, Inc. on July 31, 2020 (the “Soma Acquisition”).

 

Direct Costs of Revenue

 

Our direct costs of revenue were $25,714$30,842 and $0 for the three months ended September 30,March 31, 2021 and 2020, and 2019, respectively. The increase in direct costs of revenue is due to the Soma Acquisition.

 

OperatingExpenses

 

For the three months ended September 30, 2020,March 31, 2021, our operating expenses increased to $2,190,028$2,884,503 from $508,562$471,370 for the three months ended September 30, 2019.March 31, 2020. The increase was primarily due to the Soma Acquisition. The increase was primarily stock-based compensationprofessional fees ($1,107,085659,058 for the three months ended September 30, 2020 compared to $554,633 for the three months ended September 30, 2020), professional fees ($170,753 compared to $(48,344) for the three months ended September 30, 2020 and 2019, respectively), and salaries ($433,318March 31, 2021 compared to $0 for the three months ended September 30, 2020March 31, 2020), salary expenses ($1,036,457 for the three months ended March 31, 2021 compared to $0 for the same period in 2020), stock-based compensation ($367,718 for the three months ended March 31, 2021 compared to $0 for the same period in 2020), and 2019, respectively)depreciation and amortization ($416,595 for the three months ended March 31, 2021 compared to $0 for the same period in 2020).

 

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NetLoss

 

For the three months ended September 30, 2020,March 31, 2021, we had a net loss of $2,065,043$2,810,551 as compared to $508,562$471,370 for the three months ended September 30, 2019.March 31, 2020.

 

Comparison of Nine Months Ended September 30, 2020 and 2019

Revenues

Our total revenue was $124,985 and $0 for the nine months ended September 30, 2020 and 2019, respectively. The increase in revenue is due to the Soma Acquisition.



Direct Costs of Revenue

Our direct costs of revenue were $25,714 and $0 for the nine months ended September 30, 2020 and 2019, respectively. The increase in direct costs of revenue is due to the Soma Acquisition.

OperatingExpenses

For the nine months ended September 30, 2020, our operating expenses increased to $3,096,309 from $814,540 for the nine months ended September 30, 2019. The increase was primarily due to the Soma Acquisition. The increase was primarily stock-based compensation ($1,674,200 for the nine months ended September 30, 2020 compared to $554,633 for the nine months ended September 30, 2020), professional fees ($494,295 compared to $189,458 for the nine months ended September 30, 2020 and 2019, respectively), and salary expense ($433,318 compared to $0 for the nine months ended September 30, 2020 and 2019, respectively).

NetLoss

For the nine months ended September 30, 2020, we had a net loss of $2,971,324 as compared to $814,540 for the nine months ended September 30, 2019.

LIQUIDITY AND CAPITAL RESOURCES

 

At September 30, 2020,March 31, 2021, we had $5,196,516$834,957 in cash, compared to $90$2,902,762 at December 31, 2019.2020. At September 30, 2020,March 31, 2021, our accumulated deficit was $33,951,905$39,636,185 compared to $30,980,581$36,825,634 at December 31, 2019.2020. At March 31, 2021, our work capital surplus is $227,297. There is substantial doubt as to our ability to continue as a going concern.

 

We have generated minimal revenues to date and our cash balance as reported above is not sufficient to fund our current and planned operations for any period of time. To fully implement our plan of operations for the next 12-month period, we will need to raise a significant amount of capital through our Private Placement, of which we have conducted an initial closing, and through additional future offerings, either private or public. There can be no assurances, however, that we will be successful in these capital raising efforts.

 

Critical Accounting Policies

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires us to make a number of estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements. Such estimates and assumptions affect the reported amounts of revenues and expenses during the reporting period. We base our estimates on historical experiences and on various other assumptions that we believe to be reasonable under the circumstances. Actual results may differ materially from these estimates under different assumptions and conditions. We continue to monitor significant estimates made during the preparation of our financial statements. On an ongoing basis, we evaluate estimates and assumptions based upon historical experience and various other factors and circumstances. We believe our estimates and assumptions are reasonable in the circumstances; however, actual results may differ from these estimates under different future conditions.

 

See Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and Note 1, “Summary of Significant Accounting Policies” in our audited financial statements for the year ended December 31, 2019,2020, included in our Annual Report on Form 10-K as filed on April 15, 2020,2021, for a discussion of our critical accounting policies and estimates.

 

OFF-BALANCE SHEET ARRANGEMENTS

 

We had no off-balance sheet arrangements as of September 30, 2020March 31, 2021 and December 31, 2019.2020.

