UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For
the quarterly period ended
For the transition period from ______ to _______
Commission
File Number:
(Exact name of registrant as specified in its charter)
| (State or Other Jurisdiction of | (I.R.S. Employer | |
| Incorporation or Organization) | Identification No.) |
(Address of principal executive offices) (Zip Code)
(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.
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).
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 |
| ☒ | Smaller reporting company | ||
| Emerging growth company |
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. Yes ☐ No ☒
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| Not applicable. |
As of May 15, 2023, the registrant had shares of common stock ($0.001 par value) outstanding.
Note Regarding Presentation of Capitalization in this Report
Unless indicated otherwise, all share amounts, share price amounts and amounts derived from share amounts and share price amounts contained in this report do not give effect to: (i) the filing of a Certificate of Change Pursuant to Nevada Revised Statutes (“NRS”) 78.209 (the “First Certificate of Change”) with the Secretary of State of the State of Nevada (the “Nevada Secretary of State”) on August 3, 2022, which provided for a decrease of the registrant’s authorized common stock from 75,000,000 shares to 18,750,000 shares and corresponding decrease of every four (4) shares of the registrant’s issued and outstanding shares of common stock into one (1) share (the “First Reverse Stock Split”), and which became effective upon filing (the “First Certificate of Change Effective Time”); (ii) the filing of a Certificate of Change Pursuant to NRS 78.209 (the “Second Certificate of Change”) with the Nevada Secretary of State on January 5, 2023, which provided for a decrease of the registrant’s authorized common stock from 75,000,000 shares to 20,000,000 shares and a corresponding change of every three-and-three-quarters (3.75) shares of the registrant’s issued and outstanding shares of common stock to one (1) share (the “Second Reverse Stock Split”), and which became effective upon filing (the “Second Certificate of Change Effective Time”); (iii) the filing of a Certificate of Change Pursuant to NRS 78.209 (the “Third Certificate of Change”) with the Nevada Secretary of State on January 13, 2023, which provided for the increase of the registrant’s authorized common stock from 20,000,000 shares to 75,000,000 shares and the corresponding increase of every issued and outstanding share of the registrant’s common stock to three-and-three-quarters (3.75) shares (the “First Forward Stock Split”), and which became effective at 4:45 PM Pacific Time on January 17, 2023 (the “Third Certificate of Change Effective Time”); (iv) the filing of a Certificate of Change Pursuant to NRS 78.209 (the “Fourth Certificate of Change”) with the Nevada Secretary of State on January 13, 2023, which provided for the increase of the registrant’s authorized common stock from 75,000,000 shares to 300,000,000 shares and the corresponding increase of every issued and outstanding share of the registrant’s common stock to three-and-three-quarters (3.75) shares (the “Second Forward Stock Split”), and which became effective at 5:00 PM Pacific Time on January 17, 2023 (the “Fourth Certificate of Change Effective Time”); and (v) the filing of a Certificate of Change Pursuant to NRS 78.209 (the “Fifth Certificate of Change”) with the Nevada Secretary of State on January 13, 2023, which provided for the decrease of the registrant’s authorized common stock from 300,000,000 to 20,000,000 and the corresponding change of every fifteen (15) shares of the registrant’s issued and outstanding common stock to one (1) share (the “Consolidated Reverse Stock Split”), and became effective at 5:15 PM Pacific Time on January 17, 2023 (the “Fifth Certificate of Change Effective Time”).
This report gives effect to the Company’s filing of a Certificate of Amendment Pursuant to NRS 78.380 & 78.390 (the “Certificate of Amendment”) with the Nevada Secretary of State on December 30, 2022, which provided for the increase of the number of authorized shares of the registrant’s common stock from 18,750,000 shares of common stock to 75,000,000 shares of common stock, on a post-First Reverse Stock Split basis (the “Authorized Capital Increase”), and which became effective at the time of such filing, 11:00 AM Pacific Time, on the same date (the “Certificate of Amendment Effective Time”).
The processing of the Consolidated Reverse Stock Split on the number of shares held by each stockholder according to transfer agent or brokerage firm records and the reported price of the registrant’s common stock will occur at the time that the Consolidated Reverse Stock Split is announced by the Financial Industry Regulatory Authority, Inc. (“FINRA”) on its Daily List in accordance with FINRA Rule 6490 (the “Public Adjustment Time”), which will be subject to the completion of FINRA’s issuer corporate action processing requirements. The outcome of this matter had not been determined as of the date of this report. Assuming that FINRA processes the Consolidated Reverse Stock Split, at the time of the Public Adjustment Time, the number of shares of the registrant’s common stock held by each stockholder as reflected in the records of the registrant’s transfer agent or the stockholder’s brokerage firm records will be reduced by 1,500% to reflect the processing of the Consolidated Reverse Stock Split. At market open the following trading day, the price of the registrant’s common stock will reflect a 1,500% increase as a result of the processing of the Consolidated Reverse Stock Split. The registrant also intends to file a Current Report on Form 8-K reporting FINRA’s announcement of the Consolidated Reverse Stock Split and related material matters.
No fractional shares will be issued, and no cash or scrip will be paid in connection with the First Reverse Stock Split, the Second Reverse Stock Split, the First Forward Stock Split, the Second Forward Stock Split, or the Consolidated Reverse Stock Split. One whole share of the registrant’s common stock is issuable to any stockholder who would otherwise receive a fractional share pursuant to the First Certificate of Change or the Second Certificate of Change. No fractional shares were anticipated to become issuable pursuant to the Third Certificate of Change, the Fourth Certificate of Change, or the Fifth Certificate of Change. At the Public Adjustment Time, certain stockholders whose shares of the registrant’s common stock are converted at the Consolidated Reverse Stock Split ratio may receive one fewer whole share in lieu of fractional shares than such stockholders would have received in lieu of fractional shares from the separate rounding at different effective dates and times of post-split fractional shares provided for by the First Certificate of Change and Second Certificate of Change as compared to the adjustment to shares held by such stockholders at the time of the Public Adjustment Time. Following the Public Adjustment Time, any claim to an additional whole share issuable pursuant to the First Certificate of Change and the Second Certificate of Change of any stockholder will be addressed on a case-by-case basis upon receipt of a written notice of such claim submitted by the stockholder with supporting documentation to the registrant at the following address: Attn: Secretary, Marizyme, Inc., 555 Heritage Drive, Suite 205, Jupiter, Florida 33458.
MARIZYME, INC.
FORM 10-Q
TABLE OF CONTENTS
| Page | ||
| PART I - FINANCIAL INFORMATION | ||
| ITEM 1. | Condensed Consolidated Financial Statements | 3 |
| ITEM 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 20 |
| ITEM 3. | Quantitative and Qualitative Disclosures About Market Risk | 32 |
| ITEM 4. | Controls and Procedures | 33 |
| PART II - OTHER INFORMATION | 34 | |
| ITEM 1. | Legal Proceedings | 34 |
| ITEM 1A. | Risk Factors | 34 |
| ITEM 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 34 |
| ITEM 3. | Defaults Upon Senior Securities | 34 |
| ITEM 4. | Mine Safety Disclosures | 34 |
| ITEM 5. | Other Information | 34 |
| ITEM 6. | Exhibits | 35 |
| Signatures | 36 | |
| 2 |
PART I – FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
MARIZYME, INC.
Condensed Consolidated Balance Sheets
| March 31, 2023 | December 31, 2022 | |||||||
| (unaudited) | ||||||||
| ASSETS: | ||||||||
| Current | ||||||||
| Cash | $ | $ | ||||||
| Accounts receivable | ||||||||
| Other receivables | ||||||||
| Prepaid expenses | ||||||||
| Inventory | ||||||||
| Total current assets | ||||||||
| Non-current | ||||||||
| Property, plant and equipment, net | ||||||||
| Operating lease right-of-use assets, net | ||||||||
| Intangible assets, net | ||||||||
| Prepaid royalties, non-current | ||||||||
| Deposits | ||||||||
| Goodwill | ||||||||
| Total non-current assets | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY: | ||||||||
| Current | ||||||||
| Accounts payable and accrued expenses | $ | $ | ||||||
| Note payable | ||||||||
| Convertible notes | ||||||||
| Operating lease obligations | ||||||||
| Total current liabilities | ||||||||
| Non-current | ||||||||
| Operating lease obligations, net of current portion | ||||||||
| Convertible notes, net of current portion | ||||||||
| Derivative liabilities | ||||||||
| Contingent liabilities | ||||||||
| Total non-current liabilities | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies (Note 10) | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $ par value, shares authorized, shares issued and outstanding as of March 31, 2023 and December 31, 2022 | ||||||||
| Common stock, par value $, shares authorized, issued and outstanding shares - at March 31, 2023 and at December 31, 2022 | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
| 3 |
MARIZYME, INC.
Condensed Consolidated Statements of Operations
(Unaudited)
| Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Revenue | $ | $ | ||||||
| Direct cost of revenue | ||||||||
| Gross profit | ||||||||
| Operating expenses: | ||||||||
| Professional fees (includes related party amounts of $ | ||||||||
| Salary expenses | ||||||||
| Research and development | ||||||||
| Stock-based compensation | ||||||||
| Depreciation and amortization | ||||||||
| Royalty expense | ||||||||
| Other general and administrative expenses | ||||||||
| Total operating expenses | ||||||||
| Total operating loss | $ | ( | ) | $ | ( | ) | ||
| Other income (expense) | ||||||||
| Interest and accretion expenses | ( | ) | ( | ) | ||||
| Change in fair value of contingent liabilities | ( | ) | ||||||
| Total other income (expense) | ( | ) | ( | ) | ||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Loss per share – basic and diluted | $ | ( | ) | $ | ( | ) | ||
| Weighted average number of shares of common stock outstanding – basic and diluted | ||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
| 4 |
MARIZYME, INC.
Condensed Consolidated Statements of Changes in Stockholders’ Equity
For the Three Months Ended March 31, 2023 and 2022
(Unaudited)
| Common Stock | Additional Paid-in | Accumulated | Total Stockholders’ | |||||||||||||||||
| Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||
| Balance, December 31, 2021 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Stock-based compensation expense | - | |||||||||||||||||||
| Issuance of warrants | - | |||||||||||||||||||
| Exercise of warrants | ||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Balance, March 31, 2022 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Common Stock | Additional Paid-in | Accumulated | Total Stockholders’ | |||||||||||||||||
| Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||
| Balance, December 31, 2022 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Stock-based compensation expense | - | |||||||||||||||||||
| Issuance of shares | ||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Balance, March 31, 2023 | $ | $ | $ | ( | ) | $ | ||||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
| 5 |
MARIZYME, INC.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
| Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operations: | ||||||||
| Depreciation and amortization | ||||||||
| Stock-based compensation | ||||||||
| Interest and accretion on convertible notes and notes payable | ||||||||
| Issuance of warrants for services | ||||||||
| Change in fair value of contingent liabilities | ( | ) | ||||||
| Shares issued for a legal settlement | ||||||||
| Change in operating assets and liabilities: | ||||||||
| Accounts and other receivable | ( | ) | ||||||
| Prepaid expense | ( | ) | ( | ) | ||||
| Inventory | ||||||||
| Accounts payable and accrued expenses | ( | ) | ||||||
| Due to related parties | ( | ) | ||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from financing activities: | ||||||||
| Proceeds from financing, net of issuance cost | ||||||||
| Shares issued for exercise of warrants | ||||||||
| Proceeds from promissory notes, net of repayments | ||||||||
| Net cash provided by financing activities | ||||||||
| Net change in cash | ( | ) | ( | ) | ||||
| Cash at beginning of period | ||||||||
| Cash at end of period | $ | $ | ||||||
| Supplemental disclosure of cash flow information: | ||||||||
| Cash paid for interest | $ | $ | ||||||
| Cash paid for taxes | $ | $ | ||||||
| Non-cash investing and financing activities: | ||||||||
| Derivative liabilities and debt discount issued in connection with convertible notes | $ | $ | ||||||
| Warrants and debt discount issued in connection with convertible notes | $ | $ | ||||||
| Settlement of notes payable with convertible notes | $ | $ | ||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
| 6 |
MARIZYME, INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2023
NOTE 1 – DESCRIPTION OF BUSINESS
Marizyme,
Inc. (the “Company” or “Marizyme”) is a
On March 21, 2018, the Company’s name was changed to Marizyme, Inc., to reflect the new life sciences focus. Marizyme’s common stock is currently quoted on the OTCQB tier of OTC Markets Group, Inc. under the symbol “MRZM”.