 

RECENT ACCOUNTING PRONOUNCEMENTS

 

None

 

ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

A smaller reporting company, as defined by Item 10 of Regulation S-K, is not required to provide the information required by this item.



 

ITEM 4.CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

The Securities and Exchange Commission defines the term “disclosure controls and procedures” to mean a company’s controls and other procedures of an issuer that are designed to ensure that information required to be disclosed in the reports that it files or submits under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission’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 Securities Exchange Act of 1934 is accumulated and communicated to the issuer’s management, including its chief executive and chief financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. The Company maintains such a system of controls and procedures in an effort to ensure that all information which it is required to disclose in the reports it files under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified under the SEC’s rules and forms and that information required to be disclosed is accumulated and communicated to the chief executive and interim chief financial officer to allow timely decisions regarding disclosure.

 

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As of the end of the period covered by this report, we carried out an evaluation, under the supervision and with the participation of our Interim Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures. Based on this evaluation, the Interim Chief Executive Officer and Chief Financial Officer have concluded that the Company’s disclosure controls and procedures are not effective as of such date. The Interim Chief Executive Officer and Chief Financial Officer have determined that the Company continues to have the following deficiencies which represent a material weakness:

 

1.The Company’s lack of independent directors;  

2.Lack of in-house personnel with the technical knowledge to identify and address some of the reporting issues surrounding certain complex or non-routine transactions. With material, complex and non-routine transactions, management has and will continue to seek guidance from third-party experts and/or consultants to gain a thorough understanding of these transactions; 

3.Insufficient personnel resources within the accounting function to segregate the duties over financial transaction processing and reporting; 

4.Insufficient written policies and procedures over accounting transaction processing and period end financial disclosure and reporting processes. 

1.The Company’s lack of independent directors;
2.Lack of in-house personnel with the technical knowledge to identify and address some of the reporting issues surrounding certain complex or non-routine transactions. With material, complex and non-routine transactions, management has and will continue to seek guidance from third-party experts and/or consultants to gain a thorough understanding of these transactions;
3.Insufficient personnel resources within the accounting function to segregate the duties over financial transaction processing and reporting;
4.Insufficient written policies and procedures over accounting transaction processing and period end financial disclosure and reporting processes.

 

To remediate our internal control weaknesses, management intends to implement the following measures:

 

·The Company will add a number of independent directors to the board and establish an Audit Committee comprised of the independent directors. 

·The Company has added sufficient accounting personnel to properly segregate duties and to effect a timely, accurate preparation of the financial statements. To this end, effective September 1, 2020, the Company hired Mr. Bruce Harmon to serve as the Company’s Chief Financial Officer as well as other accounting personnel. 

·The Company has hired staff technically proficient at applying U.S. GAAP to financial transactions and reporting. 

·The Company will develop and maintain adequate written accounting policies and procedures. 

The Company will add a number of independent directors to the board and establish an Audit Committee comprised of the independent directors.
The Company has added sufficient accounting personnel to properly segregate duties and to effect a timely, accurate preparation of the financial statements. To this end, effective September 1, 2020, the Company hired Mr. Bruce Harmon to serve as the Company’s Chief Financial Officer as well as other accounting personnel.
The Company has hired staff technically proficient at applying U.S. GAAP to financial transactions and reporting.
The Company will develop and maintain adequate written accounting policies and procedures.

 

Additional hiring is contingent upon the Company’s efforts to obtain additional funding through equity or debt and the results of its operations. Management expects to secure funds in the coming fiscal year but provides no assurances that it will be able to do so.

 

Changes in Internal Control over Financial Reporting

 

As required by Rule 13a-15(d) of the Exchange Act, our management, including our principal executive officer, Dr. Neil J. Campbell,James Sapirstein, and our principal financial officer, Bruce Harmon, conducted an evaluation of the internal control over financial reporting to determine whether any changes occurred during the quarter ended September 30, 2020March 31, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. Based on that evaluation, our principal executive officer and principal financial officer concluded that there were changes during the quarter ended September 30, 2020.March 31, 2021. The Company appointed Mr. Harmon as chief financial officer and additional accounting staff to facilitate increased internal controls.



 

Limitations on the Effectiveness of Controls

 

The Company’s management, including the Interim Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect all error and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Further, the design of the control system must reflect that there are resource constraints and that the benefits must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Projections of any evaluation of controls effectiveness to future periods are subject to risks. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures.



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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.