NOTE 2 – GOING CONCERN
The
Company’s unaudited condensed consolidated financial statements are prepared using accounting principles generally accepted in
the United States of America applicable to a going concern, which contemplates the realization of assets and liquidation of liabilities
in the normal course of business. However, the Company does not have an established source of revenues sufficient to cover its operating
costs, which require the Company to rely on investing and financing activities in order to continue as a going concern. The Company,
since its inception, has incurred recurring operating losses and negative cash flows from operations and has an accumulated deficit of
$
Under the going concern assumption, an entity is ordinarily viewed as continuing its business for the foreseeable future with neither the intention or necessity of liquidation, ceasing trading, or seeking protection from creditors pursuant to the laws and regulations. Accordingly, assets and liabilities are recorded on the basis that the entity will be able to realize its assets and discharge its liabilities in the normal course of business.
The ability of the Company to continue as a going concern is dependent upon its ability to continue to successfully develop its intangible assets, receive an approval from the U.S. Food and Drug Administration (“FDA”) to extend the selling of the products into the U.S. market which may result in the Company attaining profitable operations.
During the next twelve months from the date the unaudited condensed consolidated financial statements were issued, the Company’s foreseeable cash requirements will relate to continuous operations of its business, maintaining its good standing and making the required filing with the SEC, and the payment of expenses associated with its product development. The Company may experience a cash shortfall and be required to raise additional capital. Management intends to raise additional funds by way of a private or public offering. While the Company believes in the viability of its strategy to continue to develop and expand its products and generate sufficient revenue and in its ability to raise additional funds, there can be no assurances to that effect. The ability of the Company to continue as a going concern is dependent upon the Company’s ability to further implement its business plan and generate sufficient revenue and its ability to raise additional funds by way of a public or private offering.
The unaudited condensed consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation and Principles of Consolidation
The accompanying unaudited condensed consolidated financial statements include the consolidated accounts of the Company and its wholly owned subsidiaries: My Health Logic Inc (“My Health Logic” or “MHL”), Somahlution, Inc. (“Somahlution”), Somaceutica, Inc. (“Somaceutica”), (collectively – “Somahlution”), and Marizyme Sciences, Inc. (“Marizyme Sciences”). All intercompany transactions have been eliminated on consolidation.
| 7 |
The accompanying unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K filed with the SEC on March 24, 2023 (the “2022 Form 10-K”). The condensed consolidated balance sheet as of December 31, 2022 was derived from audited consolidated financial statements included in the 2022 Form 10-K but does not include all disclosures required by U.S. GAAP for complete financial statements. The Company’s significant accounting policies are described in Note 1 to those consolidated financial statements.
Interim results may not be indicative of the results that may be expected for the full year or any future periods. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from these interim financial statements. The unaudited condensed consolidated financial statements reflect all adjustments which in the opinion of management are necessary to fairly present the results of operations, financial condition, cash flows and stockholders’ equity for the periods indicated. Except as otherwise disclosed, all such adjustments are of a normal recurring nature.
Deferred Offering Cost
The
Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process capital
stock financings as deferred offering costs until such financings are consummated. After consummation of the financing, these costs are
recorded in stockholders’ equity (deficit) as a reduction of additional paid-in capital generated as a result of the offering.
Should a planned equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses
in the statements of operations. As of March 31, 2023, the Company had recorded deferred offering costs of $
Use of Estimates
The preparation of the unaudited condensed consolidated financial statements in accordance with U.S. GAAP requires management to make use of certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the unaudited condensed consolidated financial statements and the reported amounts of revenue and expenses during the reported periods. The Company bases its estimates on historical experience and on various other assumptions that management believes are reasonable under the circumstances, the results of which form the basis for making judgments about carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates. Significant estimates are related to the recoverability of long-term assets including intangible assets and goodwill, amortization expense, valuation of warrants, stock-based compensation, derivative liabilities and contingent liabilities.
Fair Value Measurements
The Company uses the fair value hierarchy to measure the value of its financial instruments. The fair value hierarchy is based on inputs to valuation techniques that are used to measure fair value that are either observable or unobservable. Observable inputs reflect assumptions market participants would use in pricing an asset or liability based on market data obtained from independent sources, while unobservable inputs reflect a reporting entity’s pricing based upon its own market assumptions. The basis for fair value measurements for each level within the hierarchy is described below:
| ● | Level 1 – Quoted prices for identical assets or liabilities in active markets. |
| ● | Level 2 – Quoted prices for identical or similar assets and liabilities in markets that are not active; or other model-derived valuations whose inputs are directly or indirectly observable or whose significant value drivers are observable. |
| ● | Level 3 – Valuations derived from valuation techniques in which one or more significant inputs to the valuation model are unobservable and for which assumptions are used based on management estimates. |
The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value.
The carrying amounts of certain accounts and other receivables, accounts payable and accrued expenses, note payable, and amounts due to related parties approximate fair value due to the short-term nature of these instruments.
| 8 |
The fair value of lease obligations is determined using discounted cash flows based on the expected amounts and timing of the cash flows discounted using a market rate of interest adjusted for appropriate credit risk.
The contingent liabilities assumed on the acquisition of Somahlution in 2020 consist of present values of royalty payments, performance warrants and pediatric voucher warrants, future rare pediatric voucher sales, and liquidation preference. Management measured these contingencies in accordance with Level 3 of the fair value hierarchy.
| i. | The
performance warrants and pediatric vouchers warrants liabilities were valued using a Monte Carlo simulation model utilizing the following
weighted average assumptions: risk free rate of %, expected volatility of %, expected dividend of $, and expected life
of years. For the three months ended March 31, 2023, changes in these assumptions resulted in a $ | |
| ii. | The
present value of royalty payments was measured using the scenario-based methodology. In assessing the value attributed to the royalty
payments, the estimated future cash flows were discounted to their present value using a pre-tax discount rate that reflects current
market assessments of the time value of money and the risks specific to the revenue from net sales of the product. The cash flows
derived from the Company’s fifteen-year strategic plan are based on managements’ expectations of market growth, industry
reports and trends, and past performances. These projections are inherently uncertain due to the evolving impact of the COVID-19
pandemic. The discounted cash flow model included projections surrounding revenue, discount rates, and growth rates. The discount
rates used to calculate the present value of royalty payments reflect specific risks of the Company and market conditions and the
mid-range was estimated at | |
| iii. | Rare
pediatric voucher sales liability was valued based on the scenario-based methodology where the estimated future cash flows are discounted
to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the
risks specific to the asset – | |
| iv. | The
present value of liquidation preference liability, included in the contingent consideration, was determined using the Black-Scholes
option pricing method and represents the fair value of the maximum payment amount according to the agreement. The following assumptions
were used in the Black-Scholes option pricing model: risk free rate of %, expected volatility of %, expected dividend of
$, and expected life of . |
The derivative liabilities consist of optional and automatic conversion features and the share redemption feature attached to the convertible notes, issued pursuant to the convertible promissory notes and warrants transactions as described in Note 7 .
The Company has no financial assets measured at fair value on a recurring basis. None of the Company’s non-financial assets or liabilities are recorded at fair value on a non-recurring basis. No transfers between levels have occurred during the periods presented.
| 9 |
Marizyme measures the following financial instruments at fair value on a recurring basis. As of March 31, 2023, and December 31, 2022, the fair values of these financial instruments were as follows:
| Fair Value Hierarchy | ||||||||||||
| March 31, 2023 | Level 1 | Level 2 | Level 3 | |||||||||
| Liabilities | ||||||||||||
| Derivative liabilities | $ | $ | $ | |||||||||
| Contingent liabilities | ||||||||||||
| Total | $ | $ | $ | |||||||||
| Fair Value Hierarchy | ||||||||||||
| December 31, 2022 | Level 1 | Level 2 | Level 3 | |||||||||
| Liabilities | ||||||||||||
| Derivative liabilities | $ | $ | $ | |||||||||
| Contingent liabilities | ||||||||||||
| Total | $ | $ | $ | |||||||||
The following table provides a roll forward of all liabilities measured at fair value using Level 3 significant unobservable inputs:
| Derivative and Contingent Liabilities | ||||
| Balance at December 31, 2022 | $ | |||
| Change in fair value of contingent liabilities | ( | ) | ||
| Balance at March 31, 2023 | $ | |||
Research and Development Expenses and Accruals
All research and development costs are expensed in the period incurred and consist primarily of salaries, payroll taxes, and employee benefits, for individuals involved in research and development efforts, external research and development costs incurred under agreements with contract research organizations and consultants to conduct and support the Company’s ongoing clinical trials of DuraGraft, and costs related to manufacturing DuraGraft for clinical trials. The Company has entered into various research and development contracts with various organizations. Payments of these activities are based on the terms of the individual agreements which matches to the pattern of costs incurred. Payments made in advance are reflected in the accompanying balance sheets as prepaid expenses. The Company records accruals for estimated costs incurred for ongoing research and development activities. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the services, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates may be required in determining the prepaid or accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates.
Stock-based compensation expense for employees and directors is recognized in the Condensed Consolidated Statements of Operations based on estimated amounts, including the grant date fair value and the expected service period. For stock options, the Company estimates the grant date fair value using a Black-Scholes valuation model, which requires the use of multiple subjective inputs including estimated future volatility, expected forfeitures and the expected term of the awards. The Company estimates the expected future volatility based on the stock’s historical price volatility. The stock’s future volatility may differ from the estimated volatility at the grant date. For restricted stock unit (“RSU”) equity awards, the Company estimates the grant date fair value using its closing stock price on the date of grant. The Company recognizes the effect of forfeitures in compensation expense when the forfeitures occur. The estimated forfeiture rates may differ from actual forfeiture rates which would affect the amount of expense recognized during the period. The Company recognizes the value of the awards over the awards’ requisite service or performance periods. The requisite service period is generally the time over which share-based awards vest.
New Accounting Standards and Updates from the Securities and Exchange Commission (“SEC”)
In June 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2016-13, Financial Instruments - Credit Losses (Topic 326). The new standard amends guidance on reporting credit losses for assets held at amortized cost basis and available-for-sale debt securities. In February 2020, the FASB issued ASU 2020-02, Financial Instruments-Credit Losses (Topic 326) and Leases (Topic 842) - Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 119 and Update to SEC Section on Effective Date Related to Accounting Standards Update No. 2016-02, Leases (Topic 842), which amends the effective date of the original pronouncement for smaller reporting companies. ASU 2016-13 and its amendments will be effective for the Company for interim and annual periods in fiscal years beginning after December 15, 2022. CECL estimates of expected credit losses on trade receivables over their life will be required to be recorded at inception, based on historical information, current conditions, and reasonable and supportable forecasts. The Company adopted the standard in its first quarter of 2023. There was no material impact on the results of operations.
| 10 |
NOTE 4 – LEASES
On
December 11, 2020, the Company entered into a
Effective
April 1, 2022, the Company amended its lease agreement for administrative office and laboratories to add an additional
The
assets and liabilities from the lease were recognized at the lease commencement date based on the present value of remaining lease payments
over the lease term using the discount rate of
The
total rent expense for the three months ended March 31, 2023 was $
The following table summarizes supplemental balance sheet information related to the operating lease as of March 31, 2023, and December 31, 2022:
| March 31, 2023 | December 31, 2022 | |||||||
| Right-of-use asset | $ | $ | ||||||
| Operating lease liabilities, current | $ | $ | ||||||
| Operating lease liabilities, non-current | ||||||||
| Total operating lease liabilities | $ | $ | ||||||
As of March 31, 2023, the maturities of the lease liabilities for the periods ending December 31, are as follows:
| 2023 | $ | |||
| 2024 | ||||
| 2025 | ||||
| 2026 | ||||
| Total lease payments | $ | |||
| Less: Present value discount | ( | ) | ||
| Total | $ |
NOTE 5 – INTANGIBLE ASSETS
Krillase
As
part of the asset acquisition of ACB Holding AB, Reg. No. 559119-5762, completed on September 12, 2018, Marizyme acquired all rights,
titles, and interest in the Krillase technology, a group of intangible assets worth $
At
December 31, 2022, management determined that the carrying value of Krillase exceeded its recoverable amount. Impairment of $
| 11 |
DuraGraft
As
part of Somahlution acquisition in 2020, Marizyme purchased $
My Health Logic
As
part of My Health Logic acquisition completed on December 22, 2021, Marizyme purchased MHL’s lab-on-chip technology platform and
its patient-centric, digital point-of-care diagnostic device, MATLOC, fair valued at an aggregate amount of $
| March 31, 2023 | ||||||||||||
Gross Carrying Amount | Accumulated Amortization | Net Carrying Amount | ||||||||||
| Krillase intangible assets | $ | $ | $ | |||||||||
| Patents in process | ||||||||||||
| DuraGraft patent | ( | ) | ||||||||||
| DuraGraft - Distributor relationship | ( | ) | ||||||||||
| DuraGraft IPR&D - Cyto Protectant Life Sciences | ||||||||||||
| My Health Logic - Trade name | ( | ) | ||||||||||
| My Health Logic - Biotechnology | ( | ) | ||||||||||
| My Health Logic - Software | ( | ) | ||||||||||
| Total intangibles | $ | $ | ( | ) | $ | |||||||
| December 31, 2022 | ||||||||||||||||
Gross Carrying Amount | Accumulated Amortization | Impairment | Net Carrying Amount | |||||||||||||
| Krillase intangible assets | $ | $ | $ | ( | ) | $ | ||||||||||
| Patents in process | ||||||||||||||||
| DuraGraft patent | ( | ) | ||||||||||||||
| DuraGraft - Distributor relationship | ( | ) | ||||||||||||||
| DuraGraft IPR&D - Cyto Protectant Life Sciences | ||||||||||||||||
| My Health Logic - Trade name | ( | ) | ||||||||||||||
| My Health Logic - Biotechnology | ( | ) | ||||||||||||||
| My Health Logic - Software | ( | ) | ||||||||||||||
| Total intangibles | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||
| Goodwill | DuraGraft | My Health Logic | Total | |||||||||
| Balance, December 31, 2022 and March 31, 2023 | $ | $ | $ | |||||||||
The following changes to the Company’s intangible assets had taken place in the periods indicated:
| Balance, December 31, 2021 | $ | |||
| Impairment | ( | ) | ||
| Amortization expense | ( | ) | ||
| Balance, December 31, 2022 | $ | |||
| Amortization expense | ( | ) | ||
| Balance, March 31, 2023 | $ |
| 12 |
Future
amortizations for DuraGraft and My Health Logic intangible assets for the next five years will be $
NOTE 6 – NOTES PAYABLE
a)
On October 23, 2022, the Company issued a note payable to Hub International for $
b)
On December 28, 2022, the Company issued a promissory note for $
The
Company agreed to issue to the lender warrants to purchase common stock equal to $
c)
On February 2, 2023, the Company issued an unsecured promissory note to Walleye Opportunities Master Fund Ltd. for $
d)
As part of the My Health Logic acquisition, Marizyme assumed an aggregate of $
NOTE 7 - CONVERTIBLE PROMISSORY NOTES AND WARRANTS
May 2021 Unit Purchase Agreement
On
May 27, 2021, Marizyme entered into a Unit Purchase Agreement to sell up to units (the “Units”) at a price per
Unit of $.
In
May 2021, the Company issued and sold Units at a price of $ per Unit for gross proceeds of $
In
July 2021, the Company issued and sold Units under the Unit Purchase Program for gross proceeds of $
| 13 |
September 2021 Amended Unit Purchase Agreement
On September 29, 2021, due to a lower common stock price, the Company, with the consent of all Unit holders, amended the May, 2021, Unit Agreements. By rescinding their investment, the Unit holders agreed to amend the Unit Purchase Agreement resulted in the following significant changes to the offering:
| (i) | Decreased the offering price under the Unit Purchase Agreement from $ per Unit to $ per Unit for all future sales under the Unit Purchase Agreement. No proceeds from the initial investment were returned. | |
| (ii) | Decreased
the conversion price from $ | |
| (iii) | Cancelled all Class A Warrants and Class B Warrants and replaced them with Class C Warrants. |
December 2021 Unit Purchase Agreement
On
December 21, 2021, the Company entered into a Unit Purchase Agreement (the “December UPA”) to sell up to Units
at a price per unit of $.
December 2021 Exchange Agreements
On December 21, 2021, in conjunction with a $6.0 million investment, the Company and the existing Unit holders agreed to exchange the original securities (“Old Securities”) held by the current investors/unit holders for New Securities, consisting of (i) a New Note in the principal amount equal to the original principal amount of the Original Note, plus all accrued interest through the day prior to December 21, 2021, and (ii) a New Warrant (new Class C Warrants) in exchange for the original Class C Warrants. The Exchange of the Original Securities for the New Securities included the following significant changes:
| (i) | Decreased the offering price under the Unit Purchase Agreement from $ per Unit to $ per Unit. Outstanding principal and accrued interest were used to purchase Units at the new per unit price. | |
| (ii) | Extended
the maturity date of the notes to | |
| (iii) | Decreased
the conversion price from $ | |
| (iv) | Original
Class C Warrants were exchanged for New Class C warrants with an exercise price of $ |
The Company determined that the terms of the New Securities were substantially different from the Original Securities, and, as such the exchange of the Original Securities for the New Securities was accounted for as an extinguishment of debt on December 21, 2021, and the New Securities accounted for as a new debt issuance.
As
a result of this substantial modification, the total of
In
2022, the Company issued additional units under the New Securities agreement for the proceeds of $
Additionally,
on October 28, 2022, following a letter agreement entered into between the Company, Bradley Richmond, and Univest Securities, LLC (“Univest”),
dated October 28, 2022, addressed and submitted to the Corporate Financing Department of the Financial Industry Regulatory Authority,
Inc. (the “October 2022 Letter Agreement”), the Company extinguished convertible promissory notes held by Univest and Mr.
Richmond, as well as Class C Warrants, attached to them. The parties agreed to forgo compensation previously received for no consideration
in exchange. As the result of extinguishment of these obligations, the Company recorded $
The Company determined that the optional and automatic conversion feature and the share redemption feature attached to the convertible notes meet the definition of derivative liabilities and that the detachable warrants issued do not meet the definition of a liability and therefore will be accounted for as an equity instrument.
| 14 |
The fair value of the warrants issued and the fair value of derivative liabilities issued have been recorded as debt discount and are being amortized to interest and accretion expense using the effective interest method over the term of the Convertible Notes.
During
the three months ended March 31, 2023, the Company recognized interest and accretion expense of $
The following table summarizes supplemental balance sheet information related to the convertible notes, net of debt discount outstanding, as of March 31, 2023, and December 31, 2022:
| Convertible Notes, Net of Debt Discount | ||||
| Balance, December 31, 2021 | $ | |||
| Convertible notes issued - new securities | ||||
| Issuance costs | ( | ) | ||
| Debt discount | ( | ) | ||
| Debt accretion | ||||
| Debt extinguishment | ( | ) | ||
| Balance, December 31, 2022 | ||||
| Debt accretion | ||||
| Balance, March 31, 2023 | $ | |||
| March 31, 2023 | December 31, 2022 | |||||||
| Convertible notes - total principal | $ | $ | ||||||
| Unamortized issuance costs and discount | ( | ) | ( | ) | ||||
| Convertible Notes, Net of Debt Discount | $ | $ | ||||||
| March 31, 2023 | December 31, 2022 | |||||||
| Current portion | $ | $ | ||||||
| Non-current portion | ||||||||
| Convertible Notes, Net of Debt Discount | $ | $ | ||||||
Convertible Notes Terms
The
Convertible Notes mature in 24 months from the initial closing date and accrue 10% of simple interest per annum on the outstanding principal
amount.
In
the event that the Company consummates, while the Convertible Note is outstanding, an equity financing with a gross aggregate amount
of securities sold less than $
New Class C Warrants Terms
| ● | Exercise
price is the lower of (i) $ | |
| ● | Exercisable
for a period of | |
| ● | Warrant
Coverage: |
| 15 |
NOTE 8 – STOCKHOLDERS’ EQUITY
| a) | Preferred stock |
The Company is authorized to issue a total number of shares of “blank check” preferred stock with a par value of $. As of March 31, 2023, and December 31, 2022, there were shares of preferred stock issued or outstanding.
| b) | Common stock |
The Company is authorized to issue a total number of shares of common stock with a par value of $.
As of March 31, 2023, there were (December 31, 2022 - ) shares of common stock issued and outstanding. During the three months ended March 31, 2023, the Company issued shares of common stock to Nicholas DeVito as part of the Confidential Settlement Agreement, dated November 18, 2022 (Note 10).
| c) | Options |
On May 18, 2021, the Company’s Board of Directors approved the Marizyme, Inc. Amended and Restated 2021 Stock Incentive Plan (“SIP”). The SIP incorporates stock options issued prior to May 18, 2021. The SIP authorized options for issuance. On December 27, 2022, the Board of Directors requested that stockholders ratify an amendment to the SIP to increase the maximum number of shares of common stock available for issuance pursuant to awards granted under the SIP by to , which was approved by the stockholders. As of March 31, 2023, there remains options available for issuance (December 31, 2022 – ).
During the three months ended March 31, 2022, the Company granted (December 31, 2022 – ) share purchase options to directors of the Company.
Number of Options | Weighted Average Exercise Price | Weighted Average Contractual Life | Total Intrinsic Value | |||||||||||||
| Outstanding at December 31, 2021 | $ | |||||||||||||||
| Granted | ||||||||||||||||
| Expired | ( | ) | ||||||||||||||
| Forfeited | ( | ) | ||||||||||||||
| Outstanding at December 31, 2022 | $ | $ | - | |||||||||||||
| Granted/forfeited | - | - | ||||||||||||||
| Outstanding at March 31, 2023 | ||||||||||||||||
| Exercisable at March 31, 2023 | $ | $ | ||||||||||||||
Exercise Price | Number of Options Outstanding | Number of Options Exercisable | Weighted Average Remaining Contractual Years | Intrinsic Value | ||||||||||||||
| $ | $ | |||||||||||||||||
| $ | $ | |||||||||||||||||
| 16 |
| d) | Restricted Share Units |
During
the year ended December 31, 2021, the Company granted restricted share awards for an aggregate of shares of common stock to directors,
senior officers and consultants of the Company, with underlying performance conditions. As
of March 31, 2023, only two out of four performance conditions have been achieved. Compensation cost of $ for the restricted share
awards was recognized in stock-based compensation for the three months ended March 31, 2023 (March 31, 2022 - $
| e) | Warrants |
As
of March 31, 2023 and December 31, 2022, there were
| Number | Weighted Average Price | |||||||
| December 31, 2021 | $ | |||||||
| Issued pursuant to Unit Purchase Agreement | ||||||||
| Issued | ||||||||
| Exercised | ( | ) | ||||||
| Expired | ( | ) | ||||||
| Cancelled pursuant to FINRA | ( | ) | ||||||
| Cancelled as part of debt extinguishment | ( | ) | ||||||
| December 31, 2022 and March 31, 2023 | $ | |||||||
| f) | Stock-based compensation |
During the three months ended March 31, 2023, the Company recorded $ in non-cash share-based compensation (March 31, 2022 - $).