 

For information regarding the various risk factors that may affect our business, please refer to our Annual Report on Form 10-K forthe year ended December 31, 20192020 filed with the SEC on April 15, 2020,2021, which may be accessed via EDGAR through the Internet at www.sec.gov.

 

ITEM 2.UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

 

During the three-month period ended September 30, 2020,March 31, 2021, we did not conduct any unregistered sales of our equity securities that were not previously disclosed in a current report of Form 8-K and we did not repurchase any of our common stock, except as follows:

 

On September 1, 2020, the Company issued Bruce Harmon, the Company’s chief financial officer, 40,000 shares of common stock which vest over one year. These shares were issued pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended pursuant to Section 4(a)(2) of the Act and/or Rule 506 of Regulation D promulgated thereunder since, among other things, the transactions did not involve a public offering.

ITEM 3.DEFAULTS UPON SENIOR SECURITIES.

 

None.

 

ITEM 4.MINE SAFETY DISCLOSURES.

 

Not applicable.

ITEM 5.OTHER INFORMATION.

 

On October 15, 2020,April 16, 2021, the Board of Directors of the Company amendedformed the consulting agreement withfollowing committees:

Audit Committee: Terry Brostowin (Chair), Dr. Vithal Dhaduk, Dr. William Hearl, James Sapirstein (Observer) and Bruce Harmon to increase his annual compensation from $60,000 to $120,000. On October 22, 2020, the Company issued Bruce Harmon 120,000 options for common stock, vesting over three years, with an exercise price of $1.25.

Due to the acquisition of the assets of Somahlution, LLC and related parties, the Company appointed Dr. Satish Chandran as Chief Technology Officer and Dr. Catherine J. Pachuk as Chief Science Officer.  Their respective bios follow:(Observer)

 

Satish Chandran, Ph.D.Compensation Committee: Julie Kampf (Chair), Dr. Vithal Dhaduk, Terry Brostowin and James Sapirstein (Observer)

 

Nomination and Board Governance Committee: Dr. Chandran, a distinguished biotechnology veteran with over 25 years of leadership positions, was appointed as Chief Technology Officer of Marizyme, Inc. on July 31, 2020 related to the acquisition of Somahlution, LLC assets by Marizyme, Inc.  Dr. Chandran was a co-founder of Somahlution, LLCWilliam Hearl (Chair), Julie Kampf and served as its Chief Executive Officer since 2012.  Dr. Chandran has also served as Director of the Center of Excellence for Biopharmaceutical Research & Development and Professor of Pharmaceutics at North Dakota University, was Chief Technology Officer at the BioTherapeutics (OUT) Division of Pfizer, and was a professor at the Institute for Hepatitis and Virus Research.  Dr. Chandran received his Ph.D. from Memorial University in Newfoundland, Canada and completed a post-doctoral fellowship at Fox Chase Cancer Center in Philadelphia. Dr. Chandran has produced numerous publications and several patents in diverse areas of biotechnology research and development.



James Sapirstein (Observer)

 

Catherine J. Pachuk, Ph.D.

Dr. Pachuk has over 25 years of research and development leadership experience in the pharmaceutical and biotech sectors with expertise in both drug, device and vaccine development with significant experience in nucleic acid based therapeutic platforms including ASO, RNAi and nucleic acid based vaccines.  Her key areas of therapeutic focus are viral diseases including Hepatitis B, Hepatitis C, and Coronavirus, metabolic disease, HCC and indications associated with Ischemia Reperfusion Injury. She was involved in advancing multiple product candidates into the clinic and market including several first-in-man compounds. She received her Ph.D. in molecular virology from the University of Pennsylvania where she studied the molecular biology of coronaviruses. She also has a dual Regulatory Affairs Certificate from RAPS (Regulatory Affairs Professional Society) in Medical Devices and Pharmaceuticals.

Following a post-doctoral fellowship at SmithKline Beecham, she joined Apollon, Inc. to develop programs in oligonucleotide-based therapeutics, and subsequently DNA-based vaccines for both viral and oncology indications. Following the acquisition of Apollon, Inc. by Wyeth-Ayerst Research in 1998 she continued to direct several vaccine programs which resulted in several plasmid-based vaccine products being advanced into clinical trials. During this time, Dr. Pachuk worked with CBER in the drafting of a “Points to Consider” document regarding points to consider for administration of plasmid DNA compounds in humans. In 2001, she co-founded Nucleonics, a biotech focused on the development of RNAi-based therapeutics, one of which was advanced into clinical studies in Chronic Hepatitis B patients. Until April of 2008, she was VP of Preclinical Research. Dr. Pachuk then went on to lead biology and preclinical development efforts for Pfizer’s oligonucleotide therapeutic programs (ASO and siRNA) in the areas of oncology and metabolic disease and was a member of the Executive Leadership Team.