NOTE 9 – RELATED PARTY TRANSACTIONS
As
at March 31, 2023, the Company owed an aggregate of $
In
the three months ended March 31, 2023, the Company incurred and settled $
The
Company also incurred $
Additionally,
as part of the Somahlution acquisition in 2020, the Company recorded a prepaid royalty to the shareholders of Somahlution. The former
primary beneficial owner is Dr. Vithal Dhaduk, currently a director, and significant shareholder of the Company. During the
three months ended March 31, 2023, the Company accrued $
| 17 |
NOTE 10 – COMMITMENTS AND CONTINGENCIES
Legal Matters
Under a Confidential Settlement Agreement, dated November 18, 2022, the Company and Nicholas DeVito agreed that Mr. DeVito would dismiss a Complaint that Mr. DeVito filed on June 7, 2022 in the Circuit Court of the Fifteenth Judicial Circuit in and for Palm Beach County, Florida, Case No. 50-2022-CA-005437. The parties also agreed that following an anticipated reverse split, the Company was required to issue Mr. DeVito “post-split” shares to be delivered in paper certificate form within three (3) business days of the reverse split. The settlement agreement further provided that the delivered shares would be subject to normal and customary restrictions pursuant to Rule 144 of the SEC. In the event no split occurred by December 12, 2022, the Company was required to issue Mr. DeVito “pre-split” shares. In addition, the parties agreed that no further continuous service is required pursuant to Section 2 of the Mutual Release of Claims Agreement between Mr. DeVito and the Company dated as of August 27, 2020. Pursuant to the agreement, on January 4, 2023, the Company issued shares of common stock to Mr. DeVito (Note 8b).
Contingencies
| a. | On July 13, 2019, the Company signed a consulting agreement, whereby the individual will receive: |
| ● | $ | |
| ● | Option to purchase shares of common stock at a strike price of $, which vest monthly through July 13, 2021. The vesting of these options was accelerated by the Board on September 2, 2020. | |
| ● | Royalties
based on sales of Krillase assets, equal to |
| b. | As part of the DuraGraft Acquisition, completed on July 31, 2020, the Company entered into the Agreement with Somahlution stockholders, whereby Marizyme is legally obligated to pay royalties on all net sales for Somahlution, Inc. The royalties associated with the Agreement are calculated as follows: |
Royalties on U.S. sales equal to:
| ● | ||
| ● | ||
| ● |
Royalties on sales outside of the U.S.:
| ● | ||
| ● | ||
| ● |
The
royalties are in perpetuity. During the three months ended March 31, 2023, the Company had not earned any revenues from Krillase, however
the Company did incur sales of the DuraGraft products outside of the U.S., on which $
Upon receiving FDA clearance for the DuraGraft product, the Company will:
| ● | Issue performance warrants with a strike price determined based on the average of the closing prices of the Company’s common stock for the 30 calendar days following the date of the public announcement of the FDA approval; and | |
| ● | Upon
liquidation of all or substantially all of the assets relating to DuraGraft, the Company will pay |
| c. | The Company has entered into arrangements for office and laboratories spaces. As of March 31, 2023, minimum lease payments in relation to lease commitments are payable as described in Note 4. |
| 18 |
Risks and Uncertainties
Starting in late 2019, a novel strain of the coronavirus, or COVID-19, began to rapidly spread around the world and every state in the United States. At this time, there continues to be significant volatility and uncertainty relating to the full extent to which the COVID-19 pandemic and the various responses to it will impact the Company’s business, operations and financial results.
Most states and cities have at various times instituted quarantines, restrictions on travel, “stay at home” rules, social distancing measures and restrictions on the types of businesses that could continue to operate, as well as guidance in response to the pandemic and the need to contain it. As a result, 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. While there have 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 the Company might interact, might impact the approval of any applications the Company plans and will need to file in the future.
In addition, the Company is dependent upon certain contract manufacturers and suppliers and their ability to reliably and efficiently fulfill its orders is critical to the Company’s business success. The COVID-19 pandemic has impacted and may continue to impact certain of the Company’s manufacturers and suppliers. As a result, the Company has faced and may continue to face delays or difficulty sourcing certain products, which could negatively affect the Company’s business and financial results.
The spread of COVID-19 has also adversely impacted global economic activity and has contributed to significant volatility and negative pressure in financial markets. The pandemic has resulted, and may continue to result, in a significant disruption of global financial markets, which may reduce the Company’s ability to access capital in the future, which could negatively affect the Company’s liquidity.
If the COVID-19 pandemic does not continue to slow and the spread of COVID-19 is not contained, the Company’s business operations, including those of contract manufacturers, could be further delayed or interrupted. The duration of any business disruption cannot be reasonably estimated at this time but may materially affect the Company’s ability to operate the Company’s business and result in additional costs. It is not possible to reliably measure or quantify the impact COVID-19 has had on the financial results of the Company. If the COVID-19 pandemic continues for an extended period, it may materially adversely impact business operations and, consequently, future financial results.
NOTE 11 - SUBSEQUENT EVENTS
Exercise of Somahlution Warrants with Reduced Exercise Price
As
part of the Somahlution acquisition, completed on July 30, 2020, the Company issued a total of restricted shares of common
stock and -year warrants to purchase an additional
Adjustment to Conversion Price of Convertible Notes and Exercise Price of Class C Warrants
As described in Note 7, from May 2021 to August 2022, the Company conducted a series of Units Private Placements of units consisting of 10% secured convertible promissory notes and accompanying warrants, as were modified or amended from time to time.
At
the time of the Warrant Exercise, the Convertible Notes were convertible at a conversion price of $
Promissory Note Repayment Default
The
Company did not repay the unsecured promissory note to Walleye Opportunities Master Fund Ltd. on the maturity date of May 7, 2023. Therefore,
subsequently to the quarter end, on May 7, 2023, the principal amount was increased to $
| 19 |
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This discussion covers the three months ended March 31, 2023 and the subsequent period up to the date of issuance of this Quarterly Report on Form 10-Q. You should read the following discussion and analysis of our financial condition and results of operations in conjunction with the unaudited interim financial statements and notes thereto included in this Quarterly Report on Form 10-Q and with our audited consolidated financial statements and notes thereto for the year ended December 31, 2022 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K for the year ended December 31, 2022 (the “2022 Form 10-K”).
FORWARD-LOOKING STATEMENTS
This quarterly report on Form 10-Q contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 under Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements other than statements of historical facts contained in this quarterly report, including statements regarding our future results of operations and financial position, business strategy, research and development plans and costs, the impact of COVID-19, the timing and likelihood of regulatory filings and approvals, commercialization plans, pricing and reimbursement, the potential to develop future product candidates, the timing and likelihood of success of the plans and objectives of management for future operations, and future results of anticipated product development efforts, are forward-looking statements. These statements are often identified by the use of words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “should,” “estimate,” or “continue,” and similar expressions or variations. The forward-looking statements in this quarterly report are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, operating results, business strategy, short-term and long-term business operations and objectives. These forward-looking statements speak only as of the date of this quarterly report and are subject to a number of risks, uncertainties and assumptions, including those described in the Part II, Item 1A under the heading “Risk Factors.” The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
OVERVIEW
Marizyme is a multi-technology biomedical company dedicated to the accelerated development and commercialization of medical device technologies that improve patient health outcomes.
Currently, we are focused on developing three medical technology products – DuraGraft®, MATLOCTM and Krillase® – each of which is backed by a portfolio of patented or patent-pending assets. DuraGraft is a single-use intraoperative vascular graft treatment that protects against ischemic injury and reduces the incidence and complications of graft failure, therefore maintaining endothelial function and structure while improving clinical outcomes. MATLOC is a point-of-care, lab-on-chip digital screening and diagnostic device platform, initially being developed for quantitative chronic kidney disease, or CKD, assessment. Our Krillase protein enzyme provides a therapeutics opportunity for wound healing, thrombosis, and pet health.
Our three principal medical technologies – DuraGraft®, MATLOCTM and Krillase® – are expected to serve an unmet significant market need in several areas, including, cardiac surgery, CKD, and pet health. We are currently preparing DuraGraft, our endothelial damage inhibitor, or EDI, for the U.S. Food and Drug Administration, or FDA, De Novo classification process. We filed a pre-submission letter for DuraGraft with the FDA in November 2021 and we submitted the De Novo request for DuraGraft to the FDA in January 2023. Upon receiving FDA approval of DuraGraft, which we anticipate but cannot guarantee, we expect to quickly commercialize the product and build revenue rapidly utilizing multiple strategic partners and revenue channels. With our DuraGraft, MATLOC and Krillase technologies, we have the potential to bring three FDA-approved products to market.
For 2023, our primary business priority is achieving FDA approval of DuraGraft as a medical device for coronary bypass artery graft, or CABG, procedures, through the De Novo classification request process. Following FDA approval of DuraGraft, which we anticipate but cannot guarantee, we expect to begin to distribute and sell DuraGraft in the United States through the efforts of a strategic partner. If we are not able to find an appropriate strategic partner, we will have to build our own marketing and sales capabilities at a significant cost to us and with no guarantee of success. DuraGraft first received its CE marking in August 2014. CE marking signifies that DuraGraft may be sold in the European Economic Area, or EEA, and DuraGraft has therefore been assessed as meeting EEA safety, health, and environmental protection requirements. We will continue marketing efforts in Europe and in other countries that accept CE marking. In addition, we intend to fully develop and market DuraGraft in the U.S. for fat grafting procedures in plastic surgery procedures.
| 20 |
In 2023, we also intend to continue the advancement of our MATLOC CKD point-of-care device, mainly through the development of our lab-on-chip technology under a Sponsored Research Agreement, or SRA. An SRA is an agreement (which may be classified as a grant, contract or cooperative agreement) under which one party (the “Sponsor”) provides funding to a second party to support the performance of a specified research project or related activity. The Sponsor may be a foundation, government agency, for-profit entity, research institute, or another university.
As we achieve FDA approvals, which we anticipate but cannot guarantee, we intend to prioritize the commercialization of our DuraGraft, MATLOC and Krillase platform products through multiple distribution and marketing channels in the U.S. We expect that once we enter the commercialization phase, we will be able to rapidly generate revenue growth. Additionally, in the near term we expect to generate revenue from the sale of DuraGraft through the expansion of our international marketing efforts by our distribution partners.
Key elements of our strategy include:
| ● | Commercialize DuraGraft and related products. Continue (i) the distribution of DuraGraft, in Europe and other countries that accept the CE marking and (ii) the development, regulatory approval and commercialization of DuraGraft in the United States. We filed a pre-submission letter for DuraGraft with the FDA in November 2021 and we submitted the De Novo request for DuraGraft to the FDA on January 3, 2023. | |
| ● | Commercialize MATLOC 1 and related products. Complete the integration of our UACR lab-on-chip technology with our point-of-care MATLOC 1 device for FDA approval and commercialization. MATLOC 1 is expected to be used as a screening device to test those at risk of CKD to slow the progression of the disease. Following our development of MATLOC 1, we intend to develop MATLOC 2, which will incorporate eGFR lab-on-chip technology and allow for a full quantitative CKD diagnosis at point-of-care. | |
| ● | Commercialize Krillase and related products. Begin to commercialize our Krillase platform through the development of (i) various Krillase-based products and (ii) potential strategic partnerships for these products. | |
| ● | Develop MAR-FG-001 fat grafting technology and products. Continue with the development of MAR-FG-001 to validate its protective abilities and its improvements to the retention of fat volume. | |
| ● | Acquire more life science assets. Expand our product portfolio through the identification and acquisition of additional life science assets. |
Our net loss was approximately $2.6 million and $6.1 million for the three months ended March 31, 2023 and 2022, respectively. We expect to incur significant expenses and operating losses over the next several years. Accordingly, we will need additional financing to support our continuing operations. We will seek to fund our operations through public or private equity offerings, debt financings, government or other third-party funding, collaborations and licensing arrangements. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would impact our going concern and would have a negative impact on our financial condition and our ability to pursue our business strategy and continue as a going concern. We will need to generate significant revenues to achieve profitability, and we may never do so .
Impact of COVID-19 Pandemic
The Company has been impacted by the COVID-19 pandemic and related supply chain shortages and other economic conditions, and some of its earlier plans to further diversify its operations and expand its operating subsidiaries were delayed as a result. During 2021 and the first two quarters of 2022, the impact of COVID-19 on the Company’s supply chain and its ability to produce DuraGraft inventory was a primary reason that we did not generate substantial revenue from sales of DuraGraft during 2021 and 2022. There can be no assurance that future supply chain and other problems due to COVID-19 outbreaks will not adversely impact our revenues.
In addition, the Company is dependent upon certain contract manufacturers and suppliers and their ability to reliably and efficiently fulfill its orders is critical to the Company’s business success. The COVID-19 pandemic has impacted and may continue to impact certain of the Company’s manufacturers and suppliers. As a result, the Company has faced and may continue to face delays or difficulty sourcing certain products, which could negatively affect the Company’s business and financial results.
| 21 |
While it is not possible at this time to estimate the total impact that COVID-19 could have on our business in the future, the continued spread of COVID-19 and variants of the virus, the rate of vaccinations regionally and globally and the measures taken by the government authorities, and any future epidemic disease outbreaks, could: Disrupt the supply chain and the manufacture or shipment of products and supplies for use by us in our research activities and by strategic partners for their distribution and sales activities; delay, limit or prevent us in our research activities and strategic partners in their distribution and sales activities; impede our negotiations with strategic partners; impede testing, monitoring, data collection and analysis and other related activities by us; interrupt or delay the operations of the FDA or other regulatory authorities, which may impact review and approval timelines for initiation of clinical trials or marketing; or impede the launch or commercialization of any approved products; any of which could delay our strategic partnership plans, increase our operating costs, and have a material adverse effect on our business, financial condition and results of operations.
Principal Factors Affecting Our Financial Performance
Our operating results are primarily affected by the following factors:
| ● | our ability to generate revenue from sales of our products; | |
| ● | our ability to obtain FDA approval for our products; | |
| ● | our ability to access additional capital and the size and timing of subsequent financings, if any; | |
| ● | the costs of acquiring and utilizing data, technology, and/or intellectual property to successfully reach our goals and to remain competitive; | |
| ● | personnel and facilities costs in any region in which we seek to introduce and market our products; | |
| ● | the costs of sales, marketing, and customer acquisition; | |
| ● | the average price for our products that will be paid by consumers; | |
| ● | the number of our products ordered per quarter; | |
| ● | costs to manufacture our products; | |
| ● | the costs of compliance with any unforeseen regulatory obstacles or governmental mandates in any states or countries in which we seek to operate; and | |
| ● | the costs of any additional clinical studies which are deemed necessary for us to remain viable and competitive in any region of the world. |
Smaller Reporting Company
We are a “smaller reporting company” as defined in Rule 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. We will remain a smaller reporting company until the last day of the fiscal year in which (1) the market value of our shares held by non-affiliates equals or exceeds $250 million as of the prior June 30th, or (2) our annual revenues equaled or exceeded $100 million during such completed fiscal year and the market value of our shares held by non-affiliates equals or exceeds $700 million as of the prior June 30th.
KEY HIGHLIGHTS FOR THE THREE MONTHS ENDED MARCH 31, 2023
Financing
February 2023 Unsecured Subordinated Promissory Note
On February 2, 2023, the Company issued an unsecured subordinated promissory note to Walleye Opportunities Master Fund Ltd. (“Walleye”) for the principal amount of $1,000,000 bearing no interest, due on May 7, 2023. Under the terms of the promissory note, if the principal amount was not repaid by the Company by such date, then the principal amount shall be increased to $1,250,000. The Company did not repay the note upon its maturity, and as of date of this report, the principal outstanding under the note had been increased to $1,250,000.
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FINANCIAL OPERATIONS REVIEW
Component of Results of Operations
Revenue
Revenue represents gross product sales less service fees and product returns. For our distribution partner channel, we recognize revenue for product sales at the time of delivery of the product to our distribution partner. As our products have an expiration date, if a product expires, we will replace the product at no charge. Currently, all of our revenue is generated from the sale of DuraGraft in European and Asian markets where the product has the required regulatory approvals.
Direct Cost of Revenue
Direct cost of revenue include primarily product costs, which include all costs directly related to the purchase of raw materials, charges from our contract manufacturing organizations, and manufacturing overhead costs, as well as shipping and distribution charges. Direct cost of revenue also include losses from excess, slow-moving or obsolete inventory and inventory purchase commitments, if any.
Professional Fees
Professional fees include legal fees relating to intellectual property development, due diligence and corporate matters, and consulting fees for accounting, finance, and valuation services. Professional fees paid to a certain related party relate to certain consulting services. We anticipate increased expenses related to audit, legal, regulatory, and tax-related services associated with maintaining compliance with Securities and Exchange Commission, or SEC, requirements, and with listing and maintaining compliance with securities exchange requirements.
Salaries and Stock-Based Compensation
Salaries consist of compensation and related personnel costs. Stock-based compensation represents the fair value of equity-settled share awards on stock options granted by the Company to its employees, officers, directors, and consultants. The fair value of awards is calculated using the Black-Scholes option pricing model, which considers the following factors: exercise price, current market price of the underlying shares, expected life, risk-free interest rate, expected volatility, dividend yield, and forfeiture rate.
Research and Development
All research and development costs are expensed in the period incurred and consist primarily of salaries, payroll taxes, and employee benefits, those individuals involved in research and development efforts, external research and development costs incurred under agreements with contract research organizations and consultants to conduct and support the Company’s ongoing clinical trials of DuraGraft, and costs related to manufacturing DuraGraft for clinical trials. The Company has entered into various research and development contracts with various organizations and other companies.
Depreciation and Amortization
Intangible assets are recorded at cost less accumulated amortization and accumulated impairment losses. Intangible assets acquired as a result of an acquisition or in a business combination are measured at fair value at the acquisition date. The useful lives of intangible assets are assessed as either finite or indefinite. Intangible assets with finite lives are amortized over the estimated useful economic life and assessed for impairment whenever there is an indication that the intangible asset may be impaired. The estimated useful life and amortization method are reviewed at the end of each reporting period, with the effect of any changes in estimates being accounted for on a prospective basis.
Royalty Expenses
As part of the Somahlution Acquisition (as defined in “—Recent Developments – Exercise of Somahlution Warrants with Reduced Exercise Price”), the Company entered into the Somahlution Agreement (as defined in “—Recent Developments – Exercise of Somahlution Warrants with Reduced Exercise Price”), under which the Company became legally obligated to pay royalties on all net sales of certain products. Royalty expenses consists of royalty payable accrued on net sales of DuraGraft product within and outside of the U.S.
Other General and Administrative Expenses
Other general and administrative expenses consist principally of marketing and selling expenses, facility costs, administrative and office expenses, director and officer insurance premiums, and investor relations costs associated with operating a public company.
Other Income (Expenses)
Other income and expenses consist of mark-to-market adjustments on contingent liabilities assumed on the acquisition of the Somahlution Assets (as defined in “—Liquidity and Capital Resources – Recent Developments – Exercise of Somahlution Warrants with Reduced Exercise Price”) and interest and accretion expenses related to our Convertible Notes (as defined in “—Liquidity and Capital Resources – Recent Developments – Adjustment to Conversion Price of Convertible Notes and Exercise Price of Class C Warrants”).
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RESULTS OF OPERATIONS
Comparison of the Three Months Ended March 31, 2023 and 2022
The following table summarizes our results of operations for the three months ended March 31, 2023 and 2022:
| Three Months Ended March 31, | ||||||||||||
| 2023 | 2022 | Change | ||||||||||
| Revenue | $ | 128,974 | $ | - | $ | 128,974 | ||||||
| Direct cost of revenue | 39,275 | - | 39,275 | |||||||||
| Gross profit | 89,699 | - | 89,699 | |||||||||
| Operating expenses: | ||||||||||||
| Direct costs of revenue | ||||||||||||
| Professional fees | 384,806 | 544,040 | (159,234 | ) | ||||||||
| Salary expenses | 266,968 | 915,640 | (648,672 | ) | ||||||||
| Research and development | 605,997 | 1,218,296 | (612,299 | ) | ||||||||
| Stock-based compensation | 210,966 | 716,432 | (505,466 | ) | ||||||||
| Depreciation and amortization | 210,338 | 210,361 | (23 | ) | ||||||||
| Royalty expense | 36,183 | - | 36,183 | |||||||||
| Other general and administrative expenses | 507,324 | 390,572 | 116,752 | |||||||||
| Total operating expenses | 2,222,582 | 3,995,341 | (1,772,759 | ) | ||||||||
| Total operating loss | $ | (2,132,883 | ) | $ | (3,995,341 | ) | $ | 1,862,458 | ||||
| Other income (expenses): | ||||||||||||
| Interest and accretion expense | (1,697,701 | ) | (299,544 | ) | (1,398,157 | ) | ||||||
| Change in fair value of contingent liabilities | 1,276,000 | (1,830,000 | ) | 3,106,000 | ||||||||
| Net loss | $ | (2,554,584 | ) | $ | (6,124,885 | ) | $ | 3,570,301 | ||||
Revenue and Direct Cost of Revenue
We recognized revenue of approximately $0.1 million for the three months ended March 31, 2023 compared to none for the three months ended March 31, 2022. No revenue was generated in the three months ended March 31, 2022 due to the impact of the COVID-19 pandemic on the Company’s supply chain and its ability to produce DuraGraft inventory. The Company’s inventory production of DuraGraft returned to its pre-pandemic level at the end of the second quarter of 2022, but lingering effects of the pandemic continued to depress demand for DuraGraft and cause revenues from DuraGraft during the first quarter of 2023 to be minimal.
Professional Fees
Professional fees decreased by approximately $0.1 million or 29.3% to approximately $0.4 million in the three months ended March 31, 2023 compared to approximately $0.5 million in the three months ended March 31, 2022. The decrease relates to higher professional fees incurred in the prior comparative period due to legal fees incurred in connection with the initial filing of a registration statement on Form S-1 with the SEC for a public offering during the quarter ended March 31, 2022 .
Salary Expenses
Salary expenses in the three months ended March 31, 2023 were approximately $0.3 million, an approximately $0.6 million or 70.8% decrease from the comparative period. The decrease is attributable to reductions in employee salaries as part of efforts to streamline the Company’s operations.
Research and Development
Research and development expenses in the three months ended March 31, 2023 were approximately $0.6 million, approximately a $0.6 million or 50.3% decrease from the comparative period. The decrease in research and development expenses can be mainly attributed to the Company’s reduction of expenses in the later period and primary focus on progressing its De Novo FDA submission for DuraGraft approval, compared to higher expenses incurred in the quarter ended March 31, 2022 due to the simultaneous development and advancement of several projects, including the commercialization of DuraGraft, Krillase, and MATLOC 1.