Dr. Pachuk also has significant experience in nucleic-acid delivery and has led nucleic acid-delivery programs for ASO, plasmid-based therapeutics, and siRNA at Apollon/Wyeth Vaccines, Nucleonics and Pfizer.



ITEM 6.EXHIBITS

 

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

 

No.

Description

3.1.1

Articles of Incorporation (filed as an exhibit to Form SB-2 (File No: 333-146748) filed January 14, 2008)

3.1.2

Certificate of Amendment to Articles of Incorporation, effective September 6, 2010 (filed as an exhibit to Form 10-K filed July 16, 2012)

3.1.3

Certificate of Amendment to Articles of Incorporation, effective November 22, 2010 (filed as an exhibit to Form 10-K/A filed July 15, 2011)

3.1.4

Certificate of Amendment to the Articles of Incorporation regarding 1-for-29 Reverse Stock Split filed March 20, 2018 (filed as an exhibit to Form 10 (File No. 000-53223) filed on September 12, 2018)

3.1.5

Articles of Merger between Marizyme, Inc. and GBS Enterprises Incorporated filed May 19, 2018 (filed as an exhibit to Form 10 (File No. 000-53223) filed on September 12, 2018)

3.1.6

Series A Non-Convertible Preferred Certificate of Designation filed May 11, 2018 (filed as an exhibit to Form 10 (File No. 000-53223) filed on September 12, 2018)

3.2

Bylaws (Filed as an exhibit to Form SB-2 (File No: 333-146748) filed January 14, 2008)

4.1

Form of Placement Agent Common Stock Purchase Warrant for 2020 Common Stock and Warrant Private Placement (filed as an exhibit to Form 10-Q filed on August 14, 2020)

4.2

Form of Incentive Stock Option Agreement (filed as an exhibit to Form 10-Q filed on November 13, 2019)

10.1

Form of Subscription Agreement for 2020 Common Stock Private Placement (filed as an exhibit to Form 10-Q filed on August 14, 2020)

27 

 

10.2

10.2

Form of Registration Rights Agreement for 2020 Common Stock Private Placement (filed as an exhibit to Form 10-Q filed on August 14, 2020)

10.3

Employment Agreement dated November 1, 2020 with Dr. Neil J. Campbell (filed as an exhibit to Form 8-K filed on November 6, 2020)

10.4

Indemnification Agreement dated November 1, 2020 with James Sapirstein

(filed as an exhibit to Form 10-K filed on April 15, 2021)

10.5

Indemnification Agreement dated November 1, 2020 with Terry Brostowin

(filed as an exhibit to Form 10-K filed on April 15, 2021)

10.6

Indemnification Agreement dated November 1, 2020 with Bruce Harmon

(filed as an exhibit to Form 10-K filed on April 15, 2021)

31.1 (1)

Certification of Principal Executive Officer of Marizyme, Inc. required by Rule 13a-14(1) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

31.2 (1)

Certification of Principal Accounting Officer of Marizyme, Inc. required by Rule 13a-14(1) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

32.1 (1)

Certification of Principal Executive Officer of Marizyme, Inc. pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and Section 1350 Of 18 U.S.C. 63

32.2 (1)

Certification of Principal Accounting Officer of Marizyme, Inc. pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and Section 1350 Of 18 U.S.C. 63

101.INS

101.SCH

101.CAL

101.DEF

101.LAB

101.PRE

XBRL Taxonomy Extension Instance Document

101.SCHXBRL Taxonomy Extension Schema Document

101.CALXBRL Taxonomy Extension Calculation Linkbase Document

101.DEFXBRL Taxonomy Extension Definition Linkbase Document

101.LABXBRL Taxonomy Extension Label Linkbase Document

101.PREXBRL Taxonomy Extension Presentation Linkbase Document

 

(1)

Filed herewith



28 

 

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.

 

MARIZYME, INC.

(Registrant)

Date: November 16, 2020

May 6, 2021

By:

/s/ James Sapirstein

James Sapirstein

Interim Chief Executive Chairman

Officer

(Principal Executive Officer)

Date: May 6, 2021

Date: November 16, 2020

By:

By:

/s/ Bruce Harmon

Bruce Harmon

Chief Financial Officer

(Principal Accounting Officer)


31

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