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Stock-Based Compensation
Stock-based compensation decreased to approximately $0.2 million for the three quarters ended March 31, 2023 from approximately $0.7 million in the comparative quarter ended March 31, 2022, which represents 70.6% decrease period over period. The decrease in stock-based compensation was due to the relative absence in the first quarter of 2023 of expense recognition of restricted stock award compensation in comparison to $0.3 million of such expense recognized for the three months ended March 31, 2022.
Depreciation and Amortization
Depreciation and amortization remained consistent at $0.2 million in the current and comparative period. The Company did not acquire any new tangible or intangible capital assets in any of the periods indicated.
Royalty Expense
During the three months ended March 31, 2023, the Company accrued $0.04 million in royalties payable incurred on sales of DuraGraft outside of the U.S. No royalties were accrued in the comparative period as no sales of DuraGraft occurred in the three months ended March 31, 2022.
Other General and Administrative Expenses
Other general and administrative expenses increased approximately $0.1 million or 29.9% to approximately $0.5 million in the three months ended March 31, 2023. The majority of the increased expenses in the three months ended March 31, 2023 were due to the Company’s non-legal professional fees incurred in connection with amendments to a registration statement on Form S-1 that were filed with the SEC for a public offering.
Other Income (Expenses)
In the three months ended March 31, 2023, the Company incurred approximately $1.7 million of interest and accretion costs associated with convertible notes issued at discount as part of its Units Private Placement (as defined in “—Liquidity and Capital Resources – Recent Developments – Adjustment to Conversion Price of Convertible Notes and Exercise Price of Class C Warrants”) compared to $0.3 million, a $1.4 million or 466.7% increase in the comparative quarter ended March 31, 2022.
Additionally, the Company recognized $1.3 million of fair value gain from mark-to-market adjustments on the contingent liabilities assumed on the acquisition of the Somahlution Assets due to the change of the fair value of the contingent consideration compared to $1.8 million of fair value loss, an increase of $3.1 million from mark-to-market adjustment on the contingent liability in the comparative quarter ended March 31, 2022.
LIQUIDITY AND CAPITAL RESOURCES
To date, we have incurred significant net losses and negative cash flows from operations. As of March 31, 2023, we had available cash of approximately $0.3 million and accumulated deficit of approximately $88.5 million. We have funded our operations primarily from capital raises.
Recent Developments
Exercise of Somahlution Warrants with Reduced Exercise Price
As previously reported in Current Reports on Form 8-K filed by the Company on December 19, 2019 and August 5, 2020, on December 15, 2019, the Company entered into an asset purchase agreement (the “Somahlution Agreement”), as amended on March 31, 2020, May 29, 2020, and July 30, 2020, with Somahlution. Pursuant to the terms of the Somahlution Agreement, as amended, the Company agreed to purchase (the “Somahlution Acquisition”) all of the assets and none of the liabilities of Somahlution, provided that the Company agreed to acquire the outstanding capital stock of Somahlution, Inc., held by Somahlution, LLC, rather than the assets of Somahlution, Inc. (the “Somahlution Assets”). On August 4, 2020, the Somahlution Acquisition closed. As consideration for the Somahlution Acquisition, the Company issued to certain designees of Somahlution (the “Warrant Holders”) a total of 10,000,000 restricted shares of common stock and five-year warrants to purchase an additional 2,999,955 shares of common stock with an exercise price of $5.00 per share (the “Somahlution Warrants”).
On April 13, 2023, the Company delivered offer letter agreements (the “Somahlution Warrant Offer Letter Agreements”) to the Warrant Holders, which offered to allow the Warrant Holders to exercise the Somahlution Warrants to purchase the number of restricted shares of common stock issuable under their Somahlution Warrants at an exercise price reduced by the Company from $5.00 per share to $0.10 per share, on or prior to April 21, 2023, for maximum total cash proceeds of $299,995.50. As of the conclusion of this offer period, four of the Warrant Holders had entered into Somahlution Warrant Offer Letter Agreements and had exercised their Somahlution Warrants to purchase a total of 2,652,159 shares of common stock for gross proceeds of approximately $265,216 (the “Warrant Exercise”). Univest Securities, LLC (“Univest”), as the Company’s placement agent, which facilitated the Warrant Exercise, waived any fees or reimbursable expenses that would otherwise have been payable with respect to the Warrant Exercise pursuant to the Placement Agency Agreement, dated as of December 21, 2021, between Univest and the Company.
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The foregoing description of the Somahlution Warrant Offer Letter Agreements is qualified in its entirety by reference to the form of such documents which is filed as Exhibit 10.1 to the Current Report on Form 8-K filed on April 20, 2023.
Adjustment to Conversion Price of Convertible Notes and Exercise Price of Class C Warrants
As previously reported in a Current Report on Form 8-K filed by the Company on January 17, 2023 (the “January 2023 Form 8-K”), from May 2021 to August 2022, the Company conducted a private placement of units (the “Units Private Placement”) consisting of 10% secured convertible promissory notes (the “Convertible Notes”) and accompanying warrants (the “Class C Warrants”), as were modified or amended from time to time, with Univest, the terms of which were described in detail in the January 2023 Form 8-K. As reported in the January 2023 Form 8-K, among their other terms, the Convertible Notes and Class C Warrants provide that a lower price per share, or more favorable terms, respectively, under subsequent equity issuances, not including qualified financings and certain other exempt issuances, will be applicable to the conversion or exercise rights under the Convertible Notes and Class C Warrants, respectively. In addition, as reported in the January 2023 Form 8-K, under a Letter Agreement between the Company and Univest as placement agent for the investors in the Units Private Placement, dated January 12, 2023 (the “Univest Letter Agreement”), the parties agreed that simultaneously with any adjustment to the exercise price under the Class C Warrants as a result of any equity issuances, not including qualified financings and certain other exempt issuances, the number of shares of common stock that may be purchased under the Class C Warrants will be increased such that the aggregate exercise price of such shares will be the same as the same as the aggregate exercise price in effect immediately prior to the adjustment, without regard to any limitations on exercise contained in the Class C Warrants, including the beneficial ownership limitation described above.
At the time of the Warrant Exercise, the Convertible Notes were convertible at a conversion price of $1.75 per share and the Class C Warrants were exercisable at an exercise price of $2.25 per share. Outstanding Convertible Notes have underlying principal of $14,471,177, and outstanding Class C Warrants were exercisable to purchase a total of 16,538,473 shares of common stock. In connection with the transaction contemplated by the Somahlution Warrant Offer Letter Agreements and certain unrelated matters, the Company obtained exercise and conversion rights waivers and amendments from certain holders of the Convertible Notes and Class C Warrants, which reduced the principal underlying Convertible Notes’ with conversion rights to Convertible Notes with a total of $4,471,177 in principal, and reduced outstanding Class C Warrants with exercise rights to Class C Warrants having exercise rights to Class C Warrants exercisable to purchase 5,109,904 shares of common stock. As a result of the Warrant Exercise and pursuant to the adjustment provisions described above, the conversion price of the Convertible Notes and the exercise price of the Class C Warrants adjusted to $0.10 per share. As a result of these adjustment provisions and the conversion and exercise terms of the Convertible Notes and Class C Warrants, the number of shares into which the Convertible Notes may be converted adjusted from 2,554,944 shares of common stock, not including shares convertible from interest under the Convertible Notes, to 44,711,770 shares of common stock, not including shares convertible from interest under the Convertible Notes, subject to rounding adjustments, and the number of shares that the Class C Warrants may be exercised to purchase adjusted from 5,109,904 shares of common stock to 114,972,840 shares, subject to rounding adjustments.
The foregoing description of the Univest Letter Agreement, the Convertible Notes and the Class C Warrants is qualified in its entirety by reference to the description of these and related documents and transactions in “Item 1.01 Entry into a Material Definitive Agreement.” of the January 2023 Form 8-K.
Public Offering
On February 14, 2022, Marizyme filed the initial registration statement on Form S-1 relating to the Company’s proposed public offering to raise up to $17,250,000. On April 21, 2023, the Company withdrew the registration statement on Form S-1 as it does not intend to pursue the contemplated public offering at this time .
Promissory Note Repayment Default
On February 2, 2023, the Company issued an unsecured promissory note to Walleye for $1,000,000 with a maturity date of May 7, 2023. The note has no interest and the principal amount shall be paid in full on the maturity date. In the event that the principal amount is not repaid in full on maturity date, the principal amount shall be increased to $1,250,000. The Company did not repay the note upon its maturity, and as of the date of this report, the principal outstanding under the note had been increased to $1,250,000.
Funding Requirements and Other Liquidity Matters
Marizyme expects to continue to incur expenses and operating losses for the foreseeable future. We anticipate that our expenses will increase as a result of the following operational and business development efforts:
| ● | Increase our expertise and knowledge through hiring and retaining qualified operational, financial and management personnel, who are expected to develop build efficient infrastructure to support development and commercialization of therapies and devices; | |
| ● | Increase in research and development and legal support as we continue to develop our products, conduct clinical trials and pursue FDA clearances; | |
| ● | Expand our product portfolio through the identification and acquisition of additional life science assets; and | |
| ● | Seek to increase awareness about our products to boost sales and distributions internationally. |
Until such time, if ever, as we can generate substantial product revenues to support our cost structure, the Company will continue to have to raise funds beyond its current working capital balance in order to finance future development of products, potential acquisitions, and meet its debt obligations until such time as future profitable revenues are achieved.
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We expect to finance our cash needs through a combination of private and public equity offerings, debt financings, government or other third-party funding, and collaborations arrangements. To the extent that we raise additional capital through the sale of common stock, convertible securities or other equity securities, the ownership interest of our stockholders may be materially diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the interests of our common stockholders. Debt financing and preferred equity financing, if available, would result in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting our stockholders’ ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct our business. Securing additional financing could require a substantial amount of time and attention from our management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely affect our management’s ability to oversee the development or acquisition of our products.
If we raise additional funds through collaborations, strategic alliances or marketing, distribution, or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. These factors raise substantial doubt about the Company’s ability to continue as a going concern.
Cash Flows
The following table sets forth a summary of the net cash flow activity for each of the periods indicated:
| Three months ended March 31, | ||||||||||||
| 2023 | 2022 | $ Change | ||||||||||
| Net Cash provided by/(used in): | ||||||||||||
| Operating activities | $ | (1,120,156 | ) | $ | (4,313,744 | ) | $ | 3,193,588 | ||||
| Investing activities | - | - | - | |||||||||
| Financing activities | 939,096 | 3,414,372 | (2,475,276 | ) | ||||||||
| Net change in cash | $ | (181,060 | ) | $ | (899,372 | ) | $ | 718,312 | ||||
Operating Activities
Net cash used in operating activities was approximately $1.1 million and $4.3 million for the three months ended March 31, 2023 and 2022, respectively. The net cash used in operating activities for the three months ended March 31, 2023 was due to approximately $0.6 million spent on research and development, approximately $0.3 million spent on salaries and related compensation expenses, $0.5 million in other general and administrative expenses and approximately $0.4 million spent on professional fees. The net cash used in operating activities for the three months ended March 31, 2022 was due to approximately $1.2 million spent on research and development, approximately $0.5 million spent on professional fees and $0.9 million spent on salaries and related compensation expenses. The decrease in net cash used in operating activities in the three months ended March 31, 2023 compared to the three months ended March 31, 2022 was primarily due to the decrease in the Company’s research and development expenses, salaries and other compensation, and professional fees.
Financing Activities
Net cash provided by financing activities for the three months ended March 31, 2023 was due to $1.0 million of funds raised from the issuance of an unsecured promissory note to Walleye. During the three months ended March 31, 2023 the Company also repaid approximately $0.1 million in notes payable. Net cash provided by financing activities for the three months ended March 31, 2022 was due to $3.7 million of funds raised from the issuance of convertible promissory notes in connection with the Units Private Placement. The Company also settled an aggregate of $0.3 million in notes payable as part of the Units Private Placement during the three months ended March 31, 2022.
Contractual Obligations and Commitments
Other than disclosed below, there were no material changes outside the ordinary course of our business during the three months ended March 31, 2023 to the information regarding our contractual obligations that was disclosed in “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations – Liquidity and Capital Resources – Contractual Obligations and Commitments” contained in the 2022 Form 10-K.
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Royalties and Other Commitments
On December 15, 2019, the Company entered into the Somahlution Agreement to acquire the Somahlution Assets, including DuraGraft®. The Somahlution Agreement was amended on March 31, 2020 and May 29, 2020 to extend the termination date. On July 30, 2020, the Company and Somahlution entered into Amendment No. 3 to the Somahlution Agreement (“Amendment No. 3”). Pursuant to the terms of this amendment, it was agreed that, as part of the Somahlution Acquisition, the Company would acquire the outstanding capital stock of Somahlution, Inc., held by Somahlution, LLC, rather than the assets of Somahlution, Inc., in addition to the Somahlution Assets. This change to the Somahlution 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. 3, the Company agreed to assume certain payables of Somahlution related to clinical and medical expenses. The parties also orally agreed that the payments on the assumed debts would be recorded as a prepaid royalty against future royalties.
Pursuant to the Somahlution Agreement and in consideration of the outstanding capital stock of Somahlution, Inc., the Company agreed to pay to certain beneficial owner designees of Somahlution, among other consideration:
| ● | The following contingent consideration upon receiving FDA final approval and insurance reimbursement approval on the products, and in the amounts, specified below, subject to certain expiration terms, none of which had been earned or granted as of March 31, 2023: |
| ○ | DuraGraft products: |
| ■ | Royalties to be paid on all net sales of the product of 6% on the first $50 million of international net sales (and 5% on the first $50 million of U.S. net sales), 4% for greater than $50 million up to $200 million, and 2% for greater than $200 million; | |
| ■ | Payment on a pro rata basis of 10% of the cash value of rare pediatric voucher sales following FDA approval and subsequent sale to an unaffiliated third party of a rare pediatric voucher based on Somahlution’s DuraGraft product; | |
| ■ | Following the FDA approval and subsequent sale to an unaffiliated third party of a rare pediatric voucher based on Somahlution’s DuraGraft product, grant of warrants on a pro rata basis to purchase an aggregate of 250,000 shares of common stock with a term of five years and a strike price determined based on the average of the closing prices of the common stock for the 30 calendar days following the date of the public announcement of FDA approval; and | |
| ■ | Upon the sale of DuraGraft products, the Company will pay pro rata the Somahlution designees 15% of the net sale proceeds towards the liquidation preference maximum amount of $20 million described below; |
| ○ | Somahlution derived solid organ transplant products: |
| ■ | Royalties to be paid on all net sales of the product of 6% on the first $50 million of international net sales, 4% for greater than $50 million up to $200 million, and 2% for greater than $200 million; | |
| ■ | Upon the sale of DuraGraft products, the Company will pay pro rata the Somahlution designees 15% of the net sale proceeds towards the liquidation preference maximum amount of $20 million described below; |
| ○ | Somahlution Assets-derived over-the-counter products: |
| ■ | Royalties to be paid on all net sales of the product of 6% on the first $50 million of international net sales, 4% for greater than $50 million up to $200 million, and 2% for greater than $200 million; |
| ○ | Other Somahlution Assets-derived products from existing Somahlution pipelines: |
| ■ | Royalties to be paid on all net sales of the product of 1%; and |
| ● | A liquidation preference, up to a maximum of $20 million, and the Company will pay 15% of the net sale proceeds towards the liquidation preference maximum amount upon the sale by the Company of all or substantially all of the Somahlution Assets. |
For additional discussion of this transaction, see “Item 13. Certain Relationships and Related Transactions, and Director Independence – Transactions with Related Persons” of the 2022 Form 10-K.
Office and Laboratories Space Lease
The Company has entered into arrangements for office and laboratories spaces. As at March 31, 2023, minimum lease payments in relation to lease commitments were payable as outlined in “Note 4 – Leases”, included in “Item 1. Financial Statements” of this Quarterly Report on Form 10-Q.
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Promissory Notes
On October 23, 2022, the Company issued a note payable to Hub International Limited for $204,050 bearing interest at the annual rate of 6.75% per annum, due September 23, 2023, payable monthly starting November 23, 2022. As of March 31, 2023, the balance of note payable due was $103,824 (December 31, 2022 - $164,729).
On December 28, 2022, the Company issued a promissory note to Hexin Global Ltd. for the principal amount of $750,000 bearing interest at the annual rate of 20% per annum, due June 28, 2023. Pursuant to the promissory note, the Company agreed to issue warrants to purchase common stock equal to $1,500,000 with the same terms as any warrants issued in the Company’s next financing round and which will be immediately exercisable. Default in the payment of principal or interest or other material covenant under the note triggers a default penalty equal to 0.666% of $750,000 per month during the period of default, and other lender rights, including the demand of immediate payment of all amounts due including accrued but unpaid interest, and recovery of all costs, fees including attorney’s fees and disbursements, and expenses relating to collection and enforcement of the promissory note. As of March 31, 2023, the balance due under this note was $750,000.
On February 2, 2023, the Company issued an unsecured promissory note to Walleye for $1,000,000 with a maturity date of May 7, 2023. The note has no interest and the principal amount shall be paid in full on the maturity date. In the event that the principal amount is not repaid in full on maturity date, the principal amount shall be increased to $1,250,000. The Company did not repay the note upon its maturity, and as of the date of this report, the principal outstanding under the note had been increased to $1,250,000.
As part of the My Health Logic acquisition, Marizyme assumed an aggregate of $468,137 in notes payable, the notes were unsecured, bore interest at a rate of 9% per annum with no maturity date. The Company settled an aggregate of $278,678 of these notes payable as part of Units Private Placement during the year ended December 31, 2022 (see “Note 7 – Convertible Promissory Notes and Warrants”, included in “Item 1. Financial Statements” of this Quarterly Report on Form 10-Q ). For the three months ended March 31, 2023, the Company accrued $13,068 in interest on the notes payable (March 31, 2022 - $6,085). As of March 31, 2023, the balance of the remaining note payable was $231,168 (December 31, 2022 - $218,100).
Changes in Capitalization
As previously reported, on August 3, 2022, the Company filed the First Certificate of Change with the Nevada Secretary of State, which provided for the First Reverse Stock Split. Pursuant to NRS Section 78.209(3), the First Certificate of Change became effective at the First Certificate of Change Effective Time. On December 30, 2022, the Company filed the Certificate of Amendment with the Nevada Secretary of State, which provided for the Authorized Capital Increase, and which became effective at the Certificate of Amendment Effective Time. On January 5, 2023, the Second Certificate of Change was filed with the Nevada Secretary of State, which provided for the Second Reverse Stock Split. Pursuant to NRS Section 78.209(3), the Second Certificate of Change became effective at the Second Certificate of Change Effective Time.
Subsequently, the Company submitted a request to FINRA to process and announce each of the First Reverse Stock Split and Second Reverse Stock Split on FINRA’s Daily List of issuer corporate actions in accordance with FINRA Rule 6490. In order to address FINRA’s issuer corporate action processing requirements, the Third Certificate of Change, Fourth Certificate of Change and Fifth Certificate of Change was each filed by the Company with the Nevada Secretary of State. These filings provided for two forward stock splits of the authorized and issued and outstanding common stock at the same ratios as the First Reverse Stock Split and Second Reverse Stock Split followed by a reverse stock split at their combined ratio. The Fifth Certificate of Change provided for the decrease of the authorized common stock from 300,000,000 to 20,000,000 and corresponding change of every fifteen (15) shares of the issued and outstanding common stock to one (1) share, and became effective at the Fifth Certificate of Change Effective Time.
As of the date of this report, FINRA had not processed the Consolidated Reverse Stock Split. Unless indicated otherwise, all share amounts, share price amounts and amounts derived from share amounts and share price amounts contained in this report do not give effect to the First Reverse Stock Split, the Second Reverse Stock Split, the First Forward Stock Split, the Second Reverse Stock Split, or the Consolidated Reverse Stock Split. See “Note Regarding Presentation of Capitalization in this Report” of this report for additional information.
Going Concern
The Company, since its inception, has incurred recurring operating losses and negative cash flows from operations and has an accumulated deficit of $88,544,017 at March 31, 2023 (December 31, 2022 - $85,989,433). Additionally, the Company has negative working capital of $6,148,031 (December 31, 2022 - $966,464) and $329,805 (December 31, 2022 - $510,865) of cash on hand, which may not be sufficient to fund operations for the next twelve months. These factors raise substantial doubt about the Company’s ability to continue as a going concern.
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The accompanying consolidated financial statements have been prepared in conformity with U.S. GAAP, which contemplate continuation of the Company as a going concern and the realization of assets and satisfaction of liabilities in the normal course of business. The ability of the Company to continue its operations is dependent on the execution of management’s plans, which include the raising of capital through the debt and/or equity markets, until such time that funds provided by operations are sufficient to fund working capital requirements. If the Company were not to continue as a going concern, it would likely not be able to realize its assets at values comparable to the carrying value or the fair value estimates reflected in the balances set out in the preparation of the consolidated financial statements.
There can be no assurances that the Company will be successful in generating additional cash from the equity/debt markets or other sources to be used for operations. The consolidated financial statements do not include any adjustments relating to the recoverability of assets and classification of assets and liabilities that might be necessary. Based on the Company’s current resources, the Company will not be able to continue to operate without additional immediate funding. Should the Company not be successful in obtaining the necessary financing to fund its operations, the Company would need to curtail certain or all operational activities and/or contemplate the sale of its assets, if necessary.
The Company has been impacted by the COVID-19 pandemic and related supply chain shortages and other economic conditions, and some of its earlier plans to further diversify its operations and expand its operating subsidiaries were delayed as a result. See “–Impact of COVID-19 Pandemic” above.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or GAAP. The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in our financial statements and accompanying notes. We evaluate these estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are more fully described in “Note 3 – Summary of Significant Accounting Policies”, included in “Item 1. Financial Statements” of this Quarterly Report on Form 10-Q, we believe that the following accounting policies are the most critical for fully understanding and evaluating our financial condition and results of operations.
Deferred Offering Cost
The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process capital stock financings as deferred offering costs until such financings are consummated. After consummation of the financing, these costs are recorded in stockholders’ equity (deficit) as a reduction of additional paid-in capital generated as a result of the offering. Should a planned equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the statements of operations. As of March 31, 2023, the Company had recorded deferred offering costs of $549,795 (December 31, 2022 - $387,412) reported as a prepaid expense on the accompanying balance sheets.
Fair Value Measurements
The Company uses the fair value hierarchy to measure the value of its financial instruments. The fair value hierarchy is based on inputs to valuation techniques that are used to measure fair value that are either observable or unobservable. Observable inputs reflect assumptions market participants would use in pricing an asset or liability based on market data obtained from independent sources, while unobservable inputs reflect a reporting entity’s pricing based upon its own market assumptions. The basis for fair value measurements for each level within the hierarchy is described below:
| ● | Level 1 – Quoted prices for identical assets or liabilities in active markets. |
| ● | Level 2 – Quoted prices for identical or similar assets and liabilities in markets that are not active; or other model-derived valuations whose inputs are directly or indirectly observable or whose significant value drivers are observable. |
| ● | Level 3 – Valuations derived from valuation techniques in which one or more significant inputs to the valuation model are unobservable and for which assumptions are used based on management estimates. |
The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value.
The carrying amounts of certain accounts and other receivables, accounts payable and accrued expenses, note payable, and amounts due to related parties approximate fair value due to the short-term nature of these instruments.
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The fair value of lease obligations is determined using discounted cash flows based on the expected amounts and timing of the cash flows discounted using a market rate of interest adjusted for appropriate credit risk.
The contingent liabilities assumed on the acquisition of Somahlution in 2020 consist of present values of royalty payments, performance warrants and pediatric voucher warrants, future rare pediatric voucher sales, and liquidation preference. Management measured these contingencies in accordance with Level 3 of the fair value hierarchy.
| i. | The performance warrants and pediatric vouchers warrants liabilities were valued using a Monte Carlo simulation model utilizing the following weighted average assumptions: risk free rate of 1.19%, expected volatility of 69.62%, expected dividend of $0, and expected life of 5.96 years. For the three months ended March 31, 2023, changes in these assumptions resulted in a $624,000 decrease in fair value of these liabilities. At March 31, 2023, the fair market value of performance warrants and pediatric vouchers warrants liabilities was $803,000 (December 31, 2022 – $1,427,000). | |
| ii. | The present value of royalty payments was measured using the scenario-based methodology. In assessing the value attributed to the royalty payments, the estimated future cash flows were discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the revenue from net sales of the product. The cash flows derived from the Company’s fifteen-year strategic plan are based on managements’ expectations of market growth, industry reports and trends, and past performances. These projections are inherently uncertain due to the evolving impact of the COVID-19 pandemic. The discounted cash flow model included projections surrounding revenue, discount rates, and growth rates. The discount rates used to calculate the present value of royalty payments reflect specific risks of the Company and market conditions and the mid-range was estimated at 20.6%. For the three months ended March 31, 2023, changes in these assumptions resulted in a $667,000 decrease in fair value of this liability. At March 31, 2023, the fair market value of royalty payments was $4,735,000 (December 31, 2022 – $5,402,000). | |
| iii. | Rare pediatric voucher sales liability was valued based on the scenario-based methodology where the estimated future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset – 20.6%. For the three months ended March 31, 2023, changes in these assumptions resulted in a $15,000 increase in fair value of this liability. At March 31, 2023, the fair market value of rare pediatric voucher sales liability was $1,070,000 (December 31, 2022 – $1,055,000). | |
| iv. | The present value of liquidation preference liability, included in the contingent consideration, was determined using the Black-Scholes option pricing method and represents the fair value of the maximum payment amount according to the agreement. The following assumptions were used in the Black-Scholes option pricing model: risk free rate of 0.21%, expected volatility of 78.93%, expected dividend of $0, and expected life of 5 years. No changes to the fair value of liquidation preference liability were recorded in the three months ended March 31, 2023. At March 31, 2023, the fair market value of liquidation preference was $1,823,000 (December 31, 2022 – $1,823,000). |
The derivative liabilities consist of optional and automatic conversion features and the share redemption feature attached to the convertible notes, issued pursuant to certain convertible promissory notes and warrants transactions (see “Note 7 – Convertible Promissory Notes and Warrants”, included in “Item 1. Financial Statements” of this Quarterly Report on Form 10-Q).
The Company has no financial assets measured at fair value on a recurring basis. None of the Company’s non-financial assets or liabilities are recorded at fair value on a non-recurring basis. No transfers between levels have occurred during the periods presented.
Marizyme measures the following financial instruments at fair value on a recurring basis. As of March 31, 2023, and December 31, 2022, the fair values of these financial instruments were as follows:
| Fair Value Hierarchy | ||||||||||||
| March 31, 2023 | Level 1 | Level 2 | Level 3 | |||||||||
| Liabilities | ||||||||||||
| Derivative liabilities | $ | - | $ | - | $ | 4,823,725 | ||||||
| Contingent liabilities | - | - | 8,431,000 | |||||||||
| Total | $ | - | $ | - | $ | 13,254,725 | ||||||
| Fair Value Hierarchy | ||||||||||||
| December 31, 2022 | Level 1 | Level 2 | Level 3 | |||||||||
| Liabilities | ||||||||||||
| Derivative liabilities | $ | - | $ | - | $ | 4,823,725 | ||||||
| Contingent liabilities | - | - | 9,707,000 | |||||||||
| Total | $ | - | $ | - | $ | 14,530,725 | ||||||
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The following table provides a roll forward of all liabilities measured at fair value using Level 3 significant unobservable inputs:
| Derivative and Contingent Liabilities | ||||
| Balance at December 31, 2022 | $ | 14,530,725 | ||
| Change in fair value of contingent liabilities | (1,276,000 | ) | ||
| Balance at March 31, 2023 | $ | 13,254,725 | ||
Research and Development Expenses and Accruals
All research and development costs are expensed in the period incurred and consist primarily of salaries, payroll taxes, and employee benefits, for individuals involved in research and development efforts, external research and development costs incurred under agreements with contract research organizations and consultants to conduct and support the Company’s ongoing clinical trials of DuraGraft, and costs related to manufacturing DuraGraft for clinical trials. The Company has entered into various research and development contracts with various organizations. Payments of these activities are based on the terms of the individual agreements which matches to the pattern of costs incurred. Payments made in advance are reflected in the accompanying balance sheets as prepaid expenses. The Company records accruals for estimated costs incurred for ongoing research and development activities. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the services, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates may be required in determining the prepaid or accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates.
Stock-Based Compensation
Stock-based compensation expense for employees and directors is recognized in the Condensed Consolidated Statements of Operations based on estimated amounts, including the grant date fair value and the expected service period. For stock options, the Company estimates the grant date fair value using a Black-Scholes valuation model, which requires the use of multiple subjective inputs including estimated future volatility, expected forfeitures and the expected term of the awards. The Company estimates the expected future volatility based on the stock’s historical price volatility. The stock’s future volatility may differ from the estimated volatility at the grant date. For restricted stock unit (“RSU”) equity awards, the Company estimates the grant date fair value using its closing stock price on the date of grant. The Company recognizes the effect of forfeitures in compensation expense when the forfeitures occur. The estimated forfeiture rates may differ from actual forfeiture rates which would affect the amount of expense recognized during the period. The Company recognizes the value of the awards over the awards’ requisite service or performance periods. The requisite service period is generally the time over which share-based awards vest.
Off-Balance Sheet Arrangements
As of March 31, 2023, the Company has no off-balance sheet arrangements that have or are reasonably likely to have a current or future material effect on its financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable.
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ITEM 4. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
Disclosure controls and procedures are defined in Rule 13a-15(e) under the Exchange Act to mean controls and other procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
At the end of the period covered by this Quarterly Report on Form 10-Q an evaluation was carried out under the supervision of and with the participation of our management, including the Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operations of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act). Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were not effective as of March 31, 2023. This conclusion was based on the material weaknesses in our internal control over financial reporting as further described below.
Material Weaknesses
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim consolidated financial statements will not be prevented or detected and corrected on a timely basis. As previously reported in the 2022 Form 10-K, management concluded that, as of such date, our disclosure controls and procedures were not effective due to material weaknesses in our internal control over financial reporting. These material weaknesses were as follows:
| ● | We did not have adequate policies and procedures in place to ensure the timely, effective review of assumptions used in measuring the fair value of certain financial instruments, and | |
| ● | We did not have sufficient resources with appropriate knowledge, experience and/or training commensurate with our financial reporting requirements to assist us in our timely and efficient preparation and review over our financial reporting. |
In connection with our preparation of our interim condensed consolidated financial statements for the three months ended March 31, 2023, we identified material weaknesses in our disclosure controls and procedures due to the material weaknesses in internal control over financial reporting related to the following:
| ● | We did not have sufficient resources with appropriate knowledge, experience and/or training commensurate with our financial reporting requirements to assist us in our timely and efficient preparation and review over our financial reporting. |
To remediate the material weakness described above, in addition the measures that management has taken as described under “Changes in Internal Control Over Financial Reporting” below, management will continue to add controls to further enhance and revise the design of the existing controls including:
| ● | Implementing reassessed design and operation of internal controls over financial reporting and reviewing procedures over the preparation of our financial statements. | |
| ● | Engaging of permanent accounting personnel and consultants to provide support during our quarterly and annual preparation, review, and reporting of our financial statements. | |
| ● | Appointing of qualified personnel to the key management roles to provide oversight and develop stronger controls, policies and procedures. | |
| ● | Maintaining adequate internal qualified personnel to properly supervise and review the information provided by the outside consulting technical experts to ensure certain significant complex transactions and technical matters were properly accounted for. |
We cannot assure you that these ongoing or planned measures in response to the material weakness in our internal control over financial reporting will be sufficient to remediate such material weakness or to avoid potential future material weaknesses.
Changes in Internal Control Over Financial Reporting
As discussed above, the management is working on remediating the material weakness in internal control over financial reporting identified above. In the three months ended March 31, 2023, the Company took the following steps in order to improve its internal controls over financial reporting:
| ● | Implemented controls around operation of internal control over financial reporting and reviewing procedures over the preparation of our financial statements such that our management believes that the Company had adequate policies and procedures in place to ensure the timely, effective review of assumptions used in measuring the fair value of certain financial instruments. |
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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. Other than the legal proceedings described below, 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.
DeVito Litigation
On June 7, 2022, Nicholas DeVito, a former Interim Chief Executive Officer and Interim Chief Financial Officer of the Company, filed a Complaint in the Circuit Court of the Fifteenth Judicial Circuit in and for Palm Beach County, Florida, Case No. 50-2022-CA-005437 (the “Florida Circuit Court”), against the Company (the “DeVito Complaint”). Under a Confidential Settlement Agreement, dated November 18, 2022 (the “Confidential Settlement Agreement”), the Company and Nicholas De Vito agreed that Mr. De Vito would dismiss a Complaint that Mr. De Vito filed on June 7, 2022 in the Circuit Court of the Fifteenth Judicial Circuit in and for Palm Beach County, Florida, Case No. 50-2022-CA-005437. The parties also agreed that following an anticipated reverse split, the Company was required to issue Mr. DeVito certain “post-split” shares to be delivered in paper certificate form within three (3) business days of the reverse split. The Confidential Settlement Agreement further provided that the delivered shares would be subject to normal and customary restrictions pursuant to Rule 144 under the Securities Act. In the event no split occurred by December 12, 2022, the Company was required to issue Mr. DeVito 240,000 “pre-split” shares. In addition, the parties agreed that no further continuous service is required pursuant to Section 2 of the Mutual Release of Claims Agreement between Mr. DeVito and the Company dated as of August 27, 2020. Pursuant to the agreement, on January 4, 2023, the Company issued 240,000 shares of common stock to Mr. DeVito.
ITEM 1A. RISK FACTORS.
There have been no material changes to the risk factors disclosed in the 2022 Form 10-K.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
During the three-month period ended March 31, 2023, we did not conduct any unregistered sales of our equity securities that were not previously disclosed in a current report on Form 8-K and we did not repurchase any of our common stock.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM 4. MINE SAFETY DISCLOSURES.
Not applicable.
ITEM 5. OTHER INFORMATION.
None.
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ITEM 6. EXHIBITS
The following exhibits are filed as part of this report or incorporated by reference:
* Filed herewith
** Furnished herewith
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| Date: May 15, 2023 | MARIZYME, INC. | |
| /s/ David Barthel | ||
| Name: | David Barthel | |
| Title: | Chief Executive Officer | |
| (Principal Executive Officer) | ||
| /s/ George Kovalyov | ||
| Name: | George Kovalyov | |
| Title: | Chief Financial Officer | |
| (Principal Accounting and Financial Officer) | ||
